BUSCOPAN
BUSCOPAN COMPOSITUM 10 MG + 500 MG COATED TABLETS 20 TABLETS IN AL/PVC BLISTER
BUSCOPAN COMPOSITUM 10 MG + 500 MG COATED TABLETS 20 TABLETS IN AL/PVC BLISTER
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Description
Description
Name
Buscopan Compositum 10 mg + 500 mg coated tablets
Hyoscine N-butylbromide + paracetamol
What is it and what is it used for?
Buscopan Compositum contains two active ingredients: hyoscine N-butylbromide (an active ingredient used in cases of stomach and intestinal motility disorders, or bile duct disorders) and paracetamol (an active ingredient used to reduce pain).
Buscopan Compositum is indicated in adults and children over 10 years of age in cases of:
• pain and spasms in the stomach and intestines;
• pain due to obstacles in the flow of the bile ducts (where bile, a substance involved in some digestive processes, flows).
Contact your doctor if you do not feel better or if you feel worse after 3 days.
What you need to know before taking the medicine
Do not take Buscopan Compositum:
• if you are allergic to hyoscine N-butylbromide or paracetamol or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs, medicines for pain and inflammation) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from acute angle glaucoma (a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained inside the eye);
• if you suffer from prostatic hypertrophy (enlargement of the prostate);
• if you suffer from urinary retention (inability of the urinary bladder to empty completely);
• if you suffer from pyloric stenosis (narrowing of the pylorus, the terminal part of the stomach) or stenosis of other parts of the gastrointestinal tract (narrowing of other areas of the stomach and intestine);
• if you have a blocked intestine or suspect you have one; if you suffer from intestinal diseases associated with bowel movement disorders such as paralytic or obstructive ileus (intestinal obstruction). Symptoms include severe abdominal pain and lack of stool and/or nausea/vomiting;
• if you suffer from megacolon (dilation of the colon);
• if you suffer from ulcerative colitis (chronic inflammatory bowel disease);
• if you suffer from reflux esophagitis (a disorder caused by frequent regurgitation of stomach contents into the esophagus, the tube that carries food to the stomach);
• if you are elderly or if your physical condition is weak and you suffer from intestinal atony (lack of bowel movements causing intestinal obstruction);
• if you suffer from myasthenia gravis (muscle weakness);
• if under 10 years of age;
• if your body does not produce an enzyme called glucose-6-phosphate dehydrogenase (a disease known as favism, which causes the destruction of certain blood cells, red blood cells);
• if you suffer from severe haemolytic anaemia (disease caused by the destruction of red blood cells);
• if you suffer from severe hepatocellular insufficiency (alteration of liver function associated with destruction of liver cells);
• in case of rare hereditary conditions which may be incompatible with an excipient of the product (see "Warnings and precautions").
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Contact your doctor immediately if you experience severe pain in your stomach area that does not go away or gets worse, or is accompanied by symptoms such as fever, nausea, vomiting, changes in bowel movements, bloating, low blood pressure, fainting, or blood in your stool.
While taking Buscopan Compositum, tell your doctor immediately if you have any serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients with these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with rapid, deep breathing, drowsiness, nausea, and vomiting.
To avoid taking an overdose of paracetamol, one of the active ingredients of Buscopan Compositum, you must make sure that you do not take other medicines containing paracetamol at the same time, since if paracetamol is taken in high doses, serious side effects can occur, see the section "If you take more Buscopan Compositum than you should".
Do not exceed the recommended doses (see section 3 "How to take Buscopan Compositum"), as liver damage may occur (see section "If you take more Buscopan Compositum than you should").
Buscopan Compositum should be used with caution :
• if your body does not produce enough glucose-6-phosphate dehydrogenase (a disease known as favism, which causes the destruction of red blood cells);
• if you suffer from liver diseases such as hepatitis (inflammation of the liver), Gilbert's syndrome (disease characterised by an excessive increase in bilirubin in the blood), mild or moderate hepatocellular insufficiency (alteration of liver function associated with destruction of liver cells);
• if you have low glutathione reserves;
• if you are or have recently stopped regularly drinking large quantities of alcohol;
• if your kidneys aren't working well;
• if you suffer from closed-angle glaucoma (a severe form of glaucoma, an eye disease caused by increased pressure in the fluid inside the eye);
• if you are prone to intestinal or urinary tract obstructions;
• if you are prone to tachycardia (increased heart rate);
• if you have high blood pressure;
• if you suffer from congestive heart failure (heart disease);
• if you are subject to hyperthyroidism (excessive functional activity of the thyroid, with the presence of a high quantity of thyroid hormones in circulation);
• if you suffer from chronic obstructive airway diseases.
Buscopan Compositum should only be used under medical supervision :
• if you suffer from kidney failure (severe kidney disease);
• if you suffer from liver failure (severe liver disease).
In these conditions, if necessary, your doctor will reduce the dose or extend the interval between individual administrations.
Serious skin reactions: Life-threatening reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis have been reported with paracetamol use. If symptoms or signs of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis (e.g., progressive skin redness associated with blisters or mucosal lesions) occur, discontinue treatment with Buscopan Compositum immediately and contact the nearest hospital.
Even if you take paracetamol at the prescribed doses after short-term treatment and in patients without previous liver disease, liver damage (hepatotoxicity) may occur (see the section "Possible side effects").
If you need to take Buscopan Compositum for a prolonged period, you will also have to undergo the necessary tests to monitor your blood values and the function of your kidneys and liver, as prescribed by your doctor.
If you frequently use painkillers (analgesics), especially at high doses, you may experience headaches. In this case, you should not increase the dose of your painkiller to treat it.
If you experience allergic reactions after taking Buscopan Compositum (seen very rarely, see section "Possible side effects"), stop treatment with Buscopan Compositum at the first signs of an allergic reaction and contact your doctor immediately.
Do not take Buscopan Compositum for more than 3 days unless otherwise prescribed by your doctor. If the pain persists or worsens, if you experience new symptoms, or if you experience redness or swelling, consult your doctor as these could be symptoms of a serious condition.
Also, consult your doctor before taking any other medicines. See also the section "Other medicines and Buscopan Compositum".
Children
Buscopan Compositum should not be used in children under 10 years of age.
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 (redness of the skin);
• abnormal sweating;
• itching;
• nausea;
• dry mouth.
Rare (may affect up to 1 in 1,000 people)
• shock (decrease in blood pressure with severe reduction in heart function);
• tachycardia (increased heart rate);
• erythema (skin irritation).
Very rare (may affect up to 1 in 10,000 people)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (serious skin diseases characterized by erythema, bullous lesions with areas of skin detachment);
• generalized exanthematous pustulosis (characterized by the appearance of numerous small pustules, burning sensation, widespread itching and high fever);
• skin inflammation (hives, rash, exanthema).
Frequency not known (frequency cannot be estimated from the available data)
• pancytopenia (reduction in the number of all types of cells present in the blood);
• agranulocytosis (reduction in the number of granulocytes in the blood, a type of white blood cell);
• thrombocytopenia (reduction in the number of platelets in the blood);
• neutropenia (reduction in the number of neutrophils in the blood, a type of white blood cell);
• leukopenia (reduction in the number of white blood cells in the blood);
• anemia (reduction of hemoglobin in the blood, the substance that carries oxygen in the blood);
• hemolytic anemia (excessive destruction of red blood cells);
• increase in transaminases in the blood (substances present in the liver whose increase may indicate the presence of liver damage);
• allergic reactions, including serious ones (anaphylactic shock, anaphylactic reactions, drug-induced skin reaction, hypersensitivity), laryngeal edema (swelling of the larynx, the organ in the throat that produces the voice), angioedema (allergic reaction with symptoms such as swelling of the face, tongue or throat, difficulty swallowing, itching, difficulty breathing);
• skin reactions of various types and severity including cases of erythema multiforme (a condition characterised by the appearance of red spots on the skin with a "bull's eye" appearance associated with itching) and fixed drug eruption;
• difficulty breathing;
• spasms of the bronchial muscles (especially in those suffering from asthma or allergies);
• urinary retention (inability of the urinary bladder to empty completely);
• kidney disorders: acute renal failure (rapid reduction in kidney function), interstitial nephritis (inflammation of the kidneys), hematuria (presence of blood in the urine), anuria (cessation or reduction in urine production);
• difficulty urinating;
• sweating;
• mydriasis (dilation of the pupil);
• visual disturbances (accommodation disorders, i.e. difficulty focusing images, increased ocular tone, i.e. increased pressure of the fluid inside the eye);
• constipation;
• stomach and intestinal reactions;
• liver disorders (such as hepatitis which can lead to acute liver failure or liver function disorders);
• drowsiness;
• dizziness;
• a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
Buscopan Compositum 10 mg + 500 mg coated tablets
Hyoscine N-butylbromide + paracetamol
What is it and what is it used for?
Buscopan Compositum contains two active ingredients: hyoscine N-butylbromide (an active ingredient used in cases of stomach and intestinal motility disorders, or bile duct disorders) and paracetamol (an active ingredient used to reduce pain).
Buscopan Compositum is indicated in adults and children over 10 years of age in cases of:
• pain and spasms in the stomach and intestines;
• pain due to obstacles in the flow of the bile ducts (where bile, a substance involved in some digestive processes, flows).
Contact your doctor if you do not feel better or if you feel worse after 3 days.
What you need to know before taking the medicine
Do not take Buscopan Compositum:
• if you are allergic to hyoscine N-butylbromide or paracetamol or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs, medicines for pain and inflammation) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from acute angle glaucoma (a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained inside the eye);
• if you suffer from prostatic hypertrophy (enlargement of the prostate);
• if you suffer from urinary retention (inability of the urinary bladder to empty completely);
• if you suffer from pyloric stenosis (narrowing of the pylorus, the terminal part of the stomach) or stenosis of other parts of the gastrointestinal tract (narrowing of other areas of the stomach and intestine);
• if you have a blocked intestine or suspect you have one; if you suffer from intestinal diseases associated with bowel movement disorders such as paralytic or obstructive ileus (intestinal obstruction). Symptoms include severe abdominal pain and lack of stool and/or nausea/vomiting;
• if you suffer from megacolon (dilation of the colon);
• if you suffer from ulcerative colitis (chronic inflammatory bowel disease);
• if you suffer from reflux esophagitis (a disorder caused by frequent regurgitation of stomach contents into the esophagus, the tube that carries food to the stomach);
• if you are elderly or if your physical condition is weak and you suffer from intestinal atony (lack of bowel movements causing intestinal obstruction);
• if you suffer from myasthenia gravis (muscle weakness);
• if under 10 years of age;
• if your body does not produce an enzyme called glucose-6-phosphate dehydrogenase (a disease known as favism, which causes the destruction of certain blood cells, red blood cells);
• if you suffer from severe haemolytic anaemia (disease caused by the destruction of red blood cells);
• if you suffer from severe hepatocellular insufficiency (alteration of liver function associated with destruction of liver cells);
• in case of rare hereditary conditions which may be incompatible with an excipient of the product (see "Warnings and precautions").
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Contact your doctor immediately if you experience severe pain in your stomach area that does not go away or gets worse, or is accompanied by symptoms such as fever, nausea, vomiting, changes in bowel movements, bloating, low blood pressure, fainting, or blood in your stool.
While taking Buscopan Compositum, tell your doctor immediately if you have any serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients with these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with rapid, deep breathing, drowsiness, nausea, and vomiting.
To avoid taking an overdose of paracetamol, one of the active ingredients of Buscopan Compositum, you must make sure that you do not take other medicines containing paracetamol at the same time, since if paracetamol is taken in high doses, serious side effects can occur, see the section "If you take more Buscopan Compositum than you should".
Do not exceed the recommended doses (see section 3 "How to take Buscopan Compositum"), as liver damage may occur (see section "If you take more Buscopan Compositum than you should").
Buscopan Compositum should be used with caution :
• if your body does not produce enough glucose-6-phosphate dehydrogenase (a disease known as favism, which causes the destruction of red blood cells);
• if you suffer from liver diseases such as hepatitis (inflammation of the liver), Gilbert's syndrome (disease characterised by an excessive increase in bilirubin in the blood), mild or moderate hepatocellular insufficiency (alteration of liver function associated with destruction of liver cells);
• if you have low glutathione reserves;
• if you are or have recently stopped regularly drinking large quantities of alcohol;
• if your kidneys aren't working well;
• if you suffer from closed-angle glaucoma (a severe form of glaucoma, an eye disease caused by increased pressure in the fluid inside the eye);
• if you are prone to intestinal or urinary tract obstructions;
• if you are prone to tachycardia (increased heart rate);
• if you have high blood pressure;
• if you suffer from congestive heart failure (heart disease);
• if you are subject to hyperthyroidism (excessive functional activity of the thyroid, with the presence of a high quantity of thyroid hormones in circulation);
• if you suffer from chronic obstructive airway diseases.
Buscopan Compositum should only be used under medical supervision :
• if you suffer from kidney failure (severe kidney disease);
• if you suffer from liver failure (severe liver disease).
In these conditions, if necessary, your doctor will reduce the dose or extend the interval between individual administrations.
Serious skin reactions: Life-threatening reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis have been reported with paracetamol use. If symptoms or signs of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis (e.g., progressive skin redness associated with blisters or mucosal lesions) occur, discontinue treatment with Buscopan Compositum immediately and contact the nearest hospital.
Even if you take paracetamol at the prescribed doses after short-term treatment and in patients without previous liver disease, liver damage (hepatotoxicity) may occur (see the section "Possible side effects").
If you need to take Buscopan Compositum for a prolonged period, you will also have to undergo the necessary tests to monitor your blood values and the function of your kidneys and liver, as prescribed by your doctor.
If you frequently use painkillers (analgesics), especially at high doses, you may experience headaches. In this case, you should not increase the dose of your painkiller to treat it.
If you experience allergic reactions after taking Buscopan Compositum (seen very rarely, see section "Possible side effects"), stop treatment with Buscopan Compositum at the first signs of an allergic reaction and contact your doctor immediately.
Do not take Buscopan Compositum for more than 3 days unless otherwise prescribed by your doctor. If the pain persists or worsens, if you experience new symptoms, or if you experience redness or swelling, consult your doctor as these could be symptoms of a serious condition.
Also, consult your doctor before taking any other medicines. See also the section "Other medicines and Buscopan Compositum".
Children
Buscopan Compositum should not be used in children under 10 years of age.
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 (redness of the skin);
• abnormal sweating;
• itching;
• nausea;
• dry mouth.
Rare (may affect up to 1 in 1,000 people)
• shock (decrease in blood pressure with severe reduction in heart function);
• tachycardia (increased heart rate);
• erythema (skin irritation).
Very rare (may affect up to 1 in 10,000 people)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (serious skin diseases characterized by erythema, bullous lesions with areas of skin detachment);
• generalized exanthematous pustulosis (characterized by the appearance of numerous small pustules, burning sensation, widespread itching and high fever);
• skin inflammation (hives, rash, exanthema).
Frequency not known (frequency cannot be estimated from the available data)
• pancytopenia (reduction in the number of all types of cells present in the blood);
• agranulocytosis (reduction in the number of granulocytes in the blood, a type of white blood cell);
• thrombocytopenia (reduction in the number of platelets in the blood);
• neutropenia (reduction in the number of neutrophils in the blood, a type of white blood cell);
• leukopenia (reduction in the number of white blood cells in the blood);
• anemia (reduction of hemoglobin in the blood, the substance that carries oxygen in the blood);
• hemolytic anemia (excessive destruction of red blood cells);
• increase in transaminases in the blood (substances present in the liver whose increase may indicate the presence of liver damage);
• allergic reactions, including serious ones (anaphylactic shock, anaphylactic reactions, drug-induced skin reaction, hypersensitivity), laryngeal edema (swelling of the larynx, the organ in the throat that produces the voice), angioedema (allergic reaction with symptoms such as swelling of the face, tongue or throat, difficulty swallowing, itching, difficulty breathing);
• skin reactions of various types and severity including cases of erythema multiforme (a condition characterised by the appearance of red spots on the skin with a "bull's eye" appearance associated with itching) and fixed drug eruption;
• difficulty breathing;
• spasms of the bronchial muscles (especially in those suffering from asthma or allergies);
• urinary retention (inability of the urinary bladder to empty completely);
• kidney disorders: acute renal failure (rapid reduction in kidney function), interstitial nephritis (inflammation of the kidneys), hematuria (presence of blood in the urine), anuria (cessation or reduction in urine production);
• difficulty urinating;
• sweating;
• mydriasis (dilation of the pupil);
• visual disturbances (accommodation disorders, i.e. difficulty focusing images, increased ocular tone, i.e. increased pressure of the fluid inside the eye);
• constipation;
• stomach and intestinal reactions;
• liver disorders (such as hepatitis which can lead to acute liver failure or liver function disorders);
• drowsiness;
• dizziness;
• a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
BUSCOPAN
BUSCOPAN COMPOSITUM 10 MG + 500 MG COATED TABLETS 20 TABLETS IN AL/PVC BLISTER
BUSCOPAN COMPOSITUM 10 MG + 500 MG COATED TABLETS 20 TABLETS IN AL/PVC BLISTER
MINSAN code: 029454042
Previous price: €13,90
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€13,90
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€13,90
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