Tramadol Teva-Ratiopharm 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol Teva-ratiopharm 50 mg hard capsules 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 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, because it could 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.

Leaflet contents

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

1. What Tramadol Teva-ratiopharm is and what it is used for

Tramadol is a centrally-acting opioid analgesic that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

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

2. What you need to know before taking Tramadol Teva-ratiopharm

Do not take Tramadol Teva-ratiopharm

• 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 taking MAO inhibitors (a certain type of medicine used to treat depression) or have taken them within the last 14 days before starting treatment with this medicine (see "Other medicines and Tramadol Teva-ratiopharm");
• 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 or pharmacist before taking Tramadol Teva-ratiopharm

• if you think you are dependent on other painkillers (opioids);
• if you experience decreased level of consciousness (if you feel you might faint);
• if you are in shock (a sign of shock may be cold sweating);
• if you have increased intracranial pressure (e.g., after head injury or brain disease);
• 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 of these may interact with tramadol (see "Other medicines and Tramadol Teva-ratiopharm");
• if you have liver or kidney disease.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol 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 you to feel a lack of control over how much medicine you use or how often you use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to tramadol may be higher if:

• You or any of your family members have abused alcohol or have 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, 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 those prescribed, for example, "to feel calm" or "to help you sleep";
• You have made repeated unsuccessful attempts to stop using the medicine or to control your use;
• You feel unwell when you stop using the medicine, and feel better again 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).

Sleep-related breathing disorders

This medicine contains an active substance belonging to the group of opioids. Opioids may cause sleep-related breathing disorders, such as central sleep apnea (shallow breathing or pauses in breathing 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 slight risk that you may experience a serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy.

Contact a doctor immediately if you experience any symptoms related to this serious syndrome (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).

Please note that this medicine may cause physical and psychological dependence. When used for a prolonged period, its effect may decrease, requiring higher doses (development of tolerance). In patients with a tendency to drug abuse or those with drug dependence, treatment with tramadol should only be carried out for short periods and under strict medical supervision.

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

Inform your doctor, pharmacist, or nurse 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 hormonal supplements.

Other medicines and Tramadol Teva-ratiopharm

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

Concomitant treatment with tramadol and monoamine oxidase inhibitors (MAOIs), 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:

• Medicines for anxiety or treatment of insomnia (such as benzodiazepines) or medicines that may affect respiratory activity (such as other opioids, some cough medicines, certain treatments for drug dependence, medicines for mental health conditions, medicines for allergies such as antihistamines, or alcohol), as they increase 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 dosing 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.

• 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 simultaneously with these medicines. Your doctor will determine whether tramadol is suitable for you.

• Medicines used to treat depression. Tramadol may interact with these medicines, and you may experience serotonin syndrome (see section 4 “Possible side effects”).

• Coumarin anticoagulants (blood-thinning medicines) such as warfarin, while taking tramadol. The effect of these medicines on blood clotting may be altered, leading to bleeding.

• Medicines that may increase the accumulation of tramadol and, therefore, its adverse effects (for example, ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

• Gabapentin or pregabalin used to treat epilepsy or nerve pain (neuropathic pain).

• Medicines that may have anticholinergic effects, such as:

  • Medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics);

  • Medicines used to treat psychiatric disorders (antipsychotics or neuroleptics);

  • Muscle relaxants;

  • Medicines used to treat Parkinson’s disease.

as they may increase the risk of adverse effects such as constipation, urinary retention, dry mouth, or dry eyes.

Taking Tramadol Teva-ratiopharm with food, drinks, and alcohol

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

Children and adolescents

This medicine is not recommended for children under 12 years of age.

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, lactation and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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.

Lactation

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

Fertility

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

Driving and use of machines

Ask your doctor whether you can drive or operate machinery while being treated with Tramadol. It is important that you observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred vision 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 taking this medicine together with other medicines.

Tramadol Teva-ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg of tramadol hydrochloride; i.e., essentially "sodium-free".

3. How to take Tramadol Teva-ratiopharm

Follow exactly the instructions for use of this medicine given by your doctor. In case of 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 tramadol, 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).

Administration is oral. The capsules must be taken whole, without dividing or chewing, with sufficient liquid. You may take the capsules either on an empty stomach or with food.

The dose should be adjusted according to the intensity of pain and your individual sensitivity. Normally, the lowest effective dose that provides pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has instructed you otherwise.

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

Adults and adolescents over 12 years of age

Normally, the initial dose is 1–2 capsules of tramadol (equivalent to 50–100 mg of tramadol hydrochloride). Depending on the pain, the effect may last between 4–6 hours. Do not take more than 8 tramadol capsules per day unless your doctor has instructed you otherwise.

Children

This medicine is not recommended for children under 12 years of age.

Elderly patients (over 75 years of age)

In elderly patients, 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

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

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

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

If you take more Tramadol Teva-ratiopharm than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

Poisoning due to very high doses of this medicine may cause pinpoint pupils, vomiting, low 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 and death. In such a case, seek immediate medical help.

If you forget to take Tramadol Teva-ratiopharm

If you forget to take this medicine, your pain may return.

Do not take a double dose to make up for missed doses. Take the next dose as soon as possible. Then continue treatment as directed by your doctor.

If you stop taking Tramadol Teva-ratiopharm

Do 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).

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

Generally, adverse effects do not commonly occur when stopping tramadol treatment. However, in rare cases, 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, 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 can cause adverse effects, although not everyone will experience 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 and rash together with difficulty breathing.

The most common adverse effects 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 1 in 10 people

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

Uncommon: may affect 1 in 100 people

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

Rare: may affect 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 jerks, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after using 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 intensity and nature may vary (depending on the patient's personality and duration of treatment).

These may appear as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased and occasionally increased), and reduced cognitive and sensory perception (alterations in senses and perception that may lead to impaired judgment).

• May lead to drug dependence. When treatment is abruptly stopped, withdrawal syndrome may occur (see “If you stop taking Tramadol Teva-ratiopharm”).
• 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 1 in 10,000 people

• Increase in liver enzymes

Frequency not known: frequency cannot be estimated from the available data

• Decrease in blood sugar levels.
• Hiccups.
• Serotonin syndrome, which may manifest 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 you start taking Tramadol Teva-ratiopharm”).

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 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 Teva-ratiopharm

Keep this medicine out of the sight and reach of children. Store this medicine in a safe and secure place, inaccessible to others. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP or CAD. 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 medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Tramadol Teva-ratiopharm

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

• The other components are: Microcrystalline cellulose, sodium carboxymethylstarch (from potato), magnesium stearate and anhydrous colloidal silica.

• The components of the capsule shell are: Gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of Tramadol Teva-ratiopharm and contents of the container

Hard yellow gelatin capsules, size 3.

Pack sizes:

Blister packs: 20 and 60 hard capsules.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer responsible

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro da Armada, 5

Condeixa-a-Nova

3150-194 Sebal

Portugal

or

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana 26

28850 Torrejón de Ardoz (Madrid)

Date of the most recent review of this leaflet: April 2026

“Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/”