BUSCOLYSIN 10mg x 20 tabl
BUSCOLYZIN tablets * 20 SOPHARMA
LEAFLET: INFORMATION FOR THE USER
BUSCOLYSIS 10 mg coated tablets
BUSCOLYSIN 10 mg coated tablets
hyoscine butyl bromide
(hyoscine butylbromide)
Read the entire leaflet carefully as it contains important information for you.
This medicine is available without a prescription. However, in order to get the best results from the treatment, you must carefully follow the instructions for use of the medicinal product.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- You should seek medical attention if your symptoms worsen or do not improve after 2 weeks.
- If any of the side effects become serious or you notice other side effects not described in this leaflet, please inform your doctor or pharmacist.
In this leaflet:
1. What Buscolysin is and what it is used for
2. Before taking Buscolysin
3. How to take Buscolysin
4. Possible side effects
5. How to store Buscolysin
6. Additional information
1. WHAT BUSCOLYZIN IS AND WHAT IT IS USED FOR
Buscolysin has a pronounced antispasmodic (relaxing) effect on the smooth muscles of the gastrointestinal tract, biliary tract, and genitourinary system. Buscolysin is used in the complex treatment of the patient, accompanied by painful spasms of the smooth muscles of the stomach, intestines, biliary tract, genitourinary system.
2. BEFORE YOU TAKE BUSCOLYSINE
Do not take Buscolysin
- if you are allergic (hypersensitive) to the active substance or to any of the excipients of the medicinal product;
- if you have glaucoma (increased intraocular pressure);
- if you have myasthenia gravis (muscle weakness);
- if you have megacolon (widening and thickening of the colon wall).
Take special care when using Buscolysin
Before starting treatment with Buscolysin, consult your doctor if you have: heart disease, high blood pressure, hyperthyroidism (disease of the thyroid gland), lung disease, severe liver or kidney disease, epilepsy (seizures), diabetic neuropathy, evidence of intestinal obstruction (ileus), mechanical obstacles along the course of the gastrointestinal tract, narrowing of the pylorus, gastroesophageal reflux disease;
(a condition in which acidic stomach contents back up into the esophagus; achalasia (a motility disorder of the esophagus), stomach ulcer, moderate and severe ulcerative colitis (severe inflammation of the colon), prostate enlargement with urinary retention .
Due to the suppression of sweating, it should be used with caution at elevated temperatures.
Buscolysin can provoke the appearance of glaucoma (increased intraocular pressure). In the event of pain in the eye and impaired vision after the administration of Buscolysin, consultation with an ophthalmologist is necessary.
Buscolysin should be used with caution in individuals with xerostomia (dry mouth due to reduced or absent salivary secretion), dry rhinitis (chronic inflammation of the nose with little or no secretion).
Additional warnings in the treatment of irritable bowel syndrome
If any of the following warnings apply to you, consult a doctor before starting treatment Buscolysin: age over 40 years, vomiting or discomfort, decreased appetite or weight loss, severe constipation, presence of blood in defecation, abnormal vaginal bleeding or discharge, difficult or painful urination, recent travel abroad.
Taking other medicines
Please consult your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. This includes plant products.
The effect of the medicine may change if you take: medicines to treat Parkinson's disease, quinidine (antiarrhythmic agent), digoxin (cardiac glycoside), tri- and quadricyclic antidepressants (medicines to treat depression), antipsychotics (to treat psychosis) , antihistamines (anti-allergic) agents, beta adrenomimetics (e.g. drugs for the treatment of bronchial asthma, such as clenbuterol, salbutamol, etc.), ketoconazole (a drug for the treatment of fungal infections), metoclopramide (used for vomiting), corticosteroids (hormonal preparations) , antacid medications (against heartburn), citrates.
Pregnancy and breastfeeding
Ask your doctor or pharmacist before using any medicine.
It is not recommended to use the medicinal product during pregnancy, especially during the first 3 months. If you are pregnant, treatment with Buscolysin is carried out only under medical supervision.
If you are breastfeeding, treatment with Buscolysin is not recommended because part of the product is excreted in breast milk, and it can also reduce milk secretion due to suppression of exocrine glands.
Driving and using machines
Buscolysin may cause temporary visual impairment with difficulty seeing at close distances. Refrain from driving until your vision returns to normal.
Important information about some of the ingredients of Buscolysin
Buscolysin contains lactose and sucrose as excipients. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
The medicinal product contains EEC dye, which may cause allergic reactions.
3. HOW TO TAKE BUSCOLYSINE
If you are not sure how to take Buscolysin, ask your doctor or pharmacist. Tablets should be swallowed whole (on an empty stomach or before meals) with a sufficient amount of water.
The usual dose is:
Adults and children over 12 years: 1-2 tablets 2-4 times a day. The maximum daily dose is 80 mg (8 tablets).
For the treatment of irritable bowel syndrome, the recommended starting dose is 1 tablet 3 times a day. If necessary, this dose can be increased to 2 tablets 4 times a day.
Children from 6 to 12 years: 1 tablet 3 times a day.
The use of Buscolysin is not recommended for children under 6 years of age.
The duration of treatment with Buscolysin should not exceed 2 weeks.
If you have taken more than the required dose of Buscolysin
When taking higher than usual doses of Buscolysin tablets, dry mouth and throat, difficulty swallowing, agitation, increase in temperature, palpitations, reddening of the skin, hallucinations are observed.
If you suspect that you have taken more than the required dose of Buscolisine, inform your doctor immediately! He can take emergency measures if necessary.
If you forget to take Buscolysin
If you miss a dose, take it as soon as possible. If it is almost time for the next dose, take it as usual, skipping the dose you forgot. Do not take a double dose to make up for a missed dose.
If you have any further questions related to the use of this product, please ask your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, Buscolysin can cause side effects, although not everybody gets them.
Rarely may occur: dry mouth, nausea, vomiting, constipation, difficulty urinating, urinary retention, visual disturbances, pupil dilation, increased intraocular pressure, suppression of lacrimal gland secretion; tachycardia (rapid heartbeat), increase in blood pressure. Rarely, allergic reactions (hypersensitivity) such as itching, rashes, urticaria and very rarely - more pronounced, with episodes of difficulty breathing and anaphylactic shock may occur. Sometimes there is reduced sweating, dizziness, headache, nervousness, weakness, ataxia (impaired coordination of movements). In rare cases, agitation, insomnia, anxiety, hallucinations are possible (especially in children and elderly patients).
If any of the side effects become serious or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE BUSCOLYSINE
To be stored in the original packaging, in a dry and protected from light place, at a temperature below 25°C.
Keep out of the reach of children.
Do not use Buscolysin after the expiration date marked on the carton The expiration date corresponds to the last day of the indicated month.
Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
What Buscolysin contains
- The active substance is hyoscine butyl bromide 10 mg in one tablet.
- The other ingredients are:
Tablet core: lactose monohydrate, tartaric acid; cellulose, microcrystalline; sodium starch glycolate, talc, magnesium stearate.
Coating: talc, titanium dioxide, sucrose, gelatin, gum arabic, opalux yellow AS 22808 (El04, El 10, El71, El72, E211, sucrose, povidone), macrogol, glycerol.
What Buscolysin looks like and contents of the pack
Yellow, biconvex tablets, with a regular round shape and a glossy surface. 20 tablets in a rigid PVC/aluminum foil blister, 1 blister in a cardboard box, together with a leaflet.
Marketing Authorization Holder and Manufacturer
SOPHARMA AD, Bulgaria
