CODOLIPRANE ADULTE Tablet

Indications:

For adults only (from 15 years of age).

This medicine contains paracetamol and codeine.

Treatment of moderate to intense pain this is not relieved by aspirin, paracetamol or ibuprofen used alone.

Dosage:

FOR ADULTS AND CHILDREN FROM 15 YEARS OF AGE ONLY

One tablet, repeated after 4 to 6 hours if necessary, or possibly 2 tablets as a single dose for intense pain, without exceeding 6 tablets per day.

NEVER TAKE MORE THAN 4 g OF PARACETAMOL PER DAY (taking into account all medicines containing paracetamol).

THIS MEDICINE HAS BEEN GIVEN TO YOU PERSONALLY. IN A SPECIFIC SITUATION.

- IT MAY NOT BE SUITABLE FOR USE IN ANOTHER SITUATION,

- DO NOT PASS IT ON TO OTHERS.

Method and route of administration:

Oral use.

The tablets are to be swallowed with a glass of water.

Frequency and time of administration

The doses are generally taken every 6 hours, and at least 4 hours apart. When pain persists, following a regular dose schedule makes it possible to avoid peaks in the intensity of pain. In patients with serious kidney disease (severe renal insufficiency), doses must be taken at least 8 hours apart.

Treatment duration:

If pain persists for more than 4 to 5 days, do not continue treatment without asking your doctor's advice.

Never take this medicine:

- If you are allergic to any of the ingredients.

- If you have serious liver disease.

- If you are asthmatic.

- If you have respiratory difficulties.

- If you are breast-feeding, when treatment is long-term.

Codeine-related effects:

Codeine can cause the following:

- feeling of sleepiness, euphoria, mood changes.

- contraction of the pupil, difficulty in urinating,

- allergic reactions (itching, urticaria, widespread skin rash).

- constipation, nausea, vomiting.

- drowsiness, dizziness,

- difficulty breathing,

- abnormal pain, particularly in patients who have had a cholecystectomy (gallbladder removal).

- very care cases of damage to the pancreas.

Paracetamol-related effects:

- in certain rare cases, skin rash or redness, or an allergic reaction may occur, showing as sudden swelling of the face and neck, or sudden malaise with a fall in blood pressure. You must stop treatment immediately and inform your doctor, and never take any medicines containing paracetamol again.

Exceptional cases of abnormal laboratory values have been observed, requiring blood count tests: abnormally low levels of certain white blood cells or blood cells such as platelets, possibly causing nosebleeds or bleeding gums. If this occurs, seek medical advice.

This medicine should not be combined with morphine agonists/antagonists (buprenorphine, nalbuphine, pentazocine), naltrexone or alcohol.

TO AVOID ANY INTERACTION BETWEEN DIFFERENT MEDICINES, YOU MUST ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT YOU MAY BE TAKING.

Inform your doctor that you are taking this medicine, if he/she prescribes tests to determine blood uric acid level.

Pregnancy:

This medicine can be taken during pregnancy for a short period (a few days) and at the recommended doses. However, at the end of pregnancy, excessive intake of codeine may cause toxicity in the newborn infant. Consequently, you should always ask your doctor for advice before taking this medicine and never exceed the recommended dose.

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding:

This medicine is excreted in breast milk.

Excessive doses of codeine administered to breast-feeding women may cause pauses in breathing or reduced muscle tone in infants. Apart from occasional use, this medicine is contraindicated while breast-feeding.

In the event of overdose, or accidental intake of an excessive dose, consult your doctor immediately.

Taking this medicine for long periods may lead to addiction. This medicine should not be used for long periods without medical advice.

This medicine contains paracetamol and codeine, as do some other medicines. Do not take this medicine with other medications containing these substances, so as not to exceed the maximum recommended doses (see "Dosage and Method of administration”).

Alcohol should not be consumed during treatment.

Inform your doctor if you:

- Have kidney or liver disease.

- have respiratory disease (including asthma),

- have bronchial congestion (productive cough),

- have had gallbladder surgery.