ACETYLCYSTEINE SANDOZ CARE 600 mg EFFERVESCENT TABLETS

Introduction

Package Leaflet: Information for the User

Acetilcisteína Sandoz Care600 mg Effervescent Tablets

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 doctor or 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 is Acetilcisteína Sandoz Care and what is it used for
2. What you need to know before taking Acetilcisteína Sandoz Care
3. How to take Acetilcisteína Sandoz Care
4. Possible side effects
5. Storage of Acetilcisteína Sandoz Care
6. Package Contents and Additional Information

1. What is Acetilcisteína Sandoz Care and what is it used for

Acetilcisteína belongs to the group of medications called mucolytics.

It works by decreasing the viscosity of mucus, making it more fluid and easier to eliminate.

This medication is indicated to facilitate the elimination of excess mucus and phlegm in catarrhal and flu-like processes in adults.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

2. What you need to know before taking Acetilcisteína Sandoz Care

Do not take Acetilcisteína Sandoz Care:

• 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.

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, 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.

Children and Adolescents

Children and adolescents should not take this medication. There are other presentations more suitable for this population.

Taking Acetilcisteína Sandoz Care with other medications

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 take concomitantly with antitussive medications (for cough) or 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 acetilcisteína from the intake of these medications by at least 2 hours.

It is not recommended to dissolve acetilcisteína with other medications.

Taking Acetilcisteína Sandoz Care with food and beverages

The intake of food and beverages does not affect the efficacy of this medication.

Pregnancy, Breastfeeding, and Fertility

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.

Its use should be avoided during breastfeeding.

Driving and Using Machines

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

Acetilcisteína Sandoz Carecontains lactose, sorbitol, and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 139 mg of sodium (main component of table salt/cooking salt) per effervescent tablet. This is equivalent to 6.0% of the maximum daily sodium intake recommended for an adult.

This medication contains 40 mg of sorbitol per effervescent tablet.

3. How to take Acetilcisteína Sandoz Care

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: 1 tablet, 1 time a day. Do not exceed the dose of 1 tablet per day.

How to take Acetilcisteína Sandoz Care:

Acetilcisteína is taken orally.

Dissolve in a glass of water, do not drink until the effervescence has completely stopped. 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.

Use in Children and Adolescents

Children and adolescents should not take this medication. There are other presentations more suitable for this population.

If you take moreAcetilcisteína Sandoz Carethan 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, or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medication and the amount taken.

If you have any other questions 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 alteration occurs, acetilcisteína administration should be immediately discontinued and medical assistance sought.

Reporting 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 Acetilcisteína Sandoz Care

Keep this medication out of sight and reach of children.

Triple-layer paper/aluminum/polyethylene sachet:

Do not store above 30°C.

Polypropylene tube:

Do not store above 30°C.

Do not use this medication after the expiration date shown on the packaging, after CAD/EXP. 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. Package Contents and Additional Information

Composition of Acetilcisteína Sandoz Care600 mg

• The active ingredient is acetilcisteína. Each effervescent tablet contains 600 mg of acetilcisteína.

• The other components (excipients) are: anhydrous lactose, sodium hydrogen carbonate, sodium saccharin dihydrate, sodium citrate, anhydrous sodium carbonate, sodium cyclamate, mannitol (E-421), ascorbic acid, blackcurrant flavor (contains sorbitol and mannitol (E-421)), and anhydrous citric acid.

Appearance of the Product and Package Contents

Effervescent tablets are white, smooth, and round.

They are presented in packages (tubes) containing 20 effervescent tablets. Alternatively, the effervescent tablets are packaged in sachets with 10 or 20 triple-layer paper/aluminum/polyethylene sachets.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee, 1

39179 Barleben

Germany

or

Hermes Pharma GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

Germany

Date of the last revision of this package leaflet:September 2020.

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