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Patient Info Service - information for patients

1. What are Tramal tablets and what are they used for?

Tramadol - the active ingredient in Tramal tablets - is a centrally acting pain reliever from the group of opioids. Its pain-relieving effect is achieved through its action on specific nerve cells in the spinal cord and the brain.

Tramal tablets are used to treat moderate to severe pain.

2. What should you know before you take Tramal tablets?

Tramal tablets must not be taken

  • if you are allergic to tramadol, menthol, cineol or any of the other ingredients of this medicine (listed in section 6).

  • acute poisoning from alcohol, sleeping pills, painkillers or other psychotropic drugs (drugs that affect mood and emotional life).

  • if you are also taking MAO inhibitors (certain medicines that work against sad depression) or have taken them within the last 14 days before treatment with Tramal tablets (see “Other medicines and Tramal tablets”).

  • if you have epilepsy and treatment cannot adequately control it.

  • as a substitute for drug withdrawal.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Tramal tablets,

  • if you think you are dependent on other pain relievers (opioids).

  • if you have impaired consciousness (if you feel close to fainting).

  • if you are in shock (a cold sweat may be a sign of this).

  • if you suffer from conditions with increased intracranial pressure (possibly after head injuries or brain diseases).

  • if you have difficulty breathing.

  • if you are prone to epilepsy or seizures.

  • if you have liver or kidney problems.

Sleep-related breathing disorders

Tramal tablets contain 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 cessation of breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood).

The risk of developing central sleep apnea depends on the opioid dose. If you develop central sleep apnea, your doctor may consider reducing your total opioid dose.

Epileptic fits have been reported in patients taking tramadol at the recommended dose. The risk may increase if the recommended maximum daily dose of 400 mg tramadol is exceeded.

Please note that Tramal tablets can lead to emotional and physical dependence. With prolonged use, the effect of Tramal tablets can decrease, so that higher amounts of medication have to be taken (tolerance development). Treatment with Tramal tablets should therefore only be carried out for a short period and under strict medical supervision in patients who are prone to abuse or who are dependent on drugs.

Tramadol is converted by an enzyme in the liver. Some people have a modification of this enzyme, which can have different effects. Some people may not get adequate pain relief from this, and others may be more likely to experience serious side effects. If you notice any of the following side effects, stop taking this medicine and seek medical attention immediately: slow or shallow breathing, confusion, sleepiness, small pupils, nausea, vomiting, constipation, loss of appetite.

Please also tell your doctor if any of these problems occur while you are taking Tramal tablets or if these information applied to you in the past.

Other medicines and Tramal tablets

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or may take / use any other medicines.

Tramal tablets must not be taken together with MAO inhibitors (certain medicines used to treat depression) (see “Tramal tablets must not be taken”).

The pain relieving effect of Tramal tablets may be reduced and the duration of its effects shortened if you are taking medicines containing any of the following active substances:

  • Carbamazepine (for epileptic seizures)

  • Ondansetron (for nausea)

Your doctor will tell you whether you can take Tramal tablets and if so, what dose.

The risk of side effects increases

  • if you are taking Tramal tablets and medicines that also have a depressant effect on the brain at the same time. You may feel drowsy or faint. If this happens, please inform your doctor. These other medicines include certain pain relievers such as morphine and codeine (also used as cough suppressants), and alcohol.

    Simultaneous use of Tramal tablets and sedatives or sleeping pills (e.g. benzodiazepines) increases the risk of drowsiness, difficulty breathing (respiratory depression) and coma and can be life-threatening. For this reason, concomitant use should only be considered if no other treatment options are available.

    However, if your doctor prescribes Tramal tablets together with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor.

    Please inform your doctor about all sedating medicines you are taking and strictly follow your doctor’s dose recommendations. It may be helpful to tell friends or family members to look out for any of the above signs and symptoms. Contact your doctor if you experience these symptoms.

  • if you are taking medicines that can cause convulsions (fits), such as certain medicines for depression or psychosis. The risk of seizures may increase if you take Tramal tablets at the same time. Your doctor will tell you if Tramal tablets are right for you.

  • if you are taking certain medicines for depression. The effects of these medicines and Tramal tablets can affect each other and you may experience symptoms such as involuntary, rhythmic muscle twitching, including eye twitching (twitching of the muscles that control eye movement), restlessness, excessive sweating, involuntary tremors, increased reflexes, increased reflexes Muscle tension, body temperature over 38 ° C.

  • if you are taking coumarin anticoagulants (medicines that prevent normal blood clotting), e.g. warfarin, at the same time as Tramal tablets. The anticoagulant effects of these medicines can be influenced and bleeding can occur.

Tramal tablets with food, drink and alcohol

Do not drink alcohol during treatment with Tramal tablets, as its effects can be increased. Food does not affect the way Tramal tablets work.

Children and adolescents

Use in children with breathing problems

Tramadol is not recommended in children with breathing problems as symptoms of tramadol toxicity may worsen in these children.

Pregnancy and fertility

Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breastfeeding, if you suspect you may be pregnant or planning to become pregnant.

Little information is available on the safety of tramadol during pregnancy. Therefore, you should not take Tramal tablets if you are pregnant.

Repeated use of Tramal tablets during pregnancy can accustom the unborn child to tramadol and, as a result, cause withdrawal symptoms in the newborn after birth.

Experience from its use in humans suggests that tramadol does not affect male or female fertility.

Breastfeeding

Tramadol passes into breast milk. For this reason, you should not take Tramal tablets more than once if you are breast-feeding; however, if you take Tramal tablets more than once, you should interrupt breastfeeding.

Driving and using machines

Tramal tablets can cause dizziness, drowsiness and blurred vision (blurred vision), among other things, and thus affect your ability to react. If you feel that your ability to react is impaired, do not drive or any other vehicle, do not use electrical tools or machines, and do not work without a secure grip!

Tramal tablets contain sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

3. How should Tramal tablets be taken?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The dosage should be adjusted according to the severity of your pain and your individual sensitivity. In principle, the lowest dose that has an analgesic effect should be selected. Do not take more than 8 Tramal tablets (equivalent to 400 mg tramadol hydrochloride) a day, unless your doctor has specifically prescribed this.

Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents from 12 years

If the pain is moderate, 1 tablet Tramal (equivalent to 50 mg tramadol hydrochloride). If there is no relief from pain within 30 to 60 minutes, a second tablet can be taken.

If a higher requirement is to be expected in the case of severe pain, 2 Tramal tablets (equivalent to 100 mg tramadol hydrochloride) are taken as a single dose.

The effect lasts for 4 to 6 hours, depending on the pain.

Use in children and adolescents

Tramal tablets are not intended for use in children under 12 years of age.

Elderly patients

The elimination of tramadol may be delayed in elderly patients (over 75 years of age). If this applies to you, your doctor may recommend that you extend the intervals between doses.

Severe liver or kidney failure (insufficiency) / dialysis patients

If you have impaired liver and / or kidney function, your doctor may recommend that you extend the intervals between doses.

How and when should you take Tramal tablets?

To take.

Always take Tramal tablets whole, whole, whole and whole with sufficient liquid. You can take the tablets on an empty stomach or with meals.

How long should you take Tramal tablets?

Do not take Tramal tablets longer than absolutely necessary. If long-term pain treatment appears necessary, your doctor will check regularly (if necessary by taking breaks from using it) whether you should continue to take Tramal tablets and, if so, what dose.

Please talk to your doctor or pharmacist if you have the impression that the effect of Tramal tablets is too strong or too weak.

If you take more Tramal tablets than you should

If you accidentally take an extra dose of Tramal tablets, this will usually not have any negative effects. Take the next dose of Tramal tablets as prescribed.

If the drug is taken in excessively high amounts, pupils may be constricted, vomiting, drop in blood pressure, accelerated heartbeat, circulatory collapse, impaired consciousness up to coma (deep unconsciousness), epileptic seizures and reduced breathing up to respiratory arrest. Call a doctor for help immediately if these signs occur!

If you forget to take Tramal tablets

If you forget to take Tramal tablets, your pain may come back. Do not take a double dose to make up for the forgotten dose, just carry on as before.

If you stop taking Tramal tablets

If you interrupt or stop treatment with Tramal tablets prematurely, it is likely that the pain will come back again. If you want to stop the treatment because of unpleasant side effects, please contact your doctor.

In general, stopping treatment with Tramal tablets will have no after-effects. However, there may be after-effects in a small number of people who have been taking Tramal tablets for a long time and who suddenly stop taking the medicine. You may feel restless, anxious, nervous, or shaky. You could be hyperactive, have trouble sleeping, or have gastrointestinal discomfort. Very few people may have panic attacks, hallucinations, abnormal sensations such as tingling, prickling and numbness, or ringing in the ears (tinnitus). Other unusual symptoms of the central nervous system, such as confusion, delusion, altered perceptions of oneself (depersonalization) and of reality (derealization) as well as paranoia, have been observed very rarely. If you get any of these side effects after stopping treatment with Tramal tablets, please contact your doctor.

If you stop taking tramadol:

You should only stop suddenly if your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first; this is especially true if you have been taking it for a long time. Your doctor will advise you when and how to stop taking the medicine; this may be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. What side effects are possible?

Like all medicines, this medicine can have side effects, although not everybody gets them.

You should see a doctor immediately if you experience symptoms of an allergic reaction such as swelling of the face, tongue and / or throat and / or difficulty swallowing or hives with difficulty breathing.

The most common side effects that occur during treatment with Tramal tablets are nausea and dizziness, which occur more often than 1 in 10 people.

Very common (affects more than 1 in 10 people):

Dizziness, nausea.

Common (affects 1 to 10 users in 100):

Headache, drowsiness, exhaustion, vomiting, constipation, dry mouth, sweating (hyperhidrosis).

Uncommon (affects 1 to 10 users in 1,000):

Impact on the heart and circulatory regulation (palpitations, accelerated heartbeat, feeling close to fainting or circulatory collapse). These side effects can occur in particular with an upright posture and physical exertion.

Nausea (gagging), stomach discomfort (e.g. stomach pressure, bloating), diarrhea (diarrhea).

Skin reactions (e.g. itching, rash).

Rare (affects 1 to 10 users in 10,000):

Allergic reactions (e.g. shortness of breath, wheezing, swelling of the skin) and shock reactions (sudden circulatory failure) have occurred in very rare cases.

Slow heartbeat.

Increase in blood pressure.

Incorrect sensations on the skin (such as itching, tingling, numbness), tremors, epileptic fits, muscle twitching, coordination disorders, temporary unconsciousness (syncope), speech disorders.

Epileptic seizures occurred predominantly after the use of high doses of tramadol or after the simultaneous use of drugs that can trigger seizures.

Changes in appetite.

Hallucinations, confusional states, insomnia, delirium, anxiety and nightmares.

Psychological complaints can occur after treatment with Tramal tablets, although their intensity and type can vary from person to person (depending on the personality of the patient and the duration of use). This can involve changes in mood (usually elevated, occasionally also irritated mood), changes in activity (usually dampening, occasionally increasing) and a reduction in the ability to perceive and think (change in sensory perception and the recognition of what can lead to errors in decision-making behavior) .

Drug addiction can occur.

Withdrawal reactions may occur after stopping the drug (see "If you stop taking Tramal tablets").

Blurred vision, constriction of the pupils (miosis), extreme dilation of the pupils (mydriasis).

Slowed breathing, difficulty breathing (dyspnoea).

A worsening of asthma has been reported, but a causal connection with the active ingredient tramadol could not be established.

If the recommended doses are exceeded or other drugs that have a depressant effect on brain function are used at the same time, breathing may become slower.

Decreased muscle strength.

Difficult or painful urination, less urine than normal (dysuria).

Very rare (less than 1 user in 10,000):

Increases in liver enzymes.

Not known (frequency cannot be estimated from the available data):

Drop in blood sugar levels.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly via the Federal Institute for Drugs and Medical Devices Dept. Pharmacovigilance Kurt-Georg-Kiesinger Allee 3 D-53175 Bonn Website: http://www.bfarm.de Show. By reporting side effects you can help provide more information on the safety of this medicine.

5. How should Tramal tablets be stored?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 ° C.

Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.

6. Contents of the pack and other information

What Tramal tablets contain

The active substance is: tramadol hydrochloride.

Each Tramal tablet contains 50 mg tramadol hydrochloride.

The other ingredients are:

Microcrystalline cellulose, corn starch, sodium saccharin, peppermint flavor, aniseed flavor, highly dispersed silicon dioxide, magnesium stearate.

What Tramal tablets look like and contents of the pack

White or almost white, flat, round tablets with rounded edges.

Tramal tablets are available in packs of 10 tablets.

Marketing Authorization Holder and Manufacturer

Grünenthal GmbH • 52099 Aachen

Tel .: 0241 569-1111

Fax: 0241 569-1112

E-mail: [email protected]

This leaflet was last revised in September 2019.