0.5 mg / ml injection solution
atropine sulfate
1. What Atropine Mylan is and what it is used for
Atropine Mylan belongs to a group of medicines called anticholinergics. Atropine sulfate, the active substance in Atropine Mylan, temporarily blocks certain nerve endings. This reduces glandular secretions, causes certain muscles (eg in the intestines) to relax and the heart to beat faster.
Atropine Mylan is used:
- for relaxation of muscles in the gastrointestinal tract in case of cramps
- to reduce the secretion of saliva, lung secretions, and / or gastric juice
- for the treatment of slow heartbeats
- as medication during surgery.
Atropine sulfate contained in Atropin Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions
What you need to know before you take Atropine Mylan
Do not use Atropine Mylan
- if you are allergic to atropine sulfate or any of the other ingredients of this medicine (listed in section 6).
- if you have difficulty urinating (eg if you are a man and have an enlarged prostate).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Atropine Mylan.
Special care must be taken with:
- patients who have heart disease with arrhythmia
- patients with narrowing of the lower abdomen
- children with high fever
Children
Atropine Mylan should be used with caution in children, especially if they have a high fever.
Other medicines and Atropine Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There is no known effect of Atropine Mylan and other medicines.
Pregnancy and breastfeeding
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 taking this medicine.
There are no known risks when used during pregnancy.
Atropine sulfate passes into breast milk in such large quantities that there is a risk of affecting the baby. Atropine Mylan should therefore not be used during breast-feeding.
Driving and using machines
A common side effect of this drug is impaired nearsightedness and blurred vision, which should be considered when driving.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Atropine Mylan with preservative contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)
Atropine Mylan with preservative contains 0.8 mg methyl parahydroxybenzoate (E 218) and 0.2 mg propyl parahydroxybenzoate (E 216) per ml solution for injection. These ingredients can cause an allergic reaction (possibly delayed) and exceptionally spasm of the trachea.
Benzoates can increase the risk of jaundice (yellowish skin and eyes) in newborns (up to 4 weeks of age).
Atropine Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per ml solution for injection, ie is essential ‘sodium-free’.
How to take Atropine Mylan
Atropine Mylan is given as an injection by a doctor or a specially trained nurse. The injection can be given under the skin or directly into the bloodstream (in a friend).
Your doctor will decide which dose is right for you.
If you take more Atropine Mylan than you should
It is unlikely that you will receive too much of this medicine as it is only given by a doctor or nurse. If you suspect that you have been given too much, tell your doctor or nurse immediately.
Overdose of Atropine Mylan may cause dry mucous membranes and skin, thirst, flushing, arrhythmia, rapid breathing, dilation of pupils, blurred vision, fever, difficulty urinating, restlessness, seizures, disturbed state of mind, hallucinations (seeing and hearing not present), unconsciousness, high blood pressure and circulatory collapse in severe cases.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, an allergic reaction may develop. It can cause a skin rash, severe itching, scaling of the skin, swelling of the face (especially around the lips and eyes), swelling of the throat and difficulty breathing or swallowing, fever, dehydration, shock, and fainting. All of these side effects are very serious. Tell your doctor immediately if you get any of these side effects.
The most common side effect is dry mouth and affects most patients. Dry mouth involves the risk of tooth and mucous membrane damage during prolonged use.
The side effects depend on the dose you are given.
Common side effects (may affect up to 1 in 10 people):
- fast heartbeat
- hurried mood swings, confusion, hallucinations (at high doses )
- dimsyn
- dry mouth
- difficulty urinating
Rare side effects (may affect up to 1 in 1,000 people)
- allergic reactions
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Atropin Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Store in the outer carton. Sensitive to light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is atropine sulfate. 1 ml contains 0.5 mg of atropine sulfate.
- The other ingredients for 0.5 mg/ml solution for injection with preservative are sodium chloride, hydrochloric acid (for pH adjustment), water for injections, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216).
- The other ingredients for 0.5 mg/ml solution for injection are sodium chloride, hydrochloric acid (for pH adjustment), water for injections.
What the medicine looks like and the contents of the pack
0.5 mg/ml injection solution with preservatives: Vial of glass 20 ml.
0.5 mg / ml solution for injection : Glass ampoule is 10×1 ml
Marketing Authorization Holder and Manufacturer
Mylan AB
Box 23033
104 35 Stockholm
Manufacturer