ACETYLCYSTEINE AUROVITAS 200 mg EFFERVSCENT TABLETS

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 medication (listed in section 6).
• Do not administer to children under 2 years of age.
• Children and pregnant women with phenylketonuria should not take this medication (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, you should 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 fluid 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 medication influences histamine metabolism and may cause intolerance symptoms (e.g., headache, nasal discharge, itching).

• Inability to expectorate mucus

Mucolytics may 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 medications and Acetylcysteine Aurovitas

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

This applies particularly to:

• Cough suppressants

The combined use of acetylcysteine with cough suppressants may cause a dangerous accumulation of secretion 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 medication 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 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:

may affect the determination of:

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

Pregnancy andbreastfeeding

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.

Pregnancy

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

Breastfeeding

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

therefore use this medication during breastfeeding 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 Aurovitascontains lactose

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

Acetylcysteine Aurovitascontains aspartame

This medication contains 3 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 medication contains 23.274 mg of sodium (main component of table/cooking salt) in each effervescent tablet. This is equivalent to 1.17% of the maximum recommended daily intake of sodium for an adult.

3. How to take Acetylcysteine Aurovitas

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

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

Adults and children over 7 years: 1 effervescent tablet 3 times a day.

Children from 2 to 7 years: 1 effervescent tablet 2 times 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 medication 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 moreAcetylcysteine Aurovitasthan you should

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

To date, 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 medication and the amount ingested.

If you forget to take Acetylcysteine Aurovitas

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

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 will experience them.

Stop taking Acetylcysteine Aurovitas and contact your doctorif signs of allergy or a severe 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.
• Reduced 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 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this 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. Conservation of Acetylcysteine Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the strips and packaging 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.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Acetylcysteine Aurovitas

• The active ingredient is acetylcysteine.

Each effervescent tablet contains 200 mg of acetylcysteine.

• The other components 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 of the product and package contents

Effervescent tablets.

Acetylcysteine Aurovitas 200 mg effervescent tablets EFG:

White, round, beveled tablets, smooth on one side and with a score line on the other side. The tablet can be divided into equal doses.

Acetylcysteine Aurovitas 200 mg effervescent tablets are available in strips (composite film strips - 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 medication is authorized in the member states of the European Economic Area with the following names:

Belgium: Acetylcysteine AB 200mg bruistabletten / comprimés effervescents / Brausetabletten

Spain: Acetylcysteine Aurovitas 200 mg effervescent tablets EFG

Netherlands: Acetylcysteine Auro 200mg, bruistabletten

Portugal: Acetylcysteine Generis

Date of the last revision of thisleaflet: 05/2022

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/).