20 mg / ml cutaneous solution
minoxidil
What Recrea is and what it is used for
Recrea contains minoxidil and is used to treat early and less pronounced forms of hereditary hair loss ( androgenic alopecia ) in men and women over 18 years of age. For men, Recrea is also used to reduce further hair loss.
Men
Recrea is used to treat 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 have smaller skin surfaces where the hair has become thinner have the greatest prospects of responding to treatment with Recrea. 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 Recrea 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
Recrea is used to treat 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. About 3 out of 5 women get new hair growth to varying degrees.
Minoxidil contained in Recrea may also be authorized 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 Recrea
Do not use Recrea
- 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 or pharmacist before using Recrea
- 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 Recrea 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 Recrea
- 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
- If the hair loss begins in connection with childbirth
Should Recrea come into contact with the eyes, mouth, or wounds on the skin, rinsing with plenty of cold water is recommended?
Inhalation of Recrea in the form of sprayed aerosol should be avoided.
Because Recrea 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 Recrea accidentally coming into contact with other parts of the skin than the scalp.
Accidental intake of Recrea can lead to serious heart side effects. Therefore, this product must be kept out of the reach of children.
Children and young people
Recrea 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 drugs and Recrea
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Recrea should not be used at the same time as other medicines applied to the scalp.
Pregnancy, breastfeeding, and fertility
Pregnancy
The safety during pregnancy is not clear. Recrea cutaneous solution should not be used during pregnancy.
Breast-feeding
A breastfed baby may be affected. Recrea should not be used during breastfeeding.
Driving and using machines
Recrea 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 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.
Recrea contains propylene glycol and ethanol
Recrea contains 200 mg of propylene glycol per milliliter of cutaneous solution, which may cause skin irritation.
Recrea contains 550 mg of alcohol ( ethanol ) per milliliter. It can cause a burning sensation on damaged skin. It is also flammable, take this into account if e.g. hair dryer is used.
How to use Recrea
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.
The hair must be completely dry before Recrea 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).
Recrea should always be applied using the supplied applicator with or without a spray tip. If the fingers are used to distribute Recrea on the scalp, it is important to wash your hands thoroughly afterward. In order not to affect the effect of Recrea, a silicone-free shampoo should be used for hair washing (silicone can also be called dimethicone).
Spray pump
- This accessory works best when Recrea is to be applied over larger areas.
- Remove the large outer capsule; remove the smaller inner lid and discard it.
- Insert the spray applicator into the bottle and tighten it securely.
- Aim the pump towards the center of the surface to be treated, push in the pump piston once, and spread Recrea 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 large outer capsule to the bottle.
- Wash your hands thoroughly afterward.
Extended spray tip
- This accessory works best when Recrea 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.
- Remove the large outer capsule; remove the smaller inner lid and discard it.
- 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 Recrea 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.
- Wash your hands thoroughly afterward.
Length of treatment time
Because hair growth is a slow process, Recrea 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, Recrea should be used every day.
If you use more Recrea than you should
If you have used too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice (take the container with Recrea 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) ingestion, the most likely symptoms of overdose of Recrea are cardiovascular effects such as increased heart rate ( pulse ), low blood pressure, and abnormal fatigue.
If you forget to use Recrea
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 Recrea
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.
Stop taking Recrea 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 Recrea 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.
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 Recrea
Keep this medicine out of the sight and reach of children.
Flammable.
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 pack and other information
Content declaration
- The active substance is minoxidil. 1 ml Recrea contains 20 mg minoxidil.
- The other ingredients are ethanol (96% w / w), propylene glycol, and purified water. One bottle contains 60 ml of solution.
What the medicine looks like and the contents of the pack
Recrea is a clear, colorless to light yellow liquid.
The available pack sizes are 1x 60 ml and 3x 60 ml.
Holder of marketing / Information approval submitted by
Meda OTC AB, Box 906, 170 09 Solna. Tel: 08-630 19 00
Manufacturer
Delpharm Tours, 37 170 Chambray-Lès-Tours, France