Red bilberry fruit dry extract Laboratoire Pharmaceutique Pharmatoka

Package leaflet: Information for the user

Cranberry fruit, dry extract Laboratoire Pharmaceutique Pharmatoka hard capsules

Refined dry extract obtained from concentrated juice of Cranberry fruit
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if symptoms of a urinary tract infection occur during treatment with this medicine.

Contents of this leaflet:

1. What Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka is and what it is used for

2. What you need to know before using Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka

3. How to use Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka

4. Possible side effects

5. How to store Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka

6. Contents of the pack and other information

7. What Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka is and what it is used for

Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka is a traditional herbal medicine derived from plants, indicated for the prevention of recurrent acute uncomplicated lower urinary tract infections (UTIs), such as uncomplicated cystitis, in adult women aged 18 years and over.
The use of this traditional herbal medicinal product for the specified therapeutic indications is based solely on long-standing use.
If symptoms of a urinary tract infection occur during treatment with this medicine, medical advice must be sought.

2. What you need to know before using Cranberry fruit, dry extract Laboratoire Pharmaceutique Pharmatoka

Pharmaceutique Pharmatoka
Do not use Cranberry fruit, dry extract Laboratoire Pharmaceutique Pharmatoka:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from fluid retention due to kidney or heart problems
• if you currently have or have previously had kidney disorders or kidney problems, including kidney stones
• if you have a condition requiring you to limit fluid intake, such as severe heart or kidney problems
• if you are taking any anticoagulant medicines used to delay blood clotting, such as warfarin, acenocoumarol, phenprocoumon, phenindione, apixaban, edoxaban, dabigatran, or rivaroxaban. The effects of these medicines may be increased by cranberry (see also section “Other medicines and Cranberry fruit, dry extract Laboratoire Pharmaceutique Pharmatoka”)
• if you are taking tacrolimus (an immunosuppressant medicine) or are undergoing chemotherapy

(see also section “Other medicines and Cranberry fruit, dry extract Laboratoire Pharmaceutique Pharmatoka”).
Warnings and precautions
Talk to your doctor or pharmacist before using Cranberry fruit, dry extract Laboratoire Pharmaceutique Pharmatoka:

• consult your doctor or begin your usual treatment if symptoms of a urinary tract infection (UTI) occur
• consult your doctor if you are unsure whether you have a UTI
• consult your doctor if you have kidney disorders and experience recurrent urinary tract infections
• seek immediate medical attention if you develop any of the following symptoms: high temperature (fever), difficulty urinating or bladder spasms, pain during urination, blood in the urine, abdominal pain, back pain, or incontinence
• always consult your doctor if you are a man suffering from cystitis
• consult your doctor before taking this product if you are pregnant (also see section “Pregnancy and breastfeeding”).

Children and adolescents
Use in children and adolescents under 18 years of age is not recommended due to insufficient data, and medical advice must be sought before use in these age groups.
Other medicines and Cranberry fruit, dry extract Laboratoire Pharmaceutique Pharmatoka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must not use Cranberry fruit, dry extract Laboratoire Pharmaceutique Pharmatoka if you are taking any anticoagulant medicines used to delay blood clotting, the immunosuppressant medicine tacrolimus, or if you are undergoing chemotherapy (see also section “Do not use Cranberry fruit, dry extract Laboratoire Pharmaceutique Pharmatoka”).
Pregnancy and breastfeeding
The safety of concentrated Cranberry fruit juice, dry extract Laboratoire Pharmaceutique Pharmatoka during pregnancy and breastfeeding has not been established. In the absence of sufficient data, use during pregnancy and breastfeeding is not recommended.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No studies on the effects on the ability to drive vehicles or operate machinery have been conducted. However, Cranberry fruit, dry extract Laboratoire Pharmaceutique Pharmatoka is unlikely to have any effect on the ability to drive or operate machinery.

3. How to use Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka

Use this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and elderly: women over 18 years of age
Take one capsule of Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka
daily for 15 days. It is possible to continue and/or repeat the treatment to prevent recurrent infections.
It is recommended to consult your doctor to adjust the treatment frequency according to the individual patient's condition.
The capsule should be taken with a large glass of water.
Children and adolescents
The use of Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka is not
recommended in children and adolescents (see section 2).
If you take more Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka than you should
If you have accidentally taken more than the recommended dose of Mirtillo rosso frutti, estratto secco Laboratoire
Pharmaceutique Pharmatoka, this usually will not cause adverse effects. Continue taking your usual dose at the regular time. However, if you feel unwell, contact your doctor immediately or go to the nearest hospital emergency department.
If you forget to take Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur with the use of Cranberry fruit, dry extract
Laboratoire Pharmaceutique Pharmatoka are:

• Gastrointestinal effects such as malaise, nausea, diarrhoea, dyspepsia.
• Skin hypersensitivity reactions (e.g. skin rash and urticaria). Frequency is unknown. If other adverse reactions not listed above occur, consult a doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cranberry fruit, dry extract Laboratoire Pharmaceutique

Pharmatoka
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Store in the
original packaging.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka contains
Each hard capsule contains 195.7–216.9 mg of refined dry extract obtained from the concentrated juice
of Cranberry fruits ( Vaccinium macrocarpon Ait.), corresponding to 36 mg of proanthocyanidins
(PAC), calculated as PAC A2.
The other components are: mannitol, magnesium stearate (of vegetable origin), anhydrous colloidal silicon dioxide,
hypromellose 2910.

Description of the appearance of Mirtillo rosso frutti, estratto secco Laboratoire Pharmaceutique Pharmatoka and contents of the package
Hard, transparent, colourless capsules containing a dark purple powder (the natural colour of cranberry extract), packed in aluminium/PVC/PE/PVDC blisters, in pack sizes of 15, 30, 60 or 90 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratoire Pharmaceutique Pharmatoka S.A.S., 20-22 avenue de la République, 92500 Rueil Malmaison, France.
Manufacturer: Laboratoire Pharmaceutique Pharmatoka S.A.S., 20-22 avenue de la République, 92500 Rueil Malmaison, France.