PATIENT INFORMATION LEAFLET

PERMIXÓN 160 mg hard capsules

Serenoa repens lipidosterolic extract

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms of disease as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Permixón is and what it is used for

2.What you need to know before taking Permixón

3.How to take Permixón

4.Possible side effects

5Storage of Permixón

6.Contents of the pack and additional information

Permixón contains as its active ingredient lipidosterolic extract ofSerenoa repens.

It belongs to the group of medications used in the treatment ofbenign prostatic hyperplasiaand acts at the prostate level to improve symptoms associated with this diseasethanks to its inhibitory action on 5-alpha reductase (reduces the formation of the hormone responsible for increasing the volume of the prostate), its local anti-inflammatory action andantiproliferative action (reduces theproliferation of prostate cells).

Permixón is used in adult men for the treatment of moderate urinary disorders linked to benign prostatic hyperplasia.

Do not take Permixón

• if you are allergic to the active ingredient andliposterolic extract ofSerenoa repensor to any of the other components of this medication (listed in section 6).
• it is not indicated for women or children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Permixón.

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

Permixón interaction with other medications

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medication.

No interactions with other frequently used medications for this disease (urinary antibiotics, antiseptics, and anti-inflammatory agents) have been described. To avoid any potential interactions between several medications, you must consult with your doctor or pharmacist about any other treatment you are following.

Permixón with food and drink

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

Pregnancy, breastfeeding, and fertility

Permixón is not indicated for women.

Driving and operating machines

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual dose is the oral intake of1 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 Permixón than you should

You may experience symptoms in the form of transient gastrointestinal disturbances (abdominal pain).

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

If you forgot to take Permixón

Do not take a double dose to compensate for the missed doses.

Continue treatment without changing the dosage regimen.

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

Like all medications, Permixón may produce adverse effects, although not all people will experience them.

The adverse effects that may occur are:

Frequent (may affect up to 1 in 10 patients)

- Headache.

- Abdominal pain.

Possible (may affect up to 1 in 100 patients)

- Nausea.

- Increased gamma-glutamyltransferase, moderate increase in transaminases (liver enzymes).

- Skin redness (rash).

- Gynecomastia (enlargement of breast glands in men). Reversible upon treatment interruption.

Unknown frequency (cannot be estimated from available data)

- Edema.

Reporting Adverse Effects:

If you experienceany type of adverse effect, consult your doctor or pharmacist even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly tothrough the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above30°C.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicatedafter CAD..

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Permixón

• Each hard capsule contains 160 mg of lipidosterolic extract from the fruit ofSerenoa repens(Bartram) Small (DER 7-11:1). Hexanic solvent.
• The other components arepolyethylene glycol10,000 and on the capsule coating: gelatin, yellow iron oxide (E172), indigotin(E132) and titanium dioxide (E171).

Appearance of the product and content of the packaging

Each box of Permixón contains 60 hard capsules.

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

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 – Barcelona (Spain)

Responsible for manufacturing

PIERRE FABRE MEDICAMENT PRODUCTION

Rue du Lycee, Industrial Zone of Cuiry,

Gien, F-45500 France

This leaflet has been approved inOctober 2015.

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