ROVAMICINA 3,000,000 IU Фильм-coated таблетки
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Инструкция по применению ROVAMIKINA
Содержание инструкции
Rovamicina 3.000.000 U.I. film-coated tablets
spiramycin
Read this leaflet carefully before taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Rovamicina is and what it is used for
- 2. What you need to know before you take Rovamicina
- 3. How to take Rovamicina
- 4. Possible side effects
- 5. How to store Rovamicina
- 6. Contents of the pack and other information
1. What is Rovamicina and what is it used for
Rovamicina contains spiramycin, an antibiotic belonging to a group of drugs called macrolides,
which acts against some bacteria that cause the following infections:
- infections of the mouth, such as inflammation of the tissues around the tooth (periodontal diseases) and gums (gingivitis). Spiramycin, in addition to other therapies, is used to treat chronic inflammatory changes of the supporting tissues of the teeth (alveolar pyorrhea);
- infections of the respiratory tract, such as infections of the nose and throat (rhinopharyngitis, tonsillitis, laryngitis), those of the ear (otitis media), those of the bronchi and lungs (bronchitis, bronchopneumonia and pneumonia) and infections characterized by pus collection (pulmonary abscesses and empyemas);
- infectious diseases, such as whooping cough (kennel cough), erysipelas (irritation with redness of the skin), scarlet fever (with fever, sore throat, red spots on the skin) and gonorrhea (sexually transmitted disease);
- skin infections such as pyodermas, furuncles, abscesses and infected sores;
- bronchopulmonary complications related to influenza and exanthematous diseases (infectious diseases characterized by skin irritations).
2. What you need to know before taking Rovamicina
Do not take Rovamicina
If you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor before taking Rovamicina:
- if you have abnormalities in your electrocardiogram (prolongation of the QT interval);
- if you have had some heart disorders such as heart failure, myocardial infarction, slow heartbeat (bradycardia);
- if you have had some abnormal blood tests due to low levels of certain salts in the blood such as potassium (hypokalaemia) or magnesium (hypomagnesaemia);
- if you are taking medicines known to affect the heartbeat (medicines that prolong the QT interval), such as medicines used to regulate the heartbeat (antiarrhythmics), for depression (tricyclic antidepressants), some antibiotics, some medicines to treat mental illnesses (antipsychotics): this aspect is particularly important in elderly patients, in newborns and in women (see section “Other medicines and Rovamicina);
- if you suffer from skin, mouth, eye or genital lesions (such as redness of the skin with blisters or lesions of the mucous membranes) - these may be signs of a disease called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome” or “acute generalized exanthematous pustulosis”
- if you suffer from a hereditary disease characterized by a deficiency of an enzyme called glucose-6-phosphate dehydrogenase. This medicine may not be suitable for you because it may cause a decrease in hemoglobin in the blood following excessive destruction of red blood cells (acute haemolysis). This phenomenon can rarely occur.
Laboratory tests
If you need to take this medicine for a long period at high doses, your doctor will prescribe you
periodic tests to check the various elements of the blood and the functionality of your liver.
Other medicines and Rovamicina
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Tell your doctor in particular if you are taking these medicines:
- medicines known to affect the heartbeat (medicines that prolong the QT interval), such as medicines used to regulate the heartbeat (antiarrhythmics), for depression (tricyclic antidepressants), some antibiotics, some medicines to treat mental illnesses (antipsychotics). The use of antibiotics can lead to the development of bacteria resistant to therapy. It is possible that some germs that have become resistant to spiramycin, also become insensitive to similar, but not identical substances such as oleandomycin, erythromycinand other antibiotics of the macrolidegroup.
If you are being treated with carbidopa orlevodopayour doctor will monitor you and possibly correct the
levodopa dosage.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
The use of Rovamicina during breastfeeding is not recommended because spiramycin passes into
breast milk.
Driving and operating machinery
Rovamicina does not impair the ability to drive vehicles or operate machinery.
3. How to take Rovamicina
Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
The recommended dose is 2 - 3 tablets per day, divided into 2 or 3 administrations.
Swallow the tablet whole, without chewing, with plenty of water.
Use in children
The dose will be established by the doctor and depends on the child's body weight and the severity of the illness.
Follow the recommended dose carefully.
It is important to continue taking Rovamicina for at least 48 hoursafter the symptoms have disappeared.
If you take more Rovamicina than you should
If you take a dose of Rovamicina higher than that prescribed, immediately inform your doctoror go to the
nearest hospital. Bring the medicine packaging with you, so that the doctor knows what
you have taken.
If you forget to take Rovamicina
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.
Stop taking Rovamicina and seek immediate medical attention or go to the nearest hospitalif
you experience :
- difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue, skin irritation, itching and hives: these may be symptoms of severe allergic reactions (angioedema and anaphylactic reaction).
The following side effects have been reported with the use of this medicine:
Very common:
- temporary alteration of the sensitivity of the limbs or other parts of the body (transient paresthesia) Common
- abdominal pain
- nausea, vomiting;
- diarrhea;
- a particular inflammation of the terminal part of the intestine associated with severe diarrhea (pseudomembranous colitis);
- redness of the skin (rash);
- Transient alteration of taste (transient dysgeusia).
Not known:
- hives, itching, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema),
- skin, mouth, eye or genital lesions (such as skin redness with blisters or mucosal lesions) - these may be signs of a disease called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome” or “acute generalized exanthematous pustulosis”,
- severe allergic reaction (anaphylactic shock); small red or purple spots spread over the skin, sometimes associated with joint pain, muscle pain, weakness and fever, these may be symptoms of inflammation of the blood vessels (vasculitis, including Henoch-Schönlein purpura).
- inflammation of the liver that may also involve the bile ducts (cholestatic and mixed hepatitis),
- excessive destruction of red blood cells in the blood with a consequent decrease in hemoglobin (acute hemolysis),
- decrease in white blood cells (leukopenia, neutropenia),
- alterations of the heartbeat (ventricular arrhythmias or torsades de pointes that can lead to cardiac arrest), increased heartbeat (ventricular tachycardia),
- alterations of some tests to evaluate heart function (electrocardiogram: prolongation of the QT interval) and liver function (alteration of liver function tests).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the website: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store Rovamicina
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Rovamicina contains
- The active ingredient is spiramycin. One tablet contains 3,000,000 U.I. of spiramycin.
- The other ingredients are: anhydrous colloidal silica, hydroxypropylcellulose, magnesium stearate, hypromellose, corn starch, macrogol 6,000, sodium carboxymethylcellulose, microcrystalline cellulose, titanium dioxide.
Description of the appearance of Rovamicina and contents of the pack
Pack of 12 film-coated tablets in blisters.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Sanofi S.p.A. – Viale L. Bodio, 37/B – 20158 Milan - Italy
Manufacturer
FAMAR HEALTH CARE SERVICES - Avenida de Leganés, 62 - 28 923 Alcorcon (Madrid) - Spain
SANOFI S.p.A. - Strada Statale 17, Km 22 - 67019 Scoppito (AQ) - Italy
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- Страна регистрации
- Форма выпускаFilm-coated tablet, 3,000,000 IU
- Код АТХJ01FA02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги ROVAMIKINAФорма выпуска: Film-coated tablet, 150 MGДействующее вещество: roxithromycinПроизводитель: I.B.N. SAVIO S.R.LОтпускается по рецептуФорма выпуска: Film-coated tablet, 500 MGДействующее вещество: АзитромицинПроизводитель: GENETIC S.P.A.Отпускается по рецептуФорма выпуска: Film-coated tablet, 500 MGДействующее вещество: АзитромицинПроизводитель: DYMALIFE PHARMACEUTICAL S.R.L.Отпускается по рецепту
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Аналог ROVAMIKINA в Украина
Аналог ROVAMIKINA в Испания
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Часто задаваемые вопросы
ROVAMIKINA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ROVAMIKINA — Эспирамицин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ROVAMIKINA производится компанией SANOFI S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения ROVAMIKINA с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Вы можете купить ROVAMIKINA в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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Другие лекарства с тем же действующим веществом (Эспирамицин) включают ASSORAL, ATSAKID, ATSEPTIN. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
