Cinfamucol Acetylcysteine Forte 600 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cinfamucol acetylcysteine forte 600 mg effervescent tablets

Acetylcysteine

Read all of this 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 effects, consult your doctor or pharmacist, even if they are adverse effects 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 this 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 of 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 for reducing the viscosity of mucus and phlegm, thereby facilitating their expulsion in colds and flu in adults.

You should consult a doctor if your condition worsens or does 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 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

Talk to your doctor or pharmacist before taking 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 sulfur-like odor (resembling rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is spoiled.
• If you experience stomach discomfort while taking the medicine, you should stop treatment and consult your doctor or pharmacist. Caution is advised in patients with peptic ulcer or a history of peptic ulcer.
• During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease as treatment continues.

Children and adolescents

Children and adolescents should not take this medicine. Other formulations more suitable for this population are available.

Taking cinfamucol acetylcysteine forte with other medicines

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

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

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

Do not take together with antitussive medicines (for cough) or with medicines 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 certain tetracyclines, separate their administration from acetylcysteine by at least 2 hours. Dissolving cinfamucol acetylcysteine forte together with other medicines is not recommended.

Taking cinfamucol acetylcysteine forte with food and drink

Taking this medicine with food or drink does not affect its effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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.

Cinfamucol acetylcysteine forte contains sodium.

This medicine contains 194.04 mg of sodium (a main component of table/cooking salt) per tablet. This corresponds to 9.7% of the maximum daily recommended sodium intake for an adult.

3. How to take Cinfamucol acetylcysteine forte

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults

1 tablet, once daily. Do not exceed the dose of 1 tablet (600 mg) per day.

How to take

Cinfamucol acetylcysteine forte is taken orally.

Effervescent tablets must be dissolved in a glass of water. Do not drink until effervescence has completely stopped. It is advisable to drink plenty of fluids throughout the day.

You should consult a doctor if your condition worsens or if there is no improvement after 5 days of treatment.

Use in children and adolescents

This medicine must not be used in children and adolescents. There are other formulations more suitable for this population.

If you take more Cinfamucol acetylcysteine forte than you should

If you take more Cinfamucol acetylcysteine forte than recommended, you may experience: nausea, vomiting, stomach burning and pain, diarrhoea, or any other adverse effect listed in section 4: Possible side 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, stating 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 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 syndrome, sometimes identified with concomitant intake of another medicinal product.

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

If any changes occur in the skin or mucous membranes, 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 cinfamucol acetylcysteine forte

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

Keep the tube tightly closed to protect it from moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, 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 effervescent tablet contains 600 mg of acetylcysteine.
• The other components are: anhydrous citric acid (E-330), maltodextrin (from corn starch), sodium hydrogen carbonate, sodium saccharin (E-954), orange flavour (flavouring preparations, flavouring substances, natural flavouring substances, corn maltodextrin, gum arabic (E-414), ascorbic acid (E-300) and butylated hydroxyanisole (BHA) (E-320)), and leucine.

Appearance of the product and contents of the pack

Cinfamucol acetylcysteine forte is presented as a white, cylindrical, flat effervescent tablet, in packs of 10 or 20 effervescent tablets.

It is presented in polypropylene tubes closed with a polyethylene cap containing silica gel as a drying agent. Each pack contains one tube with 10 effervescent tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

E-Pharma Trento S.p.A.

Frazione Ravina, Via Provina, 2

38123 Trento (TN) - Italy

Date of the most recent revision of this leaflet: January 2021

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