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VANIQA 11.5% CREAM

VANIQA 11.5% CREAM

Ask a doctor about a prescription for VANIQA 11.5% CREAM

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use VANIQA 11.5% CREAM

Introduction

Package Leaflet: Information for the User

Vaniqa 11.5% Cream

eflornithine

Read all of this leaflet carefully before you start using this medicine because it contains important information 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 others. It may harm them, even if their signs of illness are the same 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.

Contents of the pack:

  1. What is Vaniqa and what is it used for
  2. What you need to know before you use Vaniqa
  3. How to use Vaniqa
  4. Possible side effects
  5. Storing Vaniqa
  6. Contents of the pack and other information

1. What is Vaniqa and what is it used for

Vaniqa contains the active substance eflornithine. Eflornithine delays hair growth by its effect on a specific enzyme (a protein in the body involved in hair formation).

Vaniqa is used to reduce excessive hair growth (hirsutism) on the face in women over 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

Consult your doctor or pharmacist before starting to use Vaniqa

  • tell your doctor about any other medical problems you are experiencing (especially those related to your kidneys or liver)

Excessive hair growth may be caused by underlying diseases. Consult your doctor if you have polycystic ovary syndrome (PCOS) or hormone-producing tumors, or if you are taking medications that may induce hair growth, such as cyclosporin (after organ transplantation), glucocorticoids (e.g. for rheumatic or allergic diseases), minoxidil (for hypertension), phenobarbital (for seizures), or phenytoin (for seizures) or hormone replacement therapy with effects similar to those of male hormones.

Girls and adolescents

Vaniqa is notrecommended for use in persons under 18 years of age.

Other medicines and Vaniqa

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Consult your doctor if you need to use other medicines on the skin areas where you are using the cream.

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant or breastfeeding. You should use an alternative method to treat your facial hair if you are pregnant or think you may be pregnant.

Driving and using machines

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

Vaniqa contains cetyl alcohol and stearyl alcoholwhich may cause local skin reactions (e.g. contact dermatitis). Vaniqa also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)which may cause allergic reactions (possibly delayed).

3. How to use Vaniqa

Follow exactly the instructions for administration of this medicine given by your doctor.

In case of doubt, consult your doctor or pharmacist again.

  • Use it twice a day, leaving a gap of at least 8 hours.
  • If you experience irritation (e.g. stinging), reduce the use of Vaniqa to once a day until the irritation has passed. If it persists, contact your doctor.
  • If you have shaved or used any other hair removal method, you should wait at least 5 minutesbefore using Vaniqa. It may sting or burn if you apply this cream to cut or irritated skin.
  • Clean and dry the skin areas before applying the cream.
  • Apply a thin layer of cream and massage it in until no visible residue of the product remains on the treated areas.
  • Whenever possible, do notwash these skin areas during the 4 hours following application of the cream.
  • Wash your hands after applying the cream.
  • Wait at least 5 minutesbefore using makeup or sunscreens on the same areas.
  • When using it on the face, avoidcontact with the eyes or the inside of the nose or mouth. If Vaniqa accidentally gets into your eyes, mouth, or nose, rinse them well with water.

Vaniqa is nota hair removal cream, so you may need to continue with the method you use to remove hair, such as shaving or waxing.

It may take up to 8 weeks before the results are visible. It is important to continue using the cream. If you do not see any improvement after using it for 4 months, consult your doctor. If you stop using it, your original hair growth may return in

8 weeks.

If you use more Vaniqa than you should

If you apply too much cream to the skin, it is unlikely to harm you.

If you or someone else accidentally swallows Vaniqa, tell your doctor.

If you forget to use Vaniqa

Apply it as soon as you remember, but wait at least 8 hours before using it again.

If you stop using Vaniqa

To maintain the reduction in hair growth, continue using Vaniqa as directed.

If you have any other questions about the use of this product, 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 are mild. In such cases, they usually resolve without interruption of treatment with Vaniqa.

The frequency of possible side effects listed below is defined using the following convention:

very common

(affects more than 1 user in 10)

common

(affects 1 to 10 users in 100)

uncommon

(affects 1 to 10 users in 1,000)

rare

(affects 1 to 10 users in 10,000)

very rare

(affects less than 1 user in 10,000)

not known

(cannot be estimated from the available data)

Very common (affects more than 1 user in 10)

  • acne

Common (affects 1 to 10 users in 100)

  • dry skin
  • hair loss
  • inflammation around the pore
  • itching
  • rash
  • redness
  • skin irritation and bumps caused by shaving
  • skin irritation
  • burning, itching, or tingling sensation of the skin

Uncommon (affects 1 to 10 users in 1,000)

  • papular rash
  • cold sore
  • redness and irritation at the site of application of the cream
  • eczema
  • inflamed, swollen, cracked, or dry lips
  • ingrown hairs
  • pale areas of skin
  • skin bleeding
  • skin furuncles
  • skin redness
  • skin inflammation
  • skin ulcers
  • swelling of the mouth or face
  • abnormal hair texture or abnormal hair growth

Rare (affects 1 to 10 users in 10,000)

  • abnormal skin growth (skin neoplasia)
  • excessive hair growth
  • facial redness and pimples possibly with pus
  • other skin disorders
  • inflammation and redness of the skin with scaling and itching (seborrhoeic dermatitis)
  • rash with redness, bumps, or blisters
  • skin cysts
  • skin tightness

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Vaniqa

Keep this medicine out of the sight and reach of children.

Do notuse this medicine after the expiry date which is stated on the packaging and on the bottom of the tube after EXP. The expiry date is the last day of the month stated.

Once opened, discard the tube with the remaining cream after 6 months.

Make sure to close the tube cap tightly after each use.

Do notstore above 25°C.

Medicines should notbe disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What is in Vaniqa

The active substance is eflornithine.

Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate). The other ingredients are:

Cetyl alcohol, macrogol cetostearyl ether, dimeticone, glyceryl stearate, macrogol stearate, methyl parahydroxybenzoate (E218), liquid paraffin, phenoxyethanol, propyl parahydroxybenzoate (E216), purified water, and stearyl alcohol. Small amounts of sodium hydroxide (E524) may be added to maintain normal acidity levels (pH levels).

Appearance and packaging

Vaniqa is a white to off-white cream. It is available in tubes of 15 g, 30 g, and 60 g, but 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

You can obtain further information on this medicine from the local representative of the marketing authorisation holder.

Belgium/België/Belgien

Almirall N.V.

Tel: +32 (0)2 771 86 37

Ireland/United Kingdom (Northern Ireland)

Almirall, S.A.

Tel: +353 (0) 1431 9836

Bulgaria/Czech Republic/Croatia/Estonia/Greece/Spain/Cyprus/Latvia/Lithuania/Hungary/Malta/Romania/Slovenia/Slovakia

Almirall, S.A.

Tel: +34 93 291 30 00

Netherlands

Almirall BV

Tel: +31 (0) 307991155

Denmark/Iceland/Norway/Sweden

Almirall ApS

Tel: +45 70 25 75 75

Austria

Almirall GmbH

Tel: +43 01/595 39 60

Germany/Luxembourg

Almirall Hermal GmbH

Tel: +49 (0)40 72704-0

Poland

Almirall Sp. z o.o.

Tel.: +48 22 330 02 57

France

Almirall SAS

Tel: +33(0)1 46 46 19 20

Portugal

Almirall - Produtos Farmacêuticos, Lda.

Tel: +351 21 415 57 50

Italy

Almirall SpA

Tel: +39 02 346181

Finland

Orion Pharma

Tel: +358 10 4261

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

Alternatives to VANIQA 11.5% CREAM in other countries

The best alternatives with the same active ingredient and therapeutic effect.

Alternative to VANIQA 11.5% CREAM in Poland

Dosage form: Gel, 10 mg/g
Prescription not required
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Dosage form: Liquid, (10 mg + 10 mg + 20 mg)/g

Alternative to VANIQA 11.5% CREAM in Ukraine

Dosage form: liquid, 100 ml in a glass or polymer bottle
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Prescription not required
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Dosage form: herb, 50 g in a pack
Manufacturer: TOV "Ternofarm
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Dosage form: herb, 50 g in packs
Manufacturer: PrAT "Liktravi
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