Apitussic
Poland
Table of Contents
Patient Information Leaflet
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Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.
- Keep this leaflet for future reference.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after a few days, or if you feel worse, you should contact your doctor.
Apitussic
52 mg /5 ml
Syrup
Sulfoguaiacol
Contents of the leaflet:
- What Apitussic is and what it is used for
- Important information before taking Apitussic
- How to take Apitussic
- Possible side effects
- How to store Apitussic
- Contents of the pack and other information
1. What Apitussic is and what it is used for
Apitussic is a syrup intended for children and adults. It has an expectorant effect and helps loosen mucus accumulated in the bronchial tree. It reduces the viscosity of mucus and facilitates its movement through the bronchi by stimulating the ciliary activity of the ciliated epithelium.
The presence of pine honey enhances the expectorant action of the syrup.
Use of this syrup does not cause disturbances in the composition of gastrointestinal flora.
2. Information before using Apitussic
Special precautions for certain specific groups using Apitussic
Use of Apitussic in children
This medicine should not be used in children under 6 years of age.
Pregnancy and breastfeeding
Before using any medicine, consult a doctor.
Other warnings
The medicine contains sugar (sucrose); therefore, caution should be exercised in diabetic patients.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking the medicine.
Avoid using the medicine in patients with active peptic ulcer disease – the medicine may exacerbate symptoms.
Patients who experience disturbing symptoms (e.g. laxative effect) after use
should discontinue Apitussic and consult a doctor.
During treatment and within 24 hours after the last dose, guaiacol metabolites present in
urine may alter biochemical test results, especially measurements of
5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid.
Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed to date.
Important information about certain components of Apitussic
The syrup contains pine honey. It should not be used in individuals allergic to bee products.
Use with other medicines
If Apitussic syrup is used on a doctor's advice, inform the doctor about all medicines currently being taken, including those obtained without a prescription.
3. How to use Apitussic
Proper use of Apitussic
Apitussic should be used according to the dosage instructions provided in this leaflet or as directed by a physician.
If not otherwise advised by a doctor, the recommended dosage is as follows:
children over 6 years of age: 5 ml (1 teaspoon) 3 or 4 times daily;
older children and adolescents: 10 ml (2 teaspoons) 3 or 4 times daily;
adults: 10 ml (1 tablespoon) 3 or 4 times daily.
If you feel that the effect of Apitussic is too strong or too weak, consult your doctor.
4. Possible adverse effects
No significant adverse symptoms have been observed.
There have been isolated cases of laxative effect.
Hypersensitivity to the components of the medicine is possible.
Reporting of adverse effects
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products {current address, telephone number, and fax number of the aforementioned Department}
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to collect further information on the safety of the medicine.
5. How to store Apitussic
Keep the medicine out of the reach and sight of children.
Store below 25°C.
Shelf life
2 years
30 days after first opening.
Do not use this medicine after the expiry date stated on the label and carton.
The syrup contains pine tree honey, which may cause cloudiness and sediment. Shake well before use.
6. Contents of the package and other information
What Apitussic contains
5 ml of syrup contains the active substance: sulfoguaiacol 52 mg.
Excipients: pine honey (contains sucrose), sodium benzoate, purified water.
What Apitussic looks like and contents of the pack
Amber glass bottle with an aluminium cap in a cardboard box.
1 bottle of 120 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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