Tramadol prolonged-release ViatriS 100 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Tramadol Retard Viatris 100 mg Prolonged-Release Tablets EFG

tramadol hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Tramadol Retard Viatris is and what it is used for
2. What you need to know before taking Tramadol Retard Viatris
3. How to take Tramadol Retard Viatris
4. Possible adverse effects
5. How to store Tramadol Retard Viatris
6. Contents of the pack and other information

1. What Tramadol Retard Viatris is and what it is used for

Tramadol Retard Viatris contains the active substance tramadol hydrochloride. Tramadol hydrochloride is an opioid-type analgesic that acts on the central nervous system. It relieves pain by acting on specific neurons in the spinal cord and brain.

This medicine is used for the treatment of moderate to severe pain in adults and adolescents from the age of 12.

2. What you need to know before starting to take Tramadol Retard Viatris

Do not take Tramadol Retard Viatris

• If you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• If you have consumed excessive alcohol or taken excessive sleeping pills, painkillers, opioids, or other psychotropic medicines (medicines that affect mood and emotions).
• If you are also taking MAOIs (monoamine oxidase inhibitors, used to treat depression or Parkinson’s disease) or have taken them within the previous 14 days before treatment with Tramadol Retard Viatris.
• If you have epilepsy and your seizures are not well controlled by treatment.
• For the treatment of withdrawal syndrome.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tramadol Retard Viatris if:

• You have increased pressure inside the skull causing symptoms such as headache and vomiting (possibly after a head injury or brain disease).
• You experience loss of consciousness (for example, if you feel like fainting).
• You are in a state of shock (one of the signs may be cold sweats).
• You have difficulty breathing.
• You have a tendency to epilepsy or seizures, as this may increase the risk of having a seizure.
• You have liver or kidney disease.
  • If you suffer from depression and are taking antidepressants, since some may interact with tramadol (see “Other medicines and Tramadol Retard Viatris”).

In such cases, please consult your doctor before starting to take this medicine.

Tramadol is metabolized in the liver by an enzyme. Some people have a variant of this enzyme; this may affect individuals in different ways. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, feeling unwell, constipation, loss of appetite.

There is a small risk of developing serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Seek immediate medical advice if you experience any symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Sleep-related breathing disorders

Tramadol may 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 breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Retard Viatris 100 mg may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of losing control over how much medicine you need or how often you need to take it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Tramadol Retard Viatris 100 mg may be higher if:

• You or any member of your family have abused alcohol or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had mood problems (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using Tramadol Retard Viatris 100 mg, it could be a sign of dependence or addiction:

• You need to use the medicine for longer than prescribed by your doctor.
• You need to take a higher dose than recommended.
• You are using the medicine for reasons other than prescribed, for example, “to feel calm” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop taking the medicine, and feel better once you take it again (“withdrawal effects”).

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you interrupt treatment with Tramadol Retard Viatris 100 mg).

During treatment

Seizures have been reported in patients receiving tramadol at the recommended dose level. The risk may be higher when tramadol doses exceed the upper limit of the recommended daily dose (400 mg).

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure may be signs of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

If you notice your pain worsening after taking tramadol, do not take more without speaking to your doctor. Talk to your doctor if your pain increases, you become more sensitive to pain, or you develop new pain after taking tramadol.

Children and adolescents

Use in children with respiratory problems

Tramadol is not recommended for children with respiratory problems, as symptoms of tramadol toxicity may be worse in these children.

Other medicines and Tramadol Retard Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes over-the-counter medicines, herbal medicines, or any of the following:

• Do not take tramadol at the same time as, or within 14 days after using MAOIs (e.g., moclobemide or phenelzine for depression, or selegiline for Parkinson’s disease).

The pain-relieving effect of tramadol may be weakened or shortened if you also take other medicines containing:

• Carbamazepine (used to treat epilepsy).
• Other opioids (e.g., buprenorphine, nalbuphine, or pentazocine (analgesics)).
• Ondansetron (to prevent nausea).

The risk of adverse effects increases if:

• You use sedatives, sleeping pills, other analgesics such as morphine and codeine (also as a cough medicine), and alcohol while taking this medicine. You may experience drowsiness or feel like fainting; if this occurs, contact your doctor.
• You use gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain).
• You use medicines that lower the seizure threshold or may provoke seizures, such as certain antidepressants (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants), or antipsychotics. The risk of seizures increases if you take tramadol together with these medicines. Your doctor will confirm whether tramadol is suitable for you.
• You are taking certain antidepressants (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants, or mirtazapine). Tramadol may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• You use coumarin anticoagulants (blood-thinning medicines) such as warfarin together with this medicine. The effect of these medicines on blood clotting may be affected, and bleeding may occur.

Concomitant use of tramadol retard tablets and sedatives, such as benzodiazepines or other related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes tramadol retard tablets together with sedatives, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform your friends or family members so they are aware of the signs and symptoms described above. Contact your doctor if you experience such symptoms.

Taking Tramadol Retard Viatris with food, drinks, and alcohol

Do not drink alcohol during treatment with tramadol, as its effects may be intensified. Food does not affect the action of tramadol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. There is very limited information on the safety of tramadol in human pregnancy. Therefore, you should not take tramadol if you are pregnant. Prolonged use during pregnancy may cause withdrawal symptoms in newborns.

Tramadol is excreted in breast milk. For this reason, you should not take tramadol tablets more than once during breastfeeding; alternatively, if you take it more than once, you must stop breastfeeding.

Based on human experience, tramadol hydrochloride does not affect fertility in men or women.

Driving and using machines

Ask your doctor if you can drive or operate machinery while being treated with tramadol. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Tramadol Retard Viatris contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Tramadol Retard Viatris

Dosage

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using this medicine, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

The dosing interval should be adjusted according to the intensity of pain and your individual sensitivity to pain. In general, the lowest effective dose capable of relieving pain should be taken.

Unless otherwise prescribed by your doctor, the recommended dosage is as follows:

Use in adults and patients over 12 years of age:

Tramadol Retard Viatris 100 mg tablets: one tablet (100 mg of tramadol hydrochloride) twice daily, preferably in the morning and at night.

If this is not sufficient to relieve pain, the dose may be increased as follows:

Tramadol Retard Viatris 150 mg tablets: one tablet (150 mg of tramadol hydrochloride) twice daily, preferably in the morning and at night.

or:

Tramadol Retard Viatris 200 mg tablets: one tablet (200 mg of tramadol hydrochloride) twice daily, preferably in the morning and at night.

If necessary, your doctor will prescribe a different and more appropriate dose of the medicine.

Do not take more than 400 mg of tramadol hydrochloride per day unless instructed otherwise by your doctor.

Use in children:

Tramadol must not be administered to children under 12 years of age.

Elderly patients:

In elderly patients (over 75 years of age), elimination of tramadol may be slower. If this applies to you, your doctor may recommend prolonging the dosing interval.

Severe hepatic and/or renal impairment / patients on dialysis:

Treatment with tramadol is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Method of administration

Always swallow the tablets whole with a glass of water, preferably in the morning and at night. Do not split, chew, or crush the tablets. The tablets may be taken on an empty stomach or with food.

Duration of treatment

Your doctor will determine the duration of treatment with tramadol, which depends on the cause of the pain. You should not take tramadol for longer than strictly necessary. If a longer treatment period is required, your doctor will conduct regular and frequent reviews to determine whether you should continue taking tramadol and at what dosage. Treatment breaks may be introduced if necessary. If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you take more Tramadol Retard Viatris than you should

If you (or someone else) take more tramadol than you should, contact your doctor or go immediately to the nearest hospital emergency department.

You may feel unwell, notice constricted pupils, feel dizzy due to a drop in blood pressure, lose consciousness, fall into a coma, experience seizures (convulsions), or have difficulty breathing, which may be severe.

If you accidentally take too many tablets, contact your doctor or pharmacist immediately, call the Toxicology Information Service (Tel. 91 562 04 20), stating the medicine and the amount ingested, or go to the nearest hospital emergency department.

If you forget to take Tramadol Retard Viatris

If you forget to take your tablets, your pain may return. Take your dose as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Tramadol Retard Viatris

You must not stop taking this medicine suddenly, unless your doctor tells you to do so. If you wish to stop taking the medicine, you should first discuss this with your doctor, especially if you have been taking it for a long time. Your doctor will advise you on when and how to stop taking it, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

If you interrupt or stop treatment with this medicine too early, your pain may return. If you wish to discontinue treatment despite unpleasant effects, inform your doctor.

Generally, there will be no after-effects once treatment with tramadol is completed. However, in rare cases, some people who have taken tramadol for some time may feel unwell if they stop taking it abruptly. They may feel restless, anxious, nervous, or shaky. They may also feel confused, become hyperactive, have difficulty sleeping, or suffer gastrointestinal disturbances.

In isolated cases, confusion, panic attacks, paranoid delusions (paranoia), hallucinations, disturbances in perception of reality (derealization), or a feeling of loss of identity (depersonalization) may occur. Unusual sensations such as itching, tingling, and ringing in the ears (tinnitus) may also be experienced.

If you experience any of these problems after stopping treatment with tramadol, consult your doctor.

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

4. Possible adverse effects

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

If you experience any of the following adverse effects, contact your doctor or go to an emergency service immediately:

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

• Allergic reactions, for example, difficulty breathing, wheezing, or skin swelling.
• Swelling of the face, tongue and/or throat and/or difficulty swallowing or rashes together with difficulty breathing.
• Sudden shock/circulatory failure.
• Seizures (convulsions).

Other adverse effects:

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

• Dizziness.
• Nausea.

Common (may affect up to 1 in 10 people):

• Headache, drowsiness.
• Vomiting, constipation, and dry mouth.
• Fatigue.
• Sweating.

Uncommon (may affect up to 1 in 100 people):

• Effects on the heart and blood circulation (strong heartbeat, tachycardia, feeling faint or fainting). These adverse effects may occur especially in patients in an upright position or under physical strain.
• Nausea (retching), stomach problems (for example, feeling of pressure in the stomach or bloating), diarrhea.
• Skin reactions (for example, itching or rash).

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

• Weak heartbeat and increased blood pressure.

• Slow breathing and difficulty breathing (dyspnea).

• Changes in appetite, abnormal sensations (for example, itching, tingling, and numbness), and tremors.

• Muscle contractions, muscle weakness, and lack of coordination of movements.

• Fainting (syncope).

  • Speech disorders.

• Blurred vision, small (constricted) pupils, dilated pupils.

• Difficulty or pain when urinating, reduced amount of urine compared to normal.

• Hallucinations (seeing, feeling, or hearing things that are not real), confusion, sleep disturbances, anxiety, changes in mood and attention (delirium), and nightmares.

Psychological problems may occur after treatment with tramadol, the intensity and nature of which will vary (depending on the patient's personality and duration of treatment). These problems may manifest as changes in mood (mainly excitement, sometimes irritability), changes in activity level (reduced, although sometimes increased activity), reduced consciousness, and decreased ability to make decisions, which may lead to errors in judgment. It may cause dependence.

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

• Feeling dizzy or lightheaded (balance problems (vertigo)).
• Noticeable redness of the face and often other parts of the skin (flushing).
• Increased levels of liver enzymes.

Frequency not known (cannot be estimated from available data):

• Low blood sugar levels (hypoglycemia).

• Low sodium levels in the blood, which may cause fatigue and confusion, muscle spasms, seizures, and coma (hyponatremia).

• Worsening of asthma, although it has not been determined whether these are caused by tramadol hydrochloride.

• Hiccups.

• Serotonin syndrome, which may present with changes in mental status (e.g., agitation, hallucinations, coma) and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 “What you need to know before taking Tramadol Retard Viatris”).

If the recommended doses are exceeded, or if other medicines that depress brain function are taken simultaneously, breathing may slow down.

When treatment is stopped or abruptly discontinued, withdrawal symptoms may occur (see section "If you stop treatment with Tramadol Retard Viatris").

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol Retard Viatris

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

No special storage conditions are required.

Do not use this medicine if you notice any change in the colour of the tablet or any other sign of deterioration; consult your pharmacist, who will advise you on what to do.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol Retard Viatris

• The active substance is tramadol (as hydrochloride). Each prolonged-release tablet contains 100 mg of the active substance.
• The other components are microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate.
• The tablet coating contains the following excipients: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, and titanium dioxide.

Appearance of Tramadol Retard Viatris and contents of the pack

Film-coated tablets, white or almost white, round, marked with "M" on one side and "TM1" on the other.

Packaged in:

• Blister packs supplied in cardboard boxes containing 10, 20, 28, 30, 50, 56, 60, 90, and 100 prolonged-release tablets, and single-dose perforated blisters in cardboard boxes containing 20 and 60 prolonged-release tablets.
• HDPE bottles with child-resistant closures containing 100 prolonged-release tablets.
• HDPE bottles with polypropylene screw caps containing 500 and 1,000 prolonged-release tablets (dispensing pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

Mylan utca 1

H-2900, Komárom

Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark Dolatramyl

Slovakia Tramadol Mylan 100 mg tablety s predlženým uvolnovaním

Spain Tramadol Retard Viatris 100 mg prolonged-release tablets EFG

Finland Dolatramyl

Norway Dolatramyl

Netherlands Tramadol HCI Retard Mylan 100 mg

Portugal Tramadol Mylan

United Kingdom Maneo 100 mg Prolonged-release tablets

Czech Republic Tramadol Mylan 100 mg tablety s řízeným uvolňováním

Sweden Dolatramyl

Date of the most recent revision of this leaflet: August 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/