PREDNISOLONE 5 MG GASTRO-RESISTANT TABLETS, DELTACORTRIL 5 MG GASTRO-RESISTANT TABLETS - patient leaflet, side effects, dosage

Now read the rest of this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Prednisolone is and what it is used for

• 2. What you need to know before you take Prednisolone

• 3. How to take Prednisolone

• 4. Possible side effects

• 5. How to store Prednisolone

• 6. Contents of the pack and other information

1. what prednisolone is and what it is used for

Prednisolone 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 corticosteroid (such as prednisolone) is an effective way to treat various illnesses involving inflammation in the body. Prednisolone reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

Prednisolone 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 leukaemia, lymphoma and myeloma
• to prevent organ rejection after a transplant.

Also:

• to boost steroid levels when the body is not making enough natural steroid on its own.
• to treat high calcium levels.

2. what you need to know before you take prednisolone

Check with your doctor first

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

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

Do not take Prednisolone if you:

• are allergic to prednisolone or any of the other ingredients of this medicine (listed in section 6)
• are suffering from a serious infection which is not being treated
• are suffering from a herpes infection of the eye
• are suffering from galactose or lactose intolerance or glucose-galactose malabsorption.

Warnings and precautions

Before you take prednisolone 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
• suffer from diabetes or diabetes runs in your family
• have osteoporosis (thinning of the bone), particularly if you are past the menopause (the change of life).
• are going through, or are past the menopause
• suffer from epilepsy (fits)
• suffer from stomach ulcers
• have taken prednisolone (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 which 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
• have inflammatory bowel disease such as Crohn’s disease
• have an eye disease caused by fluid build-up at the back of the eye that causes visual impairment
• are undergoing immunosuppression therapy for example in the treatment of cancer.
• have scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.

Children and adolescents

The use of steroids can slow down normal growth of children and adolescents. Your doctor may need to stop treatment or adjust the dose for your child accordingly.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take prednisolone.

Other medicines and Prednisolone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines as they may affect, or be affected by prednisolone:

Prednisolone with food and drink

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

Avoid eating liquorice whilst taking Prednisolone.

Pregnancy and breast-feeding

If you are pregnant or trying to become 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 prednisolone do not drive or operate machinery until these effects have worn off.

Prednisolone contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take prednisolone

Always take Prednisolone exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Different illnesses require different doses of prednisolone. Depending on your illness your daily dose may be between 5 and 60 mg. In some cases you may be instructed to take it every other day. Your doctor will decide when and how to treat you with prednisolone.

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.

Stopping taking Prednisolone: It is important 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, loss of weight.

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 side effects can be more serious especially brittle bone disease, diabetes, high blood pressure, infections and thinning of the skin.

Whilst you are taking Prednisolone, if any of the following occur tell your doctor straight away:

• Infections: If you think you might have an infection. You are more likely to develop illnesses due to infection whilst you are taking prednisolone. Also any existing infections may become worse. This is especially so during periods of stress. Certain infections can be serious if not controlled.
• Chicken-pox and Shingles: If you, anyone in your family or regular contacts catches chicken-pox or shingles. This is because you may become very ill if you get chicken-pox whilst taking prednisolone. You should avoid contact with people who have chicken-pox or shingles whilst taking prednisolone and for up to 3 months after you have stopped taking prednisolone. Do not stop taking prednisolone.
• Measles: If you, anyone in your family or regular contacts catches measles. You should 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 is giving you treatment such as a doctor, nurse or dentist.

Mental problems while taking Prednisolone

Mental health problems can happen while taking steroids like prednisolone (see also Section 4 Possible side effects).

• These illnesses can be serious.
• 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 problems do happen they might need treatment.

Talk to a doctor if you (or someone taking this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

What to do if you take more Prednisolone than you should

If you accidentally take too many prednisolone tablets or someone else takes any of your medicine, you should tell your doctor at once 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 Prednisolone

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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Do not worry. Like all medicines, prednisolone can cause side effects, although not everyone gets them.

Stop taking Prednisolone and contact your doctor straight away if the following allergic reaction happens:

• Puffy, swollen face, tongue or body, which may cause shortness of breath, shock and collapse.

Serious effects: tell a doctor straight away

• inflammation of the pancreas (very severe abdominal pains)
• painful skin ulcers

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.

• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Other side effects you may experience:

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store prednisolone

Keep this medicine out of the sight and reach of children.

Do not take Prednisolone after the expiry date which is 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 on how to dispose of medicines no longer required. These measures will help protect the environment.

6. contents of the pack and other information

What Prednisolone contains

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), polydimethylsi­loxane, polyethylene glycol sorbitan tristearate, silica gel, polyethylene glycol stearate, benzoic acid (E210), sulfuric acid, 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 Prednisolone 5 mg tablet also contains carmine (E120) and indigo carmine aluminium lake (E132).

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

What Prednisolone looks like and contents of the pack

Prednisolone tablets come in two strengths.

Prednisolone 2.5 mg is a brown tablet.

Prednisolone 5 mg is a maroon tablet.

They are gastro-resistant tablets.

Prednisolone tablets come in packs of 30 or 100 tablets.

Marketing Authorisation Holder and Manufacturer

The product licence holder is: Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland.

Prednisolone is manufactured by: Piramal Healthcare UK Limited, Whalton Road, Morpeth, Northumberland, NE61 3YA, UK.

The information in this leaflet applies only to prednisolone. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.

This leaflet was last revised in June 2020.

Prednisolone gastro-resistant tablets PIL UK 013