Buscopan

Leaflet attached to the packaging: patient information

Buscopan, 10 mg, coated tablets

Hyoscini butylbromidum

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 this patient leaflet or
according to the doctor's, pharmacist's, or nurse's instructions.

• 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 the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their 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., pain in the abdominal cavity 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 stone disease).

2. Important information before taking Buscopan

When not to take Buscopan

• if the patient has been diagnosed with an allergy (hypersensitivity) to hyoscine butylbromide or to any of the other ingredients of the medicine (listed in section 6);
• in patients with muscle weakness (myasthenia gravis) - a disease characterized by significant muscle weakness, and even inability to move;
• in patients with pathological dilation of the large intestine (megacolon) - significant dilation of the large intestine;
• if the patient has an intolerance to certain sugars, as the medicine contains sucrose (see section "Buscopan contains sucrose");
• if the patient has a mechanical narrowing of the digestive tract, a condition in which the movement of food content may be difficult;
• if the patient has a condition in which the intestine is blocked and does not function properly (paralytic or intestinal obstruction). Symptoms include severe abdominal pain with lack of stool and (or) nausea/vomiting.

Warnings and precautions

Particular caution should be exercised in the following circumstances:

• if the patient has heart disease (irregular heartbeat, high blood pressure);
• if the patient has glaucoma with a narrow angle of filtration;
• if the patient has had intestinal obstruction or suspected intestinal obstruction in the past;
• if the patient has had urinary tract obstruction or suspected urinary tract obstruction in the past;
• if the patient has an enlarged prostate gland (prostate);
• if the patient's abdominal pain and discomfort are different from those experienced in the past, for which the doctor has previously prescribed Buscopan;
• if the patient has sudden, severe, or acute pain that clearly differs from the usual pain or discomfort associated with spasms;
• if the pain or discomfort in the abdominal cavity associated with spasms worsens rapidly;
• if the patient's abdominal pain is sensitive to touch (it hurts when someone touches the abdomen - pressure pain);
• if the patient has a fever;
• if the patient has nausea or vomiting;
• if the patient has low blood pressure, feels like they are about to faint;
• if there is blood in the patient's stool;
• if the patient notices unexpected changes in their bowel rhythm, e.g., diarrhea;
• if the patient loses weight quickly and unexpectedly;
• if the patient is currently taking other medicines for abdominal pain and spasms, prescribed by their doctor. If the patient experiences or has experienced any of the above symptoms or conditions, they should not take Buscopan without consulting their doctor. To determine the cause of the symptoms, the doctor will recommend diagnostic tests. The patient should stop taking Buscopan and consult their doctor:
• if the pain worsens within 24 hours or lasts longer than 3 days;
• if abdominal tenderness occurs;
• if the patient experiences rectal bleeding or recurrent bleeding;
• if any additional symptoms occur.

Buscopan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking
or have recently taken, as well as any medicines they plan to take.
Before starting to take Buscopan, the patient should consult their doctor if they are taking
the following medicines:

• tricyclic and tetracyclic antidepressants (used to treat depression);
• antihistamines (used to treat certain 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; as Buscopan may enhance the effect of these medicines.

The patient should also inform their doctor about taking metoclopramide (used to treat
nausea, vomiting, or gastrointestinal disorders), as the effect of Buscopan and metoclopramide may be reduced.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child,
they should consult their 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 coated 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 the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to take Buscopan

This medicine should always be taken exactly as described in the patient leaflet or according to
the doctor's or pharmacist's instructions. If in doubt, the patient should consult their doctor or pharmacist.
Recommended dose:
unless the doctor recommends otherwise:
children aged 6 to 12 years: 3 times a day, 1 tablet,
adults and children over 12 years: 3 to 5 times a day, 1 or 2 tablets.
Do not exceed the dose of 100 mg per day. Do not use in children under 6 years of age.
Tablets should be swallowed whole, with a drink.
Do not take Buscopan for more than 3 days without consulting a doctor. If the patient needs to take Buscopan continuously or for a longer period, they should consult their doctor to determine the cause of the symptoms.

Use in children and adolescents

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

Taking a higher dose of Buscopan than recommended

In case of taking a higher dose of Buscopan than recommended or taking the medicine by a child under 6 years of age, the patient should immediately consult their doctor.
The following symptoms may occur: dry mouth, skin redness, difficulty urinating, rapid heartbeat, and vision disturbances.

Missing a dose of Buscopan

In case of missing a dose, the patient should take it as soon as they remember, but they 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 subsided.
If the patient has any further doubts about taking this medicine, they should consult their 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 result from 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 1000 patients)

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

Rare (occurring in less than 1 in 1000 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 any side effects occur, including any side effects not listed in the leaflet, the patient should consult their 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.
By reporting side effects, it is possible to 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 at a temperature not exceeding 25°C.
Do not use Buscopan after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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

• The active substance of Buscopan is hyoscine butylbromide. One coated tablet contains 10 mg of hyoscine butylbromide (Hyoscini butylbromidum)
• The other ingredients of the medicine are: calcium phosphate, corn starch, colloidal anhydrous silica, soluble starch, tartaric acid, stearic acid, coating (polyvidone, sucrose, arabic gum, talc, titanium dioxide, macrogol 6000, carnauba wax, white wax).

What Buscopan looks like and contents of the pack

Buscopan is a coated tablet.
Packaging: aluminum/PVC/PVDC or PVC/aluminum blister pack in a cardboard box.
Pack size: 10 coated tablets; 20 coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder:

IPSEN Consumer HealthCare
65 Quai Georges Gorse
92100 Boulogne-Billancourt
France

Manufacturer:

Delpharm Reims
10 rue Colonel Charbonneaux
51100 REIMS
France
To obtain more detailed information, the patient should 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

Date of last revision of the leaflet: