BRONCHO-MUNAL P CPS 3.5MG N30

ATC code: R07AX 

Active substances: Lysatum Bacteriorum Lyophilisatum

Vendor, principal: Lek. 

 Prescription drug (℞) 

BRONCHOSTAD 600MG N10

Package leaflet: Information for the user

Bronchostad, 200 mg effervescent tablets Bronchostad, 600 mg effervescent tablets Acetyl cysteine

Read all of this leaflet carefully before you start using 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.

What is in this leaflet

1.   What Bronchostad is and what it is used for
2.   What you need to know before you use Bronchostad
3.   How to use Bronchostad
4.   Possible side effects
5.   How to store Bronchostad
6.   Contents of the pack and other information

1.   What BRONCHOSTAD is and what it is used for

Bronchostad is a medicine used for loosening phlegm produced in respiratory passages. Bronchostad is used
•   for loosening phlegm in order to thin mucous in patients suffering from an acute bronchial tube or lung disease.

2.   What you need to know before you use BRONCHOSTAD Do not use Bronchostad:

•   if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Severe skin reactions, such as Stevens-Johnson syndrome and Lyell’s syndrome manifesting in temporal correlation with the use of acetylcysteine, the active substance in Bronchostad, have been reported in very rare cases. If new changes occur in the skin or mucous membranes, immediately talk to a doctor and stop using acetylcysteine.
Take special care if you have bronchial asthma or if you have or have ever had a gastric or intestinal ulcer.
Take special care and avoid long-term treatment if you have histamine intolerance, as Bronchostad influences histamine metabolism and may cause certain disturbances (intolerance reactions, such as headache, rhinitis, itching).
Using Bronchostad, especially at the beginning of treatment, may cause mucous to become thinner and an increase in the amount of bronchial secretion. If you are unable to cough out sufficient quantities of phlegm, the doctor will implement suitable measures.

Children and adolescents

Due to large content of the active substance, Bronchostad 200 mg effervescent tablets are not suitable for children under the age of 2.
Due to large content of the active substance, Bronchostad 600 mg effervescent tablets are not suitable for children under the age of 14.

Other medicines and Bronchostad

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interaction tests have been carried out only in adults.
Acetylcysteine/antitussive agents
A combination of acetylcysteine and antitussive medicines causes the risk of secretion retention due to suppressing the cough reflex. Therefore, using this combination should be carefully considered. Ask your doctor if you wish to combine these medicines.
Acetylcysteine/activated carbon
Activated carbon may decrease the effect of acetylcysteine.
Acetylcysteine/antibiotics
Tests have shown that acetylcysteine can weaken the effect of antibiotics (tetracycline, aminoglycosides, penicillin). For safety reasons, antibiotics and Bronchostad should be administered separately with an interval of at least two hours. This does not concern medicines, the active substances of which are cefixime and loracarbef. These may be taken concomitantly with acetylcysteine.
Acetylcysteine/nitroglycerin
The vasodilatory and thrombocyte aggregation inhibiting effect of glycerol trinitrate (nitroglycerin) has been reported to increase in the case of concomitant administration with acetylcysteine.
If concomitant treatment with nitroglycerin and Bronchostad is deemed necessary, the doctor will be monitoring you for a potential drop in blood pressure (hypotension), which may be severe and indicated by headaches.
Changes in laboratory analyses
Acetylcysteine can affect the colorimetric analysis of salicylates.
Acetylcysteine can affect the determination of ketones in urine analyses.
Dissolving Bronchostad with other medicines is not recommended.

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.
Pregnancy
Due to insufficient experience with using acetylcysteine during pregnancy, Bronchostad can be used during pregnancy only if your doctor considers this absolutely necessary.
Breast-feeding
Thus far, no data is available on whether acetylcysteine is excreted in breast milk. Therefore, use Bronchostad during breast-feeding only if your doctor considers this absolutely necessary.

Driving and using machines

Bronchostad has no influence on the ability to drive and use machines.

Bronchostad contains aspartame and sodium

This medicine contains aspartame, which is a source of phenylalanine and can be harmful if you have phenylketonuria.
One 200 mg effervescent tablet contains 8.3 mmol (191 mg) of sodium. Patients on a limited-sodium diet should take this into consideration.
One 600 mg effervescent tablet contains 6.5 mmol (150 mg) of sodium. Patients on a limited-sodium diet should take this into consideration.

3. How to use BRONCHOSTAD

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:

Bronchostad 200 mg:

Age Total daily dose Children aged 2-5 years 1/2 effervescent tablets 2-3 times per day Children and adolescents aged 6-14 years 1 effervescent tablet 2 times per day Adolescents over the age of 14 and adults 1 effervescent tablet 2-3 times per day

In the case of mucoviscidosis:

Age Total daily dose Children aged 2-6 years 1/2 effervescent tablets 4 times per day (corresponds to 400 mg of acetylcysteine) Children over the age of 6 and adolescents 1 effervescent tablet 3 times per day (corresponds to 600 mg of acetylcysteine)

Bronchostad 600 mg:

Adults and adolescents over the age of 14:
V2 effervescent tablets twice per day or 1 effervescent tablet once per day. Note:
Liquid consumption facilitates the mucous thinning effect of acetylcysteine.

Method of administration

Bronchostad effervescent tablets should be taken after a meal.
Dissolve the effervescent tablet in a glass of water and drink the entire mixture.
The tablets can be divided into two equal doses.

Duration of treatment

The duration of the treatment is prescribed by the doctor based on the type and severity of the disease.
In the case of chronic bronchitis and mucoviscidosis, the treatment is extended.
Warning:
The weak sulphur smell emitted during the storage of the medicine is caused by the natural preservation process of the medicine. Until the expiry date has not passed, the smell is harmless and has no effect on the efficiency or tolerability of the medicine.
If you feel that the effect of Bronchostad is too strong or too weak, talk to your doctor or pharmacist.

If you take more Bronchostad than you should

An overdose of acetylcysteine can cause gastrointestinal irritation, such as nausea, vomiting, and diarrhoea. No severe side effects or symptoms of poisoning have been reported in connection with an overdose of acetylcysteine. If overdose symptoms occur, talk to a doctor.

If you forget to take Bronchostad:

If you have forgotten to take a dose of Bronchostad or have taken less medicine than prescribed, continue following your everyday dosage regimen. Do not take a double dose to make up for a forgotten dose.

If you stop taking Bronchostad

Do not stop the treatment without first talking to your doctor, as stopping the treatment can exacerbate your illness.
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.

Side effects are grouped based on incidence as follows:

Very common Affects more than 1 user in 10 Common Affects 1-10 users in 100 Uncommon Affects 1-10 users in 1,000 Rare Affects 1-10 users in 10,000 Very rare Affects less than 1 user in 10,000 Unknown cannot be estimated from available data

Immune system disorders Uncommon: allergic reactions
Very rare: severe hypersensitivity (allergic) reactions (anaphylaxis), even shock
Nervous system disorders Uncommon: headache
Cardiac disorders
Uncommon: accelerated heart rhythm
Vascular disorders Uncommon: reduced blood pressure Very rare: bleeding
Respiratory, chest, and mediastinal disorders
Rare: dyspnoea, respiratory tract spasms (bronchospasms)
Gastrointestinal disorders
Uncommon: stomatitis, stomach pain, nausea, vomiting, diarrhoea.
Rare: heartburn
Skin and subcutaneous tissue disorders
Uncommon: allergic skin reactions: hives, itching, skin rash or redness of the skin, swelling of the skin, such as swelling of the face, lips or throat, which causes breathing and swallowing difficulty (angioedema).
General disorders and administration site reactions
Uncommon: fever
Unknown: facial swelling (facial oedema)
Severe skin reactions, such as Stevens-Johnson syndrome and Lyell’s syndrome manifesting in temporal correlation with the use of acetylcysteine, have been reported in very rare cases. In most of these cases, the patients used at least one other agent that could have facilitated the prescribed skin and mucous membrane effects.
If new changes occur on the skin or mucous membranes, immediately talk to a doctor and stop using acetylcysteine.
Very rare side reactions include bleeding occurring in connection with the administration of acetylcysteine, in some cases, in the context of hypersensitivity reactions.

Countermeasures

Stop taking Bronchostad upon the first symptoms of hypersensitivity (allergic) reactions (see above). Immediately talk to your doctor if this is the case.

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 BRONCHOSTAD

Keep this medicine out of the sight and reach of children!
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not store at a temperature higher than 25 °C.
Keep in the original package, protected from moisture and light.
The tube must be sealed after removing a tablet.
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 Bronchostad contains

The active substance is acetylcysteine.
Bronchostad 200 mg: 1 tablet contains 200 mg of acetylcysteine Bronchostad 600 mg: 1 tablet contains 600 mg of acetylcysteine
Excipients: adipic acid, aspartame, citric acid (anhydrous), sodium bicarbonate, povidone K25, lemon aroma.

What Bronchostad looks like and contents of the pack

White, slightly yellowish round effervescent tablet with a score on one side, with lemon scent. Bronchostad is available in packages of 10 or 20 effervescent tablets.

Marketing Authorisation Holder and Manufacturer

STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Almar Sehver Tartu mnt 16 10117 Tallinn Estonia
Phone: +372 660 5910 Fax: + 372 660 5912 E-mail: [email protected]
This leaflet was last revised in October 2015
6