B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Rindelt 2,5 mg tablets

Rindelt 5 mg tablets

Rindelt 10 mg tablets

Rindelt 20 mg tablets

Prednisolone

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

• Always take this medicine exactly as your doctor have told you.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Rindelt is and what it is used for

Rindelt belongs to a group of medicines called steroids (corticosteroids), which prevent and reduces allergic disease, inflammation in the body and rheumatic diseases.

Rindelt is used by a number of diseases, where reactions from the body should be reduced, e.g. rheumatoid arthritis. In other conditions, connective tissue diseases (SLE), inflammation in the blood vessels, changes in the connective tissue, asthma, serious inflammation in the colon (colitis ulcerous), certain blood diseases, serious allergic reactions and treatment of cancer.

Your doctor may have prescribed for another use. Always follow your doctor’s instructions.

2. What you need to know before you take Rindelt

Do not take Rindelt

- if you are allergic to prednisolone or any of the other ingredients in this medicine (listed in section 6).

- if you have an infection (including fungal infections) that affects the whole body, unless you are being treated for the infection.

- if you have an ulcer in your stomach (peptic ulcer) or digestive tract area (duodenal ulcer).

- if you need to have a vaccination with a ‘live virus’ vaccine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rindelt, especially if you have, have ever had suffered from:

• Infection;

• Severe depression or manic-depressive illness (bipolar disorder). This includes having had depression before or while taking steroid medicines like Rindelt);

• Stomach ulcer;

• Duodenal ulcer;

• Diabetes;

• Heart disease or recently suffered a heart attack;

• High blood pressure;

• Thinning of bones which makes fractures more likely (oesteoporosis);

• Newly established blood vessels or intestines;

• Suspected or identified tumor in your adrenal glands (pheochromocytoma);

• Epilepsy;

• An eye disease caused by a rise of pressure within the eye (glaucoma) or if any in your family suffered from glaucoma;

• Muscle problems when steroids were taken before;

• Renal failure;

• Any liver problem;

• An under-active thyroid (hypothyroidism);

• Tuberculosis and viral and fungal infections of the eye.

Take particular care to avoid exposure of chickenpox, measles or herpes when treated with Rindelt. And if exposed, seek medical advice urgently.

Contact your doctor in case you become ill or suffer an injury to see if there is the need to adjust the dose.

Mental health problems while taking prednisolone

Mental health problems can occur while taking steroids like prednisolone (see also section 4, ‘Possible side effects’).

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 problems do occur, they might need treatment.

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

Other medicines and Rindelt

Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

The treatment effect may be affected if this drug is taken simultaneously with:

- medicines to treat epilepsy (phenobarbital, phenytoin, primidone and carbamazepine),

-antibiotics (rifampicin and erythromycin),

- all vaccinations and immunisation (antibody formation),

- mifepristone (used to terminate pregnancy),

- ritonavir (used in HIV treatment),

- oral contraceptives,

- somatropin (used to treat growth problems),

- medicines for diabetes (insulin, glibenclamide or metformin),

- medicines used to treat high blood pressure, such as diuretics (water tablets) like bendroflumethiazide or furosemide,

- theophylline (used to treat asthma),

- medicines to treat fungal infections such as amphotericin, ketoconazole,

- acetazolamide (used to treat glaucoma),

- carbenoxolone (used to treat stomach ulcers),

- methotrexate (used for rheumatoid arthritis, psoriasis and certain types of cancer),

- any medicine which belongs to a group of medicines called sympathomimetics,

- medicines used to treat myastenia gravis,

- medicines used to make x-rays clearer,

Inform your doctor if you take medicines which influence the ability for your blood to coagulate, such as warfarin.

The risk of ulcers is increased if you are in concomitant treatment with so-called non-steroid anti-inflammatory drugs (NSAIDs) such as Aspirin and cortisone medicines.

Therefore, it is important that your doctor knows your entire consumption of medicine. This includes also medicines without prescription.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take Rindelt, if you are pregnant, it might harm your baby. You should not take Rindelt unless specifically advices by your doctor..

If you breast-feed your baby you should know that Rindelt passes to breast milk, but is not expected to harm the baby. Always seek advice with your doctor before taking Rindelt during breast-feeding.

Driving and using machines

Rindelt has no or negligible effect on your ability to use machines or drive.

Rindelt 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 Rindelt

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist, if you are not sure.

Your doctor decides your dose, which is adjusted specifically for you.

Usually the treatment is started with a high dose which is then reduced until a specific maintenance dose when the effect is satisfactory. When the treatment should end, the dose should be gradually reduced until it is eventually stopped.

Contact your doctor in cases of strain as fever or stress, where change in dose may be relevant.

If you take more Rindelt than you should

If you have taken more of this medicine than directed, or if a child accidentally has taken this medicine, please contact your doctor or emergency unit for judgement of the risk and advice.

If you forget to take Rindelt

Do not take a double dose to make up for a forgotten dose. Take the next dose as planned.

If you stop taking Rindelt

Rindelt is only prescribed to you if strictly necessary. Do not suddenly stop or make changes in your treatment unless advised by your doctor. It may harm you or result in worsening of your condition.

If you have stopped taking Rindelt, contact your doctor or nurse immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Steroids including prednisolone can cause severe mental health problems, such as those listed below. If you notice any of these problems talk to a doctor immediately:

• Feeling depressed, including thinking about suicide.

• Feeling high (mania) or having moods that go up and down.

• Feeling anxious, having problems sleeping, having difficulty in thinking or being confused and losing your memory.

• Feeling, seeing or hearing things which do not exist (hallucinations). Having strange and frightening thoughts, changing how you act or having feelings of being alone.

The following side effects may be signs of an allergic reaction. If you notice any of the below, stop taking Rindelt and tell your doctor immediately:

• Itching or skin rashes;

• Swelling of the face, lips or throat;

• Difficulty in breathing or wheeziness.

Side effects normally occur during long-term treatment, but is also depending on dose and individual sensitivity.

Common side effects (occur in more than 1 of 100 patients):

- Oedema in the body

- High blood pressure (hypertension)

- Influence on the hormone release from the adrenal cortex

- Thinning of skin

- Delayed wound healing

- Disturbances in the salt balance, as e.g. high sodium levels or too low levels of potassium

- Too high content of glucose in blood and urine

- Thinningof bones which makes fractures more likely (osteoporosis)

- Muscular atrophy

- Prednisolone can reduce the body’s ability to react against inflammations and infections, resulting in recurrence of infections and that local infections spreads. This medicine can make it easier for you to pick up infections which may very rarely be fatal. Infections such as chickenpox and measles can be made worse or TB (tuberculosis) may recur

- Growth inhibition in children

Less common side effects (occur in less than 1 of 100 patients):

- Glaucoma (increase eye pressure)

- Cataract (clouding of the eye lens)

- Elevated risk of blood clot

- Activation of mental disorders at high doses

Rare side effects (occur in less than 1 of 1000 patients):

- Benign increase of pressure in the skull

- Bone necrosis

- Tendon rupture

- Depression

- Mania

Side effects which frequency is not known:

The following side effects can occur if steroids are given in high doses for a long time:

• Generally feeling unwell

• Feeling sick (nausea)

• Hiccups

• Indigestion or stomach discomfort

• Stomach ulcer (which can rupture and bleed) or ulcer in the oesophagus (gullet)

• Thrush

• Inflammation of the pancreas causing abdominal pain (pancreatitis)

• Muscle weakness

• Muscle pain

• Damage to tendons

• Feeling dehydrated

• Bruising, acne, marks which look like stretch marks;

• Small red, purple or blue spots found along the surface of the skin (caused by blood vessels under the skin)

• Irregular or stopped menstrual periods

• Swollen round face (Cushingoid facies or moon-face)

• Excess hair growth

• Increased appetite and weight gain

• Intolerance to carbohydrates

• Mood changes, dependence, depression, difficulty sleeping, worsening of schizophrenia

• Severe headaches with blurred vision or temporary visual problems in children (usually after stopping treatment)

• Worsening of epilepsy

• Thinning and inflammation of the cornea (part of the eye), worsening of viral or fungal eye diseases and visual impairment

• Heart attack (sudden severe chest pains)

• Changes in body chemistry

• An increase in the number of white blood cells

• Long-term use of high dose steroids, may lead to a weakening of the immune system, which can increase the risk of your condition getting worse (malignancy).

Reporting of side effects

If you get any of the 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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Rindelt

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

Container: This medicinal product does not require any special storage conditions.

Blister pack: Do not store above 25ºC.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP (month/year). The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Rindelt contains

The active substance (the ingredient that makes the tablets work) is prednisolone.

Each tablet contains either 2,5 mg, 5 mg, 10 mg or 20 mg of prednisolone.

The other ingredients are: lactose, talc, magnesium stearate, potato starch and gelatin.

What Rindelt looks like and contents of the pack

Appearance

Rindelt 2,5 mg: white, round, biplane tablet, scored on one side.

Rindelt 5 mg: white, round, biplane tablet, scored on one side.

Rindelt 10 mg: white, round, biconvex tablet, scored on one side.

Rindelt 20 mg: white, round, biconvex tablet, scored on one side.

Tablets can be divided in two equal parts.

Pack sizes

Container or blister pack with 20 tablets.

Marketing Authorisation Holder and Manufacturer

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This leaflet was last revised in 2015-10-21