CONTRAMAL 50 mg Hard Capsules

Зміст інструкції

1. CONTRAMAL 50 mg hard capsules
   1. What is CONTRAMAL and what is it used for
   2. What you need to know before you take CONTRAMAL
   3. How to take CONTRAMAL
   4. Possible side effects
   5. How to store CONTRAMAL
   6. Contents of the pack and other information
2. CONTRAMAL 100 mg prolonged-release tablets
   1. What is CONTRAMAL and what is it used for
   2. What you need to know before you take CONTRAMAL
   3. How to take CONTRAMAL
   4. Possible side effects
   5. How to store CONTRAMAL
   6. Contents of the pack and other information
3. CONTRAMAL 100 mg/ml oral drops, solution with dropper
   1. What is CONTRAMAL and what is it used for
   2. What you need to know before you take CONTRAMAL
   3. How to use CONTRAMAL
   4. Possible side effects
   5. How to store CONTRAMAL
   6. Package contents and other information
4. CONTRAMAL 100 mg/ml oral solution with dropper
   1. What is CONTRAMAL and what is it used for
   2. What you need to know before you take CONTRAMAL
   3. How to take CONTRAMAL
   4. Possible side effects
   5. How to store CONTRAMAL
   6. Package contents and other information
5. CONTRAMAL 150 mg prolonged-release tablets, 200 mg prolonged-release tablets
   1. What is CONTRAMAL and what is it used for
   2. What you need to know before you take CONTRAMAL prolonged-release tablets.
   3. How to use CONTRAMAL
   4. Possible side effects
   5. How to store CONTRAMAL
   6. Package contents and other information
6. CONTRAMAL 50 mg /1 ml injectable solution, 100 mg /2 ml injectable solution
   1. What is CONTRAMAL and what is it used for
   2. What you need to know before you take CONTRAMAL
   3. How to use CONTRAMAL
   4. Possible side effects
   5. How to store CONTRAMAL
   6. Contents of the pack and other information

CONTRAMAL 50 mg hard capsules

Tramadol hydrochloride
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet

• 1. What CONTRAMAL is and what it is used for.
• 2. What you need to know before you take CONTRAMAL
• 3. How to take CONTRAMAL
• 4. Possible side effects
• 5. How to store CONTRAMAL
• 6. Contents of the pack and other information

1. What is CONTRAMAL and what is it used for

Tramadol – the active ingredient of Contramal is an analgesic (against pain) that derives from the
opioid class, it acts at the level of the central nervous system. It reduces pain by acting on
specific nerve cells in the spinal cord and brain.
Contramal is used for the treatment of moderate to severe pain, of various types and causes,
as well as for pain caused by diagnostic and surgical procedures.

2. What you need to know before you take CONTRAMAL

Do not take CONTRAMAL

• if you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6)
• in acute alcohol poisoning, sleeping pills, painkillers or other psychotropic drugs (drugs that affect mood and emotions)
• if you are also taking MAO inhibitors (some drugs used to treat depression) or if you have taken them within the last 14 days before treatment with Contramal (see “Other medicines and Contramal”)
• if you have epilepsy and your seizures are not adequately controlled by therapy
• as a substitute in detoxification therapy from drugs.

Warnings and precautions
Talk to your doctor or pharmacist before taking Contramal,

• if you think you are taking too many other pain relievers (opioids)
• if you suffer from loss of consciousness (if you feel faint)
• if you are in a state of shock (cold sweats may be a sign)
• if you have increased pressure in the brain (possible after a head injury or brain disease)
• if you have difficulty breathing
• if you are prone to epilepsy or seizures, as the risk of a seizure may increase
• if you suffer from liver or kidney disease.
• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Contramal”). There is a slight risk that you may develop so-called serotonin syndrome, which can occur after taking tramadol together with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Sleep-related breathing disorders
Contramal contains an active ingredient that belongs to the group of opioids. Opioids
can cause sleep-related breathing disorders, such as central sleep apnea (shallow/pauses in breathing during sleep) and sleep-related hypoxemia
(low blood oxygen levels).
The risk of central sleep apnea occurring depends on the dose of opioids. Your doctor may
consider reducing the total opioid dosage if central sleep apnea occurs.
Seizures have been reported in patients taking tramadol at the recommended dosages.
The risk may increase when tramadol dosages exceed those
recommended, beyond the daily limit of 400 mg.
Contramal can lead to physical and psychological dependence. When Contramal is administered for
a long period, its effect may decrease, therefore higher doses must be administered (development of tolerance). In patients with a tendency to abuse medicines or who are
dependent on medicines, Contramal should be taken for short periods and under strict medical control.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation
of this enzyme, which may have different effects on them. Some people may not
get enough pain relief, but others may experience serious
side effects. If you notice any of the following side effects, you should stop taking
this medicine and consult your doctor immediately: slowed or shallow breathing,
confusion, drowsiness, constricted pupils, feeling unwell or sick, constipation, loss of
appetite.
Talk to your doctor if you notice any of the following symptoms while taking
CONTRAMAL:
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or
low blood pressure. These symptoms may be indicative of adrenal insufficiency
(low levels of cortisol). If you experience these symptoms, contact your doctor, who will decide if
you need hormone replacement.

Children and adolescents
Use in children with respiratory problems
Tramadol is not recommended in children with respiratory problems, as the symptoms of tramadol toxicity may be worse in these children.

Other medicines and Contramal
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Contramal should not be taken together with MAO inhibitors (some medicines used for
depression).
The intensity and duration of the analgesic effect of Contramal may be reduced if you are taking
medicines that contain

• carbamazepine (for epilepsy)
• ondansetron (to prevent nausea). Your doctor will tell you if and what dosages of Contramal you should take.

The risk of side effects increases if you are taking:

• other painkillers such as morphine and codeine (even when taken for cough) and alcohol together with Contramal. You may feel sleepy or faint. In these cases, consult your doctor.
• the concomitant use of Contramal and sedatives or sleeping pills (e.g. benzodiazepines) increases the risk of sedation, breathing difficulties (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other types of treatment are not possible. However, if your doctor prescribes Contramal together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell them about all the sedatives you are taking and carefully follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives about the signs and symptoms above. Contact your doctor when these symptoms occur.
• medicines that can cause seizures (seizures), such as some antidepressants or antipsychotics. The risk of having a seizure may increase if you take Contramal at the same time. Your doctor will tell you if Contramal is right for you.
• certain antidepressants. Contramal may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• coumarin anticoagulants (medicines that thin the blood), such as warfarin, together with Contramal. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Contramal with food and alcohol
Do not drink alcohol during treatment with Contramal, as its effect may be
increased.
Food intake does not affect the effect of Contramal.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information regarding the safety of tramadol in pregnant women.
Therefore, if you are pregnant, you should not use Contramal capsules.
Chronic use during pregnancy may lead to withdrawal symptoms in newborns.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Contramal more
than once during breastfeeding or, alternatively, if you take Contramal more than once, you should
stop breastfeeding.
There is limited data on the effects of Contramal on fertility.

Driving and operating machinery
Contramal can cause drowsiness, dizziness and vision problems (blurred vision). If you feel that your
ability to react is affected, do not drive machines or other vehicles, do not use machinery or
tools that require a secure hold.

Contramal capsules contains less than 1 mmol (23 mg) of sodium, i.e. essentially “sodium-free”

3. How to take CONTRAMAL

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The dosage must be chosen based on the intensity of the pain and your personal sensitivity to
pain. In general, you should take the lowest dose that reduces the pain. Do not take more than 400
mg (8 capsules) of Contramal per day, unless your doctor has given you different instructions.
Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents over 12 years of age:
one or two capsules (equivalent to 50 or 100 mg of tramadol hydrochloride) every 4 – 6 hours.

Use in children and adolescents
Contramal 50 mg capsules are not recommended for children under 12 years of age.

Elderly patients
In elderly people (over 75 years of age) the elimination of tramadol may be delayed. If this is the case,
your doctor may advise you to extend the time interval between doses.

Patients with severe hepatic or renal insufficiency / dialysis
Patients with severe hepatic and/or renal insufficiency should not take Contramal. In case of
mild or moderate insufficiency, your doctor may advise you to extend the time interval between
doses.

How and when to take Contramal
Contramal 50 mg capsules are for oral use. Swallow the capsules whole, not divided or chewed with
a sufficient amount of liquid, preferably in the morning and evening. You can take the
capsules both during or away from meals.

For how long to take Contramal
You should not take Contramal for longer than necessary. If you need to continue the
treatment for a long period, your doctor will subject you to checks at short and regular intervals
(if necessary temporarily interrupting therapy) to establish whether you should continue the
treatment and with what dose.
If you feel that the analgesic effect of Contramal is too strong or too weak, consult your
doctor or pharmacist.

If you take more Contramal than you should
If you have accidentally taken an extra dose, it should not have any negative effects. You can
continue to take the medicine as prescribed.
After taking very high doses, the following may occur: pinpoint pupils, vomiting, drop in
blood pressure, rapid heartbeat, collapse, disturbances of consciousness up to coma
(profound unconsciousness), seizures, and difficulty breathing up to respiratory arrest. In
these cases, call your doctor immediately.

If you forget to take Contramal
If you forget to take Contramal, the pain is likely to return. Do not double the dose
to compensate for forgetting a single dose, simply continue to take the
capsules as before.

If you stop taking Contramal
If you stop or end the treatment too early, the pain is likely to return.
If you want to stop treatment due to unwanted effects, consult your doctor.
You should not suddenly stop taking this medicine, unless prescribed by your doctor. If you intend to stop taking the medicine, talk to your
doctor first, especially if you have been taking it for a long time. The doctor will advise you when and how
to stop it. This may happen by gradually decreasing the dose to reduce the likelihood of
developing unnecessary side effects (withdrawal symptoms).
Generally, when the treatment with Contramal is terminated, no withdrawal effects occur.
However, in rare cases, some people who have taken Contramal for a certain period of time,
when they suddenly stop taking it may not feel well.
Indeed they may

• feel restless, anxious, nervous or weak
• be hyperactive, have difficulty sleeping or have stomach or intestinal disorders
• have panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and ringing in the ears (tinnitus)
• have other unusual rare CNS symptoms such as confusion, delusion, alteration of the perception of one's own personality (depersonalization) and changes in the perception of reality (derealization) and sense of persecution (paranoia). If you experience any of these symptoms after stopping Contramal, consult your doctor.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience symptoms of an allergic reaction such as:

• swelling of the face, tongue and/or throat
• difficulty swallowing
• urticaria (hives)
• difficulty breathing.

Other possible side effects are:
Very common (may affect more than 1 in 10 people)

• nausea
• dizziness

Common (may affect up to 1 in 10 people)

• headache, drowsiness
• vomiting, constipation, dry mouth
• sweating (hyperhidrosis)
• fatigue

Uncommon (may affect up to 1 in 100 people)

• effects on the heart and blood circulation (palpitations, fast heartbeat, feeling faint or collapse). These side effects may occur particularly in patients in an upright position or during physical exertion
• urge to vomit (nausea), stomach pain (feeling of pressure in the stomach, bloating), diarrhoea
• skin reactions (itching, rash)

Rare (may affect up to 1 in 1,000 people)

• allergic reactions (e.g. difficulty breathing, shortness of breath, skin swelling) and shock (circulatory failure)
• slow heartbeat
• increased blood pressure
• abnormal sensations (e.g. tingling, itching, numbness), tremor, slow breathing, seizures, muscle spasms, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders
• seizures have occurred especially with high doses of tramadol or when tramadol was taken together with other medicines that can cause seizures
• changes in appetite
• hallucinations, confused state, sleep disturbances, delirium, anxiety and nightmares.
• Psychological symptoms may occur after treatment with Contramal, of varying nature and intensity depending on the patient's personality and the duration of therapy. These may manifest as a change in mood (especially good mood, in some cases irritated mood), changes in activity (usually decrease or repression, sometimes an increase) and decreased cognitive and sensory perception (changes in the senses and the ability to recognize emotions, which can lead to errors in judgment)
• drug dependence. When treatment is stopped abruptly, withdrawal symptoms may occur (see “If you stop taking Contramal”)
• visual disturbances, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis)
• slow breathing, shortness of breath (dyspnea). If you exceed the recommended doses, or if you are also taking medicines that reduce brain function at the same time, breathing may be slower
• worsening of asthma, however, it has not been established whether this may have been caused by tramadol
• muscle weakness
• difficulty or pain when urinating, reduced amount of urine (dysuria)

Very rare (may affect up to 1 in 10,000 people)

• increased liver enzyme values

Frequency not known (the frequency cannot be estimated from the available data)

• decrease in blood sugar levels
• hiccups
• serotonin syndrome, which can manifest as a change in mental status (for example agitation, hallucinations, coma) and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (for example nausea, vomiting, diarrhoea) (see section 2 “What you need to know before you take Contramal”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at the address: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store CONTRAMAL

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date which is stated on the package and on the blister. The
expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Contramal contains
The active ingredient is tramadol hydrochloride.
Each capsule contains 50 mg of tramadol hydrochloride.
The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal
anhydrous silica, magnesium stearate; the capsule shell contains gelatin, yellow iron
oxide (E172), titanium dioxide (E171).

Description of the appearance of Contramal 50 mg hard capsules and pack contents

Hard capsules,shiny and oblong in yellow color
The pack contains 20 hard capsules

Marketing Authorisation Holder
GRÜNENTHAL ITALIA S.r.l. – Via Carlo Bo, 11 – 20143 Milano

Manufacturer responsible for batch release
FARMACEUTICI FORMENTI S.p.A. – Via Di Vittorio, 2 – 21040 Origgio (VA)
GRÜNENTHAL GmbH, Aachen (Germany)

CONTRAMAL 100 mg prolonged-release tablets

Tramadol hydrochloride
Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet

• 1. What CONTRAMAL is and what it is used for
• 2. What you need to know before you take CONTRAMAL
• 3. How to take CONTRAMAL
• 4. Possible side effects
• 5. How to store CONTRAMAL
• 6. Contents of the pack and other information

1. What is CONTRAMAL and what is it used for

Tramadol – the active ingredient of Contramal 100 mg prolonged-release tablets - is an
analgesic (against pain) derived from the opioid class, it acts at the level of the central
nervous system. It reduces pain by acting on specific nerve cells of the spinal cord and the
brain.
Contramal is used for the treatment of moderate to severe pain, of various types and causes,
as well as for pain caused by diagnostic and surgical procedures.

2. What you need to know before you take CONTRAMAL

Do not take Contramal

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6)
• in acute alcohol poisoning, sleeping pills, painkillers or other psychotropic drugs (drugs that affect mood and emotions)
• if you are also taking MAO inhibitors (some medicines used to treat depression) or if you have taken them within the last 14 days before treatment with Contramal (see “Other medicines and Contramal”)
• if you are epileptic and your seizures are not sufficiently controlled by therapy
• as a substitute in detoxification therapy from drugs.

Warnings and precautions
Talk to your doctor or pharmacist before taking Contramal,

• if you think you are using too many other pain relievers (opioids)
• if you suffer from disorders of consciousness (if you feel faint)
• if you are in a state of shock (cold sweats may be a sign of it)
• if you have increased pressure in the brain (possible after a head injury or brain diseases)
• if you have difficulty breathing
• if you are prone to epilepsy or seizures, as the risk of an attack may increase
• if you suffer from liver or kidney diseases.
• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Contramal”). There is a slight risk that you may develop the so-called serotonin syndrome, which can occur after taking tramadol together with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Breathing-related sleep disorders
Contramal contains an active ingredient that belongs to the group of opioids. Opioids
can cause breathing-related sleep disorders, such as central sleep apnea (shallow/pauses in breathing during sleep) and sleep-related hypoxemia
(low oxygen levels in the blood).
The risk of central sleep apnea occurring depends on the dose of opioids. Your doctor may
consider reducing the total opioid dosage if central sleep apnea occurs.
Seizures have been reported in patients taking tramadol at the
recommended dosages. The risk may increase when tramadol dosages exceed those
recommended, beyond the daily limit of 400 mg.
Contramal can lead to physical and psychological dependence. When Contramal is administered for
a long period, its effect may decrease, therefore higher doses must be administered (development of tolerance). In patients with a tendency to abuse medicines or who are
dependent on medicines, Contramal must be taken for short periods and under strict medical
control.
Tell your doctor if any of these problems occur during treatment with Contramal or have occurred in the past.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation
of this enzyme, which may have different effects on them. Some people may not
get enough pain relief, but others may experience serious
side effects. If you notice any of the following side effects, you should stop taking
this medicine and consult your doctor immediately: slowed or shallow breathing,
confusion, drowsiness, constricted pupils, feeling unwell or sick, constipation, loss of
appetite.
Talk to your doctor if you notice any of the following symptoms while taking
CONTRAMAL:
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or
low blood pressure. These symptoms may be indicative of adrenal insufficiency
(low levels of cortisol). If you experience these symptoms, contact your doctor, who will decide if
you need hormone replacement therapy.

Children and adolescents
Use in children with breathing problems
Tramadol is not recommended in children with breathing problems, as the
symptoms of tramadol toxicity may be worse in these children.

Other medicines and Contramal
Tell your doctor or pharmacist if you are taking or have recently taken or might
take any other medicines.
Contramal should not be taken together with MAO inhibitors (some medicines used for
depression).
The intensity and duration of the analgesic effect of Contramal may be reduced if you are taking
medicines that contain

• carbamazepine (for seizures)
• ondansetron (to prevent nausea). Your doctor will tell you if or what dosages of Contramal you should take.

The risk of side effects increases if you are taking:

• other painkillers such as morphine and codeine (even when taken for coughs), and alcohol together with Contramal. You may feel sleepy or weak. In these cases, consult your doctor.
• the concomitant use of Contramal and sedatives or sleeping pills (e.g. benzodiazepines) increases the risk of sedation, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when other types of treatment are not possible. However, if your doctor prescribes Contramal together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell them about all the sedatives you are taking and carefully follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives about the signs and symptoms mentioned above. Contact your doctor when these symptoms occur.
• medicines that can cause seizures (attacks), such as some antidepressants or antipsychotics. The risk of having a seizure may increase if you take Contramal at the same time. Your doctor will tell you if Contramal is suitable for you
• certain antidepressants. Contramal may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• if you are taking coumarin anticoagulants (medicines that thin the blood), such as warfarin, together with Contramal. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Contramal with food, drinks and alcohol
Do not drink alcohol during treatment with Contramal, as its effect may be
increased.
Taking food does not affect the effect of Contramal.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information regarding the safety of tramadol in pregnant women.
Therefore, if you are pregnant, you should not use Contramal. Chronic use during pregnancy may
lead to withdrawal symptoms in newborns.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Contramal more
than once during breastfeeding or, alternatively, if you take Contramal more than once, you should
stop breastfeeding.
There is limited data on the effects of Contramal on fertility.

Driving and operating machinery
Contramal can cause drowsiness, dizziness and vision problems (blurred vision). If you feel that
your ability to react is affected, do not drive machines or other vehicles, do not use machinery
that requires a secure support.

Contramal 100 mg prolonged-release tablets contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.

3. How to take CONTRAMAL

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage must be chosen based on the intensity of the pain and your personal sensitivity to
pain. In general, you should take the lowest dose that reduces the pain. Do not take more than 400
mg of tramadol hydrochloride per day, unless your doctor has given you different instructions.
Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents over 12 years of age:
One Contramal 100 mg prolonged-release tablet twice a day (equivalent to 200
mg of tramadol hydrochloride per day), preferably in the morning and evening.
Your doctor may prescribe a more appropriate dosage of Contramal, if necessary.

Children
Contramal 100 mg prolonged-release tablets are not recommended for children under
12 years of age.

Elderly patients
In elderly people (over 75 years of age), the elimination of tramadol may be delayed. If this
is the case, your doctor may advise you to extend the time interval between doses.

Patients with severe hepatic or renal insufficiency / dialysis
Patients with severe hepatic and/or renal insufficiency should not take Contramal. In case of
mild or moderate insufficiency, your doctor may advise you to extend the time interval between
doses.

How and when to take Contramal 100 mg prolonged-release tablets
Contramal 100 mg prolonged-release tablets are for oral use.
Swallow the tablets whole, do not divide or chew them with a sufficient amount of liquid,
preferably in the morning or evening. You can take the tablets both during or away from
meals.

For how long should you take Contramal
You should not take Contramal for longer than necessary. If you need to continue the
treatment for a long period, your doctor will subject you to checks at short and regular
intervals (if necessary temporarily interrupting therapy) to establish whether you should continue the
treatment and with what dose.
If you feel that the analgesic effect of Contramal is too strong or too weak, consult your
doctor or pharmacist.

If you take more Contramal than you should
If you have accidentally taken an extra dose, it should not have any negative effects. You can
continue to take the medicine as prescribed.
After taking very high doses, the following may occur: pinpoint pupils, vomiting, drop in
blood pressure, rapid heartbeat, collapse, disturbances of consciousness up to coma
(profound unconsciousness), seizures, and difficulty breathing up to respiratory arrest. In
these cases, call your doctor immediately.

If you forget to take Contramal
If you forget to take Contramal, the pain is likely to return. Do not double the dose
to compensate for this forgetfulness, simply continue to take the tablets as
before.

If you stop the treatment with Contramal
If you stop or end the treatment too early, the pain is likely to return.
If you want to stop the treatment due to unwanted effects, consult your doctor.
You should not suddenly stop taking this medicine, unless prescribed by your doctor. If you intend to stop taking the medicine, talk to your
doctor first, especially if you have been taking it for a long time. The doctor will advise you when and how
to stop it. This may involve gradually decreasing the dose to reduce the likelihood of
developing unnecessary side effects (withdrawal symptoms).
Generally, when the treatment with Contramal is stopped, no withdrawal effects occur.
However, in rare cases, some people who have taken Contramal for a certain period of time,
when they suddenly stop taking it may not feel well.
Indeed they may

• feel agitated, anxious, nervous or weak
• be hyperactive, have difficulty sleeping or have stomach or intestinal disorders
• have panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and ringing in the ears (tinnitus)
• have other unusual rare CNS symptoms such as confusion, delusion, alteration of the perception of one's own personality (depersonalization) and changes in the perception of reality (derealization) and a sense of persecution (paranoia). If you experience any of these symptoms after stopping Contramal, consult your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience symptoms of an allergic reaction such as

• swelling of the face, tongue and/or throat
• difficulty swallowing
• urticaria (hives)
• difficulty breathing.

Other possible side effects are:
Very common (may affect more than 1 in 10 people)

• nausea
• dizziness

Common (may affect up to 1 in 10 people)

• headache, drowsiness
• vomiting, constipation, dry mouth
• sweating (hyperhidrosis)
• fatigue

Uncommon (may affect up to 1 in 100 people)

• effects on the heart and blood circulation (palpitations, fast heartbeat, feeling faint or collapse). These side effects may occur particularly in patients when standing up or during physical exertion
• need to vomit (nausea), stomach pain (feeling of pressure in the stomach, bloating), diarrhoea
• skin reactions (itching, rash)

Rare (may affect up to 1 in 1,000 people)

• allergic reactions (e.g. difficulty breathing, shortness of breath, skin swelling) and shock (circulatory failure)
• slow heartbeat
• increased blood pressure
• abnormal sensations (e.g. tingling, itching, numbness), tremor, slow breathing, seizures, muscle spasms, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders.
• Seizures have occurred especially with high doses of tramadol or when tramadol was taken together with other medicines that can cause seizures
• changes in appetite
• hallucinations, confusion, sleep disturbances, delirium, anxiety and nightmares.
• Psychological symptoms may occur after treatment with Contramal, of varying nature and intensity depending on the patient's personality and the duration of therapy. These may manifest as a change in mood (especially good mood, in some cases irritated mood), changes in activity (usually decrease or repression, sometimes an increase) and decreased cognitive and sensory perception (changes in the senses and the ability to emotional recognition, which can lead to errors in judgment).
• drug dependence. When treatment is stopped abruptly, withdrawal symptoms may occur (see “If you stop taking Contramal”)
• visual disturbances, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis).
• slow breathing, shortness of breath (dyspnoea). If the recommended doses are exceeded, or if medicines that reduce brain function are also taken at the same time, breathing may be slower
• worsening of asthma, however, it has not been established whether this was caused by tramadol
• muscle weakness
• difficulty or pain when urinating, reduced amount of urine (dysuria)

Very rare (may affect up to 1 in 10,000 people)

• increased liver enzyme values

Frequency not known (the frequency cannot be estimated from the available data)

• decreased blood sugar level
• hiccups
• serotonin syndrome, which can manifest as a change in mental status (for example agitation, hallucinations, coma) and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (for example nausea, vomiting, diarrhoea) (see section 2 “What you need to know before you take Contramal”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at the address: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store CONTRAMAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister. The
expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Contramal contains
The active ingredient is tramadol hydrochloride.
Each tablet contains 100 mg of tramadol hydrochloride.
The other ingredients are: core:microcrystalline cellulose, hypromellose 100,000 mPa S, anhydrous colloidal silica,
magnesium stearate; coating:hypromellose 6 mPa s, lactose monohydrate
(see section 2 “Contramal 100 mg prolonged-release tablets contains lactose”),
macrogol 6000, propylene glycol, talc, titanium dioxide (E171).

Description of the appearance of Contramal 100 mg prolonged-release tablets and pack contents
White, round tablets with the letters T1 and the logo  imprinted on them.
The pack contains 20 prolonged-release tablets

Marketing Authorisation Holder
GRÜNENTHAL ITALIA S.r.l. – Via Carlo Bo, 11 – 20143 Milan

Manufacturer responsible for batch release
GRÜNENTHAL GmbH – Zieglerstrasse 6 – Aachen (Germany)
FARMACEUTICI FORMENTI S.p.A - via Di Vittorio 2 - Origgio (Varese)

This leaflet was last updated on:

CONTRAMAL 100 mg/ml oral drops, solution with dropper

Tramadol hydrochloride
10 ml bottle with dropper
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people even if their symptoms are the same as yours because it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet

• 1. What CONTRAMAL is and what it is used for
• 2. What you need to know before you use CONTRAMAL
• 3. How to use CONTRAMAL
• 4. Possible side effects
• 5. How to store CONTRAMAL
• 6. Contents of the pack and other information

1. What is CONTRAMAL and what is it used for

Tramadol – the active ingredient of Contramal– is an analgesic (against pain) that derives from the
opioid class, it acts at the level of the central nervous system. It reduces pain by acting on
specific nerve cells in the spinal cord and the brain.
Contramal is used for the treatment of moderate to severe pain, of various types and causes,
as well as for pain caused by diagnostic and surgical procedures.

2. What you need to know before you take CONTRAMAL

Do not take Contramal dropper solution:

• if you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6)
• in acute alcohol poisoning, sleeping pills, painkillers or other psychotropic drugs (drugs that affect mood and emotions)
• if you are also taking MAO inhibitors (some drugs used to treat depression) or if you have taken them in the last 14 days before treatment with Contramal (see “Other medicines and Contramal”)
• if you have epilepsy and your seizures are not sufficiently controlled by therapy
• as a substitute in drug detoxification therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Contramal:

• if you think you are using other painkillers (opioids) excessively
• if you suffer from disorders of consciousness (if you feel faint)
• if you are in a state of shock (cold sweats may be a sign of it)
• if you have increased pressure in the brain (possible after a head injury or brain disease)
• if you have difficulty breathing
• if you are prone to epilepsy or seizures as the risk of an attack may increase
• if you suffer from liver or kidney disease.
• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Contramal”). There is a slight risk that you may develop the so-called serotonin syndrome, which can occur after taking tramadol together with certain antidepressants or tramadol as monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Sleep-related breathing disorders
Contramal contains an active ingredient that belongs to the group of opioids. Opioids
can cause sleep-related breathing disorders, such as central sleep apnea (shallow/pauses in breathing during sleep) and sleep-related hypoxemia
(low oxygen levels in the blood).
The risk of central sleep apnea occurring depends on the dose of opioids. The doctor may
consider reducing the total opioid dosage in case of central sleep apnea.
Seizures have been reported in patients taking tramadol at the recommended dosages.
The risk may increase when tramadol dosages exceed those
recommended, beyond the daily limit dose of 400 mg.
Contramal can lead to physical and psychological dependence. When Contramal is administered for
a long period, its effect may decrease, therefore higher doses must be administered (development of tolerance). In patients with a tendency to abuse medicines or who are
dependent on medicines, Contramal must be taken for short periods and under strict medical control.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation
of this enzyme, which may have different effects on them. Some people may not
get enough pain relief, but others may experience serious
side effects. If you notice any of the following side effects, you should stop taking
this medicine and consult your doctor immediately: slowed or shallow breathing,
confusion, drowsiness, constricted pupils, feeling unwell or sick, constipation, loss of
appetite.
Talk to your doctor if you notice any of the following symptoms while taking
CONTRAMAL:
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or
low blood pressure. These symptoms may be indicative of adrenal insufficiency
(low levels of cortisol). If you experience these symptoms, contact your doctor, who will decide if
you need hormone replacement.

Other medicines and Contramal
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Contramal must not be taken together with MAO inhibitors (some medicines used for
depression).

• carbamazepine (for epileptic seizures)
• ondansetron (to prevent nausea). Your doctor will tell you whether or which doses of Contramal you should take.

The risk of side effects increases if you are taking:

• other painkillers such as morphine and codeine (even when taken for cough), and alcohol together with Contramal. You may feel sleepy or weak. In these cases, consult your doctor
• the concomitant use of Contramal and sedatives or sleeping pills (e.g. benzodiazepines) increases the risk of sedation, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other types of treatment are not possible. However, if your doctor prescribes Contramal together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell him about all the sedatives you are taking and carefully follow the dosage recommendations provided by the doctor. It may be helpful to inform friends or relatives about the signs and symptoms mentioned above. Contact your doctor when these symptoms occur.
• The concomitant use of Contramal and sedatives or sleeping pills (e.g. benzodiazepines) increases the risk of sedation, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other types of treatment are not possible. However, if your doctor prescribes Contramal together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell him about all the sedatives you are taking and carefully follow the dosage recommendations provided by the doctor. It may be helpful to inform friends or relatives about the signs and symptoms mentioned above. Contact your doctor when these symptoms occur.
• medicines that can cause seizures (attacks), such as some antidepressants or antipsychotics. The risk of having an attack may increase if you take Contramal at the same time. Your doctor will tell you if Contramal is suitable for you.
• certain antidepressants, Contramal may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• coumarin anticoagulants (medicines that thin the blood), such as warfarin, together with Contramal. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Children and adolescents
Use in children with breathing problems
Tramadol is not recommended in children with breathing problems, as the
symptoms of tramadol toxicity may be worse in these children.

Contramal with food, drinks and alcohol
Do not drink alcohol during treatment with Contramal, as its effect may be
increased.
Food intake does not affect the effect of Contramal.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information on the safety of tramadol in pregnant women.
Therefore, if you are pregnant, you should not take Contramal oral drops solution with dropper.
Chronic use during pregnancy may lead to withdrawal symptoms in newborns.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Contramal more
than once during breastfeeding or, alternatively, if you take Contramal more than once, you should
stop breastfeeding.
There is limited data on the effects of Contramal on fertility.

Driving and operating machinery
Contramal can cause drowsiness, dizziness and vision problems (blurred vision). If you feel that your
ability to react is affected, do not drive machines or other vehicles, do not use machinery or
tools that require a secure support.

Contramal 100 mg/ml oral drops solution contains sucrose, macrogolglycerol
hydroxystearate, propylene glycol and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine because Contramal 100 mg/ml oral drops solution with dropper contains
sucrose.
If Contramal oral drops solution with dropper is used for chronic use (for example
for two weeks or more) it may be harmful to your teeth.
Contramal 100 mg/ml oral drops solution contains macrogolglycerol
hydroxystearate, a castor oil derivative that can cause stomach upset and diarrhea.
Contramal 100 mg/ml oral drops solution contains 150 mg of propylene glycol per ml
Contramal 100 mg/ml oral drops solution contains less than 1 mmol (23 mg) of sodium per ml,
i.e. essentially “sodium-free”.

3. How to use CONTRAMAL

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, ask your doctor or pharmacist.
The dosage must be chosen based on the intensity of the pain and your personal sensitivity to
pain. In general, you should take the lowest dose that reduces the pain. Do not take more than 160
drops per day (for example, 8 doses of 20 drops each) (equivalent to 400 mg of tramadol
hydrochloride) unless your doctor has given you different instructions. Unless otherwise prescribed
by your doctor, the usual dose is:

Adults and adolescents over 12 years of age:
20 to 40 drops (equivalent to 50 mg or 100 mg of tramadol hydrochloride), every 4-6 hours.

Use in children over 1 year of age
In children over 1 year of age, the single dose is 4-8 drops per 10 kg of weight (1-2 mg of
tramadol hydrochloride per each kg of body weight). For more detailed information on dosage
You should take the lowest dose that reduces the pain. Daily doses should not exceed
8 mg of active substance per kg of body weight or 400 mg of active substance.

For use in children, it is recommended to use Contramal oral drops solution with

droppers instead of the Contramal oral solution with a 30 ml dispenser, to

allow for precise dosing based on the child's body weight.

Elderly patients
In elderly people (over 75 years of age), the elimination of tramadol may be delayed. If this
is the case, your doctor may advise you to extend the time interval between doses.

Patients with severe hepatic or renal insufficiency / dialysis
Patients with severe hepatic and/or renal insufficiency should not take Contramal. In case of
mild or moderate insufficiency, your doctor may advise you to extend the time interval between
doses.

How and when to take Contramal
Take Contramal 100 mg/ml oral drops solution with droppers with a sugar or a
little liquid.
For information on how to use the dropper, read the information at the end of the leaflet.
Taking food does not affect the effect of Contramal.

For how long should you take Contramal
Do not take Contramal for longer than necessary. If you need to continue treatment for
a long period, your doctor will subject you to checks at short and regular intervals (if necessary
temporarily interrupting therapy) to establish whether you should continue treatment and
with what dose.
If you feel that the analgesic effect of Contramal is too strong or too weak, consult your
doctor or pharmacist.

If you take more Contramal than you should
If you have accidentally taken an extra dose, it should not have any negative effects. You can
continue to take the medicine as prescribed.
After taking very high doses, the following may occur: pinpoint pupils, vomiting, drop in
blood pressure, fast heartbeat, collapse, disturbances of consciousness up to coma
(deep unconsciousness), seizures, and difficulty breathing up to respiratory arrest. In
these cases, call your doctor immediately.

If you forget to take Contramal
If you forget to take the oral solution, the pain is likely to return. Do not double the
dose to make up for this forgetfulness, simply continue to take the medicine
as before.

If you stop taking Contramal
If you stop or end treatment too early, the pain is likely to return.
If you wish to stop treatment due to side effects, consult your doctor.
You should not suddenly stop taking this medicine unless your doctor prescribes it. If you intend to stop taking the medicine, talk to your
doctor first, especially if you have been taking it for a long time. The doctor will advise you when and how
to stop it. This may involve gradually reducing the dose to reduce the likelihood of
developing unnecessary side effects (withdrawal symptoms).
Generally, when treatment with Contramal is stopped, no withdrawal effects occur.
However, in rare cases, some people who have taken Contramal for a certain period of time,
when they suddenly stop taking it, may not feel well.
In fact, they may:

• feel agitated, anxious, nervous or weak
• be hyperactive, have difficulty sleeping or have stomach or intestinal problems
• have panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and ringing in the ears (tinnitus)
• have other rare CNS symptoms such as confusion, delusion, alteration of perception of one's personality (depersonalization) and changes in perception of reality (derealization) and a sense of persecution (paranoia). If you experience any of these symptoms after stopping therapy with Contramal, consult your doctor.

If you experience any of these symptoms after stopping Contramal, contact
your doctor
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience symptoms of an allergic reaction such as:

• swelling of the face, tongue and/or throat
• difficulty swallowing
• urticaria (hives)
• difficulty breathing.

Other possible side effects are:
Very common (may affect more than 1 in 10 people)

• nausea
• dizziness

Common (may affect up to 1 in 10 people)

• headache, drowsiness
• vomiting, constipation, dry mouth
• sweating (hyperhidrosis)
• fatigue

Uncommon (may affect up to 1 in 100 people)

• effects on the heart and blood circulation (palpitations, fast heartbeat, feeling of fainting or collapse). These side effects can occur particularly in patients in an upright position or during physical exertion
• urge to vomit (nausea), stomach pain (feeling of pressure in the stomach, bloating), diarrhea
• skin reactions (itching, rash)

Rare (may affect up to 1 in 1000 people)

• allergic reactions (e.g. difficulty breathing, shortness of breath, skin swelling) and shock (circulatory failure)
• slow heartbeat
• increased blood pressure
• abnormal sensations (e.g. tingling, itching, numbness), tremor, slow breathing, seizures, muscle spasms, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders
• seizures have occurred especially with high doses of tramadol or when tramadol was taken together with other medicines that can cause seizures
• changes in appetite
• hallucinations, confused state, sleep disturbances, delirium, anxiety and nightmares.
• Psychological symptoms may occur after treatment with Contramal, of varying nature and intensity depending on the patient's personality and the duration of therapy. These can manifest as a change in mood (especially good mood, in some cases irritated mood), changes in activity (usually decrease or repression, sometimes an increase) and decreased cognitive and sensory perception (changes in the senses and the ability to recognize emotions, which can lead to errors in judgment)
• drug dependence. When treatment is stopped abruptly, withdrawal symptoms may occur (see “If you stop taking Contramal”).
• visual disturbances, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis)
• slow breathing, shortness of breath (dyspnea). If the recommended doses are exceeded, or if medicines that reduce brain function are taken at the same time, breathing may be slower
• worsening of asthma, however, it has not been established whether this was caused by tramadol
• muscle weakness
• difficulty or pain when urinating, reduced urine output (dysuria)

Very rare (may affect up to 1 in 10000 people)

• increased liver enzyme values

Frequency not known (the frequency cannot be estimated from the available data)

• decrease in blood sugar levels
• hiccups
• serotonin syndrome, which can manifest as a change in mental state (for example, agitation, hallucinations, coma) and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (for example, nausea, vomiting, diarrhea) (see section 2 “What you need to know before you take Contramal”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CONTRAMAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the label. The
expiry date refers to the last day of that month. This medicine does not require
special storage conditions.
The medicine must be used within 12 months of first opening the bottle; after this time any remaining medicine must be disposed of.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What Contramal contains
The active ingredient is tramadol hydrochloride.
Each ml of solution contains 100 mg of tramadol hydrochloride (one drop contains 2.5 mg of
tramadol).
The other ingredients are: sucrose (0.2 g/ml solution), propylene glycol, glycerol, sodium
cyclamate, sodium saccharin, potassium sorbate, macrogolglycerol hydroxystearate, peppermint essence,
anise flavour, purified water. See the end of paragraph 2 for information on sucrose and
macrogolglycerol hydroxystearate

Description of the appearance of Contramal and contents of the pack
The Contramal 100 mg/ml oral drops solution is clear, slightly viscous, of a light yellow
colour.
The solution is contained in an amber glass bottle and contains 10 ml of solution.

Marketing Authorisation Holder
GRÜNENTHAL ITALIA S.r.l. – Via Carlo Bo, 11 – 20143 Milan

Manufacturer responsible for batch release
FARMACEUTICI FORMENTI S.p.A. – Via Di Vittorio, 2 – 21040 Origgio (VA)
GRÜNENTHAL GmbH – Aachen, Germany

Instructions for use of Contramal 100 mg/ml oral drops solution
The Contramal bottle is provided in tamper-evident packaging. The carton is sealed,
the bottle has a safety ring and only if the carton, its serrations and the bottle ring
are intact, you will be sure that the contents have not been tampered with.
If the packaging is damaged, inform your pharmacist.
Note on the amount of content
Due to the difference in wall and bottom thickness of the bottle, the liquid level may
vary by a few millimeters in the sealed pack of Contramal 100 mg/ml oral drops solution.
The Contramal 100 mg/ml oral drops solution bottle with dropper, has a child-resistant
closure. To open, press down firmly on the cap and unscrew it. After use, close the cap tightly.
To release the drops, hold the bottle in a vertical position with the opening
facing downwards. Gently tap the bottom of the bottle with a finger until
the first drop appears.
For dosage, refer to section 3 “HOW TO USE CONTRAMAL”

Tramadol hydrochloride content in the drops:

Note on the dosage of Contramal oral drops solution in children over 1 year of age
Dosage table in relation to body weight in children (see also HOW TO USE
CONTRAMAL 100 mg/ml oral drops solution with dropper)

CONTRAMAL 100 mg/ml oral solution with dropper

Tramadolo cloridrato
30 ml bottle
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet

• 1. What CONTRAMAL is and what it is used for
• 2. What you need to know before you take CONTRAMAL
• 3. How to take CONTRAMAL
• 4. Possible side effects
• 5. How to store CONTRAMAL
• 6. Contents of the pack and other information

1. What is CONTRAMAL and what is it used for

Tramadol – the active ingredient of Contramal is an analgesic (against pain) that derives from the
opioid class, it acts at the level of the central nervous system. It reduces pain by acting on
specific nerve cells of the spinal cord and the brain.
Contramal is used for the treatment of moderate to severe pain, of various types and causes,
as well as for pain caused by diagnostic and surgical procedures.

2. What you need to know before you take CONTRAMAL

Do not take Contramal

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6)
• in acute alcohol poisoning, sleeping pills, painkillers or other psychotropic drugs (drugs that affect mood and emotions)
• if you are also taking MAO inhibitors (some drugs used to treat depression) or if you have taken them in the last 14 days before treatment with Contramal (see “Other medicines and Contramal”)
• if you are epileptic and your seizures are not adequately controlled by therapy
• as a substitute in drug detoxification therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Contramal:

• if you think you are taking too many other pain relievers (opioids)
• if you suffer from loss of consciousness (if you feel faint)
• if you are in a state of shock (cold sweats may be a sign of it)
• if you have increased pressure in the brain (possible after a head injury or brain diseases)
• if you have difficulty breathing
• if you are prone to epilepsy or seizures as the risk of an attack may increase
• if you suffer from liver or kidney diseases.
• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Contramal”). There is a slight risk that you may develop so-called serotonin syndrome, which can occur after taking tramadol together with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Breathing-related sleep disorders
Contramal contains an active ingredient that belongs to the group of opioids. Opioids
can cause breathing-related sleep disorders, such as central sleep apnea (shallow/pauses in
breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).
The risk of central sleep apnea occurring depends on the dose of opioids. The doctor may
consider reducing the total opioid dosage in case of central sleep apnea.
Seizures have been reported in patients taking tramadol at the recommended dosages.
The risk may increase when tramadol dosages exceed those recommended, beyond the daily limit
of 400 mg.
Contramal can lead to physical and psychological dependence. When Contramal is administered for
a long period, its effect may decrease, therefore higher doses must be administered (development
of tolerance). In patients with a tendency to abuse medicines or who are dependent on medicines,
Contramal must be taken for short periods and under strict medical supervision.
Tramadol is transformed in the liver by an enzyme. Some people have a variation
of this enzyme, which may have different effects on them. Some people may not
get enough pain relief, but others may experience serious side effects. If you notice any of the following side effects, you should stop taking
this medicine and consult your doctor immediately: slowed or shallow breathing,
confusion, drowsiness, constricted pupils, feeling unwell or sick, constipation, loss of
appetite.
Talk to your doctor if you notice any of the following symptoms while taking
CONTRAMAL:
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or
low blood pressure. These symptoms may be indicative of adrenal insufficiency
(low levels of cortisol). If you experience these symptoms, contact your doctor, who will decide if
you need hormone replacement.

Children and adolescents
Use in children with respiratory problems
Tramadol is not recommended in children with respiratory problems, as the symptoms of tramadol toxicity may be worse in these children.

Other medicines and Contramal
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Contramal should not be taken together with MAO inhibitors (some medicines used for
depression).
The intensity and duration of the analgesic effect of Contramal may be reduced if you are taking
medicines that contain

• carbamazepine (for epileptic seizures)
• ondansetron (to prevent nausea). Your doctor will inform you if and what dosages of Contramal you should take.

The risk of side effects increases if you are taking:

• other painkillers such as morphine and codeine (even when taken for coughs), and alcohol together with Contramal. You may feel sleepy or faint. In these cases, consult your doctor
• The concomitant use of Contramal and sedatives or sleeping pills (e.g. benzodiazepines) increases the risk of sedation, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when other types of treatment are not possible. However, if your doctor prescribes Contramal together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell them about all the sedatives you are taking and carefully follow your doctor’s dosage recommendations. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when such symptoms occur
• medicines that can cause seizures (attacks), such as some antidepressants or antipsychotics. The risk of having a seizure may increase if you take Contramal at the same time. Your doctor will tell you if Contramal is suitable for you
• certain antidepressants, Contramal may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• coumarin anticoagulants (medicines that thin the blood), such as warfarin, together with Contramal. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Contramal with food, drinks and alcohol
Do not drink alcohol during treatment with Contramal, as its effect may be
increased.
Taking food does not affect the effect of Contramal.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information regarding the safety of tramadol in pregnant women.
Therefore, if you are pregnant, you should not take Contramal 100 mg/ml oral solution with
applicator.
Chronic use during pregnancy may lead to withdrawal symptoms in newborns.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Contramal more
than once during breastfeeding or, alternatively, if you take Contramal more than once, you should
stop breastfeeding
There is limited data on the effects of Contramal on fertility.

Driving and using machines
Contramal can cause drowsiness, dizziness and vision problems (blurred vision). If you feel that
your ability to react is affected, do not drive machines or other vehicles, do not use machinery
or tools that require a secure hold.

Contramal 100 mg/ml oral solution with applicator contains sucrose, macrogolglycerol
hydroxystearate, propylene glycol and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine. This is because Contramal 100 mg/ml oral solution with applicator contains
sucrose. If Contramal oral solution with applicator is used for chronic use (for
example for two weeks or more), it may be harmful to your teeth.
Contramal 100 mg/ml oral solution with applicator contains macrogolglycerol hydroxystearate,
a derivative of castor oil that can cause stomach upset and diarrhea.
Contramal 100 mg/ml oral solution contains 150 mg of propylene glycol per ml
Contramal 100 mg/ml oral solution contains less than 1 mmol (23 mg) of sodium per ml, i.e.
essentially “sodium-free”.

3. How to take CONTRAMAL

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The dosage must be chosen based on the intensity of the pain and your personal sensitivity to
pain. In general, the lowest dose that reduces the pain should be taken. Do not take more than 32
deliveries per day (e.g. 8 doses of 4 deliveries, equivalent to 400 mg of tramadol hydrochloride), unless
your doctor has given you different instructions.
Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents over 12 years of age:
4 to 8 deliveries (equivalent to 50 or 100 mg of tramadol hydrochloride) every 4 – 6 hours.

Use in children and adolescents
In children over one year of age, the single dose is 1-2 mg per each Kg of body weight
(1-2 mg of tramadol hydrochloride per kg). For detailed information on dosage in relation to
body weight, read the notes at the end of this leaflet.
In general, the lowest dose capable of relieving pain should be used.
The lowest dose that reduces the pain should be taken. Daily doses of more than 8 mg of tramadol
hydrochloride per kg of body weight or 400 mg of tramadol hydrochloride should not be exceeded.
For children, the use of the Contramal oral drops solution with dropper is recommended
instead of Contramal oral solution with applicator, to allow for a more accurate dosage in
relation to body weight.

Elderly patients
In elderly people (over 75 years of age), the elimination of tramadol may be delayed. If this is the case,
your doctor may advise you to extend the time interval between one dose and the next.

Patients with severe hepatic or renal insufficiency / dialysis
Patients with severe hepatic and/or renal insufficiency should not take Contramal. In case of
mild or moderate insufficiency, your doctor may advise you to extend the time interval between
one dose and the next.

How and when to take Contramal
Take Contramal 100 mg/ml oral solution with applicator with some sugar or a little liquid.
For detailed information on using the applicator container, read the notes at the end
of this leaflet.

How long to take Contramal
Do not take Contramal for longer than necessary. If you need to continue the
treatment for a long period, your doctor will subject you to brief and regular checks
(if necessary temporarily interrupting therapy) to establish whether you should continue the
treatment and with what dose.
If you feel that the analgesic effect of Contramal is too strong or too weak, consult your
doctor or pharmacist.

If you take more Contramal than you should
If you have accidentally taken an extra dose, it should not have any negative effects. You can
continue to take the medicine as prescribed.
After taking very high doses, the following may occur: pinpoint pupils, vomiting, drop in
blood pressure, fast heartbeat, collapse, disturbances of consciousness up to coma
(deep unconsciousness), seizures, and difficulty breathing up to respiratory arrest. In
these cases, call your doctor immediately.

If you forget to take Contramal
If you forget to take Contramal, the pain is likely to return. Do not double the dose
to make up for forgetting a single dose, simply continue to take the
oral solution as before.

If you stop taking Contramal
If you stop or end the treatment too soon, the pain is likely to return.
If you want to stop treatment due to side effects, consult your doctor.
You should not suddenly stop taking this medicine unless your doctor prescribes it. If you intend to stop taking the medicine, talk to your
doctor first, especially if you have been taking it for a long time. The doctor will advise you when and how
to stop it. This may involve gradually reducing the dose to reduce the likelihood of
developing unnecessary side effects (withdrawal symptoms).
Generally, when treatment with Contramal is terminated, no withdrawal effects occur.
However, in rare cases, some people who have taken Contramal for a certain period of time,
when they suddenly stop taking it, may not feel well. In fact, they may:

• feel agitated, anxious, nervous or weak.
• be hyperactive, have difficulty sleeping or have stomach or intestinal disorders
• have panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and ringing in the ears (tinnitus)
• have other rare and unusual CNS symptoms such as confusion, delusion, alteration of the perception of one's personality (depersonalization) and alterations of the perception of reality (derealization) and sense of persecution (paranoia). If you experience any of these symptoms after stopping therapy with Contramal, consult your doctor.

If you experience any of these symptoms after stopping Contramal, see
your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience symptoms of an allergic reaction such as:

• swelling of the face, tongue and/or throat
• difficulty swallowing
• urticaria (hives)
• difficulty breathing.

Other possible side effects are:
Very common (may affect more than 1 in 10 people)

• nausea
• dizziness

Common (may affect up to 1 in 10 people)

• headache, drowsiness
• vomiting, constipation, dry mouth
• sweating (hyperhidrosis)
• fatigue

Uncommon (may affect up to 1 in 100 people)

• effects on the heart and blood circulation (palpitations, fast heartbeat, feeling of fainting or collapse). These side effects may occur particularly in patients in an upright position or during physical exertion
• urge to vomit (nausea), stomach pain (feeling of pressure in the stomach, bloating), diarrhoea
• skin reactions (itching, rash)

Rare (may affect up to 1 in 1000 people)

• allergic reactions (e.g. difficulty breathing, shortness of breath, skin swelling) and shock (circulatory failure)
• slow heartbeat
• increased blood pressure
• abnormal sensations (e.g. tingling, itching, numbness), tremor, slow breathing, seizures, muscle spasms, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders
• seizures have occurred particularly with high doses of tramadol or when tramadol was taken together with other medicines that can cause seizures
• changes in appetite
• hallucinations, confusion, sleep disturbances, delirium, anxiety and nightmares.
• Psychological symptoms may occur after treatment with Contramal, of varying nature and intensity depending on the patient's personality and the duration of therapy. These may manifest as a change in mood (especially good mood, in some cases irritated mood), changes in activity (usually decrease or suppression, sometimes an increase) and decreased cognitive and sensory perception (changes in the senses and the ability to recognize emotions, which can lead to errors in judgment)
• drug dependence. When treatment is stopped abruptly, withdrawal symptoms may occur (see “If you stop taking Contramal”).
• vision problems, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis)
• slow breathing, shortness of breath (dyspnea). If the recommended doses are exceeded, or if medicines that reduce brain function are taken at the same time, breathing may be slower
• worsening of asthma, however, it has not been established whether this was caused by tramadol
• muscle weakness
• difficulty or pain when urinating, reduced amount of urine (dysuria)

Very rare (may affect up to 1 in 10000 people)

• increased liver enzyme values

Frequency not known (the frequency cannot be estimated from the available data)

• decrease in blood sugar levels
• hiccups
• serotonin syndrome, which can manifest as a change in mental status (for example, agitation, hallucinations, coma) and other effects, such as fever, increased

heart rate, unstable blood pressure, involuntary contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (for example, nausea, vomiting, diarrhoea) (see section 2 “What you need to know before you take Contramal”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store CONTRAMAL

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
This medicine does not require particular storage conditions.
The medicine must be used within 12 months of first opening the bottle; after this period, any remaining medicine must be disposed of.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

6. Package contents and other information

What Contramal contains
The active ingredient is tramadol hydrochloride.
Each ml of solution contains 100 mg of tramadol hydrochloride (the bottle is equipped with a dropper,
each dispensing action contains 5 drops and corresponds to 12.5 mg of tramadol).
The other ingredients are: sucrose (0.2 g/ml solution), propylene glycol, glycerol, sodium
cyclamate, sodium saccharinate, potassium sorbate, macrogolglycerol hydroxystearate, peppermint essence,
anise flavour, purified water. See the end of paragraph 2 for information on sucrose and
macrogolglycerol hydroxystearate.

Description of the appearance of Contramal and contents of the pack
Contramal 100 mg/ml oral solution with dropper is a clear, slightly viscous solution,
tending towards light yellow. The solution is contained in a glass bottle of 30 ml solution.

Marketing Authorisation Holder
GRÜNENTHAL ITALIA S.r.l. – Via Carlo Bo, 11 – 20143 Milan

Manufacturer responsible for batch release
FARMACEUTICI FORMENTI S.p.A. – Via Di Vittorio, 2 – 21040 Origgio (VA)
GRÜNENTHAL GmbH, Aachen (Germany)

Instructions for use of Contramal 100 mg/ml oral solution with dropper
Note on the amount of content
Due to the difference in wall and bottom thickness of the bottle, the liquid level
may vary by a few millimeters in the sealed pack of Contramal
100 mg/ml oral solution with dropper.
Note on use.
When using the bottle for the first time: press the dropper a couple of
times until the solution appears (for technical reasons it is
necessary to fill the pump mechanism to start a
regular dispensing action).
Place a spoon or a glass under the nozzle and press
the dropper. A complete dispensing action releases the equivalent of 5 drops
and contains 12.5 mg of tramadol hydrochloride (for dosage, read the
paragraph 3 - How to take CONTRAMAL 100 mg/ml oral solution
with dropper).
Contramal is available in both 30 ml bottles with dropper and 10 ml bottles with
dropper.
It should be noted that 1 press on the dropper (30 ml bottle with dropper) does not
correspond to 1 drop dispensed with dropper (10 ml bottle with dropper) See the table
below for more details. Dispensing of Contramal is obtained by pressing the top part of the dropper:

CONTRAMAL 150 mg prolonged-release tablets, 200 mg prolonged-release tablets

Tramadol hydrochloride
Read this leaflet carefully before taking this medicine as it contains
important information.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet

• 1. What CONTRAMAL prolonged-release tablets are and what they are used for.
• 2. What you need to know before you take CONTRAMAL prolonged-release tablets.
• 3. How to use CONTRAMAL prolonged-release tablets.
• 4. Possible side effects.
• 5. How to store CONTRAMAL prolonged-release tablets.
• 6. Contents of the pack and further information.

1. What is CONTRAMAL and what is it used for

Tramadol – the active ingredient of Contramal – is an analgesic that belongs to the class of
opioids, it acts at the level of the central nervous system. It reduces pain by acting on specific nerve
cells of the spinal cord and the brain.
Contramal is used for the treatment of moderate to severe pain.

2. What you need to know before you take CONTRAMAL prolonged-release tablets.

Do not use Contramal

• if you are allergic to tramadol or any of the excipients of Contramal
• in acute poisoning with alcohol, sleeping pills, painkillers or other psychotropic drugs (drugs that affect mood and emotions)
• if you are also taking MAO inhibitors (some drugs used to treat depression) or if you have taken them in the last 14 days before treatment with Contramal (see “Other medicines and Contramal”)
• if you are epileptic and your seizures are not sufficiently controlled by therapy
• as a substitute in detoxification therapy from drugs.

Warnings and precautions
Talk to your doctor or pharmacist before taking Contramal

• if you think you are using other painkillers (opioids) excessively
• if you suffer from disorders of consciousness (if you feel faint)
• if you are in a state of shock (cold sweats may be a sign of it)
• if you have increased pressure in the brain (possible after a head injury or brain diseases)
• if you have difficulty breathing
• if you are prone to epilepsy or seizures as the risk of an attack may increase
• if you suffer from liver or kidney diseases.
• suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Contramal”). There is a slight risk that you may develop the so-called serotonin syndrome, which can occur after taking tramadol together with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see paragraph 4 “Possible side effects”).

Sleep-related breathing disorders
Contramal contains an active ingredient that belongs to the group of opioids. Opioids
can cause sleep-related breathing disorders, such as central sleep apnea (shallow/pauses in breathing during sleep) and sleep-related hypoxemia
(low blood oxygen levels).
The risk of central sleep apnea occurring depends on the dose of opioids. Your doctor may
consider reducing the total opioid dosage if central sleep apnea occurs.
Seizures have been reported in patients taking tramadol at the recommended dosages.
The risk may increase when tramadol dosages exceed those
recommended, beyond the limit dose (400 mg).
Contramal can lead to physical and psychological dependence. When Contramal is administered for
a long period, its effect may decrease, therefore higher doses must be administered
(development of tolerance).
In patients with a tendency to abuse medicines or who are dependent on medicines, Contramal
should only be taken for short periods and under strict medical supervision.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation
of this enzyme, which can have different effects on them. Some people may not
get enough pain relief, but others may experience serious side effects. If you notice any of the following side effects, you should stop taking
this medicine and consult your doctor immediately: slowed or shallow breathing,
confusion, drowsiness, constricted pupils, feeling unwell or sick, constipation, loss of
appetite.
Talk to your doctor if you notice any of the following symptoms while taking
CONTRAMAL:
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or
low blood pressure. These symptoms may be indicative of adrenal insufficiency
(low levels of cortisol). If you experience these symptoms, contact your doctor, who will decide if
you need hormone replacement therapy.

Children and adolescents
Use in children with breathing problems
Tramadol is not recommended in children with breathing problems, as the symptoms of tramadol toxicity may be worse in these children.

Other medicines and Contramal
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Contramal must not be taken together with MAO inhibitors (some medicines used for
depression).
The intensity and duration of the analgesic effect of Contramal may be reduced if you are taking
medicines that contain:

• carbamazepine (for epileptic seizures)
• ondansetron (to prevent nausea). Your doctor will tell you if and what dosages of Contramal you should take.

The risk of side effects increases:

• if you are taking other painkillers such as morphine and codeine (even when taken for cough), and alcohol together with Contramal. You may feel sleepy or weak. If this happens, tell your doctor.
• The concomitant use of Contramal and sedatives or sleeping pills (e.g. benzodiazepines) increases the risk of sedation, breathing difficulties (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other types of treatment are not possible. However, if your doctor prescribes Contramal together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell them about all the sedatives you are taking and carefully follow your doctor's dosage recommendations. It may be helpful to inform friends or family about the signs and symptoms mentioned above. Contact your doctor when these symptoms occur.
• if you are taking medicines that can cause seizures (epileptic seizures), (such as some antidepressants or antipsychotics). The risk of seizures may increase if you are taking these drugs together with Contramal. Your doctor will tell you if Contramal is right for you.
• if you are taking certain antidepressants, Contramal may interact with these medicines and you may experience serotonin syndrome (see paragraph 4 “Possible side effects”).
• if you are taking coumarin anticoagulants (medicines that thin the blood), such as warfarin, together with Contramal. The effect of these medicines on blood coagulation may be affected and bleeding may occur.

Contramal with food and alcohol
Do not drink alcohol during treatment with Contramal, as its effect may be
increased. Food intake does not affect the effect of Contramal.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information regarding the safety of tramadol in pregnant women.
Therefore, if you are pregnant, you should not use Contramal.
Chronic use during pregnancy can lead to withdrawal symptoms in newborns.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Contramal more
than once during breastfeeding or, alternatively, if you take Contramal more than once, you should
stop breastfeeding.
Clinical experience in humans suggests that tramadol does not affect male or
female fertility.

Driving and operating machinery
Contramal can cause drowsiness, dizziness and visual disturbances (blurred vision) and therefore can
impair your reactions. If you feel that your ability to react is affected, do not drive
machines or other vehicles, do not use power tools or operate machinery.

Contramal contains lactose
If your doctor has diagnosed you with lactose intolerance, contact them before taking
this medicine, which contains lactose.

3. How to use CONTRAMAL

Always use this medicine exactly as your doctor has instructed. If you have any doubts, ask your
doctor or pharmacist.
The dosage should be chosen based on the intensity of the pain and your personal sensitivity to
pain. In general, you should take the lowest dose that reduces the pain. Do not take more than 400
mg of tramadol hydrochloride per day, unless your doctor has given you different instructions.
Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents over 12 years of age:
One Contramal prolonged-release tablet of 150 mg twice a day (equivalent to 300
mg of tramadol hydrochloride per day), preferably in the morning and evening.
One Contramal prolonged-release tablet of 200 mg twice a day (equivalent to 400
mg of tramadol hydrochloride per day), preferably in the morning and evening.
If necessary, your doctor may prescribe a different and more appropriate dose of Contramal.
If necessary, the dose may be increased to 150 mg or 200 mg twice a day
(equivalent to 300 – 400 mg of tramadol hydrochloride per day).
Do not take more than 400 mg of tramadol hydrochloride per day, unless otherwise prescribed by your doctor.

Children
Contramal prolonged-release tablets are not suitable for children under 12 years of age.

Elderly
In the elderly (over 75 years of age), the elimination of tramadol may be slower. If this is the case, your
doctor may advise you to increase the time between doses.

Patients with severe hepatic or renal insufficiency / dialysis
Patients with severe hepatic and/or renal insufficiency should not take Contramal. In case of
mild or moderate insufficiency, your doctor may advise you to increase the time between doses.

How and when to take Contramal
Contramal prolonged-release tablets should be taken orally.
Always swallow Contramal prolonged-release tablets whole, do not divide or chew them, with
sufficient liquid, preferably in the morning and evening. You can take the
tablets during or away from meals.

How long to take Contramal
Do not take Contramal for longer than necessary. If you need to continue treatment for
a long period, your doctor will subject you to short and regular check-ups (if necessary
temporarily interrupting therapy) to determine if you should continue treatment and
with what dose.
If you feel that the analgesic effect of Contramal is too strong or too weak, consult your
doctor or pharmacist.

If you take more Contramal than you should
If you have accidentally taken an extra dose, it should not have any negative effects. You can
continue to take the medicine as prescribed.
After taking very high doses, the following may occur: pinpoint pupils, vomiting, drop in
blood pressure, fast heartbeat, collapse, disturbances of consciousness up to coma
(deep unconsciousness), seizures, and difficulty breathing up to respiratory arrest. In
these cases, call your doctor immediately!

If you forget to take Contramal
If you forget to take the tablets, the pain is likely to return. Do not double the dose
to make up for this forgetfulness, simply continue to take the tablets as
before.

If you stop taking Contramal
If you stop or end treatment too early, the pain is likely to return.
If you want to stop treatment due to side effects, consult your doctor.
You should not suddenly stop taking this medicine, unless your doctor prescribes it. If you intend to stop taking the medicine, talk to your
doctor first, especially if you have been taking it for a long time. The doctor will advise you when and how
to stop it. This can be done by gradually reducing the dose to reduce the likelihood of
developing unnecessary side effects (withdrawal symptoms).
Generally, when treatment with Contramal is stopped, no withdrawal effects occur.
However, in rare cases, some people when they suddenly stop taking Contramal prolonged-release tablets
after a certain period of time, may not feel well. They may feel agitated, anxious, nervous or weak. They may be hyperactive, have difficulty sleeping or
have stomach or intestinal disorders. Very few people may have panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and ringing in the
ears (tinnitus). In addition, very rarely, unusual CNS symptoms such as
confusion, delusion, alteration of one's own personality perception (depersonalization) and
changes in the perception of reality (de-realization) and a sense of persecution (paranoia) have been reported. If you
experience any of these symptoms after stopping therapy with Contramal, consult your
doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Contramal can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience symptoms of an allergic reaction such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives combined with difficulty breathing.
The most common side effects during treatment with Contramal are nausea and dizziness, in more than 1 in 10 people
Very common: may affect more than 1 in 10 people

• dizziness
• nausea

Common: may affect up to 1 in 10 people

• headache, drowsiness
• feeling tired
• constipation, dry mouth, vomiting
• sweating (hyperhidrosis)

Uncommon: may affect up to 1 in 100 people

• effects on the heart and blood circulation (palpitations, fast heartbeat, feeling faint or collapse). These side effects can occur particularly in patients in an upright position or during physical exertion
• urge to vomit, stomach discomfort (feeling of fullness, bloating), diarrhea
• skin reactions (for example: itching, rash).

Rare: may affect up to 1 in 1,000 people

• Allergic reactions (e.g. difficulty breathing, wheezing, swelling of the skin) and shock (sudden drop in blood pressure)
• slow heartbeat
• increased blood pressure
• unusual sensations (itching, tingling, numbness), tremors, slowed breathing, seizures, muscle spasms, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures have occurred especially after the administration of high doses of tramadol or after concomitant treatment with drugs that predispose to convulsions.
• changes in appetite.
• hallucinations, confused state, sleep disturbances, delirium, anxiety and nightmares.

After treatment with Contramal, psychological disturbances may occur. Their intensity and nature can vary (depending on the patient's personality and the duration of therapy). They can manifest as a change in mood (usually euphoria, rarely irritation), activity (usually reduction, rarely increase) and reduction of sensory and cognitive perceptions (alterations of sensations and the ability to distinguish, which can lead to misjudgments).

Dependence can develop.

blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupil (miosis).

slowing of breathing, shortness of breath (dyspnea)

Worsening of bronchial asthma has been observed, however, it has not been established whether it could have been caused by tramadol. If the recommended doses are exceeded, or other drugs that depress brain function are taken at the same time, breathing may slow down

muscle weakness

difficulty or pain when urinating, reduced urine output (dysuria).

Very rare: may affect up to 1 in 10,000 people
increased levels of liver enzymes.
Not known: frequency cannot be estimated based on available data

• decrease in blood sugar level
• Hiccups
• serotonin syndrome, which can manifest as a change in mental state (e.g. agitation, hallucinations, coma) and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 “What you need to know before you take Contramal”).

When treatment is stopped abruptly, withdrawal symptoms may occur
(see “If you stop taking Contramal”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store CONTRAMAL

Keep this medicine out of the sight and reach of children.
Do not use Contramal after the expiry date which is stated on the package and blister. The expiry
date refers to the last day of that month. This medicine does not require particular
storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What Contramal contains
The active ingredient is tramadol hydrochloride.
Contramal prolonged-release tablets 150 mg
Each tablet contains 150 mg of tramadol hydrochloride.
The excipients are – core: microcrystalline cellulose, hypromellose 100,000 mPa s, magnesium
stearate, anhydrous colloidal silica; - coating:hypromellose 6 mPa s, lactose monohydrate,
macrogol 6000, propylene glycol, talc, titanium dioxide (E171), quinoline yellow (E104), iron
oxide red (E172).
Contramal prolonged-release tablets 200 mg
Each tablet contains 200 mg of tramadol hydrochloride.
The excipients are - core: microcrystalline cellulose, hypromellose 100,000 mPa s, magnesium
stearate, anhydrous colloidal silica; - coating: hypromellose 6 mPa s, lactose monohydrate,
macrogol 6000, propylene glycol, talc, titanium dioxide (E171), quinoline yellow (E104), iron
oxide red (E172), iron oxide brown (E172).

Description of the appearance of Contramal and package contents
Contramal 150 mg prolonged-release tablets are round, biconvex, light orange
in color with the letters T2 imprinted on one side and the logo  on the other side.
Contramal 200 mg prolonged-release tablets are round, biconvex, dark orange
in color with the letters T3 imprinted on one side and the logo  on the other side.
Contramal is packaged in blisters and sold in boxes of 10 tablets.

Marketing authorization holder and manufacturer
Marketing Authorization Holder: GRŰNENTHAL ITALIA S.r.l.
Via Carlo Bo 11 – 20143 Milan
Manufacturer: Farmaceutici Formenti S.p.A.
Via di Vittorio, 2 – 21040 Origgio (VA)
This medicinal product is authorized in other EU member states with the following names:
Belgium Contramal retard 50 mg 100 mg 150 mg 200 mg
Denmark Nobligan retard 100 mg 150 mg 200 mg
Finland Tramal retard 50 mg 100 mg 150 mg 200 mg
France Topalgic L.P. 100 mg 150 mg 200 mg
Germany Tramal retard 50 mg 100 mg 150 mg 200 mg
Italy Contramal 150 mg 200 mg
Luxembourg Contramal retard 50 mg 100 mg 150 mg 200 mg
Netherlands Tramal retard 100 mg 150 mg 200 mg
Poland Tramal retard 50 mg
Portugal Tramal retard 100 mg 150 mg 200 mg
Slovenia Tramal 50 mg
Spain Adolonta retard 50 mg 100 mg 150 mg 200 mg
Sweden Nobligan retard 100 mg 150 mg 200 mg

This leaflet was last approved on:

CONTRAMAL 50 mg /1 ml injectable solution, 100 mg /2 ml injectable solution

Tramadol hydrochloride
Read this leaflet carefully before you start to use this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet

• 1. What CONTRAMAL is and what it is used for
• 2. What you need to know before you use CONTRAMAL
• 3. How to use CONTRAMAL
• 4. Possible side effects
• 5. How to store CONTRAMAL
• 6. Contents of the pack and other information

1. What is CONTRAMAL and what is it used for

Tramadol – the active ingredient of Contramal injectable solution – is an analgesic (against
pain) derived from the opioid class, acting at the level of the central nervous system. It reduces
pain by acting on specific nerve cells in the spinal cord and brain.
Contramal is used for the treatment of moderate to severe pain, of various types and causes,
as well as for pain caused by diagnostic and surgical procedures.

2. What you need to know before you take CONTRAMAL

Do not use Contramal

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6)
• in acute alcohol poisoning, sleeping pills, painkillers or other psychotropic drugs (drugs that affect mood and emotions)
• if you are also taking MAO inhibitors (some medicines used to treat depression) or if you have taken them within the last 14 days before treatment with Contramal (see “Other medicines and Contramal”)
• if you have epilepsy and your seizures are not adequately controlled by therapy
• as a substitute in drug detoxification therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Contramal:

• if you think you are using other pain relievers (opioids) excessively
• if you suffer from disorders of consciousness (if you feel faint)
• if you are in a state of shock (cold sweats may be a sign of it)
• if you have increased pressure in the brain (possible after a head injury or brain disease)
• if you have difficulty breathing
• if you are prone to epilepsy or seizures, as the risk of a seizure may increase
• if you suffer from liver or kidney disease.
• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Contramal”). There is a slight risk that you may develop so-called serotonin syndrome, which can occur after taking tramadol together with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Breathing-related sleep disorders
Contramal contains an active ingredient that belongs to the group of opioids. Opioids
can cause breathing-related sleep disorders, such as central sleep apnea (shallow/pauses in breathing during sleep) and sleep-related hypoxemia
(low blood oxygen levels).
The risk of central sleep apnea occurring depends on the dose of opioids. Your doctor may
consider reducing the total opioid dosage in case of central sleep apnea.
Seizures have been reported in patients taking tramadol at the
recommended dosages. The risk may increase when tramadol dosages exceed those
recommended, beyond the daily limit of 400 mg.
Contramal can lead to physical and psychological dependence. When Contramal is administered for
a long period, its effect may decrease, therefore higher doses must be administered (development of tolerance). In patients with a tendency to abuse medicines or who are
dependent on medicines, Contramal should be taken for short periods and under strict medical
control.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation
of this enzyme, which may have different effects on them. Some people may not
get enough pain relief, but others may experience serious side effects. If you notice any of the following side effects, you should stop taking
this medicine and consult your doctor immediately: slowed or shallow breathing,
confusion, drowsiness, constricted pupils, feeling unwell or sick, constipation, loss of
appetite.
Talk to your doctor if you notice any of these symptoms while taking CONTRAMAL:
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These symptoms may be indicative of adrenal insufficiency (low levels of
cortisol). If you experience these symptoms, contact your doctor, who will decide if you need
hormonal supplementation

Children and adolescents
Use in children with breathing problems.
Tramadol is not recommended in children with breathing problems, as the
symptoms of tramadol toxicity may be worse in these children.

Other medicines and Contramal
Tell your doctor or pharmacist if you are taking or have recently taken or may
take any other medicines.
Contramal should not be taken together with MAO inhibitors (some medicines used for
depression).
The intensity and duration of the analgesic effect of Contramal may be reduced if you are taking
medicines that contain

• carbamazepine (for epileptic seizures)
• ondansetron (to prevent nausea). Your doctor will tell you if and what dosages of Contramal you should take.

The risk of side effects increases if you are taking:

• other painkillers such as morphine and codeine (even when taken for cough), and alcohol together with Contramal. You may feel sleepy or weak. In these cases, consult your doctor
• the concomitant use of Contramal and sedatives or sleeping pills (e.g. benzodiazepines) increases the risk of sedation, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when other types of treatment are not possible. However, if your doctor prescribes Contramal together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell them about all the sedatives you are taking and carefully follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives about the signs and symptoms mentioned above. Contact your doctor when these symptoms occur.
• medicines that can cause seizures (attacks), such as some antidepressants or antipsychotics. The risk of having a seizure may increase if you take Contramal at the same time. Your doctor will tell you if Contramal is right for you.
• certain antidepressants. Contramal may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• coumarin anticoagulants (medicines that thin the blood), such as warfarin, together with Contramal. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Contramal with food, drinks and alcohol
Do not drink alcohol during treatment with Contramal, as its effect may be
increased.
Taking food does not affect the effect of Contramal.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information regarding the safety of tramadol in pregnant women.
Therefore, if you are pregnant, you should not use Contramal injectable solution. Chronic use during
pregnancy may lead to withdrawal symptoms in newborns.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Contramal more
than once during breastfeeding or, alternatively, if you take Contramal more than once, you should
stop breastfeeding.
There is limited data on the effects of Contramal on fertility.

Driving and operating machinery
Contramal can cause drowsiness, dizziness and vision problems (blurred vision). If you feel that your
ability to react is affected, do not drive machines or other vehicles, do not use machinery or
tools that require a firm support.

Contramal injectable solution contains less than 1 mmol of sodium(23 mg) per ml, i.e.
essentially “sodium-free”

3. How to use CONTRAMAL

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist.
The dosage must be chosen based on the intensity of the pain and your personal sensitivity to pain. In general, the lowest dose that reduces the pain should be taken. Generally, a daily dose of up to 8 ml of Contramal injectable solution (equivalent to 8 vials of 50 mg or 4 vials of 100 mg, equivalent to 400 mg of tramadol hydrochloride) is sufficient, unless your doctor has given you different instructions.
Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents over 12 years of age:
Inject 1 or 2 ml (equivalent to 50 or 100 mg of tramadol hydrochloride) according to the intensity of the pain, every 4-6 hours.

Children over 1 year of age
The usual single dose is 1-2 mg of tramadol hydrochloride per kg of body weight. The lowest dose that reduces the pain should be taken. Daily doses exceeding 8 mg of active substance per kg of body weight or 400 mg of active substance should not be exceeded.

Elderly patients
In elderly people (over 75 years of age), the elimination of tramadol may be delayed. If this is the case, your doctor may advise you to extend the time interval between doses.

Patients with severe hepatic or renal insufficiency/dialysis
Patients with severe hepatic and/or renal insufficiency should not take Contramal. In case of mild or moderate insufficiency, your doctor may advise you to extend the time interval between doses.
How and when to administer Contramal injectable solution
Contramal injectable solution should be injected slowly, into a vein (usually in the arm) or into the muscle (usually in the buttock) or subcutaneously. Contramal injectable solution can be diluted in a suitable infusion solution and infused into a vein.

Incompatibilities of Contramal injectable solution
Contramal injectable solution should not be diluted in injectable or infusion solutions that contain: diclofenac, piroxicam, indometacin, phenylbutazone, diazepam, flunitrazepam, midazolam, nitroglycerin.

Information on how to use
Contramal injectable solution is supplied in breakable ampoules. The ampoule has an engraved breaking line, to open:

• 1) hold the ampoule with the tip pointing upwards
• 2) detach the tip by pulling downwards

How long should you take Contramal
You should not use Contramal for longer than necessary. If you need to continue treatment for a long period, your doctor will subject you to brief and regular checks (stopping therapy temporarily if necessary) to determine whether you should continue treatment and with what dose.
If you feel that the analgesic effect of Contramal is too strong or too weak, consult your doctor or pharmacist.

If you take more Contramal than you should
If you have been given an extra dose by mistake, it should not have any adverse effects. You can continue to administer the medicine as prescribed.
After very high doses, the following may occur: pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, collapse, disturbances of consciousness up to coma (deep unconsciousness), seizures, and difficulty breathing up to respiratory arrest. In these cases, call your doctor immediately.

If you forget to take Contramal
If Contramal injectable solution has not been administered, it is likely that the pain will return. Do not administer a double dose to compensate for this forgetfulness, but continue treatment according to the instructions.

If you stop taking Contramal
If you stop or end treatment too early, it is likely that the pain will return.
If you want to stop treatment due to undesirable effects, consult your doctor. Do not suddenly stop taking this medicine unless your doctor prescribes it. If you intend to stop taking the medicine, talk to your doctor first, especially if you have been taking it for a long time. The doctor will advise you when and how to stop it. This can be done by gradually reducing the dose to reduce the likelihood of developing unnecessary side effects (withdrawal symptoms).
Generally, when treatment with Contramal is stopped, no withdrawal effects occur. However, in rare cases, some people who have taken Contramal for a certain period of time, when they suddenly stop taking it, may not feel well.
In fact, they may

• feel agitated, anxious, nervous or weak
• be hyperactive, have difficulty sleeping or have stomach or intestinal disorders
• have panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and ringing in the ears (tinnitus)
• have other rare and unusual CNS symptoms such as confusion, delusion, changes in the perception of one's personality (depersonalization) and changes in the perception of reality (derealization) and a sense of persecution (paranoia).

If you experience any of these symptoms after stopping the use of Contramal, contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Seek immediate medical attention if you experience symptoms of an allergic reaction such as:

• swelling of the face, tongue and/or throat
• difficulty swallowing
• urticaria (hives)
• difficulty breathing.

Other possible side effects are:
Very common (may affect more than 1 in 10 people)

• nausea
• dizziness

Common (may affect up to 1 in 10 people)

• headache, drowsiness
• vomiting, constipation, dry mouth
• sweating (hyperhidrosis)
• fatigue

Uncommon (may affect up to 1 in 100 people)

• effects on the heart and blood circulation (palpitations, fast heartbeat, feeling of fainting or collapse). These side effects may occur particularly in patients in an upright position or during physical exertion
• urge to vomit (nausea), stomach pain (feeling of pressure in the stomach, bloating), diarrhea
• skin reactions (itching, rash)

Rare (may affect up to 1 in 1000 people)

• allergic reactions (e.g. difficulty breathing, shortness of breath, skin swelling) and shock (circulatory failure)
• slow heartbeat
• increased blood pressure
• abnormal sensations (e.g. tingling, itching, numbness), tremor, slow breathing, seizures, muscle spasms, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders
• seizures have occurred especially with high doses of tramadol or when tramadol was taken together with other medicines that can cause seizures
• changes in appetite
• hallucinations, confusion, sleep disturbances, delirium, anxiety and nightmares.
• Psychological symptoms may occur after treatment with Contramal, of varying nature and intensity depending on the patient's personality and the duration of therapy. These may manifest as a change in mood (especially good mood, in some cases irritated mood), changes in activity (usually decrease or suppression, sometimes an increase) and decreased cognitive and sensory perception (changes in the senses and the ability to recognize emotions, which can lead to errors in judgment)
• drug dependence. When treatment is stopped abruptly, withdrawal symptoms may occur (see “If you stop taking Contramal”).
• visual disturbances, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis)
• slow breathing, shortness of breath (dyspnea). If the recommended doses are exceeded, or if medicines that reduce brain function are also taken at the same time, breathing may be slower
• worsening of asthma, however, it has not been established whether this may have been caused by tramadol
• muscle weakness
• difficulty or pain when urinating, reduced urine output (dysuria)

Very rare (may affect up to 1 in 10000 people)

• increased liver enzyme values

Frequency not known (the frequency cannot be estimated from available data)

• decreased blood sugar level
• hiccups
• serotonin syndrome, which can manifest as a change in mental status (for example, agitation, hallucinations, coma) and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary contractions, rigidity

muscle, lack of coordination and/or gastrointestinal symptoms (for example, nausea,
vomiting, diarrhea) (see section 2 “What you need to know before taking Contramal”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store CONTRAMAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the label. The
expiry date refers to the last day of that month. This medicine does not require
any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Contramal contains
The active ingredient is tramadol hydrochloride.
Contramal 100 mg/2 ml injectable solution: each vial contains 100 mg of tramadol hydrochloride.
Contramal 50 mg/1 ml injectable solution: each vial contains 50 mg of tramadol hydrochloride.
The other ingredients are: sodium acetate, water for injections.

Description of the appearance of Contramal injectable solution and contents of the pack
Colourless, clear solution
Contramal injectable solution is contained in transparent glass vials, in packs of 5 vials.

Marketing Authorisation Holder
GRÜNENTHAL ITALIA S.r.l. – Via Carlo Bo, 11 – 20143 Milano

Manufacturer responsible for batch release
FARMACEUTICI FORMENTI S.p.A. – Via di Vittorio, 2 – 21040 Origgio (VA)
GRŰNENTHAL GmbH – Aachen, Germany