Hyoscine butylbromide
This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse.
Hyoscine butylbromide, the active substance of Buscopan Forte, is an antispasmodic.
Antispasmodics reduce spasms of the smooth muscles of the internal organs of the abdominal cavity –
in the digestive tract, bile ducts, urinary system, and female reproductive organs,
which relieves pain.
They are used to relieve colic pain, i.e., pain in the abdominal cavity originating from
the aforementioned internal organs, the intensity of which increases and (or) decreases and is difficult
to determine their exact location.
Buscopan can be used in conditions of smooth muscle spasms of the digestive tract
(in functional disorders of the digestive tract, painful stomach spasms, intestinal colic, irritable bowel syndrome), in conditions of spasms and dyskinesia of the bile ducts
(in functional disorders of the bile ducts, acute pain in the bile ducts, biliary colic), in conditions of spasms in the urogenital system (in painful menstruation, renal colic, spasms associated with ureteral stones).
Particular caution should be exercised in the following circumstances:
Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Before taking Buscopan Forte, consult a doctor if you are taking the following medicines:
You should also inform your doctor about taking metoclopramide (used to treat vomiting, nausea, or gastrointestinal disorders), as it may weaken the effect of Buscopan Forte and metoclopramide.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
It is recommended to avoid taking Buscopan Forte during pregnancy and breastfeeding.
No studies have been conducted on the effect of the medicine on the ability to drive and use machines. There are no recommendations for taking Buscopan Forte and driving or using machines.
The medicine contains 138.5 mg of lactose monohydrate in one tablet, which corresponds to 692.5 mg of lactose monohydrate in the maximum recommended daily dose. If you have been diagnosed with an intolerance to some sugars, you should consult a doctor before taking the medicine.
This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.
Usually, the recommended dose for adults and children over 12 years old is 1 to 5 times a day, 1 coated tablet. Do not exceed the dose of 100 mg per day. Do not take in children under 12 years old.
Swallow the tablets whole with a drink.
Do not take Buscopan Forte for more than 3 days without consulting a doctor. If you need to take Buscopan Forte continuously or for a longer period, consult a doctor to determine the cause of the symptoms.
If you take a higher dose of Buscopan Forte than recommended or if a child under 12 years old takes the medicine, consult a doctor immediately.
The following symptoms may occur: dry mouth, redness of the skin, difficulty urinating, rapid heartbeat, and vision disturbances.
If you miss a dose, take it as soon as you remember, but do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
Buscopan Forte should be taken only when needed and stopped when symptoms disappear.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.
Like all medicines, Buscopan Forte can cause side effects, although not everybody gets them.
Many of the side effects listed below are due to the anticholinergic effect of the medicine. They are usually mild and transient.
The following side effects have also been reported:
Uncommon (occurring in less than 1 in 100 patients, but more than 1 in 1000 patients);
rapid heartbeat, dry mouth, decreased sweating, skin reactions (hives, itching)
urinary retention
anaphylactic shock (a sudden and severe allergic reaction characterized by difficulty breathing, circulatory collapse, and sudden swelling), anaphylactic reactions with episodes of respiratory disorders, skin reactions (rash, redness) and other hypersensitivity reactions.
If you experience any side effects, including those not listed in the leaflet, consult a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel. (22) 49 21 301, Fax (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.
Keep the medicine out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not take Buscopan Forte after the expiry date stated on the packaging after:
Expiry date. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Buscopan Forte is a coated tablet.
Packaging: PVC/Aluminum blister pack in a cardboard box.
Pack size: 10 or 20 coated tablets.
Not all pack sizes may be marketed.
IPSEN Consumer HealthCare
65 Quai Georges Gorse
92100 Boulogne-Billancourt
France
Delpharm Reims
10 rue Colonel Charbonneaux
51100 REIMS
France
To obtain more detailed information, contact the representative of the marketing authorization holder:
MAYOLY POLSKA Sp. z o.o.
ul. Domaniewska 39B
02-672 Warsaw
tel.: 22 166 26 26
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