Active ingredients: Serenoa repens
Permixon 320 mg soft capsules
Indications Why is Permixon used? What is it for?
Permixon contains the active ingredient lipid-sterol extract of Serenoa repens; this medicine belongs to a class of other drugs used in adult male prostate enlargement (also called benign prostatic hypertrophy).
Permixon is used for the treatment of functional disorders related to this disease, such as:
- increased frequency of passing urine without increasing the amount of urine (pollakiuria), repeated need to urinate during the night (nocturia), difficult or painful passing of urine (dysuria),
- decrease in the volume and strength of the jet,
- feeling of incomplete emptying of the bladder,
- painful tension in the area between the testicles and the anus (perineum).
Permixon facilitates operability in cases where the disease requires a surgical therapeutic solution.
Contraindications When Permixon should not be used
Do not take Permixon
- if you are allergic to the active substance or any of the other ingredients of this medicine
Precautions for use What you need to know before taking Permixon
Talk to your doctor or pharmacist before taking Permixon.
During treatment, you must:
- be kept under continuous medical supervision, such as routine disease monitoring,
- take Permixon with meals, as 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
Interactions Which drugs or foods can modify the effect of 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 medicinal products.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Permixon is intended for use in men only. The product is not indicated during pregnancy and lactation.
Effects on ability to drive and use machines
Permixon does not affect the ability to drive or use machines.
Permixon contains sodium ethyl para-oxybenzoate. It can cause allergic reactions (even delayed).
Permixon contains sodium propyl para-oxybenzoate. May cause allergic reactions (including delayed).
Dose, Method and Time of Administration How to use Permixon: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, 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 can be varied according to the doctor's judgment.
It is advisable that the therapy be continued for a long period of time, in any case not less than 30 days.
Use in children and adolescents
There is no indication for a specific use of Permixon in the pediatric population.
Overdose What to do if you have taken too much Permixon
If you take more Permixon than you should
In the event of an overdose, transient gastrointestinal disturbances (abdominal pain) may occur. In case of overdose or accidental ingestion, talk to your doctor or pharmacist.
If you forget to take Permixon:
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Permixon
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect 1 to 10 users in 100)
- Headache
- Abdominal pain
Uncommon side effects (may affect 1 to 10 users in 1,000)
- Nausea, especially in cases where the product is administered on an empty stomach
- Increase in gamma-glutamyl transferase, moderate increase in transaminases (liver enzymes)
- Redness of the skin (rash)
- Excessive breast development (gynecomastia), reversible after stopping treatment
Undesirable effects with frequency not known (frequency cannot be estimated from the available data)
- Swelling
Reporting of side effects
If you get 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avversei. By reporting side effects you can help provide more information on safety. of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package.
The expiry date refers to the last day of that month.
Do not use this medicine if the pack is not intact.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Contents of the pack and other information
What Permixon contains
- The active ingredient is a lipid-sterolic extract of Serenoa repens. Each soft capsule contains 320 mg of lipid-sterol extract of Serenoa repens * (7-11: 1).
* Oily extract originating from the fruits of Serenoa repens (Bartram) Small.
Extraction solvent: hexane
- The other ingredients are gelatin, glycerol, titanium dioxide, yellow iron oxide, sodium ethyl paraoxybenzoate, sodium propyl para-oxybenzoate.
What Permixon looks like and contents of the pack
The contents of the pack are 16 soft capsules of 320 mg for oral use. The soft capsules are beige and contain a yellow to green oil
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
PERMIXON 320 MG SOFT CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains
Active principle:
Lipid-sterol extract of Serenoa repens 320 mg
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Soft capsules for oral use
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Functional disorders of benign prostatic hypertrophy.
The effects of Permixon are manifested on the symptoms of benign prostatic hypertrophy: pollakiuria, nocturia, dysuria, decrease in the volume and strength of the jet, sensation of incomplete bladder emptying and painful perineal tension.
In cases where the disease requires a surgical therapeutic solution, the administration of Permixon, improving the clinical condition of the patient, facilitates its operability.
04.2 Posology and method of administration
Route of administration: for oral use
According to medical prescription. Generally: 1 soft capsule of 320 mg 1-2 times a day, depending on the severity.
The dosage can be varied according to the judgment of the doctor. It is advisable that the therapy be continued for a long period of time, in any case not less than 30 days.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
Keep this medicine out of the reach and sight of children.
No special precautions for use.
Nausea may occasionally occur, especially when the product is administered on an empty stomach.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions with other drugs have been reported so far.
04.6 Pregnancy and lactation
Given its indications, the product is used only in male patients.
04.7 Effects on ability to drive and use machines
Taking the drug does not affect the ability to drive and use machines
04.8 Undesirable effects
The table below shows the undesirable effects observed in seven clinical studies involving a total of 3,593 patients: 2,127 treated with Permixon, for which the causality assessment was not "excluded".
Undesirable effects are listed below by MedDRA system organ class and listed below by frequency categories such as: very common (≥ 1/10), common (≥ 1/100 to
No adverse reactions were of "very rare", "rare" or "very common" frequency and therefore the relevant columns are not present in the table.
Only moderate increases in transaminases were observed during clinical trials and the increase in liver function tests was of no clinical significance.
In addition, edema has been reported in post-marketing experience with an unknown frequency (cannot be estimated from the available data).
Gynecomastia was observed but was reversible after discontinuation of treatment.
04.9 Overdose
No overdose incidents have been reported so far.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other drugs used in benign prostatic hypertrophy.
ATC code: G04CX02.
Permixon (lipid-sterolic extract of Serenoa repens) is a drug capable of carrying out a valid control on functional disorders associated with benign prostatic hypertrophy (BPH), of which it influences various pathogenetic mechanisms.
BPH is correlated with the proliferation of prostatic stromal and epithelial components, the time of onset of which coincides with the 4th-5th decade of life.
The prevalence of this disease progressively increases with age until it affects 90% of 80-year-old men.
The "onset of" BPH recognizes a "multifactorial origin in which various sex hormones play a fundamental role.
The prostate is a hormone-dependent organ whose metabolism is particularly sensitive to the action of DHT (di-hydro-testosterone), produced by 5-alpha-reductase from testosterone, of which it represents the active metabolite.
Pharmacological studies have confirmed the inhibitory action carried out by Permixon on 5-alpha-reductases. At the same time Permixon has been shown to be active in preventing the binding of DHT to its cellular receptors.
The drug does not interfere with the hypothalamic-pituitary axis.
Further pharmacological research has highlighted the anti-inflammatory effects of Permixon mediated by the inhibition of phospholipase A2, responsible through the transformation of phospholipids into arachidonic acid, of the first stage in the production of prostaglandins, substances mediating inflammatory phenomena. In particular, by interfering with the vascular inflammatory component (capillary permeability and platelet aggregation), Permixon manifests anti-edema effects and is useful in correcting the voiding alterations connected with cervico-prostatic obstruction induced by intra and peri-adenomatous congestive phenomena. Recent studies on the etiopathogenesis of BPH have taken into consideration the role played by estrogens as factors favoring the metabolic activity of the prostatic stromal portion, which in turn would influence the growth of the epithelial portion. The growth of the periurethral stromal portion also justifies multiple aspects of the clinical symptoms of BPH. Permixon has been shown to have an "activity that is expressed through the reduction of intranuclear receptors for estrogen.
The analysis of the results obtained with the clinical use of Permixon showed a statistically significant improvement of numerous urodynamic parameters within 60-90 days from the start of treatment, with a reduction in post-voiding bladder residue.
Substantial improvements in subjective symptoms occur within 30 days of starting treatment.
The anti-inflammatory properties of Permixon, which interfere with the vascular phase of inflammation, make it useful for use in those phases of the disease in which any intercurrent prostatitic processes are accompanied by a marked edematous component of the prostate tissue.
Long-term clinical studies have demonstrated the stability of Permixon's therapeutic effects.
No negative effects have been highlighted in the sexual sphere.
05.2 Pharmacokinetic properties
Bioavailability studies in humans have shown that one of the main components of the lipid-sterolic extract of Serenoa repens, lauric acid, is rapidly absorbed in the gastrointestinal tract, confirming the already known bioavailability of the active ingredient.
05.3 Preclinical safety data
The toxicology studies have made it possible to ascertain that Permixon is devoid of toxic potential and well tolerated, both in terms of macroscopic-functional, and microscopic-histopathological, for both single and repeated long-term administration. The study of acute toxicity has revealed that the safety threshold is between 120 and 5,600 times the maximum dose used in therapy (640 mg), depending on the various types of animals and the different routes of administration. Subacute toxicity has shown good tolerability at doses from 8 to 180 times the maximum therapeutic dose, while chronic toxicity (6 months) allowed to find the lack of effects for doses equal to 20-40 times the maximum therapeutic dose.
Finally, Permixon was found to be devoid of mutagenic potential and at high and repeated doses did not adversely affect the libido and reproductive capacity of males or the viability of the offspring.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Gelatin, glycerol, titanium dioxide, yellow iron oxide, sodium ethyl para-oxybenzoate, sodium propyl para-oxybenzoate.
06.2 Incompatibility
No incompatibilities with other drugs have been reported so far.
06.3 Period of validity
Shelf life with unopened packaging: 3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
16 soft capsules of 320 mg in blister packs
06.6 Instructions for use and handling
The unused product and the waste derived from this medicinal product must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
PIERRE FABRE PHARMA S.r.l.
Via G.G. Winckelmann, 1 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
320 mg soft capsules 16 capsules - AIC n. 025288059
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
April 1984 / June 2005
10.0 DATE OF REVISION OF THE TEXT
February 2013
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