TRAMADOL TEVA-RATIOPHARM 50 mg HARD CAPSULES

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

Do not take Tramadol Teva-ratiopharm

• 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, opioids, or other psychotropic medications (medications that act on mood and emotions); if you are taking monoamine oxidase inhibitors (MAOIs, a certain type of medication used to treat depression) or if you have taken them in the last 14 days before treatment with this medication (see "Other medications and Tramadol Teva-ratiopharm").
• if you have epilepsy and your seizures are not adequately controlled with treatment.
• for the treatment of withdrawal syndrome

Warnings and precautions

Talk to your doctor or pharmacist before starting Tramadol Teva-ratiopharm

• if you think you are dependent on other painkillers (opioids).
• if you have a decreased level 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 brain disease).
• if you have difficulty breathing.
• if you are epileptic or have a history of seizures, as the risk of seizures may increase.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol Teva-ratiopharm").
• if you have any liver or kidney disease.

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 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 a family member 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 longer than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medication for reasons other than prescribed, for example, "to feel calm" or "to help you sleep".
• You have made repeated 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, talk to 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).

Sleep-related breathing disorders

This medication contains an active ingredient that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, 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.

Talk to 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).

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

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

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 malaise, or vomiting, constipation, loss of appetite.

Tell 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 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.

Other medications and Tramadol Teva-ratiopharm

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

Concomitant treatment with tramadol and monoamine oxidase inhibitors (MAOIs, a certain type of medication used to treat depression) should be avoided.

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

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

Your doctor will tell you 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 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 medications for the treatment of insomnia (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when no other treatment options are possible.
• if you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

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

Tell 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. Tell your doctor if you experience any of these symptoms.

• if you are taking medications that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol simultaneously with these medications. Your doctor will tell you if tramadol is suitable for you.
• if you are taking medications for the treatment of depression. Tramadol can 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. The effect of these medications on blood coagulation may be affected, and bleeding may occur.
• if you take medications that can increase the accumulation of tramadol and, therefore, its side effects (such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

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

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

Children and adolescents

This medication is not recommended 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 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 available on the safety of tramadol in pregnant women. Therefore, you should not take this medication if you are pregnant.

Chronic treatment during pregnancy can cause withdrawal syndrome in newborns.

Breastfeeding

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 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. 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 administering it concomitantly with other medications.

Tramadol Teva-ratiopharm contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 50 mg of tramadol hydrochloride; it is essentially "sodium-free".

3. How to take Tramadol Teva-ratiopharm

Follow the instructions for administration of this medication exactly as indicated by your doctor. If in doubt, 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).

Administration will be by oral route. The capsules should be taken whole, without dividing or chewing, with sufficient liquid. You can take the capsules with or without food.

The dose should be adjusted according to the intensity of the pain and individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used. 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

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

Children

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

Elderly patients (over 75 years)

In elderly patients, the elimination of tramadol may be slow. If this is the case, 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 disease, your doctor may prolong the dosing intervals.

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, tell your doctor or pharmacist.

If you take more Tramadol Teva-ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Intoxication with very high doses of this medication can 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 this case, immediately notify a doctor.

If you forget to take Tramadol Teva-ratiopharm

If you forget to take this medication, it is likely that the pain will return.

Do not take a double dose to make up for forgotten doses. Take a new dose as soon as possible. Then continue treatment as indicated by your doctor.

If you stop taking Tramadol Teva-ratiopharm

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

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 this medication 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 side effects are experienced when stopping treatment with tramadol. However, in rare cases, people who have been taking this medication for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or trembly. They may be overactive, have difficulty sleeping, or experience digestion and intestinal problems. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, more unusual symptoms of the central nervous system have been detected, such as confusion, delirium, change in perception of personality (depersonalization), and change in perception of reality (derealization) and persecution delusions (paranoia). If you experience any of these symptoms after stopping treatment with this medication, consult your doctor.

If you have any other questions about the use of this medication, ask 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 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 and rapid heartbeats, feeling 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 the use of 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 decreased and occasionally increased), 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 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 status (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 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 Teva-ratiopharm

Keep this medicine out of the sight and reach of children. Store this medicine in a safe and protected place, to which other people cannot access. 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 packaging after the abbreviation CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging 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 packaging and medicines you no longer need. This way, you will help protect the environment.

6. Content of the Packaging and Additional Information

Composition ofTramadol Teva-ratiopharm

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

• The other components are: Microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and anhydrous colloidal silica

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

Appearance ofTramadol Teva-ratiopharmand Content of the Packaging

Hard gelatin capsules, yellow in color, size 3.

Packaging sizes:

Blisters: 20 and 60 hard capsules.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

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 Last Revision of this Prospectus:June 2024

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