20 mg / ml cutaneous solution
minoxidil
What Minoxidil Apofri is and what it is used for
Minoxidil Apofri contains the active substance minoxidil which stimulates hair growth. Minoxidil Apofri 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 Apofri is also used to reduce further hair loss.
Men
Minoxidil Apofri is used for treating hair loss or thinning hair on the scalp. The exact mechanism of action of minoxidil is not completely known. Younger people who have lost hair for a shorter period or show smaller skin areas where the hair has become thinner have the best chance of having the effect of treatment with Minoxidil Apofri. Anyone who has had widespread bald surfaces for several years or has advanced hair loss is less likely to benefit from the treatment. In about 4 out of 5 men, hair loss is slowed down and most of the people who use Minoxidil Apofri 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 Apofri is used for treating hair loss or thinning hair on the scalp. The exact mechanism of action of minoxidil is not completely known. About 3 out of 5 women get new hair growth to varying degrees.
Minoxidil contained in Minoxidil Apofri may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Minoxidil Apofri
Do not use Minoxidil Apofri
- 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 Apofri
- if you have a heart condition that includes abnormal heart rhythm or heart rate, angina or chest pain and / or circulatory disorders.
Minoxidil Apofri 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 Apofri and consult a doctor 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 Apofri
- 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
Avoid contact with eyes, mouth, and other mucous membranes as well as wounds on the skin.
Because Minoxidil Apofri contains alcohol ( ethanol ), it is highly 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 loss may occur. If the hair loss continues for more than two weeks, you should stop the treatment.
Accidental ingestion of Minoxidil Apofri 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 Apofri is only applied to the scalp and to wash your hands thoroughly each time Minoxidil Apofri is used (see section 4 Possible side effects ).
Children and young people
Minoxidil Apofri is not recommended for children and adolescents under 18 years. Information on safety and efficacy is lacking for persons under 18 years of age.
Other medicines and Minoxidil Apofri
Minoxidil Apofri 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 Apofri).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
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 Apofri should not be used during pregnancy.
Breast-feeding
A breastfed baby may be affected. Minoxidil Apofri should not be used during breastfeeding.
Driving and using machines
Minoxidil Apofri 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 Apofri contains propylene glycol and alcohol (ethanol)
This medicine contains 150 mg of propylene glycol per ml and 0.6 ml of alcohol ( ethanol ) per ml. Ethanol can cause a burning sensation on damaged skin.
How to use Minoxidil Apofri
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.
Instructions for use
Hair and scalp should be completely dry before applying Minoxidil Apofri.
Apply and distribute 1 ml of solution twice a day (morning and evening) on the scalp on the area/areas for hair loss. 1 ml corresponds to 6 spray pumps. Do not use more than 1 ml at a time and no more than twice daily (more frequent applications do not accelerate the effect). For optimal effect, Minoxidil Apofri should be used every day. Continued use is necessary to increase and maintain hair regrowth, otherwise, the hair loss will return.
Before using the spray for the first time, the pump must be mounted. Remove the screw cap of the bottle and screw on the spray pump firmly. Then press the spray nozzle firmly and press a few times so that an even spray is obtained.
- Distribute 6 spray pumps, corresponding to 1 ml, over the surfaces to be treated (morning and evening).
- Spread out and lightly massage Minoxidil Apofri into the scalp using your fingertips over the treated surfaces.
- Wash your hands thoroughly afterwards.
Minoxidil Apofri contains alcohol which may cause burning and/or irritation. Rinse with plenty of cold water if Minoxidil Apofri should come into contact with the eyes, mouth, or sores on the skin.
Avoid inhaling the sprayed solution.
In order not to affect the effect of Minoxidil Apofri, a silicone-free shampoo should be used for hair washing (silicone can also be called dimethicone).
Length of treatment time
Because hair growth is a slow process, Minoxidil Apofri needs some time to work. Continuous use 2 times a day is usually required for at least 2 – 4 months before the effect becomes noticeable. In some cases, however, it may take longer. If no effect is seen within 4 months, treatment should be discontinued. Talk to your doctor if symptoms worsen or do not improve within 4 months.
If you use more Minoxidil Apofri 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 oral administration, the most likely symptoms of overdose of Minoxidil Apofri are cardiovascular effects such as increased heart rate ( pulse ), low blood pressure, and abnormal fatigue.
If you forget to use Minoxidil Apofri
Do not use a double dose to make up for a forgotten dose. It is sufficient to resume treatment as described in section 3 “How to use Minoxidil Apofri”.
If you stop using Minoxidil Apofri
If the treatment is stopped, the effect stops 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, 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 loss may occur. This is caused by the hair follicles (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 the hair loss continues for more than 2 weeks, you should stop the treatment and consult a doctor.
Stop taking Minoxidil Apofri 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; difficulty swallowing; hives and difficulty breathing. This may be a sign of a severe allergic reaction (has been reported, occurs in an unknown number of users).
- Palpitations, dizziness or fainting spells.
Other side effects that may occur:
Very common (affects 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 Apofri 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 (affects less than 1 user in 100):
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 Apofri
Keep this medicine out of the sight and reach of children.
The container contains a highly flammable liquid and must be tightly closed. Do not expose to heat, hot surfaces, sparks, open flames, or other sources of ignition. Smoking forbidden.
Do not store above 30 ° C.
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.
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 package and other information
Content declaration
- The active substance is minoxidil 20 mg / ml
- The other ingredients are propylene glycol, ethanol and water.
What the medicine looks like and contents of the pack
Minoxidil Apofri is a clear, colorless/yellowish solution in a plastic bottle. Spray pump with extended spray head included in the package.
Minoxidil Apofri 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
Apofri AB, Box 120, 182 12 Danderyd
Manufacturer
SC Laropharm SRL, 145 A Alexandriei street, Bragadiru, Ilfov, 077025, Romania