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This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.

Grunenthal Ltd

Units 1 and 2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK
Medical Information Direct Line: +44 (0)870 351 8960
Medical Information e-mail: medicalinformationie@grunenthal.com

Patient Information Leaflet last updated on medicines.ie: 12/03/2015
XPIL Ixprim effervescent tablets


Package leaflet: information for the user

IXPRIM® effervescent 37.5 mg/325 mg effervescent tablets

Tramadol hydrochloride/Paracetamol

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, please 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 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

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IXPRIM is a combination of two analgesics, tramadol hydrochloride 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 hydrochloride and paracetamol is needed.

IXPRIM should only be taken by adults and adolescents over 12 years.

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2. What you need to know before you take IXPRIM

Do not take IXPRIM

  • if you are allergic to tramadol hydrochloride, paracetamol, sunset yellow or any of the other ingredients of this medicine (listed in section 6);
  • in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions);
  • if you are also taking MAO inhibitors (certain medicines used for treatment of depression or Parkinson’s disease) or have taken them in the last 14 days before treatment with IXPRIM;
  • if you suffer from a severe liver disorder;
  • if you have epilepsy that is not adequately controlled on your current medicine.

Warnings and precautions

Talk to your doctor before taking IXPRIM

  • if you take other medicines containing paracetamol or tramadol hydrochloride;
  • if you have liver problems or liver disease or if you notice your eyes and skin turning yellow. This may suggest jaundice or problems with your bile ducts.
  • if you have kidney problems;
  • if you have severe difficulties in breathing for example asthma or severe lung problems;
  • if you have epilepsy or have already experienced fits or seizures;
  • if you have recently suffered from a head injury, shock or severe headaches associated with vomiting;
  • if you are dependent on any medicines including those used to relieve pain, for example morphine;
  • take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine;
  • if you are going to have an anaesthetic. Tell your doctor or dentist that you are 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.

Other medicines and IXPRIM

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 hydrochloride. Tell your doctor if you are taking any other medicine containing paracetamol or tramadol hydrochloride, 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:

  • carbamazepine (a medicine commonly used to treat epilepsy or some types of pain such as severe pain attacks in the face called trigeminal neuralgia).
  • buprenorphine, nalbuphine or pentazocine (opioid-type pain relievers). The pain-relieving effect may be reduced.

The risk of side effects increases,

  • if you are taking triptans (for migraine) or selective serotonin re-uptake inhibitors, “SSRIs” (for depression ). If you experience confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles or diarrhoea you should call your doctor.
  • if you are taking tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), baclofen (a muscle relaxant) medicines used to lower blood pressure or medicines to treat allergies. You may feel drowsy or feel faint. If this happens, tell your doctor.
  • if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take IXPRIM at the same time. Your doctor will tell you whether IXPRIM is suitable for you.

if you are taking certain antidepressants. IXPRIM 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 warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur. Any prolonged or unexpected bleeding should be reported to your doctor immediately.

The effectiveness of IXPRIM may be altered if you also take

  • metoclopramide, domperidone or ondansetron (medicines for treatment of nausea and vomiting),
  • cholestyramine (medicine to reduce cholesterol in the blood),

Your doctor will tell you which medicines are safe to take with IXPRIM.

Taking IXPRIM with food and alcohol

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.

Pregnancy, breast-feeding and fertility

As IXPRIM contains tramadol hydrochloride, 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.

Small amounts of tramadol may pass into the breast-milk. Therefore you should not take this medicine during 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

IXPRIM may make you feel drowsy and this may affect your ability to drive, or use tools and machines, safely.

IXPRIM contains Sunset yellow E110

The medicinal product contains the colorant Sunset yellow E110 which may cause allergic reactions.

This medicinal product contains 7.8 mmol (or 179.4 mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

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Always take this medicine exactly as your doctor has told you. You should 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 effervescent 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 effervescent tablets per day.

Do not take IXPRIM more often than your doctor has told you.

Older people

In older 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 IXPRIM. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Method of administration:

The effervescent tablets are for oral use.

Effervescent tablets should be taken dissolved in a glass of drinking water.

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.

If you take more IXPRIM than you should:

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 IXPRIM:

If you forget to take the effervescent tablets, pain is likely to return. Do not take a double dose to make up for forgotten individual doses, simply continue taking the effervescent tablets as before.

If you stop taking IXPRIM:

Generally there will be no after-effects when treatment with IXPRIM is stopped. However, on rare occasions, people who have been taking tramadol hydrochloride for some time may feel unwell if they stop treatment abruptly (see section 4. “Possible Side Effects”). If you have been taking IXPRIM for some time, you should talk to your doctor if you want to stop because your body may have become used to it.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4. Possible side effects

Like all medicines, IXPRIM can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people - nausea,

- dizziness, drowsiness.

Common: may affect up to 1 in 10 people

  • vomiting, digestion problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth,
  • itching, sweating (hyperhidrosis),
  • headache, shaking,
  • confusional state, sleep disorders, mood changes (anxiety, nervousness, a feeling of high spirits).

Uncommon: may affect up to 1 in 100 people

  • increase in pulse or blood pressure , heart rate or heart rhythm disorders,
  • difficulty or pain on passing water,
  • skin reactions (for example rashes, hives),
  • tingling, numbness or feeling of pins and needles in the limbs, ringing in the ear, involuntary muscle twitching,
  • depression, nightmares, hallucination (hearing, seeing or sensing things that are not really there), memory lapses,
  • difficulty swallowing, blood in the stools,
  • shivering, hot flushes, pain in the chest,
  • difficulty breathing.

Rare: may affect up to 1 in 1,000 people

  • fits, difficulties in carrying out coordinated movements,
  • addiction, delirium
  • vision blurred, constriction of the pupils (miosis)
  • speech disorders,
  • excessive dilation of the pupils (mydriasis)
  • transient loss of consciousness (syncope).

Unknown: frequency not known

  • decrease in blood sugar level

The following are recognised side effects which have been reported by people using medicines that contain only tramadol hydrochloride or only paracetamol. However, if you experience any of these while taking IXPRIM, you should tell your doctor:

  • feeling faint when getting up from a lying or sitting position, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of existing asthma.
  • In some rare cases a skin rash, indicating an allergic reaction, may develop with sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting. If this happens to you, stop treatment and see a doctor immediately. You must not take the medicine again.

In rare cases, using a medicine of the type of tramadol hydrochloride may make you become dependent on it, making it hard to stop taking it.

On rare occasions, people who have been taking tramadol hydrochloride 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.

Use of IXPRIM together with medicines used to thin the blood (e.g. phenprocoumon, warfarin) may increase the bleeding risk. Any prolonged or unexpected bleeding should be reported to your doctor immediately. Very rare cases of serious skin reactions have been reported.

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 via

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

By reporting side effects, you can help provide more information on the safety of this medicine.

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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 carton and the aluminium strip or on the carton and the bottom of the plastic tablet container. The expiry date refers to the last day of that month.

Packed in strips of coated aluminium foil:

Do not store above 25° C.

Packed in plastic tablet containers:

Do not store above 30° C.

After first opening: Keep the container tightly closed in order to protect from moisture.

Do not store above 30° C.

Shelf-live after first opening: 1 year, not exceeding the expiry date.

Do not throw away any medicines 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.

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6. Contents of the pack and other information

What IXPRIM contains

  • The active substances are tramadol hydrochloride and paracetamol.
    One effervescent tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
  • The other ingredients are:
    Monosodium citrate anhydrous, citric acid anhydrous, Povidone K30, sodium hydrogen carbonate, Macrogol 6000, silica colloidal anhydrous, magnesium stearate, Flavour Orange (maltodextrin (maize), modified starch (E1450), natural and artificial flavourings), acesulfame potassium, saccharin sodium, Sunset yellow (E110)

What IXPRIM looks like and contents of the pack

IXPRIM effervescent tablets are off white to slightly rosy coloured with some coloured speckles.

The tablets are packed in strips of coated aluminium foil or plastic tubes.

IXPRIM comes in boxes of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 effervescent tablets packed in aluminium strips

or in boxes of 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 effervescent tablets packed in plastic tablet containers.

Not all pack sizes will be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Grünenthal Ltd.
Regus Lakeside House
1 Furzeground Way
Stockley Park East
UB11 1BD
United Kingdom


Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria Zaldiar® 37.5 mg / 325 mg – Brausetablette

Belgium Pontalsic® 37,5 mg / 325 mg, bruistablet / comprimé effervescent / Brausetablette

Zaldiar® 37,5 mg / 325 mg, bruistablet / comprimé effervescent / Brausetablette

France Ixprim® 37,5mg/325mg, comprimé effervescent

Zaldiar® 37,5mg/325mg, comprimé effervescent

Germany Zaldiar® 37,5 mg / 325 mg Brausetabletten

Hungary Zaldiar® 37.5 mg/325 mg, pezsgőtabletta

Ireland Ixprim® effervescent 37.5 mg/325 mg, effervescent tablet

Luxembourg Zaldiar® 37,5 mg / 325 mg, bruistablet / comprimé effervescent / Brausetablette

Netherlands Zaldiar® Bruis, 37,5 mg/325 mg, bruistabletten

Portugal Zaldiar® efervescente 37,5mg/325 mg comprimidos efervescentes

Slovenia Zaldiar® 37,5 mg/325 mg šumeče tablete

Spain Zaldiar® 37,5 mg/325 mg comprimidos efervescentes

United Kingdom Tramacet® 37.5 mg/325 mg effervescent tablet

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This leaflet was revised in January 2015

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Active Ingredients

   Tramadol Hydrochloride