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Drugs Rovamycine 3M have composition spiramycin, Rovamycine 3M is intended for the treatment and prevention of certain infections:  ENT, bronchopulmonary, cutaneous, stomatologic (mouth), and non-gonococcal genital infections, toxoplasmosis in pregnant women, prevention of meningococcal meningitis …

Doxycyclin is administered treatment for infections: respiratory tract infections, urinary tract Infections

CotrimStada forte indications for Urinary tract infections, Gastrointestinal tract infections

Aticef 500mg For treatment of mild to moderate infections caused by susceptible bacteria

IDENTIFICATION OF THE MEDICINAL PRODUCT

Name of the product :

Rovamycine 3M I U, film coated tablet.

ROVAMYCINE-3MIU-Spiramycin-3M

Quantitative and qualitative composition

Active ingredient:

– Rovamycine 3 M.I.U.: spiramycin 3M .I.U. per tablet.

Common excipients: anhydrous colloidal silica, magnesium stearate, pregelatinized maize starch, hydroxypropylcellulose, sodium croscarmellose, microcrystallin cellulose. Coating: hypromellose, macrogol 6,000, titanium dioxyde (E171). Pharmaceutical form and pack size Rovamycine 3M.I.U.: film-coated tablets – box of 2 blisters x 5. Pharmaco-therapeutic class

ANTIBACTERIAL ANTIBIOTICS of the macrolide group. (J: anti- infective).

INDICATIONS

Rovamycine 3M is intended for the treatment and prevention of certain infections caused by microorganisms susceptible to spiramycin, notably in:

–        ENT, bronchopulmonary, cutaneous, stomatologic (mouth), and non-gonococcal genital infections,

–        toxoplasmosis in pregnant women,

–        prevention of meningococcal meningitis, in particular cases (i.e. rifampicin is contraindicated),

–        chemoprophylasix of recurrences of rheumatic fever in patients allergic to betalactams.

CONTRAINDICATIONS

Rovamycine 3M must not be used in cases known allergy to spiramycin.

Rovamycine 3M is usually not recommended in case of lactation (see: Pregnancy and lactation).

In case of doubt, you should consult your Physician or Pharmacist for advice.

SPECIAL WARNINGS

If, at the start of treatment, you experience redness all over the body and pustules, accompanied by fever, a serious reaction known as acute generalized exanthematous pustulosis should be suspected (see Undesirable effects); inform your doctor immediately as treatment must be discontinued. Any further administration of spiramycin alone or in combination with another active substance in the same medicinal product is contraindicated if such a reaction occurs.

PRECAUTIONS FOR USE

Liver insufficiency: Spiramycin should be used cautiously in patients with liver dysfunction, because it may cause hepatotoxicity.

Renal insufficiency: No dose adjustment is necessary in patients with renal insufficiency.

It is important to inform your doctor if you have glucose- 6-phosphate-dehydrogenase deficiency (a rare hereditary disease which causes deficiency in a red blood cell enzyme that induces anemia).

In case of doubt you should consult your Physician or Pharmacist for advice.

INTERRACTIONS WITH OTHER DRUGS AND OTHER FORMS OF INTERACTIONS

– Combination to be taken into account

Levodopa (in combination with carbidopaj: inhibition of carbidopa absorption with decreased ievodopa plasma concentrations. Clinical monitoring and possible Ievodopa dosage adjustment.

– Special INR imbalance-related issues;

Numerous cases of increased oral anticoagulant activity have been reported in patients receiving antibiotic therapy. However, certain classes of antibiotics are more involved, particularly. fluoroquinolones, macrolides cyclins cotrimoxazole, and certain cephalosporins.

To avoid interactions between several medicines, you must systematically inform your doctor or pharmacist of any other

treatments you may be taking.

PREGNANCY AND LACTATION

– Pregnancy:

if necessary, spiramycin may be taken during pregnancy, but only on your doctor’s advice. If you discover that you are pregnant while taking spiramycin, consult your doctor because only he/she may decide whether it is necessary to pursue treatment.

– Lactation:

as spiramycin is excreted in breast milk, this drug is not recommended in case of lactation.

In case of pregnancy or lactation you always hove to osk your Physician or Pharmacist for advice before the beginning of the treatment

EFFECTS ON ABILITY TO DRIVE AND OPERATE MACHINES

No clinical study.

DOSAGE AND ADMINISTRATION

Dosage

Rovamycine 3M.I.U. tablets are not suitable for administration to children.

As an indication, the usual dosage for the treatment of certain infections is:

– adults: 6 to 9 M.I.U. per 24 hours, in 2 or 3 divided doses. Special case: treatment duration for certain cases of sore throat is 10 days.

For the prevention of certain infections, the usual dosage is:

– adults: 3 M.I.U,/12 hours for 5 days.

In all cases, strictly follow the Physician’s prescription.

Method of administration

Oral route. Swallow the tablets whole with a glass of water. Taking 2-3 hours before or after meal Duration of treatment

For the treatment to be efficient, you should complv with the doses for as long a period as the Physician will have prescribed it.

Disappearance of the temperature or of any other symptom do not mean that you are completely cured.

A possible feeling of fatigue would not be caused by the antibiotic treatment but by the infection itself. Reducing or discontinuing the treatment would not suppress the feeling of fatigue and would delay recovery.

In all cases you should follow the Physician’s prescription.

Action to be taken in case of overdosage In case of overdosage or accidental intoxication vou should immediately notify to a Phvsician who can suggest treatment and monitoring.

UNDESIRABLE EFFECTS

Like any active product. this drug may induce undesirable effects to a greater or lesser degree:

Digestive effects: stomach pain, nausea, vomiting, diarrhea; very rarely: pseudomembranous colitis (intestinal disease with diarrhea and abdominal pain).

Skin effects: rash, urticaria (skin rashes similar to nettle stings), itching; very rarely angioedema (sudden allergic swelling of the face and neck), allergic shock; very rare cases of redness all over the body with pustules, accompanied by fever (acute generalized exanthematous pustulosis) (see Special warnings). In all cases, consult your doctor.

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

– Effects on the liver: very rarely, abnormal liver tests.

–  Blood count changes: very rarely, anemia with possible destruction of red blood cells (see Precautions for use).

If you notice any undesirable effects not mentioned in this leaflet, please inform your doctor or pharmacist

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: ANTIBACTERIALS FOR SYSTEMIC USE ATC code: J01FA02

Spiramycin is an antibacterial antibiotic of the macrolide group.

Spectrum of antimicrobial activity

The critical concentrations differentiating susceptible strains from intermediate strains and the latter from resistant strains are as follows: S <=1 mg/l and R > 4 mg/l.

The prevalence of acquired resistance in certain species can vary geographically and over time. It is therefore useful to have local information on the prevalence of resistance, especially in treating severe infections.

These data are only guidelines indicating the probability of susceptibility of a bacterial strain to this antibiotic:

– Susceptible species: (1) Gram-positive aerobic: Bacillus cereus, Corynebocterium diphtheria. Enterococci, Rhodococcus equi, Staphylococcus meti-S, Staphylococcus meti-R*. Streptococcus B, Unclassified streptococcus, Streptococcus pneumoniae, Streptococcus pyogenes. (2) Gram-negative aerobic: Bordetella pertussis, Branhamella catarrhalis, Campylobacter, Legionella, Moraxella. (3) Anaerobic : Actinomyces, Bacteroides, Eubaderium, Mobiluncus, Peptostreptococcus, Porphyromonas, Prevotella, Propionibocterium ocnes. (4) Miscellaneous: Borrelia burgdorferi, Chlamydia, Coxiella, Leptospires, Mycoplasma pneumoniae, Treponema pallidum.

– Moderately susceptible species (intermediate susceptibility in vitro)-. (1) Gram-negative aerobic: Neisseria gonorrhoeae. (2)     Anaerobic: Clostridium perfringens. (3) Miscellaneous: Ureaplasma urealyticum.

– Resistant species: (1) Gram-positive aerobic: Corynebocterium jeikeium, Nocardia asteroides. (2) Gram-negative aerobic: Acinetobader, Enterobaderia, Haemophilus, Pseudomonas. (3)     Anaerobic: Fusobatierium. (4) Miscellaneous: Mycoplasma hominis.

Spiramycin has in vitro and in vivo adivity on Toxoplasma gondii.

* The incidence of methicillin resistance is approximately 30 to 50% for all staphylococci, and is mainly found in the hospital setting.

Pharmacokinetic properties

Absorption

Spiramycin is rapidly but incompletely absorbed. Food reduces absorption of spiramycin.

Distribution

After oral administration of 6 MIU of spiramycin, maximum plasma concentrations are 3.3 pg/ml. Plasma elimination half- life is approximately 8 hours.

Spiramycin does not cross the blood-brain barrier. It is however excreted in breast milk. Spiramycin is poorly plasma protein- bound (10%).

Tissue and saliva distribution is very high (lungs: 20-60 pg/g, tonsils: 20-80 pg/g, infeded sinuses: 75-110 pg/g, bones: 5-100 Mg/g)-

Ten days after treatment discontinuation, 5 to 7 pg/g of the drug substance remain in the spleen, the liver and the kidneys. Macrolides penetrate and accumulate in phagocytes (neutrophils, monocytes, peritoneal and alveolar macrophages). In man, phagocyte concentrations are high.

These properties explain macrolide adivity on intracellular bacteria.

Metabolism

Spiramycin is metabolized in the liver, forming chemically unknown but active metabolites.

Excretion

– urine: 10% of the administered dose.

– biliary excretion is high: concentrations 15 to 40 times higher than plasma concentrations.

– an appreciable amount of spiramycin can be found in the feces.

OVERDOSE

There is no known toxic dose for spiramycin.

The signs expected at high doses are gastrointestinal disorders such as nausea, vomiting, diarrhea.

Cases of prolonged QT-interval regressing on treatment discontinuation have been observed in neonates treated with high doses of spiramycin, and after intravenous administration of spiramycin in patients at risk of QT-interval prolongation.

If overdose with spiramycin occurs, an ECG is recommended to measure the QT-interval, especially if there are other risk factors (hypokalemia, congenital prolonged QTc interval, coadministration with other drugs that prolong the QT interval and/or induce torsades de pointes).

There is no specific antidote. Symptomatic treatment is recommended.

SHELF-LIFE AND STORAGE CONDITION

Respect the expiry date indicated on the outer packaging.

Shelf-life

Rovamycine 3M.I.U.: 24 months from the manufacturing date. Special storage conditions: do not store above 30°C. Specifications: Manufacturer’s

MANUFACTURER

PRESCRIPTION ONLY MEDICINE.

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. IF YOU HAVE ANY FURTHER QUESTIONS, ASK YOUR DOCTOR.

 

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