Permixon 160 mg hard capsules
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERMIXÓN 160 mg hard capsules
Lipido-sterolic extract of Serenoa repens
Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Permixón is and what it is used for
- What you need to know before taking Permixón
- How to take Permixón
- Possible side effects
- How to store Permixón
- Contents in the pack and other information
1. What Permixón is and what it is used for
Permixón contains as its active ingredient lipidosterolic extract of Serenoa repens.
It belongs to the group of medications used for benign prostatic hyperplasia and acts at the prostate level, improving the associated symptoms thanks to its 5-alpha reductase inhibitory action (reduces the formation of the hormone responsible for increasing prostate volume), as well as its local anti-inflammatory and antiproliferative effects (reduces proliferation of prostate cells).
Permixón is used in adult men for the treatment of mild to moderate urinary disorders associated with benign prostatic hyperplasia.
2. What you need to know before starting to take Permixón
Do not take Permixón
- if you are allergic to the active substance, lipidosterolic extract of Serenoa repens, or to any of the other ingredients of this medicine (listed in section 6).
- it is not indicated in women or children.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Permixón.
- Administering medicines on an empty stomach may cause nausea; therefore, Permixón should be taken with meals.
During treatment, as routine monitoring of benign prostatic hyperplasia, the patient must remain under continuous medical supervision.
Interaction of Permixón with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
No interactions have been observed with other medicines commonly used to treat this condition (urinary antibiotics, antiseptics, and anti-inflammatory drugs). To avoid potential interactions between multiple medicines, you must inform your doctor or pharmacist about all other treatments you are currently receiving.
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 use in women.
Driving and use of machines
No effects on the ability to drive or operate machinery have been observed.
3. How to take Permixón
Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.
The usual dose is oral administration of 1 capsule of 160 mg twice daily, during meals, in two doses (1 in the morning and 1 at night).
Do not chew.
In some cases, a period of 4–8 weeks may be necessary to determine whether a beneficial response has been achieved.
If you take more Permixón than you should
Symptoms such as transient gastrointestinal disturbances (abdominal pain) may occur.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Permixón
Do not take a double dose to make up for missed doses.
Continue the treatment without changing the dosage regimen.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Permixón may cause adverse effects, although not everyone experiences them.
The adverse effects that may occur are:
Common (may affect up to 1 in 10 patients)
- Headache.
- Abdominal pain.
Uncommon (may affect up to 1 in 100 patients)
- Nausea.
- Increased gamma-glutamyl transferase, moderate increase in transaminases (liver enzymes).
- Skin redness (rash).
- Gynaecomastia (enlargement of breast glands in men). Reversible after discontinuation of treatment.
Frequency not known (cannot be estimated from available data)
- Edema.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the packaging. The expiry date is the last day of the month indicated after EXP.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Permixón
- Each hard capsule contains 160 mg of lipidosterolic extract from the fruit of Serenoa repens (Bartram) Small (DER 7-11:1). Hexane 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 of the product and contents of the pack
Each Permixón box contains 60 hard capsules.
The hard capsules are pale green in colour and contain a yellowish-green paste with a characteristic odour.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PIERRE FABRE IBÉRICA, S.A.
C/ Ramón Trias Fargas, 7-11
08005 – Barcelona (Spain)
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
Progipharm site
Rue du Lycee,
Gien, 45500 France
This leaflet was approved in August 2025.
“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/”