Soriatane

What Soriatane is and what it is used for

The name of your medicine is “Soriatane 10 mg Capsules” or “Soriatane 25 mg Capsules” but will be referred to as “Soriatane” throughout the leaflet. Soriatane belongs to a group of medicines known as retinoids. Retinoids are derived from vitamin A The medicine is used to treat severe skin problems where the skin has become thick and may be scaly and which does not respond to other conventional treatments satisfactorily. Soriatane is used to treat
• extensive and serious forms of various skin disorders resulting from disturbances of the outer layer of skin (the epidermis), such as psoriasis, together with a dry, scaling, waxy rash.
• specific skin disorders characterized by dry scales as a result of marked keratinization (ichthyosis, an organic process by which keratin is deposited in cells and the cells become horny like nails and hair) and similar disorders in which a skin rash (pityriasis) or small elevations of skin and mucosa (lichen ruber) occur.

How to take Soriatane

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Take Soriatane at a meal time, preferably with a drink of milk.
• Swallow each capsule whole. The dose varies from one patient to another. Your doctor will work out the right dose for you. Adults and elderly people
• The usual starting dose for adults and elderly people is 25 mg or 30 mg once a day.
• After 2 to 4 weeks, your doctor may increase or decrease your dose. This will depend on how well it works and how it affects you.
• The maximum dose is 75 mg a day.
• Most people take Soriatane for up to 3 months. However, your doctor may decide that you need to take it for longer. Use in children and adolescents Soriatane is not normally given to children. If it is given to a child, the doctor will decide the correct dose. This is based on the child’s weight. You can use additional local treatments of the skin, including skin care products, after consultation with your doctor. If you take more Soriatane than you should If you take more Soriatane than you should, you may suffer from headache, nausea and/or vomiting, drowsiness, irritability and itching. Stop taking the medicine and consult your doctor immediately. If you forget to take Soriatane Do not take a double dose of Soriatane to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember and continue according to the dosing schedule. However, if it is nearly time for the next dose, skip the missed dose. If you stop taking Soriatane Your doctor can judge best if and how you must stop taking Soriatane. Always contact your doctor before you want to stop taking the medicine. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
• The side effects of Soriatane are dose related. The higher the daily dose, the greater the risk of side effects.
• Most side effects occur at the start of treatment when the dose still has to be adjusted. Most side effects are reversible after altering the dose or discontinuation of treatment.
• Occasionally the symptoms of your skin may get worse in the beginning of treatment.
• As Soriatane is a vitamin A derivative, most of its side effects are similar to the symptoms that occur if someone has used too much vitamin A.

Very common side effects (affecting more than 1 of 10 patients treated)
• over 80% of patients experienced: – dry skin and mucous membranes, dry lips and possibly inflamed lips.
• 40 – 80% of patients experienced: – dry mucous membranes of the skin and nose – peeling of the skin, especially the palms of the hands and soles of the feet – inflammation of the nasal mucosa.
• 10 – 40% of patients experienced: – nose bleed – scaling and thinning of healthy skin with increased sensitivity – reddening of the skin – itching – sensation of “burning skin” – sensation of “sticky skin” – inflammatory skin changes – hair loss – swelling and pain in the area around your nails – fragile nails – inflammation of the eye (conjunctivitis) – feeling more thirsty than usual – feeling cold. Using moisturisers or “emollients” from the start of treatment can help you to deal with dry skin problems. Side effects of the skin and mucous membranes occur rather soon (a few days) after start of treatment, hair loss cannot be expected until several weeks into the treatment. These side effects are reversible after altering the dose or discontinuation of treatment. However, new growth of hair will take some months, due to the hair growth cycle.

Common side effects (affecting 1 to 10 of 100 patients treated)
• chapping
• inflammation of oral mucosa and gums
• blisters on skin
• changes in skin and hair colour
• change in the growth rate and texture of hair
• visual disturbances such as dry eye, blurred vision, impaired night vision. Wearing of contact lenses might become impossible. For this reason you should wear glasses before treatment with Soriatane (see “Warnings and precautions”).

Uncommon side effects (affecting 1 to 10 of 1,000 patients treated)
• muscle, joint and bone pain After long-term treatment with Soriatane, bone changes may occur (extra growth on the surface of your bones, thinning of bones, reduced bone density [osteoporosis], premature stop of bone growth) and calcifications in soft tissues (ligaments and tendons) (see “Warnings and precautions”).
• increased retention of water in the body (oedema)
• sensation of heat
• changed sense of taste
• headache.

Rare side effects (affecting 1 to 10 of 10,000 patients treated)
• increased sensitivity of the skin to sunlight, as a result of which sunburn can occur after only a brief exposure to the sun
• inflammations or ulcers of the cornea
• gastro-intestinal troubles (e.g. nausea, vomiting, abdominal pain, diarrhoea, digestive disorders)
• inflammation of the liver (hepatitis) and jaundice
• increased pressure in the brain (pseudotumor cerebri). Symptoms can include severe headache, nausea, vomiting and blurred vision. If you experience these symptoms immediately stop taking the medicine and contact your doctor.

Not known (frequency cannot be estimated from the available data)
• A serious condition which causes the small blood vessels (capillaries) to leak (Capillary Leak Syndrome/Retinoic Acid Syndrome). This can lead to severe hypotension (low blood pressure), oedema (build up of fluid leading to swelling) and shock (collapse).
• A serious skin reaction with symptoms such as rash, blistering or peeling of the skin (Exfoliative dermatitis).
• Loss of eyelashes or eyebrows (madarosis).
• Immediate allergic reaction with symptoms such as skin rash, swelling or itching of the skin, red and swollen eyes, severe nasal congestion, asthma or wheezing. The reaction can be minor to life-threatening.

Other side effects observed during treatment with Soriatane
• increased occurrence of vaginal infection (also known as Candida or thrush)
• increased levels of liver enzymes
• increased levels of fats and cholesterol in the blood. These changes are particularly seen in patients with a disposition to increased fatty acid levels, (diabetes, obesity, alcohol misuse or disturbance of fat metabolism), but they are not of a lasting nature and may be treated by dietary means. However, potential arterial stenosis (when the carotid arteries become narrow or blocked) due to the increased fatty acid and cholesterol levels cannot be excluded.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Soriatane

Keep out of the sight and reach of children. Do not use the medicine after the expiry date which is stated on the carton and blister label after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Store in the original package, in order to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.