FORTRADOL 50 mg Hard Capsules

Зміст інструкції

1. FORTRADOL 50 mg /1 ml injectable solution
   1. What is FORTRADOL and what is it used for
   2. What you need to know before you use FORTRADOL
   3. How to use FORTRADOL
   4. Possible side effects
   5. How to store Fortradol
   6. Contents of the pack and other information
2. FORTRADOL 150 mg prolonged-release tablets
   1. What is FORTRADOL and what it is used for
   2. What you need to know before you take FORTRADOL
   3. How to take FORTRADOL
   4. Possible side effects
   5. How to store FORTRADOL
   6. Package Contents and Other Information
   7. What is FORTRADOL and what it is used for
   8. What you need to know before you take FORTRADOL
   9. How to take FORTRADOL
   10. Possible side effects
   11. How to store FORTRADOL
   12. Package Contents and Other Information
   13. What is FORTRADOL and what is it used for
   14. What you need to know before you take FORTRADOL
   15. How to take FORTRADOL
   16. Possible side effects
   17. How to store Fortradol
   18. Contents of the pack and other information
3. FORTRADOL 100 mg prolonged-release tablets
   1. What is FORTRADOL and what is it used for?
   2. What you need to know before taking FORTRADOL
   3. How to take FORTRADOL
   4. Possible side effects
   5. How to store FORTRADOL
   6. Contents of the pack and other information

FORTRADOL 50 mg /1 ml injectable solution

FORTRADOL 100 mg /2 ml injectable solution
Tramadol hydrochloride
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 only for you. Do not give it to other people even if they have the same symptoms as you, as 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 FORTRADOL is and what it is used for
• 2. What you need to know before you use FORTRADOL
• 3. How to use FORTRADOL
• 4. Possible side effects
• 5. How to store FORTRADOL
• 6. Contents of the pack and other information

1. What is FORTRADOL and what is it used for

Tramadol, the active ingredient of FORTRADOL, is a pain reliever (analgesic) that belongs to the class of
opioids and acts at the level of the central nervous system. It reduces pain by acting on specific nerve cells
in the spinal cord and brain.
Fortradol 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 use FORTRADOL

Do not use FORTRADOL

• 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 Fortradol (see “Other medicines and Fortradol”);
• if you have epilepsy and your seizures are not adequately controlled by therapy;
• as a substitute in detoxification therapy from drugs.

Warnings and precautions

Sleep-related breathing disorders
Fortradol can cause sleep-related breathing disorders, such as sleep apnea (pauses in
breathing during sleep) and sleep-related hypoxemia (low oxygen levels 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
observes these symptoms, contact your doctor, who may consider reducing the
dose.
Talk to your doctor or pharmacist before using Fortradol:

• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Fortradol”);
• 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);
• 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.

There is a slight risk that you may develop the so-called serotonin syndrome, which may
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”).
Seizures have been reported in patients taking tramadol at recommended dosages. The risk
may increase when tramadol dosages exceed the recommended ones, beyond the daily limit
of 400 mg.
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.

Tolerance, physical and psychological dependence
This medicine contains tramadol, a medicine belonging to the class of opioids.
Repeated use of opioids can lead to a decrease in the effectiveness of the medicine (the patient gets used to its
use, a phenomenon known as tolerance). Repeated use of Fortradol can also induce abuse
and physical and psychological dependence, with the consequent risk of potentially fatal overdose. The risk
of these adverse effects may increase in case of higher doses and prolonged use.
In case of physical or psychological dependence, you may feel unable to control
the amount of medication you need or the frequency with which you have to take it.
The risk of developing physical or psychological dependence varies from person to person. It is possible that the risk of
developing physical or psychological dependence on Fortradol increases if:

• You or a family member has a history of alcohol, prescription drug, or illegal drug abuse or dependence (“addiction”);
• You are a smoker;
• You have had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs while taking Fortradol, you may have developed physical or psychological dependence:
• You need to take the medicine for a longer period than recommended by the doctor;
• You need to take a higher dose than recommended;
• You use the medicine for reasons other than those for which it was prescribed, such as to “stay calm” or “promote sleep”;
• You have repeatedly tried, but unsuccessfully, to stop or control the use of the medicine;
• You feel unwell when you stop taking the medicine and feel better when you take it again (“withdrawal symptoms”).

If you notice any of these signs, consult your doctor to evaluate the most appropriate therapeutic path for you,
including when it is appropriate to stop treatment and how to do it safely (see section 3, If
you stop taking Fortradol).
In patients with a tendency to abuse medicines or who are dependent on medicines, Fortradol must 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 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 a doctor immediately: slowed or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or
sick, constipation, loss of appetite.

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

• carbamazepine (for epileptic seizures);
• pentazocine, nalbuphine or buprenorphine (analgesics);
• ondansetron (to prevent nausea). Your doctor will tell you if and what dosages of Fortradol you should take.

The risk of side effects increases if you are taking:

• other analgesics such as morphine and codeine (even when taken for cough), and alcohol together with Fortradol. You may feel drowsy or weak. In these cases, consult your doctor.
• the concomitant use of Fortradol 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 Fortradol 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 the dosage recommendations provided by the doctor. It may be helpful to inform friends or family members about the signs and symptoms 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 Fortradol at the same time. Your doctor will tell you if Fortradol is suitable for you.
• certain antidepressants, Fortradol 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 Fortradol. The effect of these medicines on blood coagulation may be affected and bleeding may occur.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain)

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

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 regarding the safety of tramadol in pregnant women. Therefore, if you
are pregnant, you should not use Fortradol 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 Fortradol more than once
during breastfeeding or, alternatively, if you take Fortradol more than once, you should stop breastfeeding.
Ask your doctor for advice.
There are limited data on the effects of Fortradol on fertility. Post-marketing data do not suggest
an effect of tramadol on fertility.

Driving and using machines
Fortradol 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 tools that require a
safe support.
Fortradol injectable solution contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially “sodium-free”.

For athletes:
The use of the drug without therapeutic necessity constitutes doping and may still result in positive
anti-doping tests.

3. How to use FORTRADOL

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Before starting treatment and at regular intervals during it, the doctor will discuss with you what
you can expect from using Fortradol, when and for how long you should take it, when you should contact
the doctor and when you should stop it (see also paragraph 2).
The dosage should 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 Fortradol solution for injection (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 of more than 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 Fortradol. In case of mild or moderate
insufficiency, your doctor may advise you to extend the time interval between doses.

How and when to administer FORTRADOL solution for injection
Fortradol solution for injection should be injected slowly, into a vein (usually in the arm) or into the muscle
(usually in the buttock) or subcutaneously. Fortradol solution for injection can be diluted in a suitable
infusion solution and infused into a vein.

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

Information on how to use
Fortradol solution for injection is supplied in snap-off ampoules. The ampoule has a scored line for opening:

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

How long should you use Fortradol
You should not use Fortradol 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 Fortradol is too strong or too weak, consult your doctor or
pharmacist.

If you use more FORTRADOL than you should
If you have been given an extra dose by mistake, this should not have any negative effects. You can
continue to administer the medicine as prescribed.
After very high doses, the following may occur: pinpoint pupils, vomiting, drop in blood pressure,
fast heartbeat, collapse, loss of consciousness up to coma, seizures, and difficulty breathing up to respiratory arrest. In these cases, call the doctor
immediately.

If you forget to use FORTRADOL
If Fortradol solution for injection has not been administered, the pain is likely to return. You should not
administer a double dose to compensate for this forgetfulness, but continue treatment according to the
instructions.

If you stop the treatment with FORTRADOL
If you stop or terminate the treatment too early, the pain is likely to return.
If you wish to stop treatment due to unwanted 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 Fortradol is stopped, no withdrawal effects occur.
However, in rare cases, some people who have taken Fortradol 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 unusual CNS symptoms such as confusion, delusion, changes in 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 Fortradol, see your doctor.

If you have any doubts about the use of this medicine, consult 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
• need to vomit (nausea), stomach pain (feeling of pressure in the stomach, bloating), diarrhea
• 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, 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 disorders, delirium, anxiety and nightmares. Psychological symptoms may occur after treatment with Fortradol, 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 Fortradol”).
• 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 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
• slow breathing

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

• decrease in blood sugar levels (hypoglycemia)
• hiccups
• sleep-related breathing disorders (central sleep apnea syndrome)
• 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, diarrhea) (see section 2 “What you need to know before using Fortradol”).

Cases of SIADH (syndrome of inappropriate antidiuretic hormone secretion) and hyponatremia (low sodium levels in the blood) have been reported in the literature, although a causal relationship for tramadol has not been established.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. 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 Fortradol

Keep out of sight and reach of children.
Store this medicine in a safe and secure place, where other people cannot access it.
It can cause serious harm and be fatal to people when it has not been prescribed for them.
Do not use this medicine after the expiry date that is reported on the package and label. The expiry date refers to the last day of the 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. Contents of the pack and other information

What FORTRADOL contains
The active ingredient is tramadol hydrochloride.
FORTRADOL 100 mg/2 ml injectable solution: each vial contains 100 mg of tramadol hydrochloride.
FORTRADOL 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 FORTRADOL injectable solution and contents of the pack
Colourless, clear solution.
FORTRADOL injectable solution is contained in clear glass vials, in packs of 5 vials.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alfasigma S.p.A. – Via Ragazzi del ’99, n. 5 – 40133 Bologna (BO)

Manufacturer responsible for batch release
Farmaceutici Formenti S.p.A. – Via di Vittorio, 2 – 21040 Origgio (VA)
Grünenthal GmbH Aachen, Germany

FORTRADOL 150 mg prolonged-release tablets

FORTRADOL 200 mg prolonged-release tablets
Tramadol hydrochloride
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 their symptoms are the same as yours because 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 FORTRADOL is and what it is used for
• 2. What you need to know before you take FORTRADOL
• 3. How to take FORTRADOL
• 4. Possible side effects
• 5. How to store FORTRADOL
• 6. Contents of the pack and other information

1. What is FORTRADOL and what it is used for

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

2. What you need to know before you take FORTRADOL

Do not take Fortradol

• 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 within the last 14 days before treatment with Fortradol (see “Other medicines and Fortradol");
• if you have epilepsy and your seizures are not adequately controlled by therapy;
• as a substitute in drug detoxification therapy.

Warnings and precautions

Sleep-related breathing disorders
Fortradol 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 staying asleep, or excessive daytime sleepiness. If you or another
person observes these symptoms, contact your doctor, who may consider reducing
the dose.

Talk to your doctor or pharmacist before taking Fortradol:

• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Fortradol”).
• if you think you are overusing 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 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;

There is a slight risk that you may develop the so-called serotonin syndrome, which may
occur after taking tramadol together with certain antidepressants or tramadol as monotherapy.
Immediately consult a doctor if you experience any of the symptoms associated with this serious syndrome
(see section 4 “Possible side effects”).
Seizures have been reported in patients taking tramadol at recommended dosages. The risk
may increase when tramadol dosages exceed those recommended, beyond the daily limit
of 400 mg.
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.

Tolerance, physical and psychological dependence
This medicine contains tramadol, a medicine belonging to the class of opioids.
Repeated use of opioids can lead to a decrease in the effectiveness of the medicine (the patient gets used to its
intake, a phenomenon known as tolerance). Repeated use of Fortradol can also induce abuse
and physical and psychological dependence, with a consequent risk of potentially fatal overdose. The risk
of these side effects may increase with higher doses and prolonged use.
In case of physical or psychological dependence, you may feel unable to control
the amount of medication you need or the frequency with which you have to take it.
The risk of developing physical or psychological dependence varies from person to person. It is possible that the risk of
developing physical or psychological dependence on Fortradol increases if:

• You or a family member has a history of alcohol, prescription drug, or illegal drug abuse or dependence (“addiction”);
• You are a smoker;
• You have had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs while taking Fortradol, you may have developed physical or psychological dependence:
• You need to take the medicine for a longer period than recommended by your doctor;
• You need to take a higher dose than recommended;
• You use the medicine for reasons other than those for which it was prescribed, such as to "stay calm" or "help you sleep";
• You have repeatedly tried, but failed, to stop or control the use of the medicine;
• You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal effects"). If you notice any of these signs, see your doctor to evaluate the most appropriate therapeutic path for you, including when it is appropriate to stop treatment and how to do so safely (see section 3, If you stop taking Fortradol).

In patients with a tendency to abuse medicines or who are dependent on medicines, Fortradol must be
taken only 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 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 a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or
sick, constipation, loss of appetite.

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

• The intensity and duration of the analgesic effect of Fortradol may be reduced if you are taking medicines
  that contain:
• carbamazepine (for epileptic seizures);
• pentazocine, nalbuphine or buprenorphine (analgesics);
• ondansetron (to prevent nausea). Your doctor will tell you if and what dosages of Fortradol you should take.

The risk of side effects increases if you are taking:

• other analgesics such as morphine and codeine (even when taken for cough), and alcohol together with Fortradol. You may feel sleepy or weak. In these cases, consult your doctor.
• The concomitant use of Fortradol 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 Fortradol 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 (attacks), such as some antidepressants or antipsychotics. The risk of having a seizure may increase if you take Fortradol at the same time. Your doctor will tell you if Fortradol is suitable for you.
• certain antidepressants, Fortradol 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 Fortradol. The effect of these medicines on blood coagulation may be affected and bleeding may occur.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain)

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or 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 Fortradol.
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 Fortradol more than once
during breastfeeding or, alternatively, if you take Fortradol more than once, you should stop
breastfeeding.
There is limited data on the effects of Fortradol on fertility. Post-marketing data do not suggest an
effect of tramadol on fertility.

Driving and operating machinery
Fortradol 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.

Fortradol prolonged-release tablets contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

For athletes:
The use of the drug without therapeutic necessity constitutes doping and may still result in positive
doping tests.

3. How to take FORTRADOL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Before starting treatment and at regular intervals during it, your doctor will discuss with you what
you can expect from using Fortradol, when and for how long you should take it, when you should contact
your doctor and when you should stop it (see also paragraph 2).
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 Fortradol 150 mg extended-release tablet twice a day (equivalent to 300 mg of
tramadol hydrochloride per day), preferably in the morning and evening.
One Fortradol 200 mg extended-release tablet 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 Fortradol.

Use in children
Fortradol extended-release tablets are not suitable 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 Fortradol. In case of mild or
moderate insufficiency, your doctor may advise you to extend the time interval between doses.

How and when to take Fortradol
Fortradol extended-release tablets are to be taken by mouth.
Always swallow Fortradol extended-release tablets whole, not divided or chewed, with a
sufficient amount of liquid, preferably in the morning and evening. You can take the tablets both
during or away from meals.

How long to take Fortradol
Do not take Fortradol 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 Fortradol is too strong or too weak, consult your doctor or
pharmacist.

If you take more Fortradol 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, low 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 Fortradol
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 taking the tablets as before.

If you stop taking Fortradol
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, which may involve
gradually reducing the dose to reduce the likelihood of developing unnecessary side effects
(withdrawal symptoms).
Generally, when treatment with Fortradol is stopped, no withdrawal effects occur.
However, in rare cases, some people who have taken Fortradol for a certain period of time, when
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 perception of one's personality (depersonalization) and changes in perception of reality (derealization) and sense of persecution (paranoia). If you experience any of these symptoms after stopping Fortradol, 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.
manifest.

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 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, 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 Fortradol, 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 Fortradol”)
• 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 could have been caused by tramadol
• muscle weakness
• difficulty or pain when urinating, reduced urine output (dysuria)

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

• increased liver enzyme values
• slow breathing

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

• decreased blood sugar levels (hypoglycemia)
• hiccups
• sleep-related breathing disorders (central sleep apnea syndrome)
• 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, diarrhea) (see section 2 “What you need to know before you take Fortradol”).

Cases of SIADH (syndrome of inappropriate antidiuretic hormone secretion) and hyponatremia (low sodium levels in the blood) have been reported in the literature, although a causal relationship for tramadol has not been established.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. 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 FORTRADOL

Keep out of sight and reach of children.
Store this medicine in a safe and secure place, where other people cannot access it.
It can cause serious harm and be fatal to people when it has not been prescribed for them.
Do not use this medicine 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 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. Package Contents and Other Information

What Fortradol Contains
The active ingredient is tramadol hydrochloride.
Fortradol prolonged-release tablets 150 mg
One tablet contains 150 mg of tramadol hydrochloride.
The other ingredients are: core: microcrystalline cellulose, hypromellose 100,000 mPa
s, magnesium
stearate, anhydrous colloidal silica; coating: hypromellose 6 mPa
s, lactose monohydrate (see
section 2 “Fortradol contains lactose”), macrogol 6000, propylene glycol, talc, titanium dioxide
(E 171), quinoline yellow (E 104), iron oxide red (E 172).
Fortradol prolonged-release tablets 200 mg
One tablet contains 200 mg of tramadol hydrochloride.
The other ingredients are: core: microcrystalline cellulose, hypromellose 100,000 mPa
s, magnesium
stearate, anhydrous colloidal silica; coating: hypromellose 6 mPa
s, lactose monohydrate (see
section 2 “Fortradol contains lactose”), macrogol 6000, propylene glycol, talc, titanium dioxide
(E 171), quinoline yellow (E 104), iron oxide red (E 172), iron oxide brown (E 172).

Description of the Appearance of Fortradol and Package Contents
Fortradol 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.
Fortradol 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.
Fortradol 150 mg and 200 mg prolonged-release tablets are packaged in blisters and sold in boxes of
10 tablets.

Marketing Authorisation Holder
Alfasigma S.p.A. – Via Ragazzi del ’99, n. 5 – 40133 Bologna (BO)

Manufacturer
Farmaceutici Formenti S.p.A. - Via di Vittorio, 2 - 21040 Origgio (VA)
Grünenthal GmbH – Zieglerstrasse 6 Aachen (Germany)

FORTRADOL 50 mg hard capsules
Tramadol hydrochloride
Read all of this leaflet carefully before you take 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 because it may be harmful.
• If you get any side effects, talk to your doctor or pharmacist.

Contents of this leaflet

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

1. What is FORTRADOL and what it is used for

Tramadol, the active ingredient of Fortradol, is a pain reliever (analgesic) that belongs to the class of
opioids and acts at the central nervous system level. It reduces pain by acting on specific nerve cells
in the spinal cord and brain.
Fortradol 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 FORTRADOL

Do not take Fortradol

• 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 in the last 14 days before treatment with Fortradol (see “Other medicines and Fortradol”)
• if you have epilepsy and your seizures are not adequately controlled by therapy;
• as a substitute in drug detoxification therapy.

Warnings and precautions

Sleep-related breathing disorders
Fortradol can cause sleep-related breathing disorders, such as sleep apnea (pauses in
breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).
Symptoms may include pauses in breathing during sleep, nighttime awakenings due to labored breathing, difficulty staying asleep, or excessive daytime sleepiness. If you or another
person observes these symptoms, contact your doctor, who may consider reducing
the dose.

Talk to your doctor or pharmacist before taking Fortradol:

• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Fortradol”).
• 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.

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”).
Seizures have been reported in patients taking tramadol at the recommended doses. The risk
may increase when tramadol doses exceed the recommended ones, beyond the daily limit
of 400 mg.
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These
symptoms may be indicative of adrenal insufficiency (low cortisol levels). If you experience these
symptoms, contact your doctor, who will decide if you need hormone replacement.

Tolerance, physical and psychological dependence
This medicine contains tramadol, a medicine belonging to the class of opioids.
Repeated use of opioids can lead to a decrease in the effectiveness of the medicine (the patient gets used to its
intake, a phenomenon known as tolerance). Repeated use of Fortradol can also induce abuse
and physical and psychological dependence, with a consequent risk of potentially fatal overdose. The risk
of these undesirable effects may increase in case of higher doses and prolonged use.
In case of physical or psychological dependence, you may feel unable to control
the amount of medication you need or the frequency with which you have to take it.
The risk of developing physical or psychological dependence varies from person to person. It is possible that the risk of
developing physical or psychological dependence on Fortradol increases if:

• You or a family member has a history of alcohol, prescription drug, or illegal drug abuse or dependence (“addiction”);
• You are a smoker;
• You have had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs while taking Fortradol, you may have developed physical or psychological dependence:
• You need to take the medicine for a longer period than recommended by your doctor;
• You need to take a higher dose than recommended;
• You use the medicine for reasons other than those for which it was prescribed, for example to "stay calm" or "promote sleep";
• You have repeatedly, but unsuccessfully, tried to stop or control the use of the medicine;
• You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal symptoms"). If you notice any of these signs, consult your doctor to evaluate the most appropriate therapeutic path for you, including when it is appropriate to stop treatment and how to do it safely (see section 3, If you stop taking Fortradol). In patients with a tendency to abuse medicines or who are dependent on medicines, Fortradol 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 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: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or
ill, constipation, loss of appetite.

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

• carbamazepine (for epileptic seizures);
• pentazocine, nalbuphine or buprenorphine (analgesics);
• ondansetron (to prevent nausea). Your doctor will inform you if and what doses of Fortradol you should take.

The risk of side effects increases if you are taking

• other pain relievers such as morphine and codeine (even when taken for cough), and alcohol together with Fortradol. You may feel sleepy or weak. In these cases, consult your doctor.
• the concomitant use of Fortradol 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 Fortradol together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Inform them 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 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 Fortradol at the same time. Your doctor will tell you if Fortradol is suitable for you.
• certain antidepressants, Fortradol 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 Fortradol. The effect of these medicines on blood clotting may be affected and bleeding may occur.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain)

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, 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 Fortradol. 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 Fortradol more than once
during breastfeeding or, alternatively, if you take Fortradol more than once, you should stop
breastfeeding.
There is limited data regarding the effects of Fortradol on fertility. Post-marketing data do not suggest
an effect of tramadol on fertility

Driving and operating machinery
Fortradol can cause drowsiness, dizziness, and vision problems (blurred vision). If you feel that your
ability to react is impaired, do not drive machines or other vehicles, do not use machinery or tools that
require a secure support.
Fortradol capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

For athletes:
The use of the drug without therapeutic necessity constitutes doping and may still result in positive
doping tests.

3. How to take FORTRADOL

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Before starting treatment and at regular intervals during it, your doctor will discuss with you what
you can expect from using Fortradol, when and for how long you should take it, when you should contact
your doctor and when you should stop taking it (see also section 2).
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 (8 capsules) 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 or two capsules (equivalent to 50 or 100 mg of tramadol hydrochloride) every 4–6 hours.

Use in childrenFortradol 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 Fortradol. In case of mild or
moderate insufficiency, your doctor may advise you to extend the time interval between doses.

How and when to take Fortradol
Fortradol 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 in the evening. You can take the capsules during
or away from meals.

How long to take Fortradol
You should not take Fortradol 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 Fortradol is too strong or too weak, consult your doctor or
pharmacist.

If you take more Fortradol 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 (profound unconsciousness),
seizures, and difficulty breathing up to respiratory arrest. In these cases, call your doctor
immediately.

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

If you stop taking Fortradol
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. Your 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).
Generally, when treatment with Fortradol is stopped, no withdrawal effects occur.
However, in rare cases, some people who have taken Fortradol 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 bowel problems
• 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 perception of one’s own personality (depersonalization) and alterations of perception of reality (derealization) and sense of persecution (paranoia).

If you experience any of these symptoms after stopping Fortradol, 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
• 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), diarrhea
• skin reactions (itching, rash)

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

• allergic reactions (e.g. difficulty breathing, shortness of breath, swelling of the skin) and shock (circulatory failure)
• slow heartbeat
• increased blood pressure
• abnormal sensations (e.g. tingling, itching, numbness), tremor, 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 Fortradol, 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 Fortradol”)
• 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 urine output (dysuria)

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

• increased liver enzyme values
• slow breathing

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

• decrease in blood sugar levels (hypoglycemia)
• hiccups
• sleep-related breathing disorders (central sleep apnea syndrome)
• 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, diarrhea) (see section 2 “What you need to know before you take Fortradol”).

Cases of SIADH (syndrome of inappropriate antidiuretic hormone secretion) and hyponatremia (low sodium levels in the blood) have been reported in the literature, although a causal relationship for tramadol has not been established.

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 FORTRADOL

Keep out of sight and reach of children.
Keep this medicine in a safe and secure place, where other people cannot access it.
It can cause serious harm and be fatal to people when it has not been prescribed for them.
Do not use this medicine after the expiry date which is stated on the pack and blister. The expiry date refers to the last day of the month.
Store at a temperature below 30 °C.
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 Fortradol Contains
The active ingredient is tramadol hydrochloride.
One capsule contains 50 mg of tramadol hydrochloride.
The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate,
anhydrous colloidal silica, the capsule shell contains: gelatin, titanium dioxide (E171), iron
oxide yellow (E172).

Description of the Appearance of Fortradol 50 mg Hard Capsules and Package Contents
Hard, shiny and oblong capsules of yellow color.
The package contains 20 hard capsules.

Marketing Authorisation Holder
Alfasigma S.p.A. – Via Ragazzi del ’99, n. 5 – 40133 Bologna (BO)

Manufacturer Responsible for Batch Release
Farmaceutici Formenti S.p.A. – Via Di Vittorio, 2 – 21040 Origgio (VA)
Grünenthal GmbH, Zieglerstrasse 6, Aachen – Germany

FORTRADOL 100 mg/ml oral drops, solution
Tramadol hydrochloride
10 ml bottle with dropper
Read this leaflet carefully before you start 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 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 FORTRADOL is and what it is used for
• 2. What you need to know before you take FORTRADOL
• 3. How to take FORTRADOL
• 4. Possible side effects
• 5. How to store FORTRADOL
• 6. Package Contents and Other Information

1. What is FORTRADOL and what is it used for

Tramadol – the active ingredient of Fortradol – is a pain reliever (analgesic) that belongs to the class of
opioids and 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.
Fortradol 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 FORTRADOL

Do not take Fortradol solution:

• 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, pain relievers or other psychotropic drugs (drugs that affect mood and emotions);
• if you are also taking MAO inhibitors (some medications used to treat depression) or if you have taken them within the last 14 days before treatment with Fortradol (see “Other medicines and Fortradol”);
• if you have epilepsy and your seizures are not adequately controlled by therapy;
• as a substitute in drug detoxification therapy.

Warnings and precautions

Sleep-related breathing disorders
Fortradol can cause sleep-related breathing disorders, such as sleep apnea (pauses in
breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).
Symptoms may include pauses in breathing during sleep, nighttime awakenings due to labored breathing, difficulty staying asleep, or excessive daytime sleepiness. If you or another
person observes these symptoms, contact your doctor, who may consider reducing the
dose.
Talk to your doctor or pharmacist before taking Fortradol:

• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Fortradol”).
• if you think you are using other pain relievers (opioids) excessively;
• if you suffer from consciousness disorders (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.

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 alone.
Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome
(see section 4 “Possible side effects”).
Seizures have been reported in patients taking tramadol at recommended dosages. The risk
may increase when tramadol dosages exceed the recommended ones, beyond the daily limit
of 400 mg.
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.

Tolerance, physical and psychological dependence
This medicine contains tramadol, a medicine belonging to the class of opioids.
Repeated use of opioids can lead to a decrease in the effectiveness of the medicine (the patient gets used to its
use, a phenomenon known as tolerance). Repeated use of Fortradol can also induce abuse
and physical and psychological dependence, with a consequent risk of potentially fatal overdose. The risk
of these undesirable effects may increase in case of higher doses and prolonged use.
In case of physical or psychological dependence, you may feel no longer able to control
the amount of drug you need or the frequency with which you have to take it.
The risk of developing physical or psychological dependence varies from person to person. It is possible that the risk of
developing physical or psychological dependence on Fortradol increases if:

• You or a family member has a history of alcohol, prescription drug, or illegal drug abuse or dependence (“addiction”);
• You are a smoker;
• You have had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs while taking Fortradol, you may have developed physical or psychological dependence:
• You need to take the medicine for a longer period than recommended by your doctor;
• You need to take a higher dose than recommended;
• You use the medicine for reasons other than those for which it was prescribed, such as to "stay calm" or "promote sleep";
• You have repeatedly, but unsuccessfully, tried to stop or control the use of the medicine;
• You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal symptoms"). If you notice any of these signs, see your doctor to assess the most appropriate therapeutic path for you, including when it is appropriate to stop treatment and how to do it safely (see section 3, If you stop taking Fortradol).

In patients with a tendency to abuse medicines or who are dependent on medicines, Fortradol must 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 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
ill, constipation, loss of appetite.

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

• carbamazepine (for epileptic seizures);
• pentazocine, nalbuphine or buprenorphine (analgesics);
• ondansetron (to prevent nausea). Your doctor will tell you if and what dosages of Fortradol you should take.

The risk of side effects increases if you are taking

• other analgesics such as morphine and codeine (even when taken for cough), and alcohol together with Fortradol. You may feel drowsy or weak. In these cases, consult your doctor.
• the concomitant use of Fortradol 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 Fortradol 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 (attacks), such as some antidepressants or antipsychotics. The risk of having a seizure may increase if you take Fortradol at the same time. Your doctor will tell you if Fortradol is suitable for you.
• certain antidepressants, Fortradol 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 Fortradol. The effect of these medicines on blood coagulation may be affected and bleeding may occur.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain)

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

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 regarding the safety of tramadol in pregnant women. Therefore, if you are
pregnant, you should not use Fortradol 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 Fortradol more than once
during breastfeeding or, alternatively, if you take Fortradol more than once, you should stop
breastfeeding.
There are limited data on the effects of Fortradol on fertility. Post-marketing data do not suggest
an effect of tramadol on fertility.

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

Fortradol 100 mg/ml oral drops solution contains sucrose, hydroxystearate macrogol glycerol,
propylene glycol and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine, as it contains sucrose.
If Fortradol 100 mg/ml oral drops solution is used for chronic use (for example for two
weeks or more), it may be harmful to your teeth.
Fortradol 100 mg/ml oral drops solution contains hydroxystearate macrogol glycerol, a derivative of
castor oil that can cause stomach upset and diarrhea.
Fortradol 100 mg/ml oral drops solution contains 150 mg of propylene glycol per ml
Fortradol100 mg/ml oral drops solution contains less than 1 mmol (23 mg) of sodium per ml, i.e.
essentially “sodium-free”.

For athletes:
The use of the drug without therapeutic necessity constitutes doping and may still result in positive
anti-doping tests.

3. How to take FORTRADOL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Before starting treatment and at regular intervals during it, your doctor will discuss with you what
you can expect from using Fortradol, when and for how long you should take it, when you should contact
your doctor and when you should stop it (see also paragraph 2).
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 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 the dosage relating to
You should take the lowest dose that reduces the pain. Daily doses of 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 Fortradol. In case of mild or
moderate insufficiency, your doctor may advise you to extend the time interval between doses.

How and when to take Fortradol
Take Fortradol 100 mg/ml oral drops solution with sugar or with 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 Fortradol.

For how long to take Fortradol
Do not take Fortradol 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 it seems to you that the analgesic effect of Fortradol is too strong or too weak, consult your doctor or
pharmacist.

If you take more Fortradol 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 (profound unconsciousness),
seizures, and difficulty breathing up to respiratory arrest. In these cases, call your doctor
immediately.

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

If you stop taking Fortradol
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, which may involve
gradually reducing the dose to reduce the likelihood of developing unnecessary side effects
(withdrawal symptoms).
Generally, when you stop treatment with Fortradol, no withdrawal effects occur.
However, in rare cases, some people who have taken Fortradol 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 unusual rare CNS symptoms such as confusion, delusion, alteration of perception of one's own personality (depersonalization) and alterations of perception of reality (derealization) and sense of persecution (paranoia). If you experience any of these symptoms after stopping Fortradol, contact your doctor.

If you have any doubts about the use of this medicine, consult 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), 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, 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 disorders, delirium, anxiety and nightmares. Psychological symptoms may occur after treatment with Fortradol, varying in 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 Fortradol”).
• 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 could have been caused by tramadol
• muscle weakness
• difficulty or pain when urinating, reduced urine output (dysuria)

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

• increased liver enzyme values
• slow breathing

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

• decrease in blood sugar level (hypoglycemia)
• hiccups
• sleep-related breathing disorders (central sleep apnea syndrome)
• 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, diarrhea) (see section 2 “What you need to know before you take Fortradol”).

Cases of SIADH (syndrome of inappropriate antidiuretic hormone secretion) and hyponatremia (low blood sodium levels) have been reported in the literature, although a causal relationship for tramadol has not been established.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. 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 Fortradol

Keep out of sight and reach of children.
Keep this medicine in a safe and secure place, where other people cannot access it.
It can cause serious harm and be fatal to people when it has not been prescribed for them.
Do not use this medicine after the expiry date which is stated on the package and label. The expiry date refers to the last day of the month. This medicine does not require special 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 protect the environment.

6. Contents of the pack and other information

What Fortradol 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.

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

Marketing Authorisation Holder
Alfasigma S.p.A. – Via Ragazzi del ’99, n. 5 – 40133 Bologna (BO)

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 Fortradol 100 mg/ml oral drops solution
The Fortradol bottle is supplied in tamper-evident packaging. The carton is sealed, the bottle
has a security 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 the 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 Fortradol 100 mg/ml oral drops solution.
The Fortradol 100 mg/ml oral drops solution bottle 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 TAKE FORTRADOL 100 mg/ml
oral drops solution”.

Tramadol hydrochloride content in the drops:

Note on the dosage of Fortradol oral drops solution in children over 1 year of age
Dosage table in relation to body weight in children (see also “HOW TO TAKE
FORTRADOL 100 mg/ml oral drops solution”).

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

1. What is FORTRADOL and what is it used for?

Tramadol, the active ingredient of Fortradol, is a pain reliever (analgesic) that belongs to the class of
opioids and acts at the level of the central nervous system. It reduces pain by acting on specific nerve cells
in the spinal cord and brain.
Fortradol 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 taking FORTRADOL

Do not take Fortradol

• 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 Fortradol (see “Other medicines and Fortradol”);
• if you have epilepsy and your seizures are not adequately controlled by therapy;
• as a substitute in detoxification therapy from drugs.

Warnings and precautions

Sleep-related breathing disorders
Fortradol 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 observes these symptoms, contact your doctor, who may consider reducing the
dose.
Talk to your doctor or pharmacist before taking Fortradol:

• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Fortradol”);
• if you think you are abusing 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 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.

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 alone.
Contact your doctor immediately if you experience any of the symptoms associated with this serious syndrome
(see section 4 “Possible side effects”).
Seizures have been reported in patients taking tramadol at the recommended dosages. The risk
may increase when tramadol dosages exceed the recommended ones, beyond the daily limit
of 400 mg.
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.

Tolerance, physical and psychological dependence
This medicine contains tramadol, a medicine belonging to the class of opioids.
Repeated use of opioids can lead to a decrease in the effectiveness of the medicine (the patient gets used to its
use, a phenomenon known as tolerance). Repeated use of Fortradol can also induce abuse
and physical and psychological dependence, with a consequent risk of potentially fatal overdose. The risk
of these adverse effects may increase in case of higher doses and prolonged use.
In case of physical or psychological dependence, you may feel unable to control
the amount of medication you need or the frequency with which you have to take it.
The risk of developing physical or psychological dependence varies from person to person. It is possible that the risk of
developing physical or psychological dependence on Fortradol increases if:

• You or a family member has a history of alcohol, prescription drug, or illegal drug abuse or dependence (“dependence”);
• You are a smoker;
• You have had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs while taking Fortradol, you may have developed physical or psychological dependence:
• You need to take the medicine for a longer period than recommended by your doctor;
• You need to take a higher dose than recommended;
• You use the medicine for reasons other than those for which it was prescribed, such as to "stay calm" or "promote sleep";
• You have repeatedly tried, but unsuccessfully, to stop or control the use of the medicine;
• You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal symptoms"). If you notice any of these signs, see your doctor to evaluate the most appropriate therapeutic path for you, including when it is appropriate to stop treatment and how to do it safely (see section 3, If you stop taking Fortradol).

In patients with a tendency to abuse medicines or who are dependent on medicines, Fortradol 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 a doctor immediately: slowed or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or
sick, constipation, loss of appetite.

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 FORTRADOL
Tell your doctor or pharmacist if you are taking or have recently taken or may take
any other medicines.
Fortradol should not be taken with MAO inhibitors (some medicines used for depression).

The intensity and duration of the analgesic effect of Fortradol may be reduced if you are taking medicines
that contain

• carbamazepine (for seizures);
• pentazocine, nalbuphine or buprenorphine (analgesics);
• ondansetron (to prevent nausea). Your doctor will tell you whether or what dosages of Fortradol you should take.

The risk of side effects increases if you are taking

• other analgesics such as morphine and codeine (even when taken for cough), and alcohol together with Fortradol. You may feel drowsy or weak. In these cases consult your doctor.
• the concomitant use of Fortradol 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 Fortradol together with sedatives, the dose and duration of concomitant treatment must be limited by your 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 Fortradol at the same time. Your doctor will tell you if Fortradol is right for you.
• certain antidepressants, Fortradol 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 Fortradol. The effect of these medicines on blood coagulation may be affected and bleeding may occur.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain)

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or 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 Fortradol. 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 Fortradol more than once
during breastfeeding or, alternatively, if you take Fortradol more than once, you should stop
breastfeeding.
There is limited data on the effects of Fortradol on fertility. Post-marketing data do not suggest an
effect of tramadol on fertility.

Driving and using machines
Fortradol 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.

Fortradol 100 mg prolonged-release tablets contains lactose
If your doctor has diagnosed you with lactose intolerance, consult him before taking this
medicine which contains lactose.

For athletes:
The use of the drug without therapeutic necessity constitutes doping and may still result in positive
anti-doping tests.

3. How to take FORTRADOL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Before starting treatment and at regular intervals during it, your doctor will discuss with you what
you can expect from using Fortradol, when and for how long you should take it, when you should contact
your doctor and when you should stop it (see also paragraph 2).
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 Fortradol 100 mg extended-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 Fortradol, if necessary.

Use in children
Fortradol 100 mg extended-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 lengthen the time interval between doses.

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

How and when to take Fortradol
Fortradol 100 mg extended-release tablets are for oral use.
Swallow the tablets whole, not divided or chewed, with a sufficient amount of liquid, preferably
in the morning or evening. You can take the tablets during or away from meals.

How long to take Fortradol
Do not take Fortradol 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 Fortradol is too strong or too weak, consult your doctor or
pharmacist.

If you take more Fortradol 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 (deep unconsciousness),
seizures, and difficulty breathing up to respiratory arrest. In these cases, call your doctor
immediately.

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

If you stop taking Fortradol
If you stop or end treatment too early, it is likely that the pain will return.
If you want to stop treatment due to side 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, which may involve
gradually decreasing the dose to reduce the likelihood of developing unnecessary side effects
(withdrawal symptoms).
Generally, when you stop treatment with Fortradol, no withdrawal effects occur.
However, in rare cases, some people who have taken Fortradol 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 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 Fortradol, contact your doctor.

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

4. Possible side effects

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

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), diarrhea
• skin reactions (itching, rash)

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

• allergic reactions (e.g. difficulty breathing, shortness of breath, swelling of the skin) and shock (circulatory failure)
• slow heartbeat
• increased blood pressure
• abnormal sensations (e.g. tingling, itching, numbness), tremor, 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 Fortradol, varying in 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 Fortradol”)
• 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 was caused by tramadol
• muscle weakness
• difficulty or pain when urinating, reduced urine output (dysuria)

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

• increased liver enzyme values
• slow breathing

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

• decreased blood sugar level (hypoglycemia)
• hiccups
• sleep-related breathing disorders (central sleep apnea syndrome)
• serotonin syndrome, which can manifest as a change 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 take Fortradol”)

Cases of SIADH (syndrome of inappropriate antidiuretic hormone secretion) and hyponatremia (low blood sodium levels) have been reported in the literature, although a causal relationship with tramadol has not been established.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. 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 FORTRADOL

Keep out of the sight and reach of children.
Store this medicine in a safe and secure place, where other people cannot access it.
It can cause serious harm and be fatal to people when it has not been prescribed for them.
Do not use this medicine after the expiry date which is stated on the pack and blister. The expiry date refers to the last day of the 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 Fortradol 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, colloidal anhydrous silica,
magnesium stearate; coating:hypromellose 6 mPas, lactose monohydrate (see paragraph 2
“Fortradol 100 mg prolonged-release tablets contains lactose”), macrogol 6000, propylene glycol,
talc, titanium dioxide (E171).

Description of the appearance of Fortradol 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
Alfasigma S.p.A. – Via Ragazzi del ’99, n. 5 – 40133 Bologna (BO)

Manufacturer responsible for batch release
Farmaceutici Formenti S.p.A. - Via di Vittorio, 2 – 21040 Origgio (VA)
Grünenthal GmbH – Zieglerstrasse 6 - Aachen (Germany)