Active ingredient
- paracetamol
- tramadol hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL21727/0039.
Tramacet 37.5 mg/ 325 mg film-coated tablets
Package leaflet: Information for the user
TRAMACET® 37.5mg/325mg film-coated tablets
Tramadol hydrochloride/Paracetamol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
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
1. What TRAMACET is and what it is used for
TRAMACET is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed.
2. What you need to know before you take TRAMACET
Do not take TRAMACET
Warnings and precautions
Talk to your doctor before taking TRAMACET
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.
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.
Other medicines and TRAMACET
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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:
The risk of side effects increases:
The effectiveness of TRAMACET may be altered if you also take:
TRAMACET with food and alcohol
Do not drink alcohol while you are taking TRAMACET, as you may feel drowsier.
Pregnancy, breast-feeding and fertility
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.
Driving and using machines
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.
TRAMACET contains lactose
Lactose is an ingredient in these tablets.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
TRAMACET contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take TRAMACET
Always take this medicine exactly as you doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
Take TRAMACET for as short a time as possible and no longer than your doctor has told you.
Adults and adolescents over 12 years:
The recommended starting dose unless otherwise prescribed by your doctor is 2 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.
Children under 12 years of age:
Older people:
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.
Severe liver or kidney disease (insufficiency)/dialysis patients:
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.
Method of administration:
The tablets are for oral use.
Swallow the tablets whole with sufficient liquid.
Do not break or chew the tablets.
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.
If you take more TRAMACET than you should
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 TRAMACET
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.
If you stop taking TRAMACET
Generally, there will be no after-effects when treatment with TRAMACET is stopped.
Rarely, people who have been using a medicine containing tramadol may become dependent on it, making it hard to stop taking it. If you have been taking TRAMACET for some time and want to stop, contact your doctor because your body may have become used to TRAMACET.
People may:
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, however not everybody gets them.
Some side effects could be serious. Contact your doctor immediately if any of the following occur:
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
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:
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 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
5. How to store TRAMACET
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.
This medicinal product does not require any special storage conditions.
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.
6. Contents of the pack and other information
What TRAMACET contains
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:
What TRAMACET looks like and contents of the pack
TRAMACET film-coated tablets are pale yellow film-coated tablets, marked with the manufacturer’s logo on one side, marked T5 on the other side.
TRAMACET film-coated tablets are packed in blister strips.
TRAMACET comes in cartons of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturers:
Other formats of this leaflet
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This leaflet was last revised in:
10 / 2019
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