ACETYLCYSTEINE CINFAC 100 MG POWDER FOR ORAL SOLUTION EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

acetylcysteine cinfa 100 mg powder for oral solution EFG

Read the entire 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, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 is acetilcisteína cinfa and what is it used for

Acetylcysteine belongs to a group of medicines called mucolytics.

Acetylcysteine is used to liquefy excessive and/or thick bronchial secretions. It is indicated as supportive treatment in respiratory conditions associated with hypersecretion, excessive or thick mucus, such as:

• Acute and chronic bronchitis (inflammation of the bronchi).
• Chronic obstructive pulmonary disease.
• Emphysema (inflammation of the lung alveoli, leading to reduced respiratory function).
• Atelectasis (reduction in lung volume) due to mucus obstruction.

2. What you need to know before starting to take acetylcysteine cinfa

Do not take acetylcysteine 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

Talk to your doctor or pharmacist before starting to take acetylcysteine cinfa.

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 while 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 over the course of treatment.

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

Children

This medicine is contraindicated in children under 2 years of age.

Other medicines and acetylcysteine 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 reduce the effectiveness of carbamazepine.

Do not administer simultaneously with antitussive medicines (for cough) or with 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), administration should be separated from acetylcysteine by at least 2 hours.

Dissolving acetylcysteine with other medicines is not recommended.

Taking acetylcysteine cinfa 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.

As a precautionary measure, it is preferable to avoid use during pregnancy.

Its use should be avoided during breastfeeding.

Driving and use of machines

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

acetylcysteine cinfa contains aspartame. This medicine contains 6.67 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 eliminate it properly.

acetylcysteine cinfa contains the colouring agent sunset yellow FCF. This medicine may cause allergic reactions as it contains sunset yellow FCF (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

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.

The recommended dose is:

Adults and children over 7 years of age:

200 mg of acetylcysteine (2 sachets of acetilcisteína cinfa 100 mg 3 times a day), every 8 hours. Do not exceed a dose of 6 sachets (600 mg of acetylcysteine) per day.

Children between 2 and 7 years of age:

100 mg of acetylcysteine (1 sachet of acetilcisteína cinfa 100 mg 3 times a day), every 8 hours. Do not exceed a dose of 3 sachets (300 mg of acetylcysteine) per day.

Pulmonary complications of cystic fibrosis:

The recommended dose in these cases is as follows:

Adults and children over 7 years of age: 200 to 400 mg of acetylcysteine every 8 hours.

Children between 2 and 7 years of age: 200 mg of acetylcysteine every 8 hours.

Acetylcysteine is taken orally.

The sachets should be dissolved in a glass of water. It is recommended to drink plenty of fluids throughout the day.

It is contraindicated in children under 2 years of age.

If you take more acetilcisteína cinfa than you should

If you take more acetylcysteine than you should, you may experience: nausea, vomiting, burning sensation and stomach pain, diarrhea, or any other adverse effect described in section 4. Possible adverse effects.

In case of overdose or accidental ingestion, consult 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.

In case of accidental massive administration, symptomatic treatment is recommended.

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 in association with the simultaneous intake of another medicine.

Frequency not known (cannot be estimated from 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 System for Pharmacovigilance of 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.

Do not store above 30°C.

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 should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of acetilcisteína cinfa

• The active substance is acetylcysteine. Each sachet contains 100 mg of acetylcysteine.
• The other components are: aspartame (E-951), mannitol (E-421), anhydrous colloidal silica, orange-yellow S colour (E-110), and 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)).

Appearance of the medicine and contents of the pack

Alu/Pe Surlyn sachets. Homogeneous powder with an orange colour and flavour.

acetilcisteína cinfa is available in sachets containing 100 mg of acetylcysteine. It comes in packs containing 30 or 500 (EC) sachets.

Only certain pack sizes may be marketed.

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 revision of this leaflet: April 2021

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66460/P_66460.html

QR code to: https://cima.aemps.es/cima/dochtml/p/66460/P_66460.html