Buscopan

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Buscopan (Buscopan Rx), 10 mg, chewable tablets

Hyoscini butylbromidum
Buscopan and Buscopan Rx are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If you do not feel better or feel worse after 3 days, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Buscopan and what is it used for
• 2. Important information before taking Buscopan
• 3. How to take Buscopan
• 4. Possible side effects
• 5. How to store Buscopan
• 6. Contents of the packaging and other information

1. What is Buscopan and what is it used for

Hyoscine butylbromide, the active substance of Buscopan, 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 tract, which relieves pain.
They are used to relieve colic pain, i.e., abdominal pain originating from the aforementioned internal organs, whose intensity 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 kidney stones).

2. Important information before taking Buscopan

When not to take Buscopan

• in patients with muscle weakness (myasthenia gravis) - a disease characterized by significant muscle weakness, and even inability to move;
• in patients with pathological enlargement of the large intestine (megacolon) - significant enlargement of the large intestine;

Warnings and precautions

You should be particularly careful in the following situations:

If you have or have had any of the above symptoms or diseases, you should not take Buscopan without consulting your doctor. To determine the cause of your symptoms, your doctor will prescribe the necessary diagnostic tests.
You should stop taking Buscopan and contact your doctor:

Buscopan and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Before taking Buscopan, you should consult your doctor if you are taking the following medicines:

• tricyclic and tetracyclic antidepressants (used to treat depression);
• antihistamines (used to treat some allergic diseases);
• antipsychotics (reducing symptoms of psychotic diseases);
• beta-sympathomimetic drugs (used to treat heart failure and (or) asthma);
• quinidine (used to treat heart rhythm disorders);
• amantadine (used to treat Parkinson's disease);
• disopyramide (used to treat irregular heartbeat);
• other cholinolytic medicines, such as ipratropium or tiotropium (used to treat chronic obstructive pulmonary disease) or compounds similar to atropine; because Buscopan may enhance the effect of these 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 and metoclopramide.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
It is recommended to avoid taking Buscopan during pregnancy and breastfeeding.

Driving and using machines

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 and driving or using machines.

Buscopan contains sucrose

One chewable tablet contains approximately 41.2 mg of sucrose, which corresponds to 411.8 mg of sucrose in the case of the maximum recommended daily dose. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Buscopan

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
Recommended dose:
unless your doctor has prescribed otherwise:
children from 6 to 12 years old: 3 times a day, 1 tablet,
adults and children over 12 years old: 3 to 5 times a day, 1 or 2 tablets.
Tablets should be swallowed whole, with a drink.
You should not take Buscopan for more than 3 days without consulting your doctor. If you need to take Buscopan continuously or for a longer period, you should consult your doctor to determine the cause of your symptoms.

Use in children and adolescents

In children over 6 years old, Buscopan can be used only with the consent of a doctor.
In children under 6 years old, Buscopan is not recommended due to the high content of the active substance.

Taking a higher dose of Buscopan than recommended

If you have taken a higher dose of Buscopan than recommended or if a child under 12 years old has taken the medicine, you should immediately consult your doctor.
The following symptoms may occur: dry mouth, skin redness, difficulty urinating, rapid heartbeat, and vision disturbances.

Missing a dose of Buscopan

If you miss a dose, you should take it as soon as you remember, but you should not take a double dose to make up for the missed dose. The next dose should be taken at the usual time.

Stopping Buscopan treatment

Buscopan should be taken only when needed and its use should be stopped after the symptoms have disappeared.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Buscopan 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.
In addition, the following side effects have been reported:

Uncommon (occurring in less than 1 in 100 patients, but more than 1 in 1,000 patients):

rapid heartbeat, dry mouth, decreased sweating, skin reactions (hives, itching).

Rare (occurring in less than 1 in 1,000 patients, but more than 1 in 10,000 patients):

urinary retention.

Frequency not known (frequency cannot be estimated from the available data):

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.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. 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.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Buscopan

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C. Store in the original packaging to protect from light.
Do not use Buscopan after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Buscopan contains

• One chewable tablet contains 10 mg of hyoscine butylbromide (Hyoscini butylbromidum).
• Other ingredients of the medicine are: calcium hydrogen phosphate, anhydrous, corn starch, colloidal silica, anhydrous, soluble starch, tartaric acid, stearic/palmitic acid, coating (polyvidone, sucrose, arabic gum, talc, titanium dioxide (E 171), macrogol 6000, carnauba wax, white wax).

What Buscopan looks like and what the packaging contains

Buscopan is a chewable tablet.
Packaging: PVC/Al blister in a cardboard box.
Pack size: 14 chewable tablets.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Ireland, the country of export:

Opella Healthcare France SAS, T/A Sanofi
82 Avenue Raspail
94250 Gentilly, France

Manufacturer:

Istituto De Angeli S.r.l.
Località Prulli n. 103/c, 50066 Reggello (FI), Italy

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Irish authorization number: PA23180/022/001

Parallel import authorization number: 409/22 Date of approval of the leaflet: 22.11.2022

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