Vaniqa
Italy
Table of Contents
Package leaflet: Information for the user
Vaniqa 11.5% cream
(eflornithine)
Read this entire leaflet carefully before using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Vaniqa is and what it is used for
- What you need to know before using Vaniqa
- How to use Vaniqa
- Possible side effects
- How to store Vaniqa
- Contents of the pack and other information
1. What Vaniqa is and what it is used for
Vaniqa contains the active substance eflornithine. Eflornithine slows down hair growth by acting on a specific enzyme (a protein in the body involved in hair production).
Vaniqa is used to reduce the growth of unwanted facial hair (hirsutism) in women over 18 years of age.
2. What you need to know before using Vaniqa
Do not use Vaniqa
- if you are allergic (hypersensitive) to eflornithine or to any of the excipients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using Vaniqa
- inform your doctor of any other medical conditions you may have (especially if related to your kidneys or liver),
- if you are unsure whether you should use this medicine, contact your doctor or pharmacist for advice.
Excessive hair growth may be a sign of an underlying medical condition. Consult your doctor if you have polycystic ovary syndrome (PCOS), if you have tumours producing specific hormones, or if you are taking medicines that may cause hair growth, such as cyclosporine (after organ transplantation), glucocorticoids (for example, to treat rheumatic or allergic diseases), minoxidil (for high blood pressure), phenobarbital (for epileptic seizures), phenytoin (for epileptic seizures), or hormone replacement therapy with masculinizing effects.
Children and adolescents
Vaniqa is not recommended for use in individuals under 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 those not requiring a prescription.
Talk to your doctor if you need to use other medicinal products on the same area of skin where you are applying the cream.
Pregnancy and breastfeeding
Do not use this medicine if you are pregnant or breastfeeding. If you are pregnant or trying to become pregnant, you should use an alternative method to treat facial hair.
Driving and using machines
Vaniqa is not expected to affect your ability to drive or operate machinery.
Vaniqa contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). Vaniqa also contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216), which may cause allergic reactions (likely of delayed type).
3. How to use Vaniqa
Use this medicine exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
- Use it twice a day, at least 8 hours apart.
- If you experience irritation (e.g. stinging or burning sensation), reduce the use of Vaniqa to once a day until the irritation disappears. If the irritation persists, consult your doctor.
- If you have just shaved or used any other hair removal method, wait at least 5 minutes before applying Vaniqa. Applying the cream on damaged or irritated skin may cause a stinging or burning sensation.
- Clean and dry the skin where you will apply the cream.
- Apply a thin layer of cream and rub vigorously until no visible residue of the 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 applying facial makeup or sunscreen to the same area.
- If applied to the face, avoid contact with the eyes or the nasal and oral cavities. If Vaniqa accidentally comes into contact with the eyes, nose, or mouth, rinse thoroughly with water.
Vaniqa is not a depilatory cream, so you may need to continue using your usual hair removal method, such as shaving or plucking.
Results may take up to 8 weeks, during which it is important to continue using the cream. If you do not notice any improvement after 4 months of use, contact your doctor. If you stop using the cream, hair growth may return to pretreatment levels within 8 weeks.
If you use more Vaniqa than you should
Applying too much cream on the skin is unlikely to cause harm.
However, if you or someone else accidentally swallows Vaniqa, contact a doctor immediately.
If you forget to use Vaniqa
Apply the product as soon as you remember, but wait at least 8 hours before the next application.
If you stop using Vaniqa
To maintain reduced hair growth, continue using Vaniqa without interruption as directed.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually side effects are limited to the skin and are mild in intensity. In these cases, they usually resolve without discontinuing Vaniqa.
The frequency of the possible side effects listed below is defined according to the following convention:
Very common (affects more than 1 in 10 people)
Common (affects between 1 and 10 in 100 people)
Uncommon (affects between 1 and 10 in 1,000 people)
Rare (affects between 1 and 10 in 10,000 people)
Very rare (affects fewer than 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data).
Very common (affects more than 1 in 10 people)
• acne
Common (affects between 1 and 10 in 100 people)
• dry skin
• hair loss
• inflammation of the hair shaft
• itching
• rash
• redness
• skin irritation and bumps caused by shaving
• skin irritation
• stinging, tingling or burning sensation on the skin
Uncommon (affects between 1 and 10 in 1,000 people)
• rash with bumps (papular rash)
• cold sores (herpes labialis)
• redness and irritation at the site of cream application
• eczema
• inflamed, dry, cracked or numb lips
• ingrown hairs
• pale patches of skin
• bleeding skin
• boils
• skin flushing
• skin inflammation
• sore skin
• swelling of the mouth or face
• abnormal hair structure or growth
Rare (affects between 1 and 10 in 10,000 people)
• abnormal skin growth (skin tumour)
• excessive hair growth
• flushing, facial redness and boils, sometimes with pus
• other skin disorders
• skin inflammation with redness, scaling and itching (seborrhoeic dermatitis)
• rash with redness, bumps or blisters
• skin cysts
• skin hardening
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Vaniqa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottom of the tube
after Exp. The expiry date refers to the last day of the stated month.
Discard the tube with any remaining cream 6 months after first opening.
Make sure the cap of the tube is tightly closed after each use.
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Vaniqa contains
The active substance is eflornithine. Each gram of cream contains 115 mg of eflornithine (monohydrate hydrochloride).
The other ingredients are:
cetyl stearyl alcohol, macrogol cetostearyl ether, dimethicone, glyceryl stearate, polyoxyethylene stearate, methyl parahydroxybenzoate (E218), liquid paraffin, phenoxyethanol, propyl parahydroxybenzoate (E216), purified water and stearyl alcohol. In some cases, small amounts of sodium hydroxide (E524) are added to maintain normal acidity levels (pH levels).
Description of the appearance of Vaniqa and contents of the pack
Vaniqa is a cream, white or almost white in colour. It is supplied in tubes of 15 g, 30 g and 60 g, although not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre 151
08022 Barcelona
Spain
Tel: +34 93 291 30 00
Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Belgique/België/Belgien Ireland / United Kingdom (Northern Ireland)
Almirall N.V. Almirall, S.A.
Tél/Tel: +32 (0)2 771 86 37 Tel.: +353 (0) 1431 9836
България / Česká republika / Hrvatska / Eesti Nederland
/ Ελλάδα / España / Κύπρος / Latvija / Lietuva Almirall BV
/ Magyarország / Malta / România / Slovenija / Tel.: +31 (0) 307991155
Slovenská republika
Almirall, S.A.
Tel/Tel/Tlf/Tηλ/Sími: +34 93 291 30 00
Deutschland Österreich
Luxembourg/Luxemburg Almirall GmbH
Almirall Hermal GmbH Tel.: +43 01/595 39 60
Tel./Tél: +49 (0)40 72704-0
Danmark / Ísland / Norge / Suomi/Finland / Polska
Sverige Almirall Sp. z o.o.
Almirall ApS Tel.: +48 22 330 02 57
Tel./Puh.: +45 70 25 75 75
France Portugal
Almirall SAS Almirall - Produtos Farmacêuticos, Lda.
Tél.: +33(0)1 46 46 19 20 Tel.: +351 21 415 57 50
Italia
Almirall SpA
Tel.: +39 02 346181
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/