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Permixon 160 mg, derived from saw palmetto, is indicated for urination disorders (urination) associated with prostate hypertrophy (enlargement).
Composition of Permixon 160 mg, Serenoa repens medication
Permixon is a herbal medication.
The active ingredient is saw palmetto (Serenoa repens).
The extraction solvent is hexane.
The other ingredients are Macrogol 10,000.
One capsule of Permixon contains 160 mg of Serenoa repens lipid-sterolic extract.
The capsule shell is composed of gelatin, yellow iron oxide, indigo carmine, and titanium dioxide.
Dosage of Permixon 160 mg
Permixon 160 mg should be taken with meals, 2 capsules per day. The duration of treatment should follow the medical advice of your doctor.
Taking Permixon 160 mg on an empty stomach can sometimes cause nausea.
Contraindications for Permixon 160 mg for the prostate
If you have a history of allergy to any of the capsule's ingredients, taking Permixon 160 mg is contraindicated.
Treatment with Permixon 160 mg requires medical supervision and regular monitoring of your prostate by your specialist.
It is advisable to inform your doctor of any medication you are currently taking while taking Permixon.
Packaging: Box of 60 or 180 capsules
Pierre Fabre Laboratories markets numerous medications, including Antacalm anti-inflammatory patches.
LEAFLET
ANSM - Updated on: 02/15/2022
Name of the medicinal product
Permixon 160 mg, capsule
Saw palmetto extract
Box
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
You must always take this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse.
What is in this leaflet? 1. What is PERMIXON 160 mg capsule and what is it used for?
2. What you need to know before taking PERMIXON 160 mg capsule?
3. How to take PERMIXON 160 mg capsule?
4. Possible side effects?
5. How to store PERMIXON 160 mg capsule?
6. Contents of the pack and other information.
1. WHAT IS PERMIXON 160 mg capsule AND WHAT IS IT USED FOR?
Herbal medicines.
Pharmacotherapeutic group: Other medicines used for benign prostatic hyperplasia.
This medicine is recommended for the treatment of certain urination problems (urination) related to prostate hypertrophy (enlargement). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERMIXON 160 mg capsules?
Do not take PERMIXON 160 mg capsules:
· If you are allergic to saw palmetto extract or any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking PERMIXON 160 mg capsules.
· Taking this medicine on an empty stomach can sometimes cause nausea.
· During your treatment, your doctor will continue to regularly monitor your prostate. Under no circumstances can PERMIXON 160 mg capsules replace surgery when it is necessary.
· Warnings and precautions
Children and adolescents
Not applicable
Other medicines and PERMIXON 160 mg capsules
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
PERMIXON 160 mg capsule with food and drink
Not applicable.
Pregnancy and breastfeeding
This medicine is not intended for women.
Driving and using machines
Not applicable.
PERMIXON 160 mg capsule contains
Not applicable
3. HOW TO TAKE PERMIXON 160 mg capsule?
Take the capsules with a glass of water during meals.
Dosage
For adult men only.
The usual dose is 2 capsules per day.
Always follow the prescribed dosage.
Method of administration
Oral use.
Duration of treatment
The maximum duration of treatment is limited to 6 months.
If you take more PERMIXON 160 mg capsule than you should
Temporary gastrointestinal disturbances (abdominal pain) may occur. In case of overdose or accidental ingestion, consult your doctor or pharmacist.
If you forget to take PERMIXON 160 mg capsules
Do not take a double dose to make up for a forgotten dose.
If you stop taking PERMIXON 160 mg capsules
Not applicable
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:
Common (1 to 10 in 100 patients)
Headache
Abdominal pain
Uncommon (1 to 10 in 1,000 patients)
Nausea
Increased gamma-glutamyltransferases and moderate increases in transaminases (liver enzymes)
Skin rash
Abnormal breast development in men (gynecomastia), reversible upon stopping treatment
Frequency cannot be estimated
Edema (skin swelling)
If you notice any side effects not listed in this leaflet, or if any of the side effects become serious, please tell your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE PERMIXON 160 mg, capsule?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the carton after EXP. The expiry date refers to the last day of that month.
This medicine must be stored below 30°C.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What PERMIXON 160 mg Capsule Contains
· The active ingredient is:
Saw palmetto (Serenoa repens (W. Bartram) Small.) (fruit extract) ……………. 160 mg
Extraction solvent: hexane
Drug/extract ratio: 7-11:1.
· The other ingredients are:
Macrogol 10,000
Capsule shell composition: gelatin, yellow iron oxide, indigo carmine, titanium dioxide.
What PERMIXON 160 mg Capsule looks like and contents of the outer packaging
This medicine is in capsule form. Box of 30, 56, 60, 100, or 180.
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
Les Cauquillous
81500 Lavaur
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
PROGIPHARM Site
RUE DU LYCEE
45500 GIEN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
This leaflet was last revised:
YYYY
Other
Detailed information on this medicinal product is available on the ANSM website (France).