Document: leaflet MAH GENERIC_PL 01883-6135R change

• leaflet MAH GENERIC_PL 01883-6135R
• leaflet MAH GENERIC_PL 35104-0008

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In this leaflet:

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

2.    Before Hyoscine Injection is given

3.    How Hyoscine Injection is given

4.    Possible side effects

5.    How to store Hyoscine Injection 5. Further information

This leaflet contains a summary of the information available for this medicine. You should ask your doctor or nurse if you are unsure about any aspect of this medicine.

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

Hyoscine Injection is used to treat nausea (feeling sick), vomiting (being sick), vertigo, loss of balance and motion sickness.

Hyoscine Injection is also used to prevent you from producing too much saliva if you have been given a general anaesthetic.

2.    Before Hyoscine Injection is given

You should not be given Hyoscine Injection if:

•    you suffer from increased pressure in the eye (glaucoma)

•    you suffer from acute porphyria (a blood disease)

•    you are in labour.

Take special care with Hyoscine Injection Tell your doctor or nurse if:

•    you have difficulty passing urine

•    you have heart disease

•    you are unable to pass faeces due to a paralysis of the bowel

•    you suffer from a narrowing of the exit from the stomach (pyloric stenosis)

•    you have asthma

•    you have a blockage in your 'guts' (gastrointestinal obstruction)

•    you have liver or kidney problems

•    you have epilepsy (fits)

•    you have thyroid gland problems

•    you are elderly.

Taking with other medicines

Please tell your doctor or the nurse if you are taking, or have ecently taken any other medicines, including medicines obtained without prescription. In particular:

•    anaesthetics

•    medicines used to treat depression, including tricyclic antidepressents e.g. amitriptyline, monoamine oxidase inhibitors (MAOIs) e.g. phenelzine

•    medicines used to treat sleep problems (sedatives and hypnotics) e.g. nitrazepam

•    muscle relaxants e.g. atracurium

•    medicines used to treat conditions which affect the way you feel, think or act such as schizophrenia e.g. phenothiazines like chlorpromazine

•    medicines used to treat Parkinson's disease (dopaminergics) e.g. amantadine

•    medicines used to treat allergies (antihistamines) e.g. cetirizine

•    medicines used to regulate the heartbeat (antiarrhythmics) e.g. disopyramide

•    medicines used for pain relief e.g. nefopam

•    medicines used to prevent chest pain (angina) e.g. sublingual nitrates

•    cisapride, a drug used to relieve heartburn

•    metoclopramide or domperidone, drugs used to treat nausea (feeling sick) and vomiting (being sick).

Using Hyoscine Injection with food and drink

You are advised not to drink alcohol whilst being treated with Hyoscine Injection.

Pregnancy and breast-feeding

This medicine will not be given to you if you are pregnant unless your doctor has specifically recommended it.

Driving and using machines

Hyoscine Injection may affect your eyesight and cause drowsiness. If affected, do not drive or use machinery until you are OK to do so.

3.    How Hyoscine Injection is given

This medicine is an injection which will be given to you by a doctor. Your doctor will determine the dose you require. It will be given under the skin or into a muscle.

Adults and the elderly

Treatment of nausea (feeling sick), vomiting (being sick), vertigo (feeling dizzy and light headed), loss of balance and motion sickness:

•    200 micrograms as a single dose.

Preventing excessive production of saliva if you have been given a general anaesthetic:

•    200-600 micrograms given 30-60 minutes before the anaesthetic.

Children over 4 months of age

Treatment of nausea (feeling sick), vomiting (being sick), vertigo (feeling dizzy and light headed), loss of balance and motion sickness:

•    6 micrograms per kg of body weight as a single dose.

Preventing excessive production of saliva if you have been given a general anaesthetic:

•    15 micrograms per kg of body weight given 30-60 minutes before the anaesthetic.

If you think you have been given too much Hyoscine Injection

This medicine is given to you by your doctor so it is unlikely you will receive too much. Your doctor has information on how to recognise and treat an overdose.

If you experience any of the following please speak to your doctor or nurse immediately:

•    excitement, delirium

•    dilated pupils

•    fast pulse

•    hot flushes

•    dry skin, dry mouth, thirst

•    difficulties breathing

•    circulatory collapse.

4.    Possible side effects

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

Possible side effects include:

•    drowsiness, blurred vision

•    dry mouth, thirst

•    difficulty passing urine

More rarely you may experience:

•    excitement, confusion, delirium

•    rashes

•    slow heartbeat

Elderly patients may also experience the following side effects:

•    jerky or irregular movements (ataxia)

•    hallucinations (seeing or hearing things that aren't real)

•    changes in behaviour (acting in a way you wouldn't normally)

•    feeling sleepy

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 nurse.

5.    How to store Hyoscine Injection

Keep out of the reach and sight of children.

You should not be given this medicine if it has passed the expiry date shown on the label. The expiry date refers to the last day of that month. The doctor or nurse will check this.

Protect from light.

6.    Further Information

What Hyoscine Injection contains

The active ingredient is Hyoscine Hydrobromide BP 0.04% w/v and 0.06% w/v. The other ingredients are sodium chloride, dilute hydrobromic acid and water for injections.

What Hyoscine Injection looks like and contents of the pack

Hyoscine Injection is a clear, colourless solution supplied in clear glass 1ml ampoules. It is supplied in cartons containing ten ampoules.

Marketing Authorisation Holder and Manufacturer

Martindale Pharmaceuticals, Harold Hill, Romford, Essex, RM3 8UG

This leaflet was last revised in: July 2012

Product License Numbers: PL 1883/6175R PL 1883/6135R

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.

100mm Measurement Verification Bar