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Tramacet 37.5 mg/325 mg effervescent tablets
TRAMACET® 37.5mg/325mg effervescent tablets
1. What TRAMACET is and what it is used for
2. What you need to know before you take TRAMACET
3. How to take TRAMACET
4. Possible side effects
5. How to store TRAMACET
6. Contents of the pack and other information
TRAMACET is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed.
Talk to your doctor before taking TRAMACET if you
Sleep-related breathing disorders
TRAMACET contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example central sleep apnea (shallow/pause of breathing during sleep) and sleep-related hypoxemia (low level of oxygen in the blood).
The risk of experiencing central sleep apnea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnea.
There is a small risk that you may experience a so-called serotonin syndrome that can occur after having taken tramadol in combination with certain antidepressants or tramadol alone. Seek medical advice immediately if you have any of the symptoms related to this serious syndrome (see section 4 “Possible side effects”).
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.
If any of the above-mentioned points applied to you in the past or applies to you while you are taking TRAMACET, please make sure your doctor knows. He/she can then decide whether you should continue to use this medicine.
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.
Talk to your doctor if you experience any of the following symptoms while taking TRAMACET:
Extreme fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplement.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor will tell you which medicines are safe to take with TRAMACET.
Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.
Do not take TRAMACET with MAOIs (see section ‘Do not take TRAMACET’).
TRAMACET is not recommended to be taken with the following:
Please inform your doctor or pharmacist if you are taking:
The risk of side effects increases,
The effectiveness of TRAMACET may be altered if you also take the following medicines:
Do not drink alcohol while you are taking TRAMACET, as you may feel drowsier.
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.
Do not take TRAMACET while you are pregnant or breast-feeding.
Check with your doctor if you become pregnant during treatment with TRAMACET and before taking any further tablets.
Tramadol is excreted into breast milk. For this reason, you should not take TRAMACET more than once during breast-feeding, or alternatively, if you take TRAMACET more than once, you should stop breast-feeding.
Based on human experience tramadol is suggested not to influence female or male fertility. No data on the influence of the combination of tramadol and paracetamol on fertility are available.
Ask your doctor or pharmacist for advice before taking any medicine.
If you feel drowsy while taking TRAMACET, do not drive, use tools or use machinery.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take TRAMACET for as short a time as possible and no longer than your doctor has told you.
The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.
The recommended starting dose, unless otherwise prescribed by your doctor is 2 effervescent tablets for adults and adolescents over 12 years.
If required, further doses may be taken, as instructed by your doctor.
The shortest time between doses must be at least 6 hours.
Do not take more than 8 tablets per day.
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.
Patients with severe liver and/or kidney insufficiency should not take TRAMACET. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
The effervescent tablets are for oral use.
Take effervescent tablets by dissolving in a glass of drinking water.
If you think that the effect of TRAMACET is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not have enough pain relief), contact your doctor.
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
If you forget to take the tablets, pain is likely to return.
Do not take a double dose to make up for forgotten individual doses; simply continue taking the tablets as before.
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).
Very few people may also get:
If you experience any of these complaints after stopping this medicine, please contact your doctor. Other side effect information is listed in section 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Additionally, if any of the following side effects get serious, contact your doctor or pharmacist:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Unknown: frequency unknown
In addition, the following side effects have been reported by people using medicines that contain only tramadol or only paracetamol:
Serotonin syndrome, that can manifest as mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 “What you need to know before you take TRAMACET”).
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the carton and, blister. The expiry date refers to the last day of that month.
Tablets packed in blister strips (aluminium foil):
Do not throw away any medicine via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substances are tramadol hydrochloride and paracetamol.
One (1) tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
The other ingredients are:
monosodium citrate anhydrous, citric acid anhydrous, polyvinylpyrrolidone, sodium hydrogen carbonate, macrogol 6000, silica colloidal anhydrous, magnesium stearate, orange flavouring (maltodextrin (maize), modified starch (E1450), natural and artificial flavourings, sulphite)), acesulfame potassium, saccharin sodium, sunset yellow (E110).
TRAMACET effervescent tablets look off white to slightly rosy coloured with some coloured speckles. The tablets may be available in strips of coated aluminium foil.
In aluminium strips: packs of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 effervescent tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
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UK-PIL Tramacet 37.5mg/325mg effervescent tablets