Patient leaflet: information for the patient

Succus Hyperici Phytopharm, 2.425 g/2.5 ml, oral liquid
Hyperici succus
Please read all of this leaflet carefully before taking this medicine, because
it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet, or
as directed by a doctor, pharmacist, or nurse.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
If there is no improvement within 7 days, or if you feel worse, you should consult your doctor.

Contents of the leaflet

What Succus Hyperici Phytopharm is and what it is used for
Important information before taking Succus Hyperici Phytopharm
How to take Succus Hyperici Phytopharm
Possible side effects
How to store Succus Hyperici Phytopharm
Contents of the pack and other information

1. What Succus Hyperici Phytopharm is and what it is used for

Succus Hyperici Phytopharm contains juice from fresh St. John's wort herb, stabilized with ethanol.
Succus Hyperici Phytopharm is a herbal medicinal product in the form of an oral liquid.
Succus Hyperici Phytopharm is a traditional herbal medicinal product intended for use in the
indication listed below, based exclusively on long-standing use.
Indications for use
Traditionally used for dyspepsia.

2. Important information before using Succus Hyperici Phytopharm

When not to use Succus Hyperici Phytopharm

in case of hypersensitivity to St. John's wort,
in case of liver damage, e.g. due to alcoholic disease or poisoning – because of the ethanol content in the preparation,
in patients after organ transplantation and in HIV-infected patients receiving protease inhibitors (e.g. indinavir),
do not use in case of hypersensitivity to ultraviolet radiation.

You should consult a doctor, even if the above warnings refer to conditions
that occurred in the past.
Succus Hyperici Phytopharm
Natural product – sediment may form during storage.
Warnings and precautions

Before starting to use Succus Hyperici Phytopharm, you should discuss this
with your doctor, pharmacist, or nurse.
Exercise particular caution when using Succus Hyperici Phytopharm, because a single dose of the medicine (2.5 ml) contains approximately 0.6 g of ethanol, equivalent to about 6 ml of wine and about 15 ml of beer. The preparation may have harmful effects in individuals with alcohol dependence. The ethanol content of the preparation should be taken into account in high-risk groups, such as patients with liver damage or those suffering from epilepsy.
Taking St. John's wort preparations may cause photosensitivity, especially in individuals with fair skin; therefore, direct exposure to sunlight should be avoided during treatment with St. John's wort preparations.

Children and adolescents
Due to the ethanol content and lack of sufficient data, the medicine should not be used in children and adolescents under 18 years of age.

Succus Hyperici Phytopharm and other medicines
Because of the ethanol content, concomitant use of Succus Hyperici Phytopharm with other medicines that may have an adverse effect on the liver is not recommended.
The preparation may reduce blood levels of the following medicines: cyclosporine, indinavir and other protease inhibitors or reverse transcriptase inhibitors, phenprocoumon, warfarin, theophylline, and digoxin. Concomitant use of St. John's wort preparations with antidepressants that inhibit serotonin reuptake is not recommended. St. John's wort juice may reduce the effectiveness of oral contraceptives.
You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Use of Succus Hyperici Phytopharm with food and drink
Food does not affect the action of the medicine.

Pregnancy, breastfeeding, and fertility
The safety of using the medicine during pregnancy and breastfeeding, as well as its effect on fertility, has not been established. The medicine should not be used during pregnancy and breastfeeding.

Driving and operating machinery
The effect of the medicine on the ability to drive motor vehicles and operate moving machinery is unknown. Immediately after taking Succus Hyperici Phytopharm, alcohol may be detected by breath alcohol testing devices. For this reason, the medicine may impair safe driving, and driving motor vehicles or operating any mechanical equipment or using dangerous tools should be avoided immediately after taking the medicine. A minimum interval of one hour should be observed.
Succus Hyperici Phytopharm

3. How to use Succus Hyperici Phytopharm

This medicine should always be used exactly as described in this patient information leaflet, or
as directed by a doctor, pharmacist, or nurse. If in doubt, consult a
doctor, pharmacist, or nurse.
Adults:
Unless otherwise advised by a doctor, take 2.5 ml of the medicine up to three times daily,
diluted in a small amount of water.
Children and adolescents under 18 years of age:
Not recommended.
Duration of use:
If symptoms persist after 7 days, consult a doctor.
If you feel that the effect of Succus Hyperici Phytopharm is too strong or too
weak, consult your doctor or pharmacist.
Taking more Succus Hyperici Phytopharm than recommended
If more of the medicine is taken than recommended, symptoms related to the ethanol content may occur.
Using the medicine in a manner inconsistent with the recommended dosage may cause harmful effects in cases of liver damage,
alcoholism, epilepsy, brain damage, or mental disorders.
Overdose may occur when much higher doses than therapeutic ones are used or when treatment is prolonged,
and may manifest as phototoxic reactions such as rash, itching, and erythema.
Missing a dose of Succus Hyperici Phytopharm
If a dose of Succus Hyperici Phytopharm is missed, continue with the recommended dosing schedule. Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Mild gastrointestinal disturbances, nausea, restlessness, fatigue, headache, or allergic reactions may occur rarely.
In individuals with fair skin, inflammatory skin reactions (rash, redness) may occur during treatment.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C,
02-222 Warsaw,
Succus Hyperici Phytopharm
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl .
Adverse effects can also be reported to the responsible entity.
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Succus Hyperici Phytopharm

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use Succus Hyperici Phytopharm after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Succus Hyperici Phytopharm contains

The active substance is Hyperici herbae recentis succus – juice from fresh St. John's wort herb (1:1), stabilized with ethanol. Extraction solvent – ethanol 96% V/V, water.

The ethanol content in the medicinal product is 25–35% V/V.
What Succus Hyperici Phytopharm looks like and contents of the packaging
The immediate packaging of Succus Hyperici Phytopharm is a 100 ml bottle made of coloured glass, with a polyethylene cap and a flow restrictor. The bottle, together with a 20 ml measuring cup made of polypropylene, is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Phytopharm Klęka S.A.
Klęka 1, 63-040 Nowe Miasto nad Wartą
Poland
Tel.: +48 61 28 68 000
Fax: +48 61 28 68 529
[email protected]