Patient leaflet - Atropine Sulfate 3 mg in 10 ml solution for injection in Pre-filled
1. What Atropine Solution for injection is and what it is used for 2. What you need to know before you are given Atropine Solution
for injection
- 3. How Atropine Solution for injection is given
- 4. Possible side effects
- 5. How to store Atropine Solution for injection
- 6. Contents of the pack and other information
- 1. What Atropine Solution for 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 or to restart the heart.
Atropine Injection is also used to treat pesticide and mushroom poisoning and can be used as an antidote for overdose of cholinesterase inhibitors (a type of medicine usually used to treat the symptoms of Alzheimer’s disease).
2. What you need to know before you are given Atropine Solution for injection
You should not be given Atropine Solution for injection if you:
- are allergic to atropine sulfate or any of the other ingredients of this medicine (listed in Section 6).
- have urinary difficulties.
- have elevated pressure in the eye (glaucoma) .
- have a disease of the muscles causing drooping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms or legs (myasthenia gravis).
- are breast-feeding.
- have difficulty having bowel movements because you have paralysis of the bowel (paralytic ileus).
- 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.
- have an inflamed gut with symptoms of blood and mucus in the faeces.
Warnings and precautions
Talk to your doctor, pharmacist or nurse if you:
- suffer from an overactive thyroid or other thyroid problems. • suffer from prostatic disease.
- suffer from liver or kidney disease.
- have had a heart attack or heart failure.
- have an irregular heart rhythm.
- have fever or when the room temperature is high. • are elderly.
- have lung disease.
Taking other medicines
Other medicines and Atropine Solution for injection
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines including medicines obtained without prescription.
Medicines which may interact with Atropine Solution for injection include:
- medicines used to treat psychosis or depression (tricyclic antidepressants) e.g. imipramine, amitriptyline.
- medicines used to treat hay fever and allergies (antihistamines) e.g. mequitazine
- medicines used to treat Parkinson’s disease (antiparkinsonian medicines) e.g. trihexyphenidyl, carbidopa-levodopa • medicines used to treat mental illness e.g. phenothiazine, or neuroleptic medicines
- medicines used to treat heart diseases e.g. quinidine, disopyramide. • medicines used to treat irritable bowel conditions (atropinic antispasmodics) e.g. hyoscine, alverine
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Atropine should not be used during pregnancy unless clearly necessary.
Breast-feeding
Atropine is passed into breast milk which may have effects on the infant. Therefore, Atropine should not be used while breast-feeding. Driving and using machines
Atropine Solution for injection may affect your vision or your mood (you might become excited or delirious or become drowsy). You should not drive or use machinery after being given this injection.
3. How Atropine Solution for injection is given This medicine is an injection which will be given to you by a doctor or nurse.
Your doctor will determine the dose you require. It will be given into a muscle or a vein (if a suitable vein is not available then it could be administered using an endotracheal (ET) tube which is inserted into the windpipe).
Your doctor will decide the correct dose you require Adults, the elderly and children over 12 years of age: As treatment to restart the heart:
- 3mg (in 10ml) into a vein
- repeated if necessary up to a maximum dose of 6mg. As an antidote to cholinesterase inhibitors:
- 2mg into a vein or muscle
- Repeated every 5-10 minutes until symptoms are reversed. As treatment for pesticide and mushroom poisoning:
- 2mg into a vein or muscle
- Repeated every 10-30 minutes until symptoms are reversed. As treatment to increase heart rate:
- 0.3mg into a vein or under the skin
- Increasing to 1mg if necessary.
Children under 12 years of age:
Not recommended.
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 Solution for injection can cause side effects, although not everybody gets them.
The following side effects have been reported.
Contact your doctor or nurse immediately if you get any of the following:
- Sudden life – threatening allergic reaction such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing. Other Side effects include:
- blurred vision
- increase in pressure in the eye
- dry mouth
- nausea
- thirst
- dilation of the pupils
- uncomfortable sensitivity to light (photophobia)
- decrease in tears production in the eyes
- flushing
- dryness of the skin
- fast heart beat ( tachycardia)
- palpitations (you are aware of your heart beating) • difficulty in passing urine
- constipation
- vomiting
- nervousness
- confusion especially in the elderly
- thickening of the phlegm produced while coughing
- restlessness
- hallucinations
- changes in the way the heart beats (arrhythmias) • severe confusion ( delirium)
Reporting of side effects
If you get any side effects, talk to your doctor 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.
5. How to store Atropine Solution for injection
Keep out of the sight and reach 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. Contents of the pack and other information
What Atropine Solution for injection contains:
Each 1ml of solution contains 0.3 mg of the active substance Atropine Sulfate.
Each pre-filled syringe (10 ml) contains 3 mg of the active substance Atropine Sulfate.
The other ingredients are water for injections, sulfuric acid and nitrogen.
What Atropine Solution for injection looks like and contents of the pack:
Atropine Injection is a clear, colourless solution supplied in 10ml prefilled syringes.
No needles are provided with this pre-filled syringe. The Marketing Authorisation Holder:
Aurum Pharmaceuticals, T/A Martindale Pharma, Bampton Road, Harold Hill, Romford,
RM3 8UG, United Kingdom.
Manufacturer:
Martindale Pharmaceuticals Ltd, Bampton Road, Romford, RM3 8UG, United Kingdom.
Product Licence Number: PL 12064/0057
This leaflet was last revised in: December 2016
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.
Read all of this leaflet carefully before you are given Atropine Solution for injection because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please 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.
Atropine Sulfate 3mg in 10ml Solution for injection
in pre-filled syringe
Atropine Sulfate (Referred to as Atropine Solution for injection in this leaflet)
Package leaflet: Information for the user C100474
100mm Measurement Verification Bar
3318-G