OKRIDO 6 MG / ML ORAL SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - OKRIDO 6 MG / ML ORAL SOLUTION

Okrido®

Active substance: prednisolone (as sodium phosphate)

Important information about this medicine

– Okrido® is a steroid medicine, prescribed for many different conditions including serious illnesses.
– You need to take it 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.
– Okrido® can cause side effects in some people (read section 4: Possible side effects). Some problems such as mood changes (feeling depressed, or ‘high’), or stomach problems can happen straight away. If you feel unwell, in any way, keep taking your medicine, but see your doctor straight away.
– Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information).
– If you take it for more than 3 weeks, in the UK, 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 chicken pox, shingles or measles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox, shingles or measles, see your doctor straight away.

Now read the rest of this leaflet.

It includes other important information on the safe and effective use of this medicine that might be especially important for you. 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 Okrido® is and what it is used for
2. What you need to know before you take Okrido®
3. How to take Okrido®
4. Possible side effects
5. How to store Okrido®
6. Contents of the pack and other information

1. what okrido® is and what it is used for

Okrido® is an oral solution containing prednisolone (as sodium phosphate). It 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 wellbeing. 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.

Okrido® can be used to treat:

allergies, severe allergic reactions (anaphylactic reactions) and bronchial asthma
diseases involving the blood, blood vessels and heart:
– haemolytic anaemia (autoimmune)
– some types of leukaemia
– malignant lymphoma (a cancer of the lymph nodes or tissues)
– multiple myeloma (a cancer of white blood cells)
– idiopathic thrombocytopenic purpura (red or purple discolorations on the skin)
– polymyositis (chronic inflammation of the muscles)
– arteritis (inflammation of the artery walls), e. g. giant cell arteritis, polyarteritis nodosa
– rheumatic fever with severe carditis (inflammation of the heart)

skin diseases:
– collagenosis (a type of connective tissue disease)
– systemic lupus erythematosus (autoimmune connective tissue disease)
– pemphigus vulgaris (skin disease with skin lesions)
– bullous pemphigoid (acute or chronic blistering skin disease)
– pyoderma gangrenosum (ulcerations of the skin)

diseases involving the lungs:
– worsening of chronic obstructive pulmonary disease (COPD, includes emphysema and chronic bronchitis)
– interstitial lung diseases such as acute alveolitis (inflammation of parts of the lung)
– pulmonary fibrosis (development of excess tissue in the lungs)
– long-term therapy of chronic forms of sarcoidosis stages II and III (chronic inflammation) with respiratory distress, cough and worsening of pulmonary function values
– prophylaxis of infant respiratory distress in premature babies
– severe forms of pollinosis and allergic rhinitis (allergic inflammation of the nasal airways)
– croup (inflammation of the upper airways)
– Quincke’s oedema (rapid swelling)
– Asthma

stomach and intestinal diseases:

– Crohn’s disease (a type of inflammatory bowel disease) – ulcerative colitis (a type of inflammatory bowel disease) – autoimmune chronic active hepatitis (inflammation of the liver)

diseases of the nervous system:
– myasthenia gravis (varying degrees of weakness of the skeletal muscles)
– chronic Guillain-Barre syndrome (a disorder affecting the peripheral nervous system)
– Tolosa-Hunt syndrome (headache associated with paralysis of muscles around the eye)
– polyneuropathy with monoclonal gammopathy
– subacute demyelinating polyneuropathy
– multiple sclerosis (disease that affects the brain and spinal cord)
– acute worsening of multiple sclerosis
– cerebral oedema (excess accumulation of fluid in the brain) as a result of cerebral metastases

systemic and immunological eye diseases
– damage to the optic nerve as a result of inflammation of the artery walls in the eye
– insufficient blood supply or injury
– Behcet’s disease (Silk Road disease)
– sarcoidosis (chronic inflammation)

kidney disorders:

– selected cases of nephrotic syndrome

rheumatic disorders
– rheumatoid arthritis
– polymyalgia rheumatica (pain or stiffness, usually in the neck, shoulders, and hips)
– juvenile chronic arthritis
– systemic lupus erythematosus (autoimmune connective tissue disease)
– dermatomyositis (inflammation of the muscles and the skin)
– polymyositis (chronic inflammation of the muscles)

toxic conditions associated with severe infectious diseases (in connection with antibiotics / chemotherapy):
– tuberculous meningitis (infection or irritation around the brain)
– severe form of progressive pulmonary tuberculosis

substitution therapy

– adrenal cortex insufficiency (a hormonal disorder) of any origin (e. g. Addison’s disease, congenital adrenal hyperplasia, adrenalectomy, ACTH deficiency) after the growing phase

others:
– hyperpyrexia (abnormally high fever)
– as an immunosuppressant in organ transplantations
– for the prevention of nausea and vomiting during certain types of cancer therapy
– multiple organ failures

Many different diseases may be improved by the careful use of medicines like Okrido®, which mainly work by reducing inflammation in the body. Ask your doctor if you are not sure why you are taking this oral solution.

2. what you need to know before you take okrido®

Do not take Okrido®

– if you are allergic to prednisolone sodium phosphate or any of the other ingredients of this medicine (listed in section 6).
– if you just have been immunised or a vaccination is planned. – if you have an infection that affects the whole body (e. g.

measles, chickenpox, herpes simplex oculi, shingles or tropical worm infections).

– if you have a duodenal or stomach (peptic) ulcer.

Warnings and precautions

Talk to 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 Okrido®.
– if any of your close family has had these illnesses.

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

Talk to your doctor or pharmacist before taking Okrido®

– if you have kidney or liver problems.
– if you have high blood pressure or heart disease.
– if you have diabetes or there is a family history of diabetes.
– if you have thinning of the bones (osteoporosis), particularly if you are a female who has been through the menopause.
– if you have had muscle weakness with this or other steroids in the past.
– if you have raised eye pressure (glaucoma) or there is a family history of glaucoma.
– if you have mental problems or you have had a mental illness which was made worse by this type of medicine such as ‘steroid psychosis’.
– if you have epilepsy.
– if you have an underactive thyroid gland.
– if you have an infection with parasites, e. g. tropical worms. – if you have tuberculosis (TB).
– if you have Scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg 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.

Mental problems while taking Okrido®

Mental health problems can happen while taking steroids like Okrido® (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 may be 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 and when doses are being lowered or stopped. In a few cases, mental problems have happened during this time.

If you develop an infection while you are taking this medicine, you should talk to your doctor. Keep away from people who have chicken pox, shingles or measles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox, shingles or measles, see your doctor straight away.

Contact your doctor if you experience blurred vision or other visual disturbances.

Please tell any doctor, dentist or person who may be giving you treatment that you are currently taking steroids or have taken them in the past. If you take it for more than 3 weeks, in the UK, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you.

Elderly

Plasma prednisolone concentrations are higher in elderly patients. Therefore, in old age common adverse effects of steroids may lead to more serious consequences, especially thinning of the bones (osteoporosis), high blood pressure (hypertension), low potassium content of the blood (hypopo-tassaemia), diabetes, susceptibility to infection and thinning of the skin. Regular check-ups at the doctor of elderly patients should be undertaken to minimize complications.

Children

If Okrido® is prescribed for a child, make sure the oral solution is taken as your doctor or this patient information says. High doses taken for a long time can stunt growth in children.

Other medicines and Okrido®

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

The effectiveness of certain treatments may be affected by combination of medicines.

Tell your doctor if you are taking:

– some antiepileptic drugs (carbamazepine, phenobarbitone, phenytoin or primidone),
– some antibiotics (fluoroquinolones, rifampicin, rifabutin or erythromycin),
– active ingredient in cough and cold remedies (ephedrine), – anticoagulants (e. g. warfarin, coumarine),
– aminoglutethimide (which reduces natural steroids in the body),
– treatments for diabetes (e. g. insulin, glibenclamide, metformin),
– acetazolamide (used for certain eye conditions),
– diuretics such as bendrofluazide and furosemide (used to treat high blood pressure, heart failure, water retention and swelling),
– other medicines used to treat high blood pressure,
– cardiac glycosides such as digoxin (used to treat heart failure and irregular heart beat),
– non-steroidal anti-inflammatory drugs such as ibuprofen, ketoprofen and diclofenac, long-term treatment with aspirin or other salicylates,
– oestrogens (found in contraceptive pills, hormone replacement therapy (HRT), and certain cancer treatments),
– anti fungal treatments (amphotericin or ketoconazole),
– somatropin (used to promote growth),
– theophylline (used to treat asthma and bronchitis),
– high doses of antiasthmatic drugs and drugs against other breathing problems: bambuterol, fenoterol, formoterol, salbutamol, salmeterol and terbutaline,
– ritodrine (used for premature labour),
– carbenoxolone (used to treat oesophageal ulceration),
– ritonavir (used to treat viral infections),
– ciclosporin (used to help the body accept bone marrow or organ transplants),
– anticholinesterases (drugs used to treat the condition myasthenia gravis),
– methotrexate (used for rheumatoid arthritis, psoriasis and certain types of cancer),
– mifepristone (used to terminate pregnancy),
– live vaccines,
– fluoroquinolone.

Note that these statements may also apply to products used some time ago or at some time in the future. Some medicines may increase the effects of Okrido® and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

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.

If steroids are taken for long periods of time or repeatedly during pregnancy, there may be an increased risk of the baby growing more slowly while in the mother’s womb. However, there are certain clinical situations where it would be more risky to the mother and child to stop taking Okrido® than carrying on taking them. Your doctor will advise you if you are pregnant or planning to become pregnant.

Breast-feeding: Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No effects are known.

Okrido® contains sorbitol (E 420)

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

Okrido® contains sodium

This medicine contains sodium. This should be taken into consideration by patients on a controlled sodium diet.

3. how to take okrido®

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

Acute or severe disease may require initial high dose therapy and, for an adult, can vary between 5 mg and 100 mg daily. The dose may be taken in portions over the day. The dose will be reduced to the lowest effective dose as soon as possible.

For some patients, a single dose taken on alternate days or even longer intervals may be preferable to a single daily dose.

The dose should not be reduced by more than 5 – 7.5 mg daily during chronic treatment.

If Okrido® is taken for a long period, the dose may be increased temporarily during periods of stress or if disease worsens.

The recommended dose is:

– for allergies and skin disorders, the usual starting dose is 5 to 15 mg daily.
– for collagenosis, the usual starting dose is 20 to 30 mg daily. If you have more severe symptoms, you may require higher doses.
– for rheumatoid arthritis, the usual starting dose is 10 to 15 mg daily. Your dose may be lowered later to a level that maintains tolerable symptomatic relief of your arthritis.
– for blood disorders and lymphoma, a starting daily dose of 15–60 mg is often necessary. The dose is usually reduced after you have shown adequate clinical or haematological response. Higher doses may be necessary to induce remission in acute leukaemia.

Please remember: Okrido® helps to reduce and alleviate the symptoms of your disease, but does not cure your disease.

Use in children and adolescents

The following are recommended dose reductions for children and adolescents. The final dose is determined by the child’s response to the medicine, just as in adults.

Treatment should be kept as short as possible and with the lowest dose possible. If possible, the treatment should be given on alternate days as single dose.

1 to 6-year olds – one quarter of the adult dose
7 to 11-year olds – one-half of the adult dose
12 to 17-year olds – three quarters of the adult dose

Method of administration

For oral use.

– If you are not sure how much medicine you should take and when to take it, ask your doctor or pharmacist.
– The oral solution is best taken undiluted.
– Shake well before use.
– If you are on long-term therapy make sure your supply of oral solution does not run out.
– Take your Okrido® as a single dose each morning, unless your doctor has advised you otherwise.

If you have the impression that the effect of Okrido® is too strong or too weak, talk to your doctor or pharmacist.

If you take more Okrido® than you should

If you may have taken more Okrido® than you should, talk to a doctor or pharmacist or go to the casualty department of your nearest hospital immediately.

It is very important to stick to the dose on the label of your medicine. Taking more than this could be dangerous, especially if a great amount of the oral solution is taken at one time.

If you forget to take Okrido®

Do not take a double dose to make up for a forgotten dose. If you forgot to take a dose, it is important to take another as soon as possible. However, if it is nearly time for the next dose, skip the missed dose. Then go on as before.

If you stop taking Okrido®

Do not suddenly stop taking your oral solution unless you have been told to do so by your doctor, as it can make you ill. When your doctor stops your steroid therapy, your doctor may choose to do this by lowering your dose gradually over a period of time

– if you have been taking any steroids (this includes tablets, oral solutions or injections) for longer than 3 weeks.
– if you have taken repeated courses of any steroids.
– if you have stopped long term therapy of any steroids in the last 12 months.
– if you have a hormonal imbalance which causes a condition known as adrenocortical insufficiency. If you are unsure, ask your doctor.
– if you have been taking high daily doses of steroids e. g. more than 40 mg of Okrido®.
– if you have usually been taking a steroid dose in the evening. You may also experience ‘withdrawal symptoms’ which include fever, muscular pain, weakness, joint pain, runny nose, an eye infection (conjunctivitis), painful itchy skin lumps, loss of weight, mental changes, mood changes, feeling sick and/or being sick, low blood pressure, feeling faint, headache, dizziness and reappearance of your disease symptoms.

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.

Most people taking this oral solution find it causes no problems if taken at the lowest effective dose for the shortest possible time.

If you get any of the following side effects, tell a doctor straight away.

Steroids including Okrido® 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 Okrido®.

– 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 that 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.

The following may be signs of an allergic reaction. Tell your doctor immediately, or go to the casualty department at your nearest hospital, if you notice

– any kind of skin rash or itching of the skin,
– difficulty in breathing or collapse.

If you get any of the following side effects see your doctor as soon as possible:

– Stomach and intestinal problems: ulcers in the throat, stomach ulcers, which may perforate or bleed, indigestion, feeling sick (nausea) or being sick (vomiting), a swollen stomach, having more of an appetite than usual, hiccups, diarrhoea, candidiasis.
– Inflamed pancreas: this may cause severe pain in the back or abdomen.
– Problems with salts in your blood such as too much sodium or low potassium or calcium. You may have water retention.
– Heart and blood problems: high blood pressure, blood clots, problems with the muscles in your heart after a recent heart attack, increase in white blood cell count.
– Bone problems: thinning of the bones (osteoporosis) with an increased risk of fractures, bone disease, tendon rupture and muscle weakness.
– Recurring infections that get worse each time such as thrush. Also chicken pox and tuberculosis.
– Skin problems: wounds that heal more slowly, bruising, acne.
– Eye problems: increased pressure in the eye including glaucoma, eye disorders such as cataracts, eye infections.
– Hormone problems: irregular or missing periods, stunted growth in children and teenagers, swelling of the face (called ‘Cushingoid’ or ‘moon’ face), it may affect your diabetes and you may notice you start needing higher doses of the medicine you take for diabetes, your body may not be able to respond normally to severe stress such as accidents, surgery or illness, growth of extra body hair (particularly in women), increased appetite or weight gain.
– Nervous system problems: fits or epilepsy may become worse, severe unusual headache with visual problems, inability to sleep, feeling depressed, extreme mood swings, schizophrenia has become worse, headache or problems with your vision (including eye pain or swelling).
– General problems: may make you feel generally unwell or tired.
– Corticoids in general may precipitate porphyria.
– One case of a reversible Steven-Johnson-Syndrome was reported.
– If you stop taking Okrido® you may experience ‘withdrawal symptoms’ (see section 3 “If you stop taking Okrido®”).

Frequency unknown:

– Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.
– Blurred vision

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. 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 Yellow Card Scheme. Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store okrido®

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

A child may be harmed by medicine prescribed for someone else.

Do not store above 25 °C. Store in the original package. Do not refrigerate.

Do not use this medicine after the expiry date which is stated on the carton and label after “Expiry date”. The expiry date refers to the last day of the 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.

What to do with unused oral solution

One bottle Okrido® is intended for single use only. Return unused oral solution to a pharmacist for safe disposal.

6. contents of the pack and other information

What Okrido® contains

– The active substance is prednisolone (as sodium phosphate). 1 ml of oral solution contains 6 mg prednisolone (as sodium phosphate).
– Other ingredients are: Sorbitol, liquid (non-crystallising), E 420; glycerol (85 %); acesulfame potassium; disodium edetate; sodium dihydrogen phosphate dihydrate; sodium hydroxide; water, purified; cherry flavour.