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Dovobet Gel Patient Information Leaflet

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Dovobet Gel Patient Information Leaflet L Scale Get-up Material No Sent by e-maiL l Scale Get-up Material No Sent by e-mail 100% Used for: GB 000000-XXComments: Insert, 2 columns Page 1 IIE015-02Subject Daivobet®, Dovobet®, Xamiol ® Date gel. SpaceDate for text: 2 X 67,5 x 580 mm. Subject Date Date INS 160 x 600 mm 05/05/20 Colour Sign. MaterialSign. number must be printed on both sides Colour Sign. Sign. 160 x 600 mm 08/09/2010 JUG Black RBE Material number on page 1, OCRB 8pt kerning+10(Quark)/ Preparation 100% 08/06/2018 OMA Place of productionOCRB MEDIUM 8pt kerning+50(Indesign) Preparation Place of production Strength ® Strength Packsize Dovobet gel Ireland Packsize Ireland Comments: Comments: Page 1 of 2 Font size: 9 pt Mock-up for reg. purpose 160 mm IIE015-02 - 160 x 600 mm - Page 1 of 2 2. 05/05/20 Package leaflet: Information for the user Dovobet® 50 micrograms/g + 0.5 mg/g gel RBE calcipotriol/betamethasone SOP_00867 SOP_003993 and SOP_000647, SOP_000962 Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. 6 • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. , What is in this leaflet If you have scalp psoriasis 1. What Dovobet® is and what it is used for • Before applying Dovobet to the scalp, comb and SOP_00867 SOP_000647, SOP_000962 2. What you need to know before you use the hair to remove any loose scales. Tilt your Dovobet® head to make sure Dovobet does not run 3. How to use Dovobet® onto your face. It may help to part your hair 4. Possible side effects before you use Dovobet. Apply Dovobet to 5. How to store Dovobet® the affected area with your fingertips, and 6. Contents of the pack and other information rub it in gently. 6 1. WHAT DOVOBET® IS AND WHAT IT IS Washing your hair before application of USED FOR Dovobet is not necessary. Dovobet is used as topical treatment of Shake bottle before scalp psoriasis in adults and on the skin of use. Dovobet other body areas to treat mild to moderate l ® Ge ® plaque psoriasis (psoriasis vulgaris) in adults. Gel Psoriasis is caused by your skin cells being Dovobet produced too quickly. This causes redness, scaling and thickness of your skin. Dovobet contains calcipotriol and 1 2 3 betamethasone. Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation. DovobeDovobet t l l ® ® ®Ge Ge ® Gel Gel 2. WHAT YOU NEED TO KNOW BEFOREDovobetDovobet YOU USE DOVOBET® Do not use Dovobet: • if you are allergic (hypersensitive) to calcipotriol, betamethasone1 1or any of the 22 33 other ingredients of this medicine (listed in section 6) Apply a drop of Apply directly to scalp • if you have problems with calcium levels in Dovobet to fingertip. areas where you can your body (ask your doctor) feel the raised plaque • if you have certain types of psoriasis: these and rub the Dovobet are erythrodermic, exfoliative and pustular gel onDovobe tot the skin. l ® Ge ® (ask your doctor). Gel 4 Dovobet Depending5 on the 6 As Dovobet contains a strong steroid, do NOT affected area 1-4 g use it on skin affected by: (up to 1 teaspoon) is • skin infections caused by viruses normally enough. 000000-XX (e.g. cold sores or chicken pox) 1 2 3 • skin infections caused by a fungus In order to achieve optimal effect, it is recommended that the hair is not washed (e.g. athlete’s foot or ringworm) immediately after application of Dovobet. • skin infections caused by bacteria Let DovobetDovobet remain on the scalp during the • skin infections caused by parasites l ® Ge ® 44 night55 or Gelduring the day. When66 washing hair (e.g. scabies) Dovobet after application the following instructions • tuberculosis (TB) might be useful: • perioral dermatitis (red rash around the mouth) • thin skin, easily damaged veins, stretch marks • ichthyosis (dry skin with fish-like1 scales) 2 3 • acne (pimples) Apply a mild shampoo • rosacea (severe flushing or redness of the 105 mm skin on the face) to the dry hair, • ulcers or broken skin. especially to those areas where the gel Warnings and precautions was applied. Talk to your doctor/nurse/pharmacist before and during use of Dovobet if: 4 5 6 • you are using other medicines that contain corticosteroids as you may get side effects • you have used this medicine for a long time and plan to stop (as there is a risk your psoriasis will get worse or ‘flare up’ when steroids are stopped suddenly) • you have diabetes mellitus (diabetes) as your blood sugar/glucose level may be affected by the steroid 4 5 6 • your skin becomes infected as you may need to stop your treatment • you have a certain type of psoriasis called Leave the shampoo Wash your hair as guttate psoriasis on the scalp for a usual. • you experience blurred vision or other visual couple of minutes disturbances. before washing. 600 mm If necessary, repeat steps 4-6 once or twice. Special precautions • Avoid use on more than 30% of your body or Duration of treatment using more than 15 grams per day • Use the gel once a day. It may be more • Avoid using under a bathing cap, bandages convenient to use the gel in the evening or dressings as it increases the absorption of • The normal initial treatment period is 4 weeks the steroid for scalp areas and 8 weeks for non-scalp • Avoid use on large areas of damaged skin, on areas mucous membranes, or in skin folds (groin, • Your doctor may decide on a different armpits, under breasts) as it increases the treatment period 105 mm absorption of the steroid • Your doctor may decide on repeated • Avoid use on your face or genitals (sex organs) treatment as they are very sensitive to steroids • Do not use more than 15 grams in one day. • Avoid excessive sunbathing, excessive use of solarium and other forms of light treatment. If you use other calcipotriol containing medicines, the total amount of calcipotriol Do not smoke or go near naked flames - medicines must not exceed 15 grams per day risk of severe burns. Fabric (clothing, bedding, and the area treated should not exceed 30% of dressings etc) that has been in contact with the total body surface. this product burns more easily and is a serious fire hazard. Washing clothing and bedding What should I expect when I use Dovobet? may reduce product build-up but not totally Most patients see obvious results after 2 weeks, remove it. even if the psoriasis is not yet cleared at that point. Children Dovobet is not recommended for the use in If you use more Dovobet than you should children below the age of 18 years. Contact your doctor if you have used more than 15 grams in one day. 000000-XX Other medicines and Dovobet Excessive use of Dovobet may also cause a Tell your doctor or pharmacist if you are taking, problem with calcium in your blood, which have recently taken or might take any other usually normalises when discontinuing medicines. treatment. Your doctor may need to carry out blood tests Pregnancy and breast-feeding to check that using too much gel has not If you are pregnant or breast-feeding, think you caused a problem with calcium in your blood. may be pregnant or are planning to have a Excessive prolonged use can also cause your baby, ask your doctor for advice before using adrenal glands to stop working properly this medicine. If your doctor has agreed that (the adrenal glands are found near the kidneys you can breast-feed, take care and do not and produce hormones). apply Dovobet to the breast area. 300 mm If you forget to use Dovobet Driving and using machines Do not take a double dose to make up for a This medicine should not have any effect on forgotten dose. your ability to drive or use machines. If you stop using Dovobet Dovobet contains butylated hydroxytoluene The use of Dovobet should be stopped as (E321) indicated by your doctor. It may be necessary Dovobet contains butylated hydroxytoluene for you to stop this medicine gradually, (E321), which may cause local skin reactions especially if you have used it for a long time. (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 3. HOW TO USE DOVOBET® Always use this medicine exactly as your 4. POSSIBLE SIDE EFFECTS doctor has told you. Check with your doctor or Like all medicines, this medicine can cause pharmacist if you are not sure. side effects, although not everybody gets them. How to put on Dovobet: Cutaneous use. Serious side effects Instructions for proper use Tell your doctor/nurse immediately or as soon • Use only on your psoriasis and do not use on as possible if any of the following happens. skin which does not have psoriasis You may have to stop your treatment. • Shake the bottle before use and remove the cap The following serious side effects have been • Squeeze the gel onto a clean finger or directly reported for Dovobet: onto the area affected by psoriasis • Apply Dovobet to the affected area with your Uncommon (may affect up to 1 in 100 people): fingertips, and rub it in gently until the area • Worsening of your psoriasis.
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