What is Rogaine 5% solution and when is it used?

Regaine 5% solution is a hair restorer for external use only, which contains the active ingredient minoxidil.

Regaine 5% solution is used to treat excessive hereditary hormonal hair loss and the onset of baldness (androgenetic alopecia) in men aged 18 to 65. It can prevent further hair loss and promote new hair growth. The mode of action is not fully understood.

Only with a doctor's prescription, Rogaine 5% solution can also be used in women to treat hereditary hormone-related hair loss (androgenetic alopecia).

What should be considered?

Typical for men and women with hereditary hair loss is a thinning of the hair growth or balding above the temples and in the crown region (see figure) .

Regrowing new hair takes at least 2-4 months. Cosmetically satisfactory regrowth of new hair is usually observed after about a year of treatment. However, the onset of action and the degree of thickening of the scalp hair vary from person to person.

If you respond to treatment, your new hair is likely to be soft and fluffy (vellus hair) and barely noticeable at first.

As the treatment continues, the new hair growth will become thicker and darker until it matches the existing scalp hair in color and texture.

Advanced cases of baldness and baldness that has been present for more than ten years rarely or not at all respond to treatment.

When not to use Rogaine 5% solution?

If you are allergic to minoxidil, propylene glycol or alcohol, do not use Rogaine 5% solution. The same applies to non-hereditary sudden and/or circular hair loss, hair loss that occurs in connection with pregnancy or childbirth, hair loss of unknown cause, hair loss that is associated with inflammation of the scalp, or if there are no cases of premature hair loss in your family hair loss occur. Also, Rogaine 5% solution is not suitable for treating complete baldness or total loss of body hair.

If you are unsure what is causing your hair loss, search

Your doctor. Regaine 5% solution should not be used in patients over 65 years of age and in patients under 18 years of age.

Rogaine 5% solution must not be used during pregnancy and breastfeeding (see «Can Rogaine 5% solution be used during pregnancy or while breastfeeding?»).

When is caution needed when using Rogaine 5% solution?

Ingesting Rogaine 5% solution can lead to serious blood pressure and cardiovascular problems. Therefore, the product must be kept out of the reach of children and may only be used externally.

In case of accidental ingestion, contact a doctor immediately.

Avoid inhaling the spray fumes.

Regaine 5% solution should only be applied to healthy scalp.

If your scalp is red, inflamed, irritated, infected or painful such as from sunburn or dermatitis, Rogaine 5% solution should not be used. Rogaine 5% solution must not be applied together with other topical medicines (ointments, creams, lotions, etc.).

If you suffer from cardiovascular diseases (e.g. cardiac arrhythmias, angina pectoris or chest pain, high blood pressure and/or circulatory disorders), consult a doctor before using Rogaine 5% solution for the first time.

You should stop taking Rogaine 5% solution and see your doctor,

• if you notice a drop in blood pressure, or
• if one or more of the following occur or worsen: chest pain, fast heart beat, feeling weak or dizzy, sudden and unexplained weight gain, swelling hands or feet, persistent redness or irritation of the scalp.

This medicine may cause low blood pressure and/or dizziness and may affect your ability to react, drive and use any tools or machines. affect! If you experience low blood pressure and/or dizziness, do not drive or use machines.

Tell your doctor, pharmacist or druggist if you

• suffer from other illnesses,
• have allergies or
• take other medicines (including those you bought yourself!) or use them externally.

This medicinal product contains 252.32 mg alcohol (ethanol 96%) per ml. It may cause a burning sensation on broken skin. It can also cause burning and irritation in the eyes. If you accidentally get Rogaine 5% solution in your eyes, mouth or on a wound, rinse the affected area thoroughly with plenty of cold water.

This medicinal product contains 518 mg propylene glycol (E 1520) per ml.

Can Rogaine 5% solution be used if you are pregnant or breastfeeding?

If you are planning to become pregnant or are pregnant or if you are breastfeeding, you can use Rogaine 5% Do not use solution.

How to use Rogaine 5% solution?

Hair and scalp must be completely dry before using Rogaine 5% solution. Rogaine 5% solution is for external use on the scalp only.

Adults aged 18 to 65

Men

Apply 1 ml of solution twice a day ( morning and evening) directly on the scalp affected by hair loss.

Do not exceed the dose of 1 ml of Rogaine 5% solution per application and do not apply Rogaine 5% solution more than 2x per day (more frequent application or using larger amounts will not bring improved results). Gently spread Rogaine 5% solution over the scalp with the applicator or fingertips (do not massage in!), starting in the center of the affected areas.

Wash your hands thoroughly after each use to avoid accidentally spilling Rogaine 5% solution through your hands to other parts of the body. If you accidentally apply the solution to an area other than the scalp, rinse that area thoroughly with plenty of water to avoid possible side effects on the skin.

Regular application (twice a day) is required to promote and maintain new hair growth. Otherwise, the hair loss will start again.

Women

The application may only take place after a doctor's prescription, then the same recommended dosage as for men applies unless otherwise prescribed by the doctor.

Stick to the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

The medicine contains three applicators: pump spray applicator, pump spray applicator with extended tip and dropper.

Instructions for use for the applicators

Unscrew the white cap from the Rogaine 5% bottle.

Pump spray applicator (for large areas)

1. Insert the pump spray applicator into the bottle and screw it on tightly.
2. Remove the transparent cap.
3. Aim the pump at the area to be treated; 6 sprays make the dose of 1 ml. After each spray, spread the solution over the affected area with your fingertips. Do not inhale spray fumes.

Pump spray applicator with extended tip (for small areas or under the hairstyle)

1. Insert the pump spray applicator into the bottle and screw on firmly.
2. Remove the clear cap and spray head.
3. Attach the extended tip and gently press down. Remove small cap.
4. Aim pump at area to be treated; 6 sprays make the dose of 1 ml. After each spray, spread the Rogaine 5% solution over the entire hairless area with your fingertip. Do not inhale spray fumes.
5. Put a small cap on the tip.

Drop pipette (for precise application on small areas)

1. Hold the dropper in the bottle.
2. Squeeze the rubber and slowly release until the solution appears at the 1mL mark.
3. With the dropper pointing down, the Apply the solution to the desired area.
4. Place the dropper on the bottle and close it.

What side effects can Rogaine 5% solution have?

The following side effects may occur when using Rogaine 5% solution:

In the first 2 - 6 weeks of use, there may be temporary increased hair loss, as the old hair is pushed out by new hair that grows back ("shedding"). This temporarily increased hair loss usually occurs 2 - 6 weeks after the start of therapy and subsides after a few weeks (first sign of the minoxidil effect). This should subside after a few weeks. If the increased hair loss persists, you should stop treatment with Rogaine and seek medical advice.

Very common (affects more than 1 user in 10):

• Headache

Common (affects 1 to 10 users in 100):

• Shortness of breath, dermatitis, acne-like dermatitis, skin reactions such as rash, local skin irritation and redness, itching, dry, scaly skin or eczema, hair loss, unwanted hair growth outside the scalp (including facial hair in women), swollen hands or legs, and weight gain

Uncommon (affects 1 to 10 users in 1000):

• Allergic reactions, hives, allergic rhinitis, generalized water retention (swelling) or swelling (edema) of the face, dizziness and nausea

Rare (affects 1 to 1 10 out of 10,000 users):

• low blood pressure, changes in hair color and texture (this is particularly possible with gray hair, when swimming in chemically treated water (swimming pool), or if Rogaine 5% solution changes colour:)

Very rare (affects less than 1 in 10,000 users):

• severe hypersensitivity reactions and angioedema characterized by swelling of the face, lips, mouth, tongue and/or throat, general itching, general skin rash and throat tightness. If any of these signs occur, stop treatment and seek medical attention immediately.
• allergic contact dermatitis, reactions at the application site (and nearby parts of the body such as ears and face) such as skin irritation, pain, swelling ( edema) and redness; These reactions can also be more serious with skin peeling, blistering, bleeding and ulceration; depressive mood, vomiting, eye irritation, visual disturbances including reduced visual acuity, chest pain, palpitations (tachycardia) or conscious perception of the heartbeat (palpitations), sexual dysfunction

If you are being treated with Regaine 5 If you suddenly develop chest pain, palpitations or low blood pressure, stop using Rogaine 5% solution and consult a doctor. The same applies if you experience fainting and/or dizziness, sudden unexplained weight gain, swollen hands or feet, persistent redness or irritation of the treated scalp or other unexpected symptoms.

If you get any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else do you need to know?

Because Rogaine 5% solution contains alcohol, it is highly flammable. Therefore, do not smoke while using Rogaine 5% solution and do not go near an open flame or other heat source. Use the spray carefully.

Store in the original packaging. Store at room temperature (15-25°C). Keep out of reach of CHILDREN.

The medicinal product may only be used up to the date marked «EXP» on the container.

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What does Rogaine 5% solution contain?

Active substance

1 ml of Rogaine 5% solution contains 50 mg Minoxidil.

Excipients

Ethanol 96%, propylene glycol (E 1520) and purified water

Approval number

48249 (Swissmedic)

Where can you get Rogaine 5% solution? What packs are available?

In pharmacies and drugstores, without a doctor's prescription.

1 bottle of 60 ml (each pack contains 3 different applicators).

3 bottles of 60 ml (each pack contains 3 different applicators).

Authorization holder

Janssen-Cilag AG, Zug, ZG.

This leaflet was last checked by the Medicines Agency (Swissmedic) in January 2022.