Package leaflet: Information for the user. Atropin Stragen 0.1 mg/ml solution for injection in prefilled syringe.

Transcription

1 Package leaflet: Information for the user Atropin Stragen 0.1 mg/ml solution for injection in prefilled syringe Atropine sulphate Read all of this leaflet carefully before you start using this medicine because it contains important information for you. (Please note this medicine is mainly used in emergency situations and the doctor will have decided that you need it. It is unlikely therefore, that you will have read this leaflet before the medicine was administered to you.) - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse.this includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Atropin Stragen is and what it is used for 2. What you need to know before you are given Atropin Stragen 3. How Atropin Stragen is given to you 4. Possible side effects 5. How to store Atropin Stragen 6. Contents of the pack and other information 1. What Atropin Stragen is and what it is used for Atropin Stragen is one of a group of medicines called anticholinergics. Atropine sulphate, the active substance contained in Atropin Stragen, temporarily blocks some nerve endings. This decreases glands secreting, makes some muscles (such as in the gut) relax and speeds up the heart. Atropin Stragen is used : - to treat a slow heart beat and conditions associated with slow heart beat. - before a general anaesthesia to dry up saliva and fluid in the lungs. - as an antidote following overdose of medicines known as anticholinesterases and poisoning from some insecticides, nerve gases and mushroom poisoning. 2. What you need to know before you use Atropin Stragen You must not be given Atropin Stragen - if you are allergic to atropine sulphate or any of the other ingredients of this medicine (listed in section 6), - if you have trouble passing urine (e.g. if you are a man and you have an enlarged prostate), - if you have paralysis of the bowel, - if you suffer from severe inflammation of the colon (ulcerative colitis) or blockage in the intestines, - if you have increased pressure in the eye (known as closed-angle or narrow-angle glaucoma), - if you have acute blood loss with unstable heart circulation. These contraindications do not apply in the event of life-threatening emergencies. Warnings and precautions Talk to your doctor or nurse before you are given Atropin Stragen if you have any of the following: - certain heart conditions, - an overactive thyroid gland, - liver or kidney problems, 1

2 - high blood pressure, - raised temperature, - chronic lung disease, - symptoms resulting from damage to the nerves that regulate blood pressure, heart rate, bowel and bladder emptying, digestion and other body function (autonomic neuropathy), - myasthenia gravis (severe muscle weakness), - bowel or stomach problems, such as stomach ulcer, heartburn or reflux, diarrhoea or infection, hiatus hernia, (when a part of the stomach prolapses through the diaphragm), - ileostomy or a colostomy (surgically created artificial opening in the small or large intestine). Children, elderly patients and other special populations Atropin 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 experience side effects. Atropin Stragen should also be used with caution in patients suffering from Down syndrome because its effect may be stronger. It should also be used with caution in patients suffering from albinism because its effect may be weaker. Note: Atropin Stragen will make you sweat less and you may overheat. This is especially important for babies and small children. Other medicines and Atropin Stragen Tell your doctor if you are taking, have recently taken or might take any other medicines. Some medicines may enhance the effect of Atropin 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 feeling or being sick), medicines that relax the muscles. Atropin Stragen may impair the effect of the following medicines: cisapride (used to treat heartburn), domperidone and metoclopramide (used to prevent nausea and vomiting). Atropin Stragen delays gastric emptying and may therefore alter the effect of other medicines. Data regarding interactions with other medicines are only available for adults. It is not known whether the extent of the interactions is similar in children. Pregnancy and breast-feeding Please inform your doctor or nurse before being given this injection if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. The doctor will then decide if this injection is suitable for you. Driving and using machines Because of your complaint being treated you will probably not feel well enough to drive or use machinery. However, consult your doctor before considering driving a car or using machinery as Atropin Stragen may cause drowsiness and blurred vision. Atropin Stragen contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium- free. 3. How Atropin Stragen is given to you 2

3 Atropin Stragen will be given to you as an injection by a doctor or a specially trained nurse. The injection may be given into a muscle or directly into the blood stream (into a vein). Your doctor will decide what dose is right for you and this will depend on what it is being used to treat. Your dose may be calculated according to your weight. What to do if you have been given more Atropin Stragen than you should This is unlikely because the dose will be administered by a doctor or nurse who will be experienced in its use. The doses of Atropin Stragen will be carefully worked out, especially for children or the elderly, because they are more sensitive to it. If you suspect that you have been given too much, you should tell the doctor or nurse immediately. If you have any further questions on the use of this product, ask your doctor or nurse. 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 discontinued. Rarely an allergic reaction may develop. This may cause skin rashes, severe itching, peeling of the skin, swelling of the face (especially around the lips and eyes), tightening of the throat and difficulty breathing or swallowing, fever, dehydration, shock and fainting. These are all very serious side effects. Tell your doctor immediately if you experience any of these side effects. You may need urgent medical attention. Very common side effects (may affect more than 1 in 10 people) visual disturbances (widening of the pupils, difficulty focussing, blurred vision, inability to tolerate light), reduced bronchial secretion, dry mouth (difficulty in swallowing and talking, feeling thirsty), constipation and heartburn (reflux), reduced secretion of gastric acid, loss of taste, nausea, vomiting, bloated feeling, lack of sweating, skin dryness, hives, rash. Common side effects (may affect up to 1 in 10 people) excitement (especially with higher dosages), loss of coordination (especially with higher dosages), confusion (especially with higher dosages), hallucinations (especially with higher dosages), overheated body, certain heart conditions (rapid heart beat, irregular heart beat, temporary further slowing down of heart beat), flushing, difficulty in passing urine. Uncommon side effects (may affect up to 1 in 100 people) psychotic reactions. 3

4 Rare side effects (may affect up to 1 in 1,000 people) allergic reactions, fits (seizures), drowsiness. Very rare side effects (may affect up to 1 in 10,000 people) severe hypersensitivity reaction, irregular heart beat, including ventricular fibrillation, chest pain, spike in blood pressure. Not known (frequency cannot be estimated from the available data) headache, restlessness, unsteady walking and balance problems, sleeplessness. 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Atropin Stragen This medicinal product does not require any special storage conditions. 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, the syringe and the blister after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment. The medical personnel will dispose of the syringe and any medicine no longer needed according to the local requirements. 6. Contents of the pack and other information What Atropin Stragen contains The active substance is atropine sulphate. Each ml of solution for injection contains 0.1 mg atropine sulphate. Each 5 ml pre-filled syringe contains 0.5 mg atropine sulphate. The other ingredients are: sodium chloride, concentrated hydrochloric acid (for ph adjustment), water for injections (See section 2 Atropin Stragen contains sodium ). What Atropin Stragen looks like and contents of the pack Atropin Stragen is a clear and colourless solution for injection in a 5 ml polypropylene pre-filled syringe with a polypropylene tip cap, sterile outer surface; individually packaged in a transparent blister pack; in box of 10. 4

5 Marketing Authorisation Holder <[To be completed nationally]> Manufacturer <[To be completed nationally]> This medicinal product is authorised in the Member States of the EEA under the following names: Sweden, Denmark, Finland, Norway: Atropin Stragen This leaflet was last revised in <[To be completed nationally]> The following information is intended for healthcare professionals only: Instructions for use: Be careful to strictly respect the protocol for the use of the syringe. The pre-filled syringe is for single patient only. Discard syringe after use. DO NOT REUSE. The content of un-opened and un-damaged blister is sterile, and must not be opened until used. The product should be inspected visually for particles and discoloration prior to administration. Only clear colourless solution free from particles or precipitates should be used. The product should not be used if the tamper evident seal on syringe is broken. Using aseptic technique, Atropin Stragen 0.1 mg/ml, Solution for injection in pre-filled syringe can be used on a sterile field. 1. Before opening the syringe, push firmly the piston rod in order to break open the syringe plunger. 2. Twist off the tip cap to break the frangible obturator. 5

6 3. Check that the sealing cap has been completely removed. 4. Purge the air of the syringe by pushing the piston slightly. 5. Connect the syringe to the IV access. Push the piston carefully to inject the required volume. Any unused product or waste material should be disposed of in accordance with local requirements. This medicinal product must not be mixed with other medicinal products. 6