Ixprim effervescent tablets

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

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.
 

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.

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 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. Concomitant use of IXPRIM and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor prescribes IXPRIM together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
  Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
• 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

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 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.

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.

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 and sodium

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 (main component of cooking/ table salt) in each effervescent tablet. This is equivalent to 9.1% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need 2 or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

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:

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).

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

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

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:

Manufacturer: