ALOPEXY solution 5% 3 spray 60 ml

ALOPEXY solution 5% 3 spray 60 ml Swissmedic-approved specialist information # Alopexy® 5%, solution for use on the skin Pierre Fabre Pharma AG The effectiveness and safety of Alopexy 5% (Switzerland) was confirmed by Swissmedic only checked summarily. The approval of Alopexy 5% (Switzerland) is based on Alopexy 50 mg/ml (France) as of November 2021, which contains the same active ingredient and is approved in France. composition Active ingredient: Minoxidil Excipients: Ethanol 96% (v/v), propylene glycol, purified water. Dosage form and amount of active ingredient per unit 1 ml Alopexy 5% contains 50 mg minoxidil. Solution for use on the skin. Indications/applications Alopexy 5% is indicated for the treatment of moderate androgenetic Alopecia in men. Note: This medicine should not be used by women because its effectiveness is limited in this patient group and because of the high Incidence of increased hair growth (hypertrichosis) outside the Application site (37% of cases). Dosage/Application Apply 1 ml to the affected areas of the scalp twice a day, starting in the middle of the affected area. Stick to them Quantity specification, regardless of the size of the area to be treated. The total dose should not exceed 2 ml. Therapy duration Continuous treatment is required to regrow hair to increase and maintain. The first results are after 2 to 4 months Twice daily use is expected. The beginning and the degree of Responses vary from person to person. If 4 months after starting treatment If no improvement in symptoms is observed, patients need alopexy Deduct 5%. During the first 2 to 6 weeks of treatment you may experience: temporary increase in hair loss. If the hair loss is longer persists for more than 6 weeks, the patient should stop using Alopexy 5% and consult your doctor (see “Warnings and precautionary measures”). The beginning and strength of new hair growth varies from person to person. Although trends in the available data suggest that the Likelihood of response in younger users, in shorter Duration of balding and smaller area of ​​balding in If the crown area is higher, the response may not be possible in individual cases predict. Some reports suggest that after discontinuation of treatment the Initial state could be reached again after 3 or 4 months. Older patients Alopexy 5% should not be used in patients over 65 years of age as for There are no data on safety and effectiveness for these patient groups. Children and young people The safety and effectiveness of Alopexy 5% have been evaluated in children under 18 not examined for years. No data is available. Hence the application of Alopexy 5% is not recommended in children under 18 years of age. Type of application For use on the skin (scalp). Each pack contains two different types of application systems: * 1 dosing dropper pipette for precise application on small areas * 1 dosing pump with applicator for application on small areas or under the hair. Use one of the application systems (see below) to get Alopexy 5% to apply. Apply the medicine with your fingertips over the entire affected area distributed. Before and after applying the solution, your hands must be cleaned thoroughly. Hair and scalp should be completely dry before application. Do not use on other parts of the body. The child-resistant closure is opened by pulling the plastic closure Press down while turning the shutter counterclockwise rotate (to the left). Only the safety ring should remain on the bottle. Application with the pipette With the dosing dropper pipette, 1 ml of solution can be precisely measured and placed on the Apply to the entire area to be treated. Application with the dosing pump with applicator Screw the dosing pump onto the bottle. Application: Aim the applicator tip at the center of the affected area, Operate the pump once and apply solution with your fingertips over the entire area spread over affected area. 6 pumps are necessary to get a dose of 1 ml to apply. Rinse applicator with hot water after each use. Contraindications * Hypersensitivity to minoxidil or any of the excipients (e.g. ethanol or propylene glycol). * Scalp diseases. * Poor tolerance of the 2% solution, regardless of symptoms. * Children and young people under 18 years of age. Warnings and precautions People with scalp dermatoses absorb minoxidil percutaneously possibly increased (see “Contraindications”). Although there have been no systemic effects when using minoxidil so far were recorded, they cannot be ruled out. Patients must be informed about potential side effects. Patients with known cardiovascular diseases or Cardiac arrhythmias should be considered before topical use of minoxidil Consult a doctor. These people should benefit from the Treatment must be weighed against the risks. The monitoring should be too Begin treatment and continue regularly thereafter. You should In particular, possible side effects should be pointed out (tachycardia, Water and sodium retention, weight gain, and other systemic Effects) to stop treatment immediately as soon as any of them occurs. For other patients in whom a systemic effect or severe Dermatological reactions occur: If hypotension is detected or if chest pain, rapid heartbeat, attacks of weakness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp occurs, The user should stop taking the medicine and consult a doctor visit. If the symptoms of hair loss after 6 weeks of Minoxidil treatment persist or worsen, or if new symptoms appear, Patients should stop treatment and seek medical advice. Because of the risk of increased hair growth (hypertrichosis) outside the This medicine is not recommended for use in women recommended. Minoxidil is not indicated if there is no family history of hair loss if there is sudden and/or uneven hair loss, pregnancy-related hair loss or hair loss of unknown cause. Precautions for use Minoxidil should only be used on normal, healthy scalp. Not Use for red, inflamed, infected, irritated or painful areas scalp. Do not use on the scalp with other medicines. Permanent treatment is required to prevent hair regrowth increase and maintain. During the first 2 to 6 weeks Treatment may cause a temporary increase in hair loss. If hair loss persists for more than 6 weeks, the patient should Stop using minoxidil and contact your doctor consult (see “Dosage/Application”). If the solution comes into contact with the eyes (especially as a result of… Alcohol content) may cause burning and irritation. When in contact with Sensitive areas (eyes, sore skin, mucous membranes) should be taken with this Rinse with plenty of cold tap water. The spray mist must not be inhaled. Accidental ingestion may cause serious cardiac side effects (see “Overdose”). Therefore, this medicine is inaccessible to children to keep. Some patients experienced changes in hair color and/or hair texture. Exposure to sunlight should be avoided while using the product become. 1 ml Alopexy 5% solution for use on the skin contains 240 mg Propylene glycol and 520 mg ethanol 96% (v/v). Propylene glycol can be used topically cause limited skin irritation (e.g. contact dermatitis). Ethanol can be on cause a burning sensation in damaged skin. Interactions Pharmacokinetic interaction studies in humans have shown that the percutaneous absorption of minoxidil by tretinoin and anthralin due to the increased permeability of the stratum corneum is increased; Betamethasone dipropionate increases local tissue concentrations of minoxidil and decreases its systemic absorption. Although not yet clinically proven, there is a risk that orthostatic hypotension in patients receiving peripheral vasodilators to be treated occurs. The absorption of topically applied minoxidil is through the stratum corneum controlled and limited. Simultaneous application topically applied drugs that have an influence on the barrier effect of the Stratum corneum can lead to increased absorption of topically applied Lead minoxidil. Therefore, the simultaneous use of Alopexy 5% and other topically applied drugs are not recommended. Pregnancy/breastfeeding This medicine is not indicated in women of childbearing potential. It must not be used in women who are or may be pregnant or breastfeeding (see “Indications/possible uses”). Pregnancy There have been no appropriate and adequately controlled studies Used in pregnant women. Animal experimental studies have… Exposure levels well above the intended human exposure showed a risk to the fetus (see “Preclinical data”). At the People are at risk (albeit low) of damage to the unborn child. Topical minoxidil should only be used during pregnancy and breastfeeding be used when the benefit to the mother outweighs the potential risk exceeds the unborn child or infant. Breastfeeding Systemically absorbed minoxidil is excreted in breast milk. Topical minoxidil should only be used during breastfeeding when the benefit to the mother outweighs the potential risk to the breastfed child exceeds. Fertility In a fertility study on male and female rats, one dose-dependent reduction in the conception rate was found (see «Preclinical Data”). The potential risk to humans is unknown. Effects on the ability to drive and operate machines Alopexy 5% has no or only a negligible influence on the Ability to drive or use machines. Adverse effects The information on side effects and their frequencies is based on one randomized, double-blind, placebo-controlled clinical trial with 393 Patients in which minoxidil 5% (157 patients) with minoxidil 2% (158 patients) and placebo (78 patients). The frequency of the reported after the marketing of minoxidil for cutaneous use Side effects are unknown. The most commonly observed reactions are mild skin reactions. The The ethanol contained in it can cause irritation and irritation if used frequently on the skin cause skin dryness. Adverse events are by MedDRA system organ class and frequency arranged according to the following convention: “very common” (≥1/10) “common” (≥1/100, <1/10), “occasionally” (≥1/1,000, <1/100) “rare” (≥1/10,000, <1/1,000) “very rare” (<1/10,000) “not known” (cannot be estimated from the available data) Infections and parasitic diseases Not known: Ear infections, otitis externa, rhinitis Diseases of the immune system Not known: Hypersensitivity, including allergic reactions Angioedema Psychiatric illnesses: Common: Depression Diseases of the nervous system: Very common: Headache Not known: Neuritis, tingling sensation, altered taste sensations, Burn Eye diseases Not known: Visual disturbances, eye irritation Diseases of the ear and inner ear Not known: Feeling dizzy Heart diseases Not known: Tachycardia, chest pain, palpitations Vascular diseases Not known: hypotension Diseases of the respiratory tract, thoracic cavity and mediastinum: Common: Dyspnea Liver and gallbladder diseases Not known: Hepatitis Diseases of the skin and subcutaneous tissue Very common: Hypertrichosis (outside the application site) Common: Contact dermatitis, pruritus, inflammatory skin diseases, acneiform rash Undetermined: Generalized erythema, alopecia, irregularities Hair coverage, hair texture change, hair color changes Diseases of the skeletal muscles and connective tissue Common: Musculoskeletal pain Diseases of the kidneys and urinary tract Not known: Kidney stones General diseases and complaints at the administration site Common: Local reactions at the application site: irritation, peeling of the skin, Dermatitis, erythema, dry skin, pruritus, peripheral edema, pain Undetermined: Facial edema, edema, asthenia Reporting of suspected side effects after approval is required great importance. It enables continuous monitoring of the Benefit-risk ratio of the drug. Relatives of Health professionals are asked to report any suspicion of a new or serious side effects via the online portal ElViS (Electronic Vigilance System). Information about this can be found at www.swissmedic.ch. Overdose 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 medicine 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. Signs and Symptoms The following very rare side effects may be due to systemic Effects of minoxidil occur: Diseases of the nervous system: Very rare: Dizziness General diseases and complaints at the administration site Very rare: Fluid retention with corresponding weight gain Heart and vascular diseases Very rare: Accelerated heartbeat, hypotension Accidental ingestion may occur due to vasodilator Properties of Minoxidil have systemic effects (5 ml solution contain 250 mg minoxidil; which corresponds to 2.5 times the maximum recommended amount for the oral treatment of arterial hypertension adults). Treatment Treatment of minoxidil overdose should be symptomatic and be supportive. Water and sodium retention can be treated with appropriate diuretics become; Tachycardia and angina with a beta-blocker or another Sympathetic blockers. Symptomatic hypotension can be treated with intravenous supplied physiological saline solution. Sympathomimetics such as norepinephrine and adrenaline should be used because of their strong heart stimulants effect cannot be taken. Properties/Effects ATC code: D11AX01 Mechanism of Action/Pharmacodynamics When applied topically, minoxidil stimulates in vitro and in vivo Keratinocyte growth and hair growth in many people androgenetic alopecia. This phenomenon occurs after approximately 2 months Treatment depends on the individual and varies from person to person. Stop after stopping treatment the hair grows again, and the initial state is over after 3 or 4 months expect. The exact mechanism of action is still unknown. Clinical effectiveness and safety Topical use of minoxidil in controlled clinical trials normotensive or untreated hypertensive patients yielded no evidence on systemic effects due to minoxidil absorption. Pharmacokinetics Absorption After topical application, only a small amount of minoxidil is absorbed: On average, 1.7% of the applied dose is reached (value range of 0.3 % to 4.5%) the systemic circulation. In comparison, minoxidil is taken in tablet form when administered orally (for Treatment of certain forms of hypertension) in the gastrointestinal tract completely absorbed. A dose of 1 ml solution corresponds to the skin application of 50 mg minoxidil and results in the absorption of approximately 0.85 mg of minoxidil. The influence of concurrent skin diseases on the minoxidil Absorption was not determined. The serum concentrations of topically administered minoxidil depend on the percutaneous absorption rate. Distribution Minoxidil does not bind to plasma proteins and crosses the blood-brain Don't barrier. Metabolism The biotransformation of absorbed minoxidil after topical administration is not fully known. Elimination After discontinuing topical application, approximately 95% of what is absorbed Minoxidil excreted in the urine within 4 days. Preclinical data Based on conventional safety pharmacology studies, toxicity with repeated administration, genotoxicity and carcinogenic potential Preclinical data do not reveal any particular hazards for humans. In Repeated dose toxicity studies were conducted in dogs at low levels 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. In an oral fertility study conducted on rats, one Dose-dependent reduction in conception rate from a dose of 3 mg/kg/day (at least 5-fold exposure in humans) reported. In a study with Subcutaneously administered minoxidil doses of more than 9 mg/kg/day (at least 14.4 times the exposure in humans) these were with a reduced conception and implantation rates as well as a reduction in Number of living descendants linked. Minoxidil had effects in rats and rabbits at oral doses of up to 10 mg/kg/day, and in rats at subcutaneous doses up to 11 mg/kg/day (at least 16 times human exposure) not teratogenic Potential. However, developmental toxicity (including increased fetal resorptions in both species, skeletal abnormalities, stillbirths and reduced survival rate of young animals in rats) only in exposures observed to be sufficiently above the maximum human exposure were considered, indicating little relevance for clinical use indicates. Other information Incompatibilities Since no compatibility studies have been carried out, this medicine may be used not be mixed with other medicines. Durability The medicine can only be used up to the limit marked “EXP” on the packaging Date can be used. Shelf life after opening Shelf life is 1 month after opening/opening. Special storage instructions Store at 15-30°C. Keep the container tightly closed. Keep out of the reach of children. Instructions for handling The medicine is flammable. Not near a flame or one Use a glowing object. Approval number 67747 (Swissmedic) Authorization holder Pierre Fabre Pharma AG, Allschwil Status of information Foreign comparison medicinal product: November 2021 Without safety-relevant additions from Swissmedic: October 2022[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row type="full_width_background" full_screen_row_position="middle" column_margin="90px" equal_height="yes" content_placement="middle" column_direction="default" column_direction_tablet="default" column_direction_phone="default" bg_color="#ffffff" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.5" gradient_direction="top_to_bottom" shape_divider_position="bottom" bg_image_animation="none" shape_type="straight_section" gradient_type="default"][vc_column column_padding="padding-4-percent" column_padding_tablet="no-extra-padding" column_padding_phone="no-extra-padding" column_padding_position="right" column_element_direction_desktop="default" column_element_spacing="10px" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" zindex="100" gradient_direction="left_t_to_right_b" overlay_strength="0.3" width="1/2" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid" offset="vc_col-xs-12"][vc_column_text css_animation="none" css=".vc_custom_1739545936729{margin-bottom: 10px !important;}" text_direction="default"]

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