Succus Hiperici Phitopharm

Patient Information Leaflet

Succus Hyperici Phytopharm

Leaflet attached to the packaging: information for the patient

Succus Hyperici Phytopharm, 2.425 g/2.5 ml, oral liquid
Hyperici succus

Read the leaflet carefully before taking the medicine, because

it contains important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet, or
according to the doctor's, pharmacist's, or nurse's instructions.

• The leaflet should be kept, so that it can be read again if necessary.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.
• If there is no improvement after 7 days or the patient feels worse, the doctor should be consulted.

Table of contents of the leaflet

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

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

Succus Hyperici Phytopharm contains fresh St. John's Wort herb juice, stabilized with ethanol. Succus Hyperici Phytopharm is a 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, resulting solely from its long-term use.

Indications for use

The medicine is traditionally used for indigestion.

2. Important information before taking Succus Hyperici Phytopharm

When not to take Succus Hyperici Phytopharm

• do not use in case of hypersensitivity to ultraviolet radiation.

A doctor should be consulted, even if the above warnings refer to past situations.

Patient Information Leaflet

Succus Hyperici Phytopharm

Natural product - during storage, sediment may form.

Warnings and precautions

Before starting to take Succus Hyperici Phytopharm, the doctor, pharmacist, or nurse should be consulted.
Particular caution should be exercised when taking Succus Hyperici Phytopharm, because the single dose of the medicine (2.5 ml) contains about 0.6 g of ethanol, which is equivalent to about 6 ml of wine and about 15 ml of beer. The preparation may cause harmful effects in people addicted to alcohol. The ethanol content in the preparation should be taken into account in people at high risk, such as patients with liver damage or suffering from epilepsy.
Taking St. John's Wort preparations may cause sensitization to sunlight, especially in people with fair skin, so direct exposure to sunlight during the use of St. John's Wort preparations is not recommended.

Children and adolescents

Due to the ethanol content and the 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

Due to the ethanol content, it is not recommended to take Succus Hyperici Phytopharm with other medicines that may have a negative effect on the liver.
The preparation may cause a decrease in the level of the following medicines in the blood: cyclosporine, indinavir, and other protease inhibitors-1 or reverse transcriptase inhibitors, fenprocoumon, warfarin, theophylline, and digoxin. It is not recommended to use St. John's Wort preparations with antidepressant medicines that inhibit serotonin reuptake. St. John's Wort juice may weaken the effect of oral contraceptives.
The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as about medicines that the patient plans to take.

Taking 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 using machines

The effect of the medicine on the ability to drive vehicles and operate machinery is not known. Immediately after taking Succus Hyperici Phytopharm, alcohol may be detectable by devices that measure alcohol in exhaled air. For this reason, the medicine may impair safe driving and operating machinery, and vehicles should not be driven and machinery should not be operated for at least one hour after taking the medicine.

Patient Information Leaflet

Succus Hyperici Phytopharm

3. How to take Succus Hyperici Phytopharm

This medicine should always be taken exactly as described in this patient information leaflet, or
according to the doctor's, pharmacist's, or nurse's instructions.
In case of doubts, the doctor, pharmacist, or nurse should be consulted.

Adults:

Unless the doctor recommends otherwise, the medicine should be taken up to 3 times a day, 2.5 ml diluted in a small amount of water.

Children and adolescents under 18 years of age:

The medicine is not recommended.

Duration of use:

If the symptoms do not improve after 7 days, the doctor should be consulted.
If the patient feels that the effect of Succus Hyperici Phytopharm is too strong or too weak, the doctor or pharmacist should be consulted.

Taking a higher dose of Succus Hyperici Phytopharm than recommended

In case of taking a higher dose of Succus Hyperici Phytopharm than recommended, symptoms related to the ethanol content may occur. Taking the medicine in a way that is not in accordance with the recommended dosage may cause harmful effects in case of liver damage, alcoholism, epilepsy, brain damage, and mental illnesses.
Overdose of the preparation may occur when much higher doses than therapeutic ones are used or when it is used for too long, and may manifest as phototoxic reactions, such as rash, itching, redness.

Missing a dose of Succus Hyperici Phytopharm

In case of missing a dose of Succus Hyperici Phytopharm, the recommended dosage should be continued, and a double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Mild gastrointestinal disorders, nausea, anxiety, fatigue, headaches, or allergic reactions may occur rarely.
In people with fair skin, inflammatory skin reactions (rash, redness) may occur during the use of the medicine.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181 C,
02-222 Warsaw,

Patient Information Leaflet

Succus Hyperici Phytopharm

tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Succus Hyperici Phytopharm

The medicine should be stored in a place that is out of sight and reach of children.
Store at a temperature below 25°C.
Succus Hyperici Phytopharm should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. 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- fresh St. John's Wort herb juice (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 what the packaging contains

The immediate packaging of Succus Hyperici Phytopharm is a 100 ml brown glass bottle with a polyethylene cap and a flow restrictor. The bottle, together with a 20 ml polypropylene measuring cup, is placed in a cardboard box.

Marketing authorization 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]

Date of the last update of the leaflet: