Orapred Dispersible (Prednisolone)

Deltacortril Gastro-resistant Tablets

What Deltacortril (Prednisolone) Is and What It Is Taken for

Deltacortril belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body and help to maintain health and well-being. Boosting your body with extra corticosteroids (such as Deltacortril) effectively treats various inflammation-related illnesses. Deltacortril reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

Ingredients

The active ingredient in this medicine is prednisolone.

The other ingredients are 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, methylcellulose (E461), sodium carboxymethyl cellulose, beeswax (E901), carnauba wax (E903), polysorbate 20 (E432) and sorbic acid (E200).

The Deltacortril 5 mg tablet also contains carmine (E120) and indigo carmine aluminum lake (E132).

The Deltacortril 2.5 mg tablet contains iron oxide (E172).

Important Information About Some of the Ingredients of Deltacortril

Deltacortril contains lactose. If your doctor has told you that you are intolerant to some sugars, contact your doctor before taking this medicinal product.

What Deltacortril Looks Like 

Deltacortril tablets come in two strengths. Deltacortril 2.5 mg is a brown tablet. Deltacortril 5 mg is a maroon tablet. They are gastro-resistant tablets.

Deltacortril tablets come in packs of 30 or 100 tablets.

Uses

Deltacortril is used in a wide range of inflammatory and auto-immune conditions, including:

• allergies, including severe allergic reactions;
• inflammation affecting the:
  • lungs, including asthma;
  • blood vessels and heart;
  • bowel or kidneys;
  • muscles and joints, including rheumatoid arthritis;
  • eye or nervous system;
  • skin conditions;
• some infections;
• some cancers, including leukemia, lymphoma, and myeloma;
• to prevent organ rejection after a transplant.

Also:

• to boost steroid levels when the body is not making enough natural steroids;
• to treat high calcium levels.

How to Take Deltacortril

Always take Deltacortril exactly as prescribed. You should check with your doctor or pharmacist if you need more information.

Different illnesses require different doses of Deltacortril. Depending on the disease, your daily dose may be between 5 and 60 mg. Sometimes, you may be instructed to take it every other day. Your doctor will decide when and how to treat you with Deltacortril.

Once your condition improves, your doctor may lower the dosage. Your doctor may also reduce your dosage before stopping treatment. 

Stopping taking Deltacortril: It is essential to discuss your treatment with your doctor before stopping treatment. 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, and weight loss.

Treatment of children: Using steroids can slow the average growth of children and adolescents. The tablets are often taken in a single dose every other day to minimize this effect.

Treatment of senior patients: When senior patients take steroids, some unwanted side effects can be more serious, especially brittle bone disease, diabetes, high blood pressure, infections, and skin thinning.

While you take Deltacortril, tell your doctor immediately if any of the following occur:

1. Infections. You are more likely to develop illnesses due to infection while taking Deltacortril. Also, any existing infections may become worse. This is especially so during periods of stress. Certain infections can be severe if not controlled.
2. Chickenpox and Shingles: If you, anyone in your family, or regular contacts catch chickenpox or shingles. You may become very ill if you get chicken pox while taking Deltacortril. Avoid contact with people who have chicken pox or shingles while taking Deltacortril and for up to 3 months after you have stopped taking Deltacortril. Do not stop taking Deltacortril.
3. Measles: If you, anyone in your family, or regular contacts catch measles. Avoid contact with people who have measles.

Your doctor will give you a steroid treatment card. You must carry it with you at all times. You should show your steroid treatment card to anyone who treats you, like a doctor, nurse, or dentist.

Taking With Food and Drink

Deltacortril should be swallowed with water. You can take Deltacortril before or after a meal.

Important Safety Information

Deltacortril is a steroid medicine prescribed for many different conditions, including serious illnesses.

It must be taken regularly to get the maximum benefit.

Don’t stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually.

Deltacortril can cause side effects in some people. Some problems, such as mood changes (feeling depressed or ‘high’) or stomach problems, can happen immediately after administering. If you feel unwell, keep taking your tablets, but see your doctor immediately.

Some side effects only happen after weeks or months. These include weakness of arms and legs and developing a rounder face.

If you take it for over 3 weeks, you will get a blue ‘steroid card.’ Always keep it with you and show it to any doctor or nurse treating you.

Keep away from people who have chickenpox or shingles if you have never had them. They could affect you severely. If you come into contact with chickenpox or shingles, see your doctor immediately.

Check With Your Doctor Before You Take Deltacortril the Following:

• If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Deltacortril.
• If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking Deltacortril. 

Do Not Take Deltacortril if You:

• are allergic (hypersensitive) to prednisolone or any of the ingredients of Deltacortril (see Further Information section);
• are suffering from a severe infection which is not being treated
• are suffering from a herpes infection of the eye.

Before you take Deltacortril, tell your doctor if you:

• suffer from or have ever been treated for tuberculosis (TB);
• have high blood pressure;
• have a heart condition;
• have liver or kidney problems;
• you or your family member have diabetes;
• have osteoporosis (thinning of the bone), particularly if you are past the menopause;
• suffer from epilepsy;
• suffer from stomach ulcers;
• had taken Deltacortril (or other steroids) before and had muscular problems (steroid myopathy);
• are receiving treatment for a condition called myasthenia gravis (a rare muscle weakness disorder)
• have ever had blood clots (for example, deep vein thrombosis [DVT] or thromboembolism);
• are planning to have a vaccination;
• have Cushing’s disease (A hormone disorder that can cause symptoms including gaining weight very quickly, especially on the trunk and face, thinning of the skin, and sweating);
• suffer from hypothyroidism (an underactive thyroid gland which can cause tiredness or weight gain);
• have Duchenne’s muscular dystrophy.

If any of the above applies to you, or if you are unsure, speak to your doctor or pharmacist before taking Deltacortril.

Pregnancy and Breast-Feeding

If you are pregnant or trying to get pregnant, you must tell your doctor before you start the treatment.

If you are breast-feeding, you must tell your doctor before you start the treatment. Your doctor will want to examine your baby during your time of treatment. Small amounts of steroids are present in breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and Using Machines

If you feel dizzy or tired after taking Deltacortril, do not drive or operate machinery until these effects have worn off.

Interactions

Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines, as they may interfere with Deltacortril:

• antivirals such as ritonavir, which can be used to treat HIV infection;
• antifungals such as ketoconazole and amphotericin, which are used to treat fungal infections;
• antibiotics such as erythromycin and rifamycin, which are used to treat bacterial infections;
• antiepileptic drugs such as carbamazepine, phenobarbital, phenytoin, and primidone, which are used to treat epilepsy;
• antiarthritis drugs;
• estrogens, for example, in the contraceptive pill or HRT,
• thiazide diuretics (“water tablets”), for example, bendroflumethiazide used for water retention or high blood pressure;
• medicines to treat high blood pressure;
• anticoagulants, for example, warfarin, which is used to thin the blood;
• carbenoxolone, which is used for ulcers;
• salbutamol, formoterol, bambuterol, fenoterol, ritodrine, salmeterol and terbutaline used to treat asthma;
• drugs for diabetes, including insulin;
• ciclosporin, which is used to treat rheumatic disease, skin complaints, or after a transplant;
• cardiac glycosides, for example, digoxin, which is used to help strengthen a weak heart;
• non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, and indometacin, used for pain relief or to treat rheumatic disease;
• mifepristone, used to induce labor or abortion;
• cytotoxic drugs, for example, methotrexate, which is used to treat cancer;
• vaccinations: you must tell your doctor or nurse that you are taking a steroid before being given any vaccinations; steroids affect your immune response, and you must not be given any live vaccines;
• somatropin, which is a growth hormone;
• acetazolamide, which is used in the treatment of glaucoma and epilepsy;
• loop diuretics, for example, furosemide, which is used to treat heart failure;
• theophylline, which is used for asthma and chronic obstructive pulmonary disease (COPD).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Possible Side Effects

Deltacortril can cause side effects like all medicines, although not everyone gets them.

Serious Effects: Tell a Doctor Straight Away

Steroids, including prednisolone, can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like prednisolone.

Mental health problems can happen while taking steroids like Deltacortril.

• These illnesses can be severe.
• Usually, they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped. However, if mental problems occur, they might need treatment.

Talk to a doctor if you (or someone taking this medicine) show signs of mental problems:

• feeling depressed, including thinking about suicide;
• feeling high (mania) or moods that go up and down;
• feeling anxious, having difficulty sleeping and thinking, or being confused and losing memory;
• Feeling, seeing, or hearing things that do not exist. Having strange and frightening thoughts, changing your behavior, or feeling alone.

If you notice any of these problems, talk to a doctor immediately.

Other Side Effects You May Experience:

• allergic reaction;
• tiredness;
• increased number of white blood cells;
• blood clotting;
• nausea and vomiting;
• high blood pressure;
• heart problems, which can cause shortness of breath;
• convulsions;
• dizziness;
• headache;
• raised pressure in the brain (which can cause headaches, nausea, and vomiting);
• pressure on the nerve to the eye (sometimes in children after stopping treatment);
• worsening of schizophrenia;
• worsening of epilepsy;
• 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);
• bulging eyes;
• thinning of the skin;
• bruising;
• stretch marks;
• patches of skin reddening;
• itching;
• rash;
• hives;
• acne;
• extra hair growth;
• slow healing of wounds;
• increased sweating;
• hiding or altering reactions to skin tests, such as for tuberculosis;
• reduction of growth in babies, children, and adolescents;
• absence or irregularity of menstrual periods;
• the face becomes round;
• weight gain;
• carbohydrate imbalance in diabetes;
• euphoria (feeling high);
• feeling of dependency on treatment;
• depression;
• worsening of viral or fungal infections of the eye;
• risk of contracting infection is increased;
• existing infections can worsen;
• signs of infection can be masked;
• previous infections, such as tuberculosis (TB), may be re-activated (flare-up);
• muscle wasting of the upper arms and legs;
• muscle pain;
• brittle bone disease or wasting of the bones;
• bone fractures;
• tendon rupture;
• indigestion;
• feeling sick;
• stomach ulcers with bleeding or perforation;
• bloating;
• ulcers in the gullet (esophagus), which may cause discomfort in swallowing;
• candidiasis (thrush);
• abdominal (stomach) pain;
• increased appetite, which may result in weight gain;
• diarrhoea;
• water and salt retention;
• high blood pressure (hypertension);
• a change in the levels of some hormones, mineral balance, or protein in blood tests;
• inflammation of the pancreas.

If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Overdose

If you accidentally take too many Deltacortril tablets or someone else takes any of your medicine, you should tell your doctor immediately or contact your nearest accident and emergency department. Show any left-over medicines or the empty packet to the doctor.

If You Forget to Take Deltacortril

Do not worry. If you forget to take a dose, take it as soon as possible unless it is almost time to take the next dose. Do not take a double dose. Then go on as before.

Ask your doctor or pharmacist if you have any further questions about using this product.

How to Store Deltacortril

Keep out of the reach and sight of children.

Do not take Deltacortril after expiry, as stated on the packaging. The expiry date refers to the last day of that month.

Store below 25°C. Keep your medicine in a dry place.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help protect the environment.