Buscopan

Package leaflet: Information for the user

BUSCOPAN 10 mg film-coated tablets, 10 mg suppositories

Hyoscine butylbromide
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What Buscopan is and what it is used for

Buscopan contains the active substance hyoscine butylbromide, which belongs to a group of medicines
called semisynthetic belladonna alkaloids used for motility disorders of the stomach, intestine, and
biliary tract (gastrointestinal tract).
Buscopan is indicated in adults and children over 6 years of age for:

• pain and spasms of the stomach and intestine,
• pain and spasms due to obstruction in the flow of the biliary tract (through which bile flows, a substance involved in certain digestive processes).
  Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Buscopan

Do not take Buscopan

• if you are allergic to the active substance hyoscine butylbromide or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe glaucoma, a disease of the eye caused by increased pressure of the fluid inside the eye (acute angle-closure glaucoma);
• if you have an enlarged prostate (prostatic hypertrophy);
• if you have an inability of the urinary bladder to empty completely (urinary retention);
• if you have narrowing of the pylorus, the lower part of the stomach (pyloric stenosis), or narrowing of other parts of the stomach and intestine (stenosis of other gastrointestinal segments);
• in case of intestinal obstruction or if you suspect intestinal obstruction;
• if you suffer from a bowel disorder associated with impaired intestinal motility (paralytic or obstructive ileus), chronic inflammatory bowel disease (ulcerative colitis), or dilation of the colon (megacolon);
• if you suffer from a condition characterized by frequent reflux of stomach contents into the oesophagus, the tube through which food passes to the stomach (reflux oesophagitis);
• if you are elderly or physically weak and suffer from lack of intestinal movement leading to intestinal obstruction (intestinal atony);
• if you suffer from muscle weakness (myasthenia gravis);
• in children under 6 years of age;
• in case of rare hereditary conditions that may be incompatible with an excipient in the product (see "Buscopan film-coated tablets contain sucrose").

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Contact your doctor immediately if you experience severe abdominal pain without an apparent cause, which persists or worsens, or is accompanied by symptoms such as fever, nausea, vomiting, intestinal motility disorders, intestinal sensitivity, low blood pressure, fainting, or blood in the stool.
Use Buscopan with caution:

• if you are elderly,
• if you suffer from a nerve disorder affecting the control of glands and organs (autonomic nervous system disorder),
• if you suffer from or are predisposed to heart rhythm disorders (cardiac tachyarrhythmias),
• if you have high blood pressure (arterial hypertension),
• if your heart lacks sufficient strength and capacity to pump blood effectively (congestive heart failure),
• if you have a thyroid disorder that may cause weight loss, fatigue, and weakness (hyperthyroidism),
• if you have liver and/or kidney disease,
• if you are predisposed to severe glaucoma, i.e. eye disease caused by increased pressure of the fluid inside the eye (acute angle-closure glaucone),
• if you are predisposed to intestinal or urinary tract obstruction (intestinal or urinary stasis),
• if you have a fever.

Medicines like Buscopan may prolong gastric emptying time, causing retention of substances.
Do not abruptly stop treatment with high doses. Your doctor will evaluate the appropriate dose to manage mild adverse effects or discontinue therapy in case of severe adverse effects.

Children and adolescents
Buscopan must not be given to children under 6 years of age.

Other medicines and Buscopan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use this medicine with caution and only under strict medical supervision in the following situations:

• if you are taking medicines such as antidepressants (particularly tricyclic and tetracyclic antidepressants), phenothiazines (medicines used for allergies or mental disorders), butyrophenones (medicines used for mental disorders and vomiting), antihistamines (drugs used for allergies), antipsychotics (drugs used for mental disorders), quinidine (a heart medicine), amantadine (a medicine for central nervous system disorders involving loss of movement control, such as Parkinson's disease), disopyramide (a heart medicine), and other medicines for respiratory diseases (such as tiotropium, ipratropium), or substances similar to atropine (substances acting on the nervous system), because their effects may be enhanced by Buscopan;
• if you are taking medicines for nausea and vomiting, such as metoclopramide, because both their effects and those of Buscopan may be reduced;
• if you are taking beta-adrenergic drugs (medicines used to treat asthma), because the tachycardia (increased heart rate) induced by these drugs may be increased by Buscopan.

Do not take Buscopan with antacids, medicines used to treat stomach acidity, as they may reduce the intestinal absorption of this medicine.

Buscopan and alcohol
Do not consume alcohol during treatment with Buscopan.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, it is preferable to avoid using Buscopan.
Your doctor will assess whether the use of this medicine is strictly necessary.

Driving and operating machinery
Medicines like Buscopan may cause visual disturbances and drowsiness: you must take this into account if driving vehicles or operating machinery, or performing tasks requiring attention and vigilance.

Buscopan film-coated tablets contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Buscopan

Take this medicine exactly as stated in this leaflet or according to your doctor’s or pharmacist’s instructions. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults and adolescents over 14 years of age is as follows, unless otherwise prescribed by a doctor:
Film-coated tablets
1-2 film-coated tablets three times a day.
The tablets should be taken whole with an adequate amount of water.
Suppositories
1 suppository three times a day.
The suppositories must be removed from their outer wrapping and inserted into the rectum with the pointed end first.
In paediatric use, for children aged between 6 and 14 years, strictly follow the doctor’s prescription.
Do not exceed the recommended doses without medical advice.
Use Buscopan only for short-term treatment.
Consult your doctor if spasms recur repeatedly or if you have noticed any recent changes in their characteristics.
Do not take Buscopan daily on a regular basis or for prolonged periods without consulting your doctor and without undergoing investigations to determine the cause of abdominal pain.
If you take more Buscopan than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
Symptoms
Overdose may cause effects such as difficulty in completely emptying the bladder (urinary retention), dry mouth, skin flushing, increased heart rate (tachycardia), intestinal motility blockage (inhibition of gastrointestinal motility), and transient visual disturbances.
Treatment
Your doctor will prescribe the appropriate treatment.
If you forget to take Buscopan
Do not take a double dose to make up for the forgotten dose.
If you stop taking Buscopan
If you have any doubts about using this medicine, consult your doctor or pharmacist.
If you have been taking high doses of Buscopan, do not stop treatment abruptly (see section “Warnings and precautions”).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below according to the following frequency:
Uncommon (may affect up to 1 in 100 people)

• skin reactions (cutaneous reactions),
• appearance of itchy wheals (urticaria),
• itching,
• increased heart rate (tachycardia),
• dry mouth,
• changes in sweating.

Rare (may affect up to 1 in 1,000 people)

• inability of the urinary bladder to empty completely (urinary retention).

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

• severe allergic reactions (anaphylactic reactions up to anaphylactic shock),
• difficulty in breathing (dyspnea),
• skin rash (cutaneous rash),
• skin irritation (erythema) and other allergic manifestations.

The following side effects have also been observed:

• dilation of the pupil (mydriasis),
• difficulty in focusing images (accommodation disorders),
• increased pressure of the fluid inside the eye (intraocular pressure),
• drowsiness,
• constipation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Buscopan

Coated tablets: this medicine does not require any special storage conditions.
Suppositories: do not store at temperatures above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Buscopan contains
Tablets

• The active substance is hyoscine N-butylbromide 10 mg.

• The other components are: core: calcium hydrogen phosphate, maize starch, soluble starch, anhydrous colloidal silica, tartaric acid, stearic acid; coating: povidone, sucrose (see section 2. Buscopan contains sucrose), talc, arabic gum, titanium dioxide (E171), macrogol 6000, carnauba wax, white wax.
  Suppositories

• The active substance is hyoscine N-butylbromide 10 mg.

• The other components are: solid semisynthetic glycerides.

Description of the appearance of Buscopan and contents of the pack
Buscopan is available as coated tablets or suppositories.
Pack sizes contain 20, 30 or 40 coated tablets and packs of 6 suppositories.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan (Italy)

Manufacturer
Istituto De Angeli S.r.l.
Loc. Prulli n. 103/c
50066 Reggello (FI)

Patient Information Leaflet

BUSCOPAN 20 mg/ml injection solution

Hyoscine butylbromide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Buscopan is and what it is used for
2. What you need to know before using Buscopan
3. How to use Buscopan
4. Possible side effects
5. How to store Buscopan
6. Contents of the pack and other information

1. What Buscopan is and what it is used for

Buscopan contains the active substance hyoscine butylbromide, which belongs to a group of medicines
called semisynthetic belladonna alkaloids used for motility disorders of the stomach, intestine,
biliary tract (gastrointestinal tract), and genitourinary tract.
Buscopan is indicated in adults for:

• pain and spasms of the stomach and intestine,
• pain and spasms due to obstruction in the flow of urine or bile (in the urinary and biliary tracts, where bile flows; bile is a substance involved in certain digestive processes).

Consult your doctor if you do not feel better or if you feel worse after using this medicine.

2. What you should know before using Buscopan

Do not use Buscopan

• if you are allergic to the active substance hyoscine butylbromide or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a severe form of glaucoma, a disease of the eye caused by increased pressure of the fluid inside it (acute angle-closure glaucoma), for which you are not taking any medication;
• if you suffer from an enlarged prostate (prostatic hypertrophy) associated with inability of the urinary bladder to empty completely (urinary retention);
• if you suffer from narrowing of the pylorus, the terminal portion of the stomach (pyloric stenosis), or narrowing of other areas of the stomach and intestine (stenosis of other gastrointestinal segments);
• if you suffer from intestinal disease associated with impaired intestinal motility (paralytic or obstructive ileus), dilation of the colon (megacolon), or chronic inflammatory bowel disease (ulcerative colitis);
• if you suffer from a condition characterized by frequent regurgitation of stomach contents into the esophagus, the tube through which food reaches the stomach (reflux esophagitis);
• if you are elderly or physically weak and suffer from lack of intestinal movement leading to intestinal obstruction (intestinal atony);
• if you suffer from muscle weakness (myasthenia gravis);
• if you suffer from increased heart rate (tachycardia);
• if you suffer from heart rhythm disorders (cardiac tachyarrhythmias).

If you are taking medicines used to reduce or prevent blood clotting (anticoagulants), do not use intramuscular Buscopan injection; instead, consult your doctor, who will administer the medicine intravenously or subcutaneously to avoid bruising.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Contact your doctor immediately if you experience severe abdominal pain without an obvious cause, which persists or worsens, or is accompanied by symptoms such as fever, nausea, vomiting, intestinal disturbances, intestinal tenderness, low blood pressure, fainting, or blood in the stool. Your doctor will perform appropriate tests to determine the cause of your symptoms.

Use Buscopan with caution:

• if you are elderly,
• if you suffer from a nervous system disorder affecting glands and organs (autonomic nervous system dysfunction),
• if you have high blood pressure (arterial hypertension),
• if your heart lacks sufficient strength and capacity to pump blood effectively (congestive heart failure),
• if you suffer from a thyroid disorder that may cause weight loss, fatigue, and weakness (hyperthyroidism),
• if you have liver and/or kidney disease,
• if you suffer from lung disease (chronic or obstructive respiratory disorders),
• if you have a fever.

If you experience eye pain and redness with vision loss after Buscopan injection, seek urgent medical attention from an ophthalmologist, as you may have a severe form of glaucoma (acute angle-closure glaucoma), which has not been previously diagnosed or treated.

Medicines like Buscopan may prolong gastric emptying time, leading to retention of contents in the stomach.

Do not abruptly stop treatment with high doses. Your doctor will evaluate the appropriate dose to manage mild adverse effects or discontinue therapy in case of severe adverse effects.

Since severe allergic reactions have been reported after injectable Buscopan administration, your doctor will monitor you after the injection.

If you have heart problems and are receiving parenteral Buscopan therapy, your doctor will closely monitor you.

Other medicines and Buscopan

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Use this medicine with caution and only under strict medical supervision in the following situations:

• if you are taking medicines such as antidepressants (particularly tricyclic and tetracyclic antidepressants), phenothiazines (used for allergies or mental disorders), butyrophenones (used for mental disorders and vomiting), antihistamines (used for allergies), antipsychotics (used for mental disorders), quinidine (a heart medication), amantadine (used for central nervous system disorders involving loss of motor control, such as Parkinson’s disease), disopyramide (a heart medication), or other respiratory medicines (e.g., tiotropium, ipratropium), or substances similar to atropine (substances acting on the nervous system), as their effects may be enhanced by Buscopan;
• if you are taking medicines for nausea and vomiting, such as metoclopramide, because both their effects and those of Buscopan may be reduced;
• if you are taking anticoagulant medicines used to reduce or prevent blood clotting (see section “Do not use Buscopan”);
• if you are taking beta-adrenergic medicines (used to treat asthma), as Buscopan may increase tachycardia.

Buscopan and alcohol

Do not consume alcohol during treatment with Buscopan.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

If you are pregnant or breastfeeding, it is preferable to avoid using Buscopan.

Your doctor will assess whether the use of this medicine is strictly necessary.

Driving and using machines

Medicines like Buscopan may cause visual disturbances, dizziness, and drowsiness: you should take this into account if driving, operating machinery, or performing tasks requiring attention and alertness.

Buscopan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is practically "sodium-free".

3. How to use Buscopan

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is:

• 1 ampoule several times a day for injection into a muscle or into a vein.

The Buscopan solution must be injected slowly.
Do not use Buscopan daily and regularly or for prolonged periods without undergoing investigations to determine the cause of abdominal pain.
Instructions for use:

1. Break the ampoule at the pre-scored line as shown in the figure; a file is not required.

2. Proceed with administration by slow injection into a vein or into a muscle.

If you use more Buscopan than you should
If you accidentally take too much Buscopan, inform your doctor immediately or go to the nearest hospital.
Symptoms
In case of overdose, effects such as difficulty of the bladder to empty completely (urinary retention), dry mouth, increased heart rate (tachycardia), mild drowsiness, and transient visual disturbances may occur.
Treatment
Your doctor will prescribe the appropriate treatment.
If you forget to use Buscopan
Do not use a double dose to make up for the missed dose.
If you stop using Buscopan
If you have any doubts about using this medicine, consult your doctor or pharmacist.
If you are taking high doses of Buscopan, do not stop treatment abruptly (see the section "Warnings and precautions").

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects are listed below according to the following frequency:
Common (may affect up to 1 in 10 people)

• difficulty focusing images (accommodation disorders),
• increased heart rate (tachycardia),
• dizziness,
• dry mouth.

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

• severe allergic reactions (anaphylactic reactions up to anaphylactic shock which may lead to death),
• difficulty breathing (dyspnoea),
• skin reactions (e.g. skin rash, itching, urticaria, skin irritation),
• dilation of the pupil (mydriasis),
• increased pressure of the fluid inside the eye,
• decreased blood pressure,
• skin redness,
• changes in sweating,
• inability of the urinary bladder to empty completely (urinary retention).

The following side effects have also been reported:

• drowsiness,
• constipation,
• difficulty urinating.

High doses may lead to signs of central nervous system stimulation, such as motor agitation and irritability, and disturbances in consciousness and heart and lung function.
Pain at the injection site is rarely observed, particularly following intramuscular administration.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Buscopan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Buscopan contains

• The active substance is hyoscine butylbromide 20 mg.
• The other components are: sodium chloride, water for injections.

Description of the appearance of Buscopan and contents of the pack
Buscopan is presented in glass vials.
It is available in packs of 6 vials of 1 ml each.
Marketing Authorization Holder and Manufacturer
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan (Italy)
Manufacturer
Boehringer Ingelheim Espana S.A.,
San Cugat del Vallès, Barcelona
Spain
Sanofi S.r.l.
Via Valcanello, 4
03012 Anagni (FR)
Italy