50 mg / ml cutaneous solution
Minoxidil
What Rogaine Forte is and what it is used for
Rogaine Forte contains minoxidil and is used to treat early and less pronounced forms of hereditary hair loss ( androgenic alopecia ) in men over the age of 18 and also to reduce further hair loss.
Rogaine Forte is used to treating hair loss or thinning hair on the scalp, as shown in the pictures below.
The exact mechanism of action of the preparation is not completely known. Younger individuals who have lost hair for a shorter period or show smaller skin areas where the hair has become thinner have the greatest prospects of responding to treatment with Rogaine Forte. Anyone who has had widespread bald surfaces for several years or has advanced hair loss has less chance of benefiting from the treatment. In about 4 out of 5 men, hair loss is slowed down and most of the individuals who use Rogaine Forte also get some form of hair regrowth. The effect of the treatment can be expected after 2-4 months, in some cases shorter or longer.
Minoxidil contained in Rogaine Forte may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Rogaine Forte
Do not use Rogaine Forte
- if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Rogaine Forte
- if you have a heart condition that includes abnormal heart rhythm or heart rate, angina or chest pain, and/or circulatory disorders.
Discontinue treatment with Rogaine Forte and consult a physician if any of the following symptoms occur:
- Chest pain
- High heart rate ( pulse )
- Dizziness and/or tendency to faint
- Sudden, unexplained weight gain
- Swelling of hands and feet
- Remaining redness and irritation of the scalp in the areas treated.
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives and difficulty breathing.
- Other new unexpected symptoms
You should not use Rogaine Forte
- If the pattern of hair loss is not characterized by the retractable hairline and/or thinning hair on the scalp
- If hair loss has not affected anyone else in the family
- If you have started to lose hair suddenly or in patches
- If you do not know the cause of hair loss
- If you have red, inflamed, irritated, or painful scalp
Should Rogaine Forte come into contact with the eyes, mouth, or sores on the skin, rinsing with plenty of cold water is recommended?
Inhalation of Rogaine Forte as a spray solution should be avoided.
Because Rogaine Forte contains alcohol, it is flammable.
Using more than the recommended dose one or more frequent uses will not improve the result.
Continued use is necessary to increase and maintain hair regrowth, otherwise, the hair loss will return.
At the beginning of the treatment, after 2-6 weeks, a temporary increase in hair rejection may occur. If the hair rejection continues for more than two weeks, the treatment should be stopped.
Unwanted hair growth in other parts of the body may be due to Rogaine Forte inadvertently coming into contact with parts of the skin other than the scalp.
Accidental ingestion of Rogaine Forte can lead to serious heart side effects. Therefore, this product must be kept out of the reach of children.
Children and young people
Rogaine Forte is not recommended for children under 18 years of age. Information on safety and efficacy is lacking for persons under 18 years of age.
Other medicines and Rogaine Forte
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Rogaine Forte should not be used at the same time as other medicines applied to the scalp.
Pregnancy, breastfeeding, and fertility
Rogaine Forte is not for women.
Driving and using machines
Rogaine Forte can cause dizziness or low blood pressure. If you experience these side effects, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rogaine Forte contains:
- 244 mg alcohol ( ethanol ) per ml. It can cause a burning sensation on damaged skin. It is also flammable, take this into account if e.g. hair dryer is used.
- 520 mg propylene glycol per ml.
How to use Rogaine Forte
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.
The hair must be completely dry before Rogaine Forte is applied and the same applies to the scalp. At 12-hour intervals (once in the morning and once in the evening), 1 ml is applied directly to the scalp and distributed over the entire surface to be treated. Do not use more than 2 ml per day and do not apply more often than twice daily (more frequent applications do not accelerate the effect).
Rogaine Forte should always be applied using the supplied applicator with or without a spray tip. If your fingers are used to distribute Rogaine Forte on the scalp, it is important to wash your hands thoroughly afterward. In order not to affect the effect of Rogaine Forte, a silicone-free shampoo should be used for hair washing (silicone can also be called dimethicone).
Spray pump
- This accessory works best when Rogaine Forte is to be applied over large areas.
- Open the child-resistant cover by pushing it downwards and at the same time turning it counterclockwise.
- Insert the spray applicator into the bottle and tighten it securely.
- Remove the small transparent lid and point the pump towards the center of the surface to be treated, push in the pump plunger once, and spread the Rogaine Forte using your fingertips over the entire surface to be treated. Perform this procedure 6 times to apply a dose, ie 1 ml of the solution. Avoid breathing spray mist.
- When not in use, attach the small transparent lid to the spray applicator. For the container to be child-resistant, you must remove the spray applicator and put the lid back on the bottle.
- Wash your hands thoroughly afterward.
Extended spray tip
- This accessory works best when Rogaine Forte is applied over small areas of the scalp or under hair.
- The spray pump must be attached to the bottle when using the extended spray tip.
- Open the child-resistant cover by pushing it downwards and at the same time turning it counterclockwise.
- Insert the spray applicator into the bottle and tighten it securely.
- Remove the smaller spray head from the top of the spray applicator; mount the extended spray tip applicator on the spray nozzle and press down firmly. Remove the small capsule at the end of the extended spray tip.
- After pointing the applicator towards the center of the surface to be treated, push in the pump piston once and spread the Rogaine Forte using your fingertips over the entire surface to be treated. Perform this procedure 6 times to apply a dose, ie 1 ml of the solution. Avoid inhaling the spray aerosol.
- When not in use, insert the small capsule into the opening on the extended spray tip. For the container to be child-resistant, you must remove the spray applicator and the extended spray-top applicator and put the cap back on the bottle.
- Wash your hands thoroughly afterward.
Length of treatment time
Because hair growth is a slow process, Rogaine Forte needs some time to work. Usually, continuous use is required twice a day for at least 2-4 months before the effect is noticeable. In some cases, however, it may take longer. If no effect is seen within 4 months, treatment should be discontinued. For optimal effect, Rogaine Forte should be used every day.
If you use more Rogaine Forte than you should
If you have used too much medicine or if e.g. a child has accidentally ingested the medicine contact a doctor or hospital for risk assessment and advice (take the container with Rogaine Forte with you if possible so that the doctor can get an idea of how much the child may have swallowed).
If used incorrectly or with particular sensitivity, there may be a risk of side effects due to increased absorption through the skin. In case of accidental oral (oral) administration, the most likely symptoms of overdose of Rogaine Forte are cardiovascular effects such as increased heart rate ( pulse ), low blood pressure, and abnormal fatigue.
If you forget to use Rogaine Forte
Do not worry if you forget one or two applications. Just keep using the product as if you had not missed a dose. Do not apply twice as much if you miss a dose.
If you stop using Rogaine Forte
If the treatment is stopped, the effect ceases within 3 to 4 months, and the hair loss returns.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, Rogaine Forte can cause side effects, although not everybody gets them.
Stop taking Rogaine Forte and contact a doctor immediately if you have any of the following symptoms – you may need immediate medical attention.
- swelling of the face, lips, or throat that makes it difficult to swallow or breathe. This may be a sign of a severe allergic reaction (has been reported, occurs in an unknown number of users).
- difficulty swallowing
- hives and difficulty breathing
- palpitations, dizziness, or fainting spells
At the beginning of the treatment, after 2-6 weeks, a temporary increase in hair rejection may occur. This is caused by the hair follicles undergoing a change from a dormant stage (old hair) to an active growing phase (new hair). When this new growth starts, the old hair is detached from the scalp, which is expressed in hair loss. If hair rejection continues for more than 2 weeks, treatment should be stopped and a doctor consulted.
Other side effects that may occur:
Very common (affects more than 1 user in 10): Headache
Common (affects more than 1 user in 100):
During treatment, some skin irritation may occur. This effect caused by the alcohols ( ethanol and propylene glycol) contained in the solution is usually transient. If this does not prove to be the case, treatment should be discontinued. If you happen to get Rogaine Forte in the eyes, in the mouth, or on damaged skin, this is most easily removed by rinsing with plenty of cold water.
Shortness of breath, swollen hands and feet, inflammation of the skin, itching, rash, weight gain, and unwanted hair growth (in places other than the scalp).
Uncommon (affects less than 1 user in 100):
Dizziness, nausea.
Rare (affects less than 1 user in 1,000) :
Palpitations, increased heart rate, chest pain, hair follicle inflammation.
Has been reported (occurs in an unknown number of users ) :
Allergic contact dermatitis, hypersensitivity, eye irritation, low blood pressure, vomiting, change in hair color and/or structure, and temporary hair loss.
Treatment site reactions that may include itching, irritation, pain, rash, swelling, dry skin, and redness of the scalp, ears, or face. The reactions can sometimes be more severe and include flaking skin, inflammation of the skin, blistering, bleeding, and ulceration.
Temporary hair loss, changes in hair color, and hair structure
How to store Rogaine Forte
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Store below 30 ° C.
Flammable.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is minoxidil. Each ml of cutaneous solution contains 50 mg of minoxidil.
- The other ingredients are propylene glycol, ethanol, and purified water.
What the medicine looks like and the contents of the pack
Clear, colorless to light yellow solution in a 60 ml plastic bottle with a child-resistant lid made of polypropylene. The container is enough for 1 month of treatment. The packages contain 1 or 3 containers.