Rovamicine

Leaflet attached to the packaging: patient information

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

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging and other information

1. What is Rovamycine and what is it used for

Rovamycine is available in the form of 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 pneumonia and bronchitis 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 gingivitis, ulcerative, necrotizing gingivitis.
• 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:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Rovamycine, discuss it with your doctor.
If the patient experiences symptoms of an allergy while taking Rovamycine, the medicine should be discontinued
and the doctor should be contacted immediately.
If the patient is allergic to other macrolide antibiotics, they should take Rovamycine with caution and, in case of worrying symptoms, consult a doctor.
If diarrhea occurs during treatment, the doctor should be contacted immediately
and medications that inhibit intestinal peristalsis should not be taken. There have been cases of pseudomembranous colitis after the use of broad-spectrum antibiotics, so it is important 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.
It should be used with caution in patients with liver failure due to the possibility of increased side effects.
It is not recommended to use spiramycin in 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, or bradycardia),
• concomitantly taking other medications that prolong the QT interval (e.g., antiarrhythmic medications belonging to class IA and class III, tricyclic antidepressants, certain medications used to treat infections, antipsychotic medications). Elderly patients, newborns, and women may be more sensitive 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).
Patients will be informed about the symptoms and will be closely monitored for skin reactions. If symptoms of Stevens-Johnson syndrome, toxic epidermal necrolysis (e.g., progressive rash, often with blisters or mucosal lesions), or acute generalized exanthematous pustulosis occur, the use of Rovamycine should be discontinued.

Children and adolescents

Tablet administration is not recommended in children under 6 years of age (risk of choking).

Rovamycine and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is especially important when taking spiramycin with medications containing levodopa and carbidopa - a dose adjustment of levodopa may be necessary.
Medications 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 medications belonging to class IA and class III, tricyclic antidepressants, certain medications used to treat infections, antipsychotic medications).
Hydroxychloroquine or chloroquine (medications used to treat rheumatoid arthritis, to treat and prevent malaria)
Concomitant use of hydroxychloroquine or chloroquine with Rovamycine may increase the risk of side effects that affect heart function, which can be life-threatening.

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 child, consult your doctor before taking this medicine.
The medicine should only be used in pregnant women if absolutely 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

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor.

Recommended dosage

Adults
Initial dose:6 million IU per day in 2 divided doses; this 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
Initial dose:150,000 IU/kg body weight per day in 2-3 divided doses;
this 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 in the ECG (decreased potassium levels in the blood, 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, consult a doctor or pharmacist immediately.

Missed dose of Rovamycine

If a dose is missed, take it as soon as possible, unless it is close to the time of the next dose. Do not take two doses of the medicine at the same time or at short intervals.
In case of doubts, consult a doctor.

Discontinuation of Rovamycine

Do not stop treatment without consulting a doctor. Treatment should be continued for as long as the doctor recommends.
In case of further doubts about the use of this medicine, consult a 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.

• transient paresthesia (sensory disturbances).

Common side effects (may occur in up to 1 in 10 patients):

• transient taste disturbances,
• abdominal pain, nausea, vomiting, diarrhea, and pseudomembranous colitis during treatment with 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 available data):

• acute hemolysis (red blood cell damage) (see "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 "Warnings and precautions"),
• cholestatic or mixed hepatitis,
• urticaria, pruritus, angioedema (skin and mucous membrane swelling, which can affect the airways and be life-threatening), Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (see "Warnings and precautions"),
• QT interval prolongation in the ECG, abnormal liver function test results.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell 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
tel.: + 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Rovamycine

Store in a temperature below 25°C.
Keep the medicine out of 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rovamycine contains

• The active substance of the medicine is spiramycin. One coated tablet contains 1.5 million IU or 3 million IU of spiramycin.
• The other ingredients are: corn starch, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, colloidal silica, 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 coated tablets.
Rovamycine, 3 million IU: the pack contains 10 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: