Protopic - patient leaflet, side effects, dosage

- 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.

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

1. What Protopic is and what it is used for

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.

2. What you need to know before you use Protopic

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 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.

3. How to use Protopic

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.

4. Possible side effects

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.

5. How to store Protopic

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.

6. Contents of the pack and other information

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-a-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 55

2750 Ballerup

Denmark

Manufacturer

Astellas Ireland Co. Ltd.

Killorglin

County Kerry

Ireland

LEO Laboratories Ltd.

285 Cashel Road

Crumlin, Dublin 12

Ireland

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

België/Belgiqu­e/Belgien LEO Pharma N.V./S.A Tél/Tel: +32 3 740 7868	Lietuva Biocodex UAB Tel: +370 37 408 681
Efc^rapufl Borola Ltd Ten.: +359 2 9156 136	Luxembourg/Lu­xemburg LEO Pharma N.V./S.A Tél/Tel: +32 3 740 7868
Česká republika LEO Pharma s.r.o. Tel: +420 225 992 272	Magyarország LEO Pharma Tel: +36 1 888 0525
Danmark LEO Pharma AB Tlf: +45 70 22 49 11	Malta E.J. Busuttil Ltd Tel: +356 2144 7184
Deutschland LEO Pharma GmbH Tel: +49 6102 2010	Nederland LEO Pharma B.V. Tel: +31 205104141
Eesti Biocodex OÜ Tel: +372 6 056 014	Norge LEO Pharma AS Tlf: +47 22514900
EÀÀàôa LEO Pharmaceutical Hellas S.A. Tql: +30 210 68 34322	Österreich LEO Pharma GmbH Tel: +43 1 503 6979
España Laboratorios LEO Pharma, S.A. Tel: +34 93 221 3366	Polska LEO Pharma Sp. z o.o. Tel: +48 22 244 18 40
France Laboratoires LEO SA Tél: +33 1 3014 40 00	Portugal LEO Farmacéuticos Lda. Tel: +351 21 711 0760
Hrvatska Remedia d.o.o. Tel:+385 1 3778 770	Romania LEO Pharma A/S Romania Tel: +40 213121963

Ireland

LEO Laboratories Ltd

Tel: +353 1 490 8924

Slovenija

PHARMAGAN d.o.o.

Tel: +386 4 2366 700

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika LEO Pharma s.r.o.

Tel: +421 2 5939 6236