TRAMADOL RETARD TEVA-RATIOPHARM 200 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol retard Teva-ratiopharm 200 mg prolonged-release tablets EFG

Tramadol hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Tramadol, the active substance of this medication, 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 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 medication (listed in section 6).
• in case of acute intoxications caused by alcohol, sleeping medications, analgesics, or other psychotropic medications (medications that act on mood and emotions).
• if you are taking MAO inhibitors (a certain type of medication used to treat depression) or if you have taken them during the last 14 days before treatment with this medication (see "Taking Tramadol retard Teva-ratiopharm with other medications").
• if you have epilepsy and your seizures are not adequately controlled with 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 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 intracranial pressure (e.g., after a head injury or diseases that affect the brain).
• if you have difficulty breathing.
• if you are epileptic or have seizure disorders, 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 "Taking Tramadol retard Teva-ratiopharm with other medications").

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication 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 a higher dose 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 notice 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, such as "to feel calm" or "to help you sleep".
• You have made repeated and 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 interrupt treatment with tramadol).

Respiratory disorders related to sleep

Tramadol retard Teva-ratiopharm contains an active substance that belongs to the group of opioids. Opioids can cause respiratory disorders related to sleep, such as central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).

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

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 alone. Consult 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 dose of tramadol exceeds the maximum recommended daily dose (400 mg).

Keep in mind that this medication can cause physical and psychological dependence. When used for a long period, its effect may decrease, requiring the use of higher doses (development of tolerance). In patients with a tendency to abuse medications or who have medication dependence, treatment with Tramadol retard Teva-ratiopharm should only be carried out for short periods and under strict medical control.

Also, inform your doctor if you experience any of these problems during treatment with this medication or if you have experienced them in the past.

Tramadol is transformed 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 experience 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.

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. They 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.

Taking Tramadol retard Teva-ratiopharm with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Concomitant treatment with Tramadol retard Teva-ratiopharm and monoamine oxidase inhibitors (MAOIs) (a certain type of medication used to treat depression) should be avoided.

Both the effect and duration of pain relief produced by tramadol may be reduced if you take medications that contain:

• Carbamazepine (for epilepsy)
• Ondansetron (medication to prevent nausea)

Your doctor will indicate if you should take this medication and in what dose.

The risk of side effects increases

• if you are taking this medication simultaneously with other analgesics 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. Concomitant use of tramadol with sedatives or medications for the treatment of insomnia (such as benzodiazepines) or gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, or can be potentially fatal. Due to this, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all sedative medications you are taking and strictly follow your doctor's dosage recommendation. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Inform your doctor if you experience any of these symptoms; if you are taking medications that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol retard Teva-ratiopharm simultaneously with these medications. Your doctor will indicate if Tramadol retard Teva-ratiopharm is suitable for you.

• if you are taking medications for the treatment of depression. Tramadol retard Teva-ratiopharm may interact with these medications, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• if you are taking anticoagulant medications, such as warfarin, while taking Tramadol retard Teva-ratiopharm. The effect of these medications on blood coagulation may be affected, and bleeding may occur.
• if you are taking medications that can increase the accumulation of tramadol and its side effects (such as 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 effect may be intensified. Food does not affect the effect of Tramadol retard Teva-ratiopharm.

Children and adolescents

Use in children with respiratory problems:

Tramadol is not recommended for children with respiratory problems, as the symptoms of tramadol toxicity can 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 medication.

Pregnancy

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

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

Breastfeeding

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

Fertility

Based on human experience, it is not suggested that tramadol affects fertility in men and women.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Tramadol retard Teva-ratiopharm. It is essential 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 see double, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administering it concomitantly with other medications.

3. How to take Tramadol retard Teva-ratiopharm

Follow the instructions for administration of this medication exactly as 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. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has indicated otherwise.

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

Adults and adolescents over 12 years

One Tramadol retard Teva-ratiopharm 200 mg prolonged-release tablet twice a day (equivalent to 400 mg of tramadol hydrochloride per day), preferably in the morning and at night.

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

Children

This medication is not recommended for children under 12 years.

Elderly patients

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

Patients with liver or kidney impairment / dialysis

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

How and when should you take Tramadol retard Teva-ratiopharm?

Tramadol retard prolonged-release tablets are administered orally.

Always swallow the Tramadol retard Teva-ratiopharm tablets whole, without dividing or chewing them, with sufficient liquid, preferably in the morning and at night. You can take the tablet with an empty stomach or with food.

For how long should you take Tramadol retard Teva-ratiopharm?

This medication 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 this medication and at what dose.

If you think the effect of this medication 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, it will generally not have negative effects. You should take the next dose as prescribed.

After taking very high doses, you may experience 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. It is recommended to bring the medication package leaflet to the healthcare professional.

If you forget to take Tramadol retard Teva-ratiopharm

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 the missed doses; simply continue treatment as indicated by your doctor.

If you interrupt treatment with Tramadol retard Teva-ratiopharm

If you interrupt or finish treatment with this medication too early, it is likely that the pain will return. If you want to interrupt treatment due to undesirable effects, consult your doctor.

Do not stop taking this medication suddenly unless your doctor indicates otherwise.

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 interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no undesirable effects occur when finishing treatment with Tramadol retard Teva-ratiopharm. However, in rare cases, when some people who have been taking Tramadol retard Teva-ratiopharm for some time stop taking it suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or trembling. They may feel hyperactive, have difficulty sleeping, or have gastrointestinal disorders. Very few people may experience 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 persecution delusions (paranoia). If you experience any of these symptoms after interrupting treatment with this medication, 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.

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.

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 and rapid heartbeats, sensation of dizziness or collapse). These adverse effects may occur particularly in patients who are incorporated or who make physical effort.
• Desire to vomit (retching), gastrointestinal discomfort (e.g., feeling of pressure in the stomach, bloating), diarrhea.
• Dermatological reactions (e.g., itching, skin 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), tremors, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after taking high doses of tramadol or when taken simultaneously with another medicine that may induce them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological changes may appear after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and the duration of treatment). These may appear in the form of mood changes (usually euphoria, occasionally irritability), changes in activity (usually decrease and occasionally increase), and decreased cognitive and sensory perception (alterations of the senses and perception that can lead to errors of judgment).
• It may cause dependence on the medicine. When treatment is interrupted abruptly, a withdrawal syndrome may appear (see "If you stop treatment with Tramadol retard Teva-ratiopharm").
• Blurred vision, contraction of the pupils (miosis), excessive dilation of the pupils (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• There have been reports of worsening asthma, however, it has not been established whether they were caused by tramadol. If the recommended doses are exceeded or if it is taken concomitantly with other medicines that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

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

• Decrease in blood sugar levels.
• Hypo.
• Serotonin syndrome, which can manifest as changes in mental state (e.g., 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 (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before you start 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 that is not listed 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-ratiopharm

Keep this medicine out of the 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.

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

This medicine does not require special storage conditions.

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-ratiopharm

• The active ingredient is tramadol hydrochloride. Each tablet contains 200 mg of tramadol hydrochloride.
• The other components are: Dicalcium phosphate dihydrate (E341), Hydroxypropylcellulose (E463), Colloidal anhydrous silica (E551), Magnesium stearate (E470b)

Appearance of the Product and Package Contents

Tramadol retard Teva-ratiopharm 200 mg prolonged-release tablets are white capsule-shaped 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

Spain

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:April 2025

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/)

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77219/P_77219.html