Package leaflet: Information for the patient

Buscopan Forte, 20 mg, film-coated tablets
Hyoscini butylbromidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or
as directed by the doctor, pharmacist, or nurse.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Leaflet contents

What Buscopan Forte is and what it is used for
Important information before taking Buscopan Forte
How to take Buscopan Forte
Possible side effects
How to store Buscopan Forte
Contents of the pack and other information

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

Hyoscine butylbromide, the active substance in Buscopan Forte, is an antispasmodic agent.
Antispasmodics reduce spasms of smooth muscles of internal organs within the abdominal cavity –
in the gastrointestinal tract, biliary tract, urinary system, and female genital tract, thereby relieving pain.
They are used to alleviate colicky pain, i.e. abdominal pain originating from the aforementioned internal organs, characterized by fluctuating intensity and difficult to localize precisely.
Buscopan may be used in spastic conditions of the gastrointestinal tract smooth muscles (in functional disorders of the gastrointestinal tract, painful gastric spasms, intestinal colic, irritable bowel syndrome), in spastic conditions and dyskinesia of the biliary tract (in functional disorders of the biliary tract, acute biliary pain, biliary colic), and in spastic conditions of the urogenital system (in dysmenorrhea, renal colic, spastic conditions associated with ureteric calculi).

2. Important information before using Buscopan Forte

When not to use Buscopan Forte

if the patient has hypersensitivity (allergy) 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 condition characterized by significant muscle weakness, even inability to move;
in patients with pathological dilation of the large intestine (megacolon – significant enlargement of the large intestine);
if the patient has intolerance to certain sugars, as the product contains lactose (see section "Buscopan Forte contains lactose");
if the patient has mechanical obstruction of the gastrointestinal tract, a condition in which movement of food through the digestive tract may be impaired;
if the patient has a condition in which the intestine is blocked and not functioning properly (paralytic ileus or intestinal obstruction). Symptoms include severe abdominal pain with absence of bowel movements and (or) nausea/vomiting.

Warnings and precautions
Special caution is required in the following situations:

if the patient has heart disease (irregular heartbeat, high blood pressure);
if the patient has narrow-angle glaucoma;
if the patient has had intestinal obstruction in the past or suspicion thereof;
if the patient has had urinary tract obstruction in the past or suspicion thereof;
if the patient has an enlarged prostate gland;
if the patient's abdominal discomfort and pain differ from previous episodes previously treated with Buscopan Forte as advised by a doctor;
if the patient experiences sudden, severe or sharp pain clearly different from usual cramp-related pain or discomfort;
if cramp-related abdominal pain or discomfort rapidly worsens;
if the patient's abdomen is tender to touch (pain upon pressing – rebound tenderness);
if the patient has fever;
if the patient has nausea or vomiting;
if the patient has low blood pressure or feels faint;
if there is blood in the patient's stool;
if the patient notices unexpected changes in bowel habits, e.g. diarrhea;
if the patient has rapidly and unexpectedly lost weight;
if the patient is currently taking other prescribed medications for abdominal pain and cramps.

If the patient has or has had any of the above-mentioned symptoms or conditions,
Buscopan Forte should not be taken without first consulting a doctor. To determine
the cause of symptoms, the doctor will recommend appropriate diagnostic tests.
The patient should stop taking Buscopan Forte and contact a doctor

if pain worsens within 24 hours or lasts longer than 3 days;
if abdominal tenderness develops;
if the patient experiences rectal bleeding or recurrent episodes of bleeding;
if any additional symptoms occur.

Buscopan Forte and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Consult a doctor before starting Buscopan Forte if the patient is taking any of the following medicines:

tricyclic and tetracyclic antidepressants (used in the treatment of depression);
antihistamines (used in the treatment of certain allergic conditions);
antipsychotics (reducing psychotic symptoms of mental illnesses);
beta-sympathomimetic drugs (used in the treatment of heart failure and (or) asthma);
quinidine (used in the treatment of heart rhythm disorders);
amantadine (used in the treatment of Parkinson's disease);
disopyramide (used in the treatment of irregular heartbeat);
other anticholinergic drugs such as ipratropium or tiotropium (used in the treatment of chronic obstructive pulmonary disease) or drugs similar to atropine; because Buscopan Forte may enhance the effects of these medicines.

Also inform the doctor about the use of metoclopramide (used to treat vomiting, nausea or gastrointestinal discomfort), as concomitant use may result in reduced efficacy of both Buscopan Forte and metoclopramide.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
It is recommended to avoid using Buscopan Forte during pregnancy and breastfeeding.

Driving and operating machinery
No studies have been conducted on the effect of the medicine on the ability to drive or operate machinery. There are no specific recommendations regarding the use of Buscopan Forte while driving or operating machinery.

Buscopan Forte contains lactose
The medicine contains 138.5 mg of monohydrate lactose per tablet, which corresponds to 692.5 mg of monohydrate lactose at the maximum recommended daily dose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Buscopan Forte

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The usual dose for adults and children over 12 years of age is 1 tablet of coated tablets 1 to 5 times daily. Do not exceed a dose of 100 mg per day. Do not use in children under 12 years of age.
The tablets should be swallowed whole with liquid.
Do not use Buscopan Forte for longer than 3 days without consulting a doctor. If the patient needs to use Buscopan Forte continuously or for a longer period, medical advice should be sought to determine the cause of symptoms.
Taking more than the recommended dose of Buscopan Forte
If a higher than recommended dose of Buscopan Forte is taken or if the medicine is taken by a child under 12 years of age, seek immediate medical advice.
The following symptoms may occur: dry mouth, skin redness, difficulty in urination, rapid heartbeat, and visual disturbances.
Missed dose of Buscopan Forte
If a dose is missed, take it as soon as remembered. However, do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping treatment with Buscopan Forte
Buscopan Forte should be taken only as needed and treatment should be discontinued once symptoms have resolved.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Buscopan Forte may cause adverse reactions, although not everyone experiences them.
Many of the adverse reactions listed below are due to the anticholinergic action of the medicine. They are usually mild and transient.
The following adverse reactions have been reported:
Uncommon (occur less frequently than in 1 out of 100 patients, but more frequently than in 1 out of 1,000 patients):
rapid heartbeat, dry mouth, reduced sweating, skin reactions (urticaria, itching)
Rare (occur less frequently than in 1 out of 1,000 patients, but more frequently than in 1 out of 10,000 patients):
urinary retention
Frequency not known (frequency cannot be estimated from the available data):
anaphylactic shock (sudden and severe allergic reaction characterized by breathing difficulties, circulatory collapse, and sudden swelling), anaphylactic reactions with episodes of respiratory disturbances, skin reactions (rash, redness), and other hypersensitivity reactions.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, consult a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Buscopan Forte

Keep this medicine out of the sight and reach of children.
No special precautions for storage are required.
Do not use Buscopan Forte after the expiry date stated on the packaging following:
Expiry date. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Buscopan Forte contains

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

What Buscopan Forte looks like and contents of the pack
Buscopan Forte is in the form of coated tablets.
Packaging: PVC/Aluminium blister in a cardboard box.
Pack size: 10 or 20 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
MAYOLY PHARMA FRANCE
3 Place Renault
92500 Rueil-Malmaison
France
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 REIMS
France
For further information, please contact the representative of the marketing authorisation holder:
MAYOLY POLSKA Sp. z o.o.
ul. Domaniewska 39B
02-672 Warszawa
tel.: 22 166 26 26