Package leaflet: Information for the user
IXPRIM 37.5mg/325mg, film-coated tablets
Tramadol hydrochloride/Paracetamol
What is in this leaflet:
1. What IXPRIM is and what it is used for
2. What you need to know before you take IXPRIM
3. How to take IXPRIM
4. Possible side effects
5. How to store IXPRIM
6. Contents of the pack and other information
1. What IXPRIM is and what it is used for
IXPRIM is a combination of two analgesics, tramadol and paracetamol, which act together to relieve your pain.
IXPRIM is intended for use in the treatment of moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed.
IXPRIM should only be taken by adults and adolescents over 12 years.
2. What you need to know before you take IXPRIM
Talk to your doctor before taking IXPRIM:
If any of the above-mentioned points applied to you in the past or applies to you while you are taking IXPRIM, please make sure your doctor knows. He/she can then decide whether you should continue to use this medicine.
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.
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Important: This medicine contains paracetamol and tramadol. Tell your doctor if you are taking any other medicine containing paracetamol or tramadol, so that you do not exceed the maximum daily doses.
You must not take IXPRIM together with monoamine oxidase inhibitors (“MAOIs”) (see section “Do not take IXPRIM”).
IXPRIM is not recommended to be taken with the following:
The risk of side effects increases,
The effectiveness of IXPRIM may be altered if you also take
Your doctor will tell you which medicines are safe to take with IXPRIM.
IXPRIM may make you feel drowsy. Alcohol may make you feel drowsier, so it is best not to drink alcohol while you are taking IXPRIM.
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.
As IXPRIM contains tramadol, you should not take this medicine during pregnancy or breast-feeding. If you become pregnant during treatment with IXPRIM, please consult your doctor before taking any further tablets.
Breast-feeding
Tramadol is excreted into breast milk. For this reason, you should not take IXPRIM more than once during breast-feeding, or alternatively, if you take IXPRIM 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.
IXPRIM may make you feel drowsy and this may affect your ability to drive, or use tools and machines, safely.
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.
IXPRIM 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 IXPRIM
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
You should take IXPRIM for as short a time as possible.
The use in children below the age of 12 years is not recommended.
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 tablets for adults and adolescents over 12 years.
If required, further doses may be taken, as recommended by your doctor. The shortest time between doses must be at least 6 hours.
Do not take more than 8 IXPRIM film-coated tablets per day.
Do not take IXPRIM more often than your doctor has told you.
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 IXPRIM. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
The tablets are for oral use.
Swallow the tablets whole with sufficient liquid. They should not be broken or chewed.
If you think that the effect of IXPRIM is too strong (i.e. you feel very drowsy or have difficulty breathing) or too weak (i.e. you have inadequate pain relief), contact your doctor.
In such cases please contact your doctor or pharmacist immediately even if you feel well. There is a risk of liver damage which may only show later.
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).
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.
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 not known
The following are recognised side effects which have been reported by people using medicines that contain only tramadol or only paracetamol. However, if you experience any of these while taking IXPRIM, you should tell your doctor:
In rare cases, using a medicine of the type of tramadol may make you become dependent on it, making it hard to stop taking it.
On rare occasions, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may also get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and noise in the ears (tinnitus). If you experience any of these complaints after stopping IXPRIM, please consult your doctor.
In exceptional cases blood tests may reveal certain abnormalities, for instance, low counts of blood platelets, which may result in nose bleeds or bleeding gums.
Very rare cases of serious skin reactions have been reported with paracetamol.
Rare cases of respiratory depression have been reported with tramadol.
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 via
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE IXPRIM
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 the edge of the blister after [EXP.:]. 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 medicines via waste water or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
Tablet core: powdered cellulose; pregelatinised starch; sodium starch glycolate (type A); maize starch; magnesium stearate.
Film-coating: hypromellose; lactose monohydrate, titanium dioxide (E 171); macrogol 6000; yellow iron oxide (E 172); propylene glycol, talc).
IXPRIM film-coated tablets are pale yellow film-coated tablets, marked with the manufacturer’s logo on one side, marked T5 on the other side.
IXPRIM film-coated tablets are packed in blister strips.
IXPRIM comes in cartons of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets. Not all pack sizes will be marketed.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Zaldiar 37,5 mg/325 mg Filmtabletten
Belgium Zaldiar 37,5 mg / 325 mg, comprimés pelliculés / filmomhulde tabletten
Pontalsic 37,5 mg / 325 mg, comprimés pelliculés / filmomhulde tabletten
France Zaldiar 37,5 mg/325 mg, comprimé pelliculé
Ixprim 37,5 mg/325 mg, comprimé pelliculé
Germany Zaldiar 37,5 mg/325 mg Filmtabletten
Dolevar 37,5 mg/325 mg Filmtabletten
Greece ZALDIAR
Hungary Zaldiar 37.5 mg/325 mg filmtabletta
Ireland Ixprim 37.5 mg/325 mg, film-coated tablets
Luxembourg Zaldiar 37,5 mg / 325 mg, comprimés pelliculés
Netherlands Zaldiar 37,5 mg/325 mg, filmomhulde tabletten
Portugal
Zaldiar 37,5 mg/325 mg comprimidos revestidos por película
Slovenia Zaldiar 37,5 mg/325 mg filmsko obložene tablete
Spain Zaldiar 37,5 mg/325 mg comprimidos recubiertos con película
Pontalsic 37,5 mg/325 mg comprimidos recubiertos con película
United Kingdom Tramacet 37.5 mg/325 mg, film-coated tablets