Minoxidil Orifarm Forte 50 mg/ml minoxidil cutaneous solution
What Minoxidil Orifarm Forte Is And What Minoxidil Orifarm Forte Used For
Minoxidil Orifarm Forte contains the active substance minoxidil, which stimulates hair growth. Minoxidil Orifarm Forte is used to treat early and less pronounced forms of hereditary hair loss ( androgenic alopecia ) in men over 18 years of age and to reduce further hair loss. In about 4 out of 5 men, hair loss is slowed down, and most individuals who use Minoxidil Orifarm Forte also get some form of hair regrowth. The effect of the treatment can be expected after 2-8 months, in some cases shorter or longer.
You must talk to your doctor if your symptoms worsen or do not improve within 8 months.
Minoxidil contained in Minoxidil Orifarm Forte may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have further questions, and always follow their instructions.
What You Need To Know Before You Use Minoxidil Orifarm Forte
Do Not Use Minoxidil Orifarm 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 Minoxidil Orifarm Forte. People with known cardiovascular disease or heart rhythm disorder should consult a physician before starting treatment.
Minoxidil Orifarm Forte should not be used in case of sudden or spotty hair loss or if the skin or scalp is red, inflamed, irritated, infected, or sore.
Discontinue treatment with Minoxidil Orifarm Forte and consult a physician if any of the following symptoms occur:
- Chest pain
- High heart rate ( pulse )
- Dizziness and 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 unexpected new symptoms
It would be best if you did not use Minoxidil Orifarm Forte
- If the pattern of hair loss is not characterized by the retractable hairline 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 a red, inflamed, irritated or painful scalp
Rinse with plenty of cold water if Minoxidil Orifarm Forte should come in contact with the skin’s eyes, mouth, or sores. You should avoid inhaling Minoxidil Orifarm Forte as a spray aerosol.
Because Minoxidil Orifarm Forte contains alcohol, it is flammable. Using more than the recommended dose or more frequently used will not improve the result.
Continued use is necessary to increase and maintain hair regrowth. Otherwise, the hair loss will return. A temporary increase in hair rejection may occur at the beginning of the treatment, after 2-6 weeks. If the hair rejection continues for more than two weeks, the treatment should be stopped.
Accidental intake of Minoxidil Orifarm Forte can lead to serious heart side effects. Therefore, this product must be kept out of the reach of children.
To reduce the risk of unwanted hair growth, ensure that Minoxidil Orifarm Forte is only applied to the scalp and wash your hands thoroughly each time Minoxidil Orifarm Forte is used (see section 4, Possible side effects ).
Children And Young People
Minoxidil Orifarm Forte is not recommended for children and adolescents below 18 years old. Information on safety and efficacy is lacking for persons under 18.
Other Medicines And Minoxidil Orifarm Forte
Tell your doctor if you are using other medicines on the skin, e.g. tretinoin, dithranol or betamethasone. These medicines may cause the skin to absorb more or less minoxidil (the active substance in Minoxidil Orifarm Forte ).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Minoxidil Orifarm Forte With Food And Drink
You can use Minoxidil Orifarm Forte with food and drink.
Pregnancy And Breastfeeding
Women should not use minoxidil Orifarm Forte.
Driving And Using Machines
Minoxidil Orifarm Forte may 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 can drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects 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.
Minoxidil Orifarm Forte Contains Ethanol And Propylene Glycol
- This medicine contains 243 mg of alcohol ( ethanol ) per ml. It can cause a burning sensation on damaged skin.
- Flammability, use near open flames, cigarettes, or certain appliances (eg hairdryer) should be considered.
- This medicine contains 520 mg of propylene glycol per ml.
How To Use Minoxidil Orifarm Forte
- Always use this medicine as described in this leaflet or as your doctor, pharmacist, or nurse has told you. If unsure, talk to your doctor, pharmacist, or nurse.
- Recommended dose
- The hair must be completely dry before Minoxidil Orifarm 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).
- Minoxidil Orifarm Forte should always be applied using the supplied spray pump. Afterwards, the fingers are used to distribute Minoxidil Orifarm Forte on the scalp, and it is important to wash the hands. In order not to affect the effect of Minoxidil Orifarm Forte, a silicone-free shampoo should be used for hair washing (silicone can also be called dimethicone).
- To use Minoxidil Forte spray:
- Remove the screw cap of the bottle.
- Insert the spray pump into the bottle and tighten it securely.
- Mount the extended spray head on the spray pump.
- After aiming the spray head at the centre of the surface to be treated, push in the pump plunger once and spread Minoxidil Orifarm Forte using your fingertips over the entire surface to be treated. Perform this procedure 10 times to apply a dose ie 1 ml of the solution.
- Wash your hands thoroughly afterwards.
Length of treatment time
Because hair growth is slow, Minoxidil Orifarm Forte needs some time to work. Continuous use is usually required twice daily for at least 2 months before the effect is noticeable. In some cases, however, it may take longer. If no effect is seen within 8 months, treatment should be discontinued. For optimal effect, Minoxidil Orifarm Forte should be used every day. If the treatment is stopped, the effect stops within 3 to 4 months, and the hair loss returns.
If You Forget To Use Minoxidil Orifarm Forte
Do not take a double dose to make up for a forgotten dose. It is sufficient to resume treatment in the prescribed manner.
In case of misuse or special sensitivity, there may theoretically be a risk of general effects due to increased absorption through the skin. In case of accidental oral administration, the most likely symptoms of overdose with Minoxidil Orifarm Forte are effects on the heart and vessels, such as increased heart rate ( pulse ), low blood pressure, and abnormal fatigue.
If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.
Possible Minoxidil Orifarm Forte Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
A temporary increase in hair rejection may occur at the beginning of the treatment, after 2-6 weeks. This is caused by the hair follicles changing 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 should be consulted.
Stop taking Minoxidil Orifarm 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 (it has been reported to occur in an unknown number of users).
- About palpitations, dizziness or fainting spells.
- Other side effects that may occur:
Very common ( may affect more than 1 user in 10): Headache.
Common ( may affect up to 1 in 10 people) :
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 is not the case, treatment should be discontinued. If you get Minoxidil Orifarm Forte in your eyes, mouth, or on damaged skin, this is most easily removed by rinsing with plenty of cold water. Shortness of breath and swollen hands and feet, skin inflammation, itching, rash, weight gain, and unwanted hair growth (in places other than the scalp).
Uncommon ( may affect up to 1 in 100 people):
- Dizziness
- Nausea
Rare Minoxidil Orifarm forte side effects(may affect up to 1 in 1,000 people):
- Palpitations
- Increased heart rate
- Chest pain
- Hair follicle inflammation
Has been reported (occurs in an unknown number of users):
- Low blood pressure
- Hypersensitivity
- Allergic contact dermatitis
- Eye irritation
- Vomiting
Treatment site reactions 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 colour, and hair structure.
How To Store Minoxidil Orifarm Forte
- Keep this medicine out of sight and reach of children.
- No special storage instructions.
- Do not use this medicine after the expiry date stated on the bottle after EXP. Dat / EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is minoxidil 50 mg/ml
- The other ingredients are propylene glycol (E1520), ethanol and purified water.
What The Medicine Looks Like And Contents Of The Pack
- Minoxidil Orifarm Forte is a plastic bottle’s clear, colourless/yellowish solution.
- Spray pump with extended spray head included in the package.
- Minoxidil Orifarm Forte is available in pack sizes of 60 ml, 2×60 ml, and 3×60 ml.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com