20 mg / ml cutaneous solution
minoxidil
What Minoxidil Orifarm is and what it is used for
Minoxidil Orifarm contains the active substance minoxidil which stimulates hair growth. Minoxidil Orifarm is used for treating early and less pronounced forms of hereditary hair loss ( androgenic alopecia ) in men and women over 18 years of age. For men, Minoxidil Orifarm is also used to reduce further hair loss.
Men
Minoxidil Orifarm is used for treating hair loss or thinning hair on the scalp. 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 Minoxidil Orifarm. 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 Minoxidil Orifarm 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.
Women
Minoxidil Orifarm is used for treating hair loss or thinning hair on the scalp. The exact mechanism of action of the preparation is not completely known. About 3 out of 5 women get new hair growth to varying degrees.
You must talk to a doctor if the symptoms worsen or do not improve within 4 months.
Minoxidil contained in Minoxidil Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. 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 you use Minoxidil Orifarm
Do not use Minoxidil Orifarm
- 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.
- if you have a heart condition that includes abnormal heart rhythm or heart rate, angina or chest pain and / or circulatory disorders
Minoxidil Orifarm 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 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 unexpected new symptoms
You should not use Minoxidil Orifarm
- If the pattern of hair loss is not characterized by 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
- If the hair loss begins in connection with childbirth
Rinse with plenty of cold water in case Minoxidil Orifarm comes into contact with the eyes, mouth, or wounds on the skin.
You should avoid inhaling Minoxidil Orifarm in the form of a sprayed aerosol .
Because Minoxidil Orifarm contains alcohol, it is flammable.
Using more than the recommended dose or more frequent use 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.
Accidental ingestion of Minoxidil Orifarm 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, make sure that Minoxidil Orifarm is only applied to the scalp and to wash your hands thoroughly each time Minoxidil Orifarm is used (see section 4, Possible side effects ).
Children and young people
Minoxidil Orifarm is not recommended for use in children and adolescents below 18 years. Information on safety and efficacy is lacking for persons under 18 years of age.
Other medicines and Minoxidil Orifarm
Minoxidil Orifarm should not be used at the same time as other medicines applied to the scalp. 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).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safety during pregnancy is not clear. Minoxidil Orifarm should not be used during pregnancy.
Breast-feeding
A breastfed baby may be affected. Minoxidil Orifarm should not be used during breastfeeding.
Driving and using machines
Minoxidil Orifarm 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 are fit to drive a motor vehicle or perform work that requires sharpened 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.
Minoxidil Orifarm contains ethanol and propylene glycol
This medicine contains 564 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 104 mg of propylene glycol per ml.
How to use Minoxidil Orifarm
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Recommended dose
The hair must be completely dry before Minoxidil Orifarm 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 should always be applied using the supplied spray pump. If your fingers are used to distribute Minoxidil Orifarm on the scalp, it is important to wash your hands afterward. In order not to affect the effect of Minoxidil Orifarm, a silicone-free shampoo should be used for hair washing (silicone can also be called dimethicone).
To use Minoxidil Orifarm:
- 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 directing the spray head towards the center of the surface to be treated, push in the pump plunger once and spread Minoxidil Orifarm 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 a slow process, Minoxidil Orifarm needs some time to work. Continuous use is usually 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, Minoxidil Orifarm 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 use more Minoxidil Orifarm than you should
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 ingestion, the most likely symptoms of overdose with Minoxidil Orifarm are cardiovascular effects such as increased heart rate ( pulse ), low blood pressure, and abnormal fatigue.
If you forget to use Minoxidil Orifarm
Do not take a double dose to make up for a forgotten dose. It is sufficient to resume treatment in the prescribed manner.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
Stop taking Minoxidil Orifarm 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.
- 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 does not prove to be the case, treatment should be discontinued. If you happen to get Minoxidil Orifarm 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 and swollen hands and feet, inflammation of the skin, 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 (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 color, and hair structure.
How to store Minoxidil Orifarm
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the bottle after 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 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 20 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 is a clear, colorless/yellowish solution in a plastic bottle.
Spray pump with extended spray head included in the package.
Minoxidil Orifarm 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