0.1 mg/ml solution for injection in a pre-filled syringe
Atropine sulfate
1. What Atropine Stragen is and what it is used for
Atropine Stragen belongs to a group of medicines called anticholinergics. Atropine sulfate, the active substance in Atropine Stragen, 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 Stragen is used:
- for the treatment of slow heartbeats and conditions associated with slow heartbeats.
- before general anesthesia to dry up saliva and fluid in the lungs.
- as an antidote after an overdose of drugs called anticholinesterases and poisoning of certain insecticides, nerve gases, and fungal poisoning.
2. What you need to know before you are given Atropine Stragen
You must not be given Atropine Stragen
- if you are allergic to atropine sulfate or any of the other ingredients of this medicine (listed in section 6).
- if you have problems urinating (eg if you are a man and have an enlarged prostate).
- if you have stagnant bowel.
- if you suffer from the severe inflammation of the colon ( ulcerative colitis ) or blockage in the intestines.
- if you have increased pressure in the eye (called glaucoma with a closed ventricular angle or narrow ventricular angle ).
- if you have acute blood loss with unstable blood circulation.
These contraindications do not apply in life-threatening emergencies.
Warnings and cautions
Talk to your doctor or nurse before giving Atropine Stragen if you have any of the following:
- certain heart diseases
- overactive thyroid gland
- liver or kidney problems
- high blood pressure
- elevated temperature
- chronic lung disease
- symptoms of damage to the nerves that regulate blood pressure, heart rate, emptying of the intestines and bladder, digestion, and other body function (autonomic neuropathy )
- myasthenia gravis (severe muscle weakness)
- intestinal or stomach problems, e.g. stomach ulcer , heartburn or reflux, diarrhea or infection, hiatus hernia (when part of the stomach falls out through the diaphragm)
- ileostomy or colostomy (surgically created artificial opening in the small or large intestine)
Children, elderly patients and other special populations
Atropine Stragen should be used with caution in children and elderly patients as they are more sensitive to the effects of the product and are more likely to suffer side effects. Atropine Stragen should also be used with caution in patients suffering from Down syndrome as the effect may be stronger. It should also be used with caution in patients suffering from a lack of pigment in the skin and hair (albinism) as the effect may be weaker.
Note! Atropine Stragen makes you sweat less and you can become overheated. This is especially important for infants and young children.
Other medicines and Atropine Stragen
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may increase the effect of Atropine Stragen. These include:
- tricyclic antidepressants (for the treatment of depression)
- antispasmodics (used to relieve bowel problems and muscle spasms or cramps)
- amantadine or similar medicines (used to treat Parkinson’s disease )
- certain antihistamines (for the treatment of hay fever and allergies )
- phenothiazines (for the treatment of anxiety or more serious mental illnesses)
- disopyramide or quinidine (medicines used to control heart rhythm)
- antiemetics (to relieve nausea or vomiting)
- drugs that relax the muscles
Atropine Stragen may impair the effect of the following medicines:
- cisapride (used to treat heartburn)
- domperidone and metoclopramide (used to prevent nausea and vomiting)
Atropine Stragen delays the emptying of the stomach and can therefore affect the effect of other medicines.
Information on interactions with other medicines is only available to adults. It is not known if the extent of the interaction is the same in children.
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 nurse for advice before giving this injection. Your doctor will then decide if this injection is suitable for you.
Driving and using machines
Because you need treatment, you probably do not feel well enough to drive or use machines. However, consult a physician before driving or using machines as Atropine Stragen may cause drowsiness and blurred vision.
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 Stragen contains sodium
The drug contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is basically “sodium-free”.
How Atropine Stragen is given to you
Use for children and adolescents
Atropine Stragen is given as an injection by a doctor or a specially trained nurse. The injection can be given into a muscle or directly into the bloodstream (in a friend).
Your doctor will decide which dose is right for you and it will depend on what the medicine is used to treat. Your dose can be calculated according to your weight.
If you have been given too much Atropine Stragen
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects depend on the dose you are given and usually disappear when the treatment is stopped.
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. You may need urgent medical attention.
Very common side effects (affects more than 1 user in 10)
- visual disturbances (dilated pupils, difficulty focusing, blurred vision, inability to tolerate light)
- reduced excretion of mucus in the trachea
- dry mouth (difficulty swallowing and speaking, thirst)
- constipation and heartburn (reflux)
- reduced excretion of stomach acid
- loss of sense of taste
- nausea
- vomiting
- bloated feeling
- loss of the ability to sweat
- dry skin
- hives
- rash
Common side effects (affects more than 1 user in 100)
- aroused mood (especially at higher doses )
- loss of coordination (especially at higher dosages )
- confusion (especially at higher dosages )
- hallucinations (especially at higher doses )
- overheated body
- certain heart diseases (fast heartbeats, irregular heartbeats, temporary worsening of already slow heartbeats)
- hemorrhage
- difficulty urinating
Uncommon side effects (affects less than 1 user in 100)
- psychotic reactions
Rare side effects (affects less than 1 user in 1,000)
- allergic reactions
- seizures (convulsions)
- somnolence
Very rare side effects (affects less than 1 user in 10,000)
- severe hypersensitivity reaction
- irregular heartbeats, including ventricular fibrillation
- chest pain
- temporary severe hypertension
None known (can not be calculated from available data)
- headache
- restlessness
- unsteady gait and balance problems
- insomnia
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 Stragen
No special storage instructions.
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 carton after EXP. date. and on the syringe and blister after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
The healthcare staff discards the syringe and any medicines that are no longer needed according to local requirements.
6. Contents of the packaging and other information
Content declaration
The active substance is atropine sulfate.
One ml solution for injection contains 0.1 mg of atropine sulfate. One 5 ml pre-filled syringe contains 0.5 mg of atropine sulfate.
The other ingredients are: sodium chloride, concentrated hydrochloric acid (for adjustment), water for injections (see section 2 “Atropine Stragen contains sodium”).
What the medicine looks like and the contents of the pack
Atropine Stragen is a clear and colorless solution for injection in a 5 ml pre-filled polypropylene syringe with a polypropylene cap, a sterile outer surface, individually packaged in a clear blister pack of 10 cartons.
Marketing Authorization Holder and Manufacturer
Holder of marketing authorization
STRAGEN Nordic A / S
Helsingørsgade 8C
3400 Hillerød
Denmark
Mail: info@stragen.dk
Manufacturer:
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON CEDEX
France
This medicinal product is authorized under the European Economic Area under the names: