Patient Information Leaflet

Intractum Hyperici Phytopharm, 4.65 g/5 ml, oral liquid
Hyperici herbae recentis intractum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your 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 your symptoms do not improve or worsen after 14 days, consult your doctor.

Contents of the leaflet

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

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

This medicine is a traditional herbal medicinal product intended for use in specific indications based exclusively on long-standing use.
Indications
Traditional herbal medicinal product used to relieve transient states of nervous exhaustion.

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 photosensitivity, especially in individuals with fair skin,
during antiviral therapy for HIV infections,
after organ transplantation.

Warnings and precautions
Before starting treatment with Intractum Hyperici Phytopharm, consult your doctor, pharmacist, or nurse.
The medicine contains 52–62% (V/V) ethanol.
This medicine contains 2.6 g of alcohol (ethanol) per 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 alcohol content in this medicine is unlikely to affect adults significantly.
If the patient is alcohol-dependent, they should consult a doctor or pharmacist before using this medicine.
Avoid exposure to sunlight while taking this medicine.
If symptoms do not improve after 14 days, consult a 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
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Substances present in St. John's wort extract (hypericin, hyperforin) may induce drug-metabolizing enzymes (cytochrome P450 subunits: 1A2, 3A4, and 2C9), which may lead to reduced plasma concentrations or diminished effects of other concurrently administered medicines. Such effects have been observed when St. John's wort preparations were used together with warfarin, cyclosporine, theophylline, and digoxin.
When used concomitantly with antiviral drugs for HIV infection, St. John's wort extracts may reduce plasma concentrations of protease inhibitors (e.g. indinavir).
Concomitant use of St. John's wort with serotonergic antidepressants (serotonin reuptake inhibitors) is not recommended without prior consultation with a physician.
Alcohol in this medicine may alter the effects 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
No data available. Note that the medicinal product Intractum Hyperici Phytopharm contains 52–62% V/V alcohol.

Pregnancy, breastfeeding, and fertility
Do not use during pregnancy or breastfeeding. The effect of the medicine on fertility has not been established.

Driving and operating machinery
Intractum Hyperici Phytopharm contains ethanol.
Immediately after administration, ethanol may be detected by breath alcohol testing devices. Do not drive or operate machinery immediately after taking this medicine. A minimum interval of 30 minutes should be observed.

3. How to take Intractum Hyperici Phytopharm

This medicine should always be taken exactly as described in this patient leaflet, or
as directed by your doctor, pharmacist, or nurse. If in doubt, consult your
doctor, pharmacist, or nurse.
Adults:
Unless otherwise prescribed by a doctor, take orally 4 times daily 5 ml of the diluted
medicine in a small amount of liquid, preferably water.
If symptoms do not improve after 14 days, consult your doctor.
Use in children and adolescents under 18 years of age:
Do not use.
Taking more Intractum Hyperici Phytopharm than recommended
There have been no reported cases of overdose with medicines containing extract from fresh
St. John's wort herb.
Missing a dose of Intractum Hyperici Phytopharm
If you miss a dose of Intractum Hyperici Phytopharm, do not take a double dose to make up
for the missed dose.

4. Possible adverse reactions

Like any medicinal product, this medicine can cause adverse reactions, although not everybody will experience them.
Gastrointestinal disorders, allergic skin reactions, fatigue and restlessness may occur. The frequency of occurrence is unknown.
In individuals with fair skin, phototoxic reactions (skin burns, headaches) may occur during treatment with this medicine.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions 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,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Intractum Hyperici Phytopharm

Keep this medicine out of sight and reach of children.
Store below 25°C.
Natural product – sediment may form during storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Intractum Hyperici Phytopharm contains

The active substance is ethanolic extract of Hypericum perforatum L., herba (fresh herb of St. John's wort) - Hyperici herbae recentis intractum (1:1). Extraction solvent: 96% ethanol (V/V). The total hypericin content in a single dose (5 ml) is 0.05 mg.

The ethanol content in the medicinal product is 52–62% (V/V).
What Intractum Hyperici Phytopharm looks like and contents of the pack
Intractum Hyperici Phytopharm is a red-brownish liquid.
The immediate packaging consists of a 100 ml amber glass bottle with a polyethylene screw cap and a flow restrictor. The bottle, together with a 20 ml polypropylene measuring cup, 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]