ACETYLCYSTEINE CINFA 600 MG EFFERVESCENT TABLETS EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

acetylcysteine cinfa 600 mg effervescent tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• 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.

Contents of the package leaflet

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

1. What acetilcisteína cinfa is and what it is used for

Acetilcisteína, the active substance of this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

This medicine is indicated to help eliminate excess mucus and phlegm in colds and flu, for adults.

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

2. What you need to know before taking acetilcisteína cinfa

Do not take acetilcisteína cinfa:

• 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

Consult your doctor or pharmacist before starting to take acetilcisteína cinfa:

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

The possible sulphurous odour (like rotten eggs) of the medicine is due to the active ingredient and does not indicate that the medicine is in poor condition.

If you experience stomach discomfort while taking the medicine, stop treatment and consult your doctor or pharmacist. 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 during the course of treatment.

Children and adolescents

Children and adolescents should not take this medicine. There are other formulations more suitable for this population.

Other medicines and acetilcisteína cinfa

Inform 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 lead to a reduction in carbamazepine efficacy.

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 containing antibiotics such as (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate their administration from acetylcysteine by at least 2 hours. Dissolving acetylcysteine with other medicines is not recommended.

Taking acetilcisteína cinfa with food and drink

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.

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.

acetilcisteína cinfa contains sodium

This medicine contains 193.9 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 9.7% of the maximum recommended daily sodium intake for an adult.

The possible presence of a slight sulphurous odour does not indicate deterioration of the tablet, but is characteristic of the active substance.

3. How to take acetilcisteína cinfa

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults: 1 tablet, once daily. Do not exceed the dose of 1 tablet per day.

How to take:

Acetylcysteine is taken orally.

Dissolve in a glass of water; do not drink until effervescence has completely stopped. It is recommended to drink plenty of fluids throughout the day.

You should consult a doctor if symptoms worsen or do not improve after 5 days of treatment.

Use in children and adolescents

Children and adolescents must not take this medicine. There are other formulations more suitable for this population.

If you take more acetilcisteína cinfa than you should

If you take more acetylcysteine than you should, you may experience: nausea, vomiting, stomach burning and pain, diarrhea, or any other adverse effect listed 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 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 the concomitant use of at least one other 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 Acetylcysteine cinfa

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

Store in the original packaging. Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging 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 containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of acetilcisteína cinfa

• The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.

• The other components are: anhydrous citric acid (E-330), maltodextrin (derived from corn starch), sodium bicarbonate, L-leucine, sodium saccharin (E-954) and orange flavouring (flavouring preparations, flavouring substances, natural flavouring substances, corn maltodextrin, gum arabic (E-414), ascorbic acid (E-300) and butylated hydroxyanisole (BHA) (E-320)).

Appearance of the product and contents of the pack

acetilcisteína cinfa is presented as effervescent tablets, white in colour, cylindrical and flat.

It is supplied in polypropylene bottles closed with a polyethylene cap containing a silica gel desiccant. Each package contains one bottle with 20 effervescent tablets.

Alternatively, the tablets are packed in 20 sealed triple-layer foil sachets composed of paper/aluminium/polyethylene.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

E-Pharma Trento S.p.A.

Frazione Ravina, Via Provina, 2

38123 Trento (TN) - Italy

Date of the most recent review of this leaflet: February 2021

Detailed 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/

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67763/P_67763.html

QR code link: https://cima.aemps.es/cima/dochtml/p/67763/P_67763.html