Patient Information Leaflet

What is in

your medicine?

Deltacortril 'Enteric' tablets come in two strengths containing 2.5 milligrams (coloured brown) or 5 milligrams (coloured red) of prednisolone. The inactive ingredients are: (both strengths) acacia, beeswax, calcium carbonate, carnauba wax, cellulose acetate phthalate, citroflex A-2 kaolin, lactose, magnesium stearate, maize starch, shellac, sucrose, talc. The 2.5 milligram tablets contain red/brown oxide (E172) and the 5 milligram tablets azo dye ponceau 4R (E 124). Deltacortril 'Enteric' is supplied in packs of 30 or 500 tablets.

Product Licence Holder

and Manufacturer

Pfizer Limited, Sandwich, Kent CT13 9NJ

What type

of medicine is

Deltacortril 'Enteric'?

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' is 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. Deltacortil ‘Enteric’' is included as part of the overall treatment of certain cancers which include: leukaemia (acute and lymphatic) malignant Lymphoma and multiple myeloma. Deltacortril ‘Enteric' is 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'

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.

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

It is also important that herpes infections of the eye are treated as they may result in complications if untreated.

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.

  • Have you had an allergic reaction to Deltacortril 'Enteric' 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.
  • Have you had an allergic reaction to azo dyes (food colourings) in the past? This may have been itching, reddening of the skin or difficulty in breathing. An azo dye is the colouring agent in the 5mg tablets while the 2.5mg tablets are free of azo dyes.
  • Have you taken Deltacortil 'Enteric' (or similar medicine) before and had muscular problems (steroid myopathy)?
  • Do you suffer from any heart condition?
  • 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 Deltacortil 'Enteric' (or similar medicine) before and suffered from serious mental illness (psychoses)?

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.

MORE INFORMATION ON DELTACORTRIL ‘ENTERIC’

  • 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: antiepileptic drugs, antiarthritis drugs, analgesics (such as aspirin and ibuprofen), oestrogens, antihypertensives, diuretics, drugs used to treat myasthenia gravis and certain cancers, anticoagulants, antidiabetic drugs including insulin and vaccines.
  • Make sure that you have hen 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' is tailored to each individual. It is important to follow your doctor's instructions.

The starting dose is usually 10-20mg daily either as a single morning dose or divided into morning and evening dose . But depending on the illness being treated this can vary from 5-60mg daily, and in some instances it can be taken every other day. Once your condition starts to get better your doctor may change your dosage to a lower one. You should be careful to follow any changes

  • Withdrawal symptoms. If treatment is for longer than 7 days 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.

What if you take

too many tablets?

Too many tablets can make you unwell. Contact your doctor or nearest hospital accident and emergency department.

What if you

miss a tablet?

Take that tablet as soon as you realise and take the next dose at the correct time.

Can your medicine

cause undesirable

effects?

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

  • Gastro-intestinal: indigestion, stomach ulcers with bleeding or perforation, bloating, oesophageal (gullet) ulcers or candidiasis (thrush) and inflammation of the pancreas.
  • Musculo-skeletal: muscle wasting of the upper arms and legs, thinning or wasting of the bones, bone fractures and tendon rupture.
  • Fluid and salts: water and salt retention, hypertension (high blood pressure), a change in the mineral balance in the blood.
  • Skin: reduction in healing, thinning of the skin, bruising, stretch marks, patches of reddening and acne.
  • 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 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), pressure on the nerve to the eye, thinning of the tissues of the eye (sclera and cornea), 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.
  • General: increased number of white blood cells, allergy, thrombosis, sickness, tiredness.
  • It is important to discuss your treatment with your doctor beore 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.

    Where to keep

    your medicine

    • Keep your medicine in a dry place, below 25°C
    • Keep all medicines out of the reach of children

    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' only.

    Date Deltacortril 'Enteric' leaflet

    United Kingdom last revised - Dec 1995

    © Pfizer Limived 1995