BUSCOPAN 10 mg Suppository

Зміст інструкції

1. BUSCOPAN 10 mg coated tablets, 10 mg suppositories
   1. What is Buscopan and what is it 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
2. BUSCOPAN 20 mg/ml injectable solution
   1. What is Buscopan and what is it 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

BUSCOPAN 10 mg coated tablets, 10 mg suppositories

N-butylscopolamine bromide

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you take 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 is Buscopan and what is it used for

Buscopan contains the active ingredient N-butylscopolamine bromide which belongs to a group of medicines
called semisynthetic belladonna alkaloids used for motility disorders of the stomach, intestines and
bile ducts (gastrointestinal tract).
Buscopan is indicated in adults and children over 6 years of age for:

• pain and spasms in the stomach and intestines,
• pain and spasms due to obstructions in the flow of the bile ducts (where bile flows, a substance involved in some digestive processes). See 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 ingredient 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, i.e. an eye disease caused by an increase in the pressure of the fluid contained within it (acute angle-closure glaucoma);
• if you suffer from an enlargement of the prostate gland (prostatic hypertrophy);
• if you suffer from an inability of the urinary bladder to empty completely (urinary retention);
• if you suffer from a narrowing of the pylorus, the terminal portion of the stomach (pyloric stenosis) or a narrowing of other areas of the stomach and intestines (stenosis of other parts of the gastrointestinal tract);
• in case of intestinal obstruction or if you suspect you have an intestinal obstruction;
• if you suffer from a disease of the intestine, associated with disturbances of the movements of the intestine (paralytic or obstructive ileus), chronic inflammatory bowel disease (ulcerative colitis) and dilation of the colon (megacolon);
• if you suffer from a disorder caused by frequent regurgitation of stomach contents into the esophagus, the duct through which food reaches the stomach (reflux esophagitis);
• if you are elderly or if your physical condition is weak and you suffer from a lack of intestinal movements, which causes 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 of the product (see “Buscopan coated tablets contains sucrose”).

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Contact your doctor immediately if you experience severe pain in the abdominal area (abdominal pain) without a reason, which persists or worsens or is accompanied by symptoms such as fever, nausea, vomiting, disturbances of intestinal movements, intestinal sensitivity, decreased blood pressure, fainting or blood in the stool.
Use Buscopan with caution:

• if you are elderly,
• if you suffer from a disorder of the nerves that maintain control of the proper functioning of glands and organs (autonomic nervous system),
• if you suffer from or are predisposed to heart rhythm disorders (cardiac tachyarrhythmias),
• if you suffer from high blood pressure (arterial hypertension),
• if your heart does not have enough strength and is inadequate to pump blood around the body (congestive heart failure),
• if you suffer from a thyroid disorder that can lead to weight loss, fatigue, and weakness (hyperthyroidism),
• if you suffer from a liver and/or kidney disease,
• if you are predisposed to a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained within it (acute angle-closure glaucoma),
• if you are predisposed to obstruction of the intestinal and urinary tracts (intestinal and urinary stasis),
• if you have a fever.

Medicines like Buscopan can prolong the time it takes for the stomach to empty with stagnation of substances.
Do not abruptly stop treatment with high doses. The doctor will assess the dose to control mild side effects or discontinue therapy in case of serious side effects.

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

Other medicines and Buscopan
Tell 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 (especially 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 (heart drug), amantadine (drug for central nervous system diseases involving a loss of movement control, such as Parkinson's disease), disopyramide (heart drug) and other drugs for respiratory diseases (such as tiotropium, ipratropium), substances similar to atropine (a substance that acts on the nervous system), because their effect may be increased by Buscopan,
• if you are taking medicines against vomiting and nausea, such as metoclopramide, because both their effect and that of Buscopan may decrease,
• 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 absorption of this medicine in the intestine.

Buscopan and alcohol
Do not drink alcohol during therapy with Buscopan.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, it is preferable to avoid using Buscopan.
The doctor will assess whether the use of this medicine is strictly necessary.

Driving and operating machinery
Medicines like Buscopan can cause visual disturbances and drowsiness: you must take this into account if you are driving vehicles or operating machinery or performing work that requires attention and vigilance.

Buscopan coated tablets contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Buscopan

Take this medicine following exactly the instructions in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose for adults and adolescents over 14 years of ageis as follows, unless otherwise prescribed by your doctor:
Coated tablets
1-2 coated tablets 3 times a day.
The tablets must be swallowed whole with an adequate amount of water.
Suppositories
1 suppository 3 times a day.
The suppositories must be removed from the outer wrapper and inserted into the rectum with the pointed end.
In paediatrics, in children between 6 and 14 years of age, follow the doctor's prescription exactly.
Do not exceed the indicated doses without consulting your doctor.
Use Buscopan only for short periods of treatment.
Consult your doctor if spasms occur repeatedly or if you have noticed any recent change in their characteristics.
Do not take Buscopan daily regularly or for prolonged periods without consulting your doctor and without undergoing investigations to find the cause of abdominal pain.

If you take more Buscopan than you should
In case of accidental ingestion/intake of an excessive dose of Buscopan, inform your doctor immediately or go to the nearest hospital.
Symptoms
In case of taking an excessive dose, effects such as difficulty of the bladder to empty completely (urinary retention), dry mouth, redness of the skin, increased number of heartbeats per minute (tachycardia), blockage of intestinal movements (inhibition of gastrointestinal motility) and transient visual disturbances have been observed.
Therapy
The doctor will prescribe the appropriate therapy.

If you forget to take Buscopan
Do not take a double dose to make up for a missed dose.

If you stop taking Buscopan
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
If you are taking high doses of Buscopan, do not stop treatment abruptly (see paragraph “Warnings and precautions”).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 blisters accompanied by itching (urticaria),
• itching,
• increased number of heartbeats per minute (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 (the frequency cannot be estimated from available data)

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

The following side effects have also been observed:

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 a temperature 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 pack after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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
Coated tablets

• The active ingredient is hyoscine butylbromide 10 mg.
• The other ingredients are: core: calcium hydrogen phosphate, corn starch, soluble starch, anhydrous colloidal silica, tartaric acid, stearic acid; coating: povidone, sucrose(see section 2. Buscopan contains sucrose), talc, gum arabic, titanium dioxide (E171), macrogol 6000, carnauba wax, white wax. Suppositories
• The active ingredient is hyoscine butylbromide 10 mg.
• The other ingredients are: solid semi-synthetic glycerides.

Description of the appearance of Buscopan and contents of the pack
Buscopan is available in the form of coated tablets or suppositories.
The pack contains 20, 30 or 40 coated tablets and 6 suppositories.
Not all pack sizes may be available.

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

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

BUSCOPAN 20 mg/ml injectable solution

N-butylscopolamine bromide

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Buscopan and what is it used for

Buscopan contains the active ingredient N-butylscopolamine bromide which belongs to a group of medicines
called semisynthetic belladonna alkaloids used for disorders of the motility of the stomach, intestines and
biliary tract (gastrointestinal tract) and the genitourinary tract.
Buscopan is indicated in adultsin cases of:

• pain and spasms in the stomach and intestines,
• pain and spasms due to obstructions in the urinary and biliary tracts (where bile flows, a substance involved in some digestive processes). Consult your doctor if you do not feel better or if you feel worse after using the medicine.

2. What you need to know before using Buscopan

Do not use Buscopan

• if you are allergic to the active ingredient N-butylscopolamine bromide or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained within it (acute angle-closure glaucoma), for which you are not taking any medication;
• if you suffer from an enlargement of the prostate gland (prostatic hypertrophy) associated with an 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 intestines (stenosis of other parts of the gastrointestinal tract);
• if you suffer from an intestinal disease, associated with disorders of intestinal movements (paralytic or obstructive ileus), dilation of the colon (megacolon) and chronic inflammatory bowel disease (ulcerative colitis);
• if you suffer from a disorder caused by frequent regurgitation of stomach contents into the esophagus, the duct through which food reaches the stomach (reflux esophagitis);
• if you are elderly or if your physical condition is weak and you suffer from a lack of bowel movements, which causes intestinal obstruction (intestinal atony);
• if you suffer from muscle weakness (myasthenia gravis);
• if you suffer from an increased heart rate (tachycardia);
• if you suffer from heart rhythm disorders (cardiac tachyarrhythmias).

If you are taking medications used to reduce or block the formation of blood clots
(anticoagulants), do not use Buscopan by injection into the muscle but consult your doctor, who will administer the
medicine intravenously or subcutaneously to avoid bruising.

Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
Contact your doctor if you experience severe pain in the abdominal area (abdominal pain) without a
reason, which persists or worsens or is accompanied by symptoms such as fever, nausea, vomiting, bowel
movement disorders, intestinal sensitivity, decreased blood pressure, fainting or blood
in the stool. The 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 disorder of the nerves that maintain control of the proper functioning of glands and organs (autonomic nervous system),
• if you suffer from high blood pressure (arterial hypertension),
• if your heart does not have enough strength and is inadequate to pump blood around (congestive heart failure),
• if you suffer from a dysfunction of the thyroid gland that can lead to weight loss, fatigue, weakness (hyperthyroidism),
• if you suffer from a disease of the liver and/or kidneys,
• if you suffer from a lung disease (chronic or obstructive inflammation of the respiratory system),
• if you have a fever.

If you experience eye pain and redness with loss of vision after the injection of Buscopan, consult
your ophthalmologist urgently as you may have a severe form of glaucoma, i.e. an eye disease
caused by an increase in the pressure of the fluid contained within it (acute angle-closure glaucoma), which has not been diagnosed or, consequently, treated.
Medicines like Buscopan can prolong the time of stomach emptying with stagnation of
substances.
Do not abruptly discontinue treatment with high doses. The doctor will evaluate the dose to control
mild side effects or discontinuation of therapy in case of serious side effects.
Since cases of severe allergic reactions have been observed after the administration of Buscopan for
injection, the doctor will keep you under observation after injecting the medicine.
If you suffer from heart problems and are undergoing parenteral therapy with Buscopan, the doctor will keep you
under observation.

Other medicines and Buscopan
Tell 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 control 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 (medicines used for allergies), antipsychotics (medicines used for mental disorders), quinidine (heart medicine), amantadine (medicine for central nervous system diseases involving a loss of movement control, such as Parkinson's disease), disopyramide (heart medicine) and other medicines for respiratory diseases (such as tiotropium, ipratropium), substances similar to atropine (a substance that acts on the nervous system), because their effect may be increased by Buscopan;
• if you are taking medicines against vomiting and nausea, such as metoclopramide, because both their effect and that of Buscopan may decrease;
• if you are taking anticoagulant medicines, used to reduce or block the formation of blood clots (see the paragraph “Do not use Buscopan”);
• if you are taking beta-adrenergic medicines (medicines used to treat asthma) because Buscopan may increase tachycardia.

Buscopan with alcohol
Do not drink alcohol during therapy with Buscopan.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, it is preferable to avoid using Buscopan.
The doctor will assess whether the use of this medicine is strictly necessary.

Driving and operating machinery
Medicines like Buscopan can cause visual disturbances, dizziness and drowsiness: you must take this into account if
you are driving vehicles or operating machinery or performing work that requires attention and vigilance.

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 following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.

Adults
The recommended dose is:

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

The Buscopan solution must be injected slowly.

Do notuse Buscopan daily and regularly or for prolonged periods without undergoing investigations for the
cause of abdominal pain.

Instructions for use:

• 1. Break the vial at the point where the pre-break line is located as shown in the figure, a file is not necessary.

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

If you use more Buscopan than you should
In case of accidental intake of an excessive dose of Buscopan, immediately inform your doctor or
go to the nearest hospital.
Symptoms
In case of taking an excessive dose, effects such as difficulty of the bladder to
empty completely (urinary retention), dry mouth, increased heart rate
per minute (tachycardia), mild sluggishness and transient visual disturbances have been observed.
Therapy
The doctor will prescribe the appropriate therapy.

If you forget to use Buscopan
Do not use a double dose to compensate for missing a dose.

If you stop using Buscopan
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
If you are taking high doses of Buscopan, do not stop treatment abruptly (read the paragraph
“Warnings and precautions”).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are listed below according to the following frequency:

Common (may affect up to 1 in 10 people)

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

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

• severe allergic reactions (anaphylactic reactions up to anaphylactic shock which may be fatal),
• difficulty breathing (dyspnea),
• skin reactions (e.g. skin rash, itching, urticaria, skin irritation),
• pupil dilation (mydriasis),
• increased pressure of the fluid contained in 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 can lead to signs of central nervous system stimulation, such as motor agitation
and irritability and interference with consciousness and heart and lung function.
Pain at the injection site rarely occurs, especially after intramuscular
administration.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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

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

Description of the appearance of Buscopan and contents of the pack
Buscopan is presented in glass ampoules.
It is available in packs of 6 ampoules of 1 ml.

Marketing authorisation holder and manufacturer
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milano (Italy)

Manufacturer
Boehringer Ingelheim Espana S.A.,
San Cugat del Vallès, Barcelona
Spain
Sanofi S.r.l.
Via Valcanello, 4
03012 Anagni (FR)
Italy