PERMIXON 160 mg Soft Capsule

Зміст інструкції

1. Permixon 320 mg soft capsules
   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

Permixon 320 mg soft capsules

Lipido-sterolic extract of Serenoa repens

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

• Keep this leaflet. 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including any not listed in this leaflet, tell 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 you take 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 ingredient, a lipido-sterolic extract of Serenoa repens; this medicine
belongs to the class of other drugs used in the increase of volume of the male prostate
(also known as benign prostatic hyperplasia).
Permixon is used for the treatment of functional disorders related to this disease, such as:

• increased frequency of urination without an increase in the amount of urine (pollakiuria), repeated need to urinate during nighttime rest (nocturia), difficult or painful urination (dysuria),
• decrease in 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 surgery in cases where the disease requires a surgical therapeutic solution.

2. What you need to know before taking Permixon

Do not take Permixon

• if you are allergic to the active ingredient 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.
During treatment, you should:

• be kept under continuous medical supervision, such as routine monitoring of the condition,
• take Permixon with meals, because nausea may occur if the product is taken on an empty stomach. Permixon does not replace surgical therapy if this proves necessary.

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

Other medicines and Permixon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Laboratory data do not indicate possible interactions with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Permixon is intended exclusively for use in men. The product is not indicated in pregnancy and during
breastfeeding.

Effects on ability to drive and operate machinery
Permixon does not alter the ability to drive vehicles or operate machinery.
Permixon contains sodium ethyl paraben. It may cause allergic reactions (including delayed reactions).
Permixon contains sodium propyl paraben. It may cause allergic reactions (including delayed reactions).

3. How to take Permixon

Take this medicine following exactly as indicated 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 a day, depending on the severity, to be taken with a glass of water.

The dose may be varied at the doctor's discretion.
It is advisable that the therapy is continued for a long period of time, however no less than 30
days.

Use in children and adolescents
There is no indication for specific use of Permixon in the pediatric population.

If you take more Permixon than you should
In case of overdose, transient gastrointestinal disorders (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 a missed 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 up to 1 in 10 people)

• Headache
• Abdominal pain

Uncommon side effects(may affect up to 1 in 1,000 people)

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

Side effects with unknown frequency(frequency cannot be estimated on the basis of the available data
)

• Swelling

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. 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 sight and reach of children.
Do not use this medicine after the expiry date which is 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Permixon contains

• The active ingredient is lipido-sterolic extract of Serenoa repens. Each soft capsule contains 320 mg of lipido-sterolic extract of Serenoa repens* (7-11: 1). *Oily extract obtained from fruits 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 yellow in colour, tending towards green.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pierre Fabre Pharma S.r.l. – Via G.G. Winckelmann, 1 – Milan

Manufacturer:
Pierre Fabre Médicament Production – Rue du Lycée, Z.I. de Cuiry – Gien - France