Tramadol Teva-Ratiopharm 150 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol retard Teva-ratiopharm 150 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. 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Tramadol, the active substance of 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 retard is indicated for the treatment of moderate to severe pain.

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

Do not take Tramadol retard Teva-ratiopharm

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tramadol retard Teva-ratiopharm

• if you think you are dependent on other painkillers (opioids).
• if you have disorders 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 trauma 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 liver or kidney disease.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Taking Tramadol retard Teva-ratiopharm with other medicines”).

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 a feeling of lack of control over the amount of medicine you need to take 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 may be higher if:

• You or anyone in your family has abused alcohol or experienced dependence 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 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).

Sleep-related respiratory disorders

Tramadol retard Teva-ratiopharm 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, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Consult 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 recommended maximum daily dose (400 mg).

Please note that this medicine may cause physical and psychological dependence. When used over a long period, its effect may decrease, requiring higher doses (development of tolerance). In patients with a tendency to drug abuse or who have drug dependence, treatment with Tramadol retard Teva-ratiopharm 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 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 consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, pinpoint 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 hormonal supplements.

Taking Tramadol retard Teva-ratiopharm with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine.

Concomitant treatment with Tramadol retard Teva-ratiopharm 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 (a medicine 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 simultaneously 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) or gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, or 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, they 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 trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol retard Teva-ratiopharm simultaneously with these medicines. Your doctor will tell you whether Tramadol retard Teva-ratiopharm is suitable for you.
• if you are taking medicines for depression. Tramadol retard Teva-ratiopharm may interact with these medicines and may cause serotonin syndrome (see section 4 “Possible side effects”).
• if you take coumarin anticoagulants (blood-thinning medicines), such as warfarin, while taking Tramadol retard Teva-ratiopharm. 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 thus its adverse effects (for example, ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

Taking Tramadol retard with food and alcohol

Do not consume alcohol during treatment with Tramadol retard Teva-ratiopharm, as its effects may be intensified. Food does not affect the action of Tramadol retard Teva-ratiopharm.

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.

Pregnancy

There is very limited information regarding the safety of tramadol during human pregnancy. Therefore, you should not take this medicine if you are pregnant.

Chronic treatment during pregnancy may lead to withdrawal syndrome in newborns.

Breastfeeding

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 retard Teva-ratiopharm more than once, you must stop breastfeeding.

Fertility

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 being treated with Tramadol retard Teva-ratiopharm. 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 vision 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.

3. How to take Tramadol retard Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor.

If you have any doubts, 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).

The dose should be adjusted according to the intensity of pain and your individual sensitivity to pain. The lowest analgesic dose that provides pain relief should normally be taken. 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

One tablet of Tramadol retard Teva-ratiopharm 150 mg prolonged-release tablets twice daily (equivalent to 300 mg of tramadol hydrochloride per day), preferably in the morning and at night.

If necessary, your doctor may prescribe a different and more appropriate dose of this medicine.

If needed, the dose may be increased up to 200 mg twice daily (equivalent to 400 mg of tramadol hydrochloride per day).

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 extend the dosing intervals.

Patients with hepatic or renal impairment / dialysis

If you have severe liver or kidney disease, you must not take Tramadol retard Teva-ratiopharm. If you have mild or moderate disorders, your doctor may extend the dosing interval.

How and when to take Tramadol retard Teva-ratiopharm

Tramadol retard prolonged-release tablets are administered orally.

The tablets of Tramadol retard Teva-ratiopharm must always be swallowed whole, not divided or chewed, with sufficient liquid, preferably in the morning and at night. You may take the tablet on an empty stomach or with food.

How long should you take Tramadol retard Teva-ratiopharm?

This medicine should not be administered for longer than strictly necessary.

If prolonged treatment is required, your doctor will monitor at short and regular intervals (if necessary with treatment interruptions) whether treatment with this medicine should continue 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 retard Teva-ratiopharm than you should

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

After taking very high doses, symptoms such as pupillary constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead to respiratory arrest may occur. In such a case, seek medical help immediately.

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

If you forget to take Tramadol retard Teva-ratiopharm

If you forget to take the tablets, your pain may return. Do not take a double dose to make up for missed doses; simply continue treatment as directed by your doctor.

If you stop taking Tramadol retard Teva-ratiopharm

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

You must not stop taking this medicine suddenly unless your doctor tells you to do so.

If you wish to stop taking your 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, no adverse effects occur when stopping treatment with Tramadol retard Teva-ratiopharm. However, in rare cases, some people who have been taking Tramadol retard Teva-ratiopharm for some time may feel unwell when stopping abruptly. They may feel restless, anxious, nervous, or shaky. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disturbances. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Rarely, other uncommon central nervous system (CNS) symptoms have been observed, such as confusion, delirium, distorted perception of self (depersonalization), altered 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 questions about the use of this medicine, consult 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, rash, together with difficulty breathing.

The most common adverse effects during treatment with Tramadol retard are nausea and dizziness, which occur in more than 1 in every 10 patients.

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 blood circulation (strong heartbeats and rapid heartbeat, feeling of dizziness or collapse). These adverse effects may occur particularly in patients who are getting up or performing physical exertion.
• Feeling the urge to vomit (nausea), gastrointestinal discomfort (e.g. feeling of pressure in the stomach, bloating), diarrhea
• Skin reactions (e.g. itching, skin 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 heart rate
• 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 other medicines 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 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 retard Teva-ratiopharm”)
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis)
• Slow breathing, shortness of breath (dyspnea)
• 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: frequency 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, diarrhea) (see section 2 “What you need to know before taking Tramadol retard 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 retard 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 carton and blister pack after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol retard Teva-ratiopharm

• The active substance is tramadol hydrochloride. Each tablet contains 150 mg of tramadol hydrochloride.
• The other components are: Calcium hydrogen phosphate dihydrate (E341), Hydroxypropylcellulose (E463), Anhydrous colloidal silica (E551), Magnesium stearate (E470b)

Appearance of the medicine and contents of the pack

Tramadol retard Teva-ratiopharm 150 mg prolonged-release tablets are whitish, capsule-shaped tablets.

Pack sizes:

Blister pack: 20 and 60 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Madrid

Spain

Manufacturer

Farmaceutisch Analytisch Laboratorium Duiven B.V (FAL Duiven B.V)

Dijkgraaf 30, 6921 RL, Duiven

Netherlands

Or

Medochemie Ltd (Factory AZ)

2 Michael Erakleous Street, Agios Athanassios Industrial Area, Limassol, 4101

Cyprus

Date of the most recent review of this leaflet: April 2025

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/)

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77218/P_77218.html