Rovamicine

Package Leaflet: Information for the Patient

ROVAMYCINE, 1.5 million IU, film-coated tablets
ROVAMYCINE, 3 million IU, film-coated tablets
Spiramycin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Rovamycine and what is it used for
• 2. Important information before taking Rovamycine
• 3. How to take Rovamycine
• 4. Possible side effects
• 5. How to store Rovamycine
• 6. Contents of the pack and other information

1. What is Rovamycine and what is it used for

Rovamycine is available in the form of film-coated tablets and contains the active substance spiramycin.
Spiramycin is an antibiotic belonging to the macrolide group.

Indications for use of Rovamycine

• Infections of the upper and lower respiratory tract:
• pharyngitis and tonsillitis caused by group A streptococci (Streptococcus pyogenes);
• sinusitis caused by: Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus;
• otitis media caused by: Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia trachomatis;
• acute bronchitis and pneumonia caused by: Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus;
• atypical pneumonia caused by: Legionella pneumophila, Chlamydia psittaci, Mycoplasma pneumoniae.
• Prevention of congenital toxoplasmosis.
• Prevention of meningococcal meningitis in cases of Neisseria meningitidiscarriage in the nasopharynx.
• Prevention of recurrent rheumatic fever, only in patients allergic to penicillin.
• In dentistry, in acute conditions: abscesses, gingivitis with hyperemia, acute periodontitis, ulcerative, necrotizing periodontitis.
• Urethritis caused by Chlamydia trachomatisof various serotypes.
• Skin infections caused by Staphylococcus aureusand Streptococcus pyogenes.
• Cryptosporidiosis caused by Cryptosporidium muris.
• Toxoplasmosis in pregnant women.

2. Important information before taking Rovamycine

When not to take Rovamycine:

Warnings and precautions

Before starting treatment with Rovamycine, discuss it with your doctor.
If you experience symptoms of an allergy while taking Rovamycine, discontinue the medicine
and contact your doctor immediately.
If you are allergic to other macrolide antibiotics, you should take Rovamycine with caution and, in case of worrying symptoms, consult your doctor.
If you experience diarrhea during treatment, contact your doctor immediately
and do not take medications that inhibit intestinal peristalsis. There have been cases of pseudomembranous colitis
after the use of broad-spectrum antibiotics, so it is essential to consider this possibility in patients who have developed acute diarrhea during or after antibiotic treatment.
Spiramycin is excreted in small amounts in the urine, and in renal failure, there is no need to modify the dose of the medicine.
Use with caution in patients with liver failure due to the possibility of increased side effects.
Spiramycin is not recommended for patients with a deficiency of glucose-6-phosphate dehydrogenase activity, as acute hemolysis has been observed in rare cases after the use of spiramycin in this group of patients.
QT interval prolongation
During treatment with macrolide antibiotics, including spiramycin, cases of QT interval prolongation have been observed. Therefore, caution should be exercised when using spiramycin in patients with conditions that favor QT interval prolongation, i.e., patients with:

• electrolyte disturbances (e.g., low potassium and/or magnesium levels in the blood),
• congenital long QT syndrome,
• heart disease (e.g., heart failure, myocardial infarction, slow heart rate, i.e., bradycardia),
• concomitantly taking other medications that prolong the QT interval (e.g., antiarrhythmic drugs belonging to class IA and class III, tricyclic antidepressants, some anti-infective drugs, antipsychotic drugs). Elderly patients, newborns, and women may be more susceptible to the QT-prolonging effect.

Severe skin reactions
During treatment with Rovamycine, cases of severe skin reactions have been reported, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (AGEP).
Patient will be informed about the signs and symptoms and will be closely monitored for skin reactions. In case of signs of Stevens-Johnson syndrome, toxic epidermal necrolysis (e.g., progressive rash, often with blisters or mucosal lesions) or acute generalized exanthematous pustulosis, the use of Rovamycine should be discontinued.

Children and adolescents

Tablets are not recommended for children under 6 years of age (risk of choking).

Rovamycine and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
This is especially important when taking spiramycin with medicines containing levodopa and carbidopa - a dose adjustment of levodopa may be necessary.
Medicines that prolong the QT interval
Spiramycin, like other macrolide antibiotics, should be used with caution in patients concomitantly receiving medications that prolong the QT interval (e.g., antiarrhythmic drugs belonging to class IA and class III, tricyclic antidepressants, some anti-infective drugs, antipsychotic drugs).

Rovamycine with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
The medicine may be used in pregnant women only if necessary.
If spiramycin treatment is necessary, the woman should not breastfeed.

Driving and using machines

No data available.

Rovamycine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Rovamycine

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor.

Recommended dosage

Adults
Basic dose:6 million IU per day in 2 divided doses; the dose can be increased to 9 million IU per day, given in 3 divided doses.
In streptococcal pharyngitis and tonsillitis, treatment lasts for 10 days.
Prevention of meningococcal meningitis:3 million IU every 12 hours for 5 days.
Children
Basic dose:150,000 IU/kg body weight per day in 2-3 divided doses;
the dose can be increased to 300,000 IU/kg body weight per day, given in 2-3 divided doses.
In streptococcal pharyngitis and tonsillitis, treatment lasts for 10 days.
Prevention of meningococcal meningitis:75,000 IU/kg body weight every 12 hours for 5 days.

Method of administration

Swallow the tablets whole with a glass of water.

Overdose of Rovamycine

As a result of taking large doses, gastrointestinal symptoms may occur: nausea, vomiting, diarrhea.
In case of spiramycin overdose, the doctor will order an ECG, especially if the patient has risk factors for QT interval prolongation (decreased potassium levels, congenital QT interval prolongation, taking medications that prolong the QT interval or increase the risk of ventricular arrhythmias).
There is no specific antidote effective in case of spiramycin overdose. In case of poisoning, symptomatic treatment is recommended.
In case of taking a higher dose of the medicine than recommended, contact your doctor or pharmacist immediately.

Missed dose of Rovamycine

If you miss a dose, take it as soon as possible, unless it is almost time for the next dose. Do not take two doses at the same time or in a short period.
If you are unsure, consult your doctor.

Discontinuation of Rovamycine

Do not stop treatment without consulting your doctor. Continue treatment for as long as your doctor recommends.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, Rovamycine can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with the medicine.

Very common side effects (may affect more than 1 in 10 people):

• transient paresthesia (sensory disturbances).

Common side effects (may affect up to 1 in 10 people):

• transient taste disturbances,
• abdominal pain, nausea, vomiting, diarrhea, and pseudomembranous colitis during the use of oral forms of the medicine (symptoms include: diarrhea, abdominal pain, fever, which can lead to dehydration),
• rash.

Side effects with unknown frequency (cannot be estimated from the available data):

• acute hemolysis (red blood cell damage) (see section "Warnings and precautions"), leukopenia, neutropenia (blood changes),
• anaphylactic shock (severe, life-threatening allergic reaction), vasculitis, including Henoch-Schönlein purpura (a disease characterized by purpura, usually on the legs or feet, joint pain and swelling, abdominal pain),
• heart rhythm disturbances, such as ventricular arrhythmias, ventricular tachycardia, rhythm disturbances of the torsade de pointestype, which can lead to cardiac arrest (see section "Warnings and precautions"),
• cholestatic or mixed hepatitis,
• urticaria, pruritus, angioedema (swelling of the skin and mucous membranes, which can affect the airways and be life-threatening), Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (see section "Warnings and precautions"),
• QT interval prolongation on the ECG, abnormal liver function test results.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rovamycine

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rovamycine contains

• The active substance of the medicine is spiramycin. One film-coated tablet contains 1.5 million IU or 3 million IU of spiramycin.
• The other ingredients are: maize starch, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, silica colloidal anhydrous, microcrystalline cellulose; coating: hypromellose, macrogol 6000, titanium dioxide (E171).

What Rovamycine looks like and contents of the pack

Rovamycine, 1.5 million IU: white or cream-white, biconvex, round tablet with the inscription RPR 107 on one side.
Rovamycine, 3 million IU: white or cream-white, biconvex, round tablet with the inscription ROVA 3 on one side.
Rovamycine, 1.5 million IU: the pack contains 16 film-coated tablets.
Rovamycine, 3 million IU: the pack contains 10 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

The Simple Pharma Company Limited
Ground Floor, 71 Lower Baggot Street,
Dublin, D02 P593, Ireland

Manufacturer

Sanofi S.r.l.
Strada Statale 17, Km 22
67019 Scoppito (AQ)
Italy
Date of last revision of the leaflet: