Laboratoires bailleul Minoxidil biorga 3 bottles 5% - solution dermal fall 60 ml

Product Description

Cutaneous solution indicated for the treatment of alopecia.

Indications

Biorga Minoxidil 5% cutaneous solution is indicated in particular for men suffering from hair loss or thinning of the hair on the top of the head and for women with generalized thinning of the hair.
Biorga Minoxidil 5% cutaneous solution is indicated for adults aged between 18 and 65 years.

Composition

Active ingredients

Minoxidil 20 mg/ml (5% w/v). One actuation of Biorga Minoxidil 5% cutaneous solution contains 2.8 mg of minoxidil.
Seven actuations are required to apply approximately 1 ml of solution containing 20 mg of minoxidil. Excipient with known effect: propylene glycol.

Excipients

Propylene glycol Ethanol 96% Purified water.

Directions for use and Dosage

The dose of 1 ml of 5% Minoxidil Biorga cutaneous solution must be applied to the scalp twice a day (once in the morning and once in the evening).
This dose should be administered regardless of the size of the affected area.
The total daily dose should not exceed 2 ml.
Paediatric population and elderly population Not recommended for children under 18 years of age and over 65 years of age due to the lack of data on safety and efficacy.

Method of administration: Biorga Minoxidil 5% cutaneous solution is for external use only.
It must be applied according to the instructions and only to the scalp.
Biorga Minoxidil 5% cutaneous solution must be applied only to dry hair and scalp.
Wash your hands thoroughly after applying the cutaneous solution.
It may be necessary to apply the product twice a day for four or more months.
In any case, your doctor should evaluate the opportunity to discontinue treatment if no results are observed within 4 months.
If hair regrowth is observed, application of Biorga Minoxidil 5% cutaneous solution should be continued twice daily to maintain its effects.
After discontinuing topical treatment with minoxidil, cessation of hair regrowth and return to the previous appearance within 3–4 months after stopping treatment has been reported occasionally.

Warnings

Patients with cardiovascular disease or known cardiac arrhythmia should consult a doctor before using Biorga Minoxidil 5% cutaneous solution.
Biorga Minoxidil 5% cutaneous solution is not indicated in cases where there is no family history of hair loss, sudden and/or patchy hair loss, hair loss due to childbirth, or when the cause of hair loss is unknown.
Biorga Minoxidil 5% cutaneous solution should only be applied to a normal, healthy scalp.
Do not use if the scalp is red, inflamed, irritated, or painful, or if you are using other medications applied to the scalp.
Some ingredients in Biorga Minoxidil 5% cutaneous solution may cause burning and irritation. In case of accidental contact with sensitive surfaces (eyes, abraded skin, and mucous membranes), the area should be rinsed with plenty of fresh tap water.
Do not inhale the spray.
Do not ingest.
The patient should stop using Biorga Minoxidil 5% cutaneous solution and consult a doctor if they experience low blood pressure, chest pain, rapid heartbeat, fainting or dizziness, sudden weight gain, swelling of the hands or feet, and persistent redness or irritation of the scalp.
Some patients have experienced changes in hair color and/or texture with the use of Minoxidil Biorga 5% cutaneous solution.
Paediatric population: Accidental ingestion may cause serious cardiac adverse events.
Therefore, Minoxidil Biorga 5% cutaneous solution should be kept out of the reach of children.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.
Minoxidil Biorga 5% cutaneous solution is not indicated in cases of alopecia areata (sudden or unexplained hair loss) or cicatricial alopecia (associated with skin with healing characteristics, such as a burn or ulcer).
Furthermore, Minoxidil Biorga 5% cutaneous solution should not be used if hair loss is associated with pregnancy, childbirth or serious conditions, such as thyroid dysfunction, lupus, hair loss associated with inflammation of the scalp or other conditions.

Side effects

Effects: The frequency of adverse reactions to minoxidil solution for topical use is defined according to the following convention:

• very common (> 1/10);
• common (> 1/100, <1/10);
• uncommon (> 1/1,000, <1/100);
• rare (> 1/10,000, <1/1,000);
• very rare (<1/10,000, <1/1,000); 1/10,000);
• not known (frequency cannot be estimated from the available data).

The following adverse events have been associated with the use of minoxidil solutions (5% and 5% combined) in both male and female subjects, with an incidence greater than 1% and higher than in placebo-controlled clinical trials.

The following adverse events have been associated with the use of topical minoxidil solutions during the post-marketing period.

Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

Signs and symptoms: There is no evidence that minoxidil applied intravenously Topically, minoxidil is absorbed in sufficient quantities to cause systemic effects.
If used as directed, overdose is unlikely.
If the product is applied to an area where the epidermal barrier is not fully intact due to trauma, inflammation, or a pathological process affecting the skin, the possibility of a systemic overdose effect exists.
Systemic effects of minoxidil may result in the following very rare adverse events:

Treatment: Treatment of minoxidil overdose should be symptomatic and supportive.
Fluid retention can be managed with appropriate diuretic therapy.
Clinically significant tachycardia may be controlled by administration of a beta-blocking agent.
Symptomatic hypotension should be treated with intravenous administration of normal saline.
The use of sympathomimetic agents, such as adrenaline and noradrenaline, should be avoided as these drugs cause excessive cardiac stimulation.

Pregnancy and breastfeeding

Pregnancy: No adequate and well-controlled studies have been performed in pregnant women.
Animal studies have shown a risk to the fetus at exposure levels that are much higher than those expected in humans.
A low risk of fetal harm is possible, although remote, in humans.
Breastfeeding: Systemically absorbed minoxidil is excreted in breast milk.
Topical minoxidil should be used during pregnancy or breastfeeding only if the benefit to the mother outweighs the risks to the fetus or infant.

Storage

Flammable product.
Protect from heat.
Keep the container tightly closed.

Format

3 vials of 60 ml