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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, HP13 4FE, Ireland
Medical Information Direct Line: +44 (0)870 351 8960
Medical Information e-mail: medicalinformationie@grunenthal.com


Patient Information Leaflet last updated on medicines.ie: 19/03/2014
XPIL Ixprim effervescent tablets

CONTAINS PARACETAMOL

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.

  • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Ixprim is and what it is used for
2. Before you take Ixprim
3. How to take Ixprim
4. Possible side effects
5. How to store Ixprim
6. Further information

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1. WHAT IXPRIM IS AND WHAT IT IS USED FOR

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. 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 Ixprim;
  • 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.

Take special care with Ixprim if you

  • take other medicines containing paracetamol or tramadol hydrochloride;
  • 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.
  • have kidney problems;
  • have severe difficulties in breathing for example asthma or severe lung problems;
  • have epilepsy or have already experienced fits or seizures;
  • have recently suffered from a head injury, shock or severe headaches associated with vomiting;
  • 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;
  • 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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 also take

  • 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.
  • 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, antidepressants or medicines to treat allergies. You may feel drowsy or feel faint. If this happens, tell your doctor.
  • antidepressants, anaesthetics, neuroleptics (medicines that affect the state of mind) or bupropion (to help stop smoking). The risk having a fit may increase. Your doctor will tell you whether Ixprim is suitable for you.
  • 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),
  • ketoconazole or erythromycin (medicines against infections).

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

Taking Ixprim with food and drink

Ixprim may make you feel drowsy. Alcohol may make you feel more drowsy, so it is best not to drink alcohol while you are taking Ixprim.

Pregnancy and breast-feeding

As Ixprim contains tramadol hydrochloride, you should not take this medicine during pregnancy. 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.

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.

Important information about some of the ingredients of Ixprim

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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3. HOW TO TAKE IXPRIM

Always take Ixprim 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.

Unless otherwise prescribed by your doctor, the usual starting dose for adults and adolescents over 12 years is 2 effervescent tablets.

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.

Your doctor may increase the time between doses

  • if you are older than 75 years,
  • if you have kidney problems or
  • if you have liver problems.

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 product, 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: more than 1 out of 10 persons treated;

  • nausea,
  • dizziness, drowsiness.

Common: less than 1 out of 10, but more than 1 out of 100 persons treated;

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

Uncommon: less than 1 out of 100, but more than 1 out of 1,000 persons treated;

  • 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, hallucinations (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: less than 1 out of 1,000, but more than 1 out of 10,000 persons treated;

  • fits, difficulties in carrying out coordinated movements,
  • addiction,
  • blurred vision
  • transient loss of consciousness (syncope).

Unknown: cannot be stimated from available data

  • low blood sugar

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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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5. HOW TO STORE IXPRIM

Keep out of the reach and sight of children.

Do not use Ixprim 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.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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6. FURTHER 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
Uxbridge
Middlesex
UB11 1BD
United Kingdom

Manufacturer:

Grünenthal GmbH
Zieglerstraße 6
D-52078 Aachen
Germany

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® 37,5 mg / 325 mg, comprimé effervescent

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

Germany Dolevar® 37,5 mg / 325 mg Brausetabletten

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 Tilalgin® efervescente 37,5mg / 325 mg comprimidos efervescentes

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

Pontalsic® 37,5 mg / 325 mg comprimidos efervescentes

United Kingdom Tramacet® 37.5 mg / 325 mg effervescent tablet

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This leaflet was approved in 09/2013

R-YJ-280114-04 50/000



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Active Ingredients

 
   Paracetamol
   Tramadol Hydrochloride