Sinecod cough sedative
Italy
Table of Contents
Package leaflet: Information for the patient
Sinecod Cough Suppressant 2 mg/ml oral drops, solution, 3 mg/10 g syrup, 5 mg tablets
butamirate
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.
Contents of this leaflet:
- What Sinecod Cough Suppressant is and what it is used for
- What you need to know before taking Sinecod Cough Suppressant
- How to take Sinecod Cough Suppressant
- Possible side effects
- How to store Sinecod Cough Suppressant
- Contents of the pack and other information
1. What Sinecod Cough Sedative is and what it is used for
Sinecod Cough Sedative contains the active substance butamirate, which reduces the urge to cough.
Sinecod Cough Sedative is indicated as a cough suppressant.
Consult your doctor if you do not feel better or if you feel worse after 7 days, or if your cough persists for more than 7 days and is accompanied by fever, difficulty breathing, or chest pain.
2. What you need to know before taking Sinecod Cough Suppressant
Do not take Sinecod Cough Suppressant 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 Cough Suppressant 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
Talk to your doctor or pharmacist before taking Sinecod Cough Suppressant.
Consult your doctor before taking this medicine:
- if you have kidney and/or liver impairment.
Do not use Sinecod Cough Suppressant if you are taking medicines that promote mucus elimination (expectorants) (see section "Other medicines and Sinecod Cough Suppressant").
Children and adolescents
Sinecod Cough Suppressant tablets must not be administered to children under 12 years of age.
Sinecod Cough Suppressant syrup and oral drops must not be administered to children under 6 years of age.
Other medicines and Sinecod Cough Suppressant
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No studies have been conducted on the possible interactions between Sinecod Cough Suppressant and other medicines.
Do not take Sinecod Cough Suppressant if you are using medicines that promote mucus elimination (expectorants), as this may lead to mucus accumulation in the airways, which could cause bronchospasm (narrowing of the bronchi) and respiratory tract infections.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Sinecod Cough Suppressant during the first three months of pregnancy.
During the second and third trimesters of pregnancy, Sinecod Cough Suppressant may be used only if strictly necessary.
Breastfeeding
It is not known whether Sinecod Cough Suppressant passes into breast milk. Consult your doctor before taking this medicine if you are breastfeeding.
Driving and using machines
Sinecod Cough Suppressant may rarely cause drowsiness; therefore, exercise caution if you need to drive or operate machinery.
Sinecod Cough Suppressant oral drops contains ethanol, methyl parahydroxybenzoate and sucrose
This medicine contains 5.1 mg of alcohol (ethanol) per 1 ml, 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 intolerance to certain sugars, contact him or her before taking this medicine.
Sinecod Cough Suppressant syrup contains ethanol, methyl parahydroxybenzoate and sorbitol
This medicine contains 4.35 mg of alcohol (ethanol) per 1 ml, 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 (pediatric dose) and 4314 mg per 15 ml (adult dose), equivalent to 287.6 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine. It may cause gastrointestinal problems and has a mild laxative effect.
3. How to take Sinecod Cough Sedative
Take this medicine exactly as stated in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses.
Respect the recommended time intervals between doses.
Do not take Sinecod Cough Sedative for prolonged periods; take this medicine only when you have symptoms.
Consult your doctor immediately if coughing persists for more than 7 days and is accompanied by fever, difficulty breathing, or chest pain.
Sinecod Cough Sedative oral drops
Take the drops with some water or milk.
Use in adults
The recommended dose is 40 drops every 6–8 hours.
Use in children aged 6 to 12 years
The recommended dose is 20 drops every 6–8 hours.
Sinecod Cough Sedative syrup
Take the syrup using the dosing cup provided in the package.
After swallowing, you may drink water or other liquids if needed.
Wash and dry the dosing cup thoroughly each time it is used, especially if used by more than one person.
Use in adults
The recommended dose is 15 ml every 6–8 hours.
Use in children aged 6 to 12 years
The recommended dose is 10 ml every 6–8 hours.
Sinecod Cough Sedative 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 may take 2 tablets consecutively before going to sleep for a prolonged effect during the night.
Use in adolescents over 12 years of age
The recommended dose is 1 tablet every 12 hours.
How to open and close the bottle
Opening
Press the cap downwards and unscrew to the left.
Closing
Screw the cap fully to the right.
If you take more Sinecod Cough Sedative than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
If you have taken an excessive dose of Sinecod Cough Sedative, you may experience: drowsiness, nausea, vomiting, diarrhoea, dizziness, and low blood pressure.
If you forget to take Sinecod Cough Sedative
Do not take a double dose to make up for the missed dose.
If you stop taking Sinecod Cough Sedative
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Rare side effects (may affect up to 1 in 1,000 people)
- dizziness
- somnolence
- nausea
- diarrhoea
- urticaria
Side effects with unknown frequency (the frequency cannot be estimated from the available data)
- hypersensitivity reactions
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via 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 Cough Suppressant
Sinecod Cough Suppressant oral drops and syrup
This medicine does not require any special storage conditions.
Sinecod Cough Suppressant tablets
Do not store 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the packaging and the leaflet.
6. Package contents and other information
What Sinecod Cough Suppressant contains
Sinecod Cough Suppressant oral drops
- The active substance is butamirate citrate. 1 g of solution (equivalent to 20 drops) contains 2 mg of butamirate citrate (corresponding to approximately 1.3 mg of butamirate).
- The other components are: glycerol, sucrose, anethole, vanillin, ethanol 96 percent, methyl p-hydroxybenzoate, purified water.
Sinecod Cough Suppressant syrup
- The active substance is butamirate citrate. 100 g of syrup contain 34.5 mg of butamirate citrate (corresponding to approximately 21.3 mg of butamirate).
- The other components are: citric acid, glycerol, sorbitol, anethole, vanillin, methyl p-hydroxybenzoate, ethanol, purified water.
Sinecod Cough Suppressant lozenges
- The active substance is butamirate citrate. Each lozenge contains 5 mg of butamirate citrate (corresponding to approximately 3.1 mg of butamirate).
- The other components are: isomalt, peppermint essence, levomenthol, acesulfame potassium, neohesperidin dihydrochalcone, mixture of vegetable oils and fats, and maize starch.
Description of the appearance of Sinecod Cough Suppressant and package contents
Sinecod Cough Suppressant oral drops
Each package of Sinecod Cough Suppressant 2 mg/ml oral drops, solution contains a dropper bottle of 15 or 20 ml with child-resistant cap.
Sinecod Cough Suppressant syrup
Each package of Sinecod Cough Suppressant 3 mg/10 g syrup contains a 125 ml or 200 ml bottle of syrup with child-resistant cap and graduated oral dosing device.
Sinecod Cough Suppressant lozenges
Each package of Sinecod Cough Suppressant 5 mg lozenges contains 18 lozenges in blister packs.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan
Manufacturer
Sinecod Cough Suppressant oral drops and Sinecod Cough Suppressant syrup
Haleon Germany GmbH,
Barthstraße 4,
80339 Munich (Germany)
Sinecod Cough Suppressant lozenges
Luigi Zaini S.p.A.
Pharmaceutical plant located at via C. Imbonati
Milan
Or
Haleon Germany GmbH,
Barthstraße 4,
80339 Munich (Germany)