Pinihelix

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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 certain conditions can be treated without the need for a doctor's consultation. However, to achieve a good treatment outcome, PiniHelix syrup must be used carefully and in accordance with the information provided in this leaflet.

• Keep this leaflet for future reference,
• Consult a doctor or pharmacist if you need advice or additional information,
• If symptoms worsen or do not improve after using the syrup, consult a doctor.

PiniHelix
Hederae helicis extractum fluidum
syrup
Contents of the pack: 120 ml
100 grams of syrup contains:
Fluid extract of ivy leaves (Hederae helicis extractum fluidum) 1.7 g,
Extraction solvent: ethanol 70% (v/v)
Dry extract of licorice root (Glycyrrhizae radix extr. sicc.) 5.0 g
extraction solvent: extraction water, ammonium hydroxide 10%
Fluid extract of thyme herb (Thymi extr. fl.) 4.0 g
extraction solvent: ethanol 30% (v/v), ammonium water, glycerol
Ammonium water, sodium benzoate, pine honey, purified water

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., Plant in Myślenice
ul. Cegielskiego 2
32-400 Myślenice

Contents of the leaflet:

1. What PiniHelix is and what it is used for
2. Before you take PiniHelix
3. How to take PiniHelix
4. Possible side effects
5. How to store PiniHelix
6. Further information about PiniHelix

1. What PiniHelix is and what it is used for

PiniHelix is a traditional herbal medicinal product intended for use in specific indications based exclusively on its long-standing use.
This herbal medicinal product is traditionally used for colds.
PiniHelix syrup contains a standardized extract of ivy leaves, as well as extracts of thyme and licorice.
The preparation is a combination of traditionally used expectorants (expectorantia).

2. Before using PiniHelix

Do not use PiniHelix in patients with hypertension, cardiac arrhythmias, liver or kidney diseases, or hypokalaemia (low blood potassium levels).
Exercise particular caution when using PiniHelix in certain specific patient groups
Use of PiniHelix in children:
Do not use in children under 12 years of age.
Pregnancy and breastfeeding:
Do not use in women who are pregnant or breastfeeding.
Other warnings:
Patients who experience alarming symptoms (e.g. laxative effect) after administration should discontinue the product and contact their doctor. Do not use for longer than 7 days without medical supervision. Do not exceed the recommended dosage.
Driving and operating machinery:
The syrup contains up to 4% v/v ethanol in the entire bottle, up to 400 mg per 10 ml dose of syrup, equivalent to 8 ml of beer or 3.4 ml of wine.
Important information about some of the ingredients in PiniHelix:
The syrup contains pine honey and sodium benzoate and should not be used in individuals allergic to bee products or sodium benzoate, or in those with hypersensitivity to the active substances or any of the other excipients contained in the preparation.
If symptoms persist during use of the product, or if adverse reactions not listed in the leaflet occur, consult a doctor.
Use with other medicines:
If PiniHelix syrup is used on a doctor's advice, inform them about all medicines taken recently, including those available without a prescription.
Prolonged use may lead to potassium deficiency, which in turn may enhance the effects of cardiac glycosides and antiarrhythmic agents. Potassium loss may be intensified when used concomitantly with thiazide diuretics, corticosteroids, or laxatives containing aloin.
Concomitant use with antitussive medicines such as codeine or dextromethorphan is not recommended.

3. How to use PiniHelix medicine

Proper use of PiniHelix preparation
PiniHelix medicine should be taken according to the recommended dosage or as directed by a physician. If
the doctor has not advised otherwise, the following dosing regimen is recommended:
Orally:
Adults and children over 12 years: 10 ml (2 teaspoonfuls) orally, three times daily.
Do not use for longer than 7 days.
If you feel that the effect of PiniHelix medicine is too strong or too weak, consult your doctor.

4. Possible adverse effects

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

• allergic reactions (such as urticaria, skin rash, dyspnoea)
• gastrointestinal symptoms (such as vomiting, nausea, diarrhoea). Very rarely (below 1/10,000), prolonged use may lead to potassium loss, sodium and water retention in the body, headache, muscle weakness, arterial hypertension, oedema. Overdose may manifest as nausea, vomiting, or diarrhoea. These symptoms usually resolve after discontinuation of the medicinal product.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, patients should inform their 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, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, E-mail: [email protected]. Adverse effects may also be reported to the marketing authorization holder. Reporting adverse effects helps to gather further information on the safety of the medicinal product.

5. Storage of the medicinal product PiniHelix

Keep the medicine out of the reach and sight of children.
Do not use after the expiry date stated on the packaging.
No special precautions for storage are required.
Store at a temperature not exceeding 25 ˚C.
Shelf life
2 years for the original sealed container.
Batch number and expiry date are indicated on the immediate packaging and outer packaging.
The syrup contains pine honey extract, which may cause cloudiness and sedimentation.
Shake well before use.
6. Other information
For further information, please contact the marketing authorisation holder:
Farmina sp. z o.o.
Lipska 44
30-721 Kraków
Date of preparation of the leaflet: 11.07.2017