SINECOD 2 mg /Ml Krople Doustne, Roztwór
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Treść ulotki
Sinecod Tosse Sedativo 2 mg/ml oral drops, solution, 3 mg/10 g syrup, 5 mg lozenges
butamirate
Read this leaflet carefully before you start taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not feel better or if your symptoms get worse after 7 days.
Contents of this leaflet:
- 1. What Sinecod Tosse Sedativo is and what it is used for
- 2. What you need to know before you take Sinecod Tosse Sedativo
- 3. How to take Sinecod Tosse Sedativo
- 4. Possible side effects
- 5. How to store Sinecod Tosse Sedativo
- 6. Contents of the pack and other information
1. What is Sinecod Tosse Sedativo and what is it used for
Sinecod Tosse Sedativo contains the active ingredient butamirate which reduces the urge to cough.
Sinecod Tosse Sedativo is indicated as a cough suppressant.
See your doctor if you do not feel better or if you feel worse after 7 days or if the cough continues
for more than 7 days and you have a fever, difficulty breathing or chest pain.
2. What you need to know before taking Sinecod Tosse Sedativo
Do not take Sinecod Tosse Sedativo tablets
- if you are allergic to butamirate, to substances closely related from a chemical point of view or to any of the other ingredients of this medicine (listed in section 6)
- if the patient is a child under 12 years of age
- if you are in the first 3 months of pregnancy.
Do not take Sinecod Tosse Sedativo syrup and oral drops
- if you are allergic to butamirate, to substances closely related from a chemical point of view or to any of the other ingredients of this medicine (listed in section 6)
- if the patient is a child under 6 years of age
- if you are in the first 3 months of pregnancy.
Warnings and precautions
Consult your doctor or pharmacist before taking Sinecod Tosse Sedativo.
Consult your doctor before taking this medicine:
- if you have kidney and/or liver failure.
Do not use Sinecod Tosse Sedativo if you are using medicines that promote the elimination of mucus
(expectorants) (see section “Other medicines and Sinecod Tosse Sedativo”).
Children and adolescents
Sinecod Tosse Sedativo tablets should not be administered to children under 12
years of age.
Sinecod Tosse Sedativo syrup and oral drops should not be administered to children under 6 years of age.
Other medicines and Sinecod Tosse Sedativo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
No studies have been conducted on the possible interactions of Sinecod Tosse Sedativo with other
medicines.
Do not take Sinecod Tosse Sedativo if you are using medicines that promote the elimination of
mucus (expectorants), because mucus may accumulate in the airways which can
cause bronchospasm (narrowing of the bronchi) and respiratory tract infection.
Pregnancy and breastfeeding
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.
Pregnancy
Do not take Sinecod Tosse Sedativo during the first three months of pregnancy.
In the second and third trimesters of pregnancy Sinecod Tosse Sedativo may only be taken if
strictly necessary.
Breastfeeding
It is not known whether Sinecod Tosse Sedativo passes into breast milk. Consult your doctor before
taking this medicine if you are breastfeeding.
Driving and operating machinery
Sinecod Tosse Sedativo can rarely cause drowsiness, so be careful if you need to
drive or operate machinery.
Sinecod Tosse Sedativo oral drops contains ethanol, methyl parahydroxybenzoate and sucrose
This medicine contains 5.1 mg of alcohol (ethanol) in 1 ml which is equivalent to 4.46 mg/g. The
amount in 1 ml of this medicine is equivalent to less than 0.2 ml of beer or 0.1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains methyl parahydroxybenzoate which may cause allergic reactions (including
delayed reactions).
This medicine contains sucrose: if your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.
Sinecod Tosse Sedativo syrup contains ethanol, methyl parahydroxybenzoate and sorbitol
This medicine contains 4.35 mg of alcohol (ethanol) in 1 ml which is equivalent to 3.71 mg/g. The
amount in 1 ml of this medicine is equivalent to less than 0.11 ml of beer or 0.05 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains methyl parahydroxybenzoate which may cause allergic reactions (including
delayed reactions).
This medicine contains 2876 mg of sorbitol per 10 ml (children's dose) and 4314 mg per 15 ml
(adult dose), equivalent to 287.6 mg/ml respectively. Sorbitol is a source of fructose. If your
doctor has told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of
hereditary fructose intolerance, a rare genetic disease in which patients cannot
metabolize fructose, talk to your doctor before you (or the child) take this medicine.
It may cause gastrointestinal problems and have a mild laxative effect.
3. How to take Sinecod Tosse Sedativo
Take this medicine following exactly as indicated in this leaflet, or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not exceed the recommended doses. Respect the time intervals indicated between one administration and the next. Do not take Sinecod Tosse Sedativo for long periods of time, take this medicine only when you have symptoms. Consult your doctor immediately if the cough persists for more than 7 days and you have fever, difficulty breathing or chest pain.
Sinecod Tosse Sedativo oral drops
Take the drops with a little water or milk.
Use in adults
The recommended dose is 40 drops every 6-5 hours.
Use in children between 6 and 12 years
The recommended dose is 20 drops every 8-6 hours.
Sinecod Tosse Sedativo syrup
Take the syrup with the measuring cup that is in the package.
After swallowing, if necessary, you can drink water or other liquids.
Wash and dry the graduated measuring cup every time you use it, especially if more than one person uses it.
Use in adults
The recommended dose is 15 ml every 8-6 hours.
Use in children between 6 and 12 years
The recommended dose is 10 ml every 8-6 hours.
Sinecod Tosse Sedativo tablets
Chew or suck the tablets.
Use in adults
The recommended dose is 1 tablet every 6 hours.
Do not exceed the maximum dose of 1 tablet every 4 hours.
You can take 2 tablets consecutively before going to bed, for a more prolonged effect during the night hours.
Use in adolescents over 12 years
The recommended dose is 1 tablet every 12 hours.
How to open and close the bottle
Opening
Press the cap down while unscrewing to the left
Closing
Screw the cap on tightly to the right
If you take more Sinecod Tosse Sedativo than you should
In case of accidental ingestion of an excessive dose of Sinecod Tosse Sedativo, immediately notify your doctor or go to the nearest hospital.
If you have taken an excessive dose of Sinecod Tosse Sedativo you may experience: drowsiness, nausea, vomiting, diarrhea, dizziness and low blood pressure.
If you forget to take Sinecod Tosse Sedativo
Do not take a double dose to make up for a missed dose.
If you stop taking Sinecod Tosse Sedativo
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.
Rare side effects (may affect up to 1 in 1,000 people)
- dizziness
- drowsiness
- nausea
- diarrhoea
- urticaria
Side effects with unknown frequency (frequency cannot be estimated from available data)
- hypersensitivity reactions
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sinecod Tosse Sedativo
Sinecod Tosse Sedativo oral drops and syrup
This medicine does not require any special storage conditions.
Sinecod Tosse Sedativo lozenges
Do not store at a temperature above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging 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 eliminate medicines that you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the
6. Package Contents and Other Information
What Sinecod Tosse Sedativo contains
Sinecod Tosse Sedativo Oral Drops
- The active ingredient is citrated butamirate. 1 g of solution (equivalent to 20 drops) contains 2 mg of citrated butamirate (equivalent to approximately 1.3 mg of butamirate).
- The other components are glycerol, sucrose, anethole, vanillin, 96 percent ethanol, methyl parahydroxybenzoate, purified water.
Sinecod Tosse Sedativo Syrup
- The active ingredient is citrated butamirate. 100 g of syrup contain 34.5 mg of citrated butamirate (equivalent to approximately 21.3 mg of butamirate).
- The other components are citric acid, glycerol, sorbitol, anethole, vanillin, methyl parahydroxybenzoate, ethanol, purified water.
Sinecod Tosse Sedativo Lozenges
- The active ingredient is citrated butamirate. Each lozenge contains 5 mg of citrated butamirate (equivalent to approximately 3.1 mg of butamirate).
- The other components are isomalt, mint essence, levomenthol, acesulfame potassium, neohesperidin dihydrochalcone, mixture of vegetable oils and fats and corn starch.
Description of the appearance of Sinecod Tosse Sedativo and package contents
Sinecod Tosse Sedativo oral drops
Each package of Sinecod Tosse Sedativo 2 mg/ml oral drops, solution contains a dropper bottle of 15 or 20 ml with a safety cap.
Sinecod Tosse Sedativo syrup
Each package of Sinecod Tosse Sedativo 3 mg/10 g syrup contains a 125 ml or
200 ml bottle of syrup with a safety cap and graduated measuring cup.
Sinecod Tosse Sedativo lozenges
Each package of Sinecod Tosse Sedativo 5 mg lozenges contains 18 lozenges in blisters.
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare S.r.l. Via Zambeletti s.n.c. Baranzate (MI)
Manufacturer
Sinecod Tosse Sedativo oral drops and Sinecod Tosse Sedativo syrup
Novartis Farma S.p.A.
Via Provinciale Schito n. 131
Torre Annunziata (NA)
Or
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG,
Barthstraße 4,
80339, Munich (Germany)
Sinecod Tosse Sedativo lozenges
Luigi Zaini S.p.A.
Pharmaceutical workshop located in via C. Imbonati
Milan
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- Kraj rejestracji
- Postać farmaceutycznaOral drops, solution, 2 MG/ML
- Kod ATCR05DB13
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki SINEKOD TOSSE SEDATIVOPostać farmaceutyczna: Syrup, 1,7 MG/5 MLSubstancja czynna: butamirateProducent: COOPER CONSUMER HEALTH B.V.Bez receptyPostać farmaceutyczna: Oral solution, 2.13 MG/MLSubstancja czynna: pentoxyverineProducent: OPELLA HEALTHCARE ITALY S.R.L.Bez receptyPostać farmaceutyczna: Oral suspension, 708/100 MLSubstancja czynna: cloperastineProducent: AESCULAPIUS FARMACEUTICI SRLBez recepty
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SINEKOD TOSSE SEDATIVO nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w SINEKOD TOSSE SEDATIVO jest butamirate. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
SINEKOD TOSSE SEDATIVO jest produkowany przez HALEON ITALY S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie SINEKOD TOSSE SEDATIVO jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić SINEKOD TOSSE SEDATIVO w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (butamirate) to m.in. FROBEN TOSSE SEKKA, BISOLSEK, KLOEL. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
