Froben dry cough
Italy
Package leaflet: Information for the patient
FROBEN TOSSE SECCA 1.7 mg/5 ml syrup
butamirate citrate
Equivalent medicine
Read 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 you.
- Keep this leaflet. You may need to read it again.
- If you would like 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 improvement or if your symptoms worsen after 7 days.
Contents of this leaflet:
- What FROBEN TOSSE SECCA is and what it is used for
- What you need to know before taking FROBEN TOSSE SECCA
- How to take FROBEN TOSSE SECCA
- Possible side effects
- How to store FROBEN TOSSE SECCA
- Contents of the pack and other information
1. What FROBEN COUGH DRY is and what it is used for
This medicinal product contains the active substance butamirate which reduces the cough reflex.
FROBEN COUGH DRY is indicated for the symptomatic treatment of dry cough.
Consult your doctor if you do not feel better or feel worse after 7 days, or if the 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 FROBEN DRY COUGH
Do not take FROBEN DRY COUGH
- if you are allergic to butamirate, to substances similar to butamirate, 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
- during the first 3 months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking FROBEN DRY COUGH.
Take this medicine only when necessary and consult your doctor if you have severe kidney problems (severe
renal insufficiency) or severe liver problems (severe hepatic insufficiency).
Do not take medicines that help loosen and expel mucus (expectorants) at the same time as FROBEN DRY COUGH
(see section Other medicines and FROBEN DRY COUGH).
Children
This medicine must not be given to children under 6 years of age.
Other medicines and FROBEN DRY COUGH
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not take expectorant medicines together with FROBEN DRY COUGH because this medicine suppresses coughing, which may lead to mucus buildup in the airways and increase the risk of bronchial problems (bronchospasm) and respiratory infections.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
Pregnancy
Avoid taking FROBEN DRY COUGH during the first three months of pregnancy.
During the rest of pregnancy, take FROBEN DRY COUGH only if strictly necessary.
Breastfeeding
It is not known whether the active substance or its metabolites pass into breast milk.
Do not take FROBEN DRY COUGH while breastfeeding unless advised by your doctor or
pharmacist.
Driving and using machines
This medicine may rarely cause drowsiness. If this occurs, avoid driving or operating machinery.
FROBEN DRY COUGH contains sorbitol and methyl parahydroxybenzoate
FROBEN DRY COUGH syrup contains 5250 mg of sorbitol per dose, equivalent to 95.45 mg/kg.
Sorbitol is a source of fructose. If your doctor has diagnosed you (or the child) with intolerance to certain sugars, or if you have hereditary fructose intolerance—a rare genetic disorder in which patients cannot metabolize fructose—talk to your doctor before taking this medicine.
It may cause gastrointestinal disturbances and has a mild laxative effect.
FROBEN DRY COUGH syrup contains parahydroxybenzoates. These may cause allergic reactions (including delayed reactions).
3. HOW TO TAKE FROBEN TOSSE SECCA
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Take this medicine to treat cough symptoms; if the cough persists for more than 7 days,
or if fever, difficulty breathing, or chest pain occur, consult your doctor. Take this
medicine only when symptoms are present.
The recommended dose for FROBEN TOSSE SECCA syrup is:
Children (6-12 years): 10 ml every 8-6 hours.
Adults: 15 ml every 8-6 hours.
Avoid exceeding the recommended doses or taking this medicine for prolonged periods.
Respect the recommended time intervals between doses.
Take the syrup using the dosing cup provided in the package. After swallowing the
syrup, you may drink water or other liquids. Wash and dry the measuring cup after each use.
If you take more FROBEN TOSSE SECCA than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose of FROBEN TOSSE SECCA may cause the following symptoms: drowsiness,
nausea, vomiting, diarrhoea, dizziness, and low blood pressure.
If you forget to take FROBEN TOSSE SECCA
Do not take a double dose to make up for a forgotten dose.
If you have any questions 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.
The following side effects may occur:
Rare (may affect up to 1 in 1,000 people)
- dizziness
- somnolence
- nausea
- diarrhoea
- skin irritation (urticaria)
- loss or reduction of appetite (anorexia).
Not known (frequency cannot be estimated from the available data)
- hypersensitivity reactions
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 FROBEN COUGH DRY
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What FROBEN TOSSE SECCA contains
FROBEN TOSSE SECCA 1.7 mg/5 ml syrup
The active substance is citrate of butamirate. 100 ml of syrup contain 34.5 mg of butamirate citrate (equivalent
to 21.3 mg of butamirate).
The other components are citric acid, glycerol, sorbitol 70%, vanillin, methyl p-
hydroxybenzoate, purified water.
Description of the appearance of FROBEN TOSSE SECCA and contents of the pack
FROBEN TOSSE SECCA 1.7 mg/5 ml syrup
This medicine is presented as a syrup packed in a bottle with a measuring cup. The pack contains 125 ml of syrup.
Marketing Authorization Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)
Manufacturers
ABC Farmaceutici S.p.A., via Canton Moretti 29, Località San Bernardo, Ivrea (TO), Italy