Apipulmol

Patient Information Leaflet
Logo
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 the
physician, pharmacist, or nurse.

• Keep this leaflet for future reference,
• If advice or further information is needed, consult your pharmacist,
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the physician, pharmacist, or nurse. See section 4.
• If there is no improvement after several days or the patient feels worse, consult a physician.

Apipulmol
(2 g + 90 mg) 100 g
syrup
Sulfoguaiacol + Ammonii chloridum
Contents of the leaflet:

1. What Apipulmol is and what it is used for
2. Important information before taking Apipulmol
3. How to take Apipulmol
4. Possible side effects
5. How to store Apipulmol
6. Contents of the package and other information

1. What Apipulmol is and what it is used for

Apipulmol is a syrup intended for adults. It has expectorant properties and helps loosen mucus accumulated in the bronchial tree. It reduces mucus viscosity and facilitates its movement through the bronchi by stimulating the ciliary activity of the ciliated epithelium. Pine honey enhances the expectorant effect of the syrup. The use of this syrup does not cause disturbances in the bacterial flora of the gastrointestinal tract.
Indications: Inflammatory conditions of the upper respiratory tract, cough.

2. Important information before using Apipulmol

Warnings and precautions
Do not use Apipulmol if hypersensitivity to sulfoguaiacol, ammonium chloride, bee products, or any excipient is present.
Patients who observe disturbing symptoms (e.g. laxative effect) after taking the syrup should discontinue the medication and consult a doctor or pharmacist.
Patients with rare hereditary fructose intolerance disorders should not take this medicinal product. Apipulmol should not be used in individuals allergic to bee products.

Use of Apipulmol in children
Apipulmol should not be used in children.

Effect on fertility, pregnancy and lactation
Well-controlled clinical studies have not been conducted in pregnant or breastfeeding women; therefore, Apipulmol should not be used during pregnancy or breastfeeding.

Driving and operating machinery
The medicinal product contains 2.5% ethanol. In 10 ml of syrup there is 33 mg of pure ethanol, equivalent to 2.75 ml of wine or 6.6 ml of beer. Caution should be exercised when driving or operating machinery.

Important information about some ingredients of Apipulmol
The syrup contains pine honey. In 10 ml of syrup there is approximately 7.5 g of sugar. A patient with rare hereditary fructose intolerance should not take this medicinal product. Due to the presence of methyl parahydroxybenzoate, the medicine may cause allergic reactions (including delayed-type reactions). The medicine contains 2.5% ethanol. One dose (10 ml) corresponds to 2.75 ml of wine or 6.6 ml of beer.

Use with other medicines
If Apipulmol syrup is used on medical advice, inform your doctor about all medicines you are currently taking, including those obtained without a prescription.

3. How to use Apipulmol?

Apipulmol 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 medicine should be used as follows:
Adults: 10 ml (1 tablespoon) 3 or 4 times daily.
The syrup contains pine herb honey, which may cause cloudiness and sedimentation. Shake well before use.
If you feel that the effect of Apipulmol is too strong or too weak, consult your doctor.
Missed dose of Apipulmol
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions:

No severe adverse reactions have been observed.
Isolated cases of laxative effect have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
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 and fax numbers of the aforementioned Department}
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicinal product.

5. How to store Apipulmol?

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 honey, which may cause cloudiness and sediment. Shake before use.

6. Contents of the packaging and other information

What Apipulmol contains
100 g of syrup contains the following active substances: 2 g sulfoguaiacol and 90 mg ammonium chloride.
Excipients: pine honey (contains sucrose), methyl parahydroxybenzoate, ethanol, purified water.
10 ml of syrup contains 260 mg sulfoguaiacol and 12 mg ammonium chloride.

What Apipulmol looks like and contents of the pack
Amber glass bottle with an aluminium screw cap, in a cardboard box.
1 bottle containing 120 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków, Poland

Manufacturer:
Farmina sp. z o.o., Myślenice Plant
ul. Cegielskiego 2
32-400 Myślenice, Poland