Leaflet : information for the user

Acetylcysteine hydrochloride 100 mg powder for oral solution EFG

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

Acetilcisteína belongs to the group of medications known as mucolítics.

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

• Acute and chronic bronchitis (inflammation of the bronchi).
• Chronic obstructive pulmonary disease.
• Emphysema (inflammation of the alveoli of the lungs, which reduces respiratory function).
• Atelectasis (reduction of lung volume) due to mucous obstruction.

Do not take acetilcisteína cinfa

Warnings and precautions

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

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 spoiled.

If you experience stomach discomfort while taking the medication, you should 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 time.

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

Children

It is contraindicated in children under 2 years old.

Other medications and acetilcisteína cinfa

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

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

The concomitant administration with the antiepileptic carbamazepine may cause a decrease in the efficacy of carbamazepine.

Do not administer concomitantly with cough medications or those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation 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 should separate your intake from the intake of acetilcisteína by at least 2 hours.

Do not dissolve acetilcisteína with other medications.

Taking acetilcisteína cinfa with food and drinks

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

Pregnancy and lactation

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

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

It should be avoided during lactation.

Driving and operating machines

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

acetilcisteína cinfa contains aspartamo. This medication contains 6.67 mg of aspartamo in each package. Aspartamo contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

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

The recommended dose is:

Adults and children over 7 years:

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

Children between 2 and 7 years:

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

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 packets are taken dissolved in a glass of water. It is recommended to drink an abundant amount of liquid during the day.

It is contraindicated in children under 2 years.

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 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 Toxicological 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.

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

The following adverse effects may occur:

Rarely(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.

Do not store at a temperature above 30°C.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of acetilcisteína cinfa

• The active ingredient is acetilcisteína. Each blister pack contains 100 mg of acetilcisteína.
• The other components are: aspartamo (E-951), manitol (E-421), anhydrous colloidal silica, yellow-orange colorant S (E-110), and 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)).

Appearance of the product and contents of the packaging

Alu/Pe Surlyn blisters. Homogeneous powder of yellow color and orange taste.

Acetilcisteína cinfa is presented in the form of blister packs containing 100 mg of acetilcisteína. It is presented in containers that contain 30or 500 (EC)blister packs.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Date of the last review of this leaflet:April 2021

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

You can access detailed and updated information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and 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