PROPOFAN Capsule

Antalgesic - central and peripheral

Treatment of moderate to intense pain in adults which cannot be relieved by paracetamol or aspirin.

Dosage

FOR ADULTS ONLY

The recommended daily dose of paracetamol is around 60mg/kg/day divided into 4-6 doses (i.e. 15mg/kg every 6 hours or 10mg/kg every 4 hours).

1 capsule and repeat if necessary after 4 hours. You may take 2 capsules in case of severe pain but do not exceed 6 capsules per day.

However, in case of intense pain and after checking with your doctor, the total dose can be increased to 4g/day.

But:

- Doses of paracetamol over 3g/day require medical advice.

- NEVER TAKE MORE THAN 4GRAMS OF PARACETAMOL PER DAY (and be aware of all medication that contains paracetamol).

Always ensure a gap of at least f hours between doses.

In case of severe kidney disease (severe renal impairment), leave 8 hours between doses and never take more than 6 capsules (3g) per day.

How to take: Orally

The capsules should not be opened and swallowed with a drink (for example, water, milk of fruit juice).

How often to take: Regular doses will avoid swings in pain or fever. Adults must leave at least 4 hours between doses. If you have severe kidney disease (severe renal impairment) doses should be at least 8 hours apart.

How long to take: Do not use for a prolonged period without first seeking medical advice. If you have taken more than you should have. In case of overdose or if you accidentally take too much, see a doctor immediately.

- The patient is under 15 years old,

- You have an allergy to paracetamol and/or codeine or other constituents,

- You have serious liver disease,

- You have any shortness of breath,

- You are breast-feeding.

LINKED TO PARACETAMOL

- In some rare cases, a rash, skin redness or an allergic reaction may occur with a sudden facial and neck swelling. Feelings of discomfort with a sudden drop in blood pressure may also occur. Stop taking the medication and seek medical advice immediately. Do not take any more medication containing paracetamol.

- In exceptional cases, biological changes requiring blood tests have occurred: abnormally low levels of certain white blood cells or certain blood cells such as platelets can result in bleeding from the nose or gums. If this happens, see a doctor.

LINKED TO CODEINE

You may experience:

- Drowsiness, euphoria, mood swings,

- Narrowing of the pupil, difficulty urinating,

- Constipation, nausea, vomiting,

- Sleepiness, dizziness,

- Hypersensitivity reactions (pruritus, urticaria and, in rare circumstances, rashes)

- Respiratory problems,

- Abdominal pain especially in cholecystectomy patients (without gallbladder.

LINKED TO CAFFEINE

This medication may cause abnormally high moods, insomnia and palpitations.

If you notice any side effects not mentioned in this leaflet or if the side effects worsen, see your doctor or pharmacist.

This medicine should be avoided with opioid agonist-antagonist drugs (buprenorphine, nalbuphine, pentazocine), the consumption of alcohol or medication containing alcohol, naltrexone or enoxacin (antibiotic).

Tell your doctor that you are taking this medication if you are requested a blood test to measure levels of uric acid.

If you take or have recently taken any other medication, including an over-the-counter medication, talk to your doctor or pharmacist.

Pregnancy

Do not use this medication during pregnancy without first talking to your doctor. If you discover that you are pregnant during treatment, consult your doctor who will advise you about continuing this medication.

Breast-feeding

This medication passes into breast milk, therefore breast-feeding is not advised during treatment. See your doctor or pharmacist before taking any medication.

This medication is not a cure for migraines or headaches.

This medication contains paracetamol in case of overdose or taken by mistake, seek immediate medical help.

This medication contains paracetamol, codeine and caffeine. Other medication also contains these constituents. Mixing them will exceed the maximum recommended doses.

Do not use this medicine for a prolonged period as this may lead to addiction.

In pain continues for more than 5 days or you have a fever for more than 3 days, or if it is not effective or other symptoms arise, do not continue taking this medication without first checking with your doctor.

If you have severe kidney or liver disease, check with your doctor before taking the medication.

As this medication contains caffeine, it may cause insomnia. Therefore, do not take it in the evening.

This medication is not recommended with opioid agonist- antagonist drugs (buprenorphine, nalbuphine, pentazocine), the consumption of alcohol or medication containing alcohol, naltrexone or enoxacin (antibiotic).

Driving and using machinery: This medicine may make you feel drowsy. If it happens, do not operate machinery or drive vehicles. These effects are reduced after several doses. This is heightened by the consumption of alcohol.