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Hyoscine Injection Bp 400mcg/Ml

Document: leaflet MAH GENERIC_PL 35104-0008 change

Patient Information Leaflet: Hyoscine 400 mcg/ml Solution for Injection BP Hyoscine hydrobromide



Read all of this leaflet carefully before you are given

this medicine.

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

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

•    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, Hyoscine 400 mcg / ml Solution for Injection will be called Hyoscine injection.

In this leaflet:

1.    What Hyoscine injection is for

2.    Before you are given Hyoscine injection

3.    How you will be given Hyoscine injection

4.    Possible side effects

5.    How to store Hyoscine injection

6.    Further information.

1. What Hyoscine injection is for

Hyoscine injection belongs to a group of medicines

called antimuscarinic or anticholinergic drugs.

Hyoscine injection is used to prepare you before you

have an operation. It works by:

•    Drying up the secretions in your mouth, nose and chest

•    It prevents spasms in your lungs and throat. This makes anaesthesia (being put to sleep) smoother for you

•    It helps to keep your heartbeat steady during anaesthesia and intubation (having a breathing tube put in your throat).

Your doctor has decided you need Hyoscine injection

to avoid possible problems during your operation.

2. Before you are given Hyoscine injection

Do not use Hyoscine injection if:

•    You are allergic to hyoscine hydrobromide or any of the other ingredients in Hyoscine injection (see Section 6)

•    You have glaucoma (raised pressure inside the eye)

•    You have porphyria (a blood disorder that may cause a rash, skin yellowing and stomach pain)

•    You are elderly (65 years or older).

If any of the above applies to you tell your doctor or

nurse.

Check with the doctor or nurse before they give you

Hyoscine injection if:

•    You have heart disease or any circulation problems

•    You have a blocked stomach, intestine or bowel, or these are not working properly

•    You have any liver or kidney problems

•    You are a man with prostate problems (difficulty in passing urine)

•    You have epilepsy

•    You have Down’s Syndrome

•    You have myasthenia gravis (a condition that causes muscle weakness).

PHOENIX LABS

Tell your doctor if you are taking any of the following medicines:

•    Disopyramide, a drug used to treat tachycardia (abnormally fast heart beat)

•    Tricyclic antidepressants (drugs to treat depression) such as amitriptyline, imipramine or dothiepin

•    Monoamine oxidase inhibitors (drugs to treat depression) such as phenelzine

•    Phenothiazines (used to treat psychiatric problems)

•    Amantadine (used to treat Parkinson’s Disease)

•    Nitrate drugs such as glyceryl trinitrate (spray or under-the-tongue tablets) for angina (chest pain)

•    Antihistamines (drugs used to treat allergic reactions)

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

Using with Alcohol

Alcohol increases the effects of Hyoscine injection and can make you ill. Tell your doctor if you have been drinking alcohol before you are given Hyoscine injection.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding tell your doctor before you are given Hyoscine Injection.

Driving and using machines

Do not drive or use machinery as this medicine may make you feel drowsy.

Important information about Sodium

This medicine contains less than 1 mmol of sodium per ml. This means it is essentially 'sodium-free'.

3. How you will be given Hyoscine injection

Important:

Your doctor will choose the dose that is right for you. The doctor will decide whether Hyoscine injection is injected into a muscle, a vein or under the skin.

Remember: Hyoscine injection will be given to you by a doctor, nurse or anaesthetist in hospital. Usually it will be given to you 30 and 60 minutes before you are put to sleep for your operation.

Adults

•    The usual dose is 200 to 600 micrograms given as an injection into a muscle or under the skin. In an emergency Hyoscine injection may be injected by the doctor into a vein.

Children

•    The usual dose for children is 15 micrograms per kilogram of bodyweight. The exact dose will be calculated by your doctor.

Elderly

•    Hyoscine injection is not recommended for use in the elderly.

If you are given more Hyoscine injection than you should

If you think you have been given too much of this medicine, tell your doctor immediately.

Symptoms of an overdose include rapid breathing and heartbeat, large pupils, restlessness, excitement, high temperature, confusion and hallucinations.

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

4.    Possible side effects

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

Seek immediate medical help if you have any of the following symptoms:

•    Breathing difficulties

•    Severe allergic reactions resulting in swelling or itching of the skin or collapse

Other side effects are:

•    Drowsiness

•    Dry mouth

•    Dizziness

•    Blurred vision

•    Difficulty in passing urine

•    Slow heart beat

•    Feeling confused or excited.

If any of these side effects gets serious or 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.

Do not use Hyoscine injection after the expiry date on the carton. The expiry date refers to the last day of that month.

Store below 25°C. Keep in the original container in order to protect from light.

Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

6. Further information

What Hyoscine injection contains

•    The active substance is hyoscine hydrobromide (400 micrograms/ml)

•    The other ingredients are: hydrobromic acid, sodium hydroxide (E524) and water.

What hyoscine injection looks like

Hyoscine injection comes in sealed 1 ml clear glass containers called ampoules. Each box of Hyoscine injection contains either 5 or 10 ampoules.

Marketing Authorisation Holder:

Phoenix Labs, Suite 12, Bunkilla Plaza,

Bracetown Business Park, Clonee, Co. Meath, Ireland. Manufacturer:

Labiana Pharmaceuticals, S.L.U., C/ Casanova 27-31, Corbera de Llobregat, Barcelona, (Spain)

This leaflet was last updated July 2014.

If this leaflet is difficult to see or read or you would like it in a different format, please contact Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park,

Clonee, Co. Meath, Ireland.

1710080-A00