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ADCORTYL INTRA-ARTICULAR/INTRADERMAL INJECTION 10MG/ML

Active substance(s): TRIAMCINOLONE ACETONIDE

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1041116B1

PATIENT INFORMATION LEAFLET
TM

ADCORTYL

INTRA-ARTICULAR / INTRADERMAL INJECTION 10 mg/ml
Triamcinolone acetonide
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
pharmacist.
- 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.
• Adcortyl IA/ID 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 using this medicine without talking to your
doctor – you may need to reduce the dose gradually.
• Adcortyl IA/ID 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, keep
using 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 are given this medicines for more than 3 weeks,
you will be given 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.
What is in this leaflet
1. What Adcortyl IA/ID Injection is and what it is used for
2. What you need to know before you are given Adcortyl IA/ID Injection
3. Receiving Adcortyl IA/ID Injection
4. Possible side effects
5. How to store Adcortyl IA/ID Injection
6. Content of the pack and other information
1. WHAT ADCORTYL IA/ID INJECTION IS AND WHAT IT IS USED FOR
The name of this medicine is Adcortyl IA/ID Injection. Each injection contains
triamcinolone acetonide 10 mg/ml as the active ingredient. Triamcinolone
acetonide belongs to a group of medicines called corticosteroids (steroids).
These corticosteroids occur naturally in the body, and help to maintain
health and well-being. Boosting your body with extra corticosteroid (such as
Adcortyl IA/ID Injection) is an effective way to treat various illnesses involving
inflammation in the body. Adcortyl IA/ID Injection reduces this inflammation,
which could otherwise go on making your condition worse. You must take this
medicine regularly to get maximum benefit from it.
Adcortyl IA/ID Injection is for the treatment of joint pain, swelling and stiffness
in inflammatory disorders such as rheumatoid arthritis.
It is also used to treat various forms of allergic dermatitis, skin overgrowths
such as thickened scar tissue, and patchy baldness, which is usually reversible.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADCORTYL IA/ID
INJECTION
Do not receive Adcortyl IA/ID Injection if;
• You have had an allergic reaction to a similar medicine or any of the
ingredients in this medicine
• You are suffering from an infection unless your doctor has also prescribed a
treatment for the infection.
Adcortyl IA/ID Injection is not recommended for children under 6 years.
You must tell your doctor if you:
• have had any recent infection (including tuberculosis (TB))
• have had recent bowel surgery
• have, or have had a bowel disorder or stomach ulcer
• have an infection or inflammation of the veins in your legs
• have had any mental health disorders or epilepsy
• have had any kidney, liver or thyroid problems as the dose of Adcortyl may
need to be adjusted
• have recently suffered from any form of cancer
• have thin or brittle bones (osteoporosis)
• have myasthenia gravis (a disease which causes weak muscles)
• have high blood pressure or heart failure
• or someone in your family has glaucoma (increased pressure in your eyes).
• are diabetic as your insulin dose may need to be changed
Check with your doctor first:
• If you have ever had severe depression or manic-depression (bipolar
disorder). This includes having had depression before or while taking steroid
medicines like Adcortyl IA/ID Injection.
• If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before Adcortyl IA/ID
Injection is given to you.
Caution is advised in taking triamcinolone acetonide (Adcortyl IA/ID Injection)
and medicines to control HIV (anti-retrovirals) or fungal infections (anti-fungals)
because you could experience more adverse effects. Refer to list of medicines
mentioned in “Taking other medicines with Adcortyl IA/ID Injection.”
Steroid medicines suppress your body’s natural immune response. Therefore,
if you come into contact with anyone who has an infectious disease such as
chickenpox, shingles or measles, consult your doctor as soon as possible.
While you are being treated with this medicine (or if you have recently stopped
a course of treatment) do not have any vaccination without consulting your
doctor first.
You must take care not to over-use a joint which feels better after you receive
Adcortyl IA/ID Injection. The joint will still need to recover from the inflammation
which caused your symptoms.
Taking other medicines with Adcortyl IA/ID Injection
Always tell your doctor about any medicines you are taking, or have recently
taken, including those obtained without a prescription.
This is especially important if you are taking:
– Aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
as corticosteroids can increase the chance of bleeding from the gut.
– Anti-retroviral inhibitors and anti-fungals: Caution is advised in
co-administration of ritonavir, atazanavir, clarithromycin, indinavir,
itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, and
telithromycin with triamcinolone because increased adverse effects may
occur, resulting in systemic corticosteroid effects including Cushing’s
syndrome and adrenal suppression
– Warfarin or other medicines to thin the blood
– Oral contraceptive pill or hormone replacement therapy (HRT)
– Human growth hormone
– A medicine called ciclosporin
– A medicine called rifampicin or medicines to treat;
– High blood pressure or irregular heart beat (e.g. digoxin)
– Myasthenia gravis (a disease which causes weak muscles)
– Epilepsy or fits (e.g. phenytoin)
– Tuberculosis (TB)
– Diabetes
– Thyroid problems
If you are taking any of these medicines, or are not sure, please consult your
doctor.
If you are due to have surgery
Before surgery and anaesthesia (even at the dentist) you should tell the doctor
or dentist that you are being treated with Adcortyl IA/ID injection.
Pregnancy and breastfeeding
If you are pregnant, planning to become pregnant, or if you are breastfeeding
you should discuss this with your doctor as soon as possible before receiving
Adcortyl IA/ID Injection.
Driving and using machines
This medicine does not usually affect your ability to drive or operate machinery
but it can affect your eyesight. Tell your doctor immediately if you have any
pain in the eyes or problems with your vision.
Steroid Treatment Card
Your doctor or pharmacist will have given you a Steroid Treatment Card with
your prescription or medicine.
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
Important information about the ingredients of Adcortyl IA/ID Injection
Adcortyl IA/ID Injection contains 15 mg/ml benzyl alcohol which may cause
harmful or allergic reactions in infants and children. Adcortyl IA/ID injection
must not be given to premature or newly born babies.
3. RECEIVING ADCORTYL IA/ID INJECTION
The effect of the injection will vary from patient to patient and further injections
may be given to you when symptoms return and not at regular intervals.
Use in inflammatory joint disorders:
The dose of injection to be given into a joint or tendon sheath depends upon
the size of the joint to be treated and the severity of the condition which is
being treated. Doses of 2.5 - 5 mg (0.25-0.5 ml) for smaller joints and 5-15 mg
(0.5-1.5 ml) for larger joints usually give relief of symptoms. This medicine
should not be used for injection into the Achilles tendon.
Use in allergic dermatitis:
The dose is usually 2-3 mg (0.2-0.3 ml) depending on the size of the problem
area of the skin but no more than 5 mg (0.5 ml) should be injected at any one
site. If several sites are injected the total dose given should not exceed 30 mg
(3 ml). Further doses may be given if necessary at one or two week intervals.
Your doctor will advise you whether it is wise for you to have further injections.
Treatment with steroids is usually kept as short as possible and must not be
stopped abruptly. Joints may become permanently damaged by repeated
injections over a long period of time.
When the treatment is stopped you may notice flu-like symptoms, runny nose
or itchy eyes or skin.
During times of illness or stress, patients on long-term treatment may require
the addition of oral steroid tablets or, if they have recently finished a course
of Adcortyl IA/ID injections, may need to start taking oral steroid tablets for a
while.
Mental health problems while Adcortyl IA/ID injection is given to you
Mental health problems can happen while taking steroids like Adcortyl IA/ID
Injection (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 who has been given this medicine), shows
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 stopped.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Serious effects: tell a doctor straight away
Steroids including Adcortyl IA/ID injection can cause serious mental health
problems. These are uncommon in both adults and children.
• Mood changes, mental health disorders, feeling dependent on the medicine,
trouble sleeping, fits or epilepsy, fainting and dizziness
• Feeling depressed, including thinking about suicide
• Feeling high (euphoria and mania) or moods that go up and down
• Feeling anxious/irritable, 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 the following side effects talk to a doctor straight away.
Serious cases of anaphylactic reactions (i.e. a serious allergic reaction) and
anaphylactic shock including death have been reported. If you notice any of
the following, contact your doctor immediately:
- Swelling of the face, lips or throat
- Breathing difficulties
- Skin itching, redness or a rash
As these may be signs of an allergic reaction.
Common: may affect up to 1 in 10 people
- Increased risk of infection
- Injection site reactions
- Headache
- Joint pain
Uncommon: may affect up to 1 in 100 people
- Changes in blood chemicals which can cause fluid retention
- Heart failure or irregular heart beat
- Weak or fragile bones or muscles, poor healing of broken bones or
destruction of the ends of bones, decrease in muscle mass, muscle or bone
pain, muscular weakness/discomfort, bone fracture
- Loss of bone tissue (osteoporosis)
- Thin/fragile skin, rashes, stretch marks, bruising, sweating, flushing and
increased hair growth, itchy bumps, loss/darkening of skin colour
- Indigestion, stomach pain, stomach ulcers and perforation, bloating, increased
appetite and weight loss, inflammation of the pancreas/oesophagus,
stomach bleeding
- Eye problems including inflammation, glaucoma and cataracts, blindness,
bulging of the eye, damage to the cornea or white of eye
- Infection of the nose
- Irregular periods/ postmenopausal women may also experience vaginal
bleeding
- Fungal or Viral eye infections
- Yeast infections e.g. thrush
- Tiredness and tingling, increased pressure in the brain
- Increased appetite
- Weight loss
- Less tolerance to carbohydrates
- Mild form of diabetes with no obvious symptoms
- Inadequately controlled diabetes mellitus, high blood sugar
- Pain, swelling and worsening of the pain in the injected joint
- Impaired healing
- High body temperature
- Treatment with steroids can stop the body from producing some hormones
and may slow or stop children’s growth.
- Hormone production by certain glands may be increased or decreased
- Vertigo
- High/low blood pressure
- Abnormal blood clots
- Longstanding chronic infections such as tuberculosis could be made worse
Reporting of side effects
If you get any 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 via the Yellow Card Scheme at: 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 ADCORTYL IA/ID INJECTION
Keep this medicine out of the sight and reach of children.
Adcortyl IA/ID injection will be kept in the pharmacy until it is given to you by
your doctor or nurse.
It should not be used after the expiry date shown on the label and carton.
It should not be stored above 25°C nor should it be allowed to freeze.
The container should be kept in the outer carton.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Adcortyl IA/ID injection contains
The active substance is triamcinolone acetonide 10 mg/ml. The other
ingredients are; benzyl alcohol, polysorbate 80, carmellose sodium, sodium
chloride and water for injection.
What Adcortyl IA/ID injection looks like and contents of the pack
Adcortyl IA/ID injection is a sterile aqueous suspension for injection and is
supplied in packs of 5 x 1.0 ml glass ampoules or a single 5 ml glass vial.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
E. R. Squibb & Sons Limited,
Uxbridge Business Park,
Sanderson Road,
Uxbridge,
Middlesex UB8 1DH
Tel.: 0800 7311736
Manufacturer
Bristol-Myers Squibb Srl,
Contrada Fontana del Ceraso,
03012 Anagni (FR),
Italy
This leaflet was last revised in April 2016
1041116B1

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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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