Depo-Medrone 40 mg/ ml Suspension for Injection 2 ml vial

Main information

  • Trade name:
  • Depo-Medrone 40 mg/ ml Suspension for Injection 2 ml vial
  • Dosage:
  • 40 milligram(s)/ millilitre
  • Pharmaceutical form:
  • Suspension for injection
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Depo-Medrone 40 mg/ml Suspension for Injection 2 ml vial
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Glucocorticoids; methylprednisolone

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Marketed
  • Authorization number:
  • PA0822/122/002
  • Authorization date:
  • 01-04-1978
  • Last update:
  • 21-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PAA122365

370644

Puurs

8 pt

Ireland

Leaflet

PAA122365

I091/A

600 x 214 mm

I-DEPO-MEDRONE 40MG/ML V

PAR-2019-0000542

Profile

Black

18:56

Barcode Nº

Datamatrix Code

Supplier Nº

Date:

30 Jan 2019

Time:

Perigord Nº

Supplier

Smallest

BODY TEXT

Size

Market

Proof Nº

Component

Drawing Nº

Dimensions

Material Name

PAR Number

Colours

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Non-Printing

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Read all of this leaflet carefully before

you start taking this medicine because

it contains important information for you

Depo-Medrone 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.

Depo-Medrone 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 Depo-Medrone,

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 round face

(read section 4. Possible side effects for more

information).

If you take it for more than 3 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 might be

especially important 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.

What is in this leaflet

1. What Depo-Medrone is and what it is used for

What you need to know before you take Depo-

Medrone

3. How to take Depo-Medrone

4. Possible side effects

5. How to store Depo-Medrone

Contents of the pack and other information

1. What Depo-Medrone is

and what it is used for

Depo-Medrone contains methylprednisolone

acetate.

Methylprednisolone 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 Depo-Medrone, is an

effective way to treat various illnesses involving

inflammation in the body. Depo-Medrone reduces

this inflammation, which could otherwise go on

making your condition worse. You must take this

medicine regularly to get maximum benefit from it.

Depo-Medrone can help when injected into

the body by a doctor or nurse, such as in or

near a joint, to treat local symptoms caused by

inflammatory or rheumatic conditions such as:

Bursitis: inflammation in the fluid containing

spaces around the shoulder, knee and/or elbow

joints. For this condition this medicine will be

injected directly into one or more of these spaces.

Osteoarthritis and rheumatoid arthritis:

inflammation located in between the joints. For

these conditions this medicine will be injected

directly into one or more joint spaces.

Skin problems: such as alopecia areata

(patchy baldness), keloids (scar tissue), lichen

planus or simplex (small, purplish raised patches

of skin or spots), discoid lupus (round-shaped

patches, often on the face) or granuloma

annulare (circular warty growths).

Epicondylitis and tenosynovitis: Tennis

elbow (epicondylitis) or a tendon’s covering

sheath (tenosynovitis). For these conditions this

medicine will be injected into the tendon or the

tendon sheath.

Alternatively this medicine may be injected into

a muscle to help treat more general (systemic)

problems affecting the whole body (e.g. symptoms

caused by a hypersensitivity to a medicine) or

allergic, inflammatory or rheumatic problems

affecting the:

brain e.g. meningitis caused by tuberculosis

bowel and gut e.g. Crohn’s disease

(inflammation of the gut) or ulcerative colitis

(inflammation of the lower bowel)

joints e.g. rheumatoid arthritis

lungs e.g. asthma, severe hay fever or

rhinitis, tuberculosis or inflammation caused

by breathing in (aspirating) vomit or stomach

contents

skin e.g. Stevens-Johnson syndrome (an

autoimmune disorder in which an immune

system causes the skin to blister and peel)

or systemic lupus erythematosus (lupus), an

autoimmune disorder which causes a rash

with fever, arthritis, inflammation of the blood

vessels, kidney problems and problems affecting

the brain.

Your doctor may use this medicine to treat

conditions other than those listed above. Ask your

doctor if you are unsure why you have been given

this medicine.

2. What you need to know

before you take

Depo-Medrone

Do not take Depo-Medrone if:

You think you have ever suffered an allergic

reaction, or any other type of reaction after

being given Depo-Medrone, methylprednisolone

acetate, another corticosteroid, or any of the

ingredients in this medicine (Section 6 of this

leaflet contains a list of ingredients). An allergic

reaction may cause a skin rash or reddening,

swollen face or lips or shortness of breath.

You get a rash, or another symptom of

a generalized (systemic) infection that is not

being treated with antibiotics or anti-virals,

or if you have a widespread (systemic) fungal

infection.

You have recently had, or are about to have any

vaccination.

See your doctor immediately if any of the

above applies to you.

This medicine should not be injected:

into the Achilles tendon (which is located behind

the ankle joint)

directly into a vein (intravenous), the spinal cord

(intrathecal), the outer covering of the brain

(extradural), into the nostrils (intranasal), in the

eye (intraocular) or by the epidural route.

Warnings and precautions

Talk to your doctor or nurse before taking

Depo-Medrone if you have any of the following

conditions. Your doctor may also have to monitor

your treatment more closely, alter your dose or

give you another medicine.

Acute adrenal insufficiency (when your body

cannot produce enough corticosteroid due to

problems with your adrenal glands).

Acute pancreatitis (inflammation of the

pancreas).

Chickenpox, measles, shingles or a herpes

eye infection. If you think you have been in

contact with someone with chickenpox, measles

or shingles and you have not already had these

illnesses, or if you are unsure if you have had

them.

If you have ever had a severe depression

or manic depression (bipolar disorder). This

includes having depression before while taking

steroid medicines like Depo-Medrone or if any

of your close family has had these illnesses.

Cushing’s syndrome (a hormone disorder

caused by high levels of cortisol in the blood)

Diabetes (or if there is a family history of

diabetes).

Epilepsy, fits or seizures.

Glaucoma (increased pressure in the eye) or if

there is a family history of glaucoma.

Contact your doctor if you experience blurred

vision or other visual disturbances.

You have recently suffered a heart attack.

Heart problems, including heart failure or

infections.

Hypertension (high blood pressure).

Hypotension (low blood pressure).

Hypothyroidism (an under-active thyroid).

Joint infection.

Kaposi’s sarcoma (a type of skin cancer).

Kidney or liver disease.

Muscle problems (pain or weakness) have

happened while taking steroid medicines in the

past.

Myasthenia gravis (a condition causing tired

and weak muscles).

Osteoporosis (brittle bones – bones that break

easily).

Pheochromocytoma (a rare tumour of adrenal

gland tissue. The adrenal glands are located

above the kidneys).

Scleroderma (also known as systemic

sclerosis, an autoimmune disorder), because the

risk of a serious complication called scleroderma

renal crisis may be increased.

Skin abscess.

Package leaflet: Information for

the patient

Depo-Medrone

40 mg/ml Suspension for

Injection

methylprednisolone acetate

The following information is intended for

healthcare professionals only.

PHYSICIAN LEAFLET

Depo-Medrone

40 mg/ml Suspension for Injection

methylprednisolone acetate

FOR FURTHER INFORMATION PLEASE REFER TO THE

SUMMARY OF PRODUCT CHARACTERISTICS.

Posology and method of administration

Depo-Medrone may be used by any of the following

routes: intramuscular, intra-articular, intralesional,

intrarectal, intrabursal, periarticular, or into the tendon

sheath. It must not be used by the intrathecal, epidural

or intravenous routes.

Undesirable effects may be minimised by using the

lowest effective dose for the minimum period.

Depo-Medrone vials are intended for single dose use only.

The following may serve as a guide:

Adults

The usual dose is 20 to 120 mg daily or weekly, with

adjustment on the basis of the individual requirements

of the patient.

Elderly patients

When used according to instructions, there is no

information to suggest that a change in dosage is

warranted in the elderly. Treatment of elderly patients,

however, particularly if long-term, should be planned

bearing in mind the more serious consequences of the

common side effects of corticosteroids in old age and

close clinical supervision is required.

Paediatric population

Dosage depends principally on the condition and to

a lesser extent on body weight and age of the patient.

Intramuscular (for sustained systemic effect):

Allergic conditions (hay fever, asthma, rhinitis, drug

reactions), 80 - 120 mg (2 - 3 ml).

Dermatological conditions, 40 - 120 mg (1 - 3 ml).

Rheumatic disorders, collagen disease, SLE,

40 - 120 mg (1 - 3 ml) per week.

Adrenogenital syndrome, 40 mg (1 ml) every two weeks.

On average the effect of a single 2 ml (80 mg) injection

may be expected to last approximately two weeks.

In the case of seasonal allergic rhinitis a single injection

is frequently sufficient. If necessary, however, a second

injection may be given after 2 to 3 weeks.

Intra-articular:

Rheumatoid arthritis, osteo-arthritis. The dose of

Depo-Medrone depends upon the size of the joint and

the severity of the condition. Repeated injections, if

needed, may be given at intervals of one to five or more

weeks depending upon the degree of relief obtained from

the initial injection. A suggested dosage guide is: large

joint (knee, ankle, shoulder), 20 - 80 mg (0.5 -2 ml);

medium joint (elbow, wrist), 10 - 40 mg (0.25 - 1 ml);

small joint (metacarpophalangeal, interphalangeal,

sternoclavicular, acromioclavicular), 4 -10 mg (0.1 -

0.25 ml).

Intrabursal:

Subdeltoid bursitis, prepatellar bursitis, olecranon

bursitis. For administration directly into bursae,

4 - 30 mg (0.1 - 0.75 ml). In most cases, repeat

injections are not needed.

Intralesional:

Keloids, localized lichen planus and simplex,

granuloma annulare, alopecia areata, and discoid

lupus erythematosus. For administration directly into

the lesion for local effect in dermatological conditions,

20 - 60 mg (0.5 - 1.5 ml).

For large lesions, the dose may be distributed by

repeated local injections of 20 - 40 mg (0.5 - 1 ml).

One to four injections are usually employed. Care

should be taken to avoid injection of sufficient material

to cause blanching, since this may be followed by

a small slough.

Rectal:

Ulcerative colitis, 40 - 120 mg (1 - 3 ml). Administer in

retention enemas or by continuous drip in 30 - 300 ml

of water, three to seven times weekly for two or more

weeks.

Periarticular:

Epicondylitis. Infiltrate 4 - 30 mg (0.1 - 0.75 ml) into

the affected area.

Into the tendon sheath:

Tendonitis, tenosynovitis, epicondylitis. For

administration directly into the tendon sheath,

4 - 30 mg (0.1 - 0.75 ml). In recurrent or chronic

conditions, repeat injections may be necessary.

Special precautions should be observed when

administering Depo-Medrone. Intramuscular injections

should be made deeply into the gluteal muscles. The

usual technique of aspirating prior to injection should

be employed to avoid intravascular administration.

Doses recommended for intramuscular injection must

not be administered superficially or subcutaneously.

Intra-articular injections should be made using

precise, anatomical localisation into the synovial space

of the joint involved. The injection site for each joint

is determined by that location where the synovial

cavity is most superficial and most free of large

vessels and nerves. Suitable sites for intra-articular

injection are the knee, ankle, wrist, elbow, shoulder,

phalangeal and hip joints. The spinal joints, unstable

joints and those devoid of synovial space are not

suitable. Treatment failures are most frequently the

result of failure to enter the joint space. Intra-articular

injections should be made with care as follows,

ensure correct positioning of the needle into the

synovial space and aspirate a few drops of joint fluid.

The aspirating syringe should then be replaced by

Stomach ulcer, diverticulitis (inflammation

of the bowel wall) or other serious stomach or

intestinal problems.

Unusual stress.

Thrombophlebitis - vein problems due to

thrombosis (clots in the veins) resulting in

phlebitis (red, swollen and tender veins).

Traumatic brain injury.

Tuberculosis (TB) or if you have suffered

tuberculosis in the past.

You must tell your doctor before you take this medicine

if you have any of the conditions listed above.

Other medicines and Depo-Medrone

Tell your doctor or nurse if you are taking, have

recently taken or might take any other medicines.

You should tell your doctor if you are taking any of

the following medicines which can affect the way

Depo-Medrone or the other medicine works:

Acetazolamide - used to treat glaucoma and

epilepsy.

Aminoglutethimide and cyclophosphamide

– used for treating cancer.

Antibacterials (such as isoniazid,

erythromycin, clarithromycin and

troleandomycin).

Anticoagulants - used to ‘thin’ the blood such

as acenocoumarol, phenindione and warfarin.

Anticholinesterases - used to treat

myasthenia gravis (a muscle condition) such as

distigmine and neostigmine.

Antidiabetics – medicines used to treat high

blood sugar.

Antiemetics (such as aprepitant and

fosaprepitant).

Aspirin and non-steroidal anti-inflammatory

medicines (also called NSAIDs) such as

ibuprofen used to treat mild to moderate pain.

Barbiturates, carbamazepine, phenytoin

and primidone – used to treat epilepsy.

Carbenoxolone - used for heartburn.

Ciclosporin - used to treat conditions such as

severe rheumatoid arthritis, severe psoriasis or

following an organ or bone marrow transplant.

Digoxin - used for heart failure and/or an

irregular heart beat.

Diltiazem – used for heart problems or high

blood pressure.

Ethinylestradiol and norethisterone – an

oral contraceptive.

Pharmacokinetic enhancers (such as

cobicistat) used to treat HIV infections.

Indinavir and ritonavir – used to treat HIV

infections.

Ketoconazole or itraconazole – used to treat

fungal infections.

Pancuronium and vecuronium – or other

medicines called neuromuscular blocking agents

which are used in some surgical procedures.

Potassium depleting agents – such

as diuretics (sometimes called water

tablets), amphotericin B, xanthenes or

beta2 agonists (e.g. medicines used to treat

asthma).

Rifampicin and rifabutin – antibiotics used to

treat tuberculosis (TB).

Tacrolimus – used following an organ

transplant to prevent rejection of the organ.

Vaccines - tell your doctor or nurse if you

have recently had, or are about to have any

vaccination. You must not have ‘live’ vaccines

while using this medicine. Other vaccines may

be less effective.

If you are taking long term medication(s)

If you are being treated for diabetes, high blood

pressure or water retention (oedema) tell your

doctor as he/she may need to adjust the dose of

the medicines used to treat these conditions.

Before you have any operation tell your doctor,

dentist or anaesthetist that you are taking this

medicine.

If you require a test to be carried out by your

doctor or in hospital it is important that you tell

the doctor or nurse that you are taking Depo-

Medrone. This medicine can affect the results of

some tests.

Depo-Medrone with drink

Do not drink grapefruit juice while taking this

medicine.

Pregnancy and breast-feeding

You must tell your doctor if you are pregnant,

think you might be pregnant, or are trying to

become pregnant as this medicine could slow the

baby’s growth. Depo-Medrone should be used

during pregnancy only if clearly needed.

Cataracts have been observed in infants born to

mothers treated with long-term corticosteroids

during pregnancy.

If you are breast-feeding, ask your doctor or

nurse for advice before taking this medicine, as

methylprednisolone is excreted into breast milk.

If you continue breast-feeding while you are having

treatment, your baby will need extra checks to

make sure he or she is not being affected by your

medicine.

Ask your doctor or nurse for advice before taking

any medicine.

Driving and using machines

Undesirable effects, such as dizziness, a feeling of

spinning (vertigo), visual disturbances and fatigue

are possible after treatment with corticosteroids. If

you are affected do not drive or operate machinery.

Depo-Medrone contains sodium

This medicinal product contains less than

1 mmol sodium (23mg) per vial, i.e. essentially

‘sodium-free’.

Continued overleaf.

3. How to take Depo-Medrone

Steroid Cards

Remember to always carry a Steroid

Treatment Card. Make sure your doctor

or nurse has filled out the details of your

medicine, including the dose and how long

you will require steroid treatment.

You should show your steroid card to anyone who

gives you treatment (such as a doctor, nurse or

dentist) while you are taking this medicine, and for

3 months after your last injection.

If you are admitted to hospital for any reason

always tell your doctor or nurse that you are taking

this medicine. You can also wear a medic-alert

bracelet or pendant to let medical staff know that

you are taking a steroid if you have an accident or

become unconscious.

Dosage information

Your doctor will decide on the site of injection, how

much of the medicine and how many injections

you will receive depending on the condition being

treated and its severity. Your doctor will inject you

with the lowest dose for the shortest possible time

to get effective relief of your symptoms.

Adults

Your doctor or nurse will tell you how many

injections you will require for the condition you are

being treated for, and when you will get them.

Joints - the normal dose for an injection into

a joint will depend on the size of the joint. Large

joints (e.g. knee, ankle and shoulder) may require

20 - 80 mg (0.5 – 2 ml), medium sized joints

(e.g. elbow or wrist) 10 - 40 mg (0.25 – 1 ml) and

small joints (e.g. finger or toe joints) may require

a 4 - 10 mg (0.1 -0.25 ml) dose.

Joint injections may be given weekly over a period

of several weeks, depending on how quickly you

respond to treatment.

Bursitis, epicondylitis (tennis elbow) and

tendonitis – the usual dose is between 4-30 mg

(0.1 - 0.75 ml). In most cases repeat injections

will not be needed for bursitis and epicondylitis.

Repeat injections may be necessary to treat long

standing tendonitis.

Skin conditions – the usual dose is between

20 – 60mg (0.5 – 1.5ml) injected into the affected

part or parts of the skin.

For other more general conditions 40 – 120 mg

(1 – 3ml) of this medicine may be injected into

a large muscle.

Elderly

Treatment will normally be the same as for

younger adults. However, your doctor may want

to see you more regularly to check how you are

getting on with this medicine.

PAA122365

PAA122365

PAA122365

370644

Puurs

8 pt

Ireland

Leaflet

PAA122365

I091/A

600 x 214 mm

I-DEPO-MEDRONE 40MG/ML V

PAR-2019-0000542

Profile

Black

18:56

Barcode Nº

Datamatrix Code

Supplier Nº

Date:

30 Jan 2019

Time:

Perigord Nº

Supplier

Smallest

BODY TEXT

Size

Market

Proof Nº

Component

Drawing Nº

Dimensions

Material Name

PAR Number

Colours

Printing

Non-Printing

Source Code

Blood, heart and circulation

not known

High blood pressure, symptoms of which

are headaches, or generally feeling unwell.

Problems with the pumping of your heart

(heart failure) symptoms of which are swollen

ankles, difficulty in breathing and palpitations

(awareness of heart beat) or irregular beating

of the heart, irregular or very fast or slow

pulse.

Low blood pressure, symptoms may

include dizziness, fainting, lightheadedness,

blurred vision, a rapid or irregular heartbeat

(palpitations).

Increase of white blood cells (leukocytosis).

Body water and salts

not known

Swelling and high blood pressure, caused by

increased levels of water and salt content.

Cramps and spasms, due to the loss of

potassium from your body. In rare cases this can

lead to congestive heart failure (when the heart

cannot pump properly).

Digestive system

not known

Ulcers.

Nausea (feeling sick) or vomiting (being sick).

Thrush in the gullet (discomfort on swallowing).

Indigestion.

Diarrhoea.

Bloated stomach.

Abdominal pain.

Persistent hiccups, especially when high doses

are taken.

Ears

not known

A feeling of dizziness or spinning (vertigo).

Eyes

not known

Cataracts (indicated by failing eyesight).

Glaucoma (raised pressure within the eye,

causing pain in the eyes and headaches).

Swollen optic nerve (causing a condition called

papilloedema, and which may cause sight

disturbance).

Increased intra-ocular pressure, with possible

damage to the optic nerve or cataracts

(indicated by failing eyesight).

Thinning of the clear part at the front of the

eye (cornea) or of the white part of the eye

(sclera).

Worsening of viral or fungal eye infections.

Protruding of the eyeballs (exophthalmos).

Disease of the retina and choroid

membrane, symptoms of which are blurred

or distorted vision (due to a disease called

chorioretinopathy).

Blurred vision.

General disorders

not known

Poor wound healing.

Irritability in children.

Feeling tired or unwell.

Skin reactions at the site of injection.

Irritability in adults.

Hepatobiliary disorders

not known

Methylprednisolone can damage your liver,

hepatitis and increase of liver enzymes have

been reported.

Hormones and metabolic system

not known

Slowing of normal growth in infants, children

and adolescents which may be permanent.

Round or moon-shaped face (Cushingoid facies).

Diabetes or worsening of existing diabetes.

Irregular or no periods in women.

Abnormal localized or tumour-like accumulations

of fat in the tissues.

Increased appetite and weight gain.

Prolonged therapy can lead to lower levels of

some hormones which in turn can cause low

blood pressure and dizziness. This effect may

persist for months.

The amount of certain chemicals (enzymes)

called alanine transaminase, aspartate

transaminase and alkaline phosphatase that help

the body digest drugs and other substances in

your body may be raised after treatment with

a corticosteroid. The change is usually small and

the enzyme levels return to normal after your

medicine has cleared naturally from your system.

You will not notice any symptoms if this happens,

but it will show up if you have a blood test.

Immune system

not known

Increased susceptibility to infections which can

hide or change normal reactions to skin tests,

such as that for tuberculosis.

Metabolism and nutrition disorders

not known

Accumulation of fat tissue on localized parts of

the body

Muscles, bones and joints

not known

Muscle weakness.

Brittle bones (bones that break easily).

Muscle wasting.

Broken bones or fractures.

Breakdown of bone due to poor circulation of

blood, this causes pain in the hip.

Joint pain.

Torn muscle tendons causing pain and/or

swelling.

Muscle cramps or spasms.

Swollen or painful joints due to infection.

Nerves and mood issues

not known

Steroids, including Depo-Medrone, can cause

serious mental health problems.

Feeling depressed, including thinking about

suicide.

Feeling high (euphoria) or moods that go up and

down.

Feeling anxious, having problems sleeping,

difficulty in thinking or being confused.

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 straight away.

Other nervous system side effects may include

convulsions (seizures), amnesia (loss of memory),

cognitive disorder (mental changes), dizziness and

headache.

Back pain or weakness (due to Epidural

Lipomatosis, a rare disorder in which an

abnormal amount of fat is deposited on or

outside the lining of the spine).

Skin

not known

Acne.

Bruising.

Poor wound healing.

Abscess, especially near injection sites.

Thinning of skin, stretch marks.

Small purple/red patches on the skin.

Pale or darker patches on your skin, or raised

patches which are an unusual colour.

Increased hair on the body and face

(hirsutism).

Rash, itching, hives.

Increased sweating.

Vascular disorders

not known

Increased clotting of the blood.

If you get any side effects, talk to your doctor or

pharmacist. This includes any possible side effects

not listed in this leaflet.

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 HPRA Pharmacovigilence,

Earlsfort Terrace, IRL - Dublin 2; Tel:

+353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; e-mail:

medsafety@hpra.ie. By reporting side effects, you

can help provide more information on the safety of

this medicine.

5. How to store Depo-Medrone

Keep this medicine out of the sight and reach of

children.

Do not use this medicine after the expiry date

which is stated on the label and carton after

EXP. The expiry date refers to the last day of that

month.

Do not store this medicine above 25°C. Do not

freeze.

Keep the vial in the outer carton.

6. Contents of the pack and

other information

What Depo-Medrone contains

The active substance is methylprednisolone

acetate. Each millilitre contains 40 mg of

methylprednisolone acetate.

The other ingredients are sodium chloride,

macrogol 3350, miripirium chloride, sodium

hydroxide, hydrochloric acid and water for

injections.

What Depo-Medrone looks like and

contents of the pack

Depo-Medrone is a sterile, white suspension

(liquid) for injection contained in a glass vial fitted

with a rubber cap and metal seal.

Depo-Medrone is available in packs containing

1 or 10 vials, containing 1 ml, 2 ml or 3ml of

suspension.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Healthcare Ireland

9, Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

Puurs, B-2870

Belgium

Company contact address:

For further information on your medicine contact

Medical Information at the following address:

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Telephone: 1800 633 363.

This leaflet was last revised in: MM/YYYY

Ref: DM 21_0 IE

another containing Depo-Medrone. To ensure position

of the needle, synovial fluid should be aspirated and the

injection made. After injection the joint is moved slightly

to aid mixing of the synovial fluid and the suspension.

Subsequent to therapy care should be taken for the

patient not to overuse the joint in which benefit has

been obtained. Negligence in this matter may permit an

increase in joint deterioration that will more than offset

the beneficial effects of the steroid.

Intrabursal injections should be made as follows: the

area around the injection site is prepared in a sterile way

and a wheal at the site made with 1 percent procaine

hydrochloride solution. A 20 to 24 gauge needle

attached to a dry syringe is inserted into the bursa and

the fluid aspirated. The needle is left in place and the

aspirating syringe changed for a small syringe containing

the desired dose. After injection, the needle is withdrawn

and a small dressing applied.

In the treatment of tenosynovitis and tendinitis care

should be taken to inject Depo-Medrone into the tendon

sheath rather than into the substance of the tendon.

Due to the absence of a true tendon sheath, the Achilles

tendon should not be injected with Depo-Medrone.

The usual sterile precautions should be observed, with

each injection.

Incompatibilities

In the absence of compatibility studies, this medicinal

product must not be mixed with other medicinal

products.

Special precautions for storage

Do not store above 25

Do not freeze.

Keep the vial in the outer carton.

Special precautions for disposal and other

handling

Depo-Medrone should not be mixed with any other

fluid. Parenteral drug products should be inspected

visually for particulate matter and discoloration prior

to administration whenever suspension and container

permit. Shake well before use.

Discard any remaining suspension after use.

HCP leaflet was last revised in: 07/2018.

Ref: DM 20_1 IE

In certain medical conditions medicines

like Depo-Medrone (steroids) should not be

stopped abruptly. If you suffer from any of

the following symptoms seek immediate

attention. Your doctor will then decide

whether you should continue taking your

medicine.

Allergic reactions such as skin rash, swelling

of the face or wheezing and difficulty breathing.

This type of side effect is rare, but can be

serious.

Pancreatitis, stomach pain spreading to your

back, possibly accompanied by vomiting, shock

and loss of consciousness.

Ulcers or bleeding ulcers, symptoms

of which are severe stomach pain which

may go through to the back and could be

associated with bleeding from the back

passage, black or bloodstained stools and/or

vomiting blood.

Infections, this medicine can hide or change

the signs and symptoms of some infections, or

reduce your resistance to the infection, so that

they are hard to diagnose at an early stage.

Symptoms might include a raised temperature

and feeling unwell. Symptoms of a flare up

of a previous TB infection could be coughing

blood or pain in the chest. This medicine may

also make you more likely to develop a severe

infection.

Peritonitis, an inflammation (irritation) of the

peritoneum, the thin tissue that lines the inner

wall of the abdomen and covers most of the

abdominal organs. Symptoms are, the stomach

(abdomen) being very painful or tender, the

pain may become worse when the stomach is

touched or when you move.

Pulmonary embolus (blood clot in the lung)

symptoms include sudden sharp chest pain,

breathlessness and coughing up blood.

Raised pressure within the skull of children

(pseudotumour cerebri) symptoms of which are

headaches with vomiting, lack of energy and

drowsiness. This side effect usually occurs after

treatment is stopped.

Thrombophlebitis (blood clots or

thrombosis in a leg vein), symptoms of which

include painful swollen, red and tender

veins.

If you experience any of the following side

effects, or if you notice any other unusual

effects not listed in this leaflet, tell your

doctor immediately.

The following side effects may occur with

certain frequencies, which are defined as

follows:

not known: frequency cannot be estimated from

the available data.

Children

Corticosteroids can affect growth in children so

your doctor will prescribe the lowest dose that will

be effective for your child.

If you take more Depo-Medrone than you

should

If you think you have been given too many

injections of this medicine please speak to your

doctor immediately.

Stopping/reducing the dose of your

Depo-Medrone

Your medicine must not be stopped suddenly.

Your doctor will decide when it is time to stop your

treatment.

You will need to come off this treatment slowly if

you:

have been given Depo-Medrone for a long time

have been given high doses of Depo-Medrone,

or have already had a course of corticosteroid

tablets or injections in the last year

already have problems with your adrenal glands

(adrenocortical insufficiency) before you started

this treatment.

You will need to come off this medicine slowly to

avoid withdrawal symptoms. These symptoms

may include itchy skin, fever, muscle and joint

pains, runny nose, sticky eyes, sweating and

weight loss.

If your symptoms seem to return or get worse as

your dose of this medicine is reduced tell your

doctor immediately.

Mental problems while taking Depo-Medrone

Mental health problems can happen while taking

steroids like Depo-Medrone (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 the

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. In a few cases

mental problems have happened when doses are

being lowered or stopped.

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.

Your doctor will have given you this medicine for

a condition which if not treated properly could

become serious.

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