Indication: It is used for the relief of spasm and movement disorders in the form of sudden, severe seizures in the muscles of the stomach, intestines, urinary bladder and urinary tract, bile ducts and reproductive organs.
Form: Tablet
Active Ingredient: Scopolamine N-Butyl Bromide
Active Ingredient Amount: 10 mg / Tablet
Commercial Form: 20 10 mg Coated Tablets
BUTOPAN®
10 mg Dragee
It is taken orally.
Active substance: Each dragee contains 10 mg Scopolamine-N-Butyl bromide.
Excipients: Lactose, gelatin, talc, magnesium stearate, sodium lauryl sulfate, silicone
dioxide, starch, sugar, tartrazine (E102), carbon tetra chloride, beeswax
Carefully follow this USE INSTRUCTIONS before you start using this medicine.
read it because it contains important information for you.
Keep these instructions for use. You can need to read again.
If you have other questions, please talk your doctor or pharmacist.
This medicine has been prescribed for you personally, do not pass it on to others.
During the use of this medicine, when you go to the doctor or hospital,
Tell your doctor.
Follow exactly what is written in this instruction. Other than the recommended dose for the drug, high or
Do not use low doses
In this Instructions for Use:
1. What is BUTOPAN and what is it used for?
2. Things to consider before using BUTOPAN
3. How to use BUTOPAN?
4. What are the possible side effects?
5. How to store BUTOPAN
Headings are included.
1. What is BUTOPAN 10 mg Dragee and what is it used for?
BUTOPAN 10 mg dragee is included in the antispasmodic drugs group. Active substance in 1 dragee
10 mg of scopolamine-N-butyl bromide.
It is presented in blister packs containing 20 dragees. Dragees are yellow in color and round.
BUTOPAN 10 mg coated sudden, severe seizures occurring in the muscles of the following organs.
It is used for contractions (spasm) and movement disorders in the form of:
2. Things to consider before using BUTOPAN 10 mg Dragee
DO NOT USE BUTOPAN 10 mg Dragee in the following situations
If;
- Scopolamine-N-butyl bromide, which is the active substance, or other content contained in BUTOPAN 10 mg dragee
If you are allergic (hypersensitive) to any of the ingredients,
- If you have an eye condition called glaucoma that causes excessive intraocular pressure, and
you are not being treated for
- A urine that causes your urine to accumulate in the bladder and make it difficult to pass
if you have a condition (e.g. an enlarged prostate gland in men)
- Intestinal obstruction or paralysis of bowel movements in your digestive system
If there is a blockage
- If you have a condition that causes an excessive increase in your heart rate
Stubborn, causing excessive enlargement of part of the large intestine called megacolon
If you have a disease with constipation and an enlarged abdomen,
- Myasthenia gravis, a rare condition that causes muscle weakness.
if you have illness
- if you are pregnant
- If you are breastfeeding.
USE BUTOPAN 10 mg Dragee CAREFULLY in the following situations
If;
- If you have a disorder called narrow angle glaucoma in your eye,
- If you have a blockage in your intestines or urinary tract,
- If you have a heart rhythm disorder with an excessive increase in your heart rate,
- If you have a thyroid gland disorder that causes excessive thyroid hormone secretion,
- If you have a problem with urination (e.g. prostate gland in men)
like growth)
If you are constipated.
- If your body temperature rises,
If these warnings are valid for you, even at any time in the past, please
Consult your doctor.
Use of BUTOPAN 10 mg Dragee with food and drink
Any statement regarding the interaction of BUTOPAN 10 mg dragee with food or drink.
there is no finding. BUTOPAN 10 mg dragee can be taken on an empty stomach or with food.
Pregnancy
Consult your doctor or pharmacist before using this medication.
If you think you are (or may be) pregnant, notify your doctor.
you must give. BUTOPAN 10 mg dragee should not be used during pregnancy.
If you notice that you are pregnant during your treatment, contact your doctor or pharmacist immediately.
Please consult.
Breast-feeding
Consult your doctor or pharmacist before using this medication.
If you are breastfeeding, you should not use BUTOPAN 10 mg dragee.
Vehicle and machine use
In some people, when using BUTOPAN 10 mg dragee, near and far vision
There may be a disorder in their adjustment. Symptoms if you have trouble with your vision
Do not use vehicles or machines until the Before driving or using machines
Consult your doctor.
Important information about some of the excipients in the content of BUTOPAN 10 g
informations
BUTOPAN contains 72.400 mg lactose in 10 mg dragee. Rare hereditary galactose
have problems with intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
patients should not use this drug.
BUTOPAN contains 78.000 mg sugar in 10 mg dragee. If your doctor has
If you have been told that you have an intolerance to some sugars, before taking this medicinal product
Please contact your doctor.
BUTOPAN contains less than 1 mmol (23 mg) sodium in a dose of 10 mg dragee; so
essentially "free of sodium".
BUTOPAN contains tartrazine (E102) in 10 mg dragee. May cause allergic reactions.
Use with other drugs
If you are using the following medicines, there is a risk of interacting with BUTOPAN,
Please inform your doctor:
When BUTOPAN 10mg dragee is used with the following medicines, dry mouth, constipation,
such as blurred vision, sweating, accumulation of urine in the urinary bladder, rapid heartbeat
anticholinergic effects may be increased:
Tricyclic antidepressant drugs used in the treatment of mental depression
Antihistamine drugs effective against allergic diseases and vehicle retention
- quinidine, disopramide used to control the heart rate
Amantadine, a drug used in Parkinson's disease
Other anticholinergic drugs used in diseases that cause shortness of breath such as asthma
(eg tiotropium, ipratropium)
- Haloperidol, fluphenazine used as an aid in the correction of mental illnesses
drugs such as butyrophenones, phenothiazines.
Always use BUTOPAN 10 mg dragee as recommended by your doctor.
BUTOPAN 10 mg dragee for adults 1-2 coated tablets 3 times a day.
Children between the ages of 6-12: 1 dragee is applied 3 times a day.
Do not use BUTOPAN 10 mg dragee for a long time or in high doses without your doctor's approval.
do not use.
Application way and method:
BUTOPAN 10 mg coated tablets are used only by mouth.
Take the dragees whole, without chewing, with a sufficient amount of liquid (e.g. with a glass of water)
Different age groups:
Use in children:
It is not recommended for use in children under 6 years of age.
Use in the elderly:
No dose adjustment is required in elderly patients.
Special use cases:
Liver / Kidney failure:
If you have liver or kidney problems, this medicine should be carefully taken under the supervision of a doctor.
should be used.
If you have an impression that the effect of BUTOPAN 10 mg Dragee is too strong or too weak.
talk to your doctor or pharmacist.
If you have used more BUTOPAN 10 mg Dragee than you should:
If you have used more than you should use BUTOPAN 10 mg dragee, a doctor or
Talk to the pharmacist.
Overdose, dry mouth, accumulation of urine in the bladder, skin rash, gastrointestinal tract
decreased movement, temporary visual disturbances, drop in blood pressure, breathing-related
can cause troubles.
If you forget to use BUTOPAN 10 mg Dragee
It is important that you take your medication dose as your doctor has described to you. If you take your medicine
If you forget, you should take this dose as soon as you remember. If it's time for the next dose,
skip the dose you did not take, continue the treatment by taking your normal dose.
Do not take a double dose to make up for forgotten doses.
Treatment is discontinued with BUTOPAN 10 mg Dragee
4. What are the possible side effects?
Like all medicines, those that are sensitive to the ingredients of BUTOPAN 10 mg dragee
There may be side effects in people.
Reported side effects are as follows according to their frequency:
Common (less than one in 10 patients, but more than one in 100 patients):
Blurred vision
Uncommon (less than one in 100 patients, but more than one in 1000 patients):
Skin reactions
Dry mouth
- Dishydrosis (a skin disease that occurs with abnormal sweating, especially in the hands and feet)
Rare (may be seen less than one in 1000 patients, but more than one in 10,000 patients):
Hypersensitivity (allergy)
Accumulation of urine in the bladder and difficulty urinating
- rapid heartbeat
Side effects of unknown frequency (based on the information available, the frequency
not calculated):
- severe sudden allergic reaction (rash, itching, swelling of the face, lips, or mouth or
swelling of the throat making swallowing or breathing difficult); hard breathing
It watches with attacks and a feeling of faintness or dizziness (shock) may be seen.
- Decrease in blood pressure and flushing may be seen.
This is a very serious side effect. You need immediate medical attention or hospitalization
may be.
If you encounter any side effects not mentioned in these instructions for use
Inform your doctor or pharmacist.
Reporting of side effects
In case of any side effects that are included in the instructions for use or not,
Talk to your doctor, pharmacist or nurse. Also the side effects you experience
By clicking on the "Drug Side Effects Notification" icon on www.titck.gov.tr or by clicking on 0 800 314
00 side effects by calling the number 08 line statement Turkey Pharmacovigilance Center (TÜFAM) What
report. The safety of the drug you are using by reporting the side effects that occur
You will contribute to obtaining more information about.
5. Hiding BUTOPAN
BUTOPAN 10 mg Dragee can be used in places out of the sight and reach of children and in its packaging.
Please keep.
Store at room temperature below 25 ° C.
Do not use BUTOPAN after the expiry date on the package.
After the expiration date on the package / blister, take BUTOPAN 10 mg dragee.
do not use.
BUTOPAN®
10 mg Dragee
It is taken orally.
Active substance: Each dragee contains 10 mg Scopolamine-N-Butyl bromide.
Excipients: Lactose, gelatin, talc, magnesium stearate, sodium lauryl sulfate, silicone
dioxide, starch, sugar, tartrazine (E102), carbon tetra chloride, beeswax
Carefully follow this USE INSTRUCTIONS before you start using this medicine.
read it because it contains important information for you.
Keep these instructions for use. You can need to read again.
If you have other questions, please talk your doctor or pharmacist.
This medicine has been prescribed for you personally, do not pass it on to others.
During the use of this medicine, when you go to the doctor or hospital,
Tell your doctor.
Follow exactly what is written in this instruction. Other than the recommended dose for the drug, high or
Do not use low doses
In this Instructions for Use:
1. What is BUTOPAN and what is it used for?
2. Things to consider before using BUTOPAN
3. How to use BUTOPAN?
4. What are the possible side effects?
5. How to store BUTOPAN
Headings are included.
1. What is BUTOPAN 10 mg Dragee and what is it used for?
BUTOPAN 10 mg dragee is included in the antispasmodic drugs group. Active substance in 1 dragee
10 mg of scopolamine-N-butyl bromide.
It is presented in blister packs containing 20 dragees. Dragees are yellow in color and round.
BUTOPAN 10 mg coated sudden, severe seizures occurring in the muscles of the following organs.
It is used for contractions (spasm) and movement disorders in the form of:
2. Things to consider before using BUTOPAN 10 mg Dragee
DO NOT USE BUTOPAN 10 mg Dragee in the following situations
If;
- Scopolamine-N-butyl bromide, which is the active substance, or other content contained in BUTOPAN 10 mg dragee
If you are allergic (hypersensitive) to any of the ingredients,
- If you have an eye condition called glaucoma that causes excessive intraocular pressure, and
you are not being treated for
- A urine that causes your urine to accumulate in the bladder and make it difficult to pass
if you have a condition (e.g. an enlarged prostate gland in men)
- Intestinal obstruction or paralysis of bowel movements in your digestive system
If there is a blockage
- If you have a condition that causes an excessive increase in your heart rate
Stubborn, causing excessive enlargement of part of the large intestine called megacolon
If you have a disease with constipation and an enlarged abdomen,
- Myasthenia gravis, a rare condition that causes muscle weakness.
if you have illness
- if you are pregnant
- If you are breastfeeding.
USE BUTOPAN 10 mg Dragee CAREFULLY in the following situations
If;
- If you have a disorder called narrow angle glaucoma in your eye,
- If you have a blockage in your intestines or urinary tract,
- If you have a heart rhythm disorder with an excessive increase in your heart rate,
- If you have a thyroid gland disorder that causes excessive thyroid hormone secretion,
- If you have a problem with urination (e.g. prostate gland in men)
like growth)
If you are constipated.
- If your body temperature rises,
If these warnings are valid for you, even at any time in the past, please
Consult your doctor.
Use of BUTOPAN 10 mg Dragee with food and drink
Any statement regarding the interaction of BUTOPAN 10 mg dragee with food or drink.
there is no finding. BUTOPAN 10 mg dragee can be taken on an empty stomach or with food.
Pregnancy
Consult your doctor or pharmacist before using this medication.
If you think you are (or may be) pregnant, notify your doctor.
you must give. BUTOPAN 10 mg dragee should not be used during pregnancy.
If you notice that you are pregnant during your treatment, contact your doctor or pharmacist immediately.
Please consult.
Breast-feeding
Consult your doctor or pharmacist before using this medication.
If you are breastfeeding, you should not use BUTOPAN 10 mg dragee.
Vehicle and machine use
In some people, when using BUTOPAN 10 mg dragee, near and far vision
There may be a disorder in their adjustment. Symptoms if you have trouble with your vision
Do not use vehicles or machines until the Before driving or using machines
Consult your doctor.
Important information about some of the excipients in the content of BUTOPAN 10 g
informations
BUTOPAN contains 72.400 mg lactose in 10 mg dragee. Rare hereditary galactose
have problems with intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
patients should not use this drug.
BUTOPAN contains 78.000 mg sugar in 10 mg dragee. If your doctor has
If you have been told that you have an intolerance to some sugars, before taking this medicinal product
Please contact your doctor.
BUTOPAN contains less than 1 mmol (23 mg) sodium in a dose of 10 mg dragee; so
essentially "free of sodium".
BUTOPAN contains tartrazine (E102) in 10 mg dragee. May cause allergic reactions.
Use with other drugs
If you are using the following medicines, there is a risk of interacting with BUTOPAN,
Please inform your doctor:
When BUTOPAN 10mg dragee is used with the following medicines, dry mouth, constipation,
such as blurred vision, sweating, accumulation of urine in the urinary bladder, rapid heartbeat
anticholinergic effects may be increased:
Tricyclic antidepressant drugs used in the treatment of mental depression
Antihistamine drugs effective against allergic diseases and vehicle retention
- quinidine, disopramide used to control the heart rate
Amantadine, a drug used in Parkinson's disease
Other anticholinergic drugs used in diseases that cause shortness of breath such as asthma
(eg tiotropium, ipratropium)
- Haloperidol, fluphenazine used as an aid in the correction of mental illnesses
drugs such as butyrophenones, phenothiazines.
Always use BUTOPAN 10 mg dragee as recommended by your doctor.
BUTOPAN 10 mg dragee for adults 1-2 coated tablets 3 times a day.
Children between the ages of 6-12: 1 dragee is applied 3 times a day.
Do not use BUTOPAN 10 mg dragee for a long time or in high doses without your doctor's approval.
do not use.
Application way and method:
BUTOPAN 10 mg coated tablets are used only by mouth.
Take the dragees whole, without chewing, with a sufficient amount of liquid (e.g. with a glass of water)
Different age groups:
Use in children:
It is not recommended for use in children under 6 years of age.
Use in the elderly:
No dose adjustment is required in elderly patients.
Special use cases:
Liver / Kidney failure:
If you have liver or kidney problems, this medicine should be carefully taken under the supervision of a doctor.
should be used.
If you have an impression that the effect of BUTOPAN 10 mg Dragee is too strong or too weak.
talk to your doctor or pharmacist.
If you have used more BUTOPAN 10 mg Dragee than you should:
If you have used more than you should use BUTOPAN 10 mg dragee, a doctor or
Talk to the pharmacist.
Overdose, dry mouth, accumulation of urine in the bladder, skin rash, gastrointestinal tract
decreased movement, temporary visual disturbances, drop in blood pressure, breathing-related
can cause troubles.
If you forget to use BUTOPAN 10 mg Dragee
It is important that you take your medication dose as your doctor has described to you. If you take your medicine
If you forget, you should take this dose as soon as you remember. If it's time for the next dose,
skip the dose you did not take, continue the treatment by taking your normal dose.
Do not take a double dose to make up for forgotten doses.
Treatment is discontinued with BUTOPAN 10 mg Dragee
4. What are the possible side effects?
Like all medicines, those that are sensitive to the ingredients of BUTOPAN 10 mg dragee
There may be side effects in people.
Reported side effects are as follows according to their frequency:
Common (less than one in 10 patients, but more than one in 100 patients):
Blurred vision
Uncommon (less than one in 100 patients, but more than one in 1000 patients):
Skin reactions
Dry mouth
- Dishydrosis (a skin disease that occurs with abnormal sweating, especially in the hands and feet)
Rare (may be seen less than one in 1000 patients, but more than one in 10,000 patients):
Hypersensitivity (allergy)
Accumulation of urine in the bladder and difficulty urinating
- rapid heartbeat
Side effects of unknown frequency (based on the information available, the frequency
not calculated):
- severe sudden allergic reaction (rash, itching, swelling of the face, lips, or mouth or
swelling of the throat making swallowing or breathing difficult); hard breathing
It watches with attacks and a feeling of faintness or dizziness (shock) may be seen.
- Decrease in blood pressure and flushing may be seen.
This is a very serious side effect. You need immediate medical attention or hospitalization
may be.
If you encounter any side effects not mentioned in these instructions for use
Inform your doctor or pharmacist.
Reporting of side effects
In case of any side effects that are included in the instructions for use or not,
Talk to your doctor, pharmacist or nurse. Also the side effects you experience
By clicking on the "Drug Side Effects Notification" icon on www.titck.gov.tr or by clicking on 0 800 314
00 side effects by calling the number 08 line statement Turkey Pharmacovigilance Center (TÜFAM) What
report. The safety of the drug you are using by reporting the side effects that occur
You will contribute to obtaining more information about.
5. Hiding BUTOPAN
BUTOPAN 10 mg Dragee can be used in places out of the sight and reach of children and in its packaging.
Please keep.
Store at room temperature below 25 ° C.
Do not use BUTOPAN after the expiry date on the package.
After the expiration date on the package / blister, take BUTOPAN 10 mg dragee.
do not use.
