Apitussic

Patient Information Leaflet

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Read the leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by
the doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.,
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after a few days there is no improvement or the patient feels worse, they should contact their doctor.

Apitussic

52 mg /5 ml
Syrup
Sulfogaiacol
Table of contents of the leaflet:

• 1. What is Apitussic and what is it used for
• 2. Important information before taking Apitussic
• 3. How to take Apitussic
• 4. Possible side effects
• 5. How to store Apitussic
• 6. Package contents and other information

1. What is Apitussic and what is it used for

Apitussic is a syrup intended for children and adults. It has an expectorant and mucolytic effect, making it easier to cough up mucus. It reduces the viscosity of mucus and facilitates its movement in the bronchi by stimulating the ciliary activity of the mucous membrane. The content of pine honey enhances the expectorant effect of the syrup. The use of the syrup does not disrupt the balance of the gut microflora.

2. Important information before taking Apitussic

Special precautions for certain groups of patients taking Apitussic

Using Apitussic in children

This medicine should not be given to children under 6 years of age.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor.

Other warnings

The medicine contains sugar (sucrose), so caution should be exercised in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. Avoid using the medicine in patients with active peptic ulcer disease - the medicine may exacerbate symptoms. Patients who have observed disturbing symptoms after taking the medicine (e.g., laxative effect) should discontinue Apitussic and consult their doctor. During treatment and within 24 hours of the last administration, metabolites of guaiacol present in the urine may alter the results of biochemical tests, especially the determination of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been reported.

Important information about some ingredients of Apitussic

The syrup contains pine honey. It should not be used in patients allergic to bee products.

Using other medicines

In the event of Apitussic being prescribed by a doctor, the patient should inform them about all medicines taken recently, including those available without a prescription.

3. How to take Apitussic

Proper use of Apitussic

Apitussic should be taken according to the dosage presented in this leaflet or as directed by the doctor. If the doctor does not recommend otherwise, the medicine should be taken as follows: children over 6 years old: 3 or 4 times a day, 5 ml (1 teaspoon); older children and adolescents: 3 or 4 times a day, 10 ml (2 teaspoons); adults: 3 or 4 times a day, 10 ml (1 tablespoon). If you feel that the effect of Apitussic is too strong or too weak, consult your doctor.

4. Possible side effects

No significant side effects have been observed. Isolated cases of laxative effect have occurred. There is a possibility of hypersensitivity to the ingredients of the medicine. Reporting side effects If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (current address, phone and fax number of the Department) e-mail: [email protected] Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Apitussic

The medicine should be stored in a place inaccessible and invisible to children. Store at a temperature below 25°C.

Shelf life

2 years After first opening: 30 days. Do not use this medicine after the expiry date stated on the label and carton. The syrup contains pine honey, which may cause cloudiness and sediment. Shake before use.

6. Package contents and other information

What Apitussic contains

5 ml of syrup contains the active substance: sulfoguaicol 52 mg. Excipients: pine honey (contains sucrose), sodium benzoate, purified water.

What Apitussic looks like and what the pack contains

Orange glass bottle with an aluminum cap in a cardboard box. 1 bottle of 120 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder: Farmina sp. z o.o. ul. Lipska 44 30-721 Kraków Manufacturer: Farmina sp. z o.o., Myślenice Plant ul. Cegielskiego 2 32-400 Myślenice Date of last update of the leaflet:31.07.2017