PERMIXON 160 mg HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PERMIXON 160 mg hard capsules

Lipidosterolic extract of Serenoa repens

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Permixon and what is it used for
2. What you need to know before you take Permixon
3. How to take Permixon
4. Possible side effects

5 Storage of Permixon

1. Contents of the pack and further information

1. What is Permixon and what is it used for

Permixon contains as active substance lipidosterolic extract of Serenoa repens.

It belongs to the group of medicines used in benign prostatic hyperplasia and acts at the prostate level, improving the symptoms associated with this disease, thanks to its inhibitory action of 5-alpha reductase (decreases the formation of the hormone responsible for increasing prostate volume), its local anti-inflammatory action, and antiproliferative action (reduces the proliferation of prostate cells).

Permixon is used in adult men for the treatment of moderate urinary disorders associated with benign prostatic hyperplasia.

2. What you need to know before you take Permixon

Do not take Permixon

• if you are allergic to the active substance lipidosterolic extract of Serenoa repensor to any of the other components of this medicine (listed in section 6).
• it is not indicated in women or children.

Warnings and precautions

Consult your doctor or pharmacist before you start taking Permixon.

• Administration of this medicine on an empty stomach may cause nausea, and therefore, it should be administered during meals.
• Permixon cannot replace prostatectomy, and during treatment, you should be under continuous medical supervision.

Interaction of Permixon with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

No interference has been described with other frequently used medicines for treating this disease (urinary antibiotics, antiseptics, and anti-inflammatories). To avoid potential interactions between several medicines, you should consult your doctor or pharmacist about any other treatment you are following.

Permixon with food and drinks

It is recommended to take Permixon during meals and with a glass of water without chewing.

Pregnancy, breastfeeding, and fertility

Permixon is not indicated for women.

Driving and using machines

No effects have been observed on the ability to drive and use machines.

3. How to take Permixon

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The normal dose is the ingestion, by oral route, of 1 capsule of 160 mg twice a day, during meals, in two doses (1 in the morning and 1 at night).

Do not chew.

In some cases, it may be necessary to wait 4-8 weeks to determine if a beneficial response has been achieved.

If you take more Permixon than you should

Transient gastrointestinal disorders (abdominal pain) may appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Permixon

Do not take a double dose to make up for forgotten doses.

Continue treatment without changing the dosage.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Permixon can cause side effects, although not everybody gets them.

The side effects that can occur are:

Frequent (may affect up to 1 in 10 patients)

• Headache.
• Abdominal pain.

Uncommon (may affect up to 1 in 100 patients)

• Nausea.
• Increased gamma-glutamyltransferase, moderate increase in transaminases (liver enzymes).
• Redness of the skin (rash).
• Gynecomastia (enlargement of breast tissue in men). Reversible after treatment discontinuation.

Frequency not known (cannot be estimated from the available data)

• Edema.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of PERMIXON

Do not store above 30°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Permixon

• Each hard capsule contains 160 mg of lipidosterolic extract of the fruit of Serenoa repens(Bartram) Small (DER 7-11:1). Hexanic solvent.
• The other components are polyethylene glycol 10,000 and in the capsule shell: gelatin, yellow iron oxide (E172), indigotine (E132), and titanium dioxide (E171).

Appearance and packaging

Each box of Permixon contains 60 hard capsules.

The hard capsules are pale green in color and contain a yellow-green paste with a characteristic odor.

Marketing authorization holder and manufacturer

Marketing authorization holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 – Barcelona (Spain)

Manufacturer

PIERRE FABRE MEDICAMENT PRODUCTION

Rue du Lycee, Zone Industrielle de Cuiry,

Gien, F-45500 France

This leaflet was approved inOctober 2015.

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”