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

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

calcipotriol/betamethasone

Calcipotriol/Betamethasone gel is used as topical treatment of scalp psoriasis in adults and on the skin of other body areas to treat mild to moderate 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 gel 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 Calcipotriol/Betamethasone gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

Instruction for proper use

• Use only on your psoriasis and do not use on skin which does not have psoriasis
• Shake the bottle before use and remove the cap
• Squeeze the gel onto a clean finger or directly onto the area affected by psoriasis
• Apply Calcipotriol/Betamethasone gel to the affected area with your fingertips, and rub it in gently until the area affected by psoriasis is covered by a thin layer of gel
• Do not bandage, tightly cover or wrap the treated skin area
• Wash your hands well after using Calcipotriol/Betamethasone gel. This will avoid accidentally spreading the gel to other parts of your body (especially the face, mouth and eyes)
• Do not worry if some gel 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 gel
• After applying the gel avoid contact with textiles which are easily stained by grease (e.g. silk).

If you have scalp psoriasis:

• Before applying Calcipotriol/Betamethasone gel to the scalp, comb the hair to remove any loose scales. It may help to part your hair. Tilt your head to make sure Calcipotriol/Betamethasone gel does not run onto your face. Washing your hair before application of Calcipotriol/Betamethasone gel is not necessary.

1. Shake bottle before use.
2. Apply a drop of Calcipotriol/Betamethasone gel to fingertip.
3. Apply directly to scalp areas where you can feel the raised plaque and rub Calcipotriol/Betamethasone gel on to the skin.

Depending on the affected area 1-4 g (up to 1 teaspoon) is normally enough.

In order to achieve optimal effect, it is recommended that the hair is not washed immediately after application of Calcipotriol/Betamethasone gel.

Let Calcipotriol/Betamethasone gel remain on the scalp during the night or during the day. When washing hair after application the following instructions might be useful:

4. Apply a mild shampoo to the dry hair, especially to those areas where the gel was applied.
5. Leave the shampoo on the scalp for a couple of minutes before washing.
6. Wash your hair as usual.

If necessary, repeat steps 4-6 once or twice.

Duration of treatment

• Use the gel once a day. It may be more convenient to use the gel in the evening.
• The normal initial treatment period is 4 weeks for scalp areas and 8 weeks for non-scalp areas.
• 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.

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.

Some serious side effects are known to be caused by betamethasone (a strong steroid), one of the ingredients in Calcipotriol/Betamethasone gel. 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 gel 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 gel, tell your doctor immediately or go to the casualty department at your nearest hospital.
• Treatment with this gel may cause the level of calcium in your blood or urine to increase (usually when too much gel 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

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

• Itching

Uncommon (may affect up to 1 in 100 people)

• Eye irritation
• Burning sensation of the skin
• Skin pain or irritation
• Inflammation or swelling of the hair root (folliculitis)
• Rash with inflammation of the skin (dermatitis)
• Redness of the skin due to widening of the small blood vessels (erythema)
• Acne (pimples)
• Dry skin
• Rash
• Pustular rash
• Infection of the skin

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

• Allergic reactions
• Stretch marks
• Skin exfoliation
• Rebound effect: A worsening of symptoms/psoriasis after ended treatment.

Frequency unknown (frequency cannot be estimated from the available data):

• White or grey hair can transiently change to a yellowish colour at the application site when used on the scalp
• Blurred vision.

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 of the skin 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).

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

If used continuously for prolonged periods a withdrawal reaction may occur on 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 out of the reach and sight of children.

Do not use Calcipotriol/Betamethasone gel 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 30 °C.

Keep the bottle in the outer carton in order to protect from light.

Discard the bottle with any remaining gel 6 months after first opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.