Intractum Hiperici Phitopharm

Leaflet attached to the packaging: patient information

Intractum Hyperici Phytopharm, 4.65 g/5 ml, oral liquid

Hyperici herbae recentis intractum

Please read carefully the contents of the leaflet before using the medicine, as it contains

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

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

This medicine is a traditional herbal medicinal product intended for use in
specific indications resulting solely from its long-term use.

Indications for use

A traditional herbal medicine used to relieve transient nervous exhaustion states.

2. Important information before using Intractum Hyperici Phytopharm

When not to use Intractum Hyperici Phytopharm

• if the patient is allergic to St. John's Wort or any of the other ingredients of this medicine,
• in case of hypersensitivity to sunlight, especially in people with fair skin,
• during antiviral therapy in the case of HIV virus infection,
• after organ transplantation.

Warnings and precautions

Before starting to use Intractum Hyperici Phytopharm, the patient should discuss it with their doctor, pharmacist, or nurse.
This medicine contains 52-62% (V/V) ethanol.
This medicine contains 2.6 g of alcohol (ethanol) in a 5 ml dose. The amount of alcohol in 5 ml of this medicine is equivalent to 65 ml of beer or 26 ml of wine.
The amount of alcohol in this medicine is unlikely to have an effect on adults.
If the patient is addicted to alcohol, they should consult their doctor or pharmacist before using this medicine.
During the use of the medicine, the patient should avoid exposure to the sun.
If the symptoms do not improve after 14 days, the patient should contact their doctor.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Intractum Hyperici Phytopharm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.
The substances contained in the St. John's Wort extract (hypericin, hyperforin) may cause induction of enzymes that metabolize medicines (cytochrome P450 subunits: 1A2, 3A4, and 2C9), which may lead to a decrease in the plasma concentration or weakening of the effect of other medicines used simultaneously with St. John's Wort extracts. Such effects have been observed when using St. John's Wort preparations together with warfarin, cyclosporine, theophylline, and digoxin.
During combination therapy for HIV virus infection with antiviral medicines, St. John's Wort extracts cause a decrease in the plasma concentration of protease inhibitors (e.g., indinavir).
It is not recommended to use St. John's Wort together with antidepressant medicines that inhibit serotonin reuptake without consulting a doctor.
The alcohol in this medicine may change the effect of other medicines.
Patients taking prescription medicines should consult their doctor or pharmacist before using St. John's Wort.

Intractum Hyperici Phytopharm with food, drink, and alcohol

There are no data. It should be remembered that the medicinal product Intractum Hyperici Phytopharm contains 52-62% V/V alcohol.

Pregnancy, breastfeeding, and fertility

Not to be used during pregnancy and breastfeeding. The effect of the medicine on fertility has not been established.

Driving and using machines

Intractum Hyperici Phytopharm contains ethanol.
Immediately after using the medicine, ethanol may be detectable by devices that measure alcohol in exhaled air. The patient should not drive vehicles or operate machinery immediately after using this medicine. A break of at least 30 minutes should be taken.

3. How to use Intractum Hyperici Phytopharm

This medicine should always be used exactly as described in this patient leaflet or
according to the doctor's, pharmacist's, or nurse's instructions. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.

Adults:

Unless the doctor has prescribed otherwise, the patient should take 4 times a day, 5 ml of the medicine diluted in a small amount of liquid, preferably water.
If the symptoms do not improve after 14 days, the patient should contact their doctor.

Use in children and adolescents under 18 years of age:

Not to be used.

Using more than the recommended dose of Intractum Hyperici Phytopharm

No cases of overdose with medicines containing fresh St. John's Wort extract have been reported.

Missing a dose of Intractum Hyperici Phytopharm

In case of a missed dose, the patient should not take a double dose 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.
Gastrointestinal disorders, skin allergic reactions, fatigue, and restlessness may occur. The frequency of these effects is not known.
In people with fair skin, phototoxic reactions (skin burns, headaches) 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 patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181 C,
02-222 Warsaw,
phone: +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 gather more information on the safety of the medicine.

5. How to store Intractum Hyperici Phytopharm

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Natural product - sediment may form during storage.
The medicine 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 patient should ask their pharmacist 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 Intractum Hyperici Phytopharm contains

• The active substance of the medicine is ethanol extract of Hypericum perforatumL., herba (fresh St. John's Wort) - Hyperici herbae recentis intractum(1:1). Extraction solvent: ethanol 96% (V/V). The content of the sum of hypericins in a single dose (5 ml) is 0.05 mg.

The ethanol content in the medicine is 52 - 62% (V/V).

What Intractum Hyperici Phytopharm looks like and what the packaging contains

Intractum Hyperici Phytopharm is a reddish-brown liquid.
The immediate packaging of the product 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
Phone: +48 61 28 68 000
Fax: +48 61 28 68 529
info@europlant-group.pl

Date of the last update of the leaflet: