PATIENT INFORMATION LEAFLET (UK)

What is in your medicine?

Deltacortril 'Enteric' coated tablets come in two strengths. Each gastro-resistant tablet contains 2.5 milligrams (coloured brown) or 5 milligrams (coloured maroon) of prednisolone.

The inactive ingredients are: (both strengths) calcium carbonate, lactose, magnesium stearate, maize starch, polyvinyl alcohol, titanium dioxide (E171), purified talc, lecithin, xanthan gum (E415), polyvinyl acetate phthalate, polyethylene glycol, sodium hydrogen carbonate, triethyl citrate, purified stearic acid, sodium alginate (E401), colloidal silicon dioxide, beeswax (E901), carnauba wax (E903), polysorbate 20 (E432) and sorbic acid (E200). Additionally the 5mg tablet contains methylcellulose (E461), sodium carboxymethyl cellulose, carmine (E120), indigo carmine aluminium lake (E132) and the 2.5mg tablet contains methylcellulose (E461), sodium carboxymethyl cellulose, iron oxide (E172).

Deltacortril 'Enteric' coated tablets are supplied in packs of 30 or 100 tablets.

What type of medicine is Deltacortril 'Enteric' coated tablets?

This medicine is one of a group of medicines called steroids (naturally occurring hormones) which are used to treat several illnesses.

What is your medicine for?

Deltacortril 'Enteric' coated tablets are used in the treatment of allergic and inflammatory diseases and immune reactions. The treatment provides relief for inflamed areas of the body and lessens swelling, redness, itching and allergic reactions.

Deltacortril 'Enteric' coated tablets are included as part of the overall treatment of certain cancers which include: leukaemia (acute and lymphatic) malignant lymphoma and multiple myeloma.

Deltacortril 'Enteric' coated tablets are also used to make up the difference when the body's production of cortisone is too low to maintain good health.

Before you take Deltacortril 'Enteric' coated tablets

Are you suffering from an untreated widespread (systemic) infection?

While you are taking steroids, you are more likely to develop illnesses due to infection. Also any existing infections may become worse resulting in septicaemia. This is especially so during periods of stress. Certain infections can be serious if not controlled.

Are you suffering from herpes infection of the eye?

It is important to be aware that contracting chickenpox during treatment or for a period afterwards can be dangerous.

If you or anyone in your family or regular contacts catches CHICKENPOX it is important to contact your doctor IMMEDIATELY. DO NOT STOP your treatment. It is also IMPORTANT that you contact your doctor if you contract CHICKENPOX within a 3 month period after stopping treatment.

 

It is also important to take particular care to avoid contact with MEASLES and to contact your doctor IMMEDIATELY if you or anyone in your family or regular contacts catches MEASLES.

• Have you had an allergic reaction to Deltacortril 'Enteric' coated tablets in the past? This may have been itching, reddening of the skin or difficulty in breathing, or any other problems when taking the tablets previously.
• This product contains lactose, which makes it unsuitable for people with lactase deficiency and other conditions known as galactosaemia or glucose/galactose malabsorption syndrome. It also contains sorbic acid, which can be an irritant. A complete list of inactive ingredients is included in the "What is in your medicine?" section of this leaflet.
• Have you taken Deltacortril 'Enteric' coated tablets (or similar medicine) before and had muscular problems (steroid myopathy)?
• Do you suffer from any heart condition or high blood pressure?
• Do you suffer from kidney problems?
• Do you suffer from liver problems?
• Do you suffer from stomach ulcers?
• Do you suffer from glaucoma or does glaucoma run in your family?
• Do you suffer from diabetes or does diabetes run in your family?
• Do you suffer from thyroid problems?
• Do you suffer from epilepsy (fits)?
• Are you suffering from, or have you been treated for tuberculosis (TB)?
• Are you past the menopause (the change of life) and suffering from osteoporosis (thinning of the bones)?
• Have you suffered from severe affective disorders (mania or depression)?
• Have you taken Deltacortril 'Enteric' coated tablets (or similar medicine) before and suffered from serious mental illness (psychoses)?
• Do you need to receive a vaccination? It is important that if you are to receive a vaccination that you tell your doctor or nurse that you are taking a steroid.
• Are you receiving treatment for a condition called myasthenia gravis?
• Do you have a disease which affects blood clotting, so that your blood clots too easily, (for example, thrombophlebitis, thromboembolism)?
• Do you have Cushing's disease?

If the answer to any of these questions is yes, tell your doctor before you start treatment. Your doctor may still want you to take the tablets.

• If you are pregnant or trying to become pregnant, you must tell your doctor before you start the treatment.
• Small amounts of steroids are present in breast milk. If you are breast feeding your doctor will want to examine your baby during your time of treatment.
• Treatment of children: The use of steroids can slow down normal growth of children and adolescents. In order to lessen this effect the tablets are often taken in a single dose every other day.
• Treatment of the elderly: When steroids are taken by elderly patients some of the unwanted effects can be more serious especially thinning of the bones, diabetes, high blood pressure, infections and thinning of the skin.
• If you are taking any other medicines it is important to tell your doctor before you start the treatment, these include: antibiotics (e.g. erythromycin), antifungal drugs (e.g. amphoterecin, ketoconazole), antiviral drugs (e.g. ritonavir), antiepileptic drugs, antiarthritis drugs, analgesics (such as aspirin and ibuprofen), oestrogens, cardiac glycosides (e.g. digoxin), medicines to treat high blood pressure, diuretics, drugs used to treat myasthenia gravis and certain cancers, ciclosporin, somatropin (growth hormone), drugs used to treat asthma, anticoagulants and antidiabetic drugs including insulin and vaccines.
• Make sure that you have been given a STEROID TREATMENT CARD by your doctor which you should always keep with you.

How to take your medicine

The tablets should only be taken by mouth and can be swallowed with water. They can be taken before or after a meal.

Treatment with Deltacortril 'Enteric' coated tablets is tailored to each individual. It is important to follow your doctor's instructions.

Different illnesses require different dosages of Deltacortril 'Enteric' coated tablets. Depending on your illness your daily dose may be between 5 and 60mg. In some cases you may be instructed to take it every other day.

Once your condition starts to get better, your doctor may change your dosage to a lower one. Your doctor may also reduce your dosage before stopping treatment completely. This may depend on your illness, your dosage and how long you have been taking this medicine. In all cases you should be careful to follow any changes.

• Withdrawal symptoms. Sudden stopping of treatment can cause the following symptoms: fever, painful muscles and joints, inflammation of the eyes and nasal passages, painful and itchy skin lumps, loss of weight.

Can your medicine cause undesirable effects?

Like most medicines Deltacortril 'Enteric' coated tablets can cause undesirable effects. These include:-

• Body as a whole: Allergic reaction, tiredness, increased number of white blood cells, blood clotting, nausea and vomiting.
• Heart and blood vessels: High blood pressure, heart failure in patients who have a risk.
• Central and Peripheral Nervous system: Convulsions, dizziness, headache, increased intracranial pressure usually after treatment.
• Gastro-intestinal: indigestion, stomach ulcers with bleeding or perforation, bloating, oesophageal (gullet) ulcers, or candidiasis (thrush) abdominal pain, increased appetite which may result in weight gain, diarrhoea, nausea and inflammation of the pancreas.
• Musculo-skeletal: muscle wasting of the upper arms and legs, muscle pain, thinning or wasting of the bones, bone fractures and tendon rupture.
• Metabolic /Nutritional: water and salt retention, hypertension (high blood pressure), a change in the mineral balance in the blood.
• Skin/Appendages: reduction in healing, thinning of the skin, bruising, stretch marks, patches of reddening, itching,rash, hives and acne. Extra hair growth, impaired wound healing, thin fragile skin, bruising, increased sweating, may suppress reactions to skin tests.
• Hormone system and metabolism: reduction in the balance between certain hormones, reduction of growth in babies, children and adolescents, absence or irregularity of menstrual periods, moon shaped face, extra hair growth, weight gain, carbohydrate imbalance in diabetes, increased appetite, reduction in protein and calcium in the blood.
• Nervous disorders: euphoria (feeling high), feeling of dependency on treatment, depression, sleeplessness, pressure on the nerve to the eye (sometimes in children after stopping treatment), worsening of schizophrenia, worsening of epilepsy.
• Eyes: increased pressure in the eyeball (glaucoma), whitening or clouding of the lens (cataracts), pressure on the nerve to the eye, thinning of the tissues of the eye (sclera and cornea), protruding eyes, worsening of viral or fungal infections of the eye.
• Effects of infections: risk of contracting infection is increased, existing infections can worsen, signs of infection can be masked, dormant infections (such as TB) can reappear.

It is important to discuss your treatment with your doctor before stopping treatment.

Although there is a risk that you may experience one or more of the above side-effects, your doctor will have chosen this treatment bearing in mind these risks and the risks to you from your illness. If you suffer from any of these or other undesirable effects they should be reported to your doctor or pharmacist.

Look after your medicine

This treatment is for YOU. Do not give it to others. It may not suit them.

Do not take this medicine after the date stamped on the pack.

Further information

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet is about Deltacortril 'Enteric' coated tablets only.