Pinihelix

Patient Leaflet

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Read the entire leaflet carefully, as it contains important information for the patient.
This medicine is available without a prescription, so that it can be used to treat certain conditionswithout the help of a doctor. However,
to achieve good treatment results, the PiniHelix syrup should be used carefully and in accordance with
the information in the leaflet.

• keep this leaflet, so that it can be read again if necessary,
• consult a doctor or pharmacist if advice or additional information is needed,and
• if symptoms worsen or do not improve after using the syrup, consult a doctor,and

PiniHelix

Hederae helicis extractum fluidum
syrup
Medicinal product content in the packaging: 120 ml
100 grams of syrup contain:
Liquid extract of ivy leaves ( Hederae helicis extractum
fluidum)
1.7 g,
Extractant: ethanol 70 % (v/v)
Dry extract of licorice root ( Glycyrrhizae radix extr.
sicc.)
5.0 g
extractant: water for extraction, ammonium hydroxide 10 %
Liquid extract of thyme herb ( Thymi extr. fl)
4.0 g
extractant: ethanol 30 % (v/v), ammoniacal water, glycerol
Ammoniacal water, sodium benzoate, pine honey,
purified water

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
Table of contents of the leaflet:

• 1. What is PiniHelix and what is it used for
• 2. Before using PiniHelix
• 3. How to use PiniHelix
• 4. Possible side effects
• 5. Storage of PiniHelix
• 6. Other necessary information about PiniHelix

1. What is PiniHelix and what is it used for

Traditional herbal medicinal product PiniHelix intended for use in specified indications resulting solely from its long-term use.

Herbal medicinal product traditionally used in colds.
PiniHelix syrup contains a standardized extract of ivy leaves and extracts of thyme and licorice.
The preparation is a composition of traditionally used expectorants.

2. Before using PiniHelix

PiniHelix must not be used in patients with hypertension, heart rhythm disorders, liver and kidney diseases, hypokalemia (low potassium level in the blood).

Special precautions in certain patient groups using PiniHelix

Using PiniHelix in children:

PiniHelix must not be used in children under 12 years of age.

Pregnancy and breastfeeding:

PiniHelix must not be used in pregnant or breastfeeding women.

Other warnings:

Patients who have observed disturbing symptoms after using the product (e.g. laxative effect) should discontinue the product and consult a doctor. The product should not be used for more than 7 days without medical supervision. Do not exceed the recommended dosage.

Driving and operating machinery:

The syrup contains a maximum of 4 % (v/v) ethanol in the entire bottle, a maximum of 400 mg per 10 ml dose of syrup, which corresponds to 8 ml of beer and 3.4 ml of wine.

Important information about some ingredients of PiniHelix:

The syrup contains pine honey and sodium benzoate, and should not be used in people allergic to bee products or sodium benzoate, and in case of hypersensitivity to the active substances or other excipients contained in the preparation.
If symptoms do not improve during use of the product or side effects occur, not mentioned in the leaflet, consult a doctor.

Using other medicines:

In case of using PiniHelix syrup on a doctor's prescription, inform about all recently taken medicines, even those available without a prescription.
In case of long-term use, potassium deficiency may occur, which in turn enhances the effect of cardiac glycosides and antiarrhythmic agents. Potassium loss may be increased when used concomitantly with thiazide diuretics, adrenal cortex steroids, and laxative preparations containing aloin.
Concomitant use with cough suppressants such as codeine or dextromethorphan is not recommended.

3. How to use PiniHelix

Proper use of PiniHelix preparation

PiniHelix should be used in accordance with the recommended dosage or as directed by a doctor. If the doctor does not recommend otherwise, the following dosage regimen is recommended:
Orally:
Adults and children over 12 years: orally 10 ml (2 teaspoons) 3 times a day
Do not use for more than 7 days.
If you feel that the effect of PiniHelix is too strong or too weak, consult a doctor.

4. Possible side effects

No serious side effects have been observed. Side effects occur very rarely, with a frequency below 1/10,000:

• allergic reactions (such as hives, skin rash, shortness of breath)
• gastrointestinal symptoms (such as vomiting, nausea, diarrhea). Very rarely (below 1/10,000) with longer use, potassium loss, sodium and water retention in the body, headaches, muscle weakness, hypertension, edema may occur. Overdose may manifest as nausea, vomiting, or diarrhea. These symptoms usually disappear after discontinuation of the product. Reporting side effects If any side effects occur, including any side effects not listed in the leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax +48 22 49 21 309, e-mail: ndl@urpl.gov.pl 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 product.

5. Storage of PiniHelix

The product should be stored in a place inaccessible and invisible to children.
Do not use after the expiry date stated on the packaging.
The product does not require special precautions for storage.
Store at a temperature not exceeding 25 ˚C.

Shelf life

2 years for the factory-sealed packaging.
Batch number and expiry date of the product on the immediate and outer packaging.
The syrup contains pine honey, which may cause cloudiness and sediment.
Shake before use.

6. Other information

To obtain more detailed information, contact the marketing authorization holder:
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
Date of preparation of the leaflet: 11.07.2017