TACROLIMUS TEVA 0.1% OINTMENT - Patient leaflet, side effects, dosage

1. What Tacrolimus 0.1% Ointment is and what it is used for

2. What you need to know before you use Tacrolimus 0.1% Ointment

3. How to use Tacrolimus 0.1% Ointment

4. Possible side effects

• 5. Howto store Tacrolimus0.1% Ointment

6. Contents of the pack and other information

ri What Tacrolimus 0.1% Ointment is and what it is used for

The active substance of Tacrolimus 0.1 % Ointment, tacrolimus monohydrate, is an immunomodulatin­g agent.

Tacrolimus 0.1% 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.

Once moderate to severe atopic dermatitis is cleared or almost cleared after upto 6 weeks treatment of a flare, andifyouareex­periencingfre­quentflares(i­.e. 4 or more per year),itmaybe­possible to prevent flares coming back or prolong the time you are free from flares by using Tacrolimus 0.1% Ointment twice weekly.

In atopic dermatitis, an over-reaction ofthe skin's immune systemcausesski­ninflammation (itchiness, redness, dryness). Tacrolimus 0.1 % Ointment alters the abnormal immune response and relievesthe skin inflammation and the itch.

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What you need to know before you use Tacrolimus 0.1% Ointment

Do not use Tacrolimus 0.1 % Ointment

• If you are allergic (hypersensitive) to tacrolimus or any ofthe other ingredients of Tacrolimus 0.1% Ointment (Iistedinsection6) orto macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).

Warnings and precautions

Talk to your doctor if you:

• have liver failure
• have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause
• have an inherited skin barrier disease such as Netherton's syn­drome, lamellar ichthyosis (extensive scaling ofthe skin due to athickening ofthe outer layer ofthe skin), or if you suffer from generalised erythroderma (inflammatory reddening and scaling ofthe entire skin)
• have a cutaneous Graft Versus Host Disease (an immune reaction ofthe skin which is a common complication in patients who have undergone a bone marrowtransplant)
• have swollen lymph nodes at initiation of treatment. If your lymph nodes become swollen during treatment with Tacrolimus0.1%0in­tment, consult your doctor
• have infected lesions. Do not apply the ointmentto infected lesions.
• notice any changetotheap­pearance of your skin, please inform your physician.
• The safety of using tacrolimus ointment for a long time is not known. A very small number of people who have used tacrolimus ointment have had malignancies (for example, skin or lymphoma). However, a linkto Tacrolimus0.1% Ointment treatment has not been shown.
• Avoid exposing the skin to long periods of sunlight or artificial sunlight such astanning beds. If you spend time outdoors after applying Tacrolimus 0.1 % Ointment, use a sunscreen and wear loose fitting clothing that protectstheskin­fromthesun.lnad­dition.askyour doctor for advice on other appropriate sun protection methods. If you are prescribed light therapy, inform yourdoctortha­tyouareusing Tacrolimus 0.1% Ointment as it is not recommended to use Tacrolimus 0.1% Ointment and light therapy at the same time.
• If your doctor tells you to use Tacrolimus 0.1% Ointment twice weekly to keep your atopic dermatitis cleared, your condition should be reviewed by your doctor at Ieastevery12months, even if it remains under control. In children, maintenance treatment should be suspended after 12 months, to assess whether the need forcontinuedtre­atmentstillexis­ts.
• Patients should be advised not to bathe, shower or swim immediately after applying the ointment; water maywashoffthe­medicine.
• Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and isaseriousfire­hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Children

• Tacrolimus 0.1 % Ointment is not approved for children youngerthan16y­earsof age. Therefore it should not be used in this age group. Please consultyour doctor.
• The effect of treatment with Tacrolimus 0.1% Ointment on the developing immune system in children, especiallythe­young.hasnotbe­enestablished.

Othermedicines­.cosmetics and Tacrolimus 0.1% Ointment Tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtainedwithou­taprescription.

You may use moisturising creams and lotions during treatment with Tacrolimus 0.1% Ointment but these products should not be used within two hours of applying Tacrolimus 0.1% Ointment.

The use oftacrolimus atthe same time as other preparationsto be used on the skin or while taking oral corticosteroid­s(e.g.cortiso­ne)ormedicines­whichaffect the immune system has not been studied.

Tacrolimus 0.1% Ointment with alcohol

While using Tacrolimus 0.1% Ointment, drinking alcohol may cause the skin or face to become flushed or red and feel hot.

Pregnancy and breast-feeding

Donotuse Tacrolimus 0.1% Ointment ifyou are pregnant or breast-feeding.

Askyour doctor or pharmacist for advice before taking anymedicine.

Howto use Tacrolimus 0.1% Ointment

Alwaysuse Tacrolimus 0.1% Ointment exactly as your doctor has told you. Check with your doctor or pharmacist if youarenotsure.

p Apply Tacrolimus 0.1% Ointment as a thin layer to affected areas of your skin.

• Tacrolimus 0.1% Ointment may be used on most parts of thebody, including the face and neck and in the creases of your elbows and knees.
• Avoid using the ointment inside your nose or mouth or inyoureyes.lfthe­ointmentgetso­nanyoftheseare­as, it should be thoroughly wiped off and/or rinsed off with water.
• Do not cover the skin being treated with bandages, wraps or other wound dressing.
• Wash your hands after applying Tacrolimus 0.1% Ointmentunles­syourhandsare­alsobeingtrea­ted. Before applying Tacrolimus 0.1% Ointment after a bath orshower, besureyour skin is completely dry. Do not bathe.shower, orswimimmedia­telyafterapply­ingthe ointment. Water may wash off the medicine.

Adults (16 years of age and older)

Two strengths of tacrolimus ointment (tacrolimus 0.03% ointmentandta­crolimus0.1%o­intment)areava­ilablefor adultpatients(16y­earsofageandol­der). Your doctor will decide which strength is best for you.

Usually, treatmentisstar­tedwith Tacrolimus 0.1% Ointment twice a day, once in the morning and once in the evening.until­theeczema has cleared. Depending on the responseofyou­reczemayourdoc­tor will decide if the frequency of application can be reduced orthe lower strength.tacrolimus 0.03% ointment, can be used.

Treat each affected region of your skin until the eczema hasgoneaway. Improvementisu­suallyseenwit­hinone 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 Tacrolimus 0.1% Ointment twice weekly once your atopic dermatitis has clearedoralmost cleared. Tacrolimus 0.1 % Ointment shouldbeappli­edonceadaytwi­ceweekly(e.g. Monday and Thursday) to areas of your body commonly affected by atopicdermati­tis.Thereshou­ld be 2–3 days without Tacrolimus 0.1% Ointment treatment between applications. If symptoms reappear you should use Tacrolimus 0.1 % Ointmenttwice­dailyasoutline­daboveandarran­getosee your doctor to review your treatment.

If you accidentally swallow some Tacrolimus 0.1 % Ointment

If you accidentally swallow the ointment, consult your doctororpharmacist as soon as possible. Do nottryto inducevomiting.

If youforgettouse Tacrolimus 0.1% Ointment

If you forgettoapplyt­heointment at the scheduled time, do it as soon as you remember and then continue as before.

Ifyou have any further questions on the use ofthis product.askyou­rdoctororphar­macist.

Possible side effects

< 5 how to store tacrolimus 0.1% ointment

^ 6 contents of the pack and other information

What Tacrolimus 0.1% Ointment contains

• The active substance is tacrolimus monohydrate.

One gram of Tacrolimus 0.1% Ointment contains 1.0 mg tacrolimus (astacrolimus­monohydrate).

• The other ingredients are paraffin, white soft, paraffin liquid,propyle­necarbonate,be­eswax,white,pa­raffin hard.

What Tacrolimus 0.1% Ointment looks like and contents of the pack

Tacrolimus 0.1% Ointment is a white to slightly yellowish ointment. It is supplied in tubes containing 10,30 or 60 grams of ointment.Nota­llpacksizesma­ybemarketed.

MarketingAutho­risationHolder

TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom

Manufacturer

LABORATORI FUNDACIO DAU, Pol. Ind. Consorci Zona

Franca, c/ C, 12–14 Barcelona, 08040, Spain

This leaflet was last revised in 04/2019

EAS1634c

INP010

10 0000 0 000000

This is a representation of an electronic record that was signed electronically and this PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V

Approvals

REG0223144

Version 2.4

Approved

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