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ROVAMYCINE 1.5 million IU FILM-COATED TABLETS

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About the medicine

How to use ROVAMYCINE 1.5 million IU FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Rovamycine 1.5 Million IU Film-Coated Tablets

Spiramycin

Read the Entire Package Leaflet Carefully Before Starting to Use the Medication

  • Keep this package leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
  • If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist. See section 4.
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Package Leaflet Contents:

  1. What is Rovamycine and what is it 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. Package contents and additional information

1. What is Rovamycine and what is it used for

Rovamycine belongs to a group of medications called macrolides. Antibiotics stop the growth of bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against

viral infections such as the flu or the common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal.Do not throw away medications down the drain or in the trash.

Rovamycine is used to treat infections caused by susceptible germs in:

  • Tonsillitis (infection of the throat). Pharyngitis (infection of the pharynx).
  • Sinusitis (infection of the paranasal sinuses around the forehead, cheeks, and eyes).
  • Otitis (infection of the ear).
  • Infections of the oral cavity.
  • Gonococcal infections (sexually transmitted infections).
  • Toxoplasmosis (infection caused by a parasite).
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2. What you need to know before taking Rovamycine

Do not take Rovamycine

If you are allergic to the active substance 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 QT interval prolongation, heart disease, and concomitant use of medications with a known effect of QT interval prolongation.

Elderly 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 occur, such as progressive skin rash, often with blisters or lesions in the mucous membranes, treatment with Rovamycine should be discontinued (see Possible side effects).
  • If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase, your doctor will recommend that you do not take Rovamycine, as very rare cases of acute hemolysis (blood disease) have been detected in this type of person.
Using Rovamycine with other medications

Inform your doctor or pharmacist if you are using, have recently used, 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 having side effects that affect your heart, which could be life-threatening.
  • It is essential to inform your doctor if you are being treated with levodopa (medication for the treatment of Parkinson's disease), as spiramycin reduces the amount of levodopa in the blood, which may decrease the effect 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 the QT interval (e.g., antiarrhythmic agents of Class IA and III, some antidepressants, antifungals, or antipsychotics) (see Warnings and precautions).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 substance of this medication, is eliminated through breast milk.

Driving and using machines

There are no studies on the influence of Rovamycine on the ability to drive and use 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; this is essentially "sodium-free".

3. How to take Rovamycine

Follow your doctor's instructions for taking Rovamycine exactly. Consult your doctor or pharmacist if you have any questions.

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 stop treatment before it is completed, as this may worsen your condition or lead to the development of bacterial resistance.

If you think the effect of Rovamycine is too strong or too weak, inform your doctor or pharmacist.

Your doctor will decide 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; if necessary, your doctor may increase the dose to 8 or 10 tablets.

If you have kidney function impairment, your doctor will not need to adjust the dose, as the amount of medication eliminated through the 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 stop treatment before your doctor indicates it, and do not take more tablets than recommended by the doctor.

If you take more Rovamycine than you should

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

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

If you forget to take Rovamycine

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

The following definitions of frequency have been used for classification:

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 levels of white blood cells).

Immune system disorders:

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

Nervous system disorders:

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

Cardiac disorders:

  • Frequency not known: ventricular arrhythmia, ventricular tachycardia, torsades de pointes that can lead to cardiac arrest (see Warnings and precautions).

Gastrointestinal disorders:

  • Common: abdominal pain, nausea, vomiting, diarrhea, and pseudomembranous colitis (severe inflammation of the intestine that can occur very rarely 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 that can cause swelling of feet, hands, throat, lips, and respiratory tract), Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, whose symptoms could be the appearance of blisters on the skin, mouth, eyes, or genitals (see Warnings and precautions).

Hepatobiliary disorders:

  • Frequency not known: cholestatic or mixed hepatitis.

Investigations:

  • Frequency not known: QT interval prolongation in the electrocardiogram, alterations in liver function tests.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Rovamycine

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

Do not store above 25°C.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

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

6. Package contents and additional information

Composition of Rovamycine
  • The active substance is spiramycin. Each tablet contains 1.5 million IU of spiramycin.

The other components are:

Core of the tablet: 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 package contents

Rovamycine is presented in the form of film-coated tablets, round, flat, white, with "RPR 107" engraved on one side.

Each package contains 24 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:

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

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Date of the last revision of this package leaflet: November 2023

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

Online doctors for ROVAMYCINE 1.5 million IU FILM-COATED TABLETS

Discuss questions about ROVAMYCINE 1.5 million IU FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
Doctor

Томаш Гжеловський

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Даниэль Чики

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance.

His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation.

Patients commonly consult Dr Daniel Cichi for:

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.
Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.
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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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Frequently Asked Questions

Is a prescription required for ROVAMYCINE 1.5 million IU FILM-COATED TABLETS?
ROVAMYCINE 1.5 million IU FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ROVAMYCINE 1.5 million IU FILM-COATED TABLETS?
The active ingredient in ROVAMYCINE 1.5 million IU FILM-COATED TABLETS is spiramycin. This information helps identify medicines with the same composition but different brand names.
How much does ROVAMYCINE 1.5 million IU FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for ROVAMYCINE 1.5 million IU FILM-COATED TABLETS is around 3.51 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures ROVAMYCINE 1.5 million IU FILM-COATED TABLETS?
ROVAMYCINE 1.5 million IU FILM-COATED TABLETS is manufactured by The Simple Pharma Company Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ROVAMYCINE 1.5 million IU FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ROVAMYCINE 1.5 million IU FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ROVAMYCINE 1.5 million IU FILM-COATED TABLETS?
Other medicines with the same active substance (spiramycin) include ARATRO 200 mg/5 ml POWDER FOR ORAL SUSPENSION IN A BOTTLE, ARATRO 500 mg FILM-COATED TABLETS, ARATRO 500 mg ORAL SUSPENSION POWDER IN SACHET. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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