PECTOX 50 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

PECTOX 50 mg/ml ORAL SOLUTION

Carbocisteine

Contents of the pack:

1. What Pectox is and what it is used for.
2. What you need to know before you take Pectox.
3. How to take Pectox.
4. Possible side effects.
5. Storage of Pectox.
6. Contents of the pack and other information.

1. What Pectox is and what it is used for

Pectox belongs to a group of medicines called mucolytics, and is used to thin out excessive and/or thick bronchial secretions.

2. What you need to know before you take Pectox

Do not take Pectox

• If you are allergic to carbocisteine or any of the other ingredients of this medicine (listed in section 6).
• If you have a stomach or duodenal ulcer.
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking Pectox.

Taking Pectox with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking medicines for cough or that reduce bronchial secretions, consult your doctor before taking Pectox together with these, as it may cause an accumulation of thinned mucus.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

Pectox contains red cochineal A (E-124)

This medicine may cause allergic reactions because it contains red cochineal A (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Pectox contains methyl parahydroxybenzoate sodium salt (E-219)

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate sodium salt (E-219).

Pectox contains sodium

This medicine contains 7.72 mg of sodium (main component of table salt/cooking salt) per ml. This is equivalent to 17% of the maximum recommended daily intake of sodium for an adult.

3. How to take Pectox

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

Remember to take your medicine.

This medicine is taken orally, alone or diluted in water or another liquid, and preferably before meals. This medicine comes with a measuring cup that has the following measures marked: 2.5 ml, 4 ml, 5 ml, 7.5 ml, 8 ml, 8.5 ml, and 10 ml.

The recommended dose is:

• Adults and adolescents (> 12 years): 15 ml (750 mg of carbocisteine) every 8 hours.
• Children from 6 to 12 years: 5 ml (250 mg of carbocisteine) every 8 hours.
• Children from 2 to 5 years: 2.5 ml (125 mg of carbocisteine) every 6-12 hours.

It is recommended to drink plenty of liquid throughout the day.

If you think the action of Pectox is too strong or too weak, tell your doctor or pharmacist.

If you take more Pectox than you should

If you have taken more than you should, consult your doctor or pharmacist, or call the Toxicology Information Service, telephone 915 62 04 20, indicating the medicine and the amount taken.

If you forget to take Pectox

Do not take a double dose to make up for forgotten doses.

If you stop taking Pectox

Your doctor will indicate the duration of your treatment with Pectox. Do not stop treatment before, as it may be harmful to your health.

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

4. Possible side effects

Like all medicines, Pectox can cause side effects, although not everybody gets them.

Uncommon side effects (affect 1 to 10 users in 1,000):

Digestive disorders such as nausea, diarrhea, gastric discomfort, especially at high doses, which usually disappear with the reduction of the administered dose.

Rare side effects (affect 1 to 10 users in 10,000):

Hypersensitivity reactions (allergic reactions), accompanied by urticaria (redness and inflammation of the skin).

Very rare side effects (affect less than 1 user in 10,000):

Bronchospasm (asthma), in which case it is recommended to stop the medication and consult a doctor.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

Reporting of 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 leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pectox

No special storage temperature is required.

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Pectox

• The active substance is carbocisteine. Each 100 ml of oral solution contains 5 g of carbocisteine.
• The other ingredients (excipients) are: sodium saccharin, methyl parahydroxybenzoate sodium salt (E-219), raspberry flavor, red cochineal A (E-124), sodium hydroxide, hydroxyethylcellulose, disodium phosphate, sodium cyclamate, citric acid, and purified water.

Appearance and packaging of the product

This medicine is a red solution that comes in 120 ml and 240 ml oral solution bottles, accompanied by a measuring cup.

Marketing authorization holder and manufacturer:

ITALFARMACO S.A.

San Rafael 3, 28108-Alcobendas (Madrid)

Tel. 916572323

Date of last revision of this leaflet: August 2021

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