PACKAGE LEAFLET: INFORMATION FOR THE USER

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER ATROPINE SULFATE STEROP 0,25mg/1ml, solution for injection ATROPINE SULFATE STEROP 0,50mg/1ml, solution for injection ATROPINE SULFATE STEROP 1mg/1ml, solution for injection Atropine sulfate Read all of this leaflet carefully before you start using this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What ATROPINE SULFATE STEROP is and what it is used for? 2. What you need to know before you use ATROPINE SULFATE STEROP? 3. How to use ATROPINE SULFATE STEROP? 4. Possible side effects 5. How to store ATROPINE SULFATE STEROP? 6. Further information 1. WHAT ATROPINE SULFATE STEROP IS AND WHAT IT IS USED FOR? Pharmacotherapeutic group or mode of action Antispasmodic, anticholinergic Therapeutic indications - Premedication before surgery - Some cases of cardiac arrest and infarction - Symptomatic treatment of the acute painful signs related to the disorder of the gastro-intestinal tract, the biliary and the urinary tract - Specific antidote in acute poisoning caused by some insecticides or by certain medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ATROPINE SULFATE STEROP? Do not use ATROPINE SULFATE STEROP - If you are hypersensitive (allergic) to atropine or any of the other ingredients of ATROPINE SULFATE STEROP. - If you suffer from : - an angle closure glaucoma, - uretroprostatic disorders, - pyloric stenosis or intestinal obstruction, - intestinal atony, - constipation following paralysis of the intestinal muscle (paralytic ileus), serious intestinal inflammation (ulcerative colitis), - oesophageal achalasiade, - bladder neck obstruction, - inflammation of the oesophagus due to gastric reflux (reflux oesophagitis), - myasthenia gravis, - thyreotoxicosis, - enlarged prostate, - adhesions between the iris and the lens of the eye.

2 Take special care with ATROPINE SULFATE STEROP - Children and the elderly are particularly sensitive to the toxic effects of antimuscarinic medicines. - ATROPINE SULFATE STEROP should be used with caution in patients with renal or hepatic insufficiency, coronary insufficiency, disorders of the cardiac rhythm, hyperthyroidism, chronic bronchitis, toxic megacolon, pylorus stenosis. - Because a possible increase in temperature may be observed with use of atropine, it should be used with caution in patients presenting with fever or when the ambient temperature is high. Given that atropine may increase heart rhythm, it must be used with caution in patients suffering from increased heart rate, insufficient cardiac output (decompensation) or coronary disorders, namely following myocardial infarction. Atropine should also be administered with extreme caution in patients suffering from autonomic neuropathy. Given the effects of atropine on the gastrointestinal tract, caution must be exercised when administering it to patients presenting with ulcers, heartburn, diarrhoea or digestive tract infection. In the lungs, atropine may provoke a reduction of excretion of bronchial secretions which could result in bronchial obstruction. Consequently, caution is required when atropine is administered to patients suffering from chronic obstructive pulmonary disease. Additional vigilance is required when using atropine in patients under extreme stress or in whom certain receptors (adrenergic receptors) are highly activated (which may result in rapid heart rhythm, high blood pressure, nervousness). Atropine should be administered with caution in these persons should they have to undergo a specific ECG (dobutamine-atropine ECG stress testing) or should they require treatment with catecholamines such as epinephrine or dopamine. Administration of these products could result in heart problems characterised by breathlessness, chest pain, hart palpitations or cardiac arrest (Tako-tsubo syndrome). Atropine may not be effective in patients presenting with severe slowing of heart rhythm (bradycardia) due to overly high potassium levels (hyperkalemia). - If the solution is not clear. - When you use ATROPINE SULFATE STEROP because this medicine does not contain antimicrobial preservatives, and therefore germs can easily develop. The drug solution must be withdrawn according to good clinical practice regulations, as aseptically as possible, using a sterile syringe immediately after the ampoule has been opened. The medicinal solution and any syringe containing the drug solution are for single and individual use only. Any unused or remaining medicinal solution must be discarded according to the clinical good practices regulations. - In general there is a risk of irritation or necrosis at the injection site, or a risk of thrombophlebitis if ATROPINE SULFATE STEROP is administered too quickly or if an excessive amount of fluid is injected. It is therefore recommended to change the injection site every 24 hours to avoid the risk of thrombophlebitis. Please consult your doctor if one of the above mentioned warnings applied to you, or has applied to you in past. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effect of atropine may be increased by concomitant administration of anticholinergics such as amantadine, certain antihistamines (remedy against allergies), butyrophenones, phenothiazines or tricyclic antidepressants (treatment for depression). Simultaneous use of parasympathomimetics decreases the effect of atropine. Neuroleptics, antiparkinsonian agents, procaine (local anaesthetic), diisopyramide and quinidine (treatment for heart rhythm disorders) may reinforce the effects of atropine. Delayed gastric emptying induced by use of atropine may increase digoxin and nitrofurantoin concentrations whereas it decreases levodopa and phenothiazines concentrations. Propofol (used for anesthetic purposes during surgery) doses may need to be increased when propofol is used concomitantly with atropine.

3 ATROPINE SULFATE STEROP with food and drink Not applicable. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Atropine crosses the placental barrier. The administration must be carefully evaluated in late pregnancy because of the risk of atropine-like effects in children (tachycardia, meconium ileus). The use of atropine has to be avoided during lactation due to the decrease in lacteous secretion and the passage of atropine in breast-milk with possible toxic reactions in children. Driving and using machines Atropine may cause mydriase and accommodation disorders. Caution should be exercised when driving a vehicle and using machines. Important information about some of the ingredients of ATROPINE SULFATE STEROP Not applicable. 3. HOW TO USE ATROPINE SULFATE STEROP? Always use ATROPINE SULFATE STEROP exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. ATROPINE SULFATE STEROP is given by subcutaneous, intramuscular or by slow intravenous injection. The injected doses vary according to the required effect and the age of the patient. ATROPINE SULFATE STEROP has to be administered under medical supervision. Usual posology: For premedication before surgery: In adults: 0,5 to 1 mg In children: according to body weight, by subcutaneous way: o Weight of 3 kg: 1/10mg (0,1mg) o Weight between 7 and 9 kg: 1/5mg (0,2mg) o Weight between 12 and 16 kg: 3/10mg (0,3mg) o Weight between 20 and 27 kg: 4/10mg (0,4mg) o Weight of 32 kg: 5/10mg (0,5mg) o Weight of 41 kg: 6/10mg (0,6mg) In cardiology : In adults: 0,5 to 1 mg by slow IV then successive doses of 0,5 mg if necessary. In children: in cardio-pulmonary reanimation, according to the age from 0,03 to 0,04 mg/kg or 0,01 to 0,02 mg/kg with a minimum of 0,1 mg, repeated up to two or three times if necessary. Antispasmodic drugs : In adults: 0.25mg to 1mg every six hours. In children: according to the age, 0.25 mg, 0.5 mg in a single dose. As antidote: In adults: initial dose from 1 to 2 mg from the start by slow IV, then 1 mg every 1/2 hours until draining of bronchial secretions. In children: test dose of 0.01mg/kg then 0.05mg/kg by slow IV every 10 to 30 minutes if necessary. Posology will be reduced in the elderly and patients suffering from a renal or hepatic insufficiency; this medicine will be administered exceptionally in children and by monitoring the possible appearance of toxic effects of atropine. If you use more ATROPINE SULFATE STEROP than you should

4 If you used too much ATROPINE SULFATE STEROP, contact your doctor, your pharmacist or the Poison Center (070/ ). Your doctor knows the symptoms of overdose and will adjust the doses administered accordingly. The most characteristic side effect associated with overdose is very dry mouth and difficulty swallowing. In this case a symptomatic treatment in hospital is necessary with cardiac and respiratory monitoring. If you forget to use ATROPINE SULFATE STEROP This should not comprise a risk for your health. If you stop using ATROPINE SULFATE STEROP Your doctor will tell you how long you will use ATROPINE SULFATE STEROP. Don t stop your treatment prematurely because your health status could feel it. If you have other questions about the use of this medicine, ask more information to your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines ATROPINE SULFATE STEROP can cause side effects, although not everybody gets them. Other side effects include dry mouth and skin, blurred vision, pupil dilation with accommodation disorders and photophobia (abnormal sensitivity to light), urinary retention in elderly subjects (essentially prostatic disorders) and feelings of tiredness. The following side effects have also been reported: - Heart: increase in heart rhythm (tachycardia), angina pectoris, cardiac conduction disorders. - Nervous system (central nervous system): confusion, disorientation, restlessness, anxiety. - Gastrointestinal: constipation caused by inhibition of gastric secretion. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE ATROPINE SULFATE STEROP? Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions. Store the primary packaging in the outer carton. Expiry date Do not use ATROPINE SULFATE STEROP after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month. Do not use ATROPINE SULFATE STEROP if you notice the presence of particles in the ampoule. 6. FURTHER INFORMATION What ATROPINE SULFATE STEROP contains The active substance is atropine sulphate. The other ingredients are sodium chloride - water for injection to 1ml. What ATROPINE SULFATE STEROP looks like and contents of the pack 1 ml white glass type I ampoules, packaged in boxes with 10 ampoules and 100 ampoules (hospital use). Marketing Authorisation Holder Laboratoires STEROP, avenue de Scheut 46-50, 1070 Brussels, Belgium.

5 Manufacturer Laboratoires STEROP, avenue de Scheut 46-50, 1070 Brussels, Belgium. Marketing Authorisation numbers ATROPINE SULFATE STEROP 0,25mg/1ml, solution for injection : BE ATROPINE SULFATE STEROP 0,50mg/1ml, solution for injection : BE ATROPINE SULFATE STEROP 1mg /1ml, solution for injection : BE Dispensation status : on medical prescription This leaflet was last approved in 09/2012