What Vaniqa is and what it is used for
Vaniqa contains the active substance eflornithine. Eflornithine slows hair growth through its effect on a special enzyme (a protein in the body that affects hair production). Vaniqa is used to reduce excessive hair growth ( hirsutism ) on the face in women older than 18 years.
What you need to know before using 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 before using Vaniqa
- also tell your doctor if you have any other medical problems (especially related to your kidneys or liver).
- if you are not sure if you should use this medicine or not, ask your doctor or pharmacist for advice.
Heavy hair growth can be caused by an underlying disease. Talk to your doctor if you have polycystic ovary syndrome ( PCOS ) or special hormone-producing tumors or if you take medicines that can induce hair growth, e.g. cyclosporine (after organ transplants), glucocorticoids (e.g. for rheumatic or allergic diseases), minoxidil (for high blood pressure ), phenobarbitone (for seizures) or hormone replacement therapy with male hormone effects.
Children and young people
Vaniqa is not recommended for use in people 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, even those without a prescription.
Talk to your doctor if you need to use other medications on the skin areas where you use cream one.
Pregnancy and breastfeeding
Do not use Vaniqa if you are pregnant or breastfeeding. You should use a different method to treat your facial hair if you are pregnant or trying to become pregnant.
Driving ability and use of machinery
Vaniqa is not expected to have any effect on your ability to drive or use machines
Vaniqa contains cetostearyl alcohol and stearyl alcohol
which can give rise to local skin reactions (e.g. contact dermatitis ). Vaniqa also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which can cause allergic reactions (possibly delayed).
How to use Vaniqa
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- Used 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 subsided. If it persists, contact your doctor.
- If you have shaved or used any other method of hair removal, wait at least 5 minutes before using Vaniqa. It may sting or burn if you apply the cream to sore or irritated skin.
- Clean and dry the skin areas where you want to use the cream.
- Apply a thin layer of cream and rub in thoroughly until no visible cream remains on the treated areas.
- If possible, do not wash these skin areas within 4 hours after the cream has been rubbed in.
- Wash your hands after the cream has been rubbed in.
- Wait at least 5 minutes before using make-up or sunscreen on the same areas.
- When using the cream on the face, avoid contact with the eyes or the inside of the nose or mouth. If you accidentally get Vaniqa in your eyes, mouth, or nose, rinse thoroughly with water.
Vaniqa is not a hair removal cream, so you may need to continue with your hair removal method, e.g. shaving or picking.
It may take 8 weeks before you see any results. You must continue to use cream one. If you do not see any improvement after using it for 4 months, consult your doctor. If you stop using cream one, the original hair growth can return within 8 weeks.
If you have used too much Vaniqa
Putting too much cream on your skin is unlikely to harm you.
If you or someone else accidentally swallows Vaniqa, contact your doctor immediately.
If you forget to use Vaniqa
Immediately rub in the cream, but wait at least 8 hours before using the medicine again.
If you stop using Vaniqa
To maintain reduced hair growth, continue to use Vaniqa continuously as directed.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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 are mild. These normally disappear without stopping treatment with Vaniqa.
The frequency of possible side effects, which is listed below, is defined as follows:
| very common | (occurs in more than 1 in 10 users) |
| usual | (affects 1 to 10 users in 100) |
| less common | (affects 1 to 10 in 1,000 users) |
| rare | (affects 1 to 10 in 10,000 users) |
| very rare | (affects less than 1 in 10,000 users) |
| no known frequency | (cannot be calculated from available data). |
Very common (affects more than 1 in 10 users)
- 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, stinging, or burning sensation in the skin
Uncommon (affects 1 to 10 users in 1,000)
- bumpy rash (papular rash)
- mouth ulcers
- redness and irritation where the cream is used
- eczema
- inflamed, dry, chapped, or numb lips
- ingrowing hair
- pale areas of the skin
- skin bleeding
- skin abscesses
- skin redness
- skin inflammation
- tender skin
- swelling of the mouth or face
- abnormal hair quality or hair growth
Rare (affects 1 to 10 users in 10,000)
- abnormal skin growth (skin neoplasm)
- strong hair growth
- redness, facial redness, and pimples possibly with var
- other skin problems
- red, scaly, and itchy skin inflammation ( seborrheic dermatitis )
- red, lumpy rash or blisters
- skin cysts
- tightening skin
How to store Vaniqa
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the box and at the bottom of the tube after { Expiration date.
The expiration date is the last day of the specified month.
Opened tube with leftover cream is discarded after 6 months.
Make sure the tube cap is securely screwed on after each use.
Store at a maximum of 25 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is eflornithine. Each gram of cream contains 115 mg of eflornithine (as a hydrochloride monohydrate).
- Other ingredients are cetostearyl alcohol, macrogol cetostearyl ether, dimethicone, glycerol stearate, macrogol stearate, methyl parahydroxybenzoate (E218), liquid paraffin, phenoxyethanol, propyl parahydroxybenzoate (E216), purified water and stearyl alcohol. Small amounts of sodium hydroxide (E524) are sometimes added to adjust the acidity ( pH ).
Appearance and package sizes of the medicine
Vaniqa is a cream with a white to off-white color. It is supplied in 15g, 30g, and 60g tubes but possibly not all pack sizes will be marketed.
Marketing Authorisation Holder
Admiral, SA
Ronda General Miter, 151
08022 Barcelona
Spain
Phone: + 34 93 291 30 00
Manufacturer
Admiral Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbeck
Germany
For further information about this medicinal product, contact the representative of the marketing authorization holder:
| Belgique/België/BelgienAdmiral NVTel/Tel: +32 (0)2 771 86 37 | IrelandAlmirall ApSTel.: +45 70 25 75 75 |
| Български / Česká republika / Hrvatska / Eesti / Ελλάδα / España / Κυπρος / Latvija / Lietuva / Magyarország / Malta / România / Slovenija / Slovenská republikaAdmiral, SATel/Tel/Tlf/Tηl/Sími: +34 93 291 30 00 | The NetherlandsAdmiral BVTel.: +31 (0) 307991155 |
| DeutschlandLuxembourg/LuxembourgAdmiral Hermal GmbHPhone: +49 (0)40 72704-0 | AustriaAlmirall GmbHTel.: +43 01/595 39 60 |
| Denmark / Ísland / Norway / Suomi/Finland / SwedenAlmirall ApSTel./Puh.: +45 70 25 75 75 | PolishAdmiralPhone: +48 22 330 02 57 |
| FranceAdmiral SASTel.: +33(0)1 46 46 19 20 | PortugalAlmirall – Produtos Farmacêuticos, Lda.Tel.: +351 21 415 57 50 |
| ItalyAlmirall SpATel.: +39 02 346181 | United Kingdom |