Tramadol 37.5 mg / 325 mg. 30 tablets
Tramadol is a combination of two painkillers - tramadol and paracetamol, which work together to relieve your pain.
Tramadol is intended for the treatment of moderate to severe pain when your doctor deems you need to combine tramadol and paracetamol.
Tramadol 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 :
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 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 notice 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.
Tramadol 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
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 the duration of the effect of tramadol.
Painkillers (buprenorphine, nalbuphine, pentazocine). If you are taking these medicines at the same time, there is a risk of a decrease in the pain-relieving 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
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 with Tramadol Combo (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.
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.
Tramadol is excreted in human milk. Therefore, 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
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.
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.
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 than you should
If you take more tablets than you should, you should contact your doctor or go to the nearest hospital.
In case of overdose, you may experience nausea (soreness), pupil contraction (miosis), vomiting, anorexia (decreased appetite), abdominal pain, cardiovascular collapse, clouding of consciousness to coma, epileptic seizures, respiratory depression, respiratory depression of breathing.
Liver damage may occur after 12 or 48 hours after overdose. In severe poisoning, liver failure can lead to severe brain disease (encephalopathy), coma, or death. Acute renal insufficiency with tubular necrosis (cellular destruction) can occur even if there is no liver damage. Cardiac arrhythmia (irregular rhythm) and pancreatitis (inflammation of the pancreas) have also been reported.
If you forget to take Tramadol Combo
If you forget to take one tablet, you may miss a dose and continue treatment as usual, or take the tablet and wait at least 6 hours until the next.
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 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: Pre-gelatinized starch, Corn 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 of PVC-PVdC / Aluminum or PVC / Aluminum containing 10, 20 and 30 film-coated tablets in carton.
Not all pack sizes may be marketed.