Ingredients: minoxidil 2%, propylene glycol, ethanol, purified water.
Marketing Authorization Holder
Johnson & Johnson Healthcare Products
Manufacturer: McNeil PPC, Inc. Skillman, NJ 08558 USA
US Patent No. 6,946,120
1. WHAT ROGAINE IS AND WHAT IT IS USED FOR
ROGAINE minoxidil is available as a topical solution (for application on the scalp), containing 2% active substance.
ROGAINE is available in packaging with one 60 ml bottle and the following applicators: spray pump, long applicator, and/or massage applicator.
What kind of medicine is ROGAINE
ROGAINE minoxidil stimulates hair growth in androgenetic alopecia (caused by male hormones), which manifests in men as balding on the top of the head, and in women as diffuse hair loss or thinning of the scalp. The exact mechanism is not fully understood, but ROGAINE may stabilize and reverse hair loss in androgenetic alopecia.
What is ROGAINE used for
Treatment of androgenetic alopecia in men and women (new hair growth) and stabilization of hair loss.
2. BEFORE YOU USE ROGAINE
Do not use ROGAINE if:
You are allergic to minoxidil or any of the excipients listed above. If you answer yes to any of the questions below, consult a doctor before using ROGAINE, as the medicine may not be suitable for you:
■ Do you have a cardiovascular disease?
■ Are you pregnant? Are you breastfeeding?
■ Are you under 18 years of age?
Pregnancy
ROGAINE should not be used during pregnancy unless prescribed by a doctor. Women of childbearing potential should use effective contraception. If you become pregnant, plan pregnancy, or suspect pregnancy while using ROGAINE, contact a doctor immediately. Consult a doctor or pharmacist before using any medicine during pregnancy.
Breastfeeding
Use of ROGAINE during breastfeeding is not recommended because minoxidil may pass into breast milk. Consult a doctor before using any medicine while breastfeeding.
Ability to drive and use machines
No data on effects on ability to drive or use machines. Due to the mode of action, no significant effects are expected. Important information about excipients: contains alcohol, which may cause burning and eye irritation. In case of accidental contact with sensitive areas (eyes, damaged skin, mucous membranes), rinse thoroughly with plenty of cold water.
Use of other medicines:
ROGAINE and some other topical medicines may interact. Minoxidil should not be used together with tretinoin (for acne treatment) or anthralin/ditranol (for psoriasis).
3. HOW TO USE ROGAINE ROGAINE
For external use only.
Use ROGAINE exactly as directed. Do not use ROGAINE on other parts of the body. The total dose should be 1 ml of ROGAINE twice daily applied to the scalp, starting at the center of the affected bald area. The dose should be applied regardless of the size of the affected area. Total daily dose should not exceed 2 ml. Wash hands thoroughly after application. ROGAINE should be applied to completely dry hair and scalp.
Application depends on the applicator used, as described below.
A. SPRAY PUMP APPLICATOR
1. This applicator is best suited for applying ROGAINE to large areas of the scalp.
2. Remove the large outer cap; remove and discard the small inner cap.
3. Attach the spray pump to the bottle and tighten securely.
4. Aim the pump at the center of the shaved scalp area, press once, and spread ROGAINE evenly with fingertips over the shaved area. Avoid inhaling the spray. After use, replace the large cap on the bottle.
B. LONG SPRAY APPLICATOR
1. This applicator is best suited for applying ROGAINE to small scalp areas or under hair.
2. To use the long applicator, the spray pump must be screwed onto the bottle. Follow steps A.2 and A.3.
3. Remove the short nozzle from the spray pump top; attach the long nozzle firmly to the pump and press tightly. Remove the small cap from the long nozzle.
4. Aim the applicator at the center of the shaved scalp area, press the pump once and spread ROGAINE evenly over the shaved area using fingertips. Repeat six times to apply 1 ml of solution. Avoid inhaling the spray. Optionally, replace the small cap on the nozzle after use.
V. APPLICATOR FOR RUBBING IN
This applicator is best suited for applying ROGAINE to small areas of the scalp.
Remove the large outer cap; remove and discard the small inner cap.
Place the rubbing applicator onto the bottle and screw it on tightly.
Holding the bottle upright, squeeze the bottle once to fill the front chamber up to the black line. This chamber contains one full dose (1 ml of solution).
Holding the bottle upside down, rub the rubbing applicator on the scalp to cover the entire balding area until the chamber is completely empty. After use, place the large outer cap back on the bottle.
Clinical experience with ROGAINE shows that application twice daily for 4 or more months is necessary before expected signs of hair growth stimulation appear. The onset and degree of this process may vary among patients. It is reported that 3 to 4 months after stopping treatment, the original appearance returns.
What happens if you accidentally swallow ROGAINE?
Accidental ingestion of ROGAINE could lead to serious cardiovascular problems: low blood pressure, rapid heartbeat, fainting, and dizziness. Inform your doctor or pharmacist if you accidentally swallowed ROGAINE.
4. POSSIBLE SIDE EFFECTS
ROGAINE, like all medicines, may cause some unwanted side effects. The most common are: Skin reactions such as local redness (erythema), itching, and dry/flaky scalp. Increased hair shedding may occur due to ROGAINE’s effect on hair cycling – old hairs fall out and new hairs grow in their place. This temporary increase in hair loss usually occurs 2 to 6 weeks after starting treatment and decreases within a few weeks (first sign of ROGAINE action).
If any of these side effects persist or become bothersome, or if you notice any side effect not mentioned in this leaflet, please consult your doctor or pharmacist.
5. STORAGE OF ROGAINE
Store your medicine below 25°C. Keep all medicines out of reach of children! Store in the original packaging.
Do not use after the expiry date stated on the packaging. ROGAINE is colorless to slightly colored. Discoloration does not affect effectiveness.
6. ADDITIONAL INFORMATION
The information in this leaflet refers only to ROGAINE. This leaflet does not contain all information about this medicine. If you have any questions or are unsure about anything, ask your doctor or pharmacist.
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