Properties
What is it?
BUSCOLIZIN® 20 mg/ml Solution for Injection HYOSCINE BUTYLBROMIDE Read this leaflet carefully as it contains important information for you. This medicine is available without a prescription. However, you must use it carefully to get the best results from your treatment. - Keep this leaflet. You may need to read it again. - If you need more information or advice, ask your pharmacist. - You must see a doctor if your symptoms worsen or do not improve within 2 weeks. - If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This leaflet contains: 1. What BUSCOLIZIN is and what it is used for 2. Before you take BUSCOLIZIN 3. How to take BUSCOLIZIN 4. Possible side effects 5. How to store BUSCOLIZIN 6. Further information 1. What BUSCOLIZIN is and what it is used for BUSCOLIZIN belongs to a group of medicines called antispasmodics, which relieve spasms of the smooth muscles of the stomach, intestines, bile ducts, and urinary tract. It is used to relieve spasms of the smooth muscles of the stomach and duodenum, bile and urinary tracts, as well as the reproductive organs. To relieve spasms of the smooth muscles of the birth canal during childbirth or abortion, as well as during complications of childbirth, during painful menstruation, to relax smooth muscles during instrumental examinations and procedures. 2. Before you take BUSCOLIZIN Do not take BUSCOLIZIN - if you are allergic (hypersensitive) to the active substance or any of the other ingredients of the medicine; - if you have glaucoma (increased intraocular pressure); - if you have myasthenia gravis (muscle weakness); - if you have megacolon (enlargement or thickening of the large intestine). Take special care with BUSCOLIZIN Before using the medicine, be sure to inform your doctor if you have: increased blood pressure, hyperthyroidism (thyroid disease), lung disease, prostate problems. BUSCOLIZIN may provoke glaucoma. If you experience eye pain and visual disturbances after using BUSCOLIZIN, you must consult an ophthalmologist. BUSCOLIZIN should be used with caution in individuals with xerostomia (dryness of the mouth due to reduced or absent salivary gland secretion), dry rhinitis (chronic inflammation of the nose with little or no secretion). Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as well as herbal preparations. Inform your doctor if you are taking medicines for: Parkinson's disease; quinidine (antiarrhythmic); digoxin (cardiac glycoside); tricyclic and tetracyclic antidepressants (medicines for depression); antipsychotics (medicines for psychosis); antihistamines (antiallergics); beta-adrenomimetics (e.g., medicines for bronchial asthma, such as: clenbuterol, salbutamol, and others); ketoconazole (medicine for fungal infections); metoclopramide (antiemetic). Pregnancy and breastfeeding Before taking any medicine, ask your doctor or pharmacist for advice. Treatment with BUSCOLIZIN during pregnancy is carried out only under medical supervision. If you are breastfeeding, BUSCOLIZIN is not recommended, as part of the medicine is excreted in breast milk, and it can also reduce milk production by suppressing glandular secretion. Driving and operating machinery BUSCOLIZIN may cause visual disturbances with difficulty seeing at close range. Avoid driving or operating machinery until your vision returns to normal. 3. How to take BUSCOLIZIN Take BUSCOLIZIN exactly as prescribed by your doctor. If you are unsure how to take BUSCOLIZIN, ask your doctor or pharmacist. The dose and duration of treatment are determined by the attending physician. BUSCOLIZIN solution for injection is administered intramuscularly or intravenously. Adults: 10-20 mg 2-4 times a day. The maximum daily dose is 100 mg. Children over 6 years old: In severe spasmodic conditions, 0.3-0.6 mg/kg body weight 2-4 times a day. The maximum daily dose is 1.2 mg/kg. If you take more BUSCOLIZIN than you should High doses can cause the following symptoms: skin redness, pupil dilation, rapid heartbeat, dry mouth and throat, difficulty swallowing, neuropsychiatric disorders (delirium, visual hallucinations, psychomotor agitation, ataxia), hyperthermia (increased temperature), urinary retention, difficulty breathing, collapse, coma. Treatment is symptomatic and is carried out in a medical facility. If you forget to take BUSCOLIZIN Do not take a double dose to make up for a missed dose. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, BUSCOLIZIN can cause side effects, although not everybody gets them. Rarely, dry mouth, nausea, vomiting, constipation, difficulty urinating, urinary retention, visual disturbances; pupil dilation; increased intraocular pressure, suppression of lacrimal gland secretion, tachycardia (rapid heart rate), increased blood pressure may occur. Sometimes reduced sweating, dizziness, headache, nervousness, weakness, ataxia (impaired coordination of movement) are observed. In rare cases, agitation, insomnia, anxiety, hallucinations (especially in children and the elderly) may occur. Redness may appear at the injection site. If any of the side effects become serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor. 5. How to store BUSCOLIZIN Store in the original packaging, protected from light, at a temperature not exceeding 25°C. Do not freeze! Keep out of reach of children. Do not use BUSCOLIZIN after the expiry date indicated on the cardboard packaging. The expiry date refers to the last day of that month. Do not dispose of medicines down the drain or in household waste containers. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment. 6. Further information What BUSCOLIZIN contains - Active substance: Hyoscine butylbromide 10 mg per ampoule. - Excipients: Sodium chloride, water for injection. What BUSCOLIZIN looks like and contents of the pack BUSCOLIZIN solution for injection is a colorless, clear liquid. 10 brown glass 1 ml ampoules in a PVC blister. 1 or 10 blisters in a cardboard box with instructions for use and a leaflet. The ampoule is opened by pressing the finger on the marking - colored dot/ring on the neck of the ampoule. Manufacturer and marketing authorization holder Sopharma AD 16 Iliensko Shose, 1220 Sofia, Bulgaria