REGAINE TOPICAL SOL 5% 60ML

ATC code: D11AX01 

Active substances: Minoxidilum

Vendor, principal: Mcneil Consumer Healthcare,joh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

REGAINE 20MG/1ML 60ML

Package leaflet: Information for the user Regaine, 20 mg/ml skin solution

Minoxidil

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Regaine is and what it is used for
2.   What you need to know before you use Regaine
3.   How to use Regaine
4.   Possible side effects
5.   How to store Regaine
6.   Contents of the pack and other information

1. What Regaine is and what it is used for

Regaine 20 mg/mL skin solution is used to treat hereditary hair loss (androgenic alopecia) in men and women. Topical minoxidil stimulates hair growth in case of hereditary hair loss (androgenic alopecia). Knowledge about the mechanism of minoxidil is incomplete.

2. What you need to know before you use Regaine Do not use Regaine:

-   if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions

Talk to your doctor or pharmacist before using Regaine.
Patients diagnosed with a cardiovascular disease or cardiac arrhythmia should ask their doctor for advice before using minoxidil.
Minoxidil must not be used topically if hair loss is non-hereditary, uneven (patchy) and/or sudden or if the cause for the hair loss is unknown.
Minodixil must not be used topically if hair loss is related to pregnancy/childbirth.
Before using Regaine 20 mg/mL, make sure that the scalp is normal and healthy. The medicine should not be used, if the scalp shows signs of redness, inflammation, infection or irritation symptoms, soreness or if you also use other medicines on the scalp.
The medicine is flammable, as it contains alcohol - therefore, do not use it near open fire or other sources of fire.
Avoid inhaling the sprayed medicine.
Stop using Regaine 20 mg/mL and talk to a doctor:
-   if your blood pressure drops;
-   if you experience chest pains or palpitations;
-   if you faint and/or experience dizziness;
-   if you experience unexplained sudden weight gain or swelling of the feet or legs;
-   if you experience persistent redness or irritation of the scalp;
-   if the symptoms persist or are exacerbated or you experience any new symptoms (see section 4 ‘Possible side effects’).
Accidental ingestion of the medicine may cause severe cardiac side effects; therefore, keep the medicine out of the reach of children.
The Regaine 20 mg/ml skin solution contains ingredients that may cause a burning sensation and irritation. In case of accidental contact with sensitive areas (eyes, scratched skin or mucous membranes), these areas must be rinsed thoroughly with cool running water.
Using the medicine in larger doses or more often does not guarantee a better result.
Continued treatment with the medicine is necessary, as it ensures thickening and growth of the hair; otherwise, the hair loss will begin again.
Within 2-6 weeks after beginning the treatment, temporary hair loss may occur.
Unwanted hair growth may occur if the medicine is accidentally applied on areas other than the scalp.

Other medicines and Regaine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use Regaine topically concomitantly with other medicines.
Do not use Regaine topically concomitantly with other medicines (e.g. corticosteroids, tretinoin, anthralin), as these topically applied medicines may increase the permeability of the skin, as a result of which the absorption of minoxidil may change. If Regaine is administered orally with guanethidine (used to lower blood pressure) by mistake, it could cause an acute decrease in blood pressure.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Regaine should not be used in pregnant or breast-feeding mothers.

Driving and using machines

Regaine may cause dizziness or low blood pressure. If these symptoms occur, do not drive or operate machinery.
Regaine 20 mg/mL skin solution contains propylene glycol as an excipient, which may cause burning sensation and irritation. In case of accidental contact with sensitive areas (eyes, scratched skin or mucous membranes), these areas must be rinsed thoroughly with cool running water.

3. How to use Regaine

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Hair and scalp must be dry before applying the medicine on the scalp. The medicine is only used externally on a healthy scalp.
Adults (starting from the age of 18)
Apply 1 mL of Regaine 20 mg/mL skin solution directly on the area of hair loss twice a day (once in the morning and once in the evening). Do not exceed the total daily dose of 2 ml. Wash your hands carefully after applying the medicine on the scalp.
The maximum recommended daily dose of minoxidil is 40 mg (2 mL). Hair growth may be restored only after more than 4 months have passed, if you continuously apply the medicine 2 times a day.

Instructions for using the applicators

Applicators are selected according to the size of the treated area of scalp.
Remove the black cap of the bottle, unscrew the smaller inner white cap and throw it away.
Sprayer (it is suitable for applying the medicine on large areas of skin; see Figure 1):
1.   Place the spray nozzle on the bottle and turn until tightly sealed.
2.   Remove the transparent cap.
3.   Point the sprayer in the middle of the area affected by hair loss, press the sprayer once and spread the solution evenly all over the affected area with your fingertips. Repeat the same procedure 5 more times. To achieve a dose of 1 mL, the spray must be pressed 6 times in total. Avoid inhaling the sprayed medicine.
4.   After use, seal the bottle with the protective cap.
Extended-nozzle sprayer (it is suitable for applying the medicine on small areas of skin or directly under hair; see Figure 2):
1.   To use the extended-nozzle sprayer, first attach the regular nozzle to the bottle as described above.
2.   Pull off the transparent cap and the small sprayer stopper from the sprayer.
3.   Place the extended nozzle on the sprayer guide and press tightly in place. Remove the small cap
from the end of the extended nozzle.
4.   Point the sprayer in the middle of the area affected by hair loss, press the sprayer once and spread
the solution evenly all over the affected area with your fingertips. Repeat the same procedure 5 more times.
To achieve a dose of 1 mL, the spray must be pressed 6 times in total. Avoid inhaling the sprayed medicine.
5.   After application, seal the extended sprayer nozzle with the respective cap.

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If you feel that the effect of Regaine is too strong or too weak, talk to your doctor or pharmacist.

Duration of treatment

Before you can expect hair growth, the medicine must be applied twice a day for at least 2-4 months. Overusing the medicine (in larger doses or more often) does not guarantee a better result. Continued treatment with the medicine is necessary, as it ensures thickening and growth of the hair; otherwise, the hair loss will begin again.
If you do not notice an improvement in hair growth after a 4-month treatment, the treatment should be discontinued. Regaine 20 mg/mL is not effective in everyone.

If you use more Regaine than you should

If you accidentally used the medicine in too large doses, talk to your doctor immediately or go to the nearest hospital.
If the medicine is used according to instructions, overdose is unlikely. If the medicine is used in larger doses than recommended on a larger area of skin or somewhere other than the scalp or on damaged skin (due to trauma, inflammation or disease), it may cause, at least in theory, a systemic effect.
The likely overdose symptoms are cardiovascular reactions that include low blood pressure, rapid heart rate and lethargy.
Keep this medication out of the sight and reach of children. If a child has ingested the medicine, seek medical attention immediately or contact the emergency room at your local hospital.

If you forget to use Regaine

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are associated with the topical use of minoxidil and are based on postmarketing data.
Very rare (< 1/10,000)
Immune system disorders: angioedema (may manifest as swelling of the lips, the perioral area, the oropharynx, the pharynx or the tongue), hypersensitivity (may manifest as facial swelling, generalised reddening or itchiness or a feeling of tightness in the larynx), contact dermatitis (an allergic skin inflammation caused by skin contact with an allergen)
Psychiatric disorders: depressed mood
Nervous system disorders: dizziness
Eye disorders: eye irritation
Cardiac disorders: rapid heart rate, palpitation
Gastrointestinal disorders: nausea, vomiting
General disorders and administration site reactions: chest pain
Skin and subcutaneous tissue disorders: administration site reactions (may affect the adjacent areas such as the ears or the face and usually manifest as itchiness, irritation, pain, rash, swelling, dry or reddened skin, but occasionally also as more severe symptoms like skin scaling, dermatitis, blisters, bleeding, or ulcers), temporary hair loss, change in hair colour, change in hair structure, excessive hair growth
Vascular disorders: low blood pressure

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Regaine

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the box and bottle. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Regaine contains

-   The active substance is minoxidil. 1 mL of solution contains 20 mg of minoxidil.
-   The other ingredients are alcohol, propylene glycol and purified water.

What Regaine looks like and contents of the pack

Skin solution. Clear, colourless or lightly yellowish solution.
The pack contains 1 HDPE bottle (60 mL) with a PP screw cap and 2 applicators: a sprayer and an extended-nozzle sprayer.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

McNeil Products Limited
c/o Johnson & Johnson Limited
Foundation Park, Roxborough Way,
Maidenhead, Berkshire, SL6 3UG,
United Kingdom

Manufacturer

Janssen-Cilag Domaine de Maigremont 27100 Val de Reuil France

Manufacturer of the medical device

ASM Aerosol-Service AG Industriestrasse 11 4313 Möhlin Switzerland

This leaflet was last revised in August 2018.

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