Leaflet: information for the user

PECTOX 50 mg/ml ORAL SOLUTION

Carbocisteine

1.What Pectox is and what it is used for.

2.What you need to know before you start taking Pectox.

3.How to take Pectox.

4.Possible side effects.

5.Storage of Pectox.

6. Contents of the pack and additional information.

Pectox belongs to a group of medications called mucolytics, and is used to liquefy excessive and/or thick bronchial secretions.

Do not take Pectox

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pectox.

Taking Pectox with other medications

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

If you are taking medications for cough or that reduce bronchial secretions, consult your doctor before taking Pectox with these, as it may cause a buildup of fluidified mucus.

Pregnancy and breastfeeding

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

Driving and operating machinery

No effects on the ability to drive and/or operate machinery have been observed.

Pectox contains Red 33 (E-124)

This medication may cause allergic reactions because it contains Red 33 (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Pectox contains Sodium benzoate (E-219)

It may cause allergic reactions (possibly delayed) because it contains Sodium benzoate (E-219).

Pectox contains Sodium

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

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.

Remember to take your medication.

This medication is taken orally, either alone or diluted in water or another liquid, and preferably before meals. This medication comes with a dosing cup that has the following measurements 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 aged 6 to 12 years: 5 ml (250 mg of carbocisteine) every 8 hours.
• Children aged 2 to 5 years: 2.5 ml (125 mg of carbocisteine) every 6-12 hours.

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

If you estimate that the action of Pectox is too strong or too weak, inform 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 Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount taken.

If you forget to take Pectox

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pectox

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

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

Like all medications, Pectox may have adverse effects, although not all people will experience them.

Less common adverse effects (affect between 1 and 10 of every 1,000 patients):

Upset stomach symptoms such as nausea, diarrhea, and stomach discomfort, especially at high doses, which usually disappear with a reduction in the administered dose.

Rare adverse effects (affect between 1 and 10 of every 10,000 patients):

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

Very rare adverse effects (affect fewer than 1 in every 10,000 patients):

Asthma, in which case it is recommended to discontinue medication and consult a doctor.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website: www.notificaram.es .

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This product does not require any special storage temperature.

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

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

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

Composition of Pectox

- The active principle is carbocisteine. Each 100 ml of oral solution contains5 gof Carbocisteine.

-The other components (excipients) are:sodium saccharin, p-hydroxybenzoate of methyl salt (E-219), raspberry essence, red cochineal A (E-124), sodium hydroxide, hydroxyethylcellulose, dibasic sodium phosphate, sodium cyclamate, citric acid, and purified water c.s.

Aspect of the product and contents of the packaging

This medicine is a red-colored solution that is presented in 120 ml and 240 ml oral solution containers accompanied by a dosing cup.

Holder of the marketing authorization and Responsible for the manufacture:

ITALFARMACO S.A.

San Rafael 3, 28108-Alcobendas (Madrid)

Tel. 916572323

Last review date of this leaflet: August 2021

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