Generic Vaniqa

Vaniqa eflornithine cream has the active ingredient eflornithine, which is a type of medicine recognized as an antiprotozoal. It is used to prevent growth of excess facial hair in women. It contains 13.9% (139 mg/g) of anhydrous eflornithine hydrochloride as eflornithine hydrochloride monohydrate (150 mg/g). Other components are: ceteareth-20, cetearyl alcohol, dimethicone, glyceryl stearate, methylparaben, mineral oil, PEG-100 stearate, phenoxyethanol, propylparaben, stearyl alcohol and water.

Vaniqa eflornithine is not a hair removal product. This product blocks the action of an enzyme called ornithine decarboxylase. This is an enzyme found in hair follicles and helps in hair growth on body. This medicine should not be used for hair on other parts of the body.

Vaniqa eflornithine HCl 13.9% cream does not include contact sensitising, photocontact allergic or phototoxic properties. Under exaggerated conditions of use it can result in irritation. This medicine, consequently, has a favourable dermal safety profile appropriate for a topical treatment to be applied routinely.

Vaniqa eflornithine is contraindicated in patients having allergic to any of the ingredients in the cream. All ingredients are listed on the tube and at the beginning of this leaflet. Moreover children less than 12 years of age should not use it.

A thin layer of this medication should be applied, at least 5 minutes after hair removal (e.g., plucking, shaving), to the affected areas of the face and chin. Apply twice daily at least 8 hours apart, or as directed by your doctor. The treated area should not be washed for at least 4 hours. Cosmetics or sunscreens may be applied over the treated areas after the medication has dried. Continue to use hair removal techniques (e.g., shaving, plucking) while using this medication. Evade getting this drug in your eyes or inside your nose or mouth. If this drug gets in your eyes, rinse thoroughly with water and contact your doctor.

A 2-year dermal carcinogenicity study in CD- 1 mice treated with VANIQA revealed no evidence of carcinogenicity at daily doses up to 600 mg/kg (950X the MRHD based on AUC comparisons).

Use of Vaniqa eflornithine may lead to burning, stinging, tingling, and redness of the skin. If these effects persist or worsen, tell your doctor.

A lot of people using this medication do not have serious side effects. Notify your doctor immediately if any of these unlikely but serious side effects occur: acne, "hair bumps" (folliculitis).

If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not apply more.

A very serious allergic reaction to Vaniqa eflornithine is exceptional. But, check with your doctor immediately if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

VANIQA should be stored at 15° C-30° C (59° F-86° F). Do not freeze. Keep this and all medicines out of the reach of children.