Zusammenfassung der Merkmale des Arzneimittels - Bronchovit Filmtabletten
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains
75 mg of extract (as dry extract) from Thymus vulgaris L. or Thymus zygis L., herba (Thyme) (610:1), extraction solvent ethanol 70% V/V and
37.5 mg of extract (as dry extract) from Primula veris L. or Primula elatior Hill., radix (Primula root) (3.5–4.5:1), extraction solvent water.
Excipients with known effect: 15.94 mg glucose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
White to pale yellow, smooth, round, biconvex.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
[Nationally approved name] is a traditional herbal medicinal product used as an expectorant in cough associated with cold.
The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.
[Nationally approved name] is indicated in adolescents from 12 years of age, adults and elderly.
4.2 Posology and method of administration
Posology
Adolescents from 12 years of age, adults and elderly:
1 tablet three times a day.
Paediatric population:
The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
Patients with renal and/or hepatic impairment:
No data are available for a dosing instruction in case of impaired renal/hepatic function.
Method of administration
For oral use.
Duration of use
If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substances or to other plants of the Lamiaceae family or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.
Caution is recommended in patients with gastritis or gastric ulcer.
If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Paediatric population
The use in children under 12 years of age has not been established due to lack of adequate data.
Patients with rare glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of thyme or primula root in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. [Nationally approved name] tablets are not recommended during pregnancy.
Breastfeeding
It is unknown whether constituents or metabolites of thyme or primula root are excreted in human milk.
A risk to newborns/infants cannot be excluded. [Nationally approved name] tablets are not recommended during breast-feeding.
Fertility
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Gastric disorders and nausea may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in.
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended
5.3 Preclinical safety data
5.3 Preclinical safety dataNo signs of genotoxicity were observed in an AMES-test (5 strains of Salmonella typhimurium; TA 98, TA 100, TA 102, TA 1535, TA 1537) with and without metabolic activation using an extract prepared with Primulae aq.siccum and Thymi e herb. spir. sicc.
Adequate tests on reproductive toxicity and carcinogenicity have not been performed.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet core:
Glucose, liquid, spray-dried Silica, colloidal, anhydrous Cellulose, microcrystalline Croscarmellose sodium Sodium stearyl fumarate
Tablet coating:
Hypromellose
Titanium dioxide
Talc
Hydroxypropylcellulose
Macrogol 3350
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Original packages contain 20 tablets. The tablets are packed in PVC/PVDC-aluminium blisters and inserted into a carton together with the package leaflet.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. REGISTRATION HOLDER
[To be completed nationally.]
8. REGISTRATION NUMBER(S)
9. DATE OF FIRST REGISTRATION/RENEWAL OF THE REGISTRATION
Date of first registration:
Mehr Informationen über das Medikament Bronchovit Filmtabletten
Arzneimittelkategorie: traditionelle pflanzliche registrierungen
Suchtgift: Nein
Psychotrop: Nein
Zulassungsnummer: 740460
Rezeptpflichtstatus: Arzneimittel zur Abgabe ohne aerztliche Verschreibung
Abgabestatus: Abgabe durch eine (öffentliche) Apotheke
Inhaber/-in:
Phytopharm Kl?ka S.A., Kl?ka 1, 63-040 Nowe Miasto nad Wart?, Polen