ACETYLCYSTEINE CINFA 200 mg POWDER FOR ORAL SOLUTION

Introduction

Leaflet: information for the user

acetilcisteína cinfa 200 mg powder for oral solution EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is acetilcisteína cinfa and what is it used for
2. What you need to know before taking acetilcisteína cinfa
3. How to take acetilcisteína cinfa
4. Possible side effects
5. Storage of acetilcisteína cinfa
6. Package contents and additional information

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

Acetilcisteína belongs to the group of medications called mucolytics.

Acetilcisteína is used to thin out excessive and/or thick bronchial secretions. It is indicated in the supportive treatment of respiratory processes that involve hypersecretion, excessive or thick mucus, such as:

• Bronchitis (inflammation of the bronchi) acute and chronic.
• Chronic obstructive pulmonary disease.
• Emphysema (inflammation of the lung alveoli, which reduces respiratory function).
• Atelectasis (decrease in lung volume) due to mucous obstruction.

2. What you need to know before taking acetilcisteína cinfa

Do not take acetilcisteína cinfa

• If you are allergic to acetilcisteína or any of the other components of this medication (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 a severe respiratory disease, you should consult your doctor before taking this medication.

The possible sulfurous odor (like rotten eggs) of the medication is characteristic of the active ingredient, but it does not indicate that the medication is in poor condition.

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

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

It should be administered with caution in long-term treatment in patients with histamine intolerance.

Children

It is contraindicated in children under 2 years of age.

Other medications and acetilcisteína cinfa

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

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

Concomitant administration with the antiepileptic carbamazepine may decrease the efficacy of carbamazepine.

Do not administer concomitantly with antitussive medications (for cough) or those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of thinned mucus.

When taking any medication that contains minerals such as iron or calcium, or any medication with antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate the intake of acetilcisteína by at least 2 hours.

It is not recommended to dissolve acetilcisteína with other medications.

Taking acetilcisteína cinfa with food and drinks

Taking food and drinks does not affect the efficacy of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

As a precaution, it is best to avoid its use during pregnancy.

Its intake should be avoided during breastfeeding.

Driving and using machines

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

acetilcisteína cinfa contains aspartame. This medication contains 6.67 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

acetilcisteína cinfa contains yellow-orange S dye. This medication may cause allergic reactions because it contains yellow-orange S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take acetilcisteína cinfa

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 7 years:

200 mg of acetilcisteína (1 sachet of acetilcisteína cinfa 200 mg 3 times a day), every 8 hours. Do not exceed the dose of 3 sachets (600 mg of acetilcisteína) per day.

Children between 2 and 7 years:

The recommended doses are lower and this presentation is not suitable, although this presentation can be used in cases of pulmonary complications of cystic fibrosis.

Pulmonary complications of cystic fibrosis:

The recommended dose in these cases is as follows:

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

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

Acetilcisteína is taken orally.

The sachets are taken dissolved in a glass of water. It is recommended to drink plenty of liquid 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 acetilcisteína than you should, you may notice: nausea, vomiting, heartburn, and stomach pain, diarrhea, or any other side effect described in section 4. Possible side effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following side effects may occur:

Uncommon(may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhea, 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, respiratory distress, gastrointestinal disorders.

Very rare(may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, hemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the concomitant use of another medication.

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

If any skin or mucous membrane disorder occurs, acetilcisteína administration should be discontinued immediately and medical assistance should be sought.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of acetilcisteína cinfa

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of acetilcisteína cinfa

• The active ingredient is acetilcisteína. Each sachet contains 200 mg of acetilcisteína.
• The other ingredients are: aspartame (E-951), mannitol (E-421), colloidal anhydrous silica, yellow-orange S dye (E-110), and orange flavor (flavoring preparations, flavoring substances, natural flavoring substances, corn maltodextrin, arabic gum (E-414), ascorbic acid (E-300), and butylated hydroxyanisole (BHA) (E-320)).

Appearance of the product and package contents

Alu/Pe Surlyn sachets. Homogeneous powder with orange color and flavor.

acetilcisteína cinfa is presented in the form of sachets containing 200 mg of acetilcisteína. It is presented in packages containing 30 or 500 (EC) sachets.

Only some package 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 last revision of this leaflet:April 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66459/P_66459.html

QR code to: https://cima.aemps.es/cima/dochtml/p/66459/P_66459.html