What Tacrolimus Accord is and what it is used for
The active substance in Tacrolimus Accord, tacrolimus monohydrate, is an immunomodulatory agent.
Tacrolimus Accord 0.1% ointment is used to treat moderate to severe atopic dermatitis ( eczema ) in adults who have not had sufficient effect from or cannot tolerate conventional treatment such as topical corticosteroids.
When moderate to severe atopic dermatitis is completely or almost completely healed, after up to 6 weeks of treatment of an eczema flare-up, and if you tend to have eczema flare-ups frequently (4 times a year or more), it may be possible to prevent the eczema flare-ups from coming back or to extend the time you have no flare-ups by using Tacrolimus Accord 0.1% ointment twice a week.
In atopic dermatitis, an overreaction in the skin’s immune system causes inflammation in the skin ( itching, redness, dryness). Tacrolimus Accord changes the abnormal immune reaction and relieves inflammation and itching in the skin.
Tacrolimus contained in Tacrolimus Accord may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Tacrolimus Accord
Do not use Tacrolimus Accord
if you are allergic to tacrolimus or any of the other ingredients of Tacrolimus Accord (listed in section 6) or to macrolide antibiotics (eg azithromycin, clarithromycin, erythromycin).
Warnings and precautions
Talk to your doctor if you:
- have liver failure.
- have any form of skin cancer (tumor) or if you have a weakened immune system (immunodeficiency), for whatever reason.
- have an inherited skin barrier disorder such as Netherton’s syndrome, lamellar ichthyosis (skin that scales heavily, due to thickening of the outermost layer of skin), or if you have generalized erythroderma (red, inflamed, scaly skin all over the body).
- have cutaneous Graft versus Host disease (an immune reaction in the skin that is a common complication in bone marrow transplant patients).
- have swollen lymph nodes at the start of treatment. If your lymph nodes swell during treatment with Tacrolimus Accord, consult your doctor.
- have infected eczema. Do not use the ointment on infected eczema.
- notice any change in the appearance of the skin, you should contact your doctor.
- Based on the results of long-term studies and experience, no relationship between treatment with Tacrolimus Accord ointment and the development of malignancy has been confirmed, but no definitive conclusions can be drawn.
- Avoid exposing the skin to sunlight for long periods and artificial sunlight such as tanning beds. If you spend a lot of time outdoors after using Tacrolimus Accord, you should use sunscreen and wear loose clothing that protects the skin from sunlight. Ask your doctor for advice on other appropriate ways to protect yourself from the sun. If you have been prescribed light therapy, you should inform your doctor that you are using Tacrolimus Accord, as simultaneous treatment with Tacrolimus Accord and light therapy are not recommended.
- If your doctor prescribes treatment with Tacrolimus Accord twice a week, to keep eczema away, your condition should be evaluated by a doctor at least once a year, even if the disease is under control. For children, a break must be made in the maintenance treatment after 12 months, to be able to assess whether continued treatment is needed.
- You should not bathe, shower, or swim immediately after using the ointment. Water can wash away the medicine.
- It is recommended to use the Tacrolimus Accord ointment with the lowest possible strength and the lowest frequency for the shortest possible time. This decision should be based on your doctor’s assessment of how your eczema responds to Tacrolimus Accord ointment.
Children and young people
- Tacrolimus Accord 0.1% ointment is not approved for the treatment of children under 16 years of age. The ointment should therefore not be used in this age group. Consult your doctor.
- The effect of treatment with Tacrolimus Accord on a developing immune system in children, especially young children, have not been investigated.
Other medicines and Tacrolimus Accord
Tell your doctor or pharmacist if you are using, have recently used, or maybe thinking about using other medicines, even non-prescription ones.
You can use emollient creams and skin lotions during treatment with Tacrolimus Accord, but these products should not be used within two hours before and after using Tacrolimus Accord.
The use of tacrolimus at the same time as other drugs for external use or during simultaneous treatment with oral corticosteroids (e.g. cortisone ) or medications that affect the immune system has not been studied.
Tacrolimus Accord with food, drink, and alcohol
When using Tacrolimus Accord, consuming alcohol may cause flushing or redness and a feeling of warmth in the skin or face.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
How to use Tacrolimus Accord
Always use Tacrolimus Accord as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- Apply a thin layer of Tacrolimus Accord to the affected skin areas.
- Tacrolimus Accord can be used on most parts of the body, including the face and neck and in the creases of the elbows and knees.
- Avoid using the ointment on the inside of the nose or mouth or in the eyes. If the ointment comes into contact with any of these areas, it should be wiped off thoroughly and/or rinsed off with water.
- Do not cover skin areas treated with the ointment with bandages or the like.
- Wash your hands after using Tacrolimus Accord, unless your hands are also to be treated.
- Before using Tacrolimus Accord after showering or bathing, the skin must be completely dry.
- You should not bathe, shower, or swim immediately after using the ointment. Water can wash away the medicine.
Adults (16 years and older)
For adult patients (16 years and older) there are two strengths of tacrolimus ointment (tacrolimus 0.03% ointment and tacrolimus 0.1% ointment). Your doctor will decide which strength is best for you.
Treatment is usually started with Tacrolimus Accord 0.1% ointment twice daily, once in the morning and once in the evening until the eczema is healed. Depending on the effect on your eczema, the doctor will decide if you can use the ointment less often or if the lower strength, tacrolimus 0.03% ointment, can be used.
Treat each affected skin area until the eczema is gone. Improvement usually occurs within a week. If you do not notice any improvement within two weeks, consult your doctor about other possible treatments.
Your doctor may prescribe you to use Tacrolimus Accord 0.1% ointment twice a week when the eczema is completely or almost healed. Tacrolimus Accord 0.1% ointment should then be used once a day two days a week (e.g. Monday and Thursday) on the skin areas where you usually get eczema. There must be 2-3 days without treatment with Tacrolimus Accord between each treatment session.
If the symptoms of the disease return, you should use Tacrolimus Accord twice daily, in the same way as described above, and contact your doctor to review the treatment.
If you accidentally swallow the ointment
If you accidentally swallow the ointment, talk to your doctor or pharmacist as soon as possible. Do not try to induce vomiting.
If you have used too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Tacrolimus Accord
If you forget to apply the ointment at the time you are supposed to, do it as soon as you remember and then continue as before.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, Tacrolimus Accord can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 users):
- burning sensation and itching
These symptoms are normally mild to moderate and usually disappear within a week of starting treatment.
Common (may affect up to 1 in 10 users):
- redness
- feeling of warmth
- pain
- increased sensitivity of the skin (especially to heat and cold)
- skin crawling and skin irritations
- rash
- local skin reactions of any cause; a reaction may be inflamed or infected hair follicles, herpes virus infections (eg cold sores, generalized herpes simplex infections )
- facial redness or skin irritation after drinking alcohol
- hypersensitivity at the treatment site
Uncommon (may affect up to 1 in 100 users):
- acne
After treatment twice a week, infection at the treatment site has been reported in adults.
Rosacea ( redness of the face), rosacea-like skin inflammation, lentigo (flat brown spots on the skin), edema (fluid accumulation) where the ointment has been applied, and herpes infection of the eye, have been reported after the product was introduced to the market.
How to store Tacrolimus Accord
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the tube and the carton after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25°C.
Discard opened tubes 90 days after opening, even if they are not empty. They should not be saved for future use.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
– The active substance is tacrolimus monohydrate.
-1 g Tacrolimus Accord 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
-Other ingredients are white vaseline, liquid paraffin, propylene carbonate, white beeswax, and solid paraffin.
Appearance and package sizes of the medicine
Tacrolimus Accord 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.
Marketing Authorization Holder
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
UK
LABORATORIES FUNDACIÓ DAU
Terminal. Ind. Consorci Zona Franca, c/ C, 12-14
Barcelona 08040
Spain
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Accord Healthcare Polska Sp.z oo,
ul. Lutomirska 50,95-200 Pabianice, Poland
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna, Germany