Betnesol 4mg/Ml Injection

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•Betnesol is a steroid medicine, prescribed for many different conditions, including serious illnesses.

•You need to use it regularly to get the maximum benefit.

•Don’t stop using this medicine without talking to your doctor - you may need to reduce the dose gradually.

•Betnesol can cause side effects in some people (read section 4 on side effects 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 medicine, 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 on side effects for more information). •If you use 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 06/2015.

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.

In this leaflet:

1. What Betnesol is for

2. Before you use Betnesol

3. How to use Betnesol

4. Possible side effects

5. How to store Betnesol

6. Further information.

1. What Betnesol is for

Betnesol 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 Betnesol) is an effective way to treat various illnesses involving inflammation in the body. Betnesol 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.

Betnesol Injection is used to treat:

• Asthma

• Severe allergic reactions including reactions to drugs

• Local inflammation eg. of joints, tendons or the eye

• As replacement for the body’s naturally occurring corticosteroid hormones when these are reduced or absent

• 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 use Betnesol

Do not use Betnesol if:

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

• You have an infection and have not yet started taking medicine (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 Betnesol

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

If either of these applies to you, talk to a

doctor before taking Betnesol.

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 this 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

• 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

• 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) and oral contraceptive (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.

Betnesol may also affect the results of gallbladder X-ray procedures.

If any of the above applies to you, talk to

your doctor before taking Betnesol.

Mental problems while using Betnesol;

Mental health problems can happen while taking steroids like Betnesol (see also 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 happen they might 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 it 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 Betnesol Injection. Taking steroids often or for a long 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 Betnesol” below).

3. How to use Betnesol

If you are breastfeeding, the steroid may enter the baby and lower their hormone levels if you are taking high doses for a long time.

Warnings about the ingredients in Betnesol Betnesol 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 taking Betnesol if this applies to you.

Always use Betnesol exactly as your doctor has told you.

Important: Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

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).

Betnesol 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 have Betnesol Injection.

The dose used will depend upon the disease, its severity, and how quickly you get better. Betnesol Injection is not intended for long term use. The following are for guidance only:

Local injections excluding eye:

Adults: 4 - 8mg (l-2ml), repeated up to 3 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: 2mg (0.5ml)

Children up to 1 year: lmg (0.25ml)

These doses can be repeated up to 4 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 use more Betnesol 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 forget to use Betnesol Injection

If you forget to have a dose, i.e. miss your doctor’s appointment; see your doctor as soon as possible.

If you stop using Betnesol

Do not stop using Betnesol without first talking to your doctor.

It is very important that you do not suddenly stop using Betnesol even if you feel better from 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, itching eyes, nose or skin, mood changes, loss of weight, low hormone levels, and 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 Betnesol Injection.

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

4. Possible side effects

Like all medicines Betnesol 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 2 weeks your doctor will prescribe as low a dose as possible. High doses taken for a long time or repeated

uch 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), or 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 problems, or worsening of epilepsy or schizophrenia if you already have either of these problems.

• Children may experience swelling and fluid build-up near the eyes and brain (this may result in a throbbing headache which may be worse upon waking up, coughing, or sudden movement, and patchy vision with blind spots and possible lack of colour vision).

• Increased pressure in the eye (glaucoma) cataract, worsening of viral or fungal diseases, thinning of the cornea or sclera (the outer membrane of the eye) or other eye problems (which may cause headaches or blurred vision).

• Heartburn or indigestion, hiccups, nausea, bloating of the abdomen, stomach ulcers which may bleed, oesophageal ulcei; thrush in the mouth or throat, or pancreas disorders.

• Bruising, poor wound healing, abscesses, acne, rashes, thinning of the skin, prominent veins, changes in skin colour, or blistering of the skin, mouth, eyes and genitals.

• Blood clots, or allergic reactions (which can include rashes, breathing difficulties or shock), blood disorders, or heart failure.

Additional care should be taken if this medicine

is given to elderly patients, as side-effects may

be more serious.

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 Betnesol

Keep out of the reach and sight of children.

Do not use Betnesol after the expiry date on the label. The expiry date refers to the last day of that month.

package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

6. Further information

What Betnesol Injection contains

The active substance is betamethasone sodium phosphate at a concentration of 4 milligrams (mg) betamethasone in 1 millilitre (mL) of sterile solution in water.

The other ingredients are disodium edetate, sodium metabisulphite, sodium chloride, sodium hydroxide, hydrochloric acid and water for injection.

What Betnesol Injection looks like

Betnesol Injection is a solution supplied in ampoules containing 1ml, in boxes of 5.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited,

Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, UK.

Manufacturer

Wasserburger Arzneimittelwerk GmbH, HerderstraBe 2, D-83512 Wasserburg, Germany Carrying your steroid card If your doctor asks you to carry a steroid card, be sure to keep it with you always.

Show it to any doctor, dentist, nurse or midwife or anyone else who is giving you treatment. Even after your treatment has finished tell any doctor, dentist, nurse, midwife or anyone else who is giving you treatment that you have had steroid treatment.

A steroid card may be obtained from your doctor; pharmacist, or local Family Health Service Authority. In Scotland, steroid cards are available from the Scottish Office of Home and Health.

This leaflet was last updated 06/2015.

If this leaflet is difficult to see or read or you would like it in a different format, please contact Focus Pharmaceuticals Limited, Unit 5, Faraday Court,

First Avenue, Centrum 100, Burton upon Trent,

Staffordshire, DE14 2WX, UK.

FOCUS

tel:

01283 495280 fax:

01283 495290

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