Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - protopic

Document Subject

Generated Narrative: MedicinalProductDefinition mpc96fdfd81478e739fb65928482a4a6c6

identifier: http://ema.europa.eu/identifier/EU/1/02/201/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Protopic 0.03% ointment

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c96fdfd81478e739fb65928482a4a6c6

identifier: http://ema.europa.eu/identifier/EU/1/02/201/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - protopic

Attesters

What is in this leaflet

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

The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent.

Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.

Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Protopic 0.03% ointment twice weekly.

In atopic dermatitis, an over-reaction of the skin s immune system causes skin inflammation (itchiness, redness, dryness). Protopic alters the abnormal immune response and relieves the skin inflammation and the itch.

Do not use Protopic

• If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section

6. or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).

Warnings and precautions Talk to your doctor before using Protopic:

• If you have liver failure.
• If you have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause.
• If you have an inherited skin barrier disease such as Netherton s syndrome, lamellar ichthyosis (extensive scaling of the skin due to a thickening of the outer layer of the skin), or if you have an inflammatory skin disease such as pyoderma gangrenosum, or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin).
• If you have a cutaneous Graft Versus Host Disease (an immune reaction of the skin which is a common complication in patients who have undergone a bone marrow transplant).
• If you have swollen lymph nodes at initiation of treatment. If your lymph nodes become swollen during treatment with Protopic, consult your doctor.
• If you have infected lesions. Do not apply the ointment to infected lesions.
• If you notice any change to the appearance of your skin, please inform your physician.
• Based on the results of long-term studies and experience, a link between Protopic ointment treatment and the development of malignancies has not been confirmed, but definitive conclusions cannot be drawn.
• Avoid exposing the skin to long periods of sunlight or artificial sunlight such as tanning beds. If you spend time outdoors after applying Protopic, use a sunscreen and wear loose fitting clothing that protects the skin from the sun. In addition, ask your doctor for advice on other appropriate sun protection methods. If you are prescribed light therapy, inform your doctor that you are using Protopic as it is not recommended to use Protopic and light therapy at the same time.
• If your doctor tells you to use Protopic twice weekly to keep your atopic dermatitis cleared, your condition should be reviewed by your doctor at least every 12 months, even if it remains under control. In children, maintenance treatment should be suspended after 12 months, to assess whether the need for continued treatment still exists.
• It is recommended to use Protopic ointment at the lowest possible strength, at the lowest frequency and for the shortest possible duration necessary. This decision should be based on your doctor s assessment of how your eczema responds to Protopic ointment.

Children

• Protopic ointment is not approved for children younger than 2 years of age. Therefore it should not be used in this age group. Please consult your doctor.
• The effect of treatment with Protopic on the developing immune system in children, especially the young, has not been established.

Other medicines, cosmetics and Protopic Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

You may use moisturising creams and lotions during treatment with Protopic but these products should not be used within two hours of applying Protopic.

The use of Protopic at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e.g. cortisone) or medicines which affect the immune system has not been studied.

Protopic with alcohol While using Protopic, drinking alcohol may cause the skin or face to become flushed or red and feel hot.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Protopic contains butylhydroxytoluene (E321) Protopic contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• Apply Protopic as a thin layer to affected areas of your skin.
• Protopic may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
• Avoid using the ointment inside your nose or mouth or in your eyes. If the ointment gets on any of these areas, it should be thoroughly wiped off and/or rinsed off with water.
• Do not cover the skin being treated with bandages or wraps.
• Wash your hands after applying Protopic unless your hands are also being treated.
• Before applying Protopic after a bath or shower, be sure your skin is completely dry.

Children (2 years of age and older) Apply Protopic 0.03 % ointment twice a day for up to three weeks, once in the morning and once in the evening. Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away.

Adults (16 years of age and older) Two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients (16 years of age and older). Your doctor will decide which strength is best for you.

Usually, treatment is started with Protopic 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared. Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopic 0.03% ointment, can be used.

Treat each affected region of your skin until the eczema has gone away. Improvement is usually seen within one week. If you do not see any improvement after two weeks, see your doctor about other possible treatments.

You may be told by your doctor to use Protopic ointment twice weekly once your atopic dermatitis has cleared or almost cleared (Protopic 0.03% for children and Protopic 0.1% for adults). Protopic ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas of your body commonly affected by atopic dermatitis. There should be 2 3 days without Protopic treatment between applications. If symptoms reappear you should use Protopic twice daily as outlined above and arrange to see your doctor to review your treatment.

If you accidentally swallow some ointment If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible. Do not try to induce vomiting.

If you forget to use Protopic If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

• burning sensation and itching
  These symptoms are usually mild to moderate and generally go away within one week of using Protopic.

Common (may affect up to 1 in 10 people):

• redness
• feeling of warmth
• pain
• increased skin sensitivity (especially to hot and cold)
• skin tingling
• rash
• local skin infection regardless of specific cause including but not limited to: inflamed or infected hair follicles, cold sores, generalised herpes simplex infections
• facial flushing or skin irritation after drinking alcohol is also common

Uncommon (may affect fewer than 1 in 100 people):

• acne

Following twice-weekly treatment application site infections have been reported in children and adults. Impetigo, a superficial bacterial skin infection that usually produces blisters or sores on skin, has been reported in children.

Rosacea (facial redness), rosacea-like dermatitis, lentigo (presence of flat brown spots on the skin), oedema at the application site and herpes eye infections have been reported during post-marketing experience.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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.

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

Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month. Do not store above 25 C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Protopic contains

• The active substance is tacrolimus monohydrate. One gram of Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
• The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321) and all-rac- -tocopherol.

What Protopic looks like and contents of the pack
Protopic is a white to slightly yellowish ointment. It is supplied in tubes containing 10, 30 or 60 grams of ointment. Not all pack sizes may be marketed. Protopic is available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).

Marketing Authorisation Holder LEO Pharma A/S Industriparken 2750 Ballerup Denmark

Manufacturer
Astellas Ireland Co. Ltd. Killorglin County Kerry Ireland

LEO Laboratories Ltd. 285 Cashel Road Crumlin, Dublin Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien LEO Pharma N.V./S.A T l/Tel: +32 3 740 7Lietuva LEO Pharma A/S Tel: +45 44 94 58
LEO Pharma A/S Te .: +45 44 94 58 Luxembourg/Luxemburg LEO Pharma N.V./S.A T l/Tel: +32 3 740 7 esk republika LEO Pharma s.r.o. Tel: +420 734 575 Magyarorsz g LEO Pharma A/S Tel: +45 44 94 58 Danmark LEO Pharma AB Tlf: +45 70 22 49 Malta LEO Pharma A/S Tel: +45 44 94 58 Deutschland LEO Pharma GmbH Tel: +49 6102 2Nederland LEO Pharma B.V.
Tel: +31 205104Eesti
LEO Pharma A/S Tel: +45 44 94 58 Norge LEO Pharma AS Tlf: +47 22514
LEO Pharmaceutical Hellas S.A. : +30 210 68 34 sterreich LEO Pharma GmbH Tel: +43 1 503 6Espa a Laboratorios LEO Pharma, S.A. Tel: +34 93 221 3Polska LEO Pharma Sp. z o.o. Tel: +48 22 244 18 France Laboratoires LEO T l: +33 1 3014 40 Portugal LEO Farmac uticos Lda.
Tel: +351 21 711 0Hrvatska LEO Pharma A/S
Tel: +45 44 94 58 Rom nia LEO Pharma A/S
Tel: +45 44 94 58 Ireland LEO Laboratories Ltd Tel: +353 (0) 1 490 8Slovenija LEO Pharma A/S Tel: +45 44 94 58 sland Vistor hf. S mi: +354 535 7Slovensk republika LEO Pharma s.r.o. Tel: +420 734 575 Italia LEO Pharma S.p.A.
Tel: +39 06 52625Suomi/Finland LEO Pharma Oy Puh./Tel: +358 20 721 8
The Star Medicines Importers Co. Ltd. : +357 2537 1Sverige LEO Pharma AB Tel: +46 40 3522 Latvija LEO Pharma A/S Tel: +45 44 94 58 United Kingdom (Northern Ireland) LEO Laboratories Ltd Tel: +44 (0) 1844 347This leaflet was last revised in.

Detailed information on this medicine is available on the European Medicines Agency web site: