ELL-CRANELL

ELL-CRANELL 250 micrograms/ml solution for application adhead.

Important notes (mandatory information)

Ell-Cranell 250, solution. Active ingredient: Alfatradiol. Areas of application: to increase the reduced anagen hair rate in mild androgenetic alopecia (hormonal-hereditary hair loss) in men and women.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ell-Cranell 250 micrograms/ml solution for application to the scalp, for use in adults
Active ingredient: Alfatradiol

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

What this package leaflet contains

1. WHAT IS ELL-CRANELL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ELL-CRANELL?
3. HOW TO USE ELL-CRANELL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ELL-CRANELL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ELL-CRANELL AND WHAT IS IT USED FOR?

Ell-Cranell is a medicine for use in a certain type of hair loss that is caused by a sex hormone (testosterone). Area of application: to increase the reduced anagen hair rate in mild androgenetic alopecia (hormonal-hereditary hair loss) in men and women.

2. WHAT SHOULD YOU CONSIDER BEFORE USING ELL-CRANELL?

Ell-Cranell must not be used if you are hypersensitive (allergic) to alfatradiol or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Ell-Cranell. For external use only, do not get in eyes or on mucous membranes.

Using Ell-Cranell with other medicines

Tell your doctor or pharmacist if you are taking/using or have recently taken/used or intend to take/use any other medicines.

Pregnancy and breast-feeding

There is no specific experience with the use of Ell-Cranell during pregnancy and breast-feeding. Ell-Cranell should not be used during pregnancy and breast-feeding unless there is an unavoidable need. Ask your doctor or pharmacist for advice before taking/using any medicines.

Driving and using machines

There is no experience with regard to impairment of driving and using machines.

3. HOW TO USE ELL-CRANELL?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, Ell-Cranell is used once a day, preferably in the evening. As soon as the first treatment successes occur, the application can be reduced to every second or third day. This can be expected at the earliest after one month.

Type of use

Ell-Cranell is applied directly to the affected areas using a scalp applicator. The application is very simple

1. Hold the bottle upright. Turn the applicator a quarter turn (90°) counterclockwise until you feel resistance. The bottle is now ready for use (marked "ON" on the bottle).
2. Hold the bottle by the base and place the applicator - through the hair - directly on the scalp or on the affected areas.
3. The medicine flows out through the small, barely visible outlet openings on the applicator. Do not press the bottle.
4. Gently guide the applicator along the scalp or the areas to be treated for about 1 minute (stroking motion). In this way, about 3 ml of the solution gets onto the scalp. Ell-Cranell can be applied comfortably. The liquid does not run down, the hairstyle remains intact.
5. Close the bottle after use by turning the applicator a quarter turn clockwise so that the solution does not leak out (marked "OFF" on the bottle).

Duration of use

There is no clinical evidence of efficacy and tolerability for use longer than 1 year. Therefore, longer use should only be after consultation with a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Ell-Cranell is too strong or too weak.

Use in children and adolescents

There is no experience with the use in children and adolescents under 18 years of age.

If you have used more Ell-Cranell than you should

The active ingredient is harmless to health at the present concentration when applied externally. Poisoning in humans is not known.

If you forget to use Ell-Cranell

If you forget to use Ell-Cranell once, please continue using it the next time as described in the dosage instructions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Frequently reported side effects are unpleasant sensations on the scalp (e.g. short-term burning or itching) in almost 7% of patients. The list includes all known side effects under treatment with alfatradiol, including those under long-term therapy in patients with androgenetic alopecia.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ELL-CRANELL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton/container. The expiry date refers to the last day of the month. Storage conditions: No special storage conditions are required for this medicine.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ell-Cranell contains

The active ingredient is: Alfatradiol. 1 ml solution for application to the scalp contains 250 micrograms of alfatradiol. The other ingredients are: 2-propanol (Ph.Eur.), glycerol, myo-inositol, purified water.

What Ell-Cranell looks like and contents of the pack

Ell-Cranell is a clear to slightly yellowish solution with a characteristic odour of 2-propanol (isopropanol). Ell-Cranell is available in plastic bottles containing 50 ml, 100 ml and 200 ml and in packs of 3 x 100 ml plastic bottles. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Galderma Laboratorium GmbH
Georg-Glock-Str. 8
40474 Düsseldorf

Manufacturer

Laboratoires Galderma
Zone Industrielle - Montdesir
74540 Alby-sur-Cheran

This package leaflet was last revised in December 2014.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Alfatradiol. Areas of application: to increase the reduced anagen hair rate in mild androgenetic alopecia (hormonal-hereditary hair loss) in men and women.