Patient leaflet - Tacrolimus 0.1% ointment

1. What Tacrolimus is and what it is used for

The active substance of Tacrolimus 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 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 Tacrolimus 0.1% ointment twice weekly.

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

2. What you need to know before you use Tacrolimus

Do not use Tacrolimus

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 Tacrolimus:

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 reactionof 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 this medicine, 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 tacrolimus 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 apply in Tacrolimus, 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 Tacrolimus as it is not recommended to use Tacrolimus and light therapy at the same time.
If your doctor tells you to use Tacrolimus 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 Tacrolimus 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 Tacrolimus ointment.

Children

Tacrolimus 0.1% ointment is not approved for children younger than 16 years of age.

Therefore it should not be used in this age group. Please consult your doctor.

The eﬀect of treatment with Tacrolimus on the developing immune system in children, especially the young, has not been established.

Other medicines, cosmetics and Tacrolimus

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 Tacrolimus but these products should not be used within two hours of applying Tacrolimus.

The use of Tacrolimus 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.

Tacrolimus with alcohol

While using Tacrolimus, 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.

Tacrolimus contains butylhydroxytoluene (E321)

Tacrolimus 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 Tacrolimus

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

Apply Tacrolimus as a thin layer to aﬀected areas of your skin.
Tacrolimus 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 Tacrolimus unless your hands are also being treated.
Before applying Tacrolimus after a bath or shower, be sure your skin is completely dry.

Adults (16 years of age and older)

Two strengths of Tacrolimus (Tacrolimus 0.03% and Tacrolimus 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 Tacrolimus 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, Tacrolimus 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 Tacrolimus 0.1% ointment twice weekly once your atopic dermatitis has cleared or almost cleared. Tacrolimus 0.1% 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 Tacrolimus treatment between applications.

If symptoms reappear you should use Tacrolimus 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 Tacrolimus

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 Tacrolimus.

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 adults.

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, pharmacist or nurse. This includes any possible side eﬀects not listed in this leaﬂet. You can also report side eﬀects directly via: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side eﬀects you can help provide more information on the safety of this medicine.

Fonts used:

Times new roman

03-09-26

Tacrolimus 0.1% ointment 30 gm

Altair Science Limited UK

Leaﬂet

210 x 440 mm

18-11-25, 10626, 110626, 170626, 240626, 030926,040926

5. How to store Tacrolimus

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.

This medicine does not require any special storage conditions. After ﬁrst opening of the tube, use the product within 3 months.

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 Tacrolimus contains

The active substance is tacrolimus monohydrate.
One gram of Tacrolimus 0.1% ointment contains 1.0 mgtacrolimus (as monohydrate).
The other ingredients are white soft paraﬃn, liquid paraﬃn, propylene carbonate, white beeswax, hard paraﬃn (containing butylated hydroxytoluene).

What Tacrolimus looks like and contents of the pack

Tacrolimus is a white to slightly yellowish ointment. It is supplied in laminated tubes with an inner lining of HDPE, having an aluminium seal and ﬁtted with a white polypropylene screw cap.

Pack size of 1 tube of 10 g or 30 g.

Not all pack sizes may be marketed.

Tacrolimus is available in two strengths (Tacrolimus 0.03% and Tacrolimus 0.1% ointment).

Marketing Authorisation Holder

Altair Science Limited

78 Wembley Park Drive, Wembley,

Middlesex, HA9 8HB

United Kingdom

Manufacturer

Beltapharm S.R.L.

Via Stelvio, 66

20095 Cusano Milanino (MI)

Italy

If you would like this leaﬂet in Braille, large print or CD format, please contact the Marketing Authorisation holder listed above. If you would like to have any further information or want to report any side eﬀects, please email at

safety@altairscience.co.uk.

This leaﬂet was last revised in September 2026.

ARTDB038770P

Prescription needed?	Yes, prescription-only medicine (POM)
Active substance	Tacrolimus
Strength	0.1% (1 mg/gram)
Pharmaceutical form	Cutaneous ointment A White to slightly yellowish ointment.
How is it taken	Cutaneous
Excipients	White soft paraffin, Liquid paraffin, Propylene carbonate, White beeswax, Hard paraffin, Butylated hydroxytoluene (E321)
Is it available?	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	Unopened tube: 24 months After first opening: Use within 180 days
Storage	This medicinal product does not require any special storage conditions.
Drug group (ATC)	Agents for dermatitis, excluding corticosteroids D Dermatologicals D11 Other dermatological preparations D11A Other dermatological preparations D11AH Agents for dermatitis, excluding corticosteroids D11AH01 tacrolimus
Marketing authorisation	PL 20416/1016 (first authorised 22 September 2026), PL 59787/0008
Marketing authorisation holder	Crescent Pharma Limited
Codes	BNF 13050300

Tacrolimus 0.1% ointment – patient leaflet, side effects, dosage