ROVAMICINA .1,5 MIU

What is Rovamicina 1.5 MIU film?
This medicine is an antibacterial antibiotic of the macrolide group.
What is Rovamicina 1.5 MIU film
This drug is used for treatment and prophylaxis of established infections caused by microorganisms sensitive to this drug.

2. Before taking Rovamicina 1.5 MIU film
WHEN should not take this medicine:
This medicine should not be used if you are allergic to spiramycin or any of the excipients.
This medicine should not be used if you are breast-feeding (see section. Pregnancy and lactation).
If you have any doubt, contact your doctor and pharmacist.
Special warnings acceptance of Rovamicina 1.5 MIU film
If, at the beginning of treatment, redness of the whole body and pustules, accompanied by fever (see section 4.8. Undesirable effects)., The treatment should be discontinued and any treatment with spiramycin alone or in combination should not be applies. Implementation of the tablets in children under 6 years is contraindicated due to the risk of choking.
In patients with renal impairment is not necessary to adjust the dose is excreted as a minor extent in the kidneys.

Precautions when taking Rovamicina 1.5 MIU table.
It is important to tell your doctor if you have glucose-6-phosphate dehydrogenase.
There have been very rare cases of haemolytic anemia in patients with glucose-6-phosphate dehydrogenase. Spriamycin in these patients is not recommended.
If you have any doubt, consult with your doctor or pharmacist.
When you are taking other medicines or substances to avoid unpleasant interactions between different drugs, you should inform your doctor or pharmacist about any other treatment you take.

Pregnancy and lactation
pregnancy
Spiramycin may be administered during pregnancy, if necessary. Extensive use of spiramycin during pregnancy has shown no evidence of harm to the fetus. breastfeeding
Studies of this product indicates that it is excreted in human milk. There are reports of gastrointestinal disorders in newborns. Therefore, breast-feeding should be discontinued at the start of treatment
As a rule, during breast-feeding You should always consult a doctor or pharmacist before taking any treatment with a drug.

DRIVE AND USE MACHINES
No effects on ability to drive and use machines.
3. How to take Rovamicina 1.5 MIU tablets?
How often taking Rovamicina 1.5 MIU tablets
According to the indications, the usual dose is:
Adults: 6 to 9 MIU / 24 hours, i.e. 4 to 6 tablets per day, divided into 2 to 3 doses.
Children: 1.5 to 3 MIU of 1o kg body weight per day in 2 to 3 doses. Recommended daily therapeutic dose for adults is 6 to 9 MIU divided into 2-3 doses.
The duration of treatment of inflammation of the throat is 10 days.
Prevention of meningococcal meningitis
Adults: 3 MIU / 12:00
Children: 75000IU / kg / 12 hours for 5 days
In patients with impaired renal function
No adjustment of dosage

Method of administration
The tablets should be swallowed with water.
In any case, strictly prescribed by your doctor.

How long should you take Rovamicina 1.5 MIU tablets
To be effective your treatment, this antibiotic should be taken regularly as prescribed and as long as your doctor prescribes.
The drop in temperature and the fading of all symptoms does not mean that you are completely healed. If you feel fatigue, it does not mean that due to the treatment, and possibly infection. Change, reduction or discontinuation, dependent only by your doctor.

If you are taking a higher dose Rovamicina 1.5 MIU tablets.
Consult your doctor, who will monitor and advise.

4. Possible side effects
As with any drug, and this can have adverse effects or some discomfort for some patients.
• Gastrointestinal: Abdominal pain, nausea, vomiting, diarrhea and very rare cases of pseudomembranous colitis.
• Skin
• Rash, urticaria, pruritus
Very rare: angioedema (severe allergic reaction causing swelling of the face), anaphylactic shock.
Very rare: acute generalized exanthematous pustoloza Peripheral and Central Nervous System:
Rare cases of transient paresthesia.
• Hepatic system:
Reported very rare cases of pathological changes in liver function tests.
• Hematology:
Reported very rare cases of haemolytic anemia.

5. How to store ROVAMICINA 1.5 MIU tablets?
Dry and protected from light at a temperature below 25 ° C. Store out of reach of children.
Do not use after the expiry date stated on the packaging.

6. Further information
Qualitative and quantitative composition
One tablet contains
Active substance: spiramycine (spiramycin) 1,500 000 IU
Excipients: silica colloidal anhydrous, magnesium stearate, pregelatinized maize starch, hydroxypropyl cellulose, microcrystalline cellulose, titanium dioxide, macrogol 6000, hypromellose. Type of packaging
The tablets are packaged in blister packs of PVC / aluminum foil 16 pieces in packaging - carton