Patient Information Leaflet    w hameln

Dexamethasone 3.3 mg/ml Injection Dexamethasone 6.6 mg/ml Injection Dexamethasone 8.3 mg/ml Injection

Important information about this medicine

Now read the rest of the leaflet. It includes other important information on the safe and effective use of this medicine that might especially be important for you. This leaflet was last updated 09/2013.

Dexamethasone - benefit information

Dexamethasone 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 dexamethasone) is an effective way to treat various illnesses involving inflammation in the body. Dexamethasone reduces inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

The name of your medicine is Dexamethasone 3.3 mg/ml Injection, Dexamethasone 6.6 mg/ml Injection and Dexamethasone 8.3 mg/ml Injection, which will be referred to as Dexamethasone Injection throughout this leaflet

Where to find information in this leaflet

1.    What Dexamethasone Injection is and what it is used for

2.    Before you are given Dexamethasone Injection

3.    How to use Dexamethasone Injection

4.    Possible side effects

5.    Storing Dexamethasone Injection

6.    Further information

1.    What Dexamethasone Injection is and what it is used for

Dexamethasone belongs to a group of medicines called steroids.

Dexamethasone is given by injection to patients unable to take a tablet form of the medicine. When given into a vein or muscle, dexamethasone reduces inflammation and suppresses the immune system and is used normally for patients with:

•    severe allergic reactions causing swelling of the face and throat, low blood pressure and collapse (angioneurotic oedema and anaphylaxis)

•    shock caused by infection or severe tuberculosis (also with anti-infective treatments e.g. antibiotics)

•    raised pressure in the skull caused by tumours or infantile spasms

•    Sometimes, the injection is given into the painful area itself e.g.inflammation of the joints (rheumatoid arthritis and osteoarthritis)

2.    Before you are given Dexamethasone Injection

You should NOT be given Dexamethasone Injection if you:

•    are sensitive or allergic to Dexamethasone or any of the other ingredients in this injection.

•    have a fungal infection that has spread to involve the whole body.

•    have any other widespread infection which is not currently being treated.

•    are to be vaccinated with live virus vaccines.

Please tell your doctor or nurse before being given the injection if:

•    you have ever had severe depression or

manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like dexamethasone.

•    any of your close family has had these illnesses. If either of these applies to you, talk to a doctor before receiving dexamethasone.

Mental health problems while taking |3j dexamethasone

Mental health problems can happen while taking steroids like dexamethasone (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 taking 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 stopped.

You should avoid any exposure to infectious diseases. If you do not have a definite history of chickenpox, you must avoid any contact with chickenpox (herpes simplex), shingles (herpes zoster) or measles. This precaution applies also if your child is the patient treated with this medicine. If you think you may have been exposed to these, please seek advice from a doctor immediately as the consequences can be serious (the steroids can stop your body defending itself against these diseases which can become severe and widespread). If you develop these infections you will need immediate treatment in hospital. Corticosteroids may mask some signs of infection and new infections may appear during their use. Your doctors will try to use the smallest dose necessary to help you. However there may be times when an increase in dose will be needed. Any reduction in dose will need to be made more slowly than an increase. Your doctor will explain this to you and will probably give you a “steroid treatment card” to show to other doctors while you need to take steroids (including by mouth). Steroid treatment cards are also available from your pharmacist.

Very occasionally your body might give you “withdrawal effects” after taking steroids or during dose reduction, including fever, tiredness and aches and pains in muscles and joints. You should tell your doctor if you develop such symptoms even though there may be other causes for these symptoms.

Corticosteroids can lead to raised blood pressure, ankle swelling (by retention of salt) and a loss of potassium in your water. Your doctor will monitor your condition and treat these if they arise. Steroids are also used cautiously, even if necessary, if a patient taking them has a heart attack.

Corticosteroids effects can be greater in patients with hypothyroidism (when the thyroid gland doesn't make enough thyroid hormone) or cirrhosis (a serious scarring of the liver) and your doctor may need to adjust the dose.

You should also tell the doctor if you:

•    suffer from heart failure or have had a recent heart attack

•    suffer from high blood pressure

•    suffer from kidney or liver problems

•    suffer from diabetes or a relative has diabetes

•    suffer from or have had a stomach or duodenal ulcer

•    suffer from osteoporosis (thinning and weakness of the bone)

•    have suffered from muscle weakness with this or other steroids in the past

•    suffer from myasthenia gravis (a disease causing weak muscles)

•    suffer from an eye infection with the herpes virus

•    suffer from glaucoma (increased pressure within the eye) or a relative has glaucoma

•    suffer from epilepsy

•    suffer from schizophrenia

•    have previously had tuberculosis

•    have previously had amoebiasis (an infection which is specific to tropical countries and causes diarrhoea)

If high doses of this medicine are administered, you may be advised to reduce salt intake and to take extra potassium in the form of tablets. Dexamethasone Injection contains 1.8 mmol (or 42 mg) sodium per maximum single dose of the medicinal product (420 mg for a person with 70 kg bodyweight).

To be taken into consideration by patients on a controlled sodium diet.

In the case of local injection of Dexamethasone Injection (e.g. injection into a joint), your doctor will take special care to reduce the particular risk of bacterial infection. This medicine should not be injected directly into an infected site. Please tell your doctor if you suffer from complications like a marked increase in pain accompanied by local swelling, further restriction of joint motion, fever or malaise after a local injection of this medicine. Your doctor will have to check if you suffer from blood poisoning and take the appropriate action. Injection into unstable joints should be avoided. Please be advised not to over-use joints that are still diseased, even if you do not suffer pain! All patients taking steroid drugs for more than a few days should carry “steroid treatment” cards, which are available from your doctor or pharmacist. These cards carry details of your medicine and your doctor. If you have an accident, fall ill, require any surgery (including at the dentist's) or are to have any vaccinations (especially with so-called “live virus vaccines”) during or after treatment with Dexamethasone Injection you must tell the doctor treating you that you are taking or have taken steroids.

Preterm neonates (premature babies)

Dexamethasone should not be used routinely in preterm neonates with respiratory problems.

Children

If the patient is a child, the doctor will monitor growth and development at intervals during treatment because this medicine can cause growth retardation. Treatment will be limited, where possible, to a single dose on alternate days.

Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Dexamethasone Injection:

•    aspirin or similar medicines

•    phenytoin (used to treat epilepsy)

•    barbiturates (sedative drugs used to treat sleeplessness and epilepsy)

•    ephedrine (for nose decongestion)

•    antibiotics called rifampicin and rifabutin (used to treat tuberculosis)

•    carbamazepine (used to treat epilepsy, pain and manic depression)

•    aminoglutethimide (an anticancer medicine)

•    anticoagulant medicines which thin the blood e.g. warfarin

•    medicines for diabetes

•    certain diuretics (water tablets)

•    antiretroviral medicines e.g. ritonavir, darunavir, indinavir, lopinavir, saquinavir and efavirenz

Because of the interactions with these drugs, your doctor might have to adjust the dosage of the medication given to you.

If you are receiving certain anticoagulants at the same time, your doctor will frequently check your blood clotting, in order to reduce the chance of bleeding.

Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection

is suitable for you.

When dexamethasone is administered for prolonged periods or repeatedly during pregnancy, there may be an increased risk for growth retardation in the unborn child.

If you are taking high doses of this medicine for prolonged periods and you are breast-feeding, your infant may take up dexamethasone through the breast milk. Your doctor will monitor this.

Driving and using machines:

You should not drive or use machinery if you are

affected by the administration of Dexamethasone Injection.

3.    How to use Dexamethasone Injection

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given. Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much or that you will miss a dose. If you think you have been given too much or that you have missed a dose, please contact your doctor immediately.

Effects when treatment with Dexamethasone Injection is stopped:

It can be dangerous to have your treatment with Dexamethasone Injection stopped abruptly. After prolonged therapy your body may have gotten used to the administration of this medicine and may have reduced the normal production of hormones like the one contained in this medicine. How your treatment is stopped will depend on the disease you are being treated for and how much Dexamethasone Injection you have been given.

It may be necessary to reduce the amount of Dexamethasone Injection you are given gradually until you stop having it altogether.

Your doctor has to make sure that the disease you have been treated for is unlikely to relapse. Dosage reduction must be adjusted if you are subjected to unusual stress (e.g. another illness, trauma or surgical procedures).

When the treatment is stopped too quickly, withdrawal symptoms like fever, muscle pain, joint pain and tiredness may occur. Too rapid a reduction following prolonged treatment can lead to insufficiency of hormone production in the adrenal gland and low blood pressure (symptoms of which can be tiredness, dizziness, headache, palpitation). In extreme cases this may be fatal.

In a few cases, mental health problems have occurred when doses are being lowered or stopped - see section 4 below.

Therefore, if you suffer from any withdrawal symptoms, please tell your doctor as soon as possible!

4.    Possible side effects

Like all medicines, Dexamethasone Injection can cause side effects, although not everybody gets them. Some side effects can happen straight away while others may take weeks or months.

If you feel unwell in any way, keep receiving your medicine, but see your doctor straight away If you experience any of the following please contact your doctor immediately as you may need urgent medical attention!

•    An allergic reaction which may include a sudden itchy rash, swelling of the extremeties (such as your hands and feet) and a swelling of your mouth and throat (which may cause difficulty in breathing

•    If you experience sudden and (in cases of longterm therapy) unusual effects like a feeling you are going to faint, bleeding, extreme weakness, or a sudden pain in any of your organs,

The following unwanted side effects have been reported for Dexamethasone Injection and are listed below according to the organs that are affected.

Psychiatric disorders (mental health problems)

Steroids including dexamethasone 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 dexamethasone.

•    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.

Carers of patients receiving Dexamethasone Injection should talk to a doctor immediately if the patient shows any signs of mental health pjjj problems. This is particularly important if the patient appears to be depressed, or mentions thoughts of suicide.

If you suffer from schizophrenia or epilepsy your symptoms may worsen.

Infections and infestations

You may experience more frequent and severe infections without noticing the symptoms as well as opportunistic infections (caused by a usually harmless microorganism in case of an impaired immune system) or the recurrence of dormant tuberculosis.

Abnormal growth of tissue You may develop sterile abscesses (enclosed collections of pus, likely to turn into hard solid lumps as they scar).

Blood systems

There may be an abnormal increase in the number of white blood cells.

Hormonal (endocrine disorders)

Menstrual irregularities, lack of menstruation, abnormal hair growth, development of Cushingoid state (symptoms of which include central obesity with thin arms, thinning of the skin with easy bruising, muscle wasting and weakness, high blood pressure, uncontrolled blood sugar, osteoporosis).

Children and adolescents may have suppressed growth. Your response to stress caused by trauma, surgery or illness may be reduced. You may also experience decreased carbohydrate tolerance, onset of latent diabetes mellitus, increased need for insulin or other medicines if you are diabetic.

Metabolism and nutrition disorders You may notice that you gain weight or have an increased appetite. Your body may also have difficulty in handling nitrogen, calcium, sodium or potassium appropriately.

Nervous system disorders You may feel increased pressure in your head with impaired vision, vertigo, headache or in preterm infants cerebral palsy (malformation of the brain) may occur.

Eye disorders

You may develop cataracts or feel increased pressure in the eye or notice abnormal bulging out of the eyeballs or thinning of the cornea or the white, outer coat of the eyeball. Your vision may become blurred due to congestion of the optic disc or glaucoma with possible damage to the optic nerves. Secondary eye infections due to fungi or viruses can occur as can rare instances of blindness associated with local therapy around the face and head. Premature babies may suffer retinopathy.

Disorders of the blood vessels or heart

High blood pressure, blood clots in the veins.

Susceptible patients may develop heart failure,

or the heart tissue may rupture following a recent heart attack. In infants with a low birth weight a heart muscle disease (hypertrophic cardiomyopathy) may occur.

If you are treated for multiple myeloma with dexamethasone in combination with lenalidomide or thalidomide you will have an increased risk of thromboembolic events including: Deep vein thrombosis (a blood clot in the veins of your leg) - a symptom of this is leg pain; Pulmonary embolism (a blood clot in the arteries leading to your lungs) - a symptom of this is chest pain or shortness of breath.

Disorders of the stomach or the digestive system You may suffer nausea, hiccups, heartburn or reflux or infection or inflammation of the tube that leads to your stomach. Peptic ulcer may occur with possible bleeding or perforation of the small and large bowel (particularly if you have inflammatory bowel disease). Your pancreas may become inflamed (pancreatitis) or your stomach may swell.

Skin disorders

Your skin may become thin or fragile with red or blood spots or bruising or it may become lighter or darker (hypo- or hyperpigmentation).

Your face may become unusually red or you may have acne, swelling around the eyes, mouth and hands, hives, allergic dermatitis or stretch marks. Wounds may take longer to heal, skin tests may be affected and you may sweat more.

After injection into a vein you may feel a burning or tingling sensation especially in the perineal area (skin between anus and genital organs).

Muscle and bone disorders You may suffer muscle weakness, loss of muscle mass, osteoporosis (loss of bone density) especially if you are postmenopausal, vertebral compression fractures (collapsing of a bone in the spine), aseptic necrosis of femoral and humeral heads (severe knee and hip joint problem, possibly requiring replacement joints), fracture of long bones, tendon rupture, postinjection flare (following local injection e.g. into a joint).

Reproductive system

The number and activity of spermatozoa may be affected in men.

General disorders

You may have a general ill feeling.

Many of these side effects are serious therefore please tell your doctor about your symptoms as soon as possible.

Please note that it is very important that you do not suddenly stop taking this medicine (even if you are suffering from a side effect) unless your doctor tells you to (see “Effects when treatment with Dexamethasone Injection is stopped" in the previous section of this leaflet).

If you think this injection is causing you any problems, or you are at all worried, talk to your Bjj doctor, nurse or pharmacist.

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.    Storing Dexamethasone Injection Store below 25°C. Do not freeze.

Keep the container in the outer carton, in order to protect from light.

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

On the label you will find the letters “exp. date” followed by some numbers. These numbers are the date when the medicine is no longer fit for use.

Do not use this medicine after this date.

6.    Further information

What Dexamethasone Injection contains:

This injection contains the active ingredient dexamethasone sodium phosphate.

Dexamethasone 3.3 mg/ml Injection

Each ml of solution for injection contains 4 mg of

dexamethasone phosphate (as dexamethasone

sodium    phosphate)    equivalent    to    3.3    mg    of

dexamethasone.

Dexamethasone 6.6 mg/ml Injection

Each ml of solution for injection contains 8 mg of

dexamethasone phosphate (as dexamethasone

sodium    phosphate)    equivalent    to    6.6    mg    of

dexamethasone.

Dexamethasone 8.3 mg/ml Injection

Each ml of solution for injection contains 10 mg of

dexamethasone phosphate (as dexamethasone

sodium    phosphate)    equivalent    to    8.3    mg    of

dexamethasone.

This injection contains the following inactive ingredients: propylene glycol, disodium edetate, sodium hydroxide and water for injections.

What Dexamethasone Injection looks like and contents of the pack:

Dexamethasone Injection is a clear, colourless and sterile solution    contained    in    clear glass

ampoules.

Dexamethasone 3.3 mg/ml Injection is available in packs of 1, 5 and 10 ampoules, each ampoule containing 1 ml or 2 ml solution.

Dexamethasone 6.6 mg/ml Injection is available in packs of 1, 5 and 10 ampoules, each ampoule containing 5 ml solution.

Dexamethasone 8.3 mg/ml Injection is available in packs of 1 and 5 ampoules, each ampoule containing 10 ml solution.

Not all pack sizes may be marketed.

The marketing authorisation numbers of these medicine are

Dexamethasone 3.3 mg/ml Injection:

PL 01502/0079

Dexamethasone 6.6 mg/ml Injection:

PL 01502/0080

Dexamethasone 8.3 mg/ml Injection:

PL 01502/0081

Marketing authorisation holder:

hameln pharmaceuticals ltd Nexus, Gloucester Business Park Gloucester, GL3 4AG, United Kingdom

Manufacturer:

•    hameln pharmaceuticals gmbh

Langes Feld 13, 31789 Hameln, Germany

•    hameln rds a.s.

Horna 36, 900 01 Modra, Slovak Republic

•    HBM Pharma s.r.o.

03680 Martin, Slabinska, Slovak Republic

For any information about this medicine, please contact the marketing authorisation holder

This leaflet was last approved 13.09.2013

46696/37/13