Buscopan forte

Leaflet attached to the packaging: Patient Information

Buscopan Forte, 20 mg, coated tablets

Hyoscine butylbromide

Read the leaflet carefully 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 as advised by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, contact a doctor.

Table of contents of the leaflet

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

1. What is Buscopan Forte and what is it used for

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).

2. Important information before taking Buscopan Forte

When not to take Buscopan Forte

• 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 some sugars, as the product contains lactose (see section "Buscopan Forte contains lactose");
• 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;
• if the patient's abdominal pain and discomfort are different from those experienced in the past, for which the doctor has previously prescribed Buscopan Forte;
• if the patient has sudden, severe, or acute pain that is clearly different from the usual pain or discomfort associated with spasms;
• if the pain or discomfort in the abdomen 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 bowel movements, such as diarrhea;
• if the patient loses weight quickly and unexpectedly;
• if the patient is currently taking other medicines for abdominal pain and spasms prescribed by a doctor. If the patient experiences or has experienced any of the above symptoms or diseases, they should not take Buscopan Forte without consulting a doctor. The doctor will recommend diagnostic tests to determine the cause of the symptoms. The patient should stop taking Buscopan Forte and contact a 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 Forte and other medicines

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:

• tricyclic and tetracyclic antidepressants (used to treat depression);
• antihistamines (used to treat some allergic diseases);
• antipsychotics (reducing symptoms of psychotic diseases);
• beta-sympathomimetics (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 Forte 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 Forte and metoclopramide.

Pregnancy, breastfeeding, and fertility

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.

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 Forte and driving or using machines.

Buscopan Forte contains lactose

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.

3. How to take Buscopan Forte

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.

Taking a higher dose of Buscopan Forte than recommended

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.

Missing a dose of Buscopan Forte

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.

Stopping Buscopan Forte

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.

4. Possible side effects

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)

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 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.

5. How to store Buscopan Forte

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.

6. Contents of the pack and other information

What Buscopan Forte contains

• The active substance of the medicine is hyoscine butylbromide. One coated tablet contains 20 mg of hyoscine butylbromide (Hyoscini butylbromidum).
• The other ingredients of the medicine are: povidone K25, lactose monohydrate, microcrystalline cellulose, lactose monohydrate (for direct tabletting), magnesium stearate. Coating: Opadry II White 85G18490 (polyvinyl alcohol, talc, titanium dioxide, lecithin, macrogol).

What Buscopan Forte looks like and what the pack contains

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.

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, 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: