I N F O R M AT I O N F O R T H E PAT I E N T APO-GAIN Minoxidil Topical Solution 2% HAIR REGROWTH TREATMENT Now available without a prescription, Apo-Gain is medically proven effective to help regrow hair in men with male pattern baldness. Please read this leaflet carefully. It will help you understand how to use Apo-Gain and what to expect from its use. If you have any questions after reading this leaflet or anytime while using Apo-Gain, ask your doctor. What is Apo-Gain? Apo-Gain contains minoxidil, a special formulation that has been shown to help regrow hair on the scalp of some men who are bald or balding. Who may use Apo-Gain? Apo-Gain may be appropriate for you if you are at least 18 years old and experiencing gradually thinning hair or gradual hair loss on the top of the head as shown. If you have more hair loss than shown, Apo-Gain may not work. The common hereditary thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss. Apo-Gain ’s effectiveness in the treatment of receding hairlines has not been demonstrated in clinical trials. Apo-Gain is not approved for use in women. What Minimal, Moderate and Dense Hair Regrowth Will Mean For You Number of Hairs Minimal Moderate Dense Some new hairs are seen, but not enough to cover thinning areas. New hairs cover some or all of thinning areas. New hairs cover, or almost completely cover thinning areas. Hairs in the thinning areas grow more closely together, but not as close together as hairs on the rest of the head. Hairs in thinning areas grow as closely together as hairs on the rest of the head. Hair Density Hairs in thinning areas do not grow as closely together as hairs on the rest of the head. How soon can I expect results from using Apo-Gain? Since normal hair usually grows 1⁄2 to 1 inch per month, hair regrowth with Apo-Gain also takes time. Continued use 2 times a day for at least 4 months is usually needed before you notice hair regrowth. If you do not see hair regrowth in 12 months, stop using Apo-Gain and see your doctor. When you first begin to use Apo-Gain, your hair loss may continue for up to 2 weeks. This hair loss is temporary. If you continue to lose hair after 2 weeks, see your doctor. Many of those experiencing hair loss have other family members with gradually thinning hair or hair loss. If there is no family history of gradually thinning hair or gradual hair loss, or hair loss is patchy or sudden in onset, talk to your doctor before using ApoGain. Who should NOT use Apo-Gain? Apo-Gain will not prevent or improve hair loss which may occur with the use of some prescription and nonprescription medications; certain severe nutritional problems (very low iron; excessive vitamin A intake); low thyroid activity (hypothyroidism); chemotherapy; or diseases which cause scarring of the scalp. Also Apo-Gain will not improve hair loss due to: • • Damage from the use of hair care products which cause scarring or deep burns of the scalp. Hair grooming methods such as cornrowing or ponytails which require pulling the hair tightly back from the scalp. You should ask your doctor if you are unsure of the cause of your hair loss. Will Apo-Gain work for me? The amount of hair regrowth is different for each person. Not everyone will respond to Apo-Gain. The response to Apo-Gain cannot be predicted. No one will be able to grow back all of their hair. You may respond better if you have been losing your hair for a shorter period of time (less than 10 years) or have little initial hair loss (less than a diameter of 10 cm). In clinical studies of men with moderate degrees of hair loss, 26% of men reported moderate to dense hair regrowth after using minoxidil for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). A similar response was obtained in 11% of men using the formulation without the medicinal ingredient, 31% of whom reported minimal regrowth at 4 months. By 12 months, 40% of minoxidil users rated their regrowth as moderate and 8% as dense; 36% reported minimal regrowth while 16% had no regrowth. If Apo-Gain is working, what will the hair look like? At first, hair growth may be soft, downy, colourless hairs. After further use, the new hair should be the same colour and thickness as the other hairs on your scalp. How long do I need to use Apo-Gain? If you respond to Apo-Gain, you will need to use it 2 times a day to keep and continue the hair regrowth. Up to 12 months of use may be needed to see your best results from ApoGain. Hair regrowth generally peaks at about one year, after which there is a slow decline in regrowth over subsequent years. What is the dosage of Apo-Gain? You should apply a dose (1 mL) of Apo-Gain directly onto the scalp in the hair loss area TWO TIMES A DAY; for example, once in the morning and once at night. Each bottle should last about 25 - 30 days, if used as directed. Please refer to the “DIRECTIONS FOR USE” section of this leaflet. What if I miss a dose or forget to use Apo-Gain? If you miss 1 or 2 daily doses of Apo-Gain, just continue with your next dose. You should not make up for missed doses. Can I use Apo-Gain more than twice a day? Will it work faster, better? No. Apo-Gain will not work faster or better if used more than 2 times a day. Studies have been carefully conducted to determine the correct amount of minoxidil needed to get the best results. More frequent use or larger doses have not been shown to speed up hair growth and may increase your chance of side effects. What happens if I completely stop using Apo-Gain? Will I keep the new hair? Continuous use of Apo-Gain is needed to maintain hair regrowth. If you stop using ApoGain, the normal hair loss process will start again. You will probably lose your newly regrown hair in three to four months. What are the most common side effects with Apo-Gain? The most common side effects are itching and other skin irritations of the treated area of the scalp. Apo-Gain contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If Apo-Gain accidentally gets into these areas, rinse with large amounts of water. Contact your doctor if irritation persists. 203287 1 of 3 I N F O R M AT I O N F O R T H E PAT I E N T APO-GAIN Minoxidil Topical Solution 2% HAIR REGROWTH TREATMENT What kind of shampoo should I use with Apo-Gain? If you wash your scalp before applying Apo-Gain, use a mild shampoo. Dry hair and scalp before application. What factors may increase the risk of serious side effects with Apo-Gain? Apo-Gain should be applied only to the scalp. The risk of side effects may be greater when it is applied to other parts of the body. Can I use hair sprays, mousses, conditioners, gels etc.? There is no need to change your usual hair care routine when using Apo-Gain. However, you should apply Apo-Gain first and wait for it to dry before applying your styling aids. DIRECTIONS FOR USE Can I have my hair coloured or permed or use hair relaxers while using Apo-Gain? We have no information that these treatments change the effect of Apo-Gain. However, to avoid possible scalp irritation, you should make sure all of the Apo-Gain has been washed off the hair and scalp before using these chemicals. Can I apply Apo-Gain and wash my hair an hour later? No. For Apo-Gain to work best, you should allow Apo-Gain to remain on the scalp for at least 4 hours. Apply a 1 mL dose twice per day directly onto the dry scalp in the hair loss area. Do not use more. Each bottle should last about 25 - 30 days, if used as directed. Use a mild shampoo if you wash your scalp before applying Apo-Gain. Avoid swimming, showering or physical activity involving excessive perspiration for at least 4 hours after application. If a dose is missed, use as soon as remembered if it is within a few hours of the usual time applied. Do not use if it is almost time for the next dose. Do not double the amount if a dose is missed. Wash hands thoroughly after use. Can I go swimming or out in the rain? Yes, as long as you use good judgment. Avoid washing off the Apo-Gain. If possible, apply Apo-Gain to a dry scalp after swimming, or wait about 4 hours after application before going swimming. Do not let your scalp get wet from the rain after applying ApoGain. Do not take Apo-Gain by mouth. Keep this and all drugs out of the reach of children. In case of accidental ingestion which can cause serious adverse effects, seek professional assistance or contact a Poison Control Centre immediately. Can Apo-Gain produce unwanted hair growth? Unwanted hair growth elsewhere on the body has been reported. This may be due to the frequent applying of Apo-Gain on areas of the skin other than the scalp. To prevent unwanted hair growth, limit the application of Apo-Gain only to the scalp. Store at controlled room temperature (15 - 30°C). Product Monograph is available to physicians and pharmacists upon request. STORAGE INSTRUCTIONS FOR USE OF APPLICATORS Can I use Apo-Gain for baldness or hair loss in babies and children? No. Apo-Gain must not be used to treat baldness or hair loss in babies and children. APPLICATOR OPTIONS Hair styles and degree of hair loss can be very different for each person. We have included three applicators that have been designed for men. You can choose whichever one works best for you. Are there any special warnings about the use of Apo-Gain? DO NOT USE APO-GAIN AND SEE YOUR DOCTOR IF YOU: a. Pump-Spray Applicator • • • • b. Extended Spray-Tip Applicator Have no family history of hair loss. Have sudden hair loss. Have patchy hair loss. Do not know the reason for your hair loss. c. Rub-on Applicator USING THE APPLICATORS a. Pump-Spray Applicator Works best for applying Apo-Gain to large areas of the scalp. DO NOT USE APO-GAIN IF YOU: • • • Are less than 18 years old or female. Have ever had an allergic reaction to any Apo-Gain ingredients. Use other topical prescription products on the scalp. 1. Unscrew small cap and discard it. 2. Insert the pump spray applicator into bottle and screw on firmly. Remove outer cap and keep it. DO NOT APPLY APO-GAIN TO YOUR SCALP IF THE SKIN IS: • • • • • • • Red or inflamed; Infected; Irritated; Painful to touch (such as severe sunburn); Broken or shaved; Burned; Sunburned. 3. After aiming the pump toward the centre of the bald area of the scalp, press the pump once and spread Apo-Gain solution with fingertips to cover all the bald area. Repeat for a total of 6 times, to apply a dose of 1 mL. Avoid breathing spray mist. 4. Replace outer cap over the pump spray applicator when not in use. STOP USING APO-GAIN AND SEE YOUR DOCTOR IF YOU GET: • • • • • • Chest pain or rapid heartbeat, as these may be signs of a serious adverse effect of the medication. Faintness and/or dizziness. Sudden, unexplained weight gain of 2.5 kg (5 pounds) or more. Swollen hands or feet. Redness or irritation on treated areas of your scalp. Unusual lesions (sores). b. Extended Spray-Tip Applicator Works best for applying Apo-Gain to small areas of the scalp or under hair. 1. Unscrew small cap and discard it. 2. Insert the pump spray applicator into bottle and screw on firmly. Remove outer cap and discard it. 203287 2 of 3 I N F O R M AT I O N F O R T H E PAT I E N T APO-GAIN Minoxidil Topical Solution 2% HAIR REGROWTH TREATMENT 3. Remove small spray head from top of pump spray applicator. 4. Fit the extended spray-tip applicator onto the spray shaft and push down firmly. 5. Remove the small cap on the end of the extended tip and keep it. 6. After aiming the pump toward the centre of the bald area of the scalp, press the pump once and spread Apo-Gain solution with fingertips to cover all the bald area. Repeat for a total of 6 times, to apply a dose of 1 mL. Avoid breathing spray mist. 7. Replace the small cap onto the end of the extended tip when not in use. c. Rub-on Applicator Works best for applying Apo-Gain to small areas of the scalp. 1. Unscrew small cap and discard it. 2. Insert the rub-on applicator into bottle and screw on firmly. Remove outer cap and keep it. 3. Hold the bottle upright and squeeze it once to half fill the upper chamber. The level of liquid in the chamber will automatically adjust to deliver one full dose (1 mL). 4. Hold the bottle upside down then rub applicator on your scalp to apply ApoGain over the entire bald area until the chamber is completely empty. 5. Replace outer cap over the rub-on applicator when not in use. 203287 3 of 3
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