TRADOGUT 100 mg /Ml Krople Doustne, Roztwór

Treść ulotki

1. TRADOGUT 50 mg hard capsules
   1. What is TRADOGUT and what is it used for
   2. What you need to know before using TRADOGUT
   3. How to use TRADOGUT
   4. Possible side effects
   5. How to store TRADOGUT
   6. Contents of the pack and other information
2. TRADOGUT 50 mg/ml injectable solution
   1. What is TRADOGUT and what is it for
   2. What you need to know before you are given TRADOGUT
   3. How TRADOGUT will be administered to you
   4. Possible side effects
   5. How to store TRADOGUT
   6. Contents of the pack and other information
3. TRADOGUT 100 mg/ml oral drops, solution
   1. What is TRADOGUT and what it is used for
   2. What you need to know before you use TRADOGUT
   3. How to take TRADOGUT
   4. Possible side effects
   5. How to store TRADOGUT
   6. Contents of the pack and other information

TRADOGUT 50 mg hard capsules

Tramadol hydrochloride
Generic medicine

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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What is TRADOGUT and what is it used for

TRADOGUT belongs to a class of medicines called analgesics, commonly known as
pain relievers. The active ingredient, tramadol hydrochloride, interrupts the sending of
pain messages to your brain and also works at the brain level to prevent pain messages from being felt. This means that TRADOGUT does not prevent pain from occurring, but prevents
you from feeling the pain anyway.
TRADOGUT is used to relieve moderate to severe pain (for example, pain after
surgery or after an injury).

2. What you need to know before using TRADOGUT

Do not use TRADOGUT if:

• you are allergic to tramadol hydrochloride, or to any of the other ingredients of this medicine (listed in section 6), as skin rash, swelling of the face or breathing difficulties may occur;
• you are taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) to treat depression (see section 2, “Other medicines and TRADOGUT”);
• you have epilepsy that is not controlled by any treatment;
• you have drunk enough alcohol to feel dizzy or intoxicated;
• you have taken a dose higher than prescribed of your sleeping tablets, neuroleptics, antidepressants (neuroleptics and antidepressants are medicines that affect mood and emotions) or other painkillers, which may slow down your breathing and reactions.

Warning and precautions
Talk to your doctor or pharmacist before using TRADOGUT, if:

• you have been taking TRADOGUT or any other medicine containing tramadol for a long period;
• you are dependent on morphine;
• you have serious problems with your liver or kidneys;
• you have recently had a head injury or have a particularly severe headache that causes you to vomit;
• you have ever had seizures (fits) or if you suffer from epilepsy;
• you suffer from asthma or breathing difficulties;
• you have recently felt confused, drowsy or weak, or if you have lost consciousness;
• you are going to have surgery with general anaesthesia;
• you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and TRADOGUT”).

If any of the conditions mentioned above apply to you, consult your doctor as they may decide to
change your treatment.
Sleep-related breathing disorders
TRADOGUT can cause sleep-related breathing disorders such as sleep apnea (pauses
in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood).
Symptoms may include pauses in breathing during sleep, night-time awakenings due to labored
breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or another
person observe these symptoms, contact your doctor, who may consider a
reduction in the dose.
Talk to your doctor if you notice any of the following symptoms while taking TRADOGUT:
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.
There is a rare possibility that TRADOGUT may cause seizures (fits). The risk increases if
doses higher than the maximum daily doses are taken and if you are also taking antidepressants or
neuroleptics.
If you are prone to addiction or drug abuse, you should only be given TRADOGUT capsules
for short periods. Inform your doctor of this because they may want to monitor your pain control more
carefully.
You should not take this medicine to treat withdrawal symptoms if you are dependent on drugs.
There is a slight risk that you may develop so-called serotonin syndrome, which may
occur after taking tramadol together with certain antidepressants or tramadol in
monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with
this serious syndrome (see section 4, “Possible side effects”).
Tramadol is broken down 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 .
Children and adolescents
TRADOGUT should not be used in children under 12 years of age.
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 TRADOGUT
Tell your doctor or pharmacist or dentist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
Do not take TRADOGUT at the same time as medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression or selegiline for Parkinson's disease), or within 14
days of taking them.
The pain-relieving effect of TRADOGUT may be weakened and/or shortened if you are also taking
medicines containing:

• carbamazepine (used to treat epilepsy)
• buprenorphine, nalbuphine or pentazocine (painkillers)
• ondansetron (prevents nausea) The doctor will tell you if you should take TRADOGUT and at what dosage.

The risk of side effects increases if you are taking medicines that can cause seizures
(fits), such as some antidepressants or neuroleptics. The risk of having a seizure may increase if
you take TRADOGUT at the same time. The doctor will tell you if TRADOGUT is suitable for you.
The risk of side effects increases if you are taking certain antidepressants. TRADOGUT may
interact with these medicines and you may experience serotonin syndrome (see section
4, “Possible side effects”).
Medicines used to treat epilepsy can very rarely cause seizures (fits),
but if you are also using TRADOGUT, the possibility of having a seizure is more likely. You should
ask your doctor for information about this.
Medicines that act on the nervous system such as hypnotics, sedatives, sleeping pills and
painkillers, may make you feel drowsy or weak when taken with TRADOGUT.
Anticoagulant medicines to thin the blood, such as warfarin. The effectiveness of these medicines may
be altered if you are also taking TRADOGUT.
The concomitant use of TRADOGUT and sedatives such as benzodiazepines or medicines related to them increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and
may be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes TRADOGUT together with sedatives, the dose and duration of
concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedatives you are taking and carefully follow
the doctor's dosage recommendations. It may be helpful to inform friends or family to pay
attention to the signs and symptoms listed above. Contact your doctor if you experience these symptoms.

Use of TRADOGUT with food, drinks and alcohol
TRADOGUT should be taken once a day with sufficient water, with or
without food. Avoid drinking alcohol while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine. Contact
your doctor if you become pregnant during your treatment.
Pregnancy
You should not take TRADOGUT during pregnancy, as tramadol crosses the placental barrier
and the safety profile during pregnancy has not been established. If you are in severe pain, consult
your treating physician, who will decide if you can take a single dose.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take TRADOGUT more than
once during breastfeeding or, alternatively, if you take TRADOGUT more than once, you should
stop breastfeeding.

Driving and using machines
TRADOGUT, even when taken as instructed, can affect the reactions of drivers,
machine operators and workers. This effect may be enhanced by the use of alcohol, at the start of
treatment, when switching medicines and if taken with other medicines that depress the central nervous
system or antihistamines. If patients are affected, they must be warned not to drive or
operate machinery.

3. How to use TRADOGUT

Always take this medicine exactly as your doctor or pharmacist has told you. If you
are unsure, ask your doctor or pharmacist.

Important: The doctor will choose the right dose for you or for your child. The dosage must be
chosen based on the intensity of your pain and your personal pain sensitivity. In general, you
should take the lowest dose that provides pain relief. The number of capsules to be taken will
be clearly indicated on the label that the pharmacist applies to the medicine. If this is not the case or
if you have any doubts, ask your doctor or pharmacist.
Swallow the capsules whole with water, without chewing.
If you have difficulty swallowing, you can open the capsules. You must open them with great care, pulling and rotating
each end over a spoon, so that the granules remain in the spoon. Do not chew.
Swallow all the granules with a little water.

Dosage for adults and adolescents from 12 years of age:
One or two capsules of TRADOGUT (equivalent to 50-100 mg of tramadol hydrochloride). Depending on the
type of pain, the effect lasts for approximately 4-8 hours. The doctor may increase this dose to 150-200 mg
twice a day, as needed.
The maximum doseis usually 400 mg per day. The daily dose prescribed will depend on the severity of
your pain.

Use in children:
TRADOGUT should not be given to children under 12 years of age.

Use in elderly patients:
In elderly patients (over 75 years of age) the elimination of tramadol may be delayed. If this is
the case, your doctor may recommend extending the dosing interval.

Use in patients with severe liver and/or kidney problems (insufficiency)/dialysis:
Patients with severe hepatic and/or renal insufficiency should not take TRADOGUT. In case of
mild or moderate insufficiency, your doctor may recommend extending the dosing interval.

If you take more TRADOGUT than you should
If you accidentally take more capsules than prescribed, immediately inform your doctor or
pharmacist and, if necessary, contact the nearest emergency room. Remember to bring the
package and any remaining medicine with you.

If you forget to take TRADOGUT
Do not take a double dose to make up for a missed dose.

If you stop taking TRADOGUT
Do not stop taking TRADOGUT or reduce the dose without first discussing it with your doctor. In
general, there will be no consequences if treatment with TRADOGUT is stopped. However,
in rare cases, people who have taken TRADOGUT for a certain time may feel unwell,
if the treatment is stopped suddenly. You may feel restless, anxious, nervous or
shaken. You may be hyperactive, have difficulty sleeping and have stomach or
intestinal problems. If you experience any of these symptoms after stopping TRADOGUT, 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, which
may involve gradually reducing the dose to reduce the likelihood of developing unnecessary side effects
(withdrawal symptoms).
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
Ask your doctor or pharmacist:

• if you are not sure how many drops you should take or when you should take them.
• if you think the effect is too strong or too weak.

4. Possible side effects

Like all medicines, TRADOGUT can cause side effects, although not everybody gets them.
The most serious side effects that may occur include allergic reaction (difficulty breathing, weakness and
swelling of the face or throat), anaphylactic reaction (a severe allergic reaction resulting in difficulty
breathing, changes in heart rate, weakness, collapse or loss of consciousness due to a drop in blood
pressure) or convulsions (seizures). If any of these symptoms occur, stop taking TRADOGUT immediately
and contact your doctor.

Very common (may affect more than 1 in 10 people)
Dizziness.
Vomiting and nausea (feeling unwell).

Common (may affect up to 1 in 10 people)
Headache, drowsiness.
Sleepiness (fatigue).
Constipation, dry mouth.
Sweating.

Uncommon (may affect up to 1 in 100 people)
Rapid heartbeat, palpitations, sudden drops in blood pressure. These adverse events may occur
particularly with intravenous administration and in physically stressed patients.
Itching, skin rash.
Nausea, feeling of fullness or bloating.

Rare (may affect up to 1 in 1,000 people)
Allergic reaction such as difficulty breathing, weakness, swelling of the face or throat.
Anaphylactic reaction (severe allergic reaction).
Changes in appetite.
Psychiatric effects including: mood changes, behaviour and perception of activities, hallucinations,
confusion, restlessness, sleep disturbances and nightmares.
Convulsions (seizures).
Tingling and tremor.
Slow heartbeat, increased blood pressure.
Muscle weakness.
Difficulty or inability to urinate.
Blurred vision.

Very rare (may affect up to 1 in 10,000 people)
Hot flushes.
Vertigo (a sensation of spinning or dizziness).
Asthma and difficulty breathing.
Increased levels of liver enzymes.

Not known (frequency cannot be estimated from the available data)
Decreased blood sugar levels.
Low blood sodium levels which can cause fatigue and confusion, muscle contractions, convulsions and
coma.
Hiccups.
Serotonin syndrome, which can manifest as changes in mental status (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, diarrhoea) (see section 2, “What you need to know before you use TRADOGUT”).
The withdrawal syndromeincludes: agitation, anxiety, nervousness, difficulty sleeping, restlessness,
tremor and gastrointestinal disorders (see section 3, “How to use TRADOGUT”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any 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 TRADOGUT

Do not store at a temperature above 30°C.
Keep this medicine out of sight and reach of children.
Do not use TRADOGUT after the expiry date stated on the packaging. The expiry date refers to
the last day of that 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 TRADOGUT contains:
The active ingredient is tramadol hydrochloride. TRADOGUT contains 50 mg of tramadol hydrochloride.
The other ingredients are: calcium hydrogen phosphate anhydrous, magnesium stearate, colloidal anhydrous silica,
gelatin, titanium dioxide (E171), shellac, iron oxide black (E172), propylene glycol, ammonium
hydroxide.

Description of the appearance of TRADOGUT and contents of the pack:
Immediate-release, hard capsules. The capsules are white and marked with T50.
The capsules are packaged in PVC/PVDC/aluminum blisters. Each blister contains 10
capsules. Each pack contains 10, 30, 50 or 100 capsules per pack. Not all pack sizes may be
marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart Dublin 15, DUBLIN, Ireland

Manufacturer
Temmler Pharma GmbH, Temmlerstrasse 2, D-35039 Marburg (Germany)
MEDA Pharma GmbH & Co. KG, Benzstrasse 1, 61352 Bad Homburg (Germany)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany: Adamon Kaps
Italy: TRADOGUT

TRADOGUT 50 mg/ml injectable solution

Tramadol hydrochloride
Generic medicine

Read this leaflet carefully before you start to use 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What is TRADOGUT and what is it for

TRADOGUT belongs to a class of medicines called analgesics, commonly known as
pain relievers. The active ingredient, tramadol hydrochloride, interrupts the sending of
pain messages to your brain and also works at the brain level to prevent pain messages from
being felt. This means that TRADOGUT does not prevent pain from occurring, but prevents
you from feeling the pain anyway.
TRADOGUT is used to relieve moderate to severe pain (for example, pain after
surgery or after an injury).

2. What you need to know before you are given TRADOGUT

Do not use TRADOGUT if:

• you are allergic to tramadol hydrochloride, or to any of the other ingredients of this medicine (listed in section 6), as skin rash, swelling of the face or breathing difficulties may occur;
• you are taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) to treat depression (see section 2, “Other medicines and TRADOGUT”);
• you have epilepsy that is not controlled by any treatment;
• you have drunk enough alcohol to feel dizzy or drunk;
• you have taken a dose higher than prescribed of your sleeping pills, neuroleptics, antidepressants (neuroleptics and antidepressants are medicines that affect mood and emotions) or other painkillers, which may slow down your breathing and your reactions.

Warnings and precautions
Talk to your doctor before you are given TRADOGUT if:

• you have taken TRADOGUT or any other medicine containing tramadol for a long period;
• you are dependent on morphine;
• you have severe liver or kidney problems;
• you have recently had a head injury or have a particularly severe headache that makes you vomit;
• you have ever had convulsions (fits) or if you suffer from epilepsy;
• you suffer from asthma or breathing difficulties;
• you have recently felt confused, sleepy or weak, or if you have lost consciousness;
• you suffer from depression and are taking antidepressants, as some of them may interact with tramadol (see section 2, “Other medicines and TRADOGUT”).

If any of the conditions mentioned above apply to you, consult your doctor as they may decide to
change your treatment.
Sleep-related breathing disorders
TRADOGUT can cause sleep-related breathing disorders such as sleep apnea (pauses
in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood).
Symptoms may include pauses in breathing during sleep, night-time awakenings due to labored breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or another
person observes these symptoms, contact your doctor, who may consider a
reduction in the dose.
Talk to your doctor if you notice any of the following symptoms while taking TRADOGUT:
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.
There is a rare possibility that TRADOGUT may cause convulsions (fits). The risk increases if
doses higher than the maximum daily doses are taken and if you are also taking antidepressants or
neuroleptics.
If you are prone to dependence or drug abuse, you should only be given TRADOGUT for
short periods. Inform your doctor of this because they may want to monitor your
pain control more closely.
You should not take this medicine to treat withdrawal symptoms if you are dependent on drugs.
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 in
monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with
this serious syndrome (see section 4, “Possible side effects”).
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 .
Children and adolescents
TRADOGUT should not be given to children under one year of age.
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 TRADOGUT
Tell your doctor or pharmacist or your dentist if you are taking or have recently taken any
other medicines, including those available without a prescription.
Do not take TRADOGUT at the same time as medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression or selegiline for Parkinson's disease), or within 14
days of taking them.
The pain-relieving effect of TRADOGUT may be weakened and/or shortened if you are also taking
medicines containing:

• carbamazepine (used to treat epilepsy)
• buprenorphine, nalbuphine or pentazocine (painkillers)
• ondansetron (prevents nausea) Your doctor will tell you if you should take TRADOGUT and at what dosage.

The risk of side effects increases if you are taking medicines that can cause convulsions
(fits), such as some antidepressants or neuroleptics. The risk of having a fit may increase if you
are given TRADOGUT at the same time. Your doctor will tell you if TRADOGUT injectable solution
is suitable for you.
The risk of side effects increases if you are taking certain antidepressants. TRADOGUT may
interact with these medicines and you may experience serotonin syndrome (see section
4, “Possible side effects”).
Medicines used to treat epilepsy can very rarely cause convulsions (fits),
but if you are also using TRADOGUT, the possibility of having a convulsion is more likely. You should
ask your doctor for information about this.
Medicines that act on the nervous system such as hypnotics, sedatives, sleeping pills and
painkillers, can make you feel sleepy or weak when taken with TRADOGUT.
Anticoagulant drugs to thin the blood, such as warfarin. The effectiveness of these medicines may
be altered if you are also taking TRADOGUT.
The concomitant use of TRADOGUT and sedatives such as benzodiazepines or medicines related
to them increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and
can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes TRADOGUT together with sedatives, the dose and duration of
concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedatives you are taking and carefully follow
your doctor's dosage recommendations. It may be helpful to tell friends or family to pay
attention to the signs and symptoms listed above. Contact your doctor if you experience these symptoms.
TRADOGUT is incompatible with injectable solutions of diclofenac, indometacin, phenylbutazone,
diazepam, flunitrazepam, midazolam and nitroglycerin.

TRADOGUT with food, drink and alcohol
Avoid drinking alcohol while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine. Contact
your doctor if you become pregnant during your treatment.
Pregnancy
You should not take TRADOGUT during pregnancy except in serious cases, in which your doctor
may decide to give you single doses.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take TRADOGUT or, in
alternatively, if you take TRADOGUT more than once, you should stop breastfeeding.

Driving and using machines
TRADOGUT can cause drowsiness, especially if used with alcohol, antihistamines and other medicines that
can cause drowsiness. Do not drive or use machines unless you know how TRADOGUT
affects you.

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

3. How TRADOGUT will be administered to you

TRADOGUT will be administered to you by a doctor or a nurse.

Important: The doctor will choose the right dose for you or for your child. The volume to
be administered will be clearly indicated on the label that the pharmacist applies to the medicine.
The injection is given intravenously, intramuscularly or subcutaneously.
The recommended dosage is:

Dosage for adults and adolescents from 12 years:
The usual dose is 50 mg (1 ml) or 100 mg (2 ml) every 4-6 hours. Intravenous injections must be
administered slowly over 2-3 minutes.
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.
The maximum doseis usually 400 mg per day (8 ml) but may be higher if the pain is severe.
The daily dose will depend on the severity of your pain.

Use in children:
TRADOGUT should not be used in children under one year of age.
Dosage for children from 1 to 12 years of age: the usual dose is a single dose of tramadol hydrochloride
from 1-2 mg per kg of body weight.

Use in elderly patients:
In elderly patients (over 75 years of age), the elimination of tramadol may be delayed. If this is the case, your
doctor may recommend that you prolong the dosage interval.

Use in patients with severe liver and/or kidney problems (insufficiency)/dialysis:
Patients with severe hepatic and/or renal insufficiency should not take TRADOGUT. In case of
mild or moderate insufficiency, your doctor may recommend that you prolong the dosage interval.
Consult your doctor or pharmacist if you feel that the effect is too strong or too weak.

If you are given more TRADOGUT than necessary
If you are given a dose higher than the prescribed one, inform your doctor or
pharmacist immediately and, if necessary, contact the nearest emergency room. Remember to bring with you the
package and unused medicine of TRADOGUT.

If you forget a dose of TRADOGUT
You should not be given a double dose to compensate for the forgotten dose.

If you stop taking TRADOGUT
In general, there will be no consequences if the treatment with TRADOGUT is stopped.
However, in rare cases, people who have been given TRADOGUT for a certain time may
feel unwell if their treatment is stopped suddenly. You may feel
agitated, anxious, nervous or shaken. You may be hyperactive, have difficulty falling asleep and have
stomach or intestinal disorders. If you experience any of these disorders after stopping
TRADOGUT, 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. Your doctor will advise you when and how to stop it, which
may involve gradually decreasing the dose to reduce the likelihood of developing unnecessary side effects
(withdrawal symptoms).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, TRADOGUT can cause side effects, although not everybody gets them.
The most serious side effects that may occur include allergic reaction (difficulty
breathing, weakness and swelling of the face or throat), anaphylactic reaction (a severe allergic
reaction resulting in difficulty breathing, changes in heart rate, weakness, collapse or
loss of consciousness due to a drop in blood pressure) or convulsions (seizures). If any of
these symptoms occur, stop TRADOGUT immediately and contact your
doctor.

Very common (may affect more than 1 in 10 people)
Dizziness.
Vomiting and nausea (feeling unwell).

Common (may affect up to 1 in 10 people)
Headache, drowsiness.
Sleepiness (fatigue).
Constipation, dry mouth.
Sweating.

Uncommon (may affect up to 1 in 100 people)
Rapid heartbeat, palpitations, sudden drops in blood pressure. These adverse events
may occur especially with intravenous administration and in physically stressed
patients.
Itching, skin rash.
Nausea, feeling of bloating or fullness.

Rare (may affect up to 1 in 1,000 people)
Allergic reaction such as difficulty breathing, weakness, swelling of the face or throat.
Anaphylactic reaction (severe allergic reaction).
Changes in appetite.
Psychiatric effects including: mood changes, behaviour and perception of activities,
hallucinations, confusion, restlessness, sleep disturbances and nightmares.
Convulsions (seizures).
Feeling of tingling and tremor.
Slow heartbeat, increased blood pressure.
Muscle weakness.
Difficulty or inability to urinate.
Blurred vision.

Very rare (may affect up to 1 in 10,000 people)
Hot flushes.
Vertigo (sensation of dizziness or “spinning”).
Asthma and difficulty breathing.
Increased levels of liver enzymes.

Not known (frequency cannot be estimated from available data)
Decreased blood sugar levels.
Low blood sodium levels which can cause fatigue and confusion, muscle contractions,
convulsions and coma.
Hiccups.
Serotonin syndrome, which can manifest as changes 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 paragraph
2, “What you need to know before you are given TRADOGUT”).
The withdrawal syndromeincludes: agitation, anxiety, nervousness, difficulty sleeping,
restlessness, tremor and gastrointestinal disturbances (see paragraph 3. How TRADOGUT injectable solution will be given to you).

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 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 TRADOGUT

Keep this medicine out of the sight and reach of children.
TRADOGUT must not be used after the expiry date stated on the packaging. The expiry date refers to the last day of that 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.
Do not store at a temperature above 30°C.
Store in the original packaging to protect the medicine from moisture.
TRADOGUT must be used immediately after first opening/dilution. Any remaining solution must be immediately discarded.

6. Contents of the pack and other information

What TRADOGUT contains:
The active ingredient is tramadol hydrochloride. TRADOGUT contains 50 mg of tramadol hydrochloride per each
ml of solution.
The other components of the contents are:
Sodium acetate trihydrate (equivalent to 0.7 mg sodium/ml)
Water for injection

Description of the appearance of TRADOGUT and contents of the pack:
Injectable solution. Colourless, clear solution.
TRADOGUT injectable solution is supplied in packs of 5, 10 and 50 glass vials, coloured,
each containing 2 ml of solution. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart Dublin 15, DUBLIN, Ireland

Manufacturer
Meda Pharma GmbH & Co. KG, Bad Homburg (Germany)
Gruenenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany: Adamon Inject
Italy: TRADOGUT

TRADOGUT 100 mg/ml oral drops, solution

Tramadol hydrochloride
Generic medicine

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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What is TRADOGUT and what it is used for

TRADOGUT belongs to a class of medicines called analgesics, commonly known as
pain relievers. TRADOGUT contains the active ingredient tramadol hydrochloride. The
active ingredient, tramadol hydrochloride, interrupts the sending of pain messages to your brain and also acts
at the brain level to prevent pain messages from being felt. This means that
TRADOGUT does not prevent pain from occurring, but prevents you from feeling the pain anyway.
TRADOGUT is used to relieve moderate to severe pain (for example, pain after
surgery, or after an injury).

2. What you need to know before you use TRADOGUT

Do not take TRADOGUT:

• if you are allergic to tramadol hydrochloride, menthol or any of the other ingredients of this medicine (listed in section 6), as skin rash, swelling of the face or breathing difficulties may occur;
• if you are taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) to treat depression (see section 2, “Other medicines and TRADOGUT”);
• if you have epilepsy that is not controlled by any treatment;
• if you have drunk enough alcohol to feel dizzy or drunk;
• if you have taken a dose higher than prescribed of your sleeping tablets, neuroleptics, antidepressants (neuroleptics and antidepressants are medicines that affect mood and emotions) or other painkillers, which may slow down your breathing and reactions.

If you are prone to addiction or abuse of drugs, you should only take TRADOGUT for short periods. Inform your doctor about this because they may want to monitor your pain control more closely. You should not take this medicine to treat withdrawal symptoms if you are dependent on drugs.

Warnings and precautions
Talk to your doctor or pharmacist before using TRADOGUT, if:
you are pregnant or breastfeeding;
you have been taking TRADOGUT or any other medicine containing tramadol for a long period;
you are dependent on morphine;
you have had an allergic reaction to any morphine-like medicine;
you have severe liver or kidney problems;
you have recently had a head injury or have a particularly severe headache that makes you vomit;
you have ever had seizures (fits) or if you suffer from epilepsy;
you suffer from asthma or breathing difficulties;
you have recently felt confused, drowsy or weak, or if you have lost consciousness;
you are taking other medicines;
you are going to have surgery with general anesthesia;
you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see section 2, “Other medicines and TRADOGUT”).
There is a rare possibility that TRADOGUT may cause seizures (fits). The risk increases if doses higher than the maximum daily doses are taken and if you are also taking antidepressants or neuroleptics.
If any of the above conditions apply to you, consult your doctor as they may decide to change your treatment.
Sleep-related breathing disorders
TRADOGUT can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to labored breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or another person observe these symptoms, contact your doctor, who may consider reducing the dose.
Talk to your doctor if you notice any of the following symptoms while taking TRADOGUT:
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.
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”).

Children and adolescents
TRADOGUT should not be given to children under one year of age.

Other medicines and TRADOGUT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
Do not take TRADOGUT at the same time as medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression or selegiline for Parkinson's disease) or within 14 days of taking them.
The pain-relieving effect of TRADOGUT may be weakened and/or shortened if you are also taking medicines containing:

• carbamazepine (used to treat epilepsy)
• buprenorphine, nalbuphine or pentazocine (painkillers)
• ondansetron (prevents nausea) Your doctor will tell you whether to take TRADOGUT and at what dosage.

The risk of side effects increases if you are taking medicines that can cause seizures (fits), such as some antidepressants or neuroleptics. The risk of having a seizure may increase if you take TRADOGUT oral drops at the same time. Your doctor will tell you if TRADOGUT is suitable for you.
The risk of side effects increases if you are taking certain antidepressants. TRADOGUT may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
Medicines used to treat epilepsy can very rarely cause seizures (fits), but if you are also using TRADOGUT, the likelihood of having a seizure is more likely. You should ask your doctor for information about this.
Medicines that act on the nervous system such as hypnotics, sedatives, sleeping pills and painkillers, can make you feel drowsy or weak when taken with TRADOGUT.
Anticoagulant drugs to thin the blood, such as warfarin. The effectiveness of these medicines may be altered if you are also taking TRADOGUT.
The concomitant use of TRADOGUT and sedative medicines and medicines with sedative properties such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes TRADOGUT together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedative medicines you are taking and carefully follow your doctor's dosage recommendations. It may be helpful to inform friends or family members to pay attention to the signs and symptoms listed above. Contact your doctor if you experience these symptoms.

TRADOGUT with food, drink and alcohol
TRADOGUT should be taken with some water, during or away from meals. Avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy and fertility
There is limited information on the safety of tramadol in human pregnancy.
Therefore, you should not take TRADOGUT if you are pregnant.
Repeated use of this medicine during pregnancy can lead to habituation of the unborn child to tramadol and, consequently, to neonatal withdrawal symptoms after birth.
Based on human experience, it is suggested that tramadol hydrochloride does not affect female or male fertility.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take TRADOGUT more than once during breastfeeding. However, if you take TRADOGUT more than once, you should stop breastfeeding.

Driving and using machines
TRADOGUT can cause drowsiness, especially if used with alcohol, antihistamines and other medicines that can cause drowsiness. Do not drive or operate machinery until you know how TRADOGUT affects you.

TRADOGUT contains ethanol (alcohol) and sucrose
This medicine contains 75.92 mg of ethanol (alcohol) per each dose (20 drops). The amount in one dose of this medicine is equivalent to less than 1.9 ml of beer or 0.8 ml of wine. The small amount of alcohol in the medicine has no noticeable effects.
This medicine also contains sucrose. If your doctor has told you that you are intolerant to certain sugars, consult your doctor before taking this medicine.

3. How to take TRADOGUT

Always take this medicine exactly as your doctor has instructed. If you have any doubts, ask your
doctor or pharmacist.

Important: Your doctor will choose the right dose for you or for your child. The number of drops to
take will be clearly indicated on the label that the pharmacist applies to the medicine. If this is not
the case or if you have any doubts, ask your doctor or pharmacist.
The bottle containing the medicine has a built-in dropper and a child-resistant screw cap.
To dispense the drops:

• press firmly on the cap and then unscrew it;
• turn the bottle upside down;
• gently tap the bottom of the bottle until the first drop appears;
• count the desired number of drops onto a spoon.

Dosage for adults and adolescents from 12 years:
The usual initial dose is 50-100 mg (20 to 40 drops) twice a day, in the morning and in the evening. The
doctor may increase this dose to 150-200 mg (60 to 80 drops) twice a day, according to
their needs. Normally you should take TRADOGUT every 12 hours, at the same time, in the morning and
in the evening.
Take TRADOGUT with a little water, with or without food.
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.
The maximum doseis usually 400 mg per day (160 drops). The daily dose prescribed will depend
on the severity of your pain.

Use in children:
TRADOGUT is not indicated in children under 1 year of age.
In children between 1 and 12 years of age, administer a single dose of tramadol hydrochloride of 1

• 2 mg per kg of weight.

The following chart shows typical examples based on specific ages (each drop of oral solution
contains approximately 2.5 mg of tramadol hydrochloride):

Use in elderly patients:
In elderly patients (over 75 years of age), the elimination of tramadol may be delayed. If this is the case,
your doctor may recommend that you prolong the dosing interval.

Use in patients with severe liver and/or kidney problems (insufficiency)/dialysis:
Patients with severe hepatic and/or renal insufficiency should not take TRADOGUT. In case of
mild or moderate insufficiency, your doctor may advise you to recommend prolonging the dosing
interval.
Ask your doctor or pharmacist:

• if you are not sure how many drops you should take or when you should take them.
• if you think the effect is too strong or too weak.

If you take more TRADOGUT than you should
If you accidentally take more drops than prescribed, immediately inform your doctor or
pharmacist and, if necessary, contact the nearest emergency room. Remember to bring the
package and any remaining medicine with you.

If you forget to take TRADOGUT
Do not take a double dose to make up for a missed dose.

If you stop taking TRADOGUT
Do not stop taking TRADOGUT or reduce the dose without first discussing it with your doctor. In
general, there will be no consequences if the treatment with TRADOGUT is stopped. However,
in rare cases, people who have taken TRADOGUT for a certain time may experience withdrawal
symptoms and feel unwell if the treatment is stopped suddenly. You may feel restless, anxious, nervous or
shaky. You may be hyperactive, have difficulty sleeping and have stomach or intestinal problems. If you
experience any of these symptoms after stopping TRADOGUT, consult your doctor.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, TRADOGUT can cause side effects, although not everybody gets them.
The more serious side effects that may occur include allergic reactions (difficulty
breathing, weakness and swelling of the face or throat), anaphylactic reactions (severe allergic
reactions resulting in difficulty breathing, changes in heart rate, weakness, collapse or
loss of consciousness due to a drop in blood pressure) or convulsions (seizures). If any of
these symptoms occur, stop taking TRADOGUT immediately and
contact your doctor.

Very common (may affect more than 1 in 10 people)

• Dizziness.
• Vomiting and nausea (feeling unwell).

Common (may affect up to 1 in 10 people)

• Headache, drowsiness.
• Sleepiness (fatigue).
• Constipation, dry mouth.
• Sweating.

Uncommon (may affect up to 1 in 100 people)

• Rapid heartbeat, palpitations, sudden drops in blood pressure. These adverse events may occur especially with intravenous administration and in physically stressed patients.
• Itching, skin rash.
• Nausea, feeling of bloating or fullness, diarrhea.

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

• Allergic reaction, such as difficulty breathing, weakness, swelling of the face or throat.
• Anaphylactic reaction (severe allergic reaction).
• Changes in appetite.
• Psychiatric effects including: mood changes, activity, behaviour and perception changes, hallucinations, confusion, restlessness, sleep disturbances and nightmares.
• Convulsions (seizures).
• Feeling of tingling and tremor.
• Slow heartbeat, increased blood pressure.
• Muscle weakness.
• Difficulty or inability to urinate.
• Slow breathing and shortness of breath (dyspnea).
• Blurred vision, small (constricted) pupil, dilated pupil.
• Worsening of asthma, however it has not been established whether this was caused by tramadol hydrochloride.

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

• Hot flushes.
• Vertigo (a sensation of spinning or dizziness).
• Increased levels of liver enzymes.

Not known (frequency cannot be estimated from the available data)

• Decreased blood sugar levels.
• Low level of sodium in the blood which can cause fatigue and confusion, muscle cramps, convulsions and coma.
• Hiccups.
• Serotonin syndrome, which can manifest as changes in mental status (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 use TRADOGUT”).

The withdrawal syndromeincludes: agitation, anxiety, nervousness, difficulty sleeping,
restlessness, tremor and gastrointestinal disorders (see section 3, “How to take TRADOGUT”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any 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 TRADOGUT

Keep this medicine out of sight and reach of children.
Do not use TRADOGUT after the expiry date which is reported on the packaging. The expiry date refers to the last day of that 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.
Do not store at a temperature above 30°C.
Store in the original packaging, to protect the medicine from moisture.
This medicine must be used within 3 months of first opening.

6. Contents of the pack and other information

What TRADOGUT contains:
The active ingredient is tramadol hydrochloride. TRADOGUT contains 100 mg of tramadol hydrochloride in each
ml of solution.
The other components of the solution are: potassium sorbate, propylene glycol, ethanol,
sucrose, polysorbate 80, peppermint oil, purified water.

Description of the appearance of TRADOGUT and contents of the pack:
Oral drops, solution. Clear solution, from colourless to pale yellow.
TRADOGUT is contained in a brown glass bottle with a child-resistant plastic cap and a dropper. Each bottle contains 10 ml of solution. The packs contain 1, 2, 5,
10, 20 or 50 bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart Dublin 15, DUBLIN, Ireland

Manufacturer(s)
Temmler Pharma GmbH, Temmlerstrasse 2, 35039 Marburg (Germany)
MEDA Pharma GmbH & Co. KG, Benzstrasse 1, 61352 Bad Homburg (Germany)

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Germany: Adamon Tropfen
Italy: TRADOGUT