Tramadol prolonged-release ViatriS 200 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tramadol Retard Viatris 200 mg prolonged-release tablets EFG

tramadol hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because 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 reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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 side 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 12 years of age.

2. What you need to know before taking 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 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 currently taking or have taken MAOIs (monoamine oxidase inhibitors, used to treat depression or Parkinson’s disease) within the previous 14 days before starting 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 taking Tramadol Retard Viatris if:

• You have increased pressure inside the skull causing symptoms such as headache and vomiting (possibly after 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 sign may be cold sweats).
• You have difficulty breathing.
• You have a tendency towards epilepsy or seizures, as tramadol may increase the risk of seizures.
• You have liver or kidney disease.
  • If you have depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol Retard Viatris”).

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

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, pain relief may be insufficient, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, stop taking this medicine immediately and consult a doctor: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, feeling unwell, constipation, loss of appetite.

There is a low risk of developing serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or with tramadol monotherapy. Seek immediate medical advice if you experience any symptoms related to this serious condition (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 blood oxygen levels). Symptoms may include breathing pauses 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 lead to reduced effectiveness (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Retard Viatris 200 mg may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may lead to a feeling of lack of control over the amount or frequency of medicine use.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Tramadol Retard Viatris 200 mg may be higher if:

• You or any member of your family has abused or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had mood disorders (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 200 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 use 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 stopping 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, 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 200 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 indicate adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether you need hormonal supplementation.

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 starting 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 more severe 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, including over-the-counter medicines, herbal medicines, or any of the following:

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

The analgesic effect of tramadol may be weakened or shortened if you also take medicines containing:

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

The risk of adverse effects increases if:

• You use sedatives, sleeping pills, other analgesics such as morphine and codeine (also as cough medicine), or 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 cause 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 may cause serotonin syndrome (see section 4 “Possible side effects”).
• You use coumarin anticoagulants (blood thinners) 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 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 about 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. Therefore, you should not take tramadol tablets more than once during breastfeeding, or alternatively, if you take it more than once, you must stop breastfeeding.

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

Driving and using machines

Ask your doctor if you can drive or operate machinery while taking 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 drowsy, 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 taking other medicines concurrently.

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 your doctor before taking this medicine.

3. How to take Tramadol Retard Viatris

Dosage

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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 needed to relieve pain should be taken.

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

Use in adults and children 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 otherwise directed by your doctor.

Use in children:

Tramadol must not be given 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 extending the dosing interval.

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

Treatment with tramadol is not recommended in patients with 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 long-term treatment is required, your doctor will schedule regular and frequent reviews to assess whether you should continue taking tramadol and at what dose. Treatment breaks may be considered when 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 prescribed, contact your doctor immediately or go to the nearest hospital emergency department.

You may feel nauseous, notice pinpoint pupils (constriction), feel dizzy due to low blood pressure, lose consciousness, fall into a coma, experience seizures (fits), 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 name of 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 the missed 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

Do not stop taking this medicine abruptly unless your doctor tells you to. 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 when and how to stop, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

If you stop or end 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 a prolonged period may feel unwell if they stop abruptly. They may feel restless, anxious, nervous, or shaky. They may also feel confused, hyperactive, have difficulty sleeping, or experience gastrointestinal disturbances.

In isolated cases, confusion, panic attacks, paranoid delusions (paranoia), hallucinations, distortions in perception of reality (derealization), or a sense 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 experiences 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 accompanied by difficulty breathing.
• Sudden circulatory shock/failure.
• Seizures (fits).

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 of faintness or fainting). These adverse effects may occur especially in patients in an upright position or under physical strain.
• Nausea (retching), stomach problems (e.g., feeling of pressure in the stomach or bloating), diarrhoea.
• Skin reactions (e.g., itching or skin rash).

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

• Weak heartbeat and increased blood pressure.

• Slow breathing and difficulty breathing (dyspnoea).

• Changes in appetite, abnormal sensations (e.g., 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 may 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 of dizziness or spinning (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 (hypoglycaemia).

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

• 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, diarrhoea) (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 stopped abruptly, 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 they are possible adverse effects not listed in this leaflet. You may 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 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 drains or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. 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 200 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, titanium dioxide, iron oxide red, and quinoline yellow lake.

Appearance of Tramadol Retard Viatris and contents of the pack

Film-coated tablets, brownish-orange in colour and capsule-shaped, marked with "M" on one side and "TM3" on the other.

Packaged as:

• 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 Authorisation 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, contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Denmark Dolatramyl
Slovakia Tramadol Mylan 200 mg tablety s predlženým uvolnovaním
Spain Tramadol Retard Viatris 200 mg prolonged-release tablets EFG
Finland Dolatramyl
Norway Dolatramyl
Netherlands Tramadol HCI Retard Mylan 200 mg
Portugal Tramadol Mylan
United Kingdom Maneo 200 mg Prolonged-release tablets
Czech Republic Tramadol Mylan 200 mg tablety sřízeným uvolnováním
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/