Tramadol teva-ratiopharm 50 mg capsulas duras efg

Leaflet: information for the user

Tramadol Teva-ratiopharm 50 mg hard capsules EFG

Tramadol, hydrochloride

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects,consult your doctor or pharmacist, evenifthey are not listed in this leaflet. See section 4.

1.What isTramadol Teva-ratiopharmand what it is used for

2.What you need to knowbeforestarting totakeTramadol Teva-ratiopharm

3.How to takeTramadol Teva-ratiopharm

4.Possible side effects

5.Storage ofTramadol Teva-ratiopharm

6. Contents of the pack and additional information

Tramadol is a central-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 in the treatment of moderate to severe pain.

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 intoxications caused by alcohol, sleeping pills, analgesics or other psychotropic drugs (medicines that act on the mood and emotions);if you are taking monoamine oxidase inhibitors (a certain type of medicine used to treat depression) or if you have taken them in 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 with treatment.
• for the treatment of withdrawal syndrome

Warnings and precautions

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

• if you think you are dependent on other analgesics (opioids).
• if you experience a decrease in 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 experience an increase in intracranial pressure (for example after a head injury or brain disease).
• if you have difficulty breathing.
• if you are epileptic or have seizures, because the risk of seizures may increase.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol Teva-ratiopharm”).
• if you have any liver or kidney disease.

Tolerance, dependence and addiction

This medicine contains tramadol, which is an opioid medicine. 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 cause dependence, abuse and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you should use or how often you should use it.

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

• You or anyone in your family have abused alcohol or experienced dependence on it, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have had any problems with your mood (depression, anxiety or a personality disorder) or have followed treatment with 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 medicine for a longer time than indicated 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 and unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, 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 for you, when it is appropriate to stop the medicine and how to do it safely (see section 3, if you interrupt treatment with tramadol).

Respiratory disorders related to sleep

This medicine contains an active ingredient 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 your doctor immediately if you experience any of the symptoms linked to this serious syndrome (see section 4 “Possible side effects”).

Clinical reports have been noted of seizures in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the maximum recommended daily dose (400 mg).

Be aware that this medicine 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 medicines or those with dependence on medicines, treatment with tramadol should only be carried out for short periods of time and under strict medical control.

Also inform your doctor if any of these problems occur during treatment with this medicine or if they have occurred at any time.

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, it may be possible to achieve insufficient relief from pain, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort 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 indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Other medicines and Tramadol Teva-ratiopharm

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

Tramadol treatment should be avoided with monoamine oxidase inhibitors (MAOIs), a certain type of medicine used to treat depression.

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

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

Your doctor will tell you if you should take this medicine and in what dose.

The risk of adverse effects increases,

• if you are taking this medicine 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.

• The concomitant use of tramadol with sedatives or sleep medicines (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma and may be potentially fatal. Therefore, only consider concomitant use when other treatment options are not 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 sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and follow your doctor's dose recommendation strictly. 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 facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol simultaneously with these medicines. Your doctor will tell you if tramadol is suitable for you.
• if you are taking medicines to treat depression. Tramadol may interact with these medicines and you may experience a serotonin syndrome (see section 4 “Possible side effects”).
• if you are taking anticoagulant coumarins (medicines to thin the blood) such as warfarin, while taking tramadol. The effect of these medicines on blood coagulation may be affected and bleeding may occur.
• if you take medicines that can increase the accumulation of tramadol and, therefore, its adverse effects (such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole and erythromycin).

Tramadol Teva-ratiopharm with food, drinks and alcohol

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

Children and adolescents

This medicine is not recommended for children under 12 years old.

Use in children with respiratory problems:

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Pregnancy, breastfeeding and fertility

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

Pregnancy

There is very little information available on the safety of tramadol in pregnant women. Therefore, do not take this medicine if you are pregnant.

Long-term treatment during pregnancy may cause withdrawal syndrome in newborns.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, do not take tramadol more than once during breastfeeding, or if you take tramadol more than once, stop breastfeeding.

Fertility

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

Driving and operating machines

Ask your doctor if you can drive or operate machines during treatment with Tramadol. It is essential to observe how this medicine affects you before driving or operating machines. Do not drive or operate 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 increasing the dose, after changing the formulation and/or when taking it 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; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during it, 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 discontinue use (see also section 2).

The administration will be oral. The capsules must be taken whole, without dividing or crushing them, with sufficient liquid. You can take the capsules either with an empty stomach or with meals.

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

Normally, the initial dose is 1-2 tramadol capsules (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 medication is not recommended for children under 12 years old.

Older adults (over 75 years old)

In older adults, the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney insufficiency/patients on dialysis

If you have a 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 see if you should continue treatment with this medication and at what dose.

If you estimate that the action of this medication 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,consult your doctor or pharmacist immediatelyor call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

High doses of this medication can cause pupil constriction, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness to coma (deep unconsciousness), seizures, and difficulty breathing that can lead to respiratory arrest. In this case, inform your doctor immediately.

If you forgot to take Tramadol Teva-ratiopharm

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

Do not take a double dose to compensate for the missed doses. Take a new dose as soon as possible. Then continue treatment as instructed by your doctor.

If you interrupt treatment with Tramadol Teva-ratiopharm

You should not stop taking this medication suddenly unless your doctor instructs 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 discontinue it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

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

Generally, no adverse effects occur when treatment with tramadol is interrupted. 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 shaky. They may be hyperactive, have difficulty sleeping, or experience gastrointestinal and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, and tingling, 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 (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia). If you experience any of these symptoms after interrupting treatment with this medication, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

You must consult your doctor immediately if you experience symptoms of an allergic reaction such as facial swelling, tongue swelling, and/or throat swelling and/or difficulty swallowing and hives along with difficulty breathing.

The most common side 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 side effects may occur particularly in patients who are lying down or who are engaging in physical effort.
• Desire to vomit (retching), gastrointestinal discomfort (e.g. feeling of pressure in the stomach, swelling), 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 heart rate
• Increased blood pressure
• Abnormal sensations (e.g. itching, tingling, numbness), tremor, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures mainly occur after taking high doses of tramadol or when another medicine that may induce them is taken simultaneously.
• Changes in appetite
• Hallucinations, confusion, alterations in sleep, delirium, anxiety, and nightmares.
• Psychological changes may occur 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 may lead to judgment errors).

• It may cause dependence on the medicine. When treatment is stopped abruptly, withdrawal syndrome (see "If you stop taking Tramadol Teva-ratiopharm") may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (midriasis).
• Slow breathing, shortness of breath (dyspnea).
• There have been reports of cases of asthma worsening, however it has not been established if they were caused by tramadol. If recommended doses are exceeded or if taken concomitantly with other medicines that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain urinating, less than normal amount of urine (dysuria).

Very rare:may affect 1 in 10,000 people

• Increased liver enzymes

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

• Decreased blood sugar levels.
• Hypophagia.
• Serotonin syndrome, which may 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before starting Tramadol Teva-ratiopharm").

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keep this medication out of the sight and reach of children. Store this medication in a safe and secure location, inaccessible to others. This medication may cause serious harm or even be fatal to individuals who have not been prescribed it.

Do not use this medicationafter the expiration date appearing on the packaging after the abbreviation CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

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 carboxymethyl starch, magnesium stearate, and anhydrous colloidal silica

• The components of the capsule coating are: Gelatin, titanium dioxide (E171), and yellow iron oxide (E 172)

AppearanceofTramadol Teva-ratiopharmand content of the container

Hard gelatin capsules, yellow in color, size 3.

Container 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)

Responsible for manufacturing

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)

Last review date of this leaflet: June 2024

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