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• leaflet MAH GENERIC_PL 20046-0281

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Betamethasone 4mg/ml Solution for Injection

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.

Read all of this leaflet carefully before you are given this medicine.

•    Keep this leaflet. You many 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.

•    In this leaflet Betamethasone 4mg/ml Solution for Injection will be called Betamethasone Injection.

In this leaflet:

1.    What Betamethasone Injection is for

2.    Before you are given Betamethasone Injection

3.    How you will be given Betamethasone Injection

4.    Possible side effects

5.    How to store Betamethasone Injection

6.    Further information

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1. What Betamethasone Injection is for

Betamethasone Injection 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 corticosteroids (such as Betamethasone Injection) is an effective way to treat various illnesses involving inflammation in the body. Betamethasone Injection reduces this inflammation, which could otherwise go on making your condition worse. You must use this medicine regularly to get maximum benefit from it.

Many different conditions can be improved by the use of corticosteroids, as they reduce inflammation (redness, tenderness, heat and swelling) in the body.

Betamethasone Injection is used to treat:

•    to treat asthma;

•    to treat severe allergic reactions including reactions to drugs;

•    to treat local inflammation e.g. of joints, tendons or the eye;

•    as replacement for the body's naturally occurring corticosteroid hormones when these are reduced or absent;

•    to treat severe shock, (collapse) due to surgery, injury or overwhelming infection.

Corticosteroids are also used to help prevent organ transplant rejection following organ transplant surgery.

2. Before you are given Betamethasone

Injection

Do not use Betamethasone Injection if:

•    You are allergic to betamethasone or any of the other ingredients of Betamethasone Injection (see section 6).

•    You have an infection and have not yet started taking any medication (e.g. antibiotics) to treat it.

If any of the above applies to you talk to

your doctor or pharmacist.

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 Betamethasone Injection.

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

If either of these applies to you, talk to a

doctor before taking Betamethasone

Injection.

Talk to your doctor:

•    If you have, or have ever had tuberculosis (TB).

•    If you have epilepsy (fits), severe mental illness, heart disease, hypertension (high blood pressure), stomach or duodenal ulcers, diverticulitis (inflammation of the bowel) or a herpes infection of the eye.

•    If you have osteoporosis (thinning of the bones). Post menopausal women are particularly at risk of this.

•    If you or any of your family have ever had glaucoma (raised eye pressure).

•    If you have recently had a heart attack.

•    If you have had a stroke, or if there is a history of stroke in your family.

•    If you have recently had a head injury.

•    If you have recently been in contact with someone who has chickenpox, shingles or measles, or recently had chickenpox, shingles or measles yourself. This product may make chickenpox, shingles or measles much worse.

•    If you or any of your family are diabetic.

•    If you have an underactive thyroid gland.

•    If you have myasthenia gravis (a disease which causes muscle weakness).

•    If you have ever suffered from muscle wasting due to corticosteroids.

•    If you have liver, kidney or heart disease.

•    If you have just been or are about to be immunised.

•    If you have an infection.

•    If you are pregnant or breast-feeding (see “Pregnancy and breast-feeding" section below).

Tell your doctor if you are taking any of the

following medicines:

•    Insulin or oral antidiabetic drugs.

•    Medicines for high blood pressure.

•    Water tablets (diuretics).

•    Medicines for thinning the blood e.g. warfarin.

•    Non-steroidal anti-inflammatory drugs e.g. ibuprofen.

•    Salicylates e.g. aspirin.

•    Medicines for myasthenia gravis called anticholinesterases.

•    Medicines for the heart called cardiac glycosides.

•    Acetazolamide (used to treat glaucoma).

•    Rifampicin and rifabutin (antibiotics for tuberculosis) and ephedrine.

•    Carbamazepine, phenytoin, primidone, phenobarbitone and aminoglutethimide for epilepsy.

•    Carbenoxolone (an ulcer healing drug), theophylline (used to treat asthma and other breathing difficulties) and amphotericin B (anti-fungal).

•    Ritonavir (anti-viral for infections) or oral contraceptives (the pill).

•    Mifepristone (anti-progesterone).

•    Somatropin (growth hormone).

•    Vecuronium and other muscle relaxants.

•    Fluoroquinolones (used for some infections).

•    Quetiapine (improves symptoms of some mental illnesses).

•    Tretinoin (used for skin problems such as bad acne).

•    Any other medicine, including medicines obtained without a prescription.

Betamethasone Injection may also affect the results of gall-bladder X-ray procedures.

If any of the above applies to you, talk to your doctor before taking Betamethasone Injection. Mental problems while using Betamethasone Injection

Mental health problems can happen while taking steroids like Betamethasone Injection (see section 4 on 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 occur they may need treatment.

Talk to a doctor if you (or someone who is taking this medicine) shows 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.

Chickenpox, shingles or measles

You should avoid contact with anyone who has either, chickenpox, shingles or measles, as it could be extremely serious if you caught any of these from them.

Advise your doctor immediately if you suspect you may have come into contact with a person who has chickenpox, shingles or measles. However do not stop using this medicine, unless your doctor tells you to.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Betamethasone Injection.

Taking steroids often, or for a long period of time, during pregnancy, can slow the baby's growth in the womb or may temporarily affect the baby’s heart and body movements.

Sometimes the baby may get digestive juices going up into the tube that carries food from the mouth to the stomach. The baby may also make less of its own steroid after birth, but this rarely causes any problems. If you become pregnant whilst taking this medicine, please tell your doctor but DO NOT stop treatment unless told to do so (see section 3 "If you stop taking Betamethasone Injection” below).

If you are breast-feeding, the steroid may enter the baby and lower their hormone levels, if you are taking high doses for a long period of time.

Warnings about the ingredients in Betamethasone Injection

Betamethasone Injection contains sodium metabisulphite (0.1% w/v) as a preservative and should not be used to treat patients with known hypersensitivity to bisulphite or metabisulphite. It also contains sodium and may not be suitable for people on a controlled sodium diet. Tell your doctor or pharmacist before you are given Betamethasone Injection if this applies to you.

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3. How you will be given Betamethasone Injection

Important: Your doctor will choose the dose that is right for you.

You may have been given a steroid card which also tells you how many injections you need each day (see section 6 “Carrying your steroid card" below).

Betamethasone Injection can be given slowly into a vein, deep into a muscle or locally at the site of inflammation. It should not be injected directly into tendons. Your doctor will decide where, how much and how often you should be given Betamethasone Injection.

The dose used will depend upon the disease, its severity, and how quickly you get better. Betamethasone Injection is not intended for long term use.

The following are for guidance only:

Local injections (excluding eye):

Adults: 4-8mg (1 -2ml), repeated up to three times.

Children may have a smaller dose.

Eye injections:

Adults and children: 2-4mg (0.5- 1ml).

Other injections: Adults: 4 - 20mg (1 - 5ml). Children 6 - 12 years: 4mg (1ml).

Children 1 - 5 years: 2 mg (0.5ml).

Children up to 1 year: 1 mg (0.25ml).

These doses can be repeated up to four times a day.

If you have any queries about the amount of medicine you have been prescribed, ask your doctor.

While you are using this medicine, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you.

If you are given more Betamethasone Injection than you should

If you think you have been given too much of the injection, immediately tell your doctor or nurse. The dose may be reduced slowly over time to minimise any effects.

If you miss a dose of Betamethasone Injection

If you miss a dose, i.e. miss your doctor's appointment see your doctor as soon as possible.

If you stop Betamethasone Injection

Do not stop Betamethasone Injection without

first talking to your doctor.

It is very important that you do not suddenly stop Betamethasone Injection even if you feel better lirom your original illness, or are suffering from a side effect unless your doctor tells you to. If you stop taking your medicine too suddenly, you may suffer from some of the following, fever, joint and muscle pain, itchy eyes, nose or skin, mood changes, loss of weight, low hormone levels or low blood pressure (symptoms of which may include dizziness, headaches or fainting). In extreme cases this can be fatal. Your doctor will tell you how to stop using Betamethasone Injection.

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

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4. Possible side effects

Like all medicines Betamethasone Injection can cause side effects, although not everybody gets them.

Serious effects: tell a doctor straight away

Steroids including betamethasone 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 betamethasone.

•    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.

Most people find that using this medicine for a short time causes no problems. If you need to take the injections for more than two weeks, your doctor will prescribe as low a dose as possible.

High doses taken for a long period of time, or repeated short courses, can lead to side effects such as:

•    Low levels of hormones which can cause irregular menstrual periods in women, suppression of growth in adolescents and children, changes in blood sugar, salt or protein levels, extra hair growth and/or weight gain, increased sweating, or increases in appetite.

•    Increased levels of cholesterol in your blood.

•    Increased susceptibility to infection, including worsening of tuberculosis (TB), if this is already present.

•    Wasting of muscles, thinning of the bones (osteoporosis) or fractures, breaking of tendons and breakdown of the bone due to lack of blood supply.

•    Water retention (which may cause a bloated feeling), higher blood pressure (symptoms may include headaches) or changes in blood chemistry due to loss of potassium.

•    If you have recently had a heart attack, betamethasone can sometimes cause a serious complication of the heart, whereby the tissues can become affected by tears or breaks.

•    Mood changes, depression, sleep

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