Package leaflet: Information for the patient
Tramadol TAD 100 mg/ml oral drops, solution tramadol hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet 1. What Tramadol TAD is and what it is used for 2. What you need to know before you take Tramadol TAD 3. How to take Tramadol TAD 4. Possible side effects 5. How to store Tramadol TAD 6. Contents of the pack and other information
1. What Tramadol TAD is and what it is used for
Tramadol – the active substance in this medicine – is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
This medicine is used for the treatment of moderate to severe pain.
2. What you need to know before you take Tramadol TAD
Do not take Tramadol TAD: - if you are allergic to tramadol, menthol, eucalyptol or any of the other ingredients of this medicine (listed in section 6); - in acute poisoning with alcohol, sleeping pills, painkillers or other psychotropic drugs (medicines that affect mood and emotions); - if you are taking MAO inhibitors (certain medicines for treating depression) or have taken them in the past two weeks (see “Other medicines and Tramadol TAD”); - if you have epilepsy that cannot be adequately controlled by treatment; - as a substitute in drug withdrawal.
Warnings and precautions Talk to your doctor or pharmacist before taking Tramadol TAD: - if you think that you are dependent on other painkillers (opioids); - if you have consciousness disturbances (feel faint); - if you are in shock (cold sweat may be a sign); - if you have elevated pressure in the skull (possibly after a head injury or brain diseases); - if you have difficulty breathing; Page 1 of 8
- if you are prone to epilepsy or seizures; - if you have liver or kidney problems.
Epileptic seizures have been described in patients taking tramadol at the recommended dose. The risk may be increased when the recommended maximum daily dose of 400 mg tramadol is exceeded.
Please note that this medicine may lead to psychological and physical dependence. With prolonged use, the effect of this medicine may subside and higher doses must be taken (development of tolerance). In patients with a tendency to drug abuse or drug dependence, treatment with this medicine should only be for short periods and under strict medical supervision.
Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
Children and adolescents Use in children with breathing problems Tramadol is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.
Please tell your doctor if any of these problems occur while taking Tramadol TAD or if this information once applied to you.
Other medicines and Tramadol TAD Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
Tramadol TAD should not be taken together with MAO inhibitors (certain medicines for treating depression) (see “Do not take Tramadol TAD”).
Concomitant use of Tramadol TAD and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Tramadol TAD together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
The pain-relieving effect of Tramadol TAD may be weakened and/or shortened if you also take medicines containing one of the following active substances: - carbamazepine (used to treat epilepsy) - ondansetron (used to stop you feeling sick)
Your doctor will tell you if you are allowed to take this medicine and what dosage you should take.
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The risk of side effects increases: - if you are taking Tramadol TAD at the same time as medicines that also have a depressant effect on brain function. You may feel dizzy or faint. If this happens, please tell your doctor. The other medicines include sedatives, sleeping pills and certain painkillers, such as morphine and codeine (also as a cough suppressant), and alcohol. - if you are taking medicines which may cause convulsions (epileptic seizures), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take this medicine at the same time. Your doctor will tell you whether Tramadol TAD is suitable for you. - if you are taking certain antidepressants. Tramadol TAD may interact with these medicines and you may experience symptoms, such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. - if you are taking coumarin anticoagulants (medicines that prevent normal blood clotting), e.g. warfarin, together with this medicine. The anticoagulant effect of these medicines may be affected and bleeding may occur.
Tramadol TAD with food and drink and alcohol You should not drink alcohol during treatment with this medicine, as its effect may be intensified. Food does not influence the effect of Tramadol TAD.
Pregnancy and 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. There is only little information regarding the safety of tramadol during pregnancy. Therefore, you should not take Tramadol TAD if you are pregnant.
Repeated use of this medicine during pregnancy can lead to habituation of the unborn child to tramadol and consequently to withdrawal symptoms after birth in the newborn.
Tramadol is excreted into breast milk. For this reason, you should not take
Experience from use in humans suggests that tramadol has no effect on male and female fertility.
Driving and using machines Tramadol TAD may cause dizziness, drowsiness and visual disturbances (blurred vision) and thus affect your ability to react. If you feel that your ability to react is impaired, do not drive a car or another vehicle, operate electrical tools or machines and work without a secure grip.
Tramadol TAD contains sucrose, propylene glycol, macrogolglycerol hydroxystearate, sodium and ethanol If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. When the Tramadol TAD is intended for chronic use (e.g. for two weeks or more) it may be harmful to the teeth.
This medicine contains 3.8 mg propylene glycol in each drop, respectively 18.8 mg propylene glycol in each press on the metering pump, which is equivalent to 150 mg propylene glycol per ml of oral drops, solution.
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Macrogolglycerol hydroxystearate may cause stomach upset and diarrhoea.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per ml of oral drops, solution.
3. How to take Tramadol TAD
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Bottles of Tramadol TAD are equipped either with a dropper or a metering pump. Please note that one press on the metering pump is not equivalent to one drop (dropper).
Before using the metering pump for the first time, press several times in order to fill up the mechanism of the pump.
The dosage should be adjusted to the intensity of your pain and your individual sensitivity. In general the lowest pain-relieving dose should be taken. Do not take more than 400 mg tramadol hydrochloride daily (pressing the pump 32 times, e.g. 8 x 4 times), unless explicitly prescribed by your doctor.
Unless otherwise prescribed by the doctor, the usual dose is:
The recommended dose is: Adults and adolescents from 12 years of age For moderate pain, 50 mg tramadol hydrochloride (pressing the pump 4 times or 20 drops) is taken as a single dose. If there is no pain relief after 30 to 60 minutes, a second single dose can be taken.
If in severe pain the demand is likely to be higher, 100 mg tramadol hydrochloride (pressing the pump 8 times or 40 drops) is taken as a single dose. Depending on the pain, the effect lasts for 4 to 6 hours.
Children This medicine is not intended for use in children under 1 year of age.
It is preferable that children 1 to 11 years of age take this medicine with a dropper so that a more accurate body weight-based dosage can be obtained. One drop contains 2.5 mg of tramadol hydrochloride. As a single dose, children 1 to 11 years of age receive 4 to 8 drops per 10 kilograms body weight (equivalent to 1 to 2 mg of tramadol hydrochloride per kilogram body weight). A daily dose of 32 drops per 10 kilogram body weight (equivalent to 8 mg tramadol hydrochloride per kilogram body weight) or 160 drops (equivalent to 400 mg of tramadol hydrochloride per kilogram body weight) should not be exceeded (the smaller of the two doses should be given), unless explicitly prescribed by your doctor.
Elderly In elderly patients (above 75 years), the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.
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Severe liver or kidney disease (insufficiency)/dialysis patients If you have impaired liver or kidney function, your doctor may recommend prolonging the dosage interval.
Method of administration Oral use.
Take Tramadol TAD with some liquid or sugar, irrespective of meals. You can find more information on the use of the metering pump at the end of this leaflet.
How long you should you take this medicine Do not take Tramadol TAD longer than absolutely necessary. If prolonged treatment is deemed necessary, your doctor will check at regular, short intervals (if necessary by breaks in treatment) whether you should continue taking this medicine and, where appropriate, at what dose.
Please talk to your doctor or pharmacist if you have the impression that the effect of Tramadol TAD is too strong or too weak.
If you take more Tramadol TAD than you should
If you have taken an additional dose of this medicine by mistake, usually there will be no negative effects. Take the next dose of Tramadol TAD as prescribed.
If you have taken a dose significantly higher than the recommended one, the following may occur: narrow pupils, vomiting, blood pressure fall, rapid heartbeat, circulatory collapse, consciousness disturbances up to coma (deep unconsciousness), epileptic seizures and difficult breathing up to respiratory arrest. If these signs occur, contact your doctor immediately.
If you forget to take Tramadol TAD
If you forget to take this medicine, your pain may return. Do not take a double dose to make up for a forgotten dose, but continue as before.
If you stop taking Tramadol TAD
If you interrupt or prematurely end the treatment with this medicine, your pain will probably return. You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first, particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms).
In general, discontinuation of treatment with Tramadol TAD does not cause any side effects. However, side effects can occur in a few patients who have been taking this medicine for a long time and suddenly stop taking the medicine. They may feel restless, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping or gastrointestinal complaints. Very few people can experience panic attacks, hallucinations, false sensations, such as tingling, prickling and numbness, or ringing in the ears (tinnitus). Unusual central nervous system symptoms, such as confusion, delusions, altered perception of oneself (depersonalisation) and reality (derealisation) and paranoia, have been reported very rarely. If any of these side effects occur after discontinuation of treatment with this medicine, please contact your doctor.
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If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact 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 Tramadol TAD are nausea and dizziness, which occur in more than 1 in 10 users.
Very common (affects more than 1 user in 10): Nausea, dizziness.
Common (affects 1 to 10 users in 100): Headache, sleepiness, tiredness, vomiting, constipation, dry mouth; sweating (hyperhidrosis).
Uncommon (affects 1 to 10 users in 1,000): Effects on cardiovascular regulation (palpitations, increased heart rate [tachycardia], dizzy spells [postural hypotension] or circulatory collapse). These side effects may occur especially when standing upright and in patients who are physically stressed.
Retching, gastric disorders (e.g. pressure in the stomach, bloating), diarrhoea.
Skin reactions (e.g. itching, rash).
Rare (affects 1 to 10 users in 10,000): Allergic reactions (e.g. difficulty breathing [dyspnoea], wheezing, water retention in tissues [angioedema]) and shock reactions (sudden circulatory failure) occur very rarely.
Slow heartbeat (bradycardia).
Increase in blood pressure.
False sensations on the skin (such as tingling, prickling, numbness), trembling (tremor), epileptiform seizures, involuntary muscle twitching, abnormal coordination, transient loss of consciousness (syncope), speech disorders.
Epileptiform seizures occurred mainly after the use of high tramadol doses or after concomitant use of medicines that can trigger seizures.
Appetite changes.
Hallucinations, confusion, sleep disorders, delirium, anxiety and nightmares.
Mental disorders can occur after treatment with Tramadol TAD; their intensity and nature may vary in individual patients (depending on the patient’s personality and duration of treatment). These include changes in mood (usually elated mood, occasionally irritated mood), changes in
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activity (usually suppression, occasionally increase) and decrease in sensory perception and cognition, which can lead to errors in decision-making (reduction in sensory and cognitive performance).
Dependence may occur.
If Tramadol TAD is taken for a longer period, dependence may occur, even though the risk is low. After treatment is stopped, withdrawal reactions may occur (see “If you stop taking Tramadol TAD”).
Blurred vision, narrow pupils (miosis), extremely dilated pupils (mydriasis).
Slowed breathing (respiratory depression), difficulty breathing (dyspnoea).
If the recommended doses are exceeded or other medicines that have a depressant effect on brain function are administered at the same time, slowing-down of breathing may occur.
Worsening of asthma has been reported, but a causal relationship with the active substance tramadol could not be established.
Decreased muscle strength (motor weakness).
Difficult or painful urination, less urine than normal (micturition disorders and dysuria).
Very rare (affects less than 1user in 10,000): Elevated liver enzymes.
Not known (frequency cannot be estimated from the available data): Low blood sugar levels.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Tramadol TAD
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 packaging after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light. This medicine does not require any special temperature storage conditions.
After first opening of the container, the product should be used within 3 months when stored at temperature below 25C. Page 7 of 8
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Tramadol TAD contains - The active substance is tramadol hydrochloride. 1 ml (40 drops or 8 presses) oral drops, solution contains 100 mg tramadol hydrochloride. 0.5 ml (20 drops or 4 presses) of solution contains 50 mg tramadol hydrochloride. - The other ingredients are sucrose, glycerol (E422), propylene glycol (E1520), macrogolglycerol hydroxystearate, potassium sorbate (E202), saccharin sodium (E954), sodium cyclamate (E952), partly dementholised mint oil, anise flavour (ethanol), purified water. See section 2 "Tramadol TAD contains sucrose, propylene glycol, macrogolglycerol hydroxystearate, sodium and ethanol".
What Tramadol TAD looks like and contents of the pack Tramadol TAD 100 mg/ml oral drops, solution is a clear, colourless to slightly yellow solution.
Tramadol TAD is available in boxes containing: - 1, 3 or 5 bottles of 10 ml oral drops, solution (oral drops) equipped with dropper and child- resistant tamper evident closure - 1 bottle of 30 ml oral drops, solution (oral drops) equipped with dropper and child-resistant tamper evident closure - 1 bottle of 96 ml oral drops, solution (oral drops) with pump and dispensing head:
Not all pack sizes may be marketed.
Marketing Authorisation Holder TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Manufacturer KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This leaflet was last revised in May 2019.
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