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OKRIDO 6MG/ML ORAL SOLUTION

Active substance(s): PREDNISOLONE SODIUM PHOSPHATE

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Druckfarbe: schwarz

Okrido

®

Falz

Package leaflet: Information for the user

6 mg/ml oral solution

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 con­
dition 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
d­ isease)
– 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-Barré 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
s­ pinal 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
– Behçet’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

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– 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 grow­
ing 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 inflam­
mation 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).
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.
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®
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicine.
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, met­
formin),
– 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),
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– 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. Tell your doctor or
­pharmacist if you are taking, or have recently taken, any other
medicine; including medicines obtained without a 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.
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 intole­
rance 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

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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 p­ roblems
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®”).
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: www.mhra.gov.uk/yellowcard. 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 phos­
phate). 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.
What Okrido® looks like and contents of the pack
Okrido® is a colourless, transparent, homogeneous and syrupy
solution. It is available in brown bottles closed with a white
­child-proof screw cap and containing 10 or 20 ml oral solution.
Marketing Authorisation Holder and Manufacturer
Pharmapol Arzneimittelvertrieb-GmbH
Kaddenbusch 11
25578 Dägeling
Phone: +49 48 21 90 06 06 01
Facsimile: +49 48 21 90 06 06 02
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything,
ask your doctor or pharmacist who has the information you
need and will advise you.
You may be able to find out more about prescribed medicines
from books in public libraries.
The information provided applies only to Okrido®.
This leaflet was last revised in May 2015
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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