Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g ointment

Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g ointment

calcipotriol/betamethasone

Calcipotriol/Betamethasone ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is caused by your skin cells being produced too quickly. This causes redness, scaling and thickness of your skin.

Calcipotriol/Betamethasone ointment contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back to normal and the corticosteroid betamethasone acts to reduce inflammation.

Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Betamethasone is classed as a strong corticosteroid.

Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.

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

How to put on Calcipotriol/Betamethasone ointment: Cutaneous use.

Instruction for proper use

• Use only on your psoriasis and do not use on skin which does not have psoriasis
• Remove the cap and check that the seal in the tube is not broken before you first use the ointment
• To break the seal, use the point in the back of the cap
• Squeeze the ointment onto a clean finger
• Rub gently into your skin to cover the affected area of psoriasis until most of the ointment has disappeared into the skin
• Do not bandage, tightly cover or wrap the treated skin area
• Wash your hands well after using Calcipotriol/Betamethasone ointment (unless you are using the ointment to treat your hands). This will avoid accidentally spreading the ointment to other parts of your body (especially the face, scalp, mouth and eyes)
• Do not worry if some ointment accidentally gets on normal skin near your psoriasis, but wipe it off if it spreads too far
• In order to achieve optimal effect, it is recommended not to take a shower or bath immediately after application of Calcipotriol/Betamethasone ointment
• After applying the ointment avoid contact with textiles which are easily stained by grease (e.g. silk).

Duration of treatment

• Use the ointment once a day. It may be more convenient to use the ointment in the evening.
• The normal initial treatment period is 4 weeks but your doctor may decide on a different treatment period
• Your doctor may decide on repeated treatment
• Do not use more than 15 grams in one day.

If you use other calcipotriol containing medicines, the total amount of calcipotriol medicines must not exceed 15 grams per day and the area treated should not exceed 30 % of the total body surface.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor/nurse immediately or as soon as possible if any of the following happens. You may have to stop your treatment.

The following serious side effects have been reported for Calcipotriol/Betamethasone ointment:

Uncommon (may affect up to 1 in 100 people)

• Worsening of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible.

Rare (may affect up to 1 in 1,000 people)

• Pustular psoriasis may occur (a red area with yellowish pustules usually on the hands or feet). If you notice this, stop using Calcipotriol/Betamethasone ointment and tell your doctor as soon as possible.

Some serious side effects are known to be caused by betamethasone (a strong steroid), one of the ingredients in Calcipotriol/Betamethasone ointment. You should tell your doctor as soon as possible if any of the serious side effects occur. These side effects are more likely to happen after long-term use, use in skin folds (e.g. groin, armpits or under breasts), use under occlusion or use on large areas of skin. The side effects include the following:

• Your adrenal glands may stop working properly. Signs are tiredness, depression and anxiety.
• Cataracts (signs are cloudy and foggy vision, difficulty seeing at night and sensitivity to light) or an increase in pressure inside the eye (signs are eye pain, red eye, decreased or cloudy vision)
• Infections (because your immune system which fights infections may be suppressed or weakened).
• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If you notice this, stop using Calcipotriol/Betamethasone ointment and tell your doctor as soon as possible.
• Impact on the metabolic control of diabetes mellitus (if you have diabetes you may experience fluctuations in the blood glucose levels).

Serious side effects known to be caused by calcipotriol

• Allergic reactions with deep swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and trouble breathing may occur. If you have an allergic reaction, stop using Calcipotriol/Betamethasone ointment, tell your doctor immediately or go to the casualty department at your nearest hospital.
• Treatment with this ointment may cause the level of calcium in your blood or urine to increase (usually when too much ointment has been used). Signs of increased calcium in blood are excessive secretion of urine, constipation, muscle weakness, confusion and coma. This can be serious and you should contact your doctor immediately. However, when the treatment is stopped, the levels return to normal.

Less serious side effects

The following less serious side effects have been reported for Calcipotriol/Betamethasone ointment.

Common side effects (may affect up to 1 in 10 people)

• Itching
• Skin exfoliation.

Uncommon (may affect up to 1 in 100 people)

• Skin pain or irritation
• Rash with inflammation of the skin (dermatitis)
• Redness of the skin due to widening of the small blood vessels (erythema)
• Inflammation or swelling of the hair root (folliculitis)
• Changes in skin colour in the area you have used the ointment
• Rash
• Burning sensation
• Infection of the skin
• Thinning of the skin
• Appearance of red or purple discolouration on the skin (purpura or ecchymosis).

Rare (may affect up to 1 in 1,000 people)

• Bacterial or fungal infection of hair follicle (furuncle)
• Allergic reactions
• Hypercalcaemia
• Stretch marks
• Sensitivity of the skin to light resulting in a rash
• Acne (pimples)
• Dry skin
• Rebound effect: A worsening of symptoms/psoriasis after ended treatment.

Less serious side effects caused by using betamethasone, especially for a long time, include the following. You should tell your doctor or nurse as soon as possible if you notice any of them.

• Thinning of the skin
• Appearance of surface blood vessels or stretch marks
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Skin rash with inflammation or swelling (allergic contact dermatitis)
• Golden coloured gel-filled bumps (colloid milia)
• Lightening of skin colour (depigmentation)
• Inflammation or swelling of the hair root (folliculitis)
• Blurred vision.

Less serious side effects known to be caused by calcipotriol include the following

• Dry skin
• Sensitivity of the skin to light resulting in a rash
• Eczema
• Itching
• Skin irritation
• Burning and stinging sensation
• Redness of the skin due to widening of the small blood vessels (erythema)
• Rash
• Rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis.

Steroid withdrawal reaction: If used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment, with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores.

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 label after EXP. The expiry date refers to the last day of that month.

Do not store the medicine above 25 °C.

Do not refrigerate.

The tube should be discarded 1 year after first opening. Write the date you first opened the tube in the space provided on the carton.

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.