Package leaflet: Information for the patient

ALLIOFIL
Allii sativi bulbus + Urticae folium
200 mg + 53.5 mg
enteric-coated tablet
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 possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If your symptoms do not improve or worsen, you should contact your doctor.

Contents of the leaflet:

What Alliofil is and what it is used for
Important information before taking Alliofil
How to take Alliofil
Possible side effects
How to store Alliofil
Contents of the pack and other information
What Alliofil is and what it is used for
Alliofil is a traditional herbal medicinal product intended for use in specific indications based solely on its long-standing use. Traditionally, Alliofil is used prophylactically and as supportive treatment in mild upper respiratory tract infections (common cold symptoms). If there is no improvement or if the patient feels worse, medical advice should be sought.
Important information before taking Alliofil
When not to take Alliofil

if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Alliofil,
if you are allergic to sulfur compounds,
if you have liver insufficiency, bronchial asthma, or food allergy.
Sulfur compounds from garlic are excreted through the skin in sweat and through the lungs, which consequently causes changes in body odor and breath.

Warnings and precautions
During treatment with Alliofil, sulfur compounds are excreted through the skin in sweat and through the lungs, leading to changes in body odor and breath.

Children and adolescents
Safety studies in children and adolescents have not been conducted.
Use in adolescents under 18 years of age should only be considered after prior consultation with a doctor.

Alliofil and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription. No interactions with other medicines have been reported so far. However, there is a potential for interaction with non-steroidal anti-inflammatory drugs (NSAIDs). Alliofil may enhance the effect of anticoagulant and antiplatelet drugs.

Taking Alliofil with food and drink
It is recommended to take the medicine after meals. Tablets should be swallowed whole.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Due to lack of data confirming safety, use of this product during pregnancy is not recommended. It is also not recommended during breastfeeding, as sulfur compounds from garlic pass into breast milk and may alter its odor.

Driving and using machines
The use of this medicine does not affect the ability to drive or operate machinery.

How to take Alliofil
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 or pharmacist.
For prophylaxis of upper respiratory tract infections: adults, 1 tablet three times daily.
Supportive treatment in mild upper respiratory tract infections (common cold symptoms): adults, 1 to 3 tablets three times daily. The medicine should be taken after main meals. Do not chew the tablets.

Duration of use: For prophylactic purposes, the medicine may be used without medical consultation for up to 6 months. If used therapeutically for common cold symptoms and symptoms do not improve within 7 days, you should contact your doctor.

Use in children and adolescents
Due to lack of data confirming safety, use of this medicine is not recommended in children. In adolescents, use may be considered after prior consultation with a doctor.

Taking more Alliofil than recommended
There is no data on symptoms of overdose. Overdose increases the risk and severity of adverse reactions.

If you miss a dose of Alliofil
Do not take a double dose to make up for a missed tablet.

Stopping Alliofil
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alliofil can cause side effects, although not everybody gets them.
During treatment, allergic skin and respiratory reactions as well as gastrointestinal disturbances may occur.
If any of the adverse reactions worsen or if you experience any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Reporting suspected adverse reactions
After a medicinal product has been authorized, it is important to report suspected adverse reactions. This allows continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare professionals are expected to report any suspected adverse reactions via the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 48 22 49 21 301, fax 48 22 49 21 309, e-mail: [email protected]

How to store Alliofil
Store at a temperature not exceeding 25°C. Keep out of the reach and sight of children.

Do not use Alliofil after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

Contents of the pack and other information
Active substances: Allii sativi bulbus (garlic bulb) dry extract 200 mg, Urticae folium (nettle leaf) dry extract 53.5 mg.
Excipients: See section 6 of the package leaflet.
Pharmaceutical form: Enteric-coated tablet.
Marketing authorization holder: [Company name and address]
Manufacturer: [Manufacturer name and address]
Pack sizes: [List of available pack sizes]
PL XXXX/XX
Date of first authorisation: [Date]
Date of latest revision of the leaflet: [Date]

6. Contents of the packaging and other information

What Alliofil contains
The active substances in the medicine are:
200 mg Allium sativum L., bulbus (garlic bulb) and 53.5 mg Urtica dioica L., folium (nettle leaf).
The medicine also contains the following excipients: microcrystalline cellulose with anhydrous colloidal silicon dioxide, magnesium stearate, povidone, sodium croscarmellose, methacrylic acid-ethyl acrylate copolymer, propylene glycol, indigo carmine E 132, quinoline yellow E 104.

What Alliofil looks like and contents of the pack
Alliofil is available as enteric-coated tablets.
The available pack contains 2 Al/PVC blisters with 15 tablets each, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Poland
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47-51, 61-896 Poznań
tel. + 48 61 886 18 00, fax +48 61 853 60 58

Label content on the immediate packaging (blister):
ALLIOFIL
Allii sativi bulbus + Urticae folium
enteric-coated tablet, 200 mg + 53.5 mg
Lot:
EXP:
Poznańskie Zakłady Zielarskie „Herbapol” S.A.

Text on the outer packaging (cardboard box for blisters):
ALLIOFIL
Allii sativi bulbus + Urticae folium
200 mg + 53.5 mg
enteric-coated tablet
supports in upper respiratory tract infections
Product intended for adults.
30 tablets
Alliofil is a traditional herbal medicinal product, the indications of which are exclusively based on long-standing use. Consult a doctor if symptoms persist during use or if adverse effects not listed in the leaflet occur.

Composition:
Active substances: 1 tablet contains: powdered garlic bulb (Allii sativi bulbus) 200 mg; powdered nettle leaf (Urticae folium) 53.5 mg.

Method of administration and dosage:
For prevention of upper respiratory tract infections: adults – 1 tablet three times daily.
As supportive treatment in mild upper respiratory tract infections (common cold symptoms): adults – 1 to 3 tablets three times daily. The medicine should be taken after main meals.

The medicine is available without a prescription – OTC.
Keep the medicine out of the reach and sight of children.
Store below 25°C.
Expiry date (EXP):

Marketing Authorisation Holder:
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47-51, 61-896 Poznań
Batch number (Lot):
Authorisation number: R/0062
EAN UCC code:
Medicinal product name in Braille