What is Vaniqa?

Vaniqa 11.5% cream is a prescription-only medicine containing eflornithine. Each gram of cream contains 115 mg of eflornithine, as eflornithine hydrochloride monohydrate.

It is a cream applied to the skin of the face and under the chin to treat excessive facial hair growth, known as facial hirsutism, in adult women.

Eflornithine slows hair growth by blocking an enzyme involved in producing the hair shaft within the hair follicle. Vaniqa reduces the rate of hair growth but does not remove existing hair and is not a depilatory cream.

Vaniqa is normally applied twice daily, with at least 8 hours between applications.

Who is it intended for?

Vaniqa is intended for women aged over 18 years with excessive hair growth on the face or under the chin.

It is not recommended for anyone younger than 18 years because its safety and effectiveness have not been established in this age group.

Excessive hair growth can sometimes be associated with an underlying condition, such as polycystic ovary syndrome or a hormone-producing tumour, or with medicines that can stimulate hair growth.

Dose or treatment stage

Vaniqa 11.5% cream is used at the same strength throughout treatment. It does not have a starting-dose or dose-escalation schedule.

Apply a thin layer to the affected areas twice daily, at least 8 hours apart.

If skin irritation develops, application may be reduced temporarily to once daily until the irritation resolves. If irritation continues, stop using the cream and contact your doctor.

Do not apply Vaniqa more frequently or use a larger amount than directed.

How is it used?

• Apply Vaniqa only to affected areas of the face and under the chin.
• Clean and dry the skin before application.
• Apply a thin layer and rub it in thoroughly until no visible cream remains.
• Wash your hands after applying the cream.
• Do not wash the treated area for 4 hours after application, where possible.
• After shaving, plucking or using another hair-removal method, wait at least 5 minutes before applying Vaniqa.
• Wait at least 5 minutes after applying Vaniqa before using make-up or sunscreen on the treated area.
• Avoid contact with the eyes and the inside of the nose or mouth. Rinse thoroughly with water if accidental contact occurs.
• Continue your usual hair-removal method if needed.

Improvement may become noticeable within 8 weeks. Continued treatment is needed to maintain the effect. Hair growth may return to its previous level within 8 weeks of stopping treatment.

Contact your doctor if there is no improvement after 4 months of treatment.

Clinical study results

In two clinical studies, 596 women with facial hair growth were treated with Vaniqa 11.5% cream or a cream without eflornithine for up to 24 weeks. At week 24, among women treated with Vaniqa:

• 6% were assessed as clear or almost clear.
• 29% had marked improvement.
• 35% had improvement.
• 30% had no improvement or had worsened.

The results relate to Vaniqa 11.5% cream applied during the studies. Individual results vary, and improvement is not guaranteed.

Patient Information Leaflet

Our service does not include a prescription. Instead, your treatment is supplied under a legal framework known as a Patient Group Direction (PGD). The process follows these steps:

1. Complete a health questionnaire

Provide detailed information about your health, medical history, and previous symptoms management efforts.

2. Pharmacist review

A pharmacist will review your responses and may contact you by phone or video call if further information is required to support safe supply.

3. Private consultation

All interactions are confidential. This provides an opportunity to discuss any questions and ensure appropriate use of the treatment.

4. Identity verification

You may be asked to provide identification to confirm that you are the intended user. This is typically required for your first order only.

5. Supporting evidence

You may be asked to provide relevant information, such as confirmation of symptoms and medical history, to support safe supply.

Your GP will be notified of your request and the outcome of the supply decision, whether the treatment is supplied or not, to support continuity of care.

Purchasing this medication does not guarantee supply. The decision to supply is made by the pharmacist based on the information provided. If supply is not appropriate, your order will be refunded.

Main ingredient: Eflornithine 115 mg per gram of cream, as eflornithine hydrochloride monohydrate.

Excipients: cetostearyl alcohol, macrogol cetostearyl ether, dimeticone, glyceryl stearate, macrogol stearate, methyl parahydroxybenzoate (E218), liquid paraffin, phenoxyethanol, propyl parahydroxybenzoate (E216), purified water, stearyl alcohol, sodium hydroxide (E524) to adjust pH.

What Vaniqa is used for

Vaniqa is used to reduce excessive hair growth on the face and under the chin in women older than 18 years.

Dose

• Apply a thin layer to the affected skin twice daily.
• Leave at least 8 hours between applications.
• Apply only to affected areas of the face and under the chin.
• The maximum amount used safely in clinical studies was 30 g per month.
• No dose adjustment is required for people older than 65 years.

How to apply Vaniqa

1. Clean and dry the affected skin.
2. Apply a thin layer of cream.
3. Rub the cream in thoroughly until no visible residue remains.
4. Wash your hands after application.
5. Where possible, do not wash the treated area for 4 hours.
6. Wait at least 5 minutes before applying make-up or sunscreen.

Vaniqa is for use on the skin only. Avoid contact with the eyes and the inside of the nose or mouth. If accidental contact occurs, rinse thoroughly with water.

Using Vaniqa with hair-removal methods

Vaniqa does not remove existing hair. Shaving, plucking or another hair-removal method may still be needed.

Wait at least 5 minutes after removing hair before applying Vaniqa. Applying the cream to cut, broken or irritated skin may cause stinging or burning.

How long treatment takes

• Improvement may be noticed within 8 weeks.
• Continued treatment may lead to further improvement.
• Continue using Vaniqa to maintain the reduction in hair growth.
• Contact your doctor if no improvement is seen after 4 months.
• Hair growth may return to its previous level within 8 weeks after treatment is stopped.

If skin irritation develops

Reduce application temporarily to once daily until the irritation resolves. If irritation continues, stop using Vaniqa and contact your doctor.

If you forget an application

Apply the cream when you remember, then wait at least 8 hours before applying it again. Do not apply two doses close together.

If you use too much

Applying too much cream to the skin is unlikely to cause harm.

If you or someone else accidentally swallows Vaniqa, contact a doctor immediately.

Always use Vaniqa as directed. Ask your doctor or pharmacist if you are unsure how to use it.

Do not use this medicine if

• You are allergic to eflornithine or any other ingredient in Vaniqa.
• You are pregnant.
• You are breastfeeding.

Speak to your doctor before use

Tell your doctor or pharmacist:

• If you have any medical problems, particularly kidney or liver problems.
• If you have polycystic ovary syndrome.
• If you have, or may have, a hormone-producing tumour.
• If you are unsure whether Vaniqa is suitable for you.

The safety and effectiveness of Vaniqa have not been established in women with liver or kidney impairment. Particular caution is required in severe kidney impairment.

Skin irritation and application precautions

• Vaniqa is for use on the skin only.
• Do not apply it to cut, broken or irritated skin.
• Avoid contact with the eyes and the inside of the nose or mouth.
• Rinse thoroughly with water if accidental contact occurs.
• If irritation develops, reduce use temporarily to once daily.
• If irritation continues, stop using Vaniqa and contact your doctor.

Cetostearyl alcohol and stearyl alcohol may cause local skin reactions, including contact dermatitis.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions, which may be delayed.

Age restrictions

Vaniqa is not recommended for anyone younger than 18 years. Its safety and effectiveness have not been established in this age group.

Pregnancy

Do not use Vaniqa if you are pregnant or trying to become pregnant. Use an alternative method of managing facial hair.

Breastfeeding

Do not use Vaniqa while breastfeeding. It is not known whether eflornithine or its breakdown products pass into breast milk.

Interactions with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or may take, including non-prescription medicines.

Speak to your doctor before applying another medicine to the same areas of skin as Vaniqa.

Tell your doctor if you take medicines that may stimulate hair growth, including:

• Cyclosporine.
• Glucocorticoids.
• Minoxidil.
• Phenobarbitone.
• Phenytoin.
• Hormone replacement therapy with male hormone-like effects.

No formal interaction studies have been performed.

Driving and using machines

Vaniqa is not expected to affect your ability to drive or use machines.

Overdose

Applying too much cream to the skin is unlikely to cause harm.

If Vaniqa is accidentally swallowed, contact a doctor immediately. Stop using the medicine if symptoms associated with overdose occur.

Serious side effects requiring urgent medical attention

Side effects are usually limited to the skin, are generally mild and normally resolve without stopping treatment.

Frequency definitions

• Very common: affects more than 1 in 10 people.
• Common: affects 1 to 10 in 100 people.
• Uncommon: affects 1 to 10 in 1,000 people.
• Rare: affects 1 to 10 in 10,000 people.
• Very rare: affects fewer than 1 in 10,000 people.
• Frequency not known: frequency cannot be estimated from the available data.

Skin and hair effects

Face, mouth and infection-related effects

Talk to your doctor, pharmacist or nurse if you experience a side effect, including one not listed here.