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Maximum allowed state defined price ( from ZVA webpage) Euro: | | Recheck | Vendor, principal: Divapharma. No prescription needed/Patient care products, dressings, gloves, medical devices,...
* This table was compiled fully automatically, independently from any advertisers, transparently and without any modification relaying the open offers available on the mentioned dates. . NEO-BRONCHOL 15MG N20
Package leaflet: Information for the user
Neo-Bronchol, 15 mg throat pastilles Ambroxol hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always use 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.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 4-5 days.
What is in this leaflet
1. What Neo-Bronchol is and what it is used for
2. What you need to know before you use Neo-Bronchol
3. How to use Neo-Bronchol
4. Possible side effects
5. How to store Neo-Bronchol
6. Contents of the pack and other information
1. What Neo-Bronchol is and what it is used for
Neo-Bronchol pastilles loosen mucus in the airways.
Indication: Loosening of mucus.
2. What you need to know before you use Neo-Bronchol Do not use Neo-Bronchol pastilles:
- if you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6).
- if you have hereditary fructose intolerance.
Children
Due to large quantity of active substance, Neo-Bronchol pastilles are not suitable for children under 6 years. If necessary, formulations with smaller quantity of active substance such as syrups/juices are available for this age group.
Warnings and precautions
Severe skin reactions have been reported when using ambroxol. If you develop rash (incl. ulcers on mucous membranes, e.g. mouth, throat, nose, eyes, genitals), discontinue using Neo-Bronchol and immediately contact your doctor.
Patients with impaired renal function or severe hepatic failure
In patients with impaired renal function or severe hepatic failure, Neo-Bronchol should be used with caution (such as lower doses or longer administration interval). See section 3.
In patients with severe renal failure, the ambroxol metabolites produced in liver may accumulate in the body.
If the motoric function of the bronchi is disturbed or extremely large quantity of secretion is produced (such as in rare malignant ciliary syndrome), use Neo-Bronchol with caution due to risk of accumulation of mucus.
Other medicines and Neo-Bronchol
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Using Neo-Bronchol in combination with medicinal products that inhibit the cough may cause dangerous accumulation of mucus due to the suppression of cough reflex. Therefore, these medicines can be used in combination with Neo-Bronchol only in extreme need.
Neo-Bronchol with food and drink
Pastilles are taken after a meal and sucked.
Drinking plenty of fluids increases the mucus-loosening effect of Neo-Bronchol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy (primarily first trimester) and breast-feeding, Neo-Bronchol pastilles can be used only by doctor’s recommendation and based on risk/benefit evaluation, because the experience with this medicine in humans is not sufficient.
In animals, ambroxol is excreted in breast milk. As relevant experience in humans is insufficient, Neo-Bronchol can be used during breast-feeding only by doctor’s recommendation.
Driving and using machines
There have been no reports on ability to drive and use machines.
Neo-Bronchol contains sorbitol
Neo-Bronchol contains sorbitol. Use of this medicine in adults and adolescents with congenital fructose intolerance is associated with a risk to health. Such patients may use this medicine only after consulting with a doctor.
Note for patients with diabetes: one pastille contains 922.2 mg non-crystalline solid matter of 70% sorbitol (corresponds to approximately 0.08 bread units).
3. How to use Neo-Bronchol
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Children from 6 to 12 years:
Administer (suck) one pastille 2...3 times a day (equivalent of 15 mg ambroxol hydrochloride 2...3 times a day).
Adults and children 12 years and older:
In the first 2...3 days administer 2 pastilles three times a day (equivalent of 30 mg ambroxol hydrochloride three times a day) and from there on 2 pastilles twice a day (equivalent of 30 mg ambroxol hydrochloride twice a day). Pastilles must be sucked.
Adults: At doctor’s recommendation, you may administer 4 pastilles at once, twice a day (equivalent of 120 mg ambroxol hydrochloride a day) to achieve maximum benefit.
Do not administer Neo-Bronchol longer than 4...5 days unless so prescribed by doctor.
If you have renal impairment or severe liver disease, administer Neo-Bronchol at lower doses or at longer intervals. See section 2.
If you feel that the effect of Neo-Bronchol is too strong or too weak, talk to your doctor or pharmacist.
If you use more Neo-Bronchol than you should
There have been no signs of intoxication resulting from Ambroxol overdose. There have been reports on short-term restlessness and diarrhoea.
Administration of extremely high doses may increase salivation and cause emetic irritation, vomiting and decrease in blood pressure.
Consult your doctor. First aid measures such as induction of emesis and gastral lavage are not usually required and they should be used only in the case of large overdose. Symptomatic treatment is recommended.
If you forget to use Neo-Bronchol
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immune system disorders:
Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions.
Not known (frequency cannot be estimated from the available data): anaphylactic reactions, incl. anaphylactic shock, angioedema (rapid swelling of the dermis, subcutaneous tissue, mucosa and submucosal tissue) and pruritus.
Gastrointestinal disorders:
Uncommon (may affect up to 1 in 100 people): nausea, abdominal pain, vomiting.
Skin and subcutaneous tissue disorders:
Rare (may affect up to 1 in 1,000 people): rash, hives.
Not known (frequency cannot be estimated from the available data): severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome/ toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
General disorders and administration site conditions:
Uncommon (may affect up to 1 in 100 people): fever.
Stop taking Neo-Bronchol as soon as the first allergic reactions occur. Inform your doctor, who will decide if you need further therapeutic measures based on the severity of such reactions.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Neo-Bronchol
Do not store above 30 °C. Store in the original package, protected from humidity. Keep this medicine out of the sight and reach of children.
Do not use Neo-Bronchol pastilles after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Neo-Bronchol contains
- The active substance is ambroxol hydrochloride. One pastille contains 15 mg of ambroxol hydrochloride.
- Excipients are sorbitol solution (non-crystallised), acacia, peppermint oil, eucalypt oil, saccharin sodium dihydrate, liquid paraffin, purified water.
What Neo-Bronchol looks like and contents of the pack
Light brown flat-faced round pastilles, approximate diameter 18 mm, blister pack.
Original pack contains 20 pastilles.
Marketing Authorisation Holder and Manufacturer
Divapharma GmbH Motzener Straße 41 D-12277 Berliin Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
H.Abbe Pharma GmbH Pirita tee 20T Tallinn 10127 Phone: +372 646 0980
This leaflet was last revised in April 2016.
Instruction, annotation source for medicine: State Agency of Medicines, Estonia • Medicaments images are for illustrative purposes only and may differ from the actual product.
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DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health
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