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Hospira

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dexamethasone 3.3 mg/ml Solution for Injection

(3.3 mg/1 ml ampoules)

•    Dexamethasone 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.

•    Dexamethasone 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 taking your tablets, 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 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 chicken pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox 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.

This leaflet was last updated in 04/2016

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 this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. WHAT DEXAMETHASONE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR

Dexamethasone Solution for Injection belongs to a group of medicines called steroids.

It is used in acute conditions in which oral steroid treatment is not possible, such as:

•    Shock (e.g. after an accident, after surgery or due to blood poisoning).

•    Swelling of the brain because of a brain tumour.

•    Diseases of joints and soft tissues, such as rheumatoid arthritis.

•    Allergic reactions.

These conditions often require the use of other medicines in addition to corticosteroids.

2. BEFORE YOU USE DEXAMETHASONE SOLUTION FOR INJECTION

Do not use Dexamethasone Solution for Injection if you have:

• Shown signs of severe allergy

(hypersensitivity) to dexamethasone or any of the other ingredients of Dexamethasone Solution for Injection (see section 6 below) in the past.

•    An infection affecting the whole body which is not being treated with antibiotics (dexamethasone treatment may still be used if it is considered to be life saving).

Tell your doctor or pharmacist if either of the above applies to you before this medicine is used.

Check with your doctor first:

•    If you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like dexamethasone.

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

If either of these applies to you, talk to a doctor before taking dexamethasone.

Take special care with Dexamethasone Solution for Injection and check with your doctor first if you have:

•    Liver, kidney or heart problems

•    High blood pressure

•    Epilepsy

•    A history of migraines

•    Osteoporosis (thinning of the bones)

•    Had tuberculosis in the past

•    An under-active thyroid

•    Had amoebiasis in the past (infection specific to tropical countries which causes diarrhoea)

•    A herpes infection of the eye

•    Diabetes (or a family history of diabetes)

•    An eye disease called glaucoma (or a family history of glaucoma)

•    Stomach ulcers

•    Experienced muscle weakness caused by previous steroid treatment.

Special care will be taken if Dexamethasone Solution for Injection is to be given to babies or children.

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

Taking/using other medicines

You should not be vaccinated with a live vaccine while having steroid therapy. Tell your doctor or pharmacist if you are planning to have a vaccination.

Special care is needed if you are taking/using other medicines as some could interact with dexamethasone, for example:

•    Barbiturates (medicines for treating sleep disorders and epilepsy)

•    Ephedrine (a medicine that is used as a nasal decongestant or for respiratory conditions)

•    Rifampicin and rifabutin (antibiotics that are used for treating tuberculosis)

•    Primidone, phenytoin, carbamazepine (medicines to treat epilepsy)

•    Aminoglutethimide (an anti-cancer medicine)

•    Anticoagulants (medicines used to thin the blood)

•    Insulin and other medicines used to treat diabetes

•    Aspirin and other anti-inflammatory drugs (medicines for treating pain and inflammation)

•    Acetozolamide (a medicine for treatment of the eye disorder glaucoma)

•    Diuretics (water tablets)

•    Carbenoxolone (a medicine for treating stomach ulcers)

•    Digoxin and other medicines which regulate heart beat

•    Antihypertensives (medicines used to treat high blood pressure)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding.

If you receive dexamethasone often or over a long period of time during pregnancy there may be a risk that the baby's growth slows down. The baby may need careful observation for a short time after being born.

If you are being given dexamethasone for a long time during breast-feeding then the baby's growth may slow down and it may have other side effects (see Section 4). Your doctor will discuss this with you and decide whether you should receive dexamethasone.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive or use machines if you experience any side effect which may lessen your ability to do so.

Important information about one of the ingredients of Dexamethasone Solution for Injection

This medicine contains 0.26 mmol sodium (6 mg) per 20 mg dose i.e. essentially "sodium-free”.

3. HOW TO USE DEXAMETHASONE SOLUTION FOR INJECTION

This medicine may be given intravenously (injection into a vein), intramuscularly

Dexamethasone 3.3 mg/ml Solution for Injection

The following information is intended for medical or healthcare professionals only

Dexamethasone Solution for Injection is for intravenous, intramuscular, intraarticular and intralesional use.

The intravenous and intramuscular route of administration of dexamethasone should only be used where acute illness or life-threatening situations exist. Oral therapy should be substituted as soon as possible.

Each 1 ml of the solution for injection contains 3.3 mg dexamethasone (as sodium phosphate) which is equivalent to 4 mg dexamethasone phosphate or 4.3 mg dexamethasone sodium phosphate.

Incompatibilities

Dexamethasone (as sodium phosphate) is physically incompatible with daunorubicin, doxorubicin and vancomycin and should not be admixed with solutions containing these

H03300 700244 Code 244

Component Specification

Item number:	H03300
Request number:	N/A
Country:	United Kingdom
OI template:	WBI002
Amalia version:	9
Dimensions:	500 x 144 mm
Container(s):	Ampoule
Supplier:	Wasserburger
Stock:	n/a
Folded dimensions:	n/a
Printed both sides:	Yes
Perforated:	No
Pharma code:	244
Pharma code length:	14.5 mm
Supplier Code:	700244
Colours
Black:	■ 1

Requester

I have checked this artwork against the registered text including spelling, layout, size, colours, registration numbers and scientific equations, the name and address and trademarks. Also for any possible changes to related items.

This artwork is in conformance with the Marketing Authorisation and can now proceed to the printing stage.

Previous Item Number: Q75037

Signed:

Date:

(injection into a muscle) or directly into a joint or soft tissue. This medicine may also be diluted with glucose or sodium chloride solution and given as a slow injection via a drip into a vein (infusion).

Dose

The dose of medicine given to you will depend on your age and medical condition and will be carefully adjusted by your doctor.

You are unlikely to need Dexamethasone Solution for Injection for more than a week or two, unless you receive it for treatment of arthritic joints when treatment may carry on for longer. If dexamethasone treatment needs to continue you may be given tablets, rather than an injection.

This medicine suppresses your body's natural ability to make its own corticosteroids. As a result, during prolonged treatment, any new illness, trauma or surgical procedure will require a temporary increase in dosage; if corticosteroids have been recently stopped they may need to be started again.

Mental problems while taking 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 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 are given too much or too little Dexamethasone Solution for Injection

This medicine will be given to you by a doctor or nurse. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

When you stop using Dexamethasone Solution for Injection

Do not stop taking this medicine suddenly as this might be dangerous. Your doctor will tell you how the treatment will be gradually reduced. When treatment is stopped, a "withdrawal syndrome” can happen, which includes fever, muscle pain, joint pain, inflammation of the lining of the nose, eye discomfort (conjunctivitis), painful itchy skin lumps and loss of weight. In children raised pressure in the skull may occur: if they complain of a headache, have a fit or are sick then tell a doctor immediately.

In a few cases, mental problems (see section 4 Possible Side Effects) have happened when doses are being lowered or stopped.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dexamethasone Solution for Injection can cause side effects, although not everybody gets them.

If any the following happen, tell your doctor straight away:

•    Severe allergic reaction - you may

experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

•    Severe infection and/or fever which makes you feel very ill.

These are very serious side effects. You may need urgent medical attention. All of these very serious side effects are rare.

Serious effects: tell a doctor straight away

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 taking/using dexamethasone should talk to the doctor straight away if the patient shows any signs of mental problems. This is particularly important if the patient appears to be depressed, or mentions thoughts of suicide.

^----------

drugs. It is also incompatible with doxapram hydrochloride and glycopyrrolate in a syringe.

Instructions for use and handling

When dexamethasone (as sodium phosphate) is given by intravenous infusion only Sodium Chloride Injection BP or Glucose Injection BP should be used as diluents. The exact concentration of dexamethasone (as sodium phosphate) per infusion container should be determined by the desired dose, patient fluid intake and drip rate required.

The product should only be used when the solution is clear and particle free.

If any of the following happen, tell your doctor as soon as possible:

•    Fits

•    Epilepsy or schizophrenia made worse

•    Breathlessness

•    Severe thirst or passing urine more than usual (may indicate raised blood sugar levels)

•    Water retention (swelling) and high blood pressure

•    Muscle weakness

•    You feel that you or your surroundings are spinning

•    Eye disorders including cataracts and glaucoma, infections of the eye may become worse

•    Swelling and weight gain of the face and body, excess body hair

•    Osteoporosis (thinning of the bones) -the doctor may ask you to have a bone scan to check for this

•    Slow growth in children or teenagers (the doctor will check for this)

•    You feel you are picking up minor infections too easily

•    Irregular periods or absence of periods in women

•    Indigestion, stomach ulcers and pain in stomach and back

•    Skin disorders such as slow healing of wounds, increased bruising, broken veins or stretch marks on the skin, increased sweating, rashes, or changes in skin pigmentation, raised itchy coloured lumps on the skin, itchy red rash with flaky white patches (thrush), acne

•    Headache

•    Pain, redness or swelling at the injection site (if the injection is into a joint)

•    Increased appetite

Many of the above side effects only occur after high dose treatment or if treatment continues for a long period of time.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE DEXAMETHASONE SOLUTION FOR INJECTION

Keep out of the reach and sight of children Expiry

This medicine must not be used after the expiry date which is stated on the ampoule and carton after 'EXP'. Where only a month and year is stated, the expiry date refers to the last day of that month.

Storage

The ampoules should be kept in the outer carton, in order to protect from light, and stored at or below 25°C. Do not freeze.

Unused portions of opened ampoules must not be stored for later use.

Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 24 hours in a refrigerator.

Visible signs of deterioration

Only clear, particle free solutions should be used.

Disposal

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Dexamethasone Solution for Injection contains

The active substance is dexamethasone. Each millilitre (ml) of solution contains 3.3 milligrams (mg) of dexamethasone (as sodium phosphate) which is equivalent to 4 mg dexamethasone phosphate or 4.3 mg dexamethasone sodium phosphate.

The other ingredients are sodium citrate, creatinine, sodium hydroxide, hydrochloric acid and Water for Injections.

What Dexamethasone Solution for Injection looks like and contents of the pack

This medicine is presented in glass containers called ampoules. Each millilitre (ml) of solution contains 3.3 milligrams (mg) of dexamethasone (as sodium phosphate) which is equivalent to 4 mg dexamethasone phosphate or 4.3 mg dexamethasone sodium phosphate. It is available in packs containing 5 ampoules.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and company responsible for batch release in the European Union is Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK.

This leaflet was last revised in April 2016

For single use only. Discard any unused contents.

In-use storage precautions

From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

H03300 700244 Code 244

Component Specification

Item number:	H03300
Request number:	N/A
Country:	United Kingdom
OI template:	WBI002
Amalia version:	9
Dimensions:	500 x 144 mm
Container(s):	Ampoule
Supplier:	Wasserburger
Stock:	n/a
Folded dimensions:	n/a
Printed both sides:	Yes
Perforated:	No
Pharma code:	244
Pharma code length:	14.5 mm
Supplier Code:	700244
Colours
Black:	■ 1

Requester

I have checked this artwork against the registered text including spelling, layout, size, colours, registration numbers and scientific equations, the name and address and trademarks. Also for any possible changes to related items.

This artwork is in conformance with the Marketing Authorisation and can now proceed to the printing stage.

Previous Item Number: Q75037

Signed:

Date: