TUSSEVAL 4 mg /5 Ml Syrop
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Treść ulotki
TUSSEVAL MUCOLITICO 4 mg/5 ml syrup
Bromexine hydrochloride
Read this leaflet carefully before taking/giving this medicine to your child
because it contains important information for you.
Always take/give this medicine to your child exactly as described in this leaflet or
as your doctor or pharmacist has told you to do.
- 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 is TUSSEVAL MUCOLITICO and what it is used for
- 2. What you need to know before taking/giving TUSSEVAL MUCOLITICO to your child
- 3. How to take/give TUSSEVAL MUCOLITICO to your child
- 4. Possible side effects
- 5. How to store TUSSEVAL MUCOLITICO
- 6. Contents of the pack and other information
1. What is TUSSEVAL MUCOLITICO and what is it used for?
TUSSEVAL MUCOLITICO contains the active ingredient bromhexine hydrochloride, which belongs to the group
of mucolytic drugs and works by fluidifying viscous mucus deposits in the respiratory tract,
thus facilitating their elimination.
TUSSEVAL MUCOLITICO is used to treat alterations of secretions (for example, the presence
of cough and phlegm) in acute and chronic respiratory diseases in adults, adolescents and children
from 2 years of age.
See a doctor if you do not feel better or if you feel worse after a short period of
treatment.
2. What you need to know before taking/giving TUSSEVAL MUCOLITICO to your child
Do not take/give TUSSEVAL MUCOLITICO to your child
- if you/your child is allergic to bromexine or any of the other ingredients of this medicine (listed in section 6).
- In case of breastfeeding (see section 2 “Pregnancy and breastfeeding”).
- In case of children under 2 years of age.
Warnings and precautions
Consult your doctor or pharmacist before taking/giving TUSSEVAL to your child:
MUCOLITICO:
- if you/your child suffers 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/your child has/has had stomach and/or intestinal lesions (gastroduodenal ulcer).
Cases of severe skin reactions associated with the administration of bromexine hydrochloride have been reported.
If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking bromexine hydrochloride and consult your doctor immediately.
These reactions may be symptoms of serious skin diseases characterized by skin peeling and severe toxic skin reaction (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. Furthermore, in the early stages of Stevens Johnson syndrome or toxic epidermal necrolysis (NET), 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 to undertake symptomatic treatment with a cough and cold therapy.
Treatment with TUSSEVAL MUCOLITICO syrup involves an increase in bronchial secretion (this promotes expectoration). Do not use/give to the child for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor.
In patients with gastroduodenal ulcer, its use is recommended only after consulting a doctor.
It is advisable to consult your doctor also in cases where these disorders have manifested in the past.
Children
Donot give this medicine to children under 2 years of age (see section “Do not use TUSSEVAL MUCOLITICO”).
Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the ability to drain bronchial mucus is limited in this age group, due to the physiological characteristics of the airways.
Other medicines and TUSSEVAL MUCOLITICO
No interactions with other medicines have been reported.
Tell your doctor or pharmacist if you/your child is taking, has recently taken or might take any other medicine.
TUSSEVAL MUCOLITICO with food and drinks
Take/give TUSSEVAL MUCOLITICO to your child 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 TUSSEVAL MUCOLITICO if you are pregnant (see section 2. “Warnings and precautions”). TUSSEVAL MUCOLITICO should be used after consulting your doctor and evaluating with him the risk/benefit ratio in your case.
Breastfeeding
TUSSEVAL MUCOLITICO should not be used during breastfeeding (see section 2. “Do not take TUSSEVAL MUCOLITICO”).
Fertility
Based on preclinical experience, there is no indication of possible effects on fertility following the use of bromexine.
Driving and operating machinery
No studies have been conducted on the effects of bromexine hydrochloride on the ability to drive vehicles and operate machinery.
TUSSEVAL MUCOLITICO contains sorbitol, alcohol, sodium and benzoic acid
TUSSEVAL MUCOLITICO contains 4 g of sorbitol per dose equivalent to 10 ml, which are equivalent to 400 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before you (or the child) take this medicine. It may cause gastrointestinal problems and have a mild laxative effect.
TUSSEVAL MUCOLITICO contains 290 mg of alcohol (ethanol) in 10 ml, which are equivalent to 29 mg/ml. The amount in 10 ml of this medicine is equivalent to less than 0.5 ml of beer or 1.25 of wine. The small amount of alcohol in this medicine will not produce significant effects.
TUSSEVAL MUCOLITICO contains 20 mg of benzoic acid per dose equivalent to 2 mg/ml.
TUSSEVAL MUCOLITICO contains less than 1 mmol (23 mg) of sodium per 10 ml, i.e. essentially “sodium-free”.
3. How to take/give TUSSEVAL MUCOLITICO to your child
Take/give this medicine to your child following the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The package contains a measuring cup to facilitate dose calculation, with markings at 2.5 ml, 5 ml and 10 ml.
The recommended dose is as follows:
Adults:
Unless otherwise prescribed by your doctor, the recommended dose is 5-10 ml three times a day.
In adults, at the beginning of treatment, it may be necessary to increase the total daily dose up to 48 mg (60 ml) divided into three times.
Children over 2 years of age:
Unless otherwise prescribed by your doctor, the recommended dose is 2.5–5 ml three times a day.
Do not exceed the recommended doses.
It is advisable to take the medicine after meals.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.
Use only for short periods of treatment.
Administer orally.
If you take/give your child too much TUSSEVAL MUCOLITICO
In case of accidental ingestion of an excessive dose of TUSSEVAL MUCOLITICO, immediately notify your doctor or go to the nearest hospital because symptomatic treatment is necessary
If you forget to take/give TUSSEVAL MUCOLITICO to your child
Do not take/give your child a double dose to make up for a missed dose.
If you stop the treatment with TUSSEVAL MUCOLITICO
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 following the use of TUSSEVAL MUCOLITICO:
Uncommon (may affect up to 1 in 100 people)
- nausea, vomiting, diarrhoea and upper abdominal pain; Rare: may affect up to 1 in 1,000:
- Hypersensitivity reactions.
- skin rash, urticaria (appearance of red spots on the skin); Not known: frequency cannot be estimated based on the available data
- Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, 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 (bronchospasm).
In such cases, discontinue treatment. These side effects are generally transient.
However, when they occur, it is advisable to consult your doctor or pharmacist.
Reporting of side effects
If you/your child experiences any side effects, including those not listed in
this leaflet, please inform your doctor, pharmacist or nurse. 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 to provide more information on the safety of this medicine.
5. How to store TUSSEVAL MUCOLITICO
This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use/do not give this medicine to your child after the expiry date which is reported on the
package after Exp. The expiry date indicated refers to the product in intact packaging,
correctly stored.
After the first opening of the bottle, the medicine must be consumed within 9 months, if the
medicine is stored at a temperature below 25°C; after this period, any excess product must be
discarded.
It is important to always have the information about the medicine available, therefore keep both
Do not dispose of any medicine in drains 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 TUSSEVAL MUCOLITICO contains
- The active ingredient is bromhexine. 5 ml of syrup contains 4 mg of bromhexine hydrochloride (equivalent to 3.65 mg bromhexine). (5 ml contains 4 mg bromhexine hydrochloride). The other components are: tartaric acid, benzoic acid, sodium carboxymethylcellulose, glycerol, liquid sorbitol, ethanol (96%), all fruit flavour, sodium hydroxide, purified water. (see paragraph 2. “TUSSEVAL MUCOLITICO contains”)
Description of the appearance of TUSSEVAL MUCOLITICO and contents of the pack
TUSSEVAL MUCOLITICO is presented in syrup form.
It is available in a pack containing 1 dark glass bottle of 250 ml with a measuring cup.
Marketing Authorisation Holder
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38
36100 Vicenza
Manufacturer
ABC FARMACEUTICI S.P.A. – Canton Moretti, 29 – 10090 San Bernardo D’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 TUSSEVAL MUKOLITIKOPostać 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
TUSSEVAL MUKOLITIKO 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 TUSSEVAL MUKOLITIKO jest bromhexine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
TUSSEVAL MUKOLITIKO jest produkowany przez MARCO VITI FARMACEUTICI S.P.A.. 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 TUSSEVAL MUKOLITIKO 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 TUSSEVAL MUKOLITIKO 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.
