Prospecto: information for the patient

Pectox Forte 100 mg/ml Oral Solution

Carbocisteine

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Pectox Forte.

3.How to take Pectox Forte.

4.Possible adverse effects.

5Storage of Pectox Forte.

6. Contents of the package and additional information.

Pectox Forte contains carbocisteine. Carbocisteine belongs to a group of medicines called mucolytics, although it has a mucoregulating action, which liquefies and reduces the viscosity of mucus to facilitate its elimination.

It is indicated in the treatment of disorders of mucous secretion that appear in acute and chronic processes of the respiratory tract.

Pectox Forte is indicated in adults (18 years and older), adolescents (over 12 years), and children from 2 years old.

Do not take Pectox Forte

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pectox Forte.

• Do not take at the same time as a medication that inhibits the cough reflex.
• During the first few days, it is normal for mucus production to increase, but if symptoms persist for more than 5 days or worsen, you must inform your doctor.

Other medications and Pectox Forte

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

Do not take this medication with antitussives (medications used for dry cough) or those that reduce bronchial secretions, as it may cause a buildup of fluidified mucus.

Taking Pectox Forte with food and drinks

See section 3 for instructions on how to take Pectox Forte.

Pregnancy, breastfeeding, and fertility

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. This medication is not recommended for use in pregnant women or breastfeeding women.

Driving and operating machines

The influence of Pectox Forte on the ability to drive and operate machines is negligible or insignificant.

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

Pectox Forte contains sodium methylparahydroxybenzoate (E-219).This medication may cause allergic reactions (possibly delayed) because it contains sodium methylparahydroxybenzoate (E-219).

Pectox Forte contains sodium.This medication contains 14.2 mg of sodium (main component of table salt/for cooking) per ml. This is equivalent to 10% 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.

The recommended dose is:

Adults and adolescents (over 12 years):

15 ml of oral solution (1,500 mg of carbocisteine) in a single dose, every 24 hours.

Pediatric population:

Children aged 6 to 12 years::

7.5 ml of oral solution (750 mg of carbocisteine) in a single dose, every 24 hours.

Children aged 2 to 5 years::

5 ml of oral solution (500 mg of carbocisteine) in a single dose, every 24 hours.

This medication is taken orally.

This medication comes with a dosing cup that has the following markings: 2.5 ml, 4 ml, 5 ml, 7.5 ml, 8 ml, 8.5 ml, and 10 ml. The oral solution is taken directly from the dosing cup or by pouring the contents of the dosing cup into a glass with a sufficient amount of water or other liquid. Take this medication preferably before meals. It is recommended to drink plenty of liquid during the day.

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

If you take more Pectox Forte than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount ingested.

If you forget to take Pectox Forte

If you forget to take a dose, take it as soon as you can.

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

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

If you interrupt treatment with Pectox Forte

Your doctor will indicate the duration of treatment. Do not discontinue treatment before, even if you feel better, as you will not have the expected effectiveness.

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

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

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

Gastrointestinal disorders such as: nausea, vomiting, diarrhea, or dyspepsia (gastrointestinal discomfort). In some cases, reducing the administered dose may be helpful.

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

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

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

Bronchospasm (asthma).

In these cases, it is recommended to discontinue treatment as soon as possible.

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.

No requires special conditions for conservation.

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.

Medications should not be thrown down the drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pectox Forte

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

Appearance of the product and contents of the packaging

This medication is presented in a transparent PET bottle containing 240 ml or 120 ml of red-colored oral solution with a raspberry odor and taste, accompanied by a 10 ml measuring cup.

Holder of the marketing authorization and responsible for manufacturing

ITALFARMACO S.A.

San Rafael, 3 – 28108 Alcobendas (Madrid)

Tel.: 91 657 2323

Date of the last review of this leaflet:August 2021

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