Vaniqa – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Vaniqa, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start us ing thi s medicine because it contains important informati on for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only . Do not pass it on to ot hers. It may harm them , even if their symptoms are the sa me as yours.
- 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.
What is i n this le aflet 1. What Vaniqa is and w hat it is used for 2. What you need to know before yo u use Vaniqa 3. How to use Vaniqa 4. Possible side effects 5. How to store Vaniqa 6. Contents of the pack and other information
ℹ️ 1. What Vaniqa is and what it is used for
Vaniqa contains the active substance e flornit hine. Eflornithine slows down the growth of hair t hrough 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.
⚠️ 2. What you need to know before you use Vaniqa
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 bef ore usi ng 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 o f hair may be a result of underlying diseases . Talk to your doctor if you suffer from polycystic ovary syndrome (PCOS) or specific hormone producing tumo urs, or if you take medicines that can induce hair growth , e.g. cyclosporine (following organ transplan ts), glucocorticoids (e.g. against rheumatic or allerg ic diseases) , minoxidil (against high blood pressure) , phenobarbitone (against seizures) , phenytoin (against seizures) or hormone replacement therapy with male hormone like ef fects.
Children and adoles cents 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 medici nes obtai ned without a pr escript ion.
Talk to your doctor if you need to use ot her 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 breas t-feeding. You should use an alternative me thod to manage your fac ial hair if you are pregnant or trying to becom e pregnant.
Driving and using machines
Vaniqa is not expected to have any effect on your ability to drive or use machines.
Vani qa cont ains cetostearyl alcohol and stearyl alcohol which may cause loc al skin reactions (e.g.
contact dermatitis). Vaniqa also contains methyl parahydroxybe nzoate (E218) and propyl
parahydroxybenzoate (E216) which may ca use allergic reactions (possibly del ayed).
💊 3. How to use Vaniqa
Always use this medicin e exactly as you r docto r has told you. C heck with your doctor or pharm acist 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 o f Vaniqa to once daily until the irritation has gone. If it pers ists co ntact your doctor.
- If you have just shaved or u sed 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 w here 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 h ours a fter applying the cream
- Wash your hands after ap plying the cream .
- Wait at least 5 minutes before using make -up or suns creen 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 accidenta lly get Vaniqa into your eyes, mouth or nose, ri nse well with wa ter.
Vaniqa is not a depilatory cream, so you may nee d to continue with your hair removal method, for example by shaving or plucking.
It may take 8 weeks before you see results. It is import ant to continue using the cream. If you do not see any improveme nt afte r 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 el se acci dentally 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 us ing Vaniqa To maintain the reduction of hair growth keep us ing Vaniqa cont inuousl y as indicated.
If you have any further questi ons on the use of this medicine, ask your doctor or pharmacist.
❗ 4. Possible side effects
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 usin g the following convention:
very common (affect s more than 1 user in 10 )
common (affect s 1 to 10 users in 10 0)
uncomm on (affect s 1 to 10 users in 1 ,000)
rare (affect s 1 to 10 users in 1 0,000)
very rare (affect s less than 1 user in 10,000 )
not known (frequency cannot be estimated from the available d ata).
Very c ommon ( affects more than 1 user in 10 ) o acne
Common ( affects 1 to 10 users in 100 )
o dry skin o hair loss o inflammation around the hair shaft o itching o rash o redness o skin irritation and bumps caused by shaving o skin irritation o stinging, tingling or bur ning feeling on the sk in
Uncommon ( may affect up to 1 users in 1 00 people )
o bumpy rash (papular rash) o cold sores o redness and irritation at the site where the cream is applied o eczema o inflammed, dry, cracked or numb lips o ingrowing hairs o pale areas on the sk in 19 o skin blee ding o skin boils o skin flushing o skin inflammation o sore skin o swelling of the mouth or face o unusual hair texture or hair growth
Rare ( may affect up to 1 users in 1 ,000 people )
o abnormal skin growth (skin neoplasm) o excessive hai r growth o flushing, f acial redness and pimples possib ly with pus o other skin disorders o red, scaly and itchy skin inflammation ( seborrhoeic dermatitis ) o red, bumpy or blistering rash o skin cysts o skin tightness
Reporting of side effects
If you get any side effects, ta lk to your do ctor or pharmacist. This include s any p ossible side effects not liste d in this leaflet. You can also report side effects directly via the national reporting system listed in Append ix 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 medicin e 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 cl osed after ea ch 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.
📦 6. Cont ents of the pa ck and other i nformation
What Vaniqa contains
The a ctive substance is eflornithin e.
Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate).
The other ingredients are: cetostearyl alcohol; macrogol cetostearyl ether; dimeticon e; glyceryl st earate; macrogol stearate; methyl parahydro xybenzoate (E218); liquid p araffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water and stearyl alcohol. Tiny amounts of sodium hydroxide (E524) are sometimes added to kee p acidity leve ls (pH lev els) normal.
20 What Vaniqa looks l ike and th e 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 Autho risation Holde r and Manufact urer
Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitr e, 151 08022 Barcelona Spain.
Tel: + 34 93 291 30 00
Manufacturer
Almirall Hermal GmbH Scholtzstrasse 3 D-21465 Reinbek Germany For any information about th is medicin e, please cont act the local representative of the Marketing Authorisation Holder:
Belgique/Belg ië/Belg ien Almirall N.V.
Tél/Tel: +32 (0)2 771 86 37 Ireland / United Kingdom (Northern Ireland) Almirall, S.A. Tel.: +353 (0) 1431 9836 Бълг ария / Česká republika / Hrvatska / Eesti / Ελλάδα / España / Κύπρος / Latvija / Lietuva / Magyarország / Malta / România / Slovenija / Slovenská republika Almirall, S.A.
Teл/Tel/Tlf/T ηλ/Sími: +34 93 291 30 00 Nederland Almirall BV Tel.: +31 (0) 30799115 5 Deutschland Luxembourg/Luxemburg Almirall Hermal GmbH Tel./ Tél: +49 (0) 40 72704- 0 Österreich Almirall GmbH Tel.: +43 01/595 39 60 Danmark / Ísland / Norge / Suomi/Finland / Sverige Almirall ApS Tel./Puh.: +45 70 25 75 75 Polska Almirall Sp. z o .o.
Tel.: +48 22 330 02 57 France Almirall SAS Tél.: +33(0)1 46 46 19 20 Italia Almirall SpA Tel.: +39 02 346181 Portugal Almirall – Produtos Farmacêuticos, Lda.
Tel.: +351 21 415 57 50 This lea flet was last revised in Detailed information on this m edicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Vaniqa (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/01/173).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.