Package Leaflet: Information for the User

Acetilcisteína Sandoz Care600 mg effervescent tablets

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

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.

- Keep this leaflet, as you may need to read it again.

- If you need advice or more information, consult your doctor or pharmacist.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if you get worse or do not improve after 5 days.

1. What is Acetilcisteína Sandoz Care and what it is 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. Contents of the pack and additional information

Acetilcisteína belongs to a group of medicines called mucolitics.

It works by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

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

You should consult your doctor if it worsens or does not improve after 5 days.

Do not take Acetilcisteína Sandoz Care:

• if you are allergic to acetilcisteína, or to any of the other components of this medication (listed in section 6),orto any of the other components of this medication (listed in section 6),
• do not administer to children under 2 years.

Warnings and precautions

Consult your doctor or pharmacist before starting to take acetilcisteína.

If you are asthmatic or have a severe respiratory disease, you must consult with your doctor before taking this medication.

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

If you experience stomach discomfort while taking the medication, discontinue treatment and consult your doctor. Caution is recommended for patients with peptic ulcers or a history of peptic ulcers.

During the first few days of treatment, you may observe an increase in mucus and phlegm, which will decrease over the course of treatment.

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 used recently, or may need to use any other medication.

The concomitant therapy with nitroglycerin may cause headaches and hypotension, which can be severe.

The concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.

Do not take concurrently with cough medications or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause a buildup of fluidified mucus.

When taking a medication that contains minerals such as iron or calcium, or an antibiotic type (amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you must separate your intake of acetilcisteína by at least 2 hours.

Do not 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, lactation, and fertility

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

It is recommended to avoid taking this medication during lactation.

Driving and operating machinery

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

Acetilcisteína Sandoz Carecontains lactose, sorbitol, and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

This medication contains 40 mg of sorbitol in each tablet.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults:1 tablet, once a day. Do not exceed 1 tablet per day.

How to Take Acetilcisteína Sandoz Care:

Acetilcisteína is taken orally.

Disolve in a glass of water, do not drink until the effervescence has completely stopped. It is recommended to drink an abundant amount of liquid during the day.

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

Use in children and adolescents

Children and adolescents cannot 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 adverse effect described in section 4. Possible adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service, phone: 91.562.04.20, indicating the medication and the amount taken.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may occur:

Rare (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.

Uncommon (may affect up to 1 in 1,000 patients): drowsiness, bronchospasm, respiratory difficulty, digestive discomfort.

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 simultaneous use of another medication.

Unknown frequency (cannot be estimated from available data): facial swelling.

In case of any alteration in the skin or mucous membranes, discontinue acetilcysteine administration immediately and seek medical assistance.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Over triple layer of paper/aluminum/polyethylene:

No conserve at a temperature above 30°C.

Polipropylene tube:

No conserve at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging, after CAD/EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGREpoint of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications.By doing so, you will help protect the environment.

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 contents of the packaging

White, smooth, and round effervescent tablets.

It is presented in packaging (tube) that contains 20 effervescent tablets. Alternatively, the effervescent tablets are packaged in packaging with 10 or 20 sealed triple-layered paper/aluminum/polyethylene pouches.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto-von-Guericke-Allee, 1

39179 Barleben

Germany

or

Hermes Pharma GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

Germany

Last review date of this prospectus:September 2020.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es