Package leaflet: Information for the patient

Atropine Sulfate injection

atropine sulfate

Important information about your medicine

►    Your doctor or nurse will give you the injection

►    If this injection causes you any problems talk to your doctor, nurse or pharmacist

►    Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine

►    Please tell your doctor or pharmacist, if you are taking any other medicines

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. In some circumstances this may not be possible

and this leaflet will be kept in a safe place should you wish to read it.

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

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

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

2.    What you need to know before you are given Atropine Sulfate Injection

3.    How to use Atropine Sulfate Injection

4.    Possible side effects

5.    How to store Atropine Sulfate Injection

6.    Contents of the pack and other information

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

Atropine Sulfate Injection belongs to a group of medicines known as anticholinergics. It is used:

•    before general anaesthesia to reduce saliva secretions.

•    to restore normal heartbeat during a cardiac arrest.

•    as an antidote to some insecticides and in mushroom poisoning.

•    in combination with other drugs to reverse the effect of muscle relaxants used during surgery.

2.    What you need to know before you are given Atropine Sulfate Injection

You should NOT be given Atropine Sulfate injection:

•    if you are sensitive or allergic to Atropine Sulfate or to any of the other ingredients (listed in section 6) in this injection.

•    if you suffer from closed-angle glaucoma (a condition that affects your eyes).

•    if you are a man with an enlarged prostate.

•    if you suffer from myasthenia gravis (weakness of breathing muscles).

•    if you suffer from pyloric stenosis (a narrowing of the opening that takes food away from your stomach).

•    if you suffer from paralytic ileus (your intestine stops functioning properly).

•    if you suffer from ulcerative colitis - a disease of the colon and rectum.

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before being given Atropine Sulfate Injection:

•    if you have urinary difficulties

•    if you have heart failure

•    if you have had a heart attack

•    if you have had a heart transplant

•    if you have chronic pulmonary obstructive disease (a condition where the airflow to your lungs is restricted and you may cough and feel breathless)

•    if you have an overactive thyroid

•    if you have high blood pressure

•    if you have fever

•    if you have diarrhoea

•    if you have reflux oesophagitis (heartburn)

Other medicines and Atropine Sulfate injection:

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Atropine Sulfate Injection:

•    medicines to treat psychosis or depression.

•    amantadine (a medicine for Parkinson's Disease)

•    antihistamines (medicines used to treat hayfever and allergies

•    medicines to regulate your heart (disopyramide and mexiletine)

•    ketoconazole (a medicine to treat fungal infections).

•    medicines that you take by allowing them to dissolve slowly in your mouth - atropine may cause your mouth to become dry, making it more difficult for these medicines to dissolve.

Pregnancy and breast feeding:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Atropine Sulfate Injection.

3. How to use Atropine Sulfate Injection

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

if you are given more Atropine Sulfate injection than you should:

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. if you think you have been given too much, or you begin to feel your heart beating very fast, you are breathing quickly, have a high temperature, feel restless, confused, have hallucinations, or lose co-ordination you must tell the person giving you the injection immediately.

4.    Possible side effects

Like all medicines, Atropine Sulfate Injection can cause side effects, although not everybody gets them. The following side effects have been reported:

•    drowsiness

•    blurred vision

•    dry mouth with difficulty swallowing

•    thirst

•    dilation of the pupils

•    flushing

•    dryness of the skin

•    slow heart beat followed by fast heart beat

•    palpitations (you are aware of your heart beating)

•    difficulty in passing urine or constipation

•    vomiting

•    rashes

•    confusion

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme - website: www.mhra.gov.uk/ yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Atropine Sulfate Injection

Keep this medicine out of the sight and reach of children.

Your injection will be stored at less than 25°C and protected from light.

Do not use this medicine after the expiry date which is stated on the label and carton after “Exp. date”. The expiry date refers to the last day of that month.

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last revised in December 2014

44171/52/14

6. Contents of the pack and other information What Atropine Sulfate injection contains:

The active ingredient is Atropine Sulfate. Each 1 ml of solution contains 600 micrograms in a sterile solution for injection.

The other ingredients are sulfuric acid and water for injections.

What Atropine Sulfate injection looks like and contents of the pack:

Atropine Sulfate Injection is a supplied in 1 ml clear glass ampoules. 10 ampoules are supplied in each carton.

The marketing authorisation number of this medicine is: PL 01502/0016R

Marketing Authorisation Holder:

hameln pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh Langes Feld 13, 31789 Hameln, Germany

hameln rds a.s.

Horna 36, 900 01 Modra, Slovak Republic

HBM Pharma s.r.o.

03680 Martin, Sklabinska, Slovak Republic