Tramadol Viatris 50 mg capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tramadol Viatris 50 mg hard capsules 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 or pharmacist.
• 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, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Tramadol Viatis is and what it is used for

Tramadol – the active substance in this medicine – is an analgesic belonging to the opioid group that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

Tramadol is used for the treatment of moderate to severe pain.

2. What you need to know before taking Tramadol Viatris

Do not take Tramadol Viatris

• if you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6);
• in cases of acute intoxication due to alcohol, sleeping medications, painkillers, or other psychotropic medicines (medicines that affect mood and emotions);
• if you are currently taking monoamine oxidase inhibitors (MAO inhibitors) (a certain type of medicine used to treat depression) or have taken them within the last 14 days prior to treatment with this medicine (see “Other medicines and Tramadol Viatris”);
• if you have epilepsy and your seizures are not adequately controlled by treatment;
• for the treatment of withdrawal syndrome.

Warnings and precautions

Talk to your doctor before starting Tramadol Viatris

• if you have disturbances of consciousness (if you feel you might faint);
• if you are in shock (a sign of this condition may be cold sweating);
• if you have increased intracranial pressure (for example, after head injury or brain diseases);
• if you have difficulty breathing;
• if you have epilepsy or suffer from seizures, as the risk of seizures may increase;
• if you have depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol Viatris”);
• if you have liver or kidney disease.

Sleep-related breathing disorders

This medicine contains an active ingredient belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels).

The risk of experiencing central sleep apnea depends on the opioid dose. Your doctor may consider reducing the total opioid dose if you develop central sleep apnea.

There is a low risk of developing serotonin syndrome after taking tramadol, either in combination with certain antidepressants or tramadol used alone. Contact a doctor immediately if you experience any symptoms associated with this serious condition (see section 4 “Possible side effects”).

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the maximum recommended daily dose (400 mg).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the drug (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of this medicine 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 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 or addicted to this medicine may be higher if:

• You or a family member have 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 received psychiatric treatment for other mental illnesses.

If you notice any of the following symptoms while using this medicine, 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 stop taking Tramadol Viatris).

Also inform your doctor if any of these problems occur during treatment with this medicine or if you have ever experienced them.

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, 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 contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Inform your doctor if you experience any of the following symptoms while taking tramadol:

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

Other medicines and Tramadol Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant treatment with tramadol and MAO inhibitors (a certain type of medicine used to treat depression) should be avoided.

The effect and duration of pain relief provided by tramadol may be reduced if you take medicines containing:

• Carbamazepine (for epileptic seizures).
• Ondansetron (to prevent nausea).

Your doctor will advise you whether you should take this medicine and at what dose.

The risk of adverse effects increases:

• if you are taking this medicine together with other painkillers such as morphine and codeine (even when used to treat cough) and alcohol. In these cases, you may feel drowsy or dizzy. If this happens, consult your doctor.

The concomitant use of Tramadol with sedatives or medicines for insomnia (such as benzodiazepines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes tramadol together with sedative medicines, your doctor will limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosage recommendations. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms:

• if you are taking medicines that may lower the seizure threshold or provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol together with these medicines. Your doctor will determine whether tramadol is suitable for you;
• if you are taking gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain);
• if you are taking medicines for depression. Tramadol may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”);
• if you are taking coumarin anticoagulants (blood-thinning medicines) such as warfarin while taking tramadol. The effect of these medicines on blood clotting may be affected, leading to bleeding;
• if you take medicines that may increase the accumulation of tramadol and, therefore, its adverse effects (such as, for example, ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

Taking Tramadol Viatris with food and alcohol

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

Children and adolescents

Use in children with respiratory problems:

The use of tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may worsen in these children.

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 available on the safety of tramadol in pregnant women. Therefore, you should not take this medicine if you are pregnant.

Chronic treatment during pregnancy may cause withdrawal syndrome in newborns.

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

Based on human experience, there is no indication that tramadol affects fertility in men and women.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while taking this medicine. 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. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Tramadol Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg of tramadol hydrochloride; therefore, it is essentially “sodium-free”.

3. How to take Tramadol Viatris

Follow exactly the instructions for using this medicine as 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 to expect from using Tramadol Viatris, 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 dose should be adjusted according to the intensity of pain and your individual sensitivity. The lowest effective dose that provides pain relief should normally be used. Do not take more than 400 mg of tramadol hydrochloride per day unless your doctor has specifically instructed you otherwise.

Unless your doctor has given you different instructions, the recommended dose is:

Adults and adolescents over 12 years of age

The usual initial dose is 1–2 capsules (equivalent to 50–100 mg of tramadol hydrochloride).

Depending on the pain, the effect may last between 4–6 hours.

Children

This medicine is not recommended for 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 intervals.

Patients with hepatic or renal impairment/patients on dialysis

This medicine 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.

How and when to take Tramadol Viatris

The capsules are taken orally.

Tramadol Viatris capsules are packaged in a child-resistant foil to ensure safety.

The child-resistant sealing foil is stronger, making it more difficult to push the capsules through.

Puncture the foil first, then push the capsule out of the blister to avoid damaging the capsules.

Swallow the capsules whole without dividing or chewing them, with sufficient liquid.

You may take the capsules either on an empty stomach or with food.

How long should you take Tramadol Viatris?

This medicine should not be used for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor at short, regular intervals (and if necessary with treatment interruptions) whether you should continue treatment with this medicine and at what dose.

If you feel the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Tramadol Viatris than you should

If you have taken an extra dose by mistake, you will generally not experience any adverse effects. Take the next dose as prescribed.

After taking very high doses of tramadol, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties that may lead to respiratory arrest may occur. In such a case, call a doctor immediately!

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine’s package leaflet to the healthcare professional.

If you forget to take Tramadol Viatris

If you forget to take the medicine, your pain may return. Do not take a double dose to make up for a missed dose; simply continue taking tramadol as you have been doing.

If you stop treatment with Tramadol Viatris

If you stop or discontinue treatment with this medicine too early, your pain is likely to return. If you wish to stop treatment due to adverse effects, consult your doctor.

You should not stop taking this medicine suddenly unless your doctor tells you to. If you wish to stop taking this medicine, speak 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, which may involve gradually reducing the dose to reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not occur when stopping tramadol treatment. However, on rare occasions, people who have been taking this medicine for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, or experience digestive and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been reported, such as confusion, delirium, changes in personality perception (depersonalization), changes in perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping treatment with this medicine, 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 may cause adverse effects, although not everyone experiences them.

You must consult your doctor immediately if you experience symptoms of an allergic reaction such as swelling of the face, tongue and/or throat and/or difficulty swallowing, rash, and difficulty breathing.

The most common adverse effects during treatment with tramadol are nausea and dizziness, which occur in more than 1 in 10 people.

Very common: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Common: may affect up to 1 in 10 people

• Headache, numbness.
• Fatigue.
• Constipation, dry mouth, vomiting.
• Sweating (hyperhidrosis).

Uncommon: may affect up to 1 in 100 people

• Effects on the heart and circulation (strong heartbeats, rapid heartbeat, feeling of dizziness or collapse). These adverse effects may occur particularly in patients who are standing up or performing physical exertion.
• Nausea (feeling of wanting to vomit), gastrointestinal discomfort (e.g., sensation of pressure in the stomach, bloating), diarrhoea.
• Skin reactions (e.g., itching, rash).

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

• Allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, numbness), tremor, epileptic seizures, muscle twitching, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after use of high doses of tramadol or when taken simultaneously with another medicine that may trigger them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological disturbances may occur after treatment with tramadol. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These may present as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment).
• May lead to drug dependence. When treatment is abruptly discontinued, withdrawal syndrome may occur (see “If you stop taking Tramadol Viatris”).
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnoea).
• Cases of worsening asthma have been reported; however, it has not been established whether they were caused by tramadol. If recommended doses are exceeded or if tramadol is taken concomitantly with other medicines that depress brain function, respiratory rate may decrease.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

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

• Increased liver enzymes.

Frequency not known: cannot be estimated from available data

• Decreased blood sugar levels.
• Hiccups.
• Serotonin syndrome, which may present as 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 Viatris”).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 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 after the expiry date which is stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at 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 Viatris

• The active substance is tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride.

• The other components are: anhydrous calcium hydrogen phosphate, magnesium stearate and anhydrous colloidal silica.

The capsule shell contains gelatin and titanium dioxide (E171). The printing ink contains: shellac, black iron oxide (E172), polyethylene glycol and ammonium hydroxide.

What Tramadol Viatris looks like and contents of the pack

Hard, oblong, opaque white capsules printed with "T50", packed in blisters. Available in packs of 20 and 60 capsules.

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Temmler Pharma GmbH

Temmlerstrasse 2

35039 Marburg, Hessen

Germany

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

Viatris Pharmaceuticals, S.L.

C/General Aranaz, 86

28027 - Madrid

Spain

Date of the most recent review of this leaflet: June 2024

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)