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PROTOPIC 0.03% OINTMENT - Patient leaflet, side effects, dosage

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Patient leaflet - PROTOPIC 0.03% OINTMENT

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.
  • 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 using 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Yellow Card Scheme

Website:

or search for MHRA Yellow Card in the Google Play or Apple App Store

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:

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:

United Kingdom

LEO Laboratories Ltd

+44 (0) 1844 347333

United Kingdom (Northern Ireland)

LEO Laboratories Ltd

+44 (0) 1844 347333

This leaflet was last revised in June 2021.

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

For information in large print, Braille or audio/CD, telephone +44 (0)1844 347333

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Frequently Asked Questions

What is Protopic 0.03% ointment used for?

Protopic 0.03% ointment is primarily used to treat eczema (atopic dermatitis) in patients who do not respond well to conventional therapies.

How does Protopic ointment work?

Protopic ointment works by suppressing the immune response in the skin, thereby reducing inflammation and symptoms associated with eczema.

Can I use Protopic ointment on my face?

Yes, Protopic can be used on the face; however, it should be applied carefully and under the guidance of a healthcare professional.

Is Protopic 0.03% ointment safe for children?

Protopic ointment can be used in children aged 2 years and older, but it’s important to consult a doctor for appropriate use and dosage.

How often should I apply Protopic 0.03% ointment?

Typically, Protopic should be applied twice daily or as directed by your healthcare provider. Always follow their instructions for best results.

What should I do if I miss a dose of Protopic ointment?

If you miss a dose, apply it as soon as you remember. If it’s almost time for your next dose, skip the missed one and continue with your regular schedule.

Are there any common side effects of using Protopic ointment?

Common side effects may include burning, itching, redness, or irritation at the application site. If these persist or worsen, contact your doctor.

Can I use other skin products while using Protopic 0.03% ointment?

It is advisable to avoid using other topical medications unless instructed by your healthcare provider to prevent irritation or interaction.

Is sunscreen necessary when using Protopic?

Yes, using sunscreen is recommended as Protopic may increase sensitivity to sunlight; protect your skin while undergoing treatment.

How long can I use Protopic 0.03% ointment continuously?

The duration of use may vary; long-term use should be closely monitored by a healthcare professional to avoid potential risks.

Can pregnant or breastfeeding women use Protopic ointment?

Consult your healthcare provider before using Protopic during pregnancy or while breastfeeding to discuss potential risks and benefits.

Will Protopic help with other skin conditions besides eczema?

Protopic is primarily indicated for eczema; it may not be effective for other skin conditions. Always seek medical advice for treatment options.

What if my eczema worsens while using Protopic?

If your condition worsens or shows no improvement after several weeks of use, contact your healthcare provider for further evaluation.

Can I stop using Protopic once my symptoms improve?

It’s important to discuss any changes in treatment with your doctor; they may advise continuing the medication to prevent flare-ups.

What are some lifestyle tips to complement my treatment with Protopic?

Keep your skin moisturized, avoid irritants (like harsh soaps), wear breathable fabrics, and manage stress levels to help control eczema symptoms.

Does Protopic have any interactions with other medications?

Inform your healthcare provider about all medications you’re taking; they can advise on any potential interactions with Protopic.

Where should I store Protopic 0.03% ointment?

Store the ointment at room temperature away from direct sunlight and moisture; keep it out of reach of children.

Can I share my Protopic ointment with someone else who has eczema?

No, you should not share your medication even if others have similar symptoms; treatment plans should be individualized per patient.

Is there a generic version of Protopic available?

As of now, there isn’t a generic version available for Protopic in many regions; consult your pharmacy or healthcare provider for alternatives.