NOTICE
ANSM - Updated on: 25/02/2015
Name of the medicinal product
PERMIXON 160 mg capsule
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, seek medical attention.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS PERMIXON 160 mg capsule AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE PERMIXON 160 mg capsule?
3. HOW TO TAKE PERMIXON 160 mg capsule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PERMIXON 160 mg capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS PERMIXON 160 mg capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Herbal medicines.
Other drugs used in benign prostatic hypertrophy.
Therapeutic indications
This medication is recommended in the treatment of certain disorders of urination (urine emission) related to hypertrophy (increase in volume) of the prostate.
2. BEFORE YOU TAKE PERMIXON 160 mg capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take PERMIXON 160 mg capsule in the following cases:
· If you are allergic to the active substance (Florida palm extract) or any of the other ingredients listed in section 6.
Precautions for use; special warnings
Take special care with PERMIXON 160 mg capsule:
· Taking this medication on an empty stomach can sometimes cause nausea.
· During your treatment, your doctor will continue to monitor your prostate regularly. Under no circumstances should PERMIXON 160 mg capsule replace surgery when it is necessary.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication is not intended for women.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE PERMIXON 160 mg capsule?
Instructions for proper use
Take the capsules with a glass of water at mealtime.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Reserved for adult man.
The usual dose is 2 capsules per day.
Always follow the prescribed dosage.
Administration mode
Oral use.
Frequency of Administration
Not applicable.
Duration of the treatment
The maximum duration of treatment is limited to 6 months.
Symptoms and Instructions for Overdose
If you take more than PERMIXON 160 mg capsule you should:
Passive gastrointestinal disorders (abdominal pain) may occur.
In case of overdose or accidental ingestion: Consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take PERMIXON 160 mg capsule:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, PERMIXON 160 mg capsule is likely to have side effects, although not everyone is.
The following side effects may occur:
Common (1 to 10 patients out of 100):
· Headaches (headache),
· Abdominal pain
Uncommon (1 to 10 of 1000 patients):
· Nausea
· An increase in gamma-glutamyltransferases and a moderate increase in transaminases (liver enzymes),
· A skin rash (rash on the skin),
· An abnormal development of the breasts in men (gynecomastia), reversible at the end of treatment.
Frequency not estimable
· Edema (swelling of the skin)
· If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, tell your doctor or pharmacist
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
5. HOW TO STORE PERMIXON 160 mg capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use PERMIXON 160 mg capsule after the expiry date which is stated on the carton.
Storage conditions
This medication should be stored at a temperature below 30 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does PERMIXON 160 mg, capsule contains?
The active substance is:
Palm tree of Florida ( Serenoa repens (W. Bartram) Small) (extract of the fruit of) ............................... 160 mg
Extraction solvent: hexane.
Report drug / excerpt: 7-11: 1.
The other components are:
Macrogol 10,000.
Composition of the capsule shell : gelatin, yellow iron oxide, indigotine, titanium dioxide.
Pharmaceutical form and content
What is PERMIXON 160 mg capsule and contents of the pack?
This medication is in the form of capsules. Box of 30, 56, 60, 100 or 180.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
exploiting
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Maker
PIERRE FABRE MEDICAMENT PRODUCTION
45, PLACE ABEL GANCE
92100 BOULOGNE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.