You can safely take 15 mg of tramadol
TRAMADOL BASICS drops
|Active ingredient||Addictive drug||Psychotropic|
What is it and what is it used for?
What is Tramadol Basics Drops and what is it used for?
Tramadol - the active ingredient in TRAMADOL BASICS drops - is a centrally acting pain reliever from the group of opioids. Its analgesic effect is achieved through its action on specific nerve cells in the spinal cord and the brain.
TRAMADOL BASICS drops are used
to treat moderate to severe pain.
What do you need to consider before use?
TRAMADOL BASICS drops must not be taken
- if you are hypersensitive (allergic) to tramadol or any of the other ingredients of TRAMADOL BASICS drops;
- in the event of acute poisoning from alcohol, sleeping pills, painkillers or other psychotropic drugs (drugs that affect mood, mood and emotional life);
- if you are also taking MAO inhibitors (certain drugs that work against pathological depression) or have taken drops within the last 14 days prior to treatment with TRAMADOL BASICS (see "If you take TRAMADOL BASICS drops with other drugs") );
- if you have epilepsy and treatment cannot adequately control it;
- as a substitute for drug withdrawal.
Take special care when taking TRAMADOL BASICS drops
- if you think you may be dependent on other pain relievers (opioids);
- if you suffer from impaired consciousness;
- 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;
In these cases, talk to your doctor before starting use.
Please note that TRAMADOL BASICS drops can lead to emotional and physical dependence. With prolonged use, the effect of TRAMADOL BASICS drops can decrease, so that higher amounts of medicine have to be used (tolerance development). In patients who are prone to drug abuse or drug dependency, treatment with TRAMADOL BASICS drops should therefore be carried out for a short time and under strict medical supervision.
Please also inform your doctor if one of these problems occurs while using TRAMADOL BASICS drops or if these details applied to you in the past.
TRAMADOL BASICS drops is not intended for use in children under 1 year of age.
In the elderly, the dosing intervals may be longer (see dosing instructions).
pregnancy and breast feeding period
If you are pregnant, your doctor will only prescribe TRAMADOL BASICS drops if there are compelling reasons to do so. In general, the use of TRAMADOL BASICS drops in this condition is not recommended, as the tolerance in pregnant women has not been investigated. The repeated administration of TRAMADOL BASICS drops during pregnancy can lead to the accustoming of the unborn child to tramadol and consequently to withdrawal symptoms in the newborn after birth.
Given before or during childbirth, TRAMADOL BASICS drops do not affect the ability of the uterus to contract, which is important for the natural birth process.
Tramadol is excreted in breast milk in very small amounts (about 0.1% of an IV dose). Therefore, tramadol should not be used during breastfeeding. With a single dose of tramadol, breastfeeding does not usually have to be interrupted.
Ask your doctor or pharmacist for advice before taking / using any medicine.
Driving and using machines:
TRAMADOL BASICS drops can cause drowsiness and visual disturbances, among other things
(blurred vision) and thus affect your ability to react. If you feel that your ability to react is impaired, do not drive, use electrical tools or machines, and do not work without a secure footing!
Important information about certain other ingredients of TRAMADOL BASICS drops
TRAMADOL BASICS drops contain sorbitol. 1 ml solution (corresponding to 40 drops or 8 pump strokes) contains 0.315 g sorbitol (corresponding to 0.026 BU). If the dosage instructions are followed, up to 0.315 g of sorbitol are administered with each application.
Please take TRAMADOL BASICS drops only after consulting your doctor if you know that you suffer from an intolerance to certain sugars.
Because of the possibility of a previously unknown fructose intolerance, this medicinal product should only be used in small children after consultation with the attending physician.
How is it used?
How to take TRamadol Basics Drops?
Always take TRAMADOL BASICS drops exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.
The dosage is adjusted according to the prescription by the doctor according to the severity of the pain and your individual sensitivity. In principle, the lowest pain relieving dose should be used.
Under no circumstances should you use TRAMADOL BASICS drops for longer than absolutely necessary.
Unless otherwise prescribed by your doctor, the usual dose is:
1 ml oral solution gives 40 drops or 8 pump strokes,
d. H. 1 drop of TRAMADOL BASICS drops contains approx.
1 Pump-Hub TRAMADOL BASICS drops contains approx. 12.5 mg tramadol hydrochloride.
Adults and adolescents from 12 years:
In the case of moderate pain, 20 drops (bottle with dropper device) or 4 pump strokes (bottle with metering pump) TRAMADOL BASICS drops (equivalent to 50 mg tramadol hydrochloride) as a single dose. If there is no relief from pain within 30-60 minutes, a second single dose can be taken.
If a higher requirement is to be expected in the case of severe pain, then as a single dose
40 drops (bottle with drip device) or 8 pump strokes (bottle with dosing pump) TRAMADOL BASICS drops (equivalent to 100 mg tramadol hydrochloride) taken.
The effect lasts for 4 to 8 hours, depending on the pain. In general, daily doses of 160 drops (bottle with dropper device) or 32 pump strokes (bottle with dosing pump) (corresponding to 400 mg tramadol hydrochloride) do not need to be exceeded. With tumor pain (pain in cancer) and severe pain after
However, operations can also require significantly higher daily doses.
Children aged 1 to 12 years receive 1 to 2 mg tramadol hydrochloride per kilogram body weight as a single dose.
The following table shows typical examples for the respective age groups (1 drop of TRAMADOL BASICS drops contains approx.2.5 mg of tramadol hydrochloride):
|Age||body weight||Number of drops|
(Bottle with drip device)
|1 year||10 kg||4 to 8|
|3 years||15 kg||6 to 12|
|6 years||20 kg||8 to 16|
|9 years||30 kg||12 to 24|
|11 years||45 kg||18 to 36|
In the case of acute pain, TRAMADOL BASICS drops are taken only once or a few times, so that a dose adjustment is not necessary. In the case of chronic pain, a dose adjustment is usually not necessary in elderly patients (up to 75 years of age) without signs of severe liver or kidney disease. Elimination may be prolonged in old patients (over 75 years of age). As a result, the intervals between the receipts may have to be extended individually.
Severe liver or kidney disease (insufficiency) / dialysis patients
In the case of acute pain, TRAMADOL BASICS drops are taken only once or a few times, so that a dose adjustment is not necessary.
If you suffer from severe liver and / or kidney problems, you should not use TRAMADOL BASICS drops. In less severe cases of impaired liver and kidney function, the intervals between doses should be increased.
The recommended dosages are guidelines. In principle, the smallest effective pain-relieving dose should be selected. In the treatment of chronic pain, preference should be given to dosing according to a fixed schedule.
type of application
Take the drops with enough liquid. The intake is independent of meals.
Please talk to your doctor or pharmacist if you have the impression that the effect of TRAMADOL BASICS drops is too strong or too weak.
If you take more TRAMADOL BASICS drops than you should,
this usually has no negative effects. You should continue taking TRAMADOL BASICS drops as you normally would, depending on the recurrence of the pain.
The use of drugs that are significantly too high leads to narrow or dilated pupils, vomiting, drop in blood pressure, increased heartbeat, circulatory collapse, impaired consciousness up to coma (deep unconsciousness), epileptiform seizures and reduced breathing up to respiratory arrest. If these symptoms appear, call the nearest doctor for help immediately!
If you forget to take TRAMADOL BASICS drops,
your pain may come back.
Do not take a double dose to make up for a forgotten dose, just carry on as before.
If you stop taking TRAMADOL BASICS drops
If you interrupt or prematurely end treatment with TRAMADOL BASICS drops, this will cause the pain to recur. If you want to stop the treatment because of unpleasant side effects, please contact your doctor.
In general, stopping treatment with TRAMADOL BASICS drops will not have any after-effects. In a few patients who have used TRAMADOL BASICS drops over a very long period of time, however, after-effects such as restlessness, anxiety, nervousness, insomnia, tremors or gastrointestinal problems can occur. If you get any of these side effects after stopping treatment with TRAMADOL BASICS drops, please contact your doctor.
If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.
What are the possible side effects?
Taking TRAMADOL BASICS drops with other drugs
Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.
The pain-relieving effect of TRAMADOL BASICS drops can be reduced and the duration of action shortened,
- if you are taking medicines containing carbamazepine (for epileptic seizures).
The risk of side effects increases
- if you use TRAMADOL BASICS drops and at the same time medicines that also have a depressant effect on the brain function, e.g. B. Cough suppressants, certain pain relievers, sleeping pills, agents for treating anxiety disorders or agents for replacement therapy for drug addiction. Here there is an increased risk of a reduction in breathing activity up to and including respiratory arrest in the event of an overdose.
with simultaneous use of drugs that lower the seizure threshold or may themselves have an anti-seizure effect (e.g. antidepressants for the treatment of certain symptoms of mental illness). Epileptiform seizures are very rarely observed.
- if you are taking serotoninergic drugs at the same time as TRAMADOL BASICS drops (drugs that are effective against pathologically sad mood [depression]). It can occasionally lead to serotonin syndrome. Symptoms of serotonin syndrome are e.g. confusion, restlessness, fever, sweating.
- if you are taking drugs at the same time as TRAMADOL BASICS drops that prevent normal blood clotting - so-called coumarin derivatives (e.g. warfarin). The anticoagulant effect of these drugs can be increased and small areas of subcutaneous bleeding (ecchymosis) can occur.
Other possible interactions:
- TRAMADOL BASICS drops should not be administered at the same time as MAO inhibitors (drugs that are effective against pathologically sad mood [depression]). When MAO inhibitors were administered within the last 14 days before administration of another opioid (pethidine), life-threatening interactions that affected the central nervous system as well as respiratory and circulatory function have been seen. The same interactions with MAO inhibitors cannot be ruled out with TRAMADOL BASICS drops.
If you take medication against pain containing buprenorphine, pentazocine or nalbuphine at the same time as TRAMADOL BASICS drops, the pain-relieving effect of TRAMADOL BASICS drops may be reduced.
Taking TRAMADOL BASICS drops with food and drink
Do not drink alcohol during treatment with TRAMADOL BASICS drops, as its effect can be intensified.
What side effects are possible?
Like all medicines, TRAMADOL BASICS Drops can have side effects, although not every person treated will experience them.
When evaluating side effects, the following frequencies are used as a basis:
|more than 1 patient in 10||1 to 10 patients in 100|
|1 to 10Treated out of 1,000||1 to 10Treated out of 10,000|
|less than 1 patient in 10,000||Not known: frequency cannot be estimated from the available data.|
The most common side effects that occur during treatment with TRAMADOL BASICS drops are nausea and dizziness, which occur more often than 1 in 10 patients.
- Influence on circulatory regulation (palpitations, increased heartbeat, attacks of weakness and circulatory collapse). These side effects can occur in particular with an upright posture and physical exertion.
- Nausea, diarrhea, stomach discomfort (e.g. stomach pressure, feeling of fullness)
- Skin symptoms (e.g. itching, rash, rapid reddening of the skin)
- Slow heart rate (bradycardia), increase in blood pressure
- Changes in appetite, abnormal sensations on the skin (such as tingling, prickling, numbness), tremors, decreased breathing, epileptiform convulsions.
If the recommended amounts of medication are exceeded or other medications that have a depressant effect on the brain are used at the same time, breathing may be reduced.
Epileptiform seizures occurred predominantly after the use of high doses of tramadol or after the simultaneous use of drugs that can themselves induce convulsions or lower the seizure threshold.
- blurred vision
- decreased muscle strength
- Urination problems or less urine than normal
Psychological complaints can occur after treatment with TRAMADOL BASICS drops, with their intensity and nature appearing differently from person to person (depending on personality and duration of use). This can include changes in mood (usually elevated, occasionally irritated mood), changes in activity (usually dampening, occasionally increasing) and changes in cognitive and sensory performance (changes in sensory perception and in recognizing what can lead to errors in decision-making behavior) .
A dependency can arise.
- Difficult breathing and worsening of asthma have been reported, although a causal connection with the active ingredient tramadol could not be established.
If TRAMADOL BASICS drops are used over a longer period of time, dependency can develop, even if the risk is low. After stopping the medication, withdrawal reactions may occur (see "If you stop taking TRAMADOL BASICS drops").
If you notice any of the serious side effects described above, call the nearest available doctor for help.
Please inform your doctor or pharmacist if you become seriously affected by any of the side effects listed, or if you notice any side effects not listed in this leaflet.
How should it be stored?
How should TRAMADOL BASICS drops be stored?
Store drug out of reach of children.
Do not use the medicine after the expiry date stated on the carton and bottle label after
What TRAMADOL BASICS drops contain
The active substance is: tramadol hydrochloride.
1 ml of oral solution contains 100 mg of tramadol hydrochloride.
Bottle with a dropper
Using a suitable dropper device, 1 ml of oral solution gives 40 drops, i.e. H. 1 drop of TRAMADOL BASICS contains approx. 2.5 mg of tra-madol hydrochloride.
Bottle with dosing pump
Using a suitable metering pump, 8 pump strokes correspond to 1 ml of oral solution. H. 1 Pump-Hub TRAMADOL BASICS drops contains approx. 12.5 mg tramadol hydrochloride.
The other ingredients are:
Sorbitol solution 70% (non-crystallizing) (Ph. Eur.), Propylene glycol, sodium saccharin, peppermint flavor, purified water.
What TRAMADOL BASICS drops look like and contents of the pack:
TRAMADOL BASICS drops is a clear, somewhat viscous colorless solution with a peppermint odor.
TRAMADOL BASICS drops are available in packs as an oral solution
20 (2x10) ml (N1) as a bottle with a dropper device and
50 ml (N2) and 100 ml (N3) as a bottle with a dosing pump
Marketing Authorization Holder and Manufacturer
Hemmelrather Weg 201
Telephone: (0214) 4 03 99-0
Fax: (0214) 4 03 99-199
E-mail: [email protected]
Internet address: www.basics.de
This leaflet was last revised in October 2007.
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