Tramadol retard teva-ratiopharm 100 mg comprimidos de liberacion prolongada efg

Prospecto: Information for the User

Tramadol retard Teva-ratiopharm 100 mg prolonged-release tablets EFG

Tramadol hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

- Keep this prospect, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

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

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

3. How to take Tramadol retard Teva-ratiopharm

4. Possible adverse effects

5. Storage of Tramadol retard Teva-ratiopharm

6. Contents of the pack and additional information

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

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 intoxications caused by alcohol, sleep-inducing drugs, analgesics, or psychotropic drugs (medicines that act on the mood and emotions).

- If you are also taking MAO inhibitors (certain medicines used to treat depression) or if you have taken them in the last 14 days before starting treatment with Tramadol retard Teva-ratiopharm (see “Taking Tramadol retard Teva-ratiopharm with other medicines”).

- If you have epilepsy and your seizures are not adequately controlled with treatment.

- As a treatment for 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 shock (a sign of this state may be cold sweat).

- If you have an increase in pressure within the skull (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 these seizures may increase.

- If you have any liver or kidney disease.

- If you suffer from depression and are taking antidepressants, since some may interact with tramadol (see “Other medicines and Tramadol retard Teva-ratiopharm”).

Please consult your doctor before taking the medicine in such cases.

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

Please note that Tramadol retard Teva-ratiopharm may cause physical and psychological dependence. When used for a long period of time, its effect may decrease, requiring 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 of time and under strict medical supervision.

Also inform your doctor if any of the following problems occur during treatment with Tramadol retard Teva-ratiopharm or if they have ever occurred.

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 may be fatal. Therefore, 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 symptoms listed 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 may affect each person differently. In some people, it may be possible to achieve insufficient pain relief, 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.

A weak risk exists 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 experience any of the symptoms associated with this severe syndrome (see section 4 “Possible adverse effects”).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (the body becomes accustomed to it, 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 medication to be used or the frequency with which it is used.

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 any of your family members have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs (“addiction”).
• You are a smoker.
• You have had any problems with mood (depression, anxiety, or a personality disorder) or have followed treatment 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 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 approach for you, when it is appropriate to discontinue 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 may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).Among the symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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

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 hormone supplements.

Children and adolescents

Tramadol retard Teva-ratiopharm is not suitable for children under 12 years old.

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-ratiopharm with other medicines

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

Tramadol retard Teva-ratiopharm should be avoided when taken simultaneously with monoamine oxidase inhibitors (MAOIs) (certain medicines for depression treatment).

The analgesic effect of Tramadol retard Teva-ratiopharm and its duration may be reduced if you take medications containing:

- Carbamazepine (for epilepsy)

- Pentazocine, nalbuphine, or buprenorphine (analgesics)

- Ondansetron (medication to prevent nausea)

Your doctor will indicate if you should take Tramadol retard Teva-ratiopharm and at what dose.

The risk of adverse effects increases:

- If you take tranquilizers, sleep-inducing drugs, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Tramadol retard Teva-ratiopharm. It may cause more sleepiness or the sensation of fainting. If this occurs, consult your doctor.

- Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

- If you are taking medications that facilitate or may cause seizures, such as some antidepressants or antipsychotics. The risk of seizures may increase if you take Tramadol retard ratiopharm at the same time. Your doctor will tell you if Tramadol retard Teva-ratiopharm is suitable for you.

- If you are taking medications for depression treatment. Tramadol retard Teva-ratiopharm may interact with them and you may experience a serotonin syndrome (see section 4 “Possible adverse effects”).

- If you take anticoagulant coumarins (medications that prevent abnormal blood coagulation), such as warfarin, along with Tramadol retard Teva-ratiopharm. The effect of these medications on blood coagulation may be affected, and may lead to bleeding.

Taking Tramadol retard with food, drinks, 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.

Pregnancy and breastfeeding

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 during human pregnancy. Therefore, do not take Tramadol retard Teva-ratiopharm if you are pregnant.

Long-term use during pregnancy may lead to withdrawal syndrome in newborns.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, do not take Tramadol retard Teva-ratiopharm more than once during breastfeeding, or if you take Tramadol retard Teva-ratiopharm more than once, discontinue breastfeeding.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with Tramadol retard Teva-ratiopharm. It is essential to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred 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 medications.

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

In case of doubts, 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 dose should be adjusted to the intensity of the pain and your individual sensitivity to pain. Normally, the lowest analgesic dose that produces pain relief should be taken.

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

Adults and adolescents over 12 years old

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

Your doctor may prescribe a different and more suitable dose of this medication if necessary.

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 indicated otherwise.

Older patients

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

Patients with liver or kidney disease / dialysis

If you have a 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 to take Tramadol retard Teva-ratiopharm?

Tramadol retard prolonged-release tablets are administered orally.

Always swallow the Tramadol retard Teva-ratiopharm tablets whole, not divided or chewed, with sufficient liquid, preferably in the morning and at night. You can take the tablet with an empty stomach or with meals.

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

Tramadol retard Teva-ratiopharm 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 Tramadol retard Teva-ratiopharm and at what dose.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Use in children

Tramadol retard Teva-ratiopharm is not suitable for children under 12 years old.

If you take more Tramadol retard Teva-ratiopharm than you should

If you have taken by mistake more Tramadol retard Teva-ratiopharm than you should, generally you will not have negative effects.

You should take the next dose as prescribed.

After taking very high doses, you may experience 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.

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-ratiopharm

If you forget to take the tablets, it is likely that the pain will reappear. Do not take a double dose to compensate for the missed doses, simply continue treatment as indicated by your doctor.

If you interrupt treatment with Tramadol retard Teva-ratiopharm

You should 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 interrupt 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 Tramadol retard Teva-ratiopharm too soon, it is likely that the pain will reappear. If you want to discontinue treatment due to undesirable effects, consult your doctor.

Generally, no adverse effects occur when discontinuing 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 shaky. They may feel hyperactive, have difficulty sleeping, or gastrointestinal or intestinal 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 central nervous system symptoms, such as confusion, delirium, distorted perception of one's own personality (derealization), and alterations in the perception of reality (depersonalization) and delusions of persecution (paranoia), have been seen. If you experience any of these symptoms after stopping Tramadol retard Teva-ratiopharm, please consult your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Side effects are usually classified by frequency as follows:

- Very common (may affect more than 1 in 10 people)

- Common (may affect up to 1 in 10 people)

- Uncommon (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 hives along with difficulty breathing.

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

Cardiovascular and blood disorders

Uncommon: Effects on the heart and blood circulation (strong and rapid heartbeats, fainting or collapse). These side effects may occur especially in patients who are bedridden or who engage in physical exertion.

Rare: Slow heart rate, increased blood pressure.

Nervous system disorders

Very common: Dizziness.

Common: Headaches, sleepiness.

Rare: Changes in appetite, abnormal sensations (such as itching, tingling, and numbness), tremor, slow breathing, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope). If the recommended doses are exceeded, or if other central nervous system depressants are taken at the same time, breathing may slow down. Seizures may occur mainly after taking high doses of tramadol or when taking medications that can cause seizures.

Frequency unknown: Speech disorders. Serotonin syndrome, which may 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-ratiopharm).

Mental and behavioral disorders

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

Problems may appear after treatment with Tramadol retard Teva-ratiopharm.

Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These problems may manifest as a change in mood (usually excessive good humor, occasionally irritable mood), changes in activity (usually suppression, occasionally increase) and decreased cognitive and sensory perception (changes in senses and recognition, which may lead to judgment errors).

Dependence may occur.

Eye disorders

Rare: Blurred vision.

Frequency unknown: Excessive pupil dilation (mydriasis).

Respiratory, thoracic, and mediastinal disorders

Rare: Shortness of breath. Asthma exacerbation has been reported, however, a causal relationship with tramadol has not been established.

Frequency unknown: Hiccups.

Gastrointestinal disorders

Very common: Nausea.

Common: Vomiting, constipation, dry mouth.

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

Metabolism and nutrition disorders

Frequency unknown: Decreased blood sugar levels

Skin disorders

Common: Sweating.

Uncommon: Skin reactions (such as itching, hives).

Musculoskeletal disorders

Rare: Muscle weakness.

Liver and biliary tract disorders

Very rare: Increased liver enzyme values.

Urinary disorders

Rare: Difficulty or pain urinating, decreased urine output.

General disorders

Common: Fatigue.

Rare: In rare cases, allergic reactions (such as difficulty breathing, buzzing, skin swelling) and shock (sudden circulatory failure) have been reported. When treatment is stopped abruptly, withdrawal symptoms may occur (see "If you stop taking Tramadol retard 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 protected place where others cannot access it. This medication can cause serious harm or even be fatal to people who have not been prescribed it.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box and the blister pack after "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 the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Tramadol retard Teva-ratiopharm

• The active ingredient is tramadol hydrochloride. Each tablet contains 100 mg of tramadol hydrochloride.
• The other components are: Calcium dihydrogen phosphate (E341),

Hydroxypropylcellulose (E463), Colloidal anhydrous silica (E551), Magnesium stearate (E470b)

Appearance of the product and content of the packaging

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

Packaging sizes:

Blister pack: 20 and 60 tablets

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Madrid

Responsible for manufacturing

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

Last review date of this leaflet:June 2024

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

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77218/P_77218.html