PACKAGE LEAFLET: INFORMATION FOR THE USER    D00301

Atropine Sulphate Injection BP 1mg in 5ml (Pre-filled Syringe)

Atropine Sulphate

(Referred to as Atropine Injection in this leaflet)

Read all of this leaflet carefully before you are given Atropine Injection

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

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

•    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.

In this leaflet:

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

2.    Before Atropine Injection is given

3.    How Atropine Injection is given

4.    Possible side effects

5.    How to store Atropine Injection

6.    Further information

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

Atropine belongs to a group of medicines called antimuscarinics. These medicines are often used in anaesthesia to reduce the flow of saliva and other body fluids. Atropine may also act on the vagus nerve (a nerve that sends information from the brain to other parts of the body). This helps to make the heart beat faster.

Atropine Injection is used to raise the heart rate if it has become too slow after a heart attack

2.    Before Atropine Injection is given

You should not be given Atropine Injection if:

•    you are allergic (hypersensitive) to Atropine or any of the other ingredients listed in Section 6 of this leaflet

•    you have problems with your prostate, often indicated by difficulty passing urine, particularly in elderly men

•    you have glaucoma (increased pressure in the eye)

•    you have difficulty having bowel movements because you have paralysis of the bowel (paralytic ileus)

•    you have a condition called pyloric stenosis which means that it is difficult for food to move from your stomach into the small intestine and which causes pain or vomiting

•    you have a muscle weakening disease known as myasthenia gravis

•    you have an inflamed gut with symptoms of blood and mucus in the faeces.

Take special care with Atropine Injection Tell your doctor if:

•    you have a fever

•    you have diarrhoea

•    you have problems passing urine

•    you have a heart disorder or high blood pressure

•    you have acid reflux with heartburn (gastro-oesophageal reflux)

•    you have Down's Syndrome

•    you have lung disease

•    you have had a heart attack or heart failure

•    you suffer from an overactive thyroid or other thyroid problems

•    you have had heart surgery.

•    Special care will be taken when giving this medicine to children and the elderly and when the weather is hot as this can affect how Atropine Injection works.

If any of the above applies to you, please tell your doctor.

Taking other medicines

Please tell your doctor or nurse if you are taking, or have recently taken, any other medicines including medicines obtained without prescription.

Medicines which may interact with Atropine Injection include:

•    medicines used to treat allergies (antihistamines)

•    medicines used to treat depression (SSRIs and tricyclic antidepressants) such as paroxetine

•    medicines used to treat severe depression known as monoamine oxidase inhibitors (MAOIs)

•    medicines used to treat schizophrenia and other mental disorders (phenothiazines) such as haloperidol and clozapine

•    drugs used in the treatment of Parkinson's disease such as amantidine and levodopa

•    metoclopramide, a medicine used to stop you being sick

•    medicines used to stabilise the heart beat e.g. disopyramide, mexilitine and digoxin

•    nefopam, a pain killer

•    drugs used to treat fungal infections such as itraconazole and ketoconazole

•    medicines that are designed to be placed under the tongue e.g. sublingual nitrates

•    medicines used to treat bacterial infections (antibiotics) such as erythromycin and clarithromycin

•    medicines used to treat HIV such as ritonavir and atazanavir

•    medicines used to treat high blood pressure (calcium channel blockers) such as verapamil

•    medicines used to treat feeling or being sick such as domperidone and metoclopramide

•    ciclosporin, a medicine used to prevent rejection after an organ transplant and to treat certain skin conditions

•    memantine, a medicine used to treat Alzheimer's disease

•    medicines used to treat the muscle disorder myasthenia gravis and to reverse the effects of an anaesthetic such as neostigmine, edrophonium chloride and pyridostigmine bromide

•    pilocarpine, a medicine used to treat raised pressure in the eye (glaucoma)

•    medicines used to treat difficulty passing urine such as bethanechol chloride and distigmine bromide

Continued overleaf

Pregnancy and breast-feeding

This medicine should be avoided if you are pregnant, trying to become pregnant or breast-feeding, unless your doctor has recommended it.

Driving and using machines

Atropine Injection may affect your vision or your mood (you might become excited or delirious or become confused). If you feel at all unwell you should not drive or use machinery.

Having Atropine Injection with food and drink

You are advised not to drink alcohol during your treatment with this medicine

3.    How Atropine Sulphate 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 into a vein.

Adults, the elderly and children over 12 years of age:

•    0.5mg into a vein, followed by further doses of 0.5mg if necessary, up to a maximum of 3mg.

Children under 12 years of age:

This medicine is not recommended for children under 12.

If you think you have been given too much Atropine 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 are concerned about your treatment, please talk to your doctor.

4.    Possible side effects

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

If any of the following symptoms occur tell your doctor or nurse immediately. These are symptoms of a serious allergic reaction.

•    sudden wheeziness and tightness of chest

•    swelling of eyelids, face or lips

•    skin lumps or hives

•    skin rash (red spots), itchiness, fever

•    collapse

Other possible side effects include:

•    dilated pupils and sensitivity to light

•    blurred vision or difficulty focusing

•    hot flush

•    dry skin

•    dry mouth, difficulty swallowing and thirst

•    a dry cough

•    an irregular heart beat (arrhythmias)

•    difficulty passing urine

•    constipation.

Rare side effects include:

•    fever

•    a feeling of confusion, particularly if you are elderly

•    a rash

•    feeling sick and being sick

•    excitement

•    feeling giddy

•    raised pressure in the eye (angle closure glaucoma).

If any of these side effects get serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or nurse.

5.    Storing Atropine Sulphate 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 that the product has not passed this date.

Store below 25°C. Protect from light.

6.    Further Information

What Atropine Injection contains:

The active ingredient is Atropine Sulphate 0.02% w/v.

The other ingredients are water for injections, sulphuric acid and nitrogen.

What Atropine Injection looks like and contents of the pack:

Atropine Injection is a clear, colourless solution supplied in 5ml prefilled syringes.

The Marketing Authorisation Holder:

Aurum Pharmaceuticals, Bampton Road, Harold Hill, Romford,

RM3 8UG, UK.

Manufacturer:

Martindale Pharmaceuticals, Bampton Road, Harold Hill, Romford, RM3 8UG, UK.

Product Licence Number: PL 12064/0035 Date of revision: September 2008

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

MARTINDALE

Pharmaceuticals

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom