ALOPEXY solution 2% spray 3×60 ml

ALOPEXY solution 2% spray 3×60 ml Swissmedic-approved specialist information # Alopexy® 2%, solution for use on the skin Pierre Fabre Pharma AG composition active ingredient Minoxidil. Excipients: γ-Cyclodextrin, ethanol 96% (v/v), propylene glycol, purified water. 1 ml Alopexy 2% solution for use on the skin contains 50 mg propylene glycol and 443.9 mg ethanol 96% (v/v). Dosage form and amount of active ingredient per unit 1 ml topical solution contains 20 mg minoxidil. Solution for topical application. Indications/applications Treatment of hereditary and hormonal hair loss (alopecia androgenetic) Treatment of androgenetic alopecia in women and men. See “Warnings and precautionary measures”. Reduction of excessive hair loss in androgenetic alopecia. Dosage/Application Adult: Alopexy 2% is only for external use on healthy scalp Adults intended. Apply a dose of 1 ml to the scalp twice a day, starting from the center of the affected area. This dose should be regardless of the size be applied to the affected area. No more than 2 ml should be consumed per day be applied. The preparation must not be applied to any other part of the body. After Wash your hands thoroughly before applying the solution. Alopexy 2% should Only be applied to completely dry hair and hair base. It may No hairdryer should be used to avoid evaporation of the solution accelerate. Application with the dosing pipette Using the dosing pipette, exactly 1 ml of the solution can be taken and applied to the whole applied to the head area to be treated. Application with the dosing pump with applicator This system is suitable for use on small surfaces or under the hair. Remove the cap and place the dosing pump on it Screw the bottle. Apply the applicator to the center of the area to be treated straighten, press once and spread the preparation with your fingertips so that that the entire area to be treated is covered. Application 6 times repeat to reach a dose of 1 ml. Visible hair re-growth should not occur before 4 or more months treatment is expected. After stopping treatment, the growth stops Hair grows and the condition before treatment disappears after a few months on again. The use and safety in children and young people is not yet known been shown. Contraindications Hypersensitivity to minoxidil or one of the excipients (e.g. Ethanol or propylene glycol). Children and young people under 18 years of age. Warnings and precautions Before treatment with Alopexy 2%, the patient should be thoroughly examined and his anamnesis should be clarified. The patient’s scalp should be normal and be healthy. It should not be used if the scalp has redness, has inflammation, infection, irritation or painful areas, or when other treatments are performed on the scalp. Minoxidil is not indicated if there is no family history of alopecia, sudden and/or irregular hair loss, hair loss after birth or There is hair loss due to an unknown cause. The effect of Alopexy 2% in patients with concurrent skin diseases or patients receiving topical corticosteroids or other dermatological Use preparations are not yet known. Alopexy 2% should not be used other topical agents can be used. It’s not clear yet been shown whether the absorption of minoxidil under occlusion (wig) is increased. Although systemic effects attributable to minoxidil when used the solution has not been observed, the occurrence of such reactions may occur cannot be ruled out (see also under “Undesirable effects”, “Interactions” and “Overdose”). As a precaution, the occurrence of Symptoms that indicate a systemic effect, e.g. water and salt retention, generalized or local edema, pericardial effusion, Pericarditis, cardiac tamponade, increase or first occurrence of one Angina pectoris, low blood pressure, tachycardia, should be checked regularly. Should systemic effects or severe skin reactions occur the patient should be advised to stop treatment immediately and contact your treating doctor. The patient should stop use and consult a doctor if at least one of the following symptoms is noted: hypotension, chest pain, rapid heart rate, fainting or dizziness, unexplained sudden weight gain, hand or Foot edema, a persistent redness or irritation of the scalp. Patients with a history of cardiovascular disease should be advised Be warned that treatment with Alopexy 2% increases the risk of worsening of your illness. Patients with known cardiac Circulatory diseases or cardiac arrhythmias should be considered before use If you take Minoxidil, see a doctor. Accidental ingestion of the solution can cause serious adverse effects entail. If the solution comes into contact with the eyes, it may cause burning and irritation. At Contact with sensitive areas (eyes, skin abrasions, mucous membranes) These should be rinsed with plenty of running water. Inhaling the spray mist should be avoided. Intense exposure to sunlight should be avoided during the duration of therapy become. The effectiveness and safety in patients under 18 or over 65 years is not sufficiently documented. Interactions Pharmacokinetic interaction studies in humans have shown that the percutaneous absorption of minoxidil by tretinoin and anthralin increased permeability of the stratum corneum; Betamethasone dipropionate increases local tissue concentrations of minoxidil and reduces its systemic absorption. Although not clinically proven, the risk of orthostatic Hypotension in patients taking peripheral vasodilators concomitantly, cannot be excluded. However, interactions of this kind have not yet occurred not documented. Pregnancy/breastfeeding Pregnancy There have been no appropriate and adequately controlled studies Used in pregnant women. Animal studies have one Reproductive toxicity has been shown (see “Preclinical data”). In humans There is a risk (albeit low) of harm to the unborn child child. Alopexy 2% must not be used during pregnancy unless because that treatment with minoxidil is necessary due to the clinical condition of the woman is required. Breastfeeding Systemically absorbed minoxidil passes into breast milk. A risk for the newborn/child cannot be excluded. A decision must be made about whether to continue breastfeeding should be interrupted or whether the treatment with Alopexy 2% should be interrupted. Both the benefits of breastfeeding for the child and the benefits of Therapy for the mother should be taken into account. Fertility There are no clinical data available. Animal studies with minoxidil have demonstrated fertility toxicity (see “Preclinical data”). Effects on the ability to drive and operate machines No relevant studies have been conducted. Adverse effects The following undesirable effects have been reported with the use of minoxidil Solution (2% and 5% combined) in men and women with a frequency of more than 1% and more than placebo in seven placebo-controlled associated with clinical trials. The undesirable effects are classified according to organ classes according to the MedDRA System and broken down into frequencies in percent: very common (>1/10); common (>1/100, <1/10); occasionally (>1/1000, <1/100); rare (>1/10’000, <1/1000); very rare (<1/10,000) Infections and parasitic diseases: Isolated cases of ear infections, otitis externa, rhinitis. Diseases of the immune system Frequency not known: allergic reactions including angioedema, Hypersensitivity. Psychiatric illnesses: Common: Depression. Diseases of the nervous system: Very common: Headache. Isolated cases of neuritis, tingling sensation, altered taste sensations, burning feeling. Eye diseases Very rare: Visual disturbances (including reduction in visual acuity), Eye irritation. Diseases of the ear and labyrinth Very rare: Dizziness. Heart and vascular diseases: Very rare: Chest pain, changes in arterial blood pressure, Changes in pulse, syncope, edema, isolated cases of palpitations. Respiratory diseases: Isolated cases of dyspnea. Diseases of the gastrointestinal tract Very rare: Changes in taste. Affections of the liver and gallbladder Very rare: Hepatitis. Diseases of the skin and subcutaneous tissue Common: mild contact dermatitis of the scalp, local skin reactions such as Irritation, dry skin, skin peeling, erythema, pruritus, eczematous Reactions, scaling, hypertrichosis (including growth of facial hair in women). Very rare: Alopecia, generalized erythema. Isolated cases of irregular hair growth, changes in hair structure, Change in hair color. Skeletal muscle, connective tissue and bone diseases Very rare: Polymyalgia: A possible connection with topical Use of minoxidil and observed (poly)myalgia, sometimes with signs liver involvement is discussed. Diseases of the kidneys and urinary tract Very rare: Kidney stones. Diseases of the sexual organs and the mammary gland Very rare: Sexual disorders. General diseases and complaints at the administration site Common: Local reactions at the application site: irritation, exfoliation, Dermatitis, erythema, dry skin, pruritus, pain. Very rare: Edema. Overdose Signs and Symptoms Signs and symptoms of a possible overdose are likely to be: cardiovascular effects with lowering blood pressure, tachycardia and water and express salt retention. There is no evidence that topically applied minoxidil in sufficient amount is absorbed to cause systemic effects cause. When used as directed, an overdose is unlikely. If this product is applied to an area whose epidermal barrier is weakened by trauma, inflammation or a skin disease, There is a possibility of a systemic overdose effect. Accidental ingestion may cause systemic effects associated with the related to the vasodilating effect of minoxidil (5 ml of the solution contain 100 mg of minoxidil, i.e. which contributes to the treatment of hypertension Maximum recommended oral daily dose for adults). Treatment The water and salt retention can be controlled with a suitable Diuretic therapy, tachycardia and angina with beta-blockers or a treat with another inhibitor of the sympathetic nervous system. At Symptomatic hypotension could use physiological saline intravenously be administered. Sympathomimetics, such as norepinephrine or epinephrine, are with regard to to avoid their strong cardiac stimulating effect. Properties/Effects # ATC code D11AX01 Mechanism of Action/Pharmacodynamics In vitro and in vivo, minoxidil stimulates keratinocyte growth. The Topical administration of minoxidil promotes in certain individuals Alopecia androgenetica affects hair growth. With regular use of the The prescribed dose of the solution is achieved in most patients after a few A reduction in hair loss was noted within weeks. The first signs of hair growth stimulation after approximately 4-8 months (or more) visible and hair growth varies depending on the patient. The exact one Mechanism of action is unknown. The oral administration of minoxidil has a vasodilating effect. Clinical effectiveness In up to 40% of the treated cases, the results were aesthetic seen as satisfactory. For advanced alopecia androgenetica as well with alopecia lasting more than ten years, the success rate was lower. After Treatment ends after three to four months with a return the condition before treatment can be expected. Pharmacokinetics Absorption When applied topically, minoxidil is absorbed through the skin limited: The percutaneous absorption of minoxidil after topical application of 2% hydroalcoholic solutions of the drug containing propylene glycol is generally 0.3-4.5% of the applied dose. The systemic one Bioavailability of minoxidil 20 mg/ml topical solution (20 mg) at steady-state State (examined in comparison to that of an oral 2.5 mg tablet) is an average of 1.4%. After applying 1 ml of Alopexy 20 twice daily mg/ml cutaneous solution for seven days on an area of ​​100 cm2 on the Scalp of 24 healthy subjects with androgenetic alopecia was one Cmax of minoxidil was found to be less than 2 ng/ml. The hemodynamic effects of minoxidil only become evident when the average concentration of minoxidil in serum was 21.7 ng/ml reached. When administered orally (used to treat certain forms of high blood pressure) Minoxidil is almost completely absorbed from the gastrointestinal tract. The systemic concentrations of minoxidil following topical application are depending on the dose applied, the frequency of application and the Barrier function of the stratum corneum. Distribution Minoxidil does not bind to plasma proteins and crosses the blood-brain Don't barrier. Metabolism The biotransformation of minoxidil absorbed after topical application is not yet fully clarified. Minoxidil is administered orally mainly through conjugation with glucuronic acid, as well as through conversion metabolized into more polar products. The known metabolites have a significantly weaker pharmacological activity than minoxidil. Elimination Renal clearance correlates with glomerular filtration rate. After Upon discontinuation of treatment, approximately 95% of minoxidil will be systemically absorbed excreted in the urine within 4 days. Kinetics of special patient groups If the horny layer of the scalp has already been damaged (e.g. due to sunburn, Shaving or other factors) percutaneous absorption may be increased, which lead to an increase or intensification of the undesirable effects can. Preclinical data Based on conventional safety pharmacology studies, Genotoxicity and carcinogenic potential are based on preclinical data do not recognize any particular dangers for humans. Toxicity after repeated administration In repeated dose toxicity studies in dogs, low levels were reported Doses specific cardiac effects observed were significant caused hemodynamic effects in connection with cardiac changes. According to available data, comparable effects remain in humans oral or cutaneous use of minoxidil. Reproductive toxicity Preclinical fertility studies in rats have shown that subcutaneous administered minoxidil dose of 80 mg/kg/day (at least 128 times that expected exposure in humans) with reduced conception and implantation rates and a reduction in the number of live puppies is connected. The potential risk to humans is unknown. Minoxidil showed efficacy in rats at doses up to 11 mg/kg/d s.c. (at least 17.5 times human exposure) not teratogenic Potential, indicating no safety concerns for clinical use points out. Nevertheless, at a dose of 80 mg/kg/d s.c. Embryo and Fetotoxicity observed, associated with maternal toxicity from 9 mg/kg/d s.c., so that minoxidil-related prenatal and postnatal adverse events Effects cannot be absolutely ruled out. Other information Durability The medicine can only be used up to the limit marked “EXP” on the packaging Expiry date can be used. Special storage instructions Store at 15-30°C. Keep out of the reach of children. The product is flammable. Not near a flame or one Use a glowing object. Keep the container closed. Shelf life after opening: 1 month. Approval number 51853 (Swissmedic). Authorization holder Pierre Fabre Pharma AG, Allschwil. 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