BRONCHIPRET FILM-COATED TABLETS
Ask a doctor about a prescription for BRONCHIPRET FILM-COATED TABLETS
How to use BRONCHIPRET FILM-COATED TABLETS
Introduction
Package Leaflet: Information for the Patient
Bronchipret Film-Coated Tablets
Dry Extract of Primula
Dry Extract of Thyme
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.
- Keep this package leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
- You should consult a doctor if your symptoms worsen or do not improve after 1 week.
Contents of the Package Leaflet
- What is Bronchipret and what is it used for
- What you need to know before taking Bronchipret
- How to take Bronchipret
- Possible side effects
- Storage of Bronchipret
- Package Contents and Additional Information
1. What is Bronchipret and what is it used for
Bronchipret is a herbal-based medication used in cases of productive cough to facilitate the expectoration of mucus.
2. What you need to know before taking Bronchipret
Do not take Bronchipret:
- if you are allergic to the active substances, to other plants of the Lamiaceae family, or to any of the other components of this medication (listed in section 6).
Warnings and Precautions
Consult your doctor or pharmacist before starting to take Bronchipret:
- if you have shortness of breath, fever, or purulent sputum;
- if you suffer from gastritis or gastric ulcer;
- if symptoms worsen during medication use.
Children and Adolescents
The use of Bronchipret in children and adolescents under 18 years of age has not been established due to a lack of adequate data on its efficacy.
Taking Bronchipret with Other Medications
No clinical interaction studies have been conducted.
Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
Pregnancy and Breastfeeding
Safety during pregnancy has not been established.
Due to a lack of sufficient data, the use of Bronchipret during pregnancy is not recommended.
It is unknown whether the active substances or metabolites of Bronchipret are excreted in breast milk. Therefore, Bronchipret should not be used during the breastfeeding period.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
Driving and Using Machines
No studies have been conducted on the ability to drive and use machinery.
Bronchipret Contains Glucose and Lactose
If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medication.
Bronchipret Contains Sodium
This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".
3. How to Take Bronchipret
Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.
The Recommended Dose is:
Adults: 1 tablet 3 times a day (maximum, 3 tablets per day).
Take Bronchipret without chewing before meals and with sufficient liquid (preferably, a glass of water).
If symptoms persist for more than 1 week during medication use, you should consult a doctor or a qualified healthcare professional.
There is not enough data to recommend dosage in patients with reduced renal or hepatic function.
Use in Children and Adolescents
The use of Bronchipret in children and adolescents under 18 years of age is not recommended (see section 2).
If You Take More Bronchipret Than You Should
No cases of overdose have been reported.
An overdose could cause discomfort, vomiting, or diarrhea.
Inform your doctor if you have taken more Bronchipret than you should. Your doctor will decide on the necessary measures.
If You Forget to Take Bronchipret
Do not take a double dose to make up for the forgotten dose, but continue taking Bronchipret as prescribed by your doctor or as described in this package leaflet.
If You Stop Taking Bronchipret
Generally, stopping treatment with Bronchipret is harmless.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medications, this medication can cause side effects, although not everyone will experience them.
Uncommon side effects (may affect up to 1 in 100 people):
Gastrointestinal disorders, such as cramps, nausea, vomiting, and diarrhea.
Very rare side effects (may affect up to 1 in 10,000 people)
Hypersensitivity reactions, such as shortness of breath, rash, urticaria, and swelling of the face, mouth, or throat.
In the event of observing the first symptoms of a hypersensitivity reaction, do not take Bronchipret again.
Reporting Side Effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Bronchipret
Do not store above 25°C.
Keep the blisters in the original package to protect from light and moisture.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.
6. Package Contents and Additional Information
Composition of Bronchipret
- The active substances are 60 mg of extract (as dry extract) of Primula veris L./Primula elatior (L.) Hill, radix (primula root) (6-7:1). Extraction solvent: Ethanol 47.4% (V/V).
160 mg of extract (as dry extract) of Thymus vulgarisL./Thymus zygisL., herba (thyme) (6-10:1). Extraction solvent: Ethanol 70% (V/V).
- The other components are: microcrystalline cellulose, lactose monohydrate, spray-dried glucose liquid, colloidal anhydrous silica, 30% polyacrylate dispersion, crospovidone, hypromellose, talc, povidone K 25, magnesium stearate, titanium dioxide (E171), propylene glycol, peppermint flavor (contains gum arabic, maltodextrin, lactose), copper chlorophyllin E141 (contains glucose syrup), sodium saccharin, simethicone, dimethicone, riboflavin (E101).
Appearance of the Product and Package Contents
The film-coated tablets are green, round, and biconvex with a semi-matte surface. The film-coated tablet has a diameter of 10.1 to 10.3 mm.
Bronchipret is presented in PVC/PVDC/aluminum blisters.
It is available in the following package sizes:
20 tablets
50 tablets
100 tablets
Not all package sizes may be marketed.
Marketing Authorization Holder and Manufacturer
BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Germany
Tel.: +49 (0)9181 231-90
Fax: +49 (0)9181 231-265
E-mail: [email protected]
This medication is authorized in EEA member states under the following names:
Austria, Bulgaria, Croatia, Germany, Luxembourg, Netherlands, Norway, Slovenia, | Bronchipret TP |
Estonia, Finland, France, Latvia, Denmark, Lithuania, Sweden | Mucopret |
Poland | Bronchitabs |
Romania | Mucopret film-coated tablets |
Spain | Bronchipret film-coated tablets |
Slovakia | Mucopret film-coated tablets |
Date of the Last Revision of this Package Leaflet: October 2022
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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