1. What are Tramadol and what is it used for?

Tramadol hydrochloride - the active ingredient in Tramadol - is an analgesic (analgesic) from the group of opioids, which acts on the central nervous system. Its pain relief reaches it by its effect on certain nerve cells of the spinal cord and the brain.

Tramadol are used to treat moderate to severe pain.

2. What should you watch out for before taking Tramadol?

Tramadol should not be taken,

    If you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
    in acute poisoning with alcohol, sleeping pills, analgesics or other psychotropic drugs (drugs with effects on mood and emotional life).
    if you are taking MAO inhibitors (medicines to treat depression) or if you have taken drops within the last 14 days prior to treatment with Tramal (see "Taking Tramadol with other medicines").
    if you have epilepsy and your seizures can not be adequately controlled by treatment.
    as a substitute for drug withdrawal.

Warnings and Precautions:

Please talk to your doctor or pharmacist before you use Tramadol,

    if you think you are dependent on other painkillers (opioids) or have already been sensitive to opioids in the past.
    if you have a mental disorder (if you feel close to fainting).
    when you are in shock (cold sweat may be an indication).
    if you have conditions with increased intracranial pressure (possibly after a head injury or brain disease).
    if you have difficulty breathing.
    if you are prone to epilepsy or seizures.
    if you have liver or kidney problems.

Epileptic seizures have been reported in patients taking tramadol at the recommended dose. The risk could increase if the recommended maximum daily dose (400 mg) is exceeded.

Please note that Tramadol can lead to a physical and emotional dependence. With prolonged use, the effect of Tramadol may decrease, so that higher doses (amounts of the drug) must be taken (tolerance development). Patients who are prone to drug abuse or have drug dependence should therefore only receive Tramal treatment at short notice and under the strictest medical supervision.

If a patient discontinues tramadol therapy, especially after prolonged use, a gradual dose reduction is recommended to avoid withdrawal symptoms.

Please also tell your doctor if any of these problems occur while you are taking Tramadol, or if this information was previously available to you.

Taking Tramadol with other medicines

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

Tramadol should not be taken with MAO inhibitors (certain medicines used to treat depression).

The analgesic effect of Tramadol can be reduced and the duration of action shortened if you take medicines containing any of the following active ingredients.

    Carbamazepine (for epileptic seizures)
    Ondansetron (for nausea)

Your doctor will tell you if and if so in what dosage Tramadol may be taken.

The risk of side effects increases when you

    Tramadol and sedatives, hypnotics, other painkillers such as Take morphine or codeine (also cough medicine) and alcohol. They may feel drowsy or feel close to fainting. If this happens, please inform your doctor.
    Taking medicines that can cause seizures (seizures), such as certain antidepressants or antipsychotics (medicines that affect the consciousness). The risk of having a seizure may be increased if you take Tramal retard. Your doctor will tell you if Tramal retard is right for you.
    take certain antidepressants (medicines for depression). Tramal retard may interact with this medicine and you may experience symptoms such as involuntary, rhythmic muscle contractions, including muscle, which control the movement of the eyes, restlessness, excessive sweating, tremors, exaggerated reflexes, increase in muscle tension, body temperature above 38 ° C feel.
    concomitantly with Tramadol coumarin anticoagulants (medicines for blood thinning), e.g. Warfarin. The effect of these medicines on blood coagulation may be affected and bleeding may occur.

Taking Tramadol along with food and alcohol

Do not drink alcohol during treatment with Tramadol, as its effects may be increased. Foods do not affect Tramadol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
pregnancy

There is limited information on the safety of tramadol hydrochloride in pregnancy. Therefore, you should not take Tramadol during pregnancy.

Prolonged use during pregnancy may lead to withdrawal symptoms in the newborn (the neonate may experience a change in the respiratory rate).

Your doctor will therefore only prescribe Tramadol during pregnancy if you have to.
lactation

Taking tramadol hydrochloride while breast-feeding is generally not recommended. Tramadol hydrochloride is excreted in breast milk in very small amounts. With a single dose, an interruption of breastfeeding is usually not required.
Procreation / childbearing

Based on human experience, tramadol does not affect female or male fertility.
Driving and using machines

CAUTION: This medicine may affect the ability to react and to drive!

Traminal drops can cause drowsiness, dizziness, and blurred vision, and affect your ability to react. If you feel that your responsiveness is impaired, do not drive a car or other vehicle, do not operate electrical tools or machinery.
Tramadol contains sucrose and macrogolglycerol hydroxystearate

If your doctor has told you that you have an intolerance to certain sugars, ask your doctor for advice before taking Tramadol, as the tablets contain sucrose. If Tramadol are intended for chronic use (i.e., for two weeks or longer), they could be detrimental to the teeth.

Tramadol contain macrogolglycerol hydroxystearate, a derivative of castor oil that can cause stomach upset and diarrhea.

3. How to take Tramadol?

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

The dose should be adjusted to the intensity of your pain and to your individual pain sensation. In general, the smallest possible dose, with which freedom from pain is achieved, should be taken.

Do not take more than 160 drops (for example, 8 times 20 drops) (equivalent to 400 mg tramadol hydrochloride) daily, unless your doctor has ordered it accordingly.

Unless otherwise prescribed by the doctor, the usual dose is:
Adults and adolescents from 12 years

The usual dose of Tramadol in the dropper bottle is 20 to 40 drops (equivalent to 50 to 100 mg of tramadol hydrochloride).

The effect lasts about 4 to 8 hours, depending on the intensity of the pain.

For moderately severe pain, 50 mg tramadol hydrochloride (20 drops) should be administered. If there is no adequate pain relief within 30 to 60 minutes, another 50 mg can be administered. For severe pain conditions, 100 mg tramadol hydrochloride (40 drops) may be given as an initial dose.
Children from 1 year

The usual single dose Tramadol in the dropper bottle for infants from 1 year of age with the dropper is 4 to 8 drops per 10 kg of body weight (corresponding to about 1-2 mg of tramadol hydrochloride per kg of body weight). You will find detailed information about the body weight dose at the end of this leaflet.

In general, the lowest effective dose is chosen to achieve freedom from pain.

Daily doses of 8 mg tramadol hydrochloride per kg body weight or 400 mg tramadol hydrochloride (whichever is lower) should not be exceeded.

For the use of Tramadol in children it is recommended to administer the solution by means of a dropper bottle and not with the aid of a bottle with a dosing pump in order to allow an exact body weight related dosage.
Elderly patients

In elderly patients (over 75 years), excretion of tramadol hydrochloride may be delayed. If this applies to you, your doctor may recommend that you prolong the dose interval.

Severe liver or kidney disease (insufficiency) / dialysis patients

If you have liver and / or kidney failure, your doctor may recommend prolonging the dose interval.
How and when should you take Tramadol?

Oral drops (for oral use).

Take the drops with some liquid or on a sugar cube. A detailed description of the use of the dropper bottle can be found at the end of this leaflet. You can take Tramadol on an empty stomach or with a meal.
How long should you take Tramadol?

You should not take Tramadol for longer than absolutely necessary. If, depending on the type and severity of the disease, a longer lasting pain treatment seems to be necessary, your doctor will check at regular intervals (possibly by taking breaks), if you should continue to use Tramadol and if so in which dose.

Please talk to your doctor or pharmacist if you think the effects of Tramadol are too strong or too weak.
If you take more Tramadol than you should

Inadvertently, if you accidentally take an additional dose of Tramadol, it will not have a negative effect. Further intake of Tramadol should be made as prescribed.

Ingestion of very high doses can lead to narrow pupils, vomiting, drop in blood pressure, accelerated heartbeat, circulatory collapse, impaired consciousness, even coma (deep unconsciousness), epileptiform seizures and difficulty breathing, including respiratory arrest. Immediately call a doctor for help when these signs appear!
If you forget to take Tramadol

If you forget to take Tramadol, your pain may recur. Do not take the double dose, but continue as before.
If you stop taking Tramadol

If you stop treatment with Tramadol or stop prematurely, this will lead to a recurrence of the pain. If you would like to discontinue the treatment because of unpleasant side effects, please contact your doctor.

In general, stopping treatment with Tramadol will have no after-effects. In rare cases, however, patients treated with Tramadol for extended periods of time may feel uncomfortable when treatment is stopped abruptly. You may feel restless, anxious, nervous or shaky. You may be hyperactive, have difficulty sleeping or have gastrointestinal discomfort. Very few people may experience panic attacks, cognitive disorders, abnormalities such as itching, tingling and numbness and tinnitus. Other unusual disorders affecting the central nervous system, such as Confusion, delusions, disturbance of the ego experience (depersonalization), disturbance in the perception of reality (derealization) and persecution mania (paranoia) were observed very rarely. If any of these symptoms occur after stopping treatment, contact your doctor.

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

4. What side effects are possible from tramadol?

Like all medicines, this medicine can cause 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 in swallowing or rash with concomitant breathing difficulties.

The most common side effects that occur during treatment with Tramadol are nausea and dizziness, which is more common than in 1 in 10 people.
Very common: may affect more than 1 in 10 people

    dizziness
    nausea

Frequently: can affect up to 1 in 10 people

    Headache, drowsiness
    Constipation, dry mouth, vomiting
    Sweating (hyperhidrosis)
    exhaustion

Uncommon: may affect up to 1 in 100 people

    Influencing the heart activity (palpitations, increased heartbeat). These side effects can occur especially with upright posture and physical stress.
    Nausea, stomach discomfort (eg stomach pressure, feeling of fullness), diarrhea
    Skin reactions (eg itching, rash)

Rarely: can affect up to 1 in 1000 people

    allergic reactions (e.g., difficulty breathing, wheezing, swelling of the skin) and shock (sudden circulatory failure) have occurred in very rare cases
    Slowed heartbeat
    Increase in blood pressure
    Misbehavior (such as itching, tingling sensation, numbness), trembling, epileptic seizures, muscle twitching, coordination disorders, temporary loss of consciousness (fainting), speech disorders
    Epileptic seizures occurred predominantly after administration of high doses of tramadol or when tramadol is taken concomitantly with drugs that cause seizures.
    appetite changes
    Perception disorders (hallucinations), confusion, sleep disorders, delirium, anxiety and nightmares
    Mental complaints may occur after treatment with Tramal, with their intensity and nature varying in individual ways (depending on the patient's personality and duration of use). These may be mood changes (usually elevated, occasionally irritable mood), changes in activity (usually attenuation, occasional increase) and reduction in cognitive and sensory performance (change in sensory perception and cognition, which can lead to errors in decision-making behavior) ,
    A dependency can occur. If Tramadol are taken over a longer period of time, drug dependency may develop, although the risk is low. With abrupt discontinuation of the drug withdrawal reactions may occur (see "If you stop using Tramadol").
    Blurred vision, narrowing of the pupils (miosis), strong pupillary dilation (mydriasis)
    Reduction of breathing, shortness of breath (dyspnoea)
    An exacerbation of asthma has been reported, but a link with the drug tramadol hydrochloride could not be established. Exceeding the recommended doses or using other medicines that act to depress the brain at the same time may result in decreased breathing.
    Decreased muscle power
    Difficult or painful urination or less urine than normal (dysuria)

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

    Increase in liver enzyme levels

5. How to store Tramadol?

Tramadol are stable after opening at 25 ° C - 30 ° C until the expiry date stated.

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 the glass bottle label. The expiry date refers to the last day of the specified month.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect our environment.