Regaine 50 mg/g cutaneous foam
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Regaine 50 mg/g cutaneous foam
minoxidil
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if there is no improvement after 4 months.
Leaflet contents:
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What Regaine is and what it is used for
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What you need to know before using Regaine
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How to use Regaine
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Possible side effects
- Storage of Regaine
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Contents of the pack and other information
1. What Regaine is and what it is used for
Regaine contains minoxidil. Minoxidil promotes hair regrowth and helps stabilize hair loss in men with receding hairline and vertex baldness by revitalizing the hair follicle.
Regaine is used to treat hereditary hair loss (also called androgenetic alopecia) in men. Use only on the scalp (head).
2. What you need to know before using Regaine
Do not use Regaine
- if you are allergic to minoxidil or any of the other ingredients of Regaine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Regaine if:
- you have any heart disease, including irregular heartbeat, angina, or chest pain and/or circulation problems.
When minoxidil enters the bloodstream, it may cause side effects related to low blood pressure such as chest pain, rapid heartbeat, weakness, dizziness, sudden and unexplained weight gain, or swollen hands and feet. It may also cause persistent redness or irritation of the scalp. If you experience any of these effects, stop treatment and consult your doctor.
Some patients have experienced changes in hair color and texture while using this medicine.
An initial increase in hair loss (old hairs fall out as new hair grows in their place) may occur during the first 2–6 weeks (small flakes of scalp skin may shed). This is a sign that the medicine is working and new hairs are replacing the old ones. This effect resolves within two weeks. If hair loss persists, discontinue use of Regaine and consult your doctor.
Polysorbates may cause allergic reactions.
Accidental ingestion may lead to serious cardiac adverse effects; therefore, this product must be kept out of the reach of children.
If the foam is accidentally applied to other areas of the body besides the scalp, rinse immediately with plenty of water to avoid unwanted hair growth.
If symptoms persist or worsen, or if new symptoms occur, stop using the product and consult a doctor.
You should not use Regaine if:
- you have a different pattern of hair loss than receding hairline and crown baldness.
- you do not have a family history of hair loss.
- you have sudden and/or patchy hair loss.
- you do not know the cause of your hair loss.
- your scalp is inflamed, infected, irritated, or painful.
Regaine 50 mg/g topical foam is EXTREMELY FLAMMABLE!
Avoid contact with fire, flames, or smoking during and immediately after application.
Children and adolescents
Regaine must not be used by children and adolescents under 18 years of age.
Use of Regaine with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Regaine must not be used together with other topical medicines applied to the scalp.
Use of Regaine with other hair cosmetic products
Use of shampoos during treatment
You should use a mild shampoo in combination with Regaine. The scalp must be completely dry before applying Regaine.
Use of hair styling products during treatment
For best results, Regaine should be fully absorbed into the scalp before using any hair styling products. Apply Regaine first, then apply your normal hair products as usual. Do not mix Regaine with other products for use on the scalp.
Advice for people with dyed or permed hair
There is no available information on changes in the effects of Regaine due to these treatments. However, to avoid possible scalp irritation, ensure that Regaine has been completely removed by washing the hair and scalp before undergoing such treatments.
You should inform your hair care professional that you are using Regaine.
Pregnancy, breastfeeding, and fertility
Regaine must not be used by women.
This medicine is not recommended during pregnancy, breastfeeding, or when trying to become pregnant. Consult a doctor before using if you are pregnant or breastfeeding.
Driving and operating machinery
Regaine may cause dizziness or low blood pressure. If you experience these side effects, do not drive or operate machinery.
Regaine contains ethanol (alcohol)
This medicine contains 564.6 mg of alcohol (ethanol) in each dose (1 gram) of topical foam, equivalent to 564 mg/g (564.6% w/w). This may cause a burning sensation on damaged skin. If Regaine gets into the eyes, mouth, or an open skin wound, rinse the area thoroughly with cold water.
Regaine contains butylated hydroxytoluene
This medicine may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylated hydroxytoluene.
Regaine contains cetyl and stearyl alcohol
This medicine may cause local skin reactions (e.g., contact dermatitis) because it contains cetyl and stearyl alcohol.
3. How to use Regaine
Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use twice daily to achieve and maintain the desired hair regrowth effect.
This foam is for use on normal, healthy scalp only. DO NOT apply to other parts of the body.
Make sure to apply directly onto the scalp.
Avoid contact with the eyes. If foam gets into the eyes, rinse thoroughly with plenty of water.
Before using the foam:
Both hair and scalp must be completely dry.
How to use the foam:
Apply one dose of 1 g (equivalent to the volume of half a cap) to the area of hair loss twice daily.
- To open the container, align the arrow on the ring of the cap with the arrow on the cap. Remove the cap (Figure 1).
- The foam may start to melt upon contact with warm skin. If your fingers are warm, cool them first with water. Make sure to dry them before handling the foam.
- Hold the can upside down and press the nozzle to dispense the foam onto the fingertips (Figure 2). The total amount of foam applied should not exceed 1 g (equivalent to the volume of half a cap).
- Using your fingers, gently massage the foam into the affected areas of the scalp (Figure 3), and wash your hands immediately after applying the foam.
- After each use, close the container by replacing the cap on the can.
Figure 1 Figure 2 Figure 3
Duration of treatment with Regaine
Hair regrowth may take time to become noticeable. Results may not appear until after two months of twice-daily application. Some men may need to use the product for 4 months before observing results.
What to expect when using Regaine
During the first two months, some users have experienced an increased hair loss after first using the foam. This may be a sign that Regaine is working. This temporary increase in hair loss usually occurs between 2 and 6 weeks after starting treatment and subsequently resolves.
If increased hair loss continues beyond 6 weeks, consult your doctor.
The new hair is normally soft and colourless at first. With continued use, the new hair should gradually match the colour and thickness of other hair on your head. Since hair grows slowly, it takes time to see results.
Results may be seen within 2–4 months with two daily applications of the product.
If no hair regrowth is observed after four months, you should stop using Regaine.
The amount of hair regrown varies from person to person. This product may not work for all men.
Continued use is necessary to increase and maintain hair growth; otherwise, hair loss will resume.
If you use more Regaine than you should
Follow the instructions for use. Do not use more than 2 g (equivalent to the volume of one cap) per day, and never apply more than twice daily. Using more foam or applying it more frequently will not make hair grow faster or improve benefits.
If a child swallows any Regaine, take them to hospital immediately (bring the Regaine can if possible, so the doctor can assess how much has been ingested).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at: 91 562 04 20.
If you forget to use Regaine
Do not worry if you miss one or two applications. Continue using the product as if no dose had been missed. Do not apply a double amount to make up for a missed dose, as this may cause low blood pressure, rapid heartbeat, dizziness, or fatigue.
If you stop treatment with Regaine
If you stop using the foam, hair regrowth may cease and the scalp may return to its original condition within 3–4 months.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Regaine can cause adverse effects, although not everyone experiences them.
STOP using the foam and contact your doctor immediately if you notice any of the following adverse effects. You may require urgent medical treatment.
- Swelling of the hands or feet (uncommon)
- Swelling of the face, lips, or throat causing difficulty swallowing or breathing. This could be a sign of a severe allergic reaction (Frequency not known, cannot be estimated from available data)
- Persistent redness, itching, or irritation of the scalp (frequency not known)
- Weakness or dizziness (uncommon)
- Tachycardia (rapid heartbeat) or irregular heartbeat (rare)
- Chest pain (rare)
- Hypotension (low blood pressure) (frequency not known)
- Sudden and unexplained weight gain (frequent)
Other adverse effects that may occur:
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Frequent (may affect up to 1 in 10 people):
- Headache
- Severe itching or skin rash
- Shortness of breath or difficulty breathing
- Excessive hair growth
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Uncommon (may affect up to 1 in 100 people):
- Nausea
Adverse effects with unknown frequency (frequency cannot be estimated from available data):
- Eye irritation
- Vomiting
- Temporary hair loss
- Changes in hair color and/or texture
- Application site reactions, which may include itching, irritation, pain, rash, swelling, dry skin, and redness of the scalp, ears, or face, but which may sometimes be more severe and include peeling, dermatitis, blistering, bleeding, and ulceration.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Regaine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the letters “EXP”.
The expiry date refers to the last day of the month indicated.
Warning: Extremely flammable aerosol. Pressurised container: may burst if heated. Keep away from heat sources, sparks, open flames or hot surfaces, and other sources of ignition. – Do not smoke. Do not spray on an open flame or other source of ignition. Do not pierce or burn, even after use. Protect from sunlight and store the container in its box. Do not expose to temperatures above 50°C.
Do not expose the container and its contents to flames during application. Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Regaine
- The active substance is minoxidil. Each gram of cutaneous foam contains 50 mg of minoxidil.
- The other components are: anhydrous ethanol, purified water, butylhydroxytoluene (E321), lactic acid, anhydrous citric acid, glycerol, cetyl alcohol, stearyl alcohol, polysorbate 60 and propane/butane/isobutane (propellant).
Appearance of the product and contents of the container
This medicine is presented as a cutaneous foam in a pressurized container with a child-resistant polypropylene protective cap. The foam is white to slightly yellowish in color and fragrance-free. It is contained in a 60 g container (equivalent to 73 ml). The container holds enough product for 1 month of treatment. The carton may contain 1 or 3 containers.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
JNTL Consumer Health (Spain), S.L.
C/Vía de los Poblados 1, Edificio E, Planta 3
28033 Madrid
Spain
Manufacturer:
JNTL Consumer Health (France) S.A.S.
Domaine de Maigremont, 27100,
Val de Reuil,
France
This medicinal product has been authorized in the Member States of the EEA under the following names:
Finland, Norway, Sweden: Rogaine
Austria, Ireland, Romania, Slovenia, Spain: Regaine
France: Alostil
Date of the most recent review of this leaflet: September 2025
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/