PACKAGE LEAFLET: INFORMATION FOR THE USER Promethazine Hydrochloride Injection BP 2.5% w/v

Read all of this leaflet carefully because it contains important information for you.

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

You should contact a doctor if your symptoms worsen or do not improve

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

IN THIS LEAFLET

1.    What Promethazine Hydrochloride Injection is and what it is used for

2.    Before you are given Promethazine Hydrochloride Injection

3.    How Promethazine Hydrochloride Injection is given

4.    Possible side effects

5.    How to store Promethazine Hydrochloride Injection

6.    Further information

1.    WHAT PROMETHAZINE HYDROCHLORIDE INJECTION IS AND WHAT IT IS USED FOR

Promethazine Hydrochloride is an antihistamine. Antihistamines help to relieve the symptoms of some allergies.

Promethazine Hydrochloride is used :

•    In the treatment of allergic conditions

•    As pre-medication prior to an anaesthetic (for a calming effect, to prevent nausea and vomiting, and to prevent too much secretion from forming in the mouth and lungs)

•    As a sedative (calming effect) and hypnotic (to induce sleep)

2.    BEFORE YOU ARE GIVEN PROMETHAZINE HYDROCHLORIDE INJECTION You should NOT be given Promethazine Hydrochloride Injection if you:

•    are allergic to Promethazine or to any other ingredient in this medicine (Listed in Section 6 below) or to any phenothiazine drug

•    are taking a monoamine oxidase inhibitor (MAOI) drug for depression or if you have taken one within the past 14 days.

Promethazine Hydrochloride should not be given to patients who are unconscious (in a coma) and to children less than 2 years of age.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before having Promethazine hydrochloride Injection.

Take special care with Promethazine Hydrochloride Tell your doctor before you are given this medicine if you:

•    have difficulty in breathing, wheezing, tightness in the chest (asthma) or an infection in your lungs (bronchitis)

•    have coronary heart disease or any serious heart problems

•    have increased pressure in the eye (glaucoma)

•    suffer from fits (epilepsy) or if you have severe headache.

•    are sick and confused following a viral illness (suffer from Reye's Syndrome)

•    have a disease of the liver, kidneys or bladder

•    have an enlarged prostate gland or if you have difficulty in passing water

•    feel raised pressure in brain .

•    use this medicine with painkiller such as salicylates.

•    have an obstruction (blockage) in your stomach or intestine

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before having Promethazine hydrochloride Injection.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

This includes medicines you can buy without prescription, including herbal medicines. This is because Promethazine Hydrochloride Injection can affect the way some medicines work. Also some medicines can affect the way Promethazine Hydrochloride Injection works.

Talk to your doctor if you are taking any of the following:

•    antidepressant drug called monoamine oxidase inhibitors (MAOIs) in last two weeks.

•    anticholinergic drugs (which can be present in various medicines, including some for treating tummy problems, urine incontinence or Parkinson’s disease)

•    tricyclic antidepression drugs or other drugs to treat depression

•    sedatives, sleeping tablets

•    medicines for high blood pressure

•    medicines that can cause your skin to over react to sunlight (such as aspirin or salicylates)

•    any medicine that can cause liver problems, eye changes or changes in the rhythm of your heart

•    medicines for fits (epilepsy)

Your doctor may need to change the dose of your medicine.

Promethazine can interfere with some laboratory tests. If you are having a urine test for pregnancy or a skin test for allergy, tell your doctor that you are being treated with Promethazine Hydrochloride injection.

You should avoid strong sunlight as the skin may over react.

If you are not sure ask your doctor or pharmacist

Taking your medicine with food and drink: Do not drink alcohol whilst you are receiving Promethazine Hydrochloride .

Pregnancy and Breast feeding: If you are pregnant, or planning to become pregnant ask your doctor for advice before taking any medicine. You should not take Promethazine Hydrochloride during pregnancy or whilst breast feeding unless considered essential by your doctor.

Driving and using machines: Promethazine Hydrochloride may affect your reaction time and may cause drowsiness, confusion or dizziness. If affected, do not drive or operate machinery. This effect will be worse if you are also taking sedatives or drinking alcohol.

Important information about some of the ingredients of Promethazine Hydrochloride

•    Promethazine Hydrochloride Injection contains sodium metabisulphite (E223) which may rarely cause severe allergic or hypersensitivity reactions and difficulty in breathing, wheezing and tightness in the chest (bronchospasm).

•    This medicinal product also contains less than 1 millimoles per dose of sodium (0.0813 millimoles) i.e. essentially sodium free.

3. HOW PROMETHAZINE HYDROCHLORIDE INJECTION IS GIVEN

This medicine will normally be given to you by a doctor or nurse. Promethazine Hydrochloride Injection is given by deep injection into a muscle. In emergencies, it may be diluted (see below) and injected slowly into a vein. If you feel the effect of your medicine is too weak or too strong, tell your doctor.

Adults: The usual dose is 25 to 50mg (1ml to 2ml) by deep injection into a muscle. In an emergency, 25mg (1ml) may be diluted to 10 times its volume with water for injections. The diluted solution may then be injected slowly into a vein at a rate not exceeding 25mg per minute. The maximum dose by injection is 100mg (4ml).

Children aged 2 - 10 years

•    Children aged five to 10 years may be given a dose of 6.25 to 12.5mg (1/4 to % of 1ml) by deep injection into a muscle.

•    Caution should be exercised when giving this medicine to children two years of age and older

Children less than 2 years: Promethazine Hydrochloride Injection should NOT be given to children under the age of two years.

If you are given more Promethazine Hydrochloride than you should

As Promethazine Hydrochloride Injection is administered by a healthcare professional it is unlikely that you will be given too much. In this event, you will be treated in the hospital and you will be given the necessary treatment.

If you are at all concerned, speak to your doctor.

If you miss a dose of Promethazine Hydrochloride Injection

This is unlikely as the injection is given by a healthcare professional but if you are concerned about missing a dose, speak to your doctor.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Promethazine Hydrochloride can cause side effects, although not everybody gets them.

If the following happens, tell your doctor immediately:

•    A severe allergic reaction (swelling of the face, lips, mouth or throat leading to severe difficulty in breathing or swallowing; skin rash, itching or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. The following side effects have been reported with Promethazine Hydrochloride. Tell your doctor if you notice any of the following:

•    Drowsiness, dizziness, restlessness, headache, low blood pressure, nightmares or tiredness

•    Feeling confused about days, dates, people or places

•    Over-excitement (some children may show this effect)

•    Confusion, disorientation, blurred vision, dry mouth or difficulty in passing water (elderly patients are more susceptible to these effects)

•    Tummy upset or loss of appetite

•    Faintness, palpitation or change in normal heartbeat

•    Twitching of the head or face, or other odd movements.

•    Tiredness which lasts for a long time. This may be due to a blood problem called anaemia.

•    Yellowing of the skin or the whites of the eyes

•    Bruising of the skin, persistent sore throat or fever

•    An abnormal reaction of the skin to sunlight (avoid strong sunlight)

•    Pain, inflammation or swelling at the site of the injection.

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

5.    HOW TO STORE PROMETHAZINE HYDROCHLORIDE INJECTION

•    Keep out of the reach and sight of children.

•    Do not use after the expiry date printed on the ampoule and carton.

•    Do not store above 25°C.

•    Keep the ampoule in the outer carton in order to protect from light.

•    If only part of the contents of an ampoule are used, the remaining solution should be discarded.

•    For single use only.

6.    FURTHER INFORMATION

What Promethazine Hydrochloride Injection contains:

•    The active ingredient is Promethazine hydrochloride

•    The other ingredients are sodium metabisulphite (E223), sodium sulphite anhydrous and sodium chloride in water for injections

What Promethazine Hydrochloride Injection looks like and contents of the pack

•    Promethazine Hydrochloride Injection BP 2.5% w/v is a clear, colourless or almost colourless sterile solution for injection. Each 1ml of solution contains 25mg of Promethazine hydrochloride.

•    The product is presented in clear glass ampoules

•    Each pack contains 10 x 1ml and 10 x 2ml ampoules.

Marketing Authorisation Holder:

Mercury Pharma International Ltd 4045, Kingswood Road,

City West Business Park,

Co Dublin, Ireland

Manufacturer:

Lomapharm Rudolf Lohmann GmbH KG, Langes Feld 5, 31860, Emmerthal,

Germany.

This leaflet was last approved in March 2012.