Cinfamucol acetylcysteine forte 600 mg powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

cinfamucol acetylcysteine forte 600 mg powder for oral solution

acetylcysteine

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

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

Contents of the leaflet

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

1. What is cinfamucol acetylcysteine forte and what is it used for

Acetylcysteine, the active substance in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medicine is indicated to reduce the viscosity of mucus and phlegm, thus facilitating its expulsion in catarrhal and influenza-like conditions in adults.

You should consult your doctor if you worsen or do not improve after 5 days.

2. What you need to know before starting to take cinfamucol acetylcysteine forte

Do not take cinfamucol acetylcysteine forte

• If you are allergic to acetylcysteine and its derivatives, or to any of the other ingredients of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfamucol acetylcysteine forte.

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 when taking the medicine, you should stop treatment and consult your doctor. Caution is advised 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 during the course of treatment.

Children and adolescents

Individuals under 18 years of age should not take this medicine. There are other more suitable formulations available.

Other medicines and acetylcysteine forte

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

Concomitant administration with the antiepileptic carbamazepine may reduce the effectiveness of carbamazepine.

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

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

Dissolving cinfamucol acetylcysteine forte with other medicines is not recommended.

Taking cinfamucol acetylcysteine forte with food and drinks

Taking food and drinks 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.

As a precautionary measure, it is preferable to avoid using this medicine during pregnancy.

You should avoid taking this medicine during breastfeeding.

Driving and using machines

There is no evidence of effects on the ability to drive or use machines.

cinfamucol acetylcysteine forte contains aspartame

This medicine contains 20.00 mg of aspartame per sachet.

Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

cinfamucol acetylcysteine forte contains sunset yellow FCF

This medicine may cause allergic reactions because it contains sunset yellow FCF (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take cinfamucol acetilcisteína forte

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults (from 18 years of age)

Administer 1 sachet (600 mg of acetylcysteine). Do not exceed the dose of 1 sachet (600 mg) per day.

Use in children and adolescents

This medicine must not be used in individuals under 18 years of age.

How to take it

cinfamucol acetilcisteína forte is taken orally.

Dissolve the contents of the sachet in a glass of water. It is recommended to drink plenty of fluids throughout the day.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

If you take more cinfamucol acetilcisteína forte than you should

If you take more cinfamucol acetilcisteína forte than you should, you may experience nausea, vomiting, burning or stomach pain, diarrhoea, or any other adverse effect described in section 4. Possible adverse effects.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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 cause adverse effects, although not everyone experiences 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 available data): facial swelling.

If any skin changes or mucosal membrane alterations 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 through 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 cinfamucol acetylcysteine forte

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of cinfamucol acetylcysteine forte

• The active substance is acetylcysteine. Each sachet contains 600 mg of acetylcysteine.
• The other components are: aspartame (E-951), orange flavour (flavouring preparations, flavouring substances, natural flavouring substances, corn maltodextrin, arabic gum (E-414), ascorbic acid (E-300) and butylated hydroxyanisole (BHA) (E-320)), orange-yellow S dye (E-110), mannitol (E-421) and anhydrous colloidal silica.

Appearance of the product and contents of the pack

cinfamucol acetylcysteine forte is presented in sachets containing a homogeneous orange-coloured, orange-flavoured powder.

Each pack contains 10 sachets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: December 2020

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