TRAMADOL RETARD TEVA 100 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol retard Teva 100 mg prolonged-release tablets EFG

Tramadol hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Tramadol is an analgesic belonging to the group of opioids 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 you take Tramadol retard Teva

Do not take Tramadol retard Teva

• If you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6).
• In case of acute intoxication with alcohol, hypnotics, analgesics, or psychotropic drugs (drugs that act on mood and emotions).
• If you are taking, or have taken in the last 14 days, monoamine oxidase inhibitors (MAOIs) (certain medicines for the treatment of depression) (see "Taking Tramadol retard Teva with other medicines").
• If you have epilepsy and your seizures are not adequately controlled with treatment.
• As treatment for withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Tramadol retard Teva

• If you think you are dependent on other analgesics (opioids).
• If you have disorders of consciousness (if you think you are going to faint).
• If you are in a state of shock (a sign of this state may be cold sweat).
• If you have increased pressure inside the skull (e.g., after a head injury or brain disease).
• If you have difficulty breathing.
• If you are epileptic or have a history of seizures, as the risk of these seizures may increase.
• If you have any liver or kidney disease.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol retard Teva").

In such cases, please consult your doctor before taking the medicine.

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

Please note that Tramadol retard Teva can cause physical and psychological dependence. When Tramadol retard Teva is used for a long period, its effect may decrease, and higher doses may be needed (development of tolerance).

In patients with a tendency to abuse medications or who are dependent on medications, treatment with Tramadol retard Teva 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 Tramadol retard Teva or if you have had them before.

The concomitant use of tramadol and sedative medications such as benzodiazepines or related medications increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol along with sedative medications, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedative medications you are taking, and follow your doctor's dosage recommendations carefully. It may be helpful to inform your friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to suffer from serious side effects. If you notice any of the following side effects, you must stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult a doctor immediately if you present any of the symptoms related to this serious syndrome (see section 4 "Possible side effects").

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the drug less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of tramadol can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may be greater with higher doses and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication you need to use or how often you need to 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 greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you observe any of the following symptoms while using tramadol, it could be a sign of dependence or addiction:

• You need to use the medication for a longer period than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medication 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 medication or control its use.
• You feel unwell when you stop using the medication, and you feel better once you take it again ("withdrawal symptoms").

If you notice any of these signs, consult your doctor to determine the best treatment option for you, when it is appropriate to stop the medication, and how to do it safely (see section 3, if you stop treatment with tramadol).

Respiratory disorders related to sleep

Tramadol retard Teva may cause sleep-related respiratory disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Among the symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider a dose reduction.

Talk to your doctor, pharmacist, or nurse if you experience any of the following symptoms while taking Tramadol retard Teva:

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

Children and adolescents

Tramadol retard Teva is not suitable for children under 12 years of age.

Use in children with respiratory problems

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

Use of Tramadol retard Teva with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Concomitant treatment with Tramadol retard Teva and monoamine oxidase inhibitors (MAOIs) (medicines for the treatment of depression) should be avoided.

The analgesic effect of Tramadol retard Teva, as well as its duration, may be reduced if you take medications that contain:

• Carbamazepine (for epileptic seizures)
• Pentazocine, nalbuphine, or buprenorphine (analgesics);
• Ondansetron (medication to prevent nausea)

Your doctor will tell you if you should take Tramadol retard Teva and at what dose.

The risk of side effects increases

• If you take tranquilizers, hypnotics, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Tramadol retard Teva. It may cause more drowsiness or make you feel like you are going to faint. If this happens, consult your doctor.
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

• If you are taking medications that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of having seizures may increase if you take Tramadol retard Teva at the same time. Your doctor will tell you if Tramadol retard Teva is suitable for you.
• If you are taking medications for the treatment of depression. Tramadol retard Teva may interact with them, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• If you take anticoagulant medications, such as warfarin, with Tramadol retard Teva. The effect of these medications on blood clotting may be affected, and it may lead to bleeding.

Taking Tramadol retard Teva with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

Pregnancy

There is very little information on the safety of tramadol during human pregnancy.

Therefore, you should not take Tramadol retard Teva if you are pregnant.

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

Breastfeeding

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

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Tramadol retard Teva. It is important that before driving or using machines, you observe how this medication affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administered concomitantly with other medications.

3. How to take Tramadol retard Teva

Follow exactly the administration instructions of this medication indicated by your doctor.

In case of doubts, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from the use of 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 the pain and your individual sensitivity to pain. Normally, you should take the lowest analgesic dose that produces pain relief.

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

Adults and adolescents over 12 years of age

One Tramadol retard Teva 100 mg prolonged-release tablet twice a day (equivalent to 200 mg of tramadol hydrochloride per day), preferably in the morning and evening.

If necessary, your doctor may prescribe a different and more suitable dose of this medication for you.

If necessary, the dose can be increased up to 150 mg or 200 mg twice a day (equivalent to 300 mg - 400 mg of tramadol hydrochloride per day).

Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has instructed you to do so.

Elderly patients

In elderly patients (over 75 years of age), the elimination of tramadol may be slow. If this is your case, your doctor may prolong the dosing intervals.

Patient with liver or kidney failure / dialysis

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

How and when should you take Tramadol retard Teva?

Tramadol retard prolonged-release tablets are administered orally.

Tramadol retard Teva tablets should always be swallowed whole, not divided or chewed, with sufficient liquid, preferably in the morning and evening. You can take the tablet with an empty stomach or with food.

For how long should you take Tramadol retard Teva?

Tramadol retard Teva should not be administered for longer than strictly necessary.

If you require prolonged treatment, your doctor will monitor you at short and regular intervals (if necessary, with interruptions in treatment) to determine if you should continue treatment with Tramadol retard Teva and at what dose.

If you think the effect of this medication is too strong or too weak, tell your doctor or pharmacist.

Use in children

Tramadol retard Teva is not suitable for children under 12 years of age.

If you take more Tramadol retard Teva than you should

If you have taken more Tramadol retard Teva than you should by mistake, you will not usually have negative effects. You should take the next dose as prescribed.

After taking very high doses, it may cause constricted pupils, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), seizures, and difficulty breathing that can lead to respiratory arrest. In such a case, contact a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

If you forget to take Tramadol retard Teva

If you forget to take the tablets, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses; simply continue treatment as indicated by your doctor.

If you stop treatment with Tramadol retard Teva

Do not stop taking this medication suddenly unless your doctor tells you to do so.

If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

If you stop or finish treatment with Tramadol retard Teva too soon, it is likely that the pain will return. If you want to stop treatment due to undesirable effects, consult your doctor.

Generally, no undesirable effects occur when finishing treatment with Tramadol retard Teva. However, in rare cases, when some people who have been taking Tramadol retard Teva for some time stop taking it suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or trembly. They may feel hyperactive, have difficulty sleeping, or have gastrointestinal disorders. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Rarely, other unusual symptoms of the central nervous system have been seen, such as confusion, delirium, distorted perception of one's own personality (depersonalization), and altered perception of reality (derealization) and delusions of persecution (paranoia). If you present any of these symptoms after stopping Tramadol retard Teva, please consult your doctor.

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Normally, the frequency of adverse effects is classified as follows:

• Very frequent (may affect more than 1 in 10 people)
• Frequent (may affect up to 1 in 10 people)
• Infrequent (may affect up to 1 in 100 people)
• Rare (may affect 1 in 1,000 people)
• Very rare (may affect 1 in 10,000 people)
• Frequency not known (cannot be estimated from available data)

You should 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 along with difficulty breathing.

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

Cardiac and Blood Disorders:

Infrequent: Effects on the heart and blood circulation (strong and rapid heartbeats, fainting or collapse). These adverse effects may occur especially in patients who are incorporated or who make physical effort.

Rare: Slow heartbeat, increased blood pressure.

Disorders of the Nervous System

Very frequent: Dizziness.

Frequent: Headaches, sleepiness.

Rare: Changes in appetite, abnormal sensations (such as itching, tingling, and numbness), tremors, slow breathing, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness (syncope). If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down. Epileptic seizures may occur mainly after taking high doses of tramadol or when taking medicines that can cause epileptic seizures.

Frequency not known: Speech disorders. Serotonin syndrome, which can manifest as changes in mental state (such as agitation, hallucinations, coma), and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (such as nausea, vomiting, diarrhea) (see section 2 "what you need to know before taking Tramadol retard Teva").

Psychiatric Disorders

Rare: Hallucinations, confusion, sleep disturbances, anxiety, and nightmares.

Psychological problems may appear after treatment with Tramadol retard Teva. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These problems can manifest as a change in mood (usually excessive cheerfulness, occasionally irritated mood), changes in activity (usually suppression, occasionally increase), and decreased cognitive and sensory perception (changes in senses and recognition, which can lead to errors in judgment).

Dependence may occur.

Ocular Disorders

Rare: Blurred vision.

Frequency not known: Excessive dilation of the pupils (mydriasis).

Respiratory, Thoracic, and Mediastinal Disorders

Rare: Shortness of breath (dyspnea). Worsening of asthma has been reported, however, no causal relationship with tramadol has been established.

Frequency not known: Hiccup.

Digestive Disorders

Very frequent: Nausea.

Frequent: Vomiting, constipation, dry mouth.

Infrequent: Retching, stomach problems (such as feeling of pressure in the stomach, bloating), diarrhea.

Metabolic and Nutritional Disorders:

Frequency not known: Decrease in blood sugar levels

Skin Disorders

Frequent: Sweating.

Infrequent: Skin reactions (such as itching, rash).

Muscular Disorders

Rare: Muscle weakness.

Liver and Biliary Disorders

Very rare: Increase in liver enzyme values.

Urinary Disorders

Rare: Difficulty or pain when urinating, less urine than normal.

General Disorders

Frequent: Fatigue.

Rare: In very rare cases, allergic reactions (such as difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have been reported. When treatment is abruptly stopped, signs of withdrawal (see "If you stop taking Tramadol retard Teva") may appear.

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol retard Teva

Keep out of sight and reach of children. Store this medicine in a safe and protected place, where others cannot access it. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the box and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tramadol retard Teva

• The active ingredient is tramadol hydrochloride. Each tablet contains 100 mg of tramadol hydrochloride.
• The other components are: Dihydrate calcium hydrogen phosphate (E341), Hydroxypropylcellulose (E463), Anhydrous colloidal silica (E551), Magnesium stearate (E470b)

Appearance of the Product and Package Contents

Tramadol retard Teva 100 mg prolonged-release tablets are white, round, biconvex tablets.

Package 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, 1ª planta, Alcobendas

28108 Madrid

Manufacturer

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

Dijkgraaf 30, 6921 RL, Duiven

Netherlands

O

Medochemie Ltd (Factory AZ)

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

Cyprus

Date of the Last Revision of this Prospectus:June 2024

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