Betamethasone valerate 0.1% / Clioquinol 3% Cream What Betamethasone valerate/ Clioquinol is used for: This product is used for the effective and fast treatment of some skin problems involving skin inflammation in which the risk of a concomitant infection is a concern, such as: Eczema (common skin disorder that causes the skin to become itchy and red). Prurigo Nodularis (formation of hard and itchy lumps on the skin). lichen simplex chronicus (patches of itchy, thickened skin from scratching). Psoriasis (thickened patches of red and inflamed skin, usually covered with silvery scales), excluding widespread plaque psoriasis. lichen planus (red to purple, itchy and flat-topped bumps on the forearms, lower legs or wrists). Allergic skin reaction (e.g. contact dermatitis) due to a substance or an allergen that comes in contact with your skin. Otitis externa (inflamed, flaky and red skin of the outer ear and ear canal). Skin reactions due to insect bites. Seborrheic dermatitis (a scaly, red and itchy rash on the scalp, chest, back, and face). Prickly heat (skin rash caused by sweat trapped in the skin). Genital and anal intertrigo (rash that usually affects skin folds in the vagina or penis due to skin rubbing together and moisture). Do not use Betamethasone valerate/ Clioquinol: If you have an allergy to betamethasone valerate, clioquinol, iodine or any of the ingredients present in this product. If the package is ripped or has signs of tampering. If the expiry date mentioned on the medication box has passed. If you experience an allergic reaction or skin irritation upon use of this cream. If you are pregnant, plan on getting pregnant or breastfeeding. If you may be suffering from other skin problems (e.g. widespread plaque psoriasis, fungal infections such as athletes foot or oral thrush, bacterial skin infections, skin tuberculosis, anal or genital itching, cold sores, shingles, chickenpox, skin tuberculosis, acne, itchy skin that is not inflamed, skin inflammation around the mouth, unusual redness of the face with papules or tiny blood vessels or pus-filled bumps known as rosacea). The use of this medicine for other skin disorders may worsen your problem. Ask your doctor or pharmacist if you are not sure. In children under the age of 2 years. Warnings & Precautions: Stop the medication right away and talk to your doctor or pharmacist if you develop any allergic or skin reactions to any of the ingredients present in this cream such as skin itchiness, skin redness, shortness of breath, skin rash, swelling of the face or neck, decreased blood pressure and dizziness. This medicine is designed for external topical use only. Do not swallow this product. Avoid contact of the cream with your lips, eyes, mouth, sensitive areas of the neck and angles of the nose in order to avoid irritation. In case of accidental contact, make sure to rinse the area very well with warm water and then pat dry. Talk to your doctor immediately if you, or your child develop any vision problems (e.g. blurred vision). Make sure not to use any occlusive dressings if you have a skin infection. Talk to your doctor before starting this medicine if you have an allergy to any other medicines, dyes, foods or preservatives, If you are pregnant, plan on getting pregnant, breastfeeding or plan on breastfeeding, If you have any other health problems (especially if you suffer from an infection). Make sure to tell your healthcare providers that you are using this medicine. Talk to your doctor if your skin condition is getting worse or infected or if it does not seem to get better after 2 to 4 weeks of starting this medicine, If you are being treated for psoriasis and you experience raised bumps with pus below the skin. Your doctor may need to see you more often if you have psoriasis. Talk to your doctor if you do not use this product as directed to make sure that he/she does not change you to another therapy thinking that this medicine did not work for you. Do not share this medicine with anyone else even if they have the same signs. Do not use tight-fitting nappies or plastic pants if this product is to be used on the nappy area of young children. If your doctor recommends that you use a dressing; clean the skin very well before you apply it in order to prevent infections. Do not apply this medicine under tight fitting clothes to avoid skin thinning. Do not use this medicine for a long period of time on large areas to prevent its excessive absorption and subsequent undesirable side effects like blood vessels under your skin, stretch marks, changes in skin color, increased body hair growth, rounding of the face, skin thinning, or weight gain. Do not use this product for other purposes. Do not dilute this product. You are at higher risk of developing an allergic reaction or an infection if you apply this product on an area of the skin that has eczema around a leg ulcer. Talk to your doctor if you have a leg ulcer. This medicine may cause skin, clothing and hair staining. Avoid contact of the cream with hair or clothing. Possible Side Effects: Possible side effects include blurred vision, allergy reactions, worsening of your skin condition or infected skin and pustular psoriasis (raised bumps filled with pus below the skin that may rarely happen during or after the treatment if you have psoriasis). Common side effects include itching, burning and local skin pain. Other rare side effects (more likely to happen with prolonged use of this product on large skin areas especially if applied under tight dressings) include tiny blood vessels below the skin, stretch marks, weight gain, rounding of the face, skin infection, hair loss, skin redness, skin dryness, skin wrinkling, thinning of the skin, hair discoloration, increase in hair growth and change in skin color. Other rare side effects that may occur in children include delayed weight gain and slow growth. Other medicines and Betamethasone valerate/ Clioquinol: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications including topical products (e.g. creams, lotions, ointments). If you are taking itraconazole (used to treat some fungal infections). If you are taking ritonavir (used to treat human immunodeficiency virus). If you are taking vigabatrin (used to treat some type of seizures). How to use Betamethasone valerate/ Clioquinol: Adults Apply a thin layer of cream and gently massage it into the affected area as directed by your doctor (usually 1 to 2 times per day). Children Do not use this medicine in children under the age of 2 years. Use of this medicine is not recommended in children unless recommended by your doctor. If recommended by the doctor, he/she should follow up closely with the child to check for the development of any undesirable side effect like growth retardation or adrenocortical suppression (lower production of cortisol in the body). How To Use: Wash and dry your hands before and after using the cream (do not wash your hands after using it if it is being used for the skin of your hands). If you are applying this medicine to someone else, make sure to wear disposable plastic gloves or wash your hands immediately after applying the cream. Make sure to replace the cap on the tube after using the cream in order to avoid leakage of the medicine. Make sure to follow the directions of your healthcare provider. Make sure to keep the cream away from your eyes. If accidental contact happens, wash your eyes thoroughly with running water for at least 10 minutes. Make sure not to apply the cream below a dressing (e.g. bandage or plaster) in order to prevent excessive absorption of the medicine and subsequent undesirable side effects (damage to the nervous system). If you are using a moisturizer, give time for this cream to be absorbed into your skin before you apply your moisturizer. If you are taking this medicine for thick patches due to psoriasis on your elbows or knees, your doctor may recommend applying the cream under an airtight dressing at night in order to help the medicine to start working. You will then apply your cream normally after a short period of time. Do not use this cream on your face unless directed by your doctor. If your skin condition does not improve, make sure to contact your doctor right away. Do not use this cream on skin wounds or on large areas of the skin or in skin folds (e.g. the back of the knee) unless directed by your doctor. Using less than recommended of this medicine may cause your skin not to improve. Your doctor will determine for how long you will be using this product and may also adjust the frequency of using it depending on your response and. This medicine is associated with more side effects if used for longer periods of time. Do not change how you use this medicine without consulting your doctor first. How to store Betamethasone valerate/ Clioquinol: Keep out of the reach of children and pets (e.g. a locked cupboard at least one-and-a-half meter above the ground) Store in a dry place below 30°C Do not use beyond the expiry date mentioned on the cream Do not dispose medication in the wastewater or household waste, ask your pharmacist how to dispose medicines you no longer use Do not leave your medicine on windowsills or in the car Keep medication in its original pack to protect it from moisture and light A valid prescription should be available upon delivery

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