Document: Roquinna cutaneous foam ENG PL change

• Roquinna cutaneous foam PL
• Roquinna cutaneous foam ENG PL

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Package leaflet: Information for the user

Roquinna 50 mg/g, cutaneous foam

Minoxidil

Read all of this leaflet carefullybefore 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.

• You must talk to a doctor if your symptoms worsen or do not improve after 6 months.

In this leaflet:

1. What Roquinna is and what it is used for

2. What you need to know before you use Roquinna

3. How to use Roquinna

4. Possible side effects

5. How to store Roquinna

6. Contents of the pack and other information

1. What is Regaine for Women and what it is used for

Roquinnacontains minoxidil. Minoxidil regrows hair in women by revitalization of hair follicles.

What is female pattern baldness:

• Hair thins on the crown of the scalp. It usually starts with a widening through the parting.

• The front hairline remains unaffected except for normal receding of hair, which happens to everyone as time passes.

Roquinnais used to treat women with common hereditary thinning or hair loss in the parting (also called androgenetic alopecia, female type).

2. What you need to know before you use Roquinna

Before the start of the treatment with Roquinna you should be thoroughly examined. Hairloss due to disorders of the hormonal system (endocrinological disorders), underlying diseases or malnutrion has to be excluded. In this case you will need a specific treatment.

Do NOT use Roquinna if you:

• are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6).

• are using other topical medicinal products on the scalp concomitantly.

Warning and precautions

Talk to your doctor or your pharmacist before using Roquinnaif you

Roquinna is to be used only on the scalp.

Some patients have experienced changes in hair colour and texture with this medicine.

Increased hair shedding (small scalp skin layers that fall off) may occur during the initial 2 – 6 weeks of treatment. This is a sign that it is working and that new hairs are replacing old hairs. If shedding persists, stop using Roquinnaand consult with your doctor.

When treatment with minoxidil is stopped, shedding of the hairs will occur again.

Accidental ingestion may cause serious effects to your heart. Therefore this product has to be kept out of the reach of children.

You should not useRoquinnaif

• the pattern of your hair loss differs from hair thinning mainly on the top and crown of the scalp

• you have no family history of gradual thinning or gradual hair loss

• your hair loss is sudden and/or patchy

• your hair loss is due to childbirth

• you do not know the reason for your hair loss

• your scalp is red, inflamed, irritated or painful.

Roquinna is an EXTREMELY FLAMMABLE AEROSOL!

Avoid fire, flame, or smoking during and immediately following application.

Children and adolescents

Roquinnashould not be used by children and adolescents below 18 years of age.

Other medicines and Roquinna

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Roquinnashould not be used at the same time with other medications applied topically on the scalp.

Other cosmetic hair products and Roquinna

Use of shampoo during treatment

You should use a mild shampoo in conjunction with using Roquinna. Your scalp must be dry before you apply Roquinna.

Use of hair grooming products during treatment

For best results, Roquinnashould be allowed to soak into the scalp before using any styling products. ApplyRoquinnafirst, and then apply your styling products as usual. Do not mix with any other preparation for use on the scalp.

Advice about hair colour or perming

There is no available information about whether these treatments change the effect of Roquinna. However, to avoid possible scalp irritation, you should make sure all of the Roquinnahas been washed off the hair and scalp before using these chemicals. Also, you should tell your hair care professional that you are using Roquinna.

Pregnancy, breastfeeding and fertility

This medicine is not recommended during pregnancy, lactation or when trying to conceive.

Driving and using machines

It is not expected thatRoquinnawould interfere with your ability to drive or operate machinery.

You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other tasks that demand increased concentration. Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines. Descriptions of these effects can be found in other sections.

Read all the information in this leaflet for guidance.

Discuss with your doctor, nurse or pharmacist if you are unsure about anything.

Roquinna contains:

Ethanol(alcohol) which will cause burning and irritation if you get it in your eye. If you get Roquinnain your eye, mouth or a cut or damaged skin, wash the area well with plenty of cool tap water.

Butylated hydroxytoluenewhich may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Cetyl alcohol andstearyl alcoholwhich may cause local skin reactions (e.g. contact dermatitis).

3. How to use Roquinna

Always use Roquinnaexactly as stated in this package leaflet or as your doctor or your pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Use this foam once a day to achieve and maintain the desired effect on hair growth.

This foam is for use on the scalp only. Do NOT apply on other parts of the body.

Make sure to apply the foam directly to the scalp.

Avoid contact with the eyes. If you get the foam in your eyes, rinse your eyes immediately with plenty of cool tap water.

Before using the foam:

Your hair and scalp should be dry.

How to apply the foam:

Apply a dose of 1 g (equivalent to the volume of half a capful) to the hair loss area once a day.

To open the container, match the arrow on the can ring with the arrow on the cap. Remove the cap (Figure 1).

The foam may begin to melt on contact with warm skin. If your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam.

Hold the can upside down and press the nozzle to dispense the foam product onto a non-absorbent surface like a clean dish or saucer. The total amount of foam applied should not be more than 1g (equivalent to the volume of half a capful). (Figure 2)

Within your hair thinning areas, make a centre part to help maximize scalp exposure. (Figure 3)

Using your fingertips, spread just enough foam over the hair loss areas and gently massage the foam

into the scalp starting from the back to front (forehead) direction. (Figure 4)