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PREDNISOLONE ACETATE 25MG/ML SUSPENSION FOR INJECTION

Active substance(s): PREDNISOLONE ACETATE / PREDNISOLONE ACETATE

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22595244

Deltastab 25 mg/ml
Suspension for Injection

161

161

depression before while taking steroid medicines like
Deltastab Injection or if anyone in your family has suffered
from these illnesses;
• if you have TB (tuberculosis);
• if you have diabetes;
• if you have epilepsy;
• if you have an eye disease caused by a rise of pressure
within the eye (glaucoma);
• if you have osteoporosis (thinning of the bones);
• if you have muscle problems when steroids have been
taken before;
• if you have stomach ulcers;
• if you have high blood pressure or heart failure;
• if you have any liver or kidney problems;
• if you have an under-active thyroid (hypothyroidism);
• if you are elderly your doctor may need to monitor you
closely;
• if you are going to receive an organ transplant.
Contact your doctor if you experience blurred vision or other
visual disturbances.
If any of the above applies to you or you are not sure please
tell your doctor or nurse before you use this medicine.
Mental health problems while receiving prednisolone
Mental health problems can occur while being given 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 is given 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
happened when doses are being lowered or the medicine
stopped altogether.
Other medicines and Deltastab Injection
Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
This is especially important if you are taking:
• Some medicines may increase the effects of Deltastab
Injection and your doctor may wish to monitor you
carefully if you are taking these medicines (including some
medicines for HIV: ritonavir, cobicistat);
• Medicines for epilepsy such as carbamazepine,
phenobarbitone, phenytoin or primidone;
• Antibiotics such as rifampicin, rifabutin;
• Mifepristone (used to terminate pregnancy);
• Oral contraceptives;
• Somatropin (used to treat growth problems);
• Medicines for diabetes such as insulin, glibenclamide or
metformin;
• Medicines to treat high blood pressure, such as diuretics
(water tablets) like bendroflumethiazide and furosemide;
• Warfarin or other medicines used to thin the blood;
• Non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin;
• 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);
• Etoposide (used to treat cancer);
• Any medicine which belong to a group of medicines called
sympathomimetics.
• Medicines used to treat myasthenia gravis;
• Medicines used to make x-rays clearer;
• Ciclosporin (used to stop the body rejecting bone marrow
or organ transplants);
• Aminoglutethimide (used to treat Cushing's disease or
some breast cancers);
• Retinoids.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before you are given this medicine.
Driving and using machines
This medicine should not affect your ability to drive or use
machines.
Carrying a Steroid card
Your doctor or pharmacist will have given you a Steroid
Treatment Card with your prescription or medicine.

161

Prednisolone Acetate
Read all of this leaflet carefully before you start using
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 nurse.
• If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
See section 4.
The name of medicine is Deltastab 25 mg/ml Suspension
for Injection. It will be referred to as Deltastab Injection for
ease of use hereafter.
- Deltastab Injection 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 receiving this medicine without talking to
your doctor - you may need to reduce the dose gradually.
- Deltastab Injection can cause side effects in some
people (read section 4 below). Some problems such as
mood changes (feeling depressed or ‘high’) or stomach
problems can happen straight away. If you feel unwell in
any way, 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 this medicine for more than three 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 do come into contact with chickenpox
or shingles, 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 may be especially important for you.
Prednisolone - benefit information
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.
What is in this leaflet
1. What Deltastab Injection is and what it is used for
2. What you need to know before you are given Deltastab
Injection
3. How Deltastab Injection is given to you
4. Possible side effects
5. How to store Deltastab Injection
6. Contents of the pack and other information
1. WHAT DELTASTAB INJECTION IS AND WHAT IT IS USED
FOR
The name of your medicine is Deltastab Injection. Deltastab
Injection contains the active ingredient prednisolone acetate
which belongs to a group of medicines called corticosteroids
or ‘steroids’. Steroids work by reducing inflammation and
lowering the body’s immune response.
Deltastab Injection is used to treat adults. This medicine is
used to treat swollen, painful joints and tendons in conditions
such as arthritis, tennis elbow and golfer’s elbow.
Deltastab Injection can also be used to treat conditions such
as asthma, severe allergic reactions, ulcerative colitis and
Crohn’s disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
DELTASTAB INJECTION
Deltastab Injection is not suitable for use in children.
You should not be given Deltastab injection:
• if you are allergic to prednisolone or any of the other
ingredients of this medicine (listed in section 6) (allergic
reactions include mild symptoms such as itching and/or
rash. More severe symptoms include swelling of the face,
lips, tongue and/or throat with difficulty in swallowing or
breathing);
• if you just had a vaccination or have a vaccination planned;
• if you have a viral infection such as measles,
chickenpox or shingles or any other infection. Tell your
doctor immediately if you have come into contact with
anyone suffering with measles, chickenpox or shingles in
the last three months.
Warnings and precautions
Talk to your doctor or nurse before you are given Deltastab
Injection.
• if you have severe depression or manic-depressive
illness (bipolar disorder). This includes having had

YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must
be shown to any of the following persons:
Doctor or Nurse - before having any surgery or
emergency treatment or if any new
treatment is prescribed.
Dentist
- before having any dental surgery.
Pharmacist
- before buying any medicine.
Optician
- it is advisable to have regular eye
tests.
Deltastab Injection contains sodium and benzyl alcohol
Sodium- This medicinal product contains less than 1 mmol
(23 mg) sodium per dose, i.e. essentially ‘sodium-free’.
Benzyl alcohol- Must not be given to premature babies or
neonates. May cause toxic reactions and allergic reactions in
infants and children up to 3 years old.
3. HOW DELTASTAB INJECTION IS GIVEN TO YOU
This medicine will be given to you by a doctor or nurse. The
doctor will decide upon the most suitable dose for you, but
the recommended doses are:
Adults:
For joint injections: Between 5 mg and 25 mg depending on
the size of the joint. Not more than 3 joints will be treated in
one day. The injections may be repeated if needed.
For muscle (systemic) injections: Between 25 mg and 100 mg
once or twice a week, depending on your condition.
Elderly:
Your doctor will use the lowest dose for the shortest period of
time to treat your condition. This is important to reduce the
possible side effects.
Method of administration:
Deltastab Injection will be injected into or around a joint or
into a muscle, depending on the condition being treated.
If you think you have been given more Deltastab Injection
than you should have
Overdosing is unlikely. If it does happen the doctor will treat
any symptoms that follow.
If you stop taking Deltastab Injection
If treatment is stopped too quickly it can lead to severe
problems of the adrenal gland, low blood pressure and death.
You may also experience ‘withdrawal symptoms’ which
include fever, muscular pain, joint pain, runny nose, an eye
infection (conjunctivitis), painful itchy skin lumps, loss of
weight, increased pressure in the brain with headache and
vomiting, reappearance of your disease symptoms and
swelling eye nerve.
Children may also experience swelling of the nerves in the
eyes due to increase in pressure in and around the brain. The
normal growth of infants, children and adolescents can slow
down.
If you have any further questions on the use of this medicine,
ask your doctor or nurse.
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.
These are common in both adults and children. They can
affect about five in every 100 people taking medicines like
prednisolone.
• 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.
• 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
immediately.
If you notice:
• itching or skin rashes;
• swelling of the face, lips or throat;
• difficulty in breathing or wheeziness.
Tell your doctor immediately. These may be signs of an
allergic reaction.
If you are having injections into a joint, the most likely side
effect is increased pain and swelling after the injection. This
usually goes away after a few hours and you should rest the
joint as much as possible.
If you are having muscle (systemic) injections the steroid will
enter your system.
The side effects which can occur if steroids are given in high
doses for a long time are:
Not known: frequency cannot be estimated from the available
data
• generally feeling unwell;
• feeling sick (nausea);

• hiccups;
• indigestion or stomach discomfort;
• stomach ulcer (which can rupture and bleed) or ulcer in
the oesophagus (gullet);
• small bowel perforation;
• thrush;
• inflammation of the pancreas causing abdominal pain
(pancreatitis);
• muscle weakness;
• muscle pain;
• thinning of bones which makes fractures more likely
(osteoporosis);
• damage to tendons;
• joint stiffness causing limited motion, pain and muscle
spasms;
• fluid retention causing swelling;
• feeling dehydrated;
• high blood pressure;
• slow healing of wounds, thinning of the skin, bruising,
marks which look like stretch marks and acne;
• small red, purple or blue spots found along the surface of
the skin (caused by blood vessels under the skin);
• low adrenal gland function;
• irregular or stopped menstrual periods;
• swollen, round face (Cushingoid facies);
• excess hair growth;
• increased appetite and weight gain;
• intolerance to carbohydrates;
• mood changes, dependence, depression, difficulty
sleeping, worsening of schizophrenia;
• worsening of epilepsy;
• raised pressure in the eyes (glaucoma), cataracts, thinning
and inflammation of the cornea (part of the eye),
worsening of viral or fungal eye diseases and visual
impairment;
• heart attack;
• changes in body chemistry;
• an increase in the number of white blood cells in the
blood;
• formation of blood clots;
• Long term use of high dose steroids, may lead to a
weakening of the immune system, which can increase the
risk of malignancy;
• Blurred vision.
Kaposi’s sarcoma (a type of cancer) has also been reported to
occur in patients receiving corticosteroids. However, once the
treatment has been stopped, this may go away.
Injections like these 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.
Additional side effects in children and adolescents
• slowed growth in infants, children and teenagers;
• severe headaches with blurred vision or temporary visual
problems in children (usually after stopping treatment).
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. 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 DELTASTAB INJECTION
Keep this medicine out of the sight and reach of children.
Deltastab Injection ampoules will be stored at the healthcare
centre.
They should be stored at 15°C-25°C and kept in the carton in
order to protect from light.
The doctor or nurse will check that the expiry date on the
label has not passed before you are given the injection.
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 Deltastab Injection contains
- The active substance is Prednisolone Acetate. Each 1ml
Deltastab Injection ampoule contains 25 mg of the active
ingredient Prednisolone Acetate.
- The other ingredients are water for injections, sodium
chloride, benzyl alcohol, sodium carboxymethylcellulose,
polysorbate 80, with sodium hydroxide and/or
hydrochloric acid as pH adjusters.
What Deltastab Injection looks like and the contents of
the pack
Deltastab injection is a white or almost white suspension.
Deltastab injection is available in 1 ml clear glass ampoules.
It is available in packs containing 10 x 1 ml ampoules.
Marketing Authorisation Holder and Manufacturer:
Amdipharm UK Limited,
Capital House, 85 King William Street, London, EC4N 7BL,
United Kingdom
The information in this leaflet applies only to Deltastab
Injection (prednisolone acetate 25 mg/ml).
This leaflet was last revised in May 2017.

Version No.:
Product Name:

102412/LF/057/05

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Deltastab Injection
25 mg in 1 ml
100 Tablets
Leaflet
102412
UK
Haupt Pharma
1
18/05/2017
ADD
AMCo.CRF. 133.2013

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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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