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Tramadol Combo 37.5 mg. / 325 mg. 20 tablets

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Tramadol Combo is a combination of two painkillers - tramadol and paracetamol, which work together to relieve your pain.

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What Tramadol Combo is and what it is used for

Tramadol Combo is a combination of two painkillers - tramadol and paracetamol, which work together to relieve your pain.

Tramadol Combo is intended for the treatment of moderate to severe pain when your doctor deems you need to combine tramadol and paracetamol.

Tramadol Combo should only be taken by adults and adolescents over 12 years of age.

2. What you need to know before taking Tramadol Combo

Do not take Tramadol Combo:

if you are allergic to tramadol or paracetamol or any of the other ingredients of this medicine (listed in section 6);

acute alcoholic poisoning;

if you take sleeping pills, painkillers that affect your mood and emotions;

if you are taking medicines called monoamine oxidase inhibitors (MAOIs) or have been taking them for the last two weeks. MAO inhibitors are used to treat depression and Parkinson's disease;

if you suffer from severe liver damage;

if you have epilepsy that is not well enough controlled with the medicines you are taking.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramadol Combo:

If you are taking other medicines containing paracetamol and tramadol;

If you have serious kidney problems, the use of Tramadol Combo is not recommended. In the case of moderate renal impairment, separate administration of Tramadol Combo tablets should be made at intervals of not less than 12 hours;

If you have liver problems or liver disease, or if you notice yellowing of your eyes and skin. This may be due to jaundice;

If you have difficulty breathing, e.g. asthma or severe lung problems;

If you suffer from a drug addiction (eg with morphine);

If you have recently had a head injury, shock or severe headache, whether or not accompanied by vomiting;

If you are epileptic or have seizures or seizures;

If you are disturbed without a clear reason;

If you need anesthesia (anesthesia). Tell your doctor or dentist that you are taking Tramadol Combo.

In all cases described, Tramadol Combo should be used with caution.

Tramadol is transformed into the liver by an enzyme. In some people this enzyme is altered and it can affect them in many ways. Some people may not get enough pain relief, but other people are more likely to experience serious side effects. If you experience any of the following side effects, you should stop taking the medicine and seek medical attention immediately: slow or shallow breathing, confusion, drowsiness, contraction of the pupils, nausea or vomiting, constipation, lack of appetite.

Tramadol should not be used as a replacement therapy in patients with opioid dependence as it cannot prevent withdrawal symptoms seen with morphine treatment.

Normal therapeutic doses of tramadol can cause seizures. Patients with epilepsy who are on treatment as well as patients who are predisposed to seizures or seizures should not be treated with Tramadol Combo unless absolutely necessary.

Children

Tramadol Combo is not recommended for use in children under 12 years. The efficacy and safety of children has not been established.

Use in children with respiratory problems

Tramadol is not recommended in children with respiratory problems as the symptoms of tramadol toxicity may be exacerbated in these children.

Other medicines and Tramadol Combo

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

Important: This medicine contains tramadol and paracetamol. Tell your doctor if you are taking other medicines containing tramadol or paracetamol so that the maximum daily doses are not exceeded.

Tramadol Combo should not be taken in combination with:

MAO inhibitors (used to treat depression and Parkinson's disease as there is a risk of developing serotonergic syndrome. Symptoms of serotonergic syndrome include diarrhea, heart rate, excessive sweating, fever, confusion and even coma. In the case of recent MAO treatment. inhibitors, a 2-week interval is required before treatment with tramadol.

Tramadol Combo is not recommended in combination with:

Carbamazepine (a medicine used to treat epilepsy or pain). If you are taking these medicines at the same time, there is a risk of a decrease in the efficacy and shortening of the duration of the effect of tramadol.

Painkillers (buprenorphine, nalbuphine, pentazocine). If you take these medicines at the same time, there is a risk of a decrease in the analgesic effect of Tramadol Combo and the appearance of withdrawal symptoms.

Tramadol Combo is also not recommended in combination with:

Some antidepressants and tryptanes used to treat migraines. Tramadol Combo may interact with these medicines and symptoms such as involuntary muscle contractions may occur, incl. of the muscles that the horse

Medicines that can cause seizures (such as some depressants, antipsychotics or bupropion). The risk of seizures is greater when you take Tramadol Combo at the same time. Your doctor will decide if Tramadol Combo is right for you.

Other opioid derivatives (including cough suppressant drugs and substitution treatment), barbiturates, benzodiazepines (sedatives). If taken at the same time, the risk of respiratory depression increases, which can be fatal especially in cases of overdose;

Other central nervous system depressants, anxiolytics (acting to overcome anxiety), hypnotics, sedative antidepressants, sedative antihistamines (used to treat allergies), neuroleptics (to treat psychosis), centrally acting antihypertensive drugs lowering blood pressure), thalidomide (sedative) and baclofen (muscle relaxant). These medicines can aggravate existing depression. Attention is disturbed and this makes driving and operating machines dangerous.

Warfarin-like medicines (for blood thinning). Your doctor should regularly study prothrombin time.

Other medicines known as inhibitors of the liver enzyme CYP3 A4, such as ketoconazole and erythromycin.

Metoclopramide or domperidone - medicines used to treat nausea and vomiting. The absorption of paracetamol is increased if you are taking these medicines at the same time.

Cholestyramine (a medicine for lowering cholesterol in the blood) - the absorption of Tramadol Combo may be reduced.

If you take ondosterone (for nausea), the effectiveness of Tramadol Combo may be reduced.

Tramadol Combo with food, drink and alcohol

Tramadol Combo can be taken with or without food. You should not drink alcohol during treatment as alcohol increases the feeling of drowsiness when taken together with Tramadol Combo (the so-called sedative effect).

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

You should not take this medicine during pregnancy. Prolonged treatment during pregnancy may lead to symptoms of withdrawal of the newborn due to a developed drug addiction.

Breastfeeding

Tramadol is excreted in human milk. For this reason, you should not take Tramadol Combo more than once while breast-feeding or, alternatively, if you take Tramadol Combo more than once, you should stop breast-feeding. Breast-feeding should be discontinued if continuous administration is required.

Driving and using machines

This medicine can cause drowsiness, which can be exacerbated by the use of alcohol or other depressants that affect the central nervous system. If you experience such changes, do not drive or delay work requiring the use of power tools or machines.

3. How to take Tramadol Combo

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The dosage should be tailored to the severity of the pain and the patient's individual sensitivity to pain.

The recommended dose is:

Adults and adolescents (over 12 years)

The usual starting recommended dose is 1 tablet of Tramadol Combo in the morning and 1 tablet in the evening. The interval between the two doses should be at least 6 hours.

If necessary, you can take more tablets without exceeding the intake of 8 tablets (equivalent to 300 mg tramadol and 2600 mg paracetamol) per day. You should also not take other medicines such as paracetamol or tramadol to avoid overdose.

Old age

In elderly patients (> 75 years of age), elimination of tramadol may be delayed and therefore the interval between doses may need to be increased individually.

Patients with severe hepatic or renal insufficiency / dialysis patients

Patients with severe hepatic and renal impairment should not take Tramadol Combo. Your doctor should consider extending the interval between doses in mild or moderate hepatic or renal failure.

Application method:

The tablets are for oral use (oral).

The tablets should be swallowed whole with sufficient amount of liquid (eg 200 ml glass of water). They should not be broken or chewed.

Duration of treatment

You should take this medicine for as long as your doctor deems it necessary. Careful evaluation should be made when continuing therapy or a new course of treatment (depending on the severity of the disease). Temporary interruptions of treatment should be provided, where possible, especially for long-term therapies.

If you take more Tramadol Combo than you should

Uncommon: may affect up to 1 in 100 patients:

Depression, hallucinations, nightmares, memory loss;

Involuntary muscle contractions, tingling and numbness, tinnitus;

High blood pressure, palpitations, rapid heart rate, irregular heart rhythm;

Difficulty breathing;

Difficulty swallowing, bloody stools;

Increased values ​​of hepatic transaminases;

Skin reactions (eg rash, hives);

Albuminuria (albumin) in the urine, impaired urination (dysuria, urinary retention);

Shivering, warm waves, chest pain.

Rare: may affect up to 1 in 1,000 patients:

Drug dependence;

Lack of coordination, fits;

Blurred vision.

Very rare: may affect up to 1 in 10,000 patients:

Abuse.

With unknown frequency (cannot be estimated from available data):

Low blood sugar (hypoglycemia).

The following side effects have been reported by patients using medicines containing tramadol or paracetamol. You should tell your doctor if you experience any of the conditions described below while taking Tramadol Combo:

Exacerbation of asthma;

Feeling dizzy when lying down or sitting, slow heart rate, seizures, change in appetite, muscle weakness, delayed or superficial breathing, mood swings, changes in movements, changes in perceptions;

In rare cases - skin rash, which is a sign of an allergic reaction, sudden swelling of the face and neck, difficulty in breathing, sudden drop in blood pressure, which can lead to a seizure. If this happens to you, stop the treatment and contact your doctor immediately. You should not take this medicine again.

In rare cases, taking medicines such as tramadol can lead to drug dependency and stop treatment difficult.

In rare cases, patients who have taken tramadol for some time may feel ill if they suddenly stop treatment. They may feel agitated, restless, nervous or shivering. They can be overactive, insomnia and gastrointestinal disorders. Very few people can experience a panic attack, hallucinations, unusual sensations such as itching, numbness and tingling and tinnitus.

If you notice any of the above signs after you stop treatment with Tramadol Combo, talk to your doctor.

In exceptional cases, blood tests may show any abnormalities such as decreased platelet count, which may manifest with bleeding from the nose or gums.

Concomitant use of Tramadol Combo and medicines used to thin the blood (eg fenprocoumon, warfarin) may increase the risk of bleeding. Any prolonged or unexpected bleeding should be discussed with your doctor.

How to store Tramadol Combo

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Tramadol Combo contains

The active substances are tramadol hydrochloride and paracetamol. Each film-coated tablet contains 37.5 mg of tramadol hydrochloride (tramadol hydrochloride) and 325 mg of paracetamol (paracetamol).

The other ingredients (excipients) are:

Core: Pregelatinized starch, Maize starch, Sodium starch glycolate (type A), Microcrystalline cellulose (Avicell PH 102), Magnesium stearate.

Sheath: Resist yellow 03K82345 (hypromellose 6 cPs (E464), titanium dioxide (E171), triacetin, yellow iron oxide.

What Tramadol Combo looks like and contents of the pack

Light yellow, oblong, biconvex tablets without labeling.

Blister packs PVC-PVdC / Aluminum or PVC / Aluminum containing 10, 20 and 30 film-coated tablets, cartoned.

Not all pack sizes may be marketed.

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