Acetylcysteine Bexal 600 mg effervescent tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylcysteine Bexal 600 mg effervescent tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Acetilcisteína Bexal is and what it is used for

Acetylcysteine belongs to the group of medicines known as mucolytics and is used to liquefy excessive and/or thick bronchial secretions.

It is indicated to facilitate the removal of excess mucus and phlegm in respiratory conditions characterized by excessive or thick mucous secretion, such as acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, pulmonary complications of fibrosis, and other related disorders.

2. What you need to know before starting to take Acetylcysteine Bexal

Do not take Acetylcysteine Bexal

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• do not administer in children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acetylcysteine Bexal.

If you have asthma or suffer from a serious respiratory disease, you should consult your doctor before taking this medicine.

The possible sulfurous odor (like rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is in poor condition.

If you experience stomach discomfort after taking the medicine, stop treatment and consult your doctor. Caution is recommended in patients with peptic ulcer or history of peptic ulcer.

During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease throughout the treatment.

Use with caution in long-term treatment of patients with histamine intolerance.

Paediatric population

It is contraindicated in children under 2 years of age.

Taking Acetylcysteine Bexal with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant use with nitroglycerin may cause headache, and the occurrence of hypotension—which may be severe—should be monitored.

Concomitant administration with the antiepileptic carbamazepine may lead to reduced efficacy of carbamazepine.

Do not take together with antitussive medicines (for cough) or those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may cause accumulation of liquefied mucus.

When taking medicines containing minerals such as iron or calcium, or medicines with antibiotics such as (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), administration should be separated from acetylcysteine by at least 2 hours.

Dissolving acetylcysteine together with other medicines is not recommended.

Taking Acetylcysteine Bexal with food and drink

Taking food and drink does not affect the effectiveness of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Its use should be avoided during breastfeeding.

Driving and using machines

There is no evidence of effects on the ability to drive or operate machinery.

Acetylcysteine Bexal contains lactose, sodium, and sorbitol

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 138.07 mg of sodium (main component of table/cooking salt) per tablet. This corresponds to 6.9% of the maximum daily recommended sodium intake for an adult.

This medicine contains 40 mg of sorbitol per tablet.

3. How to take Acetylcysteine Bexal

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist.

The dose of acetylcysteine should be taken directly by dissolving one effervescent tablet in a glass of water and immediately drinking the solution.

Your doctor will advise you on how long to take acetylcysteine. Do not stop treatment early, as doing so may prevent you from achieving the desired effect.

Adults and children over 7 years: the recommended daily dose is 600 mg of acetylcysteine per day (1 tablet of Acetylcysteine Bexal per day).

If you take more Acetylcysteine Bexal than you should

If you have taken more Acetylcysteine Bexal than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Acetylcysteine Bexal

Do not take a double dose to make up for a missed dose. Take the missed dose as soon as possible. However, if it is almost time for your next dose, wait until then and continue with your regular dosing schedule.

If you stop taking Acetylcysteine Bexal

Do not stop treatment prematurely, as you will not achieve the intended effect.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

The following adverse effects may occur:

Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhoea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Rare (may affect up to 1 in 1,000 patients): somnolence, bronchospasm, breathing difficulty, gastrointestinal discomfort.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, haemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome, sometimes identified with the concomitant intake of at least one other medicinal product.

Frequency not known (cannot be estimated from the available data): facial swelling.

If any skin or mucous membrane changes occur, administration of acetylcysteine must be stopped immediately and medical advice sought.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine Bexal

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 packaging after CAD/EXP. The expiry date refers to the last day of the month indicated.

Triple-layer paper/aluminum/polyethylene sachet:

Do not store above 30°C.

Polypropylene tube:

Do not store above 30°C.

Keep the packaging tightly closed to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetylcysteine Bexal

• The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
• The other components are: ascorbic acid, anhydrous citric acid, anhydrous lactose, mannitol, anhydrous sodium carbonate, sodium citrate dihydrate, sodium saccharin dihydrate, sodium hydrogen carbonate, sodium cyclamate, blackberry flavour (vanillin, maltodextrin, mannitol, gluconolactone, sorbitol and anhydrous colloidal silica).

Appearance of the product and contents of the pack

Acetylcysteine Bexal is presented as white, round, flat effervescent tablets, with one side scored, containing 600 mg of acetylcysteine. It is supplied in polypropylene tubes containing 20 effervescent tablets. Alternatively, the effervescent tablets are packed in sealed triple-layer foil sachets composed of paper/aluminium/polyethylene.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bexal Farmacéutica, s.a.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Hermes Pharma GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

Germany

This leaflet was approved in February 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es