Pintal 1.5mg/ml Syrup

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

BUTAMIRATE CITRATE

Disponibil de la:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Codul ATC:

R05DB13

INN (nume internaţional):

BUTAMIRATE CITRATE 1.5 mg

Forma farmaceutică:

SYRUP

Compoziție:

BUTAMIRATE CITRATE 1.5 mg

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

COUGH AND COLD PREPARATIONS

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2015-04-13

Prospect

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pintal 1.5 mg/ ml syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of syrup contains 1.5 mg butamirate citrate equivalent to 0.924
mg butamirate.
Excipient with known effect:
1 ml of oral suspension contains 450 mg of sorbitol.
1 ml of oral suspension contains 125 mg of glycerol.
3.
PHARMACEUTICAL FORM
Syrup
Colourless or pale yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of non-productive cough.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
Recommended dose - 15 ml up to 4 times daily
Treatment is limited to the symptomatic period.
Medical advice should be sought if the cough lasts longer than 4-5
days or if fever, dyspnoea
or chest pain develops.
_Patients with renal or hepatic impairment_
Data is lacking in patients with impaired renal or hepatic function.
Patients with renal and/or liver
disease may be at greater risk for adverse effects from butamirate due
to drug and metabolite
accumulation.
Method of administration
Pintalsyrup should be taken orally.
4.3.
CONTRAINDICATIONS
Page 2 of 5
-
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
-
Children and adolescents under 18 years of age.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Before prescribing an antitussive treatment, the causes of the cough
should be investigated to assess
the need for aetiological treatment. If the cough persists after
taking the antitussive treatment at the
usual dose, the dose should not be increased; instead, the clinical
situation should be reviewed.
Antitussives should not be used for prolonged periods.
Due to inhibition of the cough reflex by butamirate, the concomitant
administration of expectorants
must be avoided because this can lead to the stagnation of mucus in
the respiratory tract, increasing
the risk of bronchospasm and respiratory tract infections.
This medicinal product contains sorbitol. Patients with rare
hereditary problems

Caracteristicilor produsului

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pintal 1.5 mg/ ml syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of syrup contains 1.5 mg butamirate citrate equivalent to 0.924
mg butamirate.
Excipient with known effect:
1 ml of oral suspension contains 450 mg of sorbitol.
1 ml of oral suspension contains 125 mg of glycerol.
3.
PHARMACEUTICAL FORM
Syrup
Colourless or pale yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of non-productive cough.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
Recommended dose - 15 ml up to 4 times daily
Treatment is limited to the symptomatic period.
Medical advice should be sought if the cough lasts longer than 4-5
days or if fever, dyspnoea
or chest pain develops.
_Patients with renal or hepatic impairment_
Data is lacking in patients with impaired renal or hepatic function.
Patients with renal and/or liver
disease may be at greater risk for adverse effects from butamirate due
to drug and metabolite
accumulation.
Method of administration
Pintalsyrup should be taken orally.
4.3.
CONTRAINDICATIONS
Page 2 of 5
-
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
-
Children and adolescents under 18 years of age.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Before prescribing an antitussive treatment, the causes of the cough
should be investigated to assess
the need for aetiological treatment. If the cough persists after
taking the antitussive treatment at the
usual dose, the dose should not be increased; instead, the clinical
situation should be reviewed.
Antitussives should not be used for prolonged periods.
Due to inhibition of the cough reflex by butamirate, the concomitant
administration of expectorants
must be avoided because this can lead to the stagnation of mucus in
the respiratory tract, increasing
the risk of bronchospasm and respiratory tract infections.
This medicinal product contains sorbitol. Patients with rare
hereditary problems