Patient Information Leaflet

Rovamycine 1.5 million IU film-coated tablets

Espiramicina

Read this leaflet carefully before you start taking the medicine

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can report it to your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Rovamycine is and what it is used for
2. What you need to know before taking Rovamycine
3. How to take Rovamycine
4. Possible side effects
5. Storage of Rovamycine
6. Contents of the pack and additional information

Rovamycine belongs to a group of medications known as macrolides.Antibiotics prevent the growth of bacteria that cause infections.

Rovamycine is used in the treatment of infections caused by susceptible pathogens in:

• Tonsillitis (throat infection). Pharyngitis (infection of the pharynx).
• Sinusitis (infection of the paranasal sinuses located around the forehead, cheeks, and eyes).
• Otitis (ear infection).
• Oral cavity infections.

• Gonococcal infections (sexually transmitted infections).

• Toxoplasmosis (infection caused by a parasite).

Do not take Rovamycine

If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rovamycine.

• Caution should be exercised in patients with known risk factors for cardiac arrhythmias such as QT interval prolongation: hypocalcemia, hypomagnesemia, congenital long QT syndrome, heart disease, and concomitant use of medications known to prolong the QT interval.

Older patients, neonates, and women may be more sensitive to the effect of QT interval prolongation.

• Severe skin reactions have been reported. If signs of these severe reactions such as progressive skin rash, often with blisters or lesions on mucous membranes, are present, treatment with Rovamycine should be discontinued (see Possible adverse reactions).

• If you have glucose-6-phosphate dehydrogenase deficiency, your doctor will recommend that you not take Rovamycine as rare cases of acute hemolysis (blood disease) have been detected in this type of person.

Use of Rovamycine with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication, including those purchased without a prescription.

- Hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis, or to treat or prevent malaria): Taking these medications at the same time as Rovamycine may increase the likelihood of adverse effects that affect the heart and may put your life at risk.

- It is essential to inform your doctor if you are being treated with levodopa (medication for Parkinson's disease treatment) as spiramycin reduces the amount of this in the blood and this may cause a decrease in the effectiveness of levodopa treatment, so your doctor will adjust the levodopa dose.

Spiramycin, like other antibiotics, should be used with caution in patients being treated with medications known to affect QT interval prolongation (e.g. Class IA and III antiarrhythmics, some antidepressants, antifungals, or antipsychotics) (see Warnings and precautions).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of using Rovamycine during pregnancy has not been studied, although no effects on fetal or neonatal development have been observed to date, the potential risks and benefits of its use should be carefully evaluated.

If you are breastfeeding, it is recommended not to take Rovamycine, as spiramycin, the active ingredient in this medication, is excreted in breast milk.

Driving and operating machinery

No studies have been conducted on the influence of Rovamycine on the ability to drive and operate machinery, however, to date, no influence has been observed.

Rovamycine contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for Rovamycine as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Take Rovamycine tablets with a sufficient amount of liquid (a glass of water).

Your doctor will indicate the duration of your treatment with Rovamycine. Do not discontinue treatment beforehand, as this could worsen your condition or lead to the development of bacterial resistance.

If you estimate that the action of Rovamycine is too strong or weak, inform your doctor or pharmacist.

Your doctor will decide what is the most suitable dose for you.

The normal dose is:

Adults

The dose for adults is generally 4 tablets per day, divided into 2 or 3 doses, and in some cases, your doctor may increase the dose to 8 or 10 tablets.

If you have any kidney function impairment, your doctor will not need to adjust your dose, as the amount of medication eliminated through urine is very small.

Children

In children, the daily dose is 1 to 4 tablets, divided into 2 or 3 doses.

Your doctor will indicate the duration of your treatment with Rovamycine. Do not discontinue treatment before your doctor indicates it, nor take more tablets than recommended by your doctor.

If you take more Rovamycine than you should

Consult your doctor or pharmacist immediately, or go to the nearest hospital emergency department where you will be treated for your symptoms. Bring this leaflet with you. Due to the risk of QT interval prolongation, electrocardiogram monitoring is recommended.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Rovamycine

Do not take a double dose to compensate for the missed doses.

Like all medicines, Rovamycine can cause side effects, although not everyone will experience them.

To classify them, the following definitions of frequency have been used:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Frequency not known (cannot be estimated from available data)

Blood and lymphatic system disorders:

• Frequency not known: acute hemolysis (blood disease) (see warnings and precautions), leukopenia, neutropenia (low white blood cell count).

Immune system disorders:

• Frequency not known: anaphylactic shock (severe allergic reaction that can be life-threatening), vasculitis (inflammation of blood vessels) including Henoch-Schonlein purpura.

Nervous system disorders:

• Very common: occasional transient paresthesia (tingling in hands or feet).
• Common: transient disgeusia (change in taste).

Cardiac disorders:

• Frequency not known: ventricular arrhythmia, ventricular tachycardia, torsade de pointes that may lead to cardiac arrest (see Warnings and Precautions section).

Gastrointestinal disorders:

• Common: abdominal pain, nausea, vomiting, diarrhea, and pseudomembranous colitis (severe intestinal inflammation that may rarely occur after antibiotic treatment).

Skin and subcutaneous tissue disorders:

• Common: rash (skin eruption).
• Frequency not known: urticaria (hives, skin irritation, and itching), pruritus (itching), angioedema (allergic reaction with inflammation of feet, hands, throat, lips, and respiratory tract), Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, and Acute Generalized Pustular Psoriasis whose symptoms may include skin blistering on the skin, mouth, eyes, or genitals (see Warnings and Precautions section).

Hepatobiliary disorders:

• Frequency not known: cholestatic or mixed hepatitis.

Investigations:

• Frequency not known: prolongation of the QT interval on the electrocardiogram, liver function test abnormalities.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the reach and sight of children.

Do not store at a temperature above 25°C.

Do not dispose of medications through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Do not use Rovamycine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Rovamycine

• The active principle is spiramycin. Each tablet contains 1.5 million IU of spiramycin.

The other components are:

Tablet core: pregelatinized cornstarch, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica, microcrystalline cellulose.

Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E 171).

Appearance of the product and content of the packaging

Rovamycine is presented in the form of coated tablets with a film, round, flat, white, with “RPR 107” engraved on one face.

Each package contains 24 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

The Simple Pharma Company Limited

Ground Floor, 71 Lower Baggot Street, Dublin,

D02 P593, Ireland

Responsible for manufacturing:

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Last review date of this leaflet: November 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.