VANIQA 11.5% Крем

Содержание инструкции

1. Vaniqa 11.5% cream
   1. What Vaniqa is and what it is used for
   2. What you need to know before you use Vaniqa
   3. How to use Vaniqa
   4. Possible side effects
   5. How to store Vaniqa
   6. Package contents and other information

Vaniqa 11.5% cream

(eflornithine)
Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Vaniqa is and what it is used for

Vaniqa contains the active ingredient eflornithine. Eflornithine slows down hair growth through its
effect on a specific enzyme (a protein in the body involved in hair production).
Vaniqa is used to reduce unwanted facial hair (hirsutism) in women over the age of
18 years.

2. What you need to know before you use Vaniqa

Do not use Vaniqa

• if you are allergic (hypersensitive) to eflornithine or any of the other ingredients listed in section 6.

Warnings and precautions
Talk to your doctor or pharmacist before using Vaniqa

• report to your doctor any other problems that may occur (especially if related to your kidneys or liver),
• if you have any doubts about whether to use this medicine, contact your doctor or pharmacist for advice.

Excessive hair growth may be a manifestation of an underlying disease. See your
doctor if you suffer from polycystic ovary syndrome (PCOS), if you have tumors that produce a
specific hormone, or if you are taking medications that can induce hair growth, such as cyclosporine
(following an organ transplant), glucocorticoids (for example as treatment for
rheumatic or allergic diseases), minoxidil (for high blood pressure), phenobarbital (for
seizures), phenytoin (for seizures), or hormone replacement therapy with effects
similar to those of male hormones.

Children and adolescents
Vaniqa is notrecommended for use in people under the age of 18.

Other medicines and Vaniqa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Talk to your doctor if you need to use other medicines on the skin area where you are using the
cream.

Pregnancy and breastfeeding
Do not usethis medicine if you are pregnant or breastfeeding. If you are pregnant or trying to
become pregnant, you should use an alternative method to treat facial hair.

Driving and using machines
No effects of Vaniqa on the ability to drive and operate machines are expected.

Vaniqacontains cetostearyl alcohol and stearyl alcohol,which can cause local skin reactions
(e.g. contact dermatitis). Vaniqa also contains methylparaben (E218) and
propylparaben (E216)which can cause allergic reactions (likely to be delayed).

3. How to use Vaniqa

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.

• Use it twice a day, at intervals of at least 8 hours.
• If you develop irritation (e.g. a burning or stinging sensation), reduce the use of Vaniqa to once a day until the irritation disappears. If the irritation persists, consult your doctor.
• If you have just shaved or used any other hair removal method, wait at least 5 minutesbefore using Vaniqa. Applying the cream to wounded or irritated skin may cause a stinging or burning sensation.
• Clean and dry the skin where you will use the cream.
• Apply a thin layer of cream and massage vigorously until any visible residue of the product disappears from the treated areas.
• If possible, do notwash these parts of the skin for 4 hours after applying the cream.
• Wash your hands after applying the cream.
• Wait at least 5 minutesbefore using facial makeup or sunscreen on the same area.
• If you use it on your face, avoidcontact with your eyes or the cavities of your nose and mouth. If Vaniqa accidentally comes into contact with your eyes, nose or mouth, rinse thoroughly with water.

Vaniqa is nota depilatory cream, so you may need to continue using your usual hair removal method, such as shaving or waxing.
Results may take 8 weeks to appear, during which it is important to continue using the cream. If you do not see any improvement after using it for 4 months
contact your doctor. If you stop applying it, hair growth may return to initial levels
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 another person accidentally swallow Vaniqa, contact your doctor immediately.

If you forget to use Vaniqa
Apply the product immediately, but wait at least 8 hours before repeating the application.

If you stop the treatment with Vaniqa
To maintain the reduction of hair growth, continue to use Vaniqa without interruption as
indicated.
If you have any doubts about the use of the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually side effects are limited to the skin and of mild intensity. In these cases they generally
resolve without stopping Vaniqa.
The frequency of possible side effects reported below is defined according to the following
convention:
Very common (affects more than 1 in 10 people)
Common (affects between 1 and 10 people in 100)
Uncommon (affects between 1 and 10 people in 1,000)
Rare (affects between 1 and 10 people in 10,000)
Very rare (affects less than 1 in 10,000 people)
Not known (frequency cannot be estimated from available data).

Very common (affects more than 1 in 10 people)
o acne

Common (affects between 1 and 10 people in 100)
o skin dryness
o hair loss
o inflammation of the hair shaft
o itching
o rash
o redness
o skin irritation and bumps caused by shaving
o skin irritation
o stinging, tingling or burning sensation on the skin

Uncommon (affects between 1 and 10 people in 1,000)
o rash with bumps (papular rash)
o cold sores
o redness and irritation at the site of cream application
o eczema
o inflamed, dry, cracked or numb lips
o ingrown hairs
o pale skin patches
o bleeding skin
o boils
o hot flushes
o skin inflammation
o painful skin
o swelling of the mouth or face
o abnormal hair structure or growth

Rare (affects between 1 and 10 people in 10,000)
o abnormal skin growth (skin tumor)
o excessive hair growth
o hot flushes, facial redness and boils, possibly with pus
o other skin disorders
o skin inflammation with redness, scaling and itching (seborrheic dermatitis)
o rash with redness, bumps or blisters
o skin cysts
o skin hardening

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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. How to store 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 pack and at the base of the tube
after Exp. The expiry date refers to the last day of the month.
Dispose of the tube with any remaining cream after 6 months from first opening.
Ensure the tube cap is tightly closed after each use.

Do notstore at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vaniqa contains
The active ingredient is eflornithine. Each gram of cream contains 115 mg of eflornithine (hydrochloride
monohydrate).
The excipients are:
cetostearyl alcohol, macrogol cetostearyl ether, dimethicone, glyceryl stearate, macrogol stearate, methyl
parahydroxybenzoate (E218), liquid paraffin, phenoxyethanol, propyl parahydroxybenzoate (E216),
purified water and stearyl alcohol. To maintain normal acidity levels (pH levels), small amounts of sodium
hydroxide (E524) are added in some cases.

Description of Vaniqa and package contents
Vaniqa is a cream ranging in color from white to off-white. It is dispensed 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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

Belgique/België/Belgien
Almirall N.V.
Tél/Tel: +32 (0)2 771 86 37

Ireland / United Kingdom (Northern Ireland)
Almirall, S.A.
Tel.: +353 (0) 1431 9836

България / Česká republika / Hrvatska / Eesti
/ Ελλάδα / España / Κύπρος / Latvija / Lietuva
/ Magyarország / Malta / România / Slovenija /
Slovenská republika
Almirall, S.A.
Teл/Tel/Tlf/Tηλ/Sími: +34 93 291 30 00

Nederland
Almirall BV
Tel.: + 31 (0) 307991155

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
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/