ROVAMYCINE Tablet

To treat or prevent certain infections caused by bacteria against which spiramycin is effective.

Dosage

These tablets are for use in adults and children over 6 years of age only.

To treat certain infections, the usual dosage is :

- In adults: 4-6 tablets per day, taken in 2-3 doses.

- In children: 1-2 tablets/kg of bodyweight/day, taken in 2-3 doses.

If your doctor has prescribed this medicine to treat a sore throat, the treatment lasts for 10 days.

To prevent certain infections, the usual dosage is:

- In adults: 3 MIU every 12 hours for 5 days.

- In children: 75 000 IU/kg every 12 hours for 5 days.

This medicine should be swallowed with a glass of water.

You should divide the tablets into 2-3 doses to be taken throughout the day.

To be effective, this this antibiotic must be used at the prescribed dose and for as long as your doctor has told you to.

If your fever or any other symptoms disappear, this does not mean that you have completely recovered.

If you feel tired, this is not due to the treatment but to the infection itself. Reducing or stopping your treatment would have no effect on this feeling and would delay your recovery.

- If you are allergic to spiramycin or any of the other ingredients of this medicine.

- If your child is under 6 years of age, as he/she could choke on the tablet.

You should stop your treatment and contact your doctor immediately if any of the following signs appear:

- Redness all over your body with pustules and fever. This might be the sign of a serious reaction called acute generalized exanthematous pustulosis. This effect generally occurs at the start of treatment. If this effect occurs, you must never again take any medicine containing spiramycin.

- Allergy. Signs of allergy include rashes (such as spots), hives (a skin rash similar to that caused by stinging nettles), itching, very rarely, sudden swelling of the face and neck (angioedema), and, very rarely, sudden faintness with a severe drop in blood pressure (anaphylactic shock).

The following side effects may also occur:

- Digestive effects: stomach pain, nausea, vomiting, diarrhea, and, very rarely, pseudomembranous colitis (an intestinal disease with symptoms that typically include diarrhea and abdominal pain).

- Effects on the nervous system: occasional brief prickling or tingling sensation

- Liver effects: hepatitis (liver inflammation).

- Effects that can be seen in blood tests: very rarely, changes in blood tests that show how healthy your liver is, hemolytic anemia (destruction of red blood cells).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask doctor for advice before taking this medicine.

Pregnancy

If necessary, this medicine may be taken during pregnancy. Do not use this medicine during pregnancy unless you are advised to do so by your doctor.

Breast-feeding

Spiramycin passes into breast milk. Breast-feeding is not recommended during treatment with this medicine. Spiramycin can cause digestive disorders in newborn babies.

The 1.5 million international units dosage strength of Rovamycine is for use in adults and children over 6 years of age only.

You must talk to your doctor before using this medicine if:

- you have a rare hereditary disease which affects the number of red blood cells in your body and causes tiredness, paleness or difficulty breathing (a disease called glucose-6-phosphate-dehyddrogenase deficiency).

This medicine is an antibacterial antibiotic belonging to the macrolide group.