Permixon

Package leaflet: Information for the user

Permixon 320 mg soft capsules

Lipido-sterolic extract of Serenoa repens
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Permixon is and what it is used for
2. What you need to know before taking Permixon
3. How to take Permixon
4. Possible side effects
5. How to store Permixon
6. Contents of the pack and other information

1. What Permixon is and what it is used for

Permixon contains the active substance lipidosterolic extract of Serenoa repens; this
medicinal product belongs to the class of other drugs used in the treatment of enlarged prostate
in adult males (also known as benign prostatic hyperplasia).
Permixon is used for the treatment of functional disorders related to this condition, such as:

• increased frequency of urination without an increase in urine volume (pollakiuria), repeated need to urinate during the night (nocturia), difficult or painful urination (dysuria),
• reduced volume and force of the urinary stream,
• sensation of incomplete bladder emptying,
• painful tension in the area between the testicles and the anus (perineum).

Permixon facilitates surgical intervention in cases where the condition requires a surgical
therapeutic approach.

2. What you should know before taking Permixon

Do not take Permixon

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Permixon.
Taking the medicine on an empty stomach may cause nausea; therefore, it should be taken during meals.
During treatment, as part of routine monitoring for benign prostatic hyperplasia, you must remain under continuous medical supervision.

Children and adolescents
This medicine must not be used in children and adolescents.

Other medicines and Permixon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions have been observed with other medicines commonly used in the treatment of this condition (antibiotics for the urinary tract, antiseptics, and anti-inflammatory agents).
To avoid possible interactions, you must inform your doctor or pharmacist about all other ongoing treatments.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Permixon is intended exclusively for use in men. The product is not indicated during pregnancy and breastfeeding.

Driving and using machines
Permixon does not affect the ability to drive vehicles or operate machinery.
Permixon contains sodium ethyl para-hydroxybenzoate. It may cause allergic reactions (including delayed reactions).
Permixon contains sodium propyl para-hydroxybenzoate. It may cause allergic reactions (including delayed reactions).

3. How to take Permixon

Take 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.
The recommended dose is:

• 1 soft capsule of 320 mg, 1-2 times daily, depending on severity, to be taken with a glass of water.

The dose may be adjusted at the physician's discretion.
It is advisable that treatment be continued for a prolonged period, but in any case not less than 30 days.
Use in children and adolescents
There is no indication for the specific use of Permixon in the paediatric population.
If you take more Permixon than you should
In case of overdose, transient gastrointestinal disturbances (abdominal pain) may occur. In case of overdose or accidental ingestion, contact your doctor or pharmacist.
If you forget to take Permixon:
Do not take a double dose to make up for the forgotten dose.
If you have any doubts 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.
Common side effects (may affect from 1 to 10 out of 100 patients)

• Headache
• Abdominal pain

Uncommon side effects (may affect from 1 to 10 out of 1,000 patients)

• Nausea, especially when the product is administered on an empty stomach
• Increased gamma-glutamyl transferase, mild increase in transaminases (liver enzymes)
• Skin redness (rash)
• Excessive breast development (gynecomastia), reversible after discontinuation of treatment

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Swelling

Reporting of side effects
If you experience any side effects, 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 the following website:
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 Permixon

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 refers to the last day of that month.
Do not use this medicine if the packaging is not intact.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to discard medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Permixon contains

• The active substance is lipidosterolic extract of Serenoa repens. Each soft capsule contains 320 mg of lipidosterolic extract of Serenoa repens* (7-11: 1). *Oily extract derived from the fruit of Serenoa repens (Bartram) Small. Extraction solvent: hexane.
• The other components are gelatin, glycerol, titanium dioxide, yellow iron oxide, sodium ethyl para-hydroxybenzoate, sodium propyl para-hydroxybenzoate.

Description of the appearance of Permixon and contents of the pack
The pack contains 16 soft capsules of 320 mg for oral use.
The soft capsules are beige and contain an oil which is yellowish-green in colour.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Pierre Fabre Pharma S.r.l. – Via G. Washington, 70 – 20146 Milan - ITALY
Manufacturer:
Pierre Fabre Médicament Production – Rue du Lycée, Z.I. de Cuiry – Gien - France