Name of the medicinal product

Epila

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Epila® (Epila hydrochloride) cream, 13.9% is indicated for the reduction of unwanted facial hair in women.

Epila® has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement.

Epila interferes with a chemical in the hair follicles of the skin. This results in slower hair growth where Epila topical is applied.

Epila topical is used to reduce unwanted facial hair in women. Epila topical does not permanently remove hair or "cure" unwanted facial hair. Epila topical will help you manage your condition and improve your appearance.

Epila topical may also be used for purposes other than those listed in this medication guide.

Dosage (Posology) and method of administration

Apply a thin layer of Epila® (Epila hydrochloride) cream, 13.9% to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice daily at least 8 hours apart or as directed by a physician. The patient should continue to use hair removal techniques as needed in conjunction with Epila®. (Epila® should be applied at least 5 minutes after hair removal.) Cosmetics or sunscreens may be applied over treated areas after cream has dried.

How supplied

Epila® (Epila hydrochloride) cream, 13.9% is available as: 45 gram tube NDC 0023-4857-45 Storage: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze. See tube crimp and carton end for expiration date and lot number.

Distributed by: Allergan, Inc., Irvine, CA 92612. Revised: Sep 2013

Contraindications

Epila topical is for external use only.

Continue to use Epila topical even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with Epila topical should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with Epila topical.

Special warnings and precautions for use

Apply Epila topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Epila topical does not permanently remove hair or "cure" unwanted facial hair. It is not a hair remover (depilatory). You will need to continue using your current hair removal techniques. Epila topical will help you manage your condition and improve your appearance.

Epila topical is for external use only.

Epila topical is usually applied twice daily, at least eight hours apart, or as directed by your doctor.

Wash your hands before and after each application of Epila topical.

Remove any facial hair that is present using your current hair removal techniques. Wait at least 5 minutes after hair removal before applying Epila topical. Apply a thin layer of Epila topical to the affected areas of the face and nearby affected areas under the chin and rub it in thoroughly.

Cosmetics or sunscreen may be used after applying Epila topical, but you should wait a few minutes to allow the treatment to be absorbed before applying them.

Do not wash the treatment areas for at least 4 hours after application of Epila topical.

Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If Epila topical gets in your eyes, rinse them thoroughly with water and contact your doctor.

Epila topical may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of Epila topical to once a day. If irritation continues, stop using Epila topical and contact your doctor.

Continue to use Epila topical even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with Epila topical should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with Epila topical.

Store Epila topical at room temperature away from moisture and heat. Do not allow the medication to freeze.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

This medication is used to slow down the growth of unwanted hair on the face and under the chin in women. It should not be used for hair on other parts of the body. It blocks a certain natural substance (an enzyme) that is needed for hair growth in the skin. This effect slows hair growth and may also make the hair finer and lighter. It does not remove hair or cause the hair to fall out.

This drug is not for use in children younger than 12 years.

How to use Epila topical

This medicine comes with a Patient Information Leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.

Apply a thin layer of this medication only to the affected areas of the face and chin, and rub in well. It is usually applied twice daily at least 8 hours apart or as directed by your doctor. Do not apply for at least 5 minutes after hair removal (e.g., plucking, shaving). Do not wash the treated area for at least 4 hours.

Wash hands immediately after using this product. This medication is for use on the skin only. Avoid getting the product in your eyes, nose, or mouth. If the medication gets in these areas, rinse immediately with clean water. If this drug gets in your eyes, rinse thoroughly with water and contact your doctor.

Wait until the medication has dried completely before applying cosmetics, moisturizers, or sunscreens over the treated areas.

This product is not a hair removal product. Continue to use hair removal techniques (e.g., shaving, plucking) while using this medication. If you stop using this product, hair growth will return.

You should see some improvement in 4 to 8 weeks. This medication works slowly. Use exactly as directed. Do not use more of this product or use it more often. Your condition will not improve faster, and the risk of side effects will increase. Tell your doctor if your skin becomes red or irritated. Your doctor may direct you to apply the medication only once a day or stop the medication.

Tell your doctor if your condition persists or worsens.

Interaction with other medicinal products and other forms of interaction

It is not known if Epila® has any interaction with other topically applied drug products.

Undesirable effects

Adverse events reported for most body systems occurred at similar frequencies in Epila® (Epila hydrochloride) cream, 13.9% and vehicle control groups. The most frequent adverse events related to treatment with Epila® were skin-related. The following table notes the percentage of adverse events associated with the use of Epila® or its vehicle that occurred at greater than 1% in both the vehicle-controlled studies and the open-label safety studies up to 1 year of continuous use.

Adverse Event Term	Vehicle-Controlled Studies	Vehicle-Controlled and Open-Label Studies
Epila® (n=393)	Vehicle (n=201)	Epila® (n=1373)
Acne	21.3	21.4	10.8
Pseudofolliculitis Barbae	16.3	15.4	4.9
Stinging Skin	7.9	2.5	4.1
Headache	3.8	5.0	4.0
Burning Skin	4.3	2.0	3.5
Dry Skin	1.8	3.0	3.3
Pruritus (itching)	3.8	4.0	3.1
Erythema (redness)	1.3	0.0	2.5
Tingling Skin	3.6	1.5	2.2
Dyspepsia	2.5	2.0	1.9
Skin Irritation	1.0	1.0	1.8
Rash	2.8	0.0	1.5
Alopecia	1.5	2.5	1.3
Dizziness	1.5	1.5	1.3
Folliculitis	0.5	0.0	1.0
Hair Ingrown	0.3	2.0	0.9
Facial Edema	0.3	3.0	0.7
Anorexia	1.0	2.0	0.7
Nausea	0.5	1.0	0.7
Asthenia	0.0	1.0	0.3
Vertigo	0.3	1.0	0.1

Treatment-related skin adverse events that occurred in less than 1% of the subjects treated with Epila® are: bleeding skin, cheilitis, contact dermatitis, swelling of lips, herpes simplex, numbness, and rosacea.

Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of Epila®. Only 2% of subjects discontinued studies due to an adverse event related to use of Epila®.

Laboratory Test Abnormalities

No laboratory test abnormalities have been consistently found to be associated with Epila®. In an open-label study, some patients showed an increase in their transaminases; however, the clinical significance of these findings is not known.

Qualitative and quantitative composition

Epila is a prescription drug indicated in the treatment of facial hirsutism (excessive hair growth). Epila hydrochloride cream for topical application is intended for use in women suffering from facial hirsutism and is sold by Allergan, Inc. under the brand name Epila. Besides being a non-mechanical and non-cosmetic treatment, Epila is the only non-hormonal and non-systemic prescription option available for women who suffer from facial hirsutism. Epila for injection against sleeping sickness was manufactured by Sanofi Aventis and sold under the brand name Ornidyl in the USA. It is now discontinued. Epila is on the World Health Organization's List of Essential Medicines.

Epila price

We have no data on the cost of the drug.
However, we will provide data for each active ingredient

The approximate cost of Eflornithine 13.9 % per unit in online pharmacies is from 1.73$ to 49.01$, per package is from 43$ to 146$.

The approximate cost of Eflornithine 13.9 (11.5) % per unit in online pharmacies is from 1.53$ to 2.87$, per package is from 39$ to 226$.

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