FROBEN 4 mg /5 Ml Syrop
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Treść ulotki
Froben Tosse Grassa 4 mg/5 ml syrup
bromexine hydrochloride
Equivalent Medicinal Product
Read this leaflet carefully before 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.
- See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.
Contents of this leaflet:
- 1. What Froben Tosse Grassa is and what it is used for
- 2. What you need to know before you take Froben Tosse Grassa
- 3. How to take Froben Tosse Grassa
- 4. Possible side effects
- 5. How to store Froben Tosse Grassa
- 6. Contents of the pack and other information
1. What is Froben Tosse Grassa and what is it for
Froben Tosse Grassa contains the active ingredient bromhexine. Bromhexine is a substance capable of
fluidizing the mucus that stagnates in the respiratory tract. This promotes the expulsion of mucus from the
respiratory tract and consequently makes breathing easier.
Froben Tosse Grassa is therefore indicated in the symptomatic treatment of productive cough and in secretion disorders during acute and chronic respiratory diseases (such as bronchitis).
2. What you need to know before taking Froben Tosse Grassa
Do not take/administer Froben Tosse Grassa
- if you are allergic to bromhexine or any of the other ingredients of this medicine (listed in section 6)
- if you are breastfeeding (see section 2 “Pregnancy, breastfeeding and fertility”)
- if the person who is to take the medicine is a child under 2 years of age.
Warnings and precautions
Consult your doctor or pharmacist before taking Froben Tosse Grassa:
- if you suffer from a respiratory disease that occurs and worsens in a relatively short period of time (acute respiratory conditions). Consult your doctor if symptoms do not improve or worsen during therapy;
- if you are pregnant (see section 2 “Pregnancy, breastfeeding and fertility”);
- if you suffer from injuries to the stomach or intestines (ulcers).
Cases of severe skin reactions associated with the administration of bromhexine have been reported. If you develop
a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop
taking Froben Tosse Grassa and consult your doctor immediately.
These reactions may be symptoms of serious skin diseases characterized by peeling of the
skin and a severe toxic reaction of the skin (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis).
Most of these may be due to pre-existing serious illnesses or the concurrent use of
other drugs.
In addition, in the early stages of Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN),
you may experience non-specific symptoms similar to those of the flu, such as fever, chills,
runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, it is possible that you will undertake a
symptomatic treatment with a cough and cold therapy.
Treatment with Froben Tosse Grassa involves an increase in bronchial secretion (this promotes
expectoration).
Take/administer this medicine for short periods.
Children
Donot give this medicine to children under 2 years of age. Mucolytics, such as Froben Tosse Grassa,
can cause bronchial obstruction due to the physiological characteristics of children in this age group.
Othermedicinesand Froben Tosse Grassa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
There is no information on the interaction between Froben Tosse Grassa and other medicines.
Froben Tosse Grassa with food
Take/administer Froben Tosse Grassa after meals.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect 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
As a precaution, it is preferable to avoid taking this medicine if you are pregnant. Take
this medicine only after consulting your doctor.
Breastfeeding
Do not take Froben Tosse Grassa while breastfeeding as bromhexine passes into breast milk.
Fertility
Based on preclinical experience, there is no indication of possible effects of bromhexine on fertility.
Driving and operating machinery
Froben Tosse Grassa does not affect the ability to drive vehicles and operate machinery.
Froben Tosse Grassa containsin each maximum dose (20 ml):
- 40 mg of benzoic acid equivalent to 0.73 mg/kg;
- less than 23 mg of sodium, i.e. essentially “sodium-free”;
- 11.43 g of sorbitol equivalent to 207.8 mg/kg. 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;
- 576 mg of alcohol (ethanol) which is equivalent to 10.47 mg/kg. The volume amount of this medicine is equivalent to less than 15 ml of beer or 6 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
3. How to take Froben Tosse Grassa
Take/administer this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1-2 teaspoons (5-10 ml) 3 times a day. Your doctor may decide to increase
your dose at the beginning of treatment.
Children over 2 years
The recommended dose in children over 2 years is half a teaspoon/1 teaspoon (2.5–5 ml) 3 times a
day.
Method of administration
Oral use.
Take/administer the medicine after meals.
Avoid exceeding the recommended doses and taking this medicine for long periods.
If you do not notice any improvement or if you notice a worsening of symptoms after a short period of treatment, consult
your doctor.
This medicine can be taken by children over 2 years and by diabetics because it does not contain fructose and
sucrose.
If you take more Froben Tosse Grassa than you should
If you (or someone else) have ingested an excessive amount of syrup, or if you think a child has
ingested the medicine, consult a doctor immediately.
In case of accidental ingestion/taking of an excessive dose of Froben Tosse Grassa, immediately notify
your doctor or go to the Emergency Room of the nearest hospital.
Bring this leaflet, the bottle and its container to the hospital or doctor so they know
which medicine was consumed.
If you forget to take Froben Tosse Grassa
If you forget to take/administer a dose of the medicine, take it as soon as you remember, unless
it is almost time to take the next dose. Do not take/administer a double dose to compensate
for the missed dose.
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.
The following side effects may occur with the use of Froben Tosse Grassa:
Uncommon(may affect up to 1 in 100 people)
- diarrhoea, nausea, vomiting and upper abdominal pain Rare(may affect up to 1 in 1,000)
- hypersensitivity reactions
- skin rash (rash), urticaria (appearance of red spots on the skin) Not known(frequency cannot be estimated based on available data)
- anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching
- severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)
- narrowing of the bronchi making breathing difficult (obstruction)
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 Froben Tosse Grassa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the bottle after “Scad.”. The expiry
date refers to the last day of that month.
After first opening the bottle, the product must be consumed within 9 months, if the product is
stored at a temperature below 25°C; after this time, any excess product must be discarded.
Remember to note the date of first opening on the packaging.
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 Froben Tosse Grassa contains
- The active ingredient is bromhexine hydrochloride. 5 ml of syrup contains 4 mg of bromhexine hydrochloride (equivalent to 3.65 mg of bromhexine).
- The other ingredients are: tartaric acid, benzoic acid, sodium carboxymethylcellulose, glycerol, liquid sorbitol, ethanol (96%), all fruit flavour, sodium hydroxide, purified water.
Description of the appearance of Froben Tosse Grassa and contents of the pack
Froben Tosse Grassa is presented in syrup form. The pack contains one 250
ml bottle.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(Netherlands)
Manufacturer
ABC Farmaceutici S.p.A., Canton Moretti 29, Località San Bernardo, 10015 Ivrea (TO)
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- Kraj rejestracji
- Postać farmaceutycznaSyrup, 4 MG/5 ML
- Kod ATCR05CB02
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki FROBEN TOSSE GRASSAPostać farmaceutyczna: Oral solution, 2 MG/MLSubstancja czynna: bromhexineProducent: OPELLA HEALTHCARE ITALY S.R.L.Bez receptyPostać farmaceutyczna: Syrup, 4 MG/5 MLSubstancja czynna: bromhexineProducent: TOWA PHARMACEUTICAL S.P.A.Bez receptyPostać farmaceutyczna: Syrup, 4 MG/5 MLSubstancja czynna: bromhexineProducent: AESCULAPIUS FARMACEUTICI SRLBez recepty
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Często zadawane pytania
FROBEN TOSSE GRASSA 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 FROBEN TOSSE GRASSA jest bromhexine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
FROBEN TOSSE GRASSA jest produkowany przez COOPER CONSUMER HEALTH B.V.. 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 FROBEN TOSSE GRASSA 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 FROBEN TOSSE GRASSA w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (bromhexine) to m.in. BISOLVON, BROMEXINA PENSA, FLUTOXIL. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
