PACKAGE LEAFLET: INFORMATION FOR THE USER

Triamcinolone hexacetonide 20 mg/ml suspension for injection

Triamcinolone hexacetonide may also be used for the intraarticular use (injection into the joint) in children aged 3-12 years with Juvenile Idiopathic Arthritis.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TRIAMCINOLONE HEXACETONIDE

You should not be given Triamcinolone hexacetonide

-    if you are allergic to triamcinolone hexacetonide or any of the other ingredients of this medicine (listed in section 6).

-    Must not be given to newborn and premature babies and children up to 3 years of age.

-    if you suffer from active tuberculosis, herpes simplex infection of the eye, acute psychosis or a generalised fungal and parasite infections.

Warnings and precautions

Triamcinolone hexacetonide contains a potent steroid and so should be used with caution if you have any of the following diseases.

Therefore you must tell your doctor before administration of Triamcinolone hexacetonide if you have any of the following conditions:

-    heart failure, acute coronary artery disease

- hypertension (high blood pressure)

- thrombophlebitis (blood clots), thromboembolism (blood clot that breaks loose and is carried by the blood stream to plug another vessel)

-    myasthenia gravis (muscle weakness)

-    osteoporosis (brittle bones)

-    gastric ulcer (stomach ulcer), diverticulitis (inflammation of the small pouches of the inner lining of the large intestine), ulcerative colitis (chronic inflammation in the large intestine), recent intestinal anastomosis (surgery following removal of part of the intestines)

-    any skin disease such as eczema

-    psychosis (mental health problems with hallucinations or delusions),

-    "moon face" and obesity of the trunk (Cushing’s syndrome),

-    diabetes mellitus,

-    underactive thyroid gland (hypothyroidism)

-    reduced kidney function, acute glomerulonephritis (damage to the tiny filters inside the kidney), chronic nephritis (long-lasting inflammation of the kidney)

-    liver cirrhosis

-    infections that cannot be treated with antibiotics

-    metastatic carcinoma (cancer that spreads from one organ or part to another non-adjacent organ or part)

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 Triamcinolone hexacetonide.

•    If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before Triamcinolone hexacetonide is given to you.

Mental health problems while taking triamcinolone hexacetonide

Mental health problems can happen while taking steroids like triamcinolone hexacetonide (see also section 4 Possible Side Effects).

• These illnesses can be serious.

The following information is intended for medical or healthcare professionals only

How to prepare and administer Triamcinolone hexa-cetonide 20 mg/ml

Aseptic techniques must be observed when using the medicine. Medicines that are administered by injection must be inspected visually for particles and discolouration before injecting. The Triamcinolone hexacetonide ampoule must be shaken well before use to ensure an even suspension. Sterilisation technique should be the same as that used at lumbar puncture. No more than two joints should be treated at each treatment session.

If necessary, Triamcinolone hexacetonide can be mixed with 1% or 2% lidocaine hydrochloride or other equivalent local anaesthetic. Triamcinolone hexacetonide must be drawn up into the syringe before the local anaesthetic in order to prevent contamination. Tip the syringe gently backwards and forwards, and inject the solution immediately.

The use of solvents containing methylparaben, propylparaben, phenol, etc. should be avoided. These can cause precipitation of the steroid.

Recommended dose

For intraarticular use (injections into the joint, dosage for adults and adolescents) for all indications

The dose is determined for you individually. It can vary from 2-20 mg depending on the size of the joint and the amount of fluid in the joint. Usually, 10-20 mg (0.5-1 ml) is used in large joints (such as hips, knees and shoulders), 5-10 mg (0.25-0.5 ml) is used in medium-sized joints (such as elbows and wrists) and 2-6 mg (0.1 -0.3 ml) is used in smaller joints (such as hands and feet). If a lot of fluid is present in the joint, this may be withdrawn before the injection. The next dose and the number of injections depend on how your disease responds. Because Triamcinolone hexacetonide is

Other medicines and Triamcinolone hexacetonide

Please tell your doctor if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are also taking:

Amphotericin B injection and potassium-depleting agents:

since the combination of these with Triamcinolone hexacetonide may cause potassium levels in the blood to become too low.

Anticholinesterases (AChEI): since they may be less effective.

Anticholinergics (e.g. atropine): since the pressure in the eye

may increase.

Anti-blood clotting tablets (Anticoagulants, oral): Steroids may increase or decrease blood-thinning (anticoagulant) effect.

Blood sugar lowering drugs (antidiabetics, e.g. sulfonylurea derivatives, and insulin): Steroids may increase the levels of glucose in the blood.

Blood pressure lowering drugs (antihypertensives, including diuretics): may become less effective.

Drugs to treat tuberculosis, e.g. isoniazid: The concentration of isoniazid in the blood may be decreased.

Immune suppressing drugs (cyclosporin): When used together, cyclosporin may produce an increase in both cyclosporin and steroid activity.

Heart failure medicines (digitalis glycosides): administered together with Triamcinolone hexacetonide may increase the likelihood of digitalis toxicity.

Drugs that increase the amount of special liver enzymes

(e.g. barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglutethimide): may reduce the effect of Triamcinolone hexacetonide.

Human growth hormone (somatropin): The growth-promoting effect may be reduced during long-term therapy with Triamcinolone hexacetonide.

Drugs to treat fungal infections (ketoconazole): Steroid effects of Triamcinolone hexacetonide may be increased.

Protease inhibitors to treat HIV infection (ritonavir):

Steroid effects may be increased or prolonged. These include Cushing’s syndrome (high levels of a hormone called cortisol with symptoms such as weight gain, thin skin and a rounded "moon" face) and underactive adrenal glands.

Non-depolarising muscle relaxants: Steroids may decrease or increase the neuromuscular blocking action.

Non-steroidal anti-inflammatory agents (NSAIDs): Steroids may increase the incidence and/or severity of gastrointestinal bleeding and ulceration associated with NSAIDs. Steroids may also reduce serum salicylate levels and therefore decrease their efficacy. Discontinuing steroids during high-dose salicylate therapy may result in salicylate toxicity. If you use aspirin and have low prothrombin levels, inform your doctor or nurse.

Hormones to prevent pregnancy, including the “pill" (oral contraceptives): The steroid effect of Triamcinolone hexacetonide may last longer.

Thyroid drugs: If you have an underactive thyroid (hypothyroid), or overactive thyroid (hyperthyroid), inform your doctor or nurse since the dose may need to be adjusted.

Vaccines: Neurological complications and a reduced antibody response may occur in special situations when patients

____________________________

long-acting, no joint should be treated more than once every 3-4 weeks.

Use in children aged 3-12 years with Juvenile Idiopathic Arthritis

The dosage regime for triamcinolone hexacetonide intraarticular injection for JIA in children is 1 mg/kg for large joints (knees, hips, and shoulders) and 0.5 mg/kg for smaller joints (ankles, wrists, and elbows). For the hands and feet, 1 -2 mg/joint for metacarpophalangeal/metatarsophalangeal (MCP/MTP) joints, and 0.6-1 mg/joint for proximal interphalangeal (PIP) joints may be used.

For periarticular use (injections around the joint, dosage for adults and adolescents only)

Bursitis/Epicondylitis: Usually 10-20 mg (0.5-1.0 ml) depending on the size of the bursa and the severity of the condition. In most cases, one treatment is sufficient.

Synovitis/Tendinitis: Usually 10-20 mg (0.5-1.0 ml). The need for further injections is based on the response to treatment.

How to store TRIAMCINOLONE HEXACETONIDE

This medicinal product does not require any special storage conditions.

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

Do not use Triamcinolone hexacetonide after the expiry date which is stated on the ampoule label and outer carton after "EXP". The expiry date refers to the last day of that month.

Do not use Triamcinolone hexacetonide if you notice any visible change in the appearance of the medicine.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

114126114

30002030

taking steroids are vaccinated. (see section 2 Warnings and precautions)

Medicines that prolong the QT interval or induce torsade de pointes: Use of Triamcinolone hexacetonide and class la antiarrhythmic agents such as disopyramide, quinidine and procainamide, or other class II antiarrhythmic drugs such as amiodarone, bepridil and sotalol, is not recommended.

Extreme caution is required when Triamcinolone hexacetonide is used in combination with phenothiazines, tricyclic antidepressants, terfenadine and astemizole, vincamine, erythromycin i.v., halofantrine, pentamidine and sultopride.

Combination with agents that cause electrolyte disturbances such as low potassium levels (potassium-depleting diuretics, amphotericin B i.v. and certain laxatives), low magnesium levels and severely reduced calcium levels in the blood is not recommended.

Athletes should be informed that this medicinal product contains an ingredient that may produce a positive result in anti-doping tests.

Paediatric population

Interaction studies have only been performed in adults.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you are pregnant or are planning to have a baby, ask your doctor for advice before taking any medicine.

Driving and using machines

Triamcinolone hexacetonide is not expected to have an influence on the ability to drive and use machines.

Steroid Treatment Card

Your doctor or pharmacist may give 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

Triamcinolone hexacetonide contains benzyl alcohol and sorbitol (E420).

Benzyl alcohol may cause toxic and serious allergic reactions in infants and children up to 3 years old.

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

3. HOW TRIAMCINOLONE HEXACETONIDE IS GIVEN

A doctor (or nurse instructed by the doctor) will give the injection of Triamcinolone hexacetonide. The dose is determined by the doctor.

This formulation is intended for intraarticular, periarticular and intrasynovial use (into and around the joints).

This formulation must not be used intravenously (into the vein), intradermally (into the skin), subcutaneously (below the skin), intramuscularly (into the muscle), intraocularly (into the eye), epidurally (into the spinal canal) or intrathecally use (into the brain or spinal cord).

Your doctor will prescribe the dose which is best for you.

Post-treatment pain control: The pain in a joint caused by intraarticular injection can be prevented or relieved by avoiding unnecessary movement for 12 hours after injection.

If you are given too much Triamcinolone hexacetonide

Overdose can cause changes to the skin around the injection site as is the case when the interval between injections at the same site is too short. If this occurs, it can take many months to heal due to the long-acting effect of the medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLESIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects depend on the dose and the duration of treatment. Systemic side effects are rare, but may occur as a result of repeated periarticular injection. As with other intraarticular steroid treatments, transient adrenocortical suppression has been observed during the first week after injection. This effect is enhanced if corticotropin or oral steroids are used in combination.

Serious effects: tell a doctor straight away Steroids including Triamcinolone hexacetonide can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people who have been given medicines like Triamcinolone hexacetonide.

•    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 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.

Serious allergic reactions 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.

Tell your doctor immediately if you notice any sticky black stools, get severe abdominal pain or if you vomit blood.

Other side effects of Triamcinolone hexacetonide include:

Common side effects (may affect up to 1 in 10 people)

•    local reactions at the injection site such as abscesses, redness, pain, swelling and tissue damage

Rare side effects (may affect up to 1 in 1,000 people)

•    Excess dosage or too-frequent administration of injections into the same site may cause localised thinning of the top two layers in the skin, the dermis or epidermis, causing a depression in the skin. Due to the long-lasting effect of Triamcinolone hexacetonide, the skin will only return to normal after several months.

•    Vertigo (a feeling of dizziness or "spinning")

The following information is intended for medical or healthcare professionals only

How to prepare and administer Triamcinolone hexa-cetonide 20 mg/ml

Aseptic techniques must be observed when using the medicine. Medicines that are administered by injection must be inspected visually for particles and discolouration before injecting. The Triamcinolone hexacetonide ampoule must be shaken well before use to ensure an even suspension. Sterilisation technique should be the same as that used at lumbar puncture. No more than two joints should be treated at each treatment session.

If necessary, Triamcinolone hexacetonide can be mixed with 1% or 2% lidocaine hydrochloride or other equivalent local anaesthetic. Triamcinolone hexacetonide must be drawn up into the syringe before the local anaesthetic in order to prevent contamination. Tip the syringe gently backwards and forwards, and inject the solution immediately.

The use of solvents containing methylparaben, propylparaben, phenol, etc. should be avoided. These can cause precipitation of the steroid.

Recommended dose

For intraarticular use (injections into the joint, dosage for adults and adolescents) for all indications

The dose is determined for you individually. It can vary from 2-20 mg depending on the size of the joint and the amount of fluid in the joint. Usually, 10-20 mg (0.5-1 ml) is used in large joints (such as hips, knees and shoulders), 5-10 mg (0.25-0.5 ml) is used in medium-sized joints (such as elbows and wrists) and 2-6 mg (0.1 -0.3 ml) is used in smaller joints (such as hands and feet). If a lot of fluid is present in the joint, this may be withdrawn before the injection. The next dose and the number of injections depend on how your disease responds. Because Triamcinolone hexacetonide is

Very rare side effects (may affect up to 1 in 10,000 people)

•    serious allergic reaction which causes difficulty breathing or dizziness, swelling of the face lips or throat, skin itching, redness or rash

•    formation of blot clots

•    formation of calcium deposits in and around of the treated joints; tearing of the tendon

•    darkening or lightening of the skin

Not known side effects (frequency cannot be estimated from the available data)

•    changes in blood chemicals which can cause fluid retention, heart failure or irregular heart beat

•    high blood pressure

•    weak muscles; osteoporosis (brittle bone disease); destruction of the ends of bones; spontaneous fractures; Charcot-like arthropathy with swollen joints and edema

•    stomach ulcers and stomach pain; inflammation of the pancreas

•    delayed wound healing; thin and fragile skin; pinpoint bleeding in the skin and bruises; facial redness and/or rash; increased sweating; red or purple discoloration on the skin; stretch marks; skin condition looking like acne; hives

•    raised blood pressure within the brain with no known cause usually after treatment with headache, ear ringing, blurred or dimmed vision, nausea, vomiting, dizziness, seeing light flashes, neck shoulder or back pain (pseudotumor cerebri); headache

•    insomnia (sleeplessness); depression (sometimes severe); euphoria; mood swings; halucinations and delusions

•    irregular periods; in postmenopausal women vaginal bleeding may occur; abnormal hair growth; development of a cushingoid state (large rounded face, obesity of the trunk); inactivity or shrinkage of parts of the adrenal gland, particularly during periods of stress (e.g. trauma, surgery or illness); decreased tolerance to sugars; high blood sugar (characterised by symptoms such as excessive thirst, passing large amounts of urine, increase in appetite and feeling weak)

•    eye problems including cataracts and glaucoma

•    negative nitrogen balance due to breakdown of proteins

•    increased risk of infections

Hypersensitivity reactions caused by benzyl alcohol may rarely occur.

Children:

There is a risk that their growth may be slowed down. 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.nnv.uk/yellnwcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE TRIAMCINOLONE HEXACETONIDE

Your doctor, nurse or pharmacist know how to store this medicine properly (see section 6).

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Triamcinolone hexacetonide contains

-    The active substance is triamcinolone hexacetonide 20 mg/ml.

-    1 ampoule with 1 ml suspension for injection contains 20 mg triamcinolone hexacetonide.

-    The other ingredients per 1 ml are sorbitol (E420) 455 mg, polysorbate 80:4 mg, benzyl alcohol 9 mg and water for injection.

What Triamcinolone hexacetonide looks like and contents of the pack

Triamcinolone hexacetonide is a milky white suspension.

Triamcinolone hexacetonide is available in packs of 10 ampoules.

A colourless 1 ml glass ampoule.

Marketing Authorisation Holder

Intrapharm Laboratories Ltd.

The Courtyard Barns Choke Lane Maidenhead Berkshire, SL6 6PT United Kingdom

Manufacturer

RIEMSER Pharma GmbH

An der Wiek 7, D-17493 Greifswald - Insel Riems Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Czech Republic, Slovenia, The Netherlands: TRISPAN, in Portugal and Spain: BLUXAM and in the United Kingdom: Triamcinolone hexacetonide.

This leaflet was last revised in February 2016.

mtrapharm

laboratories

____________________________

long-acting, no joint should be treated more than once every 3-4 weeks.

Use in children aged 3-12 years with Juvenile Idiopathic Arthritis

The dosage regime for triamcinolone hexacetonide intraarticular injection for JIA in children is 1 mg/kg for large joints (knees, hips, and shoulders) and 0.5 mg/kg for smaller joints (ankles, wrists, and elbows). For the hands and feet, 1 -2 mg/joint for metacarpophalangeal/metatarsophalangeal (MCP/MTP) joints, and 0.6-1 mg/joint for proximal interphalangeal (PIP) joints may be used.

For periarticular use (injections around the joint, dosage for adults and adolescents only)

Bursitis/Epicondylitis: Usually 10-20 mg (0.5-1.0 ml) depending on the size of the bursa and the severity of the condition. In most cases, one treatment is sufficient.

Svnovitis/Tendinitis: Usually 10-20 mg (0.5-1.0 ml). The need for further injections is based on the response to treatment.

How to store TRIAMCINOLONE HEXACETONIDE

This medicinal product does not require any special storage conditions.

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

Do not use Triamcinolone hexacetonide after the expiry date which is stated on the ampoule label and outer carton after "EXP". The expiry date refers to the last day of that month.

Do not use Triamcinolone hexacetonide if you notice any visible change in the appearance of the medicine.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

114126114

30002030