ACETYLCYSTEINE AUROVITAS 600 mg EFFERVSCENT TABLETS

Introduction

Leaflet:information for the user

Acetylcysteine Aurovitas 600 mg effervescent tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• 1. If you have any doubts, consult your doctor, pharmacist, or nurse.

• This medicine 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, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Acetylcysteine Aurovitas and what is it used for
2. What you need to know before taking Acetylcysteine Aurovitas
3. How to take Acetylcysteine Aurovitas
4. Possible side effects

5 Conservation of Acetylcysteine Aurovitas

1. Package contents and additional information

1. What is Acetylcysteine Aurovitas and what is it used for

Acetylcysteine Aurovitas contains the active ingredient acetylcysteine, which liquefies the viscous mucus of the respiratory tract.

Acetylcysteine is used to expelmucus and relieve coughin cases of colds in adults.

2. What you need to know before taking Acetylcysteine Aurovitas

Do not take Acetylcysteine Aurovitas

• if you are allergicto acetylcysteine or any of the other components of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.
• Children and pregnant women with phenylketonuria should not take this medicine (phenylketonuria is a congenital metabolic error).

Warnings and precautions

Consult your doctor or pharmacist before starting to take acetylcysteine.

• Bronchial asthma.

If you have bronchial asthma, acetylcysteine should be taken under close medical supervision because it can cause narrowing of the airways (bronchospasm). If you experience such symptoms, stop using acetylcysteine immediately.

• Past or current stomach or intestinal ulcers.

If you have or have had a peptic ulcer, as acetylcysteine can irritate the gastric lining. Especially if you use other medications that irritate the gastric lining.

• Changes in skin and mucous membranes.

Very rarely, serious skin reactions, such as Stevens-Johnson syndrome and Lyell syndrome, have been reported in relation to the use of acetylcysteine. If new changes in the skin and mucous membranes occur, consult a doctor without delay and stop using acetylcysteine.

• As the thick phlegm becomes more fluid, its volume will increase, especially at the start of treatment. If you cannot cough up this liquid phlegm efficiently, you should consult a doctor so that appropriate measures can be taken to remove the phlegm.
• Hypersensitivity to histamine.

Long-term treatment should be avoided in these patients, as this medicine influences histamine metabolism and may cause intolerance symptoms (e.g., headache, nasal discharge, itching).

• Inability to expectorate mucus

Mucolytics can obstruct the airways of children under 2 years of age due to their characteristics and limited ability to cough up sputum. Therefore, children under 2 years of age should not use mucolytics.

Other medicines and Acetylcysteine Aurovitas

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

This applies particularly to:

• Cough suppressants

The combined use of acetylcysteine with cough suppressants can cause a dangerous accumulation of secretions due to the reduction of the cough reflex. A particularly careful diagnosis is required for this combined treatment. It is essential that you ask your doctor before using this combination.

• Antibiotics

Experimental studies show evidence of a weakening effect of antibiotics (tetracyclines, aminoglycosides, penicillins) due to acetylcysteine. For safety reasons, antibiotics should be taken separately and with an interval of at least 2 hours. This does not apply to medications with the active ingredients cefixime or loracarbef. These can be taken with acetylcysteine at the same time.

• Activated charcoal
• Glyceryl trinitrate: a medicine also known as nitroglycerin, used to dilate blood vessels.

Your doctor will monitor if you have low blood pressure, which could be severe and could be detected by a headache.

• Carbamazepine

When used at the same time as carbamazepine, the effects of carbamazepine may be reduced due to the decrease in plasma levels.

Laboratory tests

Tell your doctor that you are taking acetylcysteine if you need a test for the following:

may affect the determination of:

• Salicylates: medicines for treating pain, inflammation, or rheumatism,
• ketone bodies in urine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Since there is not enough experience with the use of this medicine in pregnant women, you can only use acetylcysteine during pregnancy if your doctor considers it absolutely necessary.

Breast-feeding

No information is available on the excretion of acetylcysteine in breast milk. You should

therefore use this medicine during breast-feeding only if your doctor considers it absolutely necessary.

Driving and using machines

the influence of this on the ability to drive or use machines is not known.

Acetylcysteine Aurovitas contains lactose

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

Acetylcysteine Aurovitas contains aspartame

This medicine contains 15 mg of aspartame in each effervescent tablet.

Aspartame (E951) contains a source of phenylalanine, which 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.

Acetylcysteine Aurovitas contains sodium

This medicine contains 65.71 mg of sodium (main component of table/cooking salt) in each effervescent tablet. This is equivalent to 3.29% of the maximum recommended daily intake of sodium for an adult.

3. How to take Acetylcysteine Aurovitas

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

The recommended dose, unless your doctor prescribes otherwise, is:

Adults from 18 years: 1 effervescent tablet once a day.

Method of administration

Dissolve the effervescent tablet in half a glass of water and drink the solution immediately.

It is recommended that patients who have difficulty expelling phlegm (elderly and debilitated patients) take the effervescent tablet in the morning.

Duration of treatment

Do not use this medicine for more than 14 days without consulting your doctor.

If your symptoms worsen or do not improve after 4-5 days, you should consult your doctor.

If you take more Acetylcysteine Aurovitas than you should

In case of overdose, stomach and intestinal irritations, such as abdominal pain, nausea, vomiting, diarrhea, may occur.

So far, no serious side effects or symptoms of intoxication have been observed, even in the case of massive overdose. However, if an overdose with acetylcysteine is suspected, please inform your doctor.

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 medicine and the amount ingested

If you forget to take Acetylcysteine Aurovitas

Do not take a double dose to make up for missed doses. Simply take your next dose at the usual time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop taking Acetylcysteine Aurovitas and contact your doctor if signs of allergy or a serious skin reaction appear.

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions.

Very rare (may affect up to 1 in 10,000 people)

• Severe allergic reactions, including shock.
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Other possible side effects may occur with the following frequencies:

Uncommon (may affect up to 1 in 100 people)

• Headache.
• Fever.
• Inflammation of the inner lining of the mouth.
• Abdominal pain.
• Nausea, vomiting.
• Diarrhea.
• Ringing or buzzing in the ears.
• Accelerated heartbeats.
• Low blood pressure.
• Itching, hives, skin rash.
• Generalized rash.
• Severe, mostly painful, inflammation of the deep layers of the skin, mainly on the face.

Rare (may affect up to 1 in 1,000 people)

• Difficulty breathing.
• Bronchospasm - predominantly in patients with a hyperreactive bronchial system in the presence of bronchial asthma.
• Indigestion.

Very rare (may affect up to 1 in 10,000 people)

• Bleeding.

Frequency not known (frequency cannot be estimated from available data)

• Inflammation of the tissue in the face caused by excess fluid.
• Reduction of blood platelet accumulation.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Acetylcysteine Aurovitas

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

Do not use this medicine after the expiration date stated on the strips and the package after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Keep in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Acetylcysteine Aurovitas

• The active ingredient is acetylcysteine.

Each effervescent tablet contains 600 mg of acetylcysteine.

• The other ingredients are: Ascorbic acid, citric acid, sodium hydrogen carbonate, crospovidone (Type-B), lactose monohydrate, orange flavor (contains flavoring preparations, flavoring substances, natural flavoring substances, maltodextrin, gum arabic (E 414), butylated hydroxyanisole (E 320)), peppermint flavor (contains flavoring preparations, natural flavoring substances, maltodextrin, gum arabic (E 414)), aspartame (E951), leucine.

Appearance and package contents of the product

Effervescent tablets.

Acetylcysteine Aurovitas 600 mg effervescent tablets EFG:

White, flat, round, and beveled tablets.

Acetylcysteine Aurovitas 600 mg effervescent tablets are available in strips (composite film - PAPER/AL/PE).

Package sizes:

Strips: 10, 20, 30, and 60 effervescent tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Acetylcysteine AB 600 mg bruistabletten / comprimés effervescents / Brausetabletten

Spain: Acetilcisteína Aurovitas 600mg comprimidos efervescentes EFG

Italy: Acetilcisteina Aurobindo

Netherlands: Acetylcysteine Auro 600mg, bruistabletten

Poland: Aceflucil

Portugal: Acetilcisteína Generis

Date of last revision of this leaflet:05/2022

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