Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vaniqa

Document Subject

Generated Narrative: MedicinalProductDefinition mp6054fe37439ac8bd57061a7fc8bca219

identifier: http://ema.europa.eu/identifier/EU/1/01/173/001-003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Vaniqa 11.5% cream

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-6054fe37439ac8bd57061a7fc8bca219

identifier: http://ema.europa.eu/identifier/EU/1/01/173/001-003

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - vaniqa

Attesters

What is in this leaflet

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

Vaniqa contains the active substance eflornithine. Eflornithine slows down the growth of hair through its effect on a specific enzyme (a protein in the body involved in the production of hair).

Vaniqa is used to reduce the growth of excessive hair (Hirsutism) on the face of women older than 18 years of age.

Do not use Vaniqa

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

Warnings and precautions Talk to your doctor or pharmacist before using Vaniqa.

• tell your doctor of any other medical problems you may be experiencing (especially related to your kidneys or liver).
• if you are unsure whether or not to use this medicine, contact your doctor or pharmacist for advice.

Excessive growth of hair may be a result of underlying diseases. Talk to your doctor if you suffer from polycystic ovary syndrome (PCOS) or specific hormone producing tumours, or if you take medicines that can induce hair growth, e.g. cyclosporine (following organ transplants), glucocorticoids (e.g. against rheumatic or allergic diseases), minoxidil (against high blood pressure), phenobarbitone (against seizures), phenytoin (against seizures) or hormone replacement therapy with male hormone like effects. Children and adolescents

Vaniqa is not recommended for use in anyone younger than 18 years of age.

Other medicines and Vaniqa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Talk to your doctor if you need to use other medicines on the areas of skin where you are using the cream.

Pregnancy and breast-feeding

Do not use Vaniqa if you are pregnant or breast-feeding. You should use an alternative method to manage your facial hair if you are pregnant or trying to become pregnant.

Driving and using machines

Vaniqa is not expected to have any effect on your ability to drive or use machines.

Vaniqa contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Vaniqa also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• Use twice a day, at least 8 hours apart.
• If you experience irritation (e.g. stinging burning), reduce the use of Vaniqa to once daily until the irritation has gone. If it persists contact your doctor.
• If you have just shaved or used any other hair removal method, wait at least 5 minutes before using Vaniqa. It may sting or burn if you put this cream on cut or irritated skin.
• Clean and dry the areas of the skin where you will be using the cream.
• Apply a thin layer of cream and rub it in thoroughly until no visual residual product remains on the treated areas.
• If possible, do not wash these areas of skin for 4 hours after applying the cream
• Wash your hands after applying the cream.
• Wait at least 5 minutes before using make-up or sunscreen on the same areas.
• When using on the face, avoid contact with your eyes or the inside of your nose or mouth. If you should accidentally get Vaniqa into your eyes, mouth or nose, rinse well with water.

Vaniqa is not a depilatory cream, so you may need to continue with your hair removal method, for example by shaving or plucking.

It may take 8 weeks before you see results. It is important to continue using the cream. If you do not see any improvement after using it for 4 months contact your doctor. If you stop using it your original hair growth may return within 8 weeks.

If you use more Vaniqa than you should

If you put too much cream on your skin, it is unlikely to harm you.

If you or anyone else accidentally swallows Vaniqa, contact your doctor immediately.

If you forget to use Vaniqa

Apply straight away, but wait at least 8 hours before using it again.

If you stop using Vaniqa

To maintain the reduction of hair growth keep using Vaniqa continuously as indicated.

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

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

Side effects are usually limited to the skin and mild in intensity. In such cases they normally resolve without discontinuation of Vaniqa.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).

Very common (affects more than 1 user in 10) * acne

Common (affects 1 to 10 users in 100) * dry skin * hair loss * inflammation around the hair shaft * itching * rash * redness * skin irritation and bumps caused by shaving * skin irritation * stinging, tingling or burning feeling on the skin

Uncommon (may affect up to 1 users in 100 people) * bumpy rash (papular rash) * cold sores * redness and irritation at the site where the cream is applied * eczema * inflammed, dry, cracked or numb lips * ingrowing hairs * pale areas on the skin * skin bleeding * skin boils * skin flushing * skin inflammation * sore skin * swelling of the mouth or face * unusual hair texture or hair growth

Rare (may affect up to 1 users in 1,000 people) * abnormal skin growth (skin neoplasm) * excessive hair growth * flushing, facial redness and pimples possibly with pus * other skin disorders * red, scaly and itchy skin inflammation (seborrhoeic dermatitis) * red, bumpy or blistering rash * skin cysts * skin tightness

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the box and on the bottom of the tube after EXP. The expiry date refers to the last day of that month.

Discard the opened tube with any remaining cream after 6 months.

Make sure the cap of the tube is tightly closed after each use.

Do not store above 25 C.

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.

What Vaniqa contains

The active substance is eflornithine. Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate).

The other ingredients are: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water and stearyl alcohol. Tiny amounts of sodium hydroxide (E524) are sometimes added to keep acidity levels (pH levels) normal.

What Vaniqa looks like and the contents of the pack

Vaniqa is a cream which is white to off white in colour. It is supplied in tubes of 15 g, 30 g and 60 g but not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Almirall, S.A. Ronda General Mitre, 08022 Barcelona Spain.
Tel: + 34 93 291 30 Manufacturer

Almirall Hermal GmbH Scholtzstrasse 3 D-21465 Reinbek Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/Belgi /Belgien Almirall N.V. T l/Tel: +32 (0)2 771 86 Ireland / United Kingdom (Northern Ireland) Almirall, S.A. Tel: +353 (0) 1431 9 / esk republika / Hrvatska / Eesti / / Espa a / / Latvija / Lietuva / Magyarorsz g / Malta / Rom nia / Slovenija / Slovensk republika Almirall, S.A. Te ./Tel/T /: +34 93 291 30 Nederland Almirall BV Tel: +31 (0) 307991Danmark / sland / Norge / Sverige Almirall ApS Tlf/S mi/Tel: +45 70 25 75 sterreich Almirall GmbH Tel: +43 01/595 39 Deutschland Luxembourg/Luxemburg Almirall Hermal GmbH Tel/T l: +49 (0)40 72704-0

Polska Almirall Sp. z o.o. Tel.: +48 22 330 02 France Almirall SAS T l: +33(0)1 46 46 19 Portugal Almirall - Produtos Farmac uticos, Lda. Tel: +351 21 415 57 Italia Almirall SpA Tel: +39 02 346Suomi/Finland Orion Pharma Puh/Tel: +358 10 4This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: