CINFAMUCOL ACETYLCYSTEINE 200 mg ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

cinfamucol acetilcisteína 200 mg powder for oral solution

acetilcisteína

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Contents of the Package Leaflet

1. What cinfamucol acetilcisteína is and what it is used for
2. What you need to know before taking cinfamucol acetilcisteína
3. How to take cinfamucol acetilcisteína
4. Possible side effects
5. Storage of cinfamucol acetilcisteína
6. Contents of the pack and further information

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

Acetilcisteína, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by reducing the viscosity of mucus, making it more fluid and easier to eliminate.

This medication is indicated to reduce the viscosity of mucus and phlegm, making it easier to expel, in catarrhal and flu-like processes, in adults and adolescents from 12 years old. You should consult a doctor if your condition worsens or does not improve after 5 days.

2. What you need to know before taking cinfamucol acetilcisteína

Do not take cinfamucol acetilcisteína

• If you are allergic to acetilcisteína and its derivatives, or to any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years old.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take cinfamucol acetilcisteína.

If you have asthma or a severe respiratory disease, you should consult your doctor before taking this medication.

The possible sulfur-like 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 days of treatment, you may notice an increase in mucus and phlegm that will decrease throughout the treatment.

Children and Adolescents

Children between 2 and 12 years old should not take this medication. There are other presentations more suitable for this population.

Other Medications and Acetilcisteína

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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 cause a decrease in the efficacy of carbamazepine.

Do not administer concomitantly with antitussive medications (for cough) or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidified 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 cinfamucol acetilcisteína by at least 2 hours.

It is not recommended to dissolve cinfamucol acetilcisteína with other medications.

Taking cinfamucol acetilcisteína with Food and Drinks

The intake of 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.

cinfamucol acetilcisteína 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.

cinfamucol acetilcisteína contains orange yellow S

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

3. How to Take cinfamucol acetilcisteína

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and Adolescents between 12 and 18 years old

Administer 1 sachet (200 mg of acetilcisteína) per intake, 3 times a day. Do not exceed the dose of 3 sachets (600 mg) per day.

Use in Children

Children under 12 years old cannot take this medication. There are other presentations more suitable for this population.

How to Take

cinfamucol acetilcisteína is taken orally.

Dissolve the contents of the sachet in a glass of water. It is recommended to drink plenty of liquid 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 than you should

If you take more cinfamucol acetilcisteína than you should, you may notice nausea, vomiting, burning, 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.

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.

In case of any skin or mucous membrane alteration, the administration of acetilcisteína should be stopped 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 package 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 cinfamucol acetilcisteína

Keep this medication out of the 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 your 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. Contents of the Pack and Further Information

Composition of cinfamucol acetilcisteína

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

Appearance of the Product and Contents of the Pack

cinfamucol acetilcisteína is presented in the form of sachets with a homogeneous orange-colored and flavored powder.

Each pack contains 20 sachets.

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 Package Leaflet:December 2020

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/