Buscopan 10mg Tablets
S496 LEAFLET P Buscopan 20140514
PACKAGE LEAFLET: INFORMATION FOR THE USER BUSCOPAN 10mg TABLETS (hyoscine-N-butylbromide)
The name of your medicine is Buscopan 10mg Tablets but will be referred to as Buscopan Tablets throughout the following leaflet.
Read all of this leaflet carefully before you start taking Buscopan Tablets, because it contains important information for you to get the best results.
• Keep this leaflet. You may need to use it again
• Ask your pharmacist if you need more information or advice
• You must contact a doctor if your symptoms worsen or do not improve after two weeks
• If a side effect occurs and gets troublesome, or seems serious to you, or if you experience a side effect not listed in this leaflet, please tell your pharmacist or doctor
In this leaflet:
1. What Buscopan Tablets are and what they are used for
2. Before you take Buscopan Tablets
3. How to take Buscopan Tablets
4. Possible side effects
5. How to store Buscopan Tablets
6. Further information
1. WHAT BUSCOPAN TABLETS ARE AND WHAT THEY ARE USED FOR
• Buscopan Tablets contain a medicine called “hyoscine butylbromide”. It belongs to a group of medicines called antispasmodics.
• It is used to relieve stomach and bowel cramps which cause pain and discomfort associated with your digestive tract, and in Irritable Bowel Syndrome.
• It may also be recommended by your doctor for spasm of the bladder and urinary tubes (urinary tract).
• It works by relaxing the cramping muscles of your stomach and bowel, or urinary tract.
What are abdominal cramps?
Abdominal cramps (or spasm) are due to the sudden, irregular tightening up of muscles in the wall of your stomach or bowel. While the precise cause is unknown, the muscles of the stomach and bowel appear to be very sensitive to things like:
• Stress, eating and drinking habits
• Food allergies or intolerances
• Stimulants such as coffee
• Hormonal factors
Such things can trigger painful abdominal cramps or spasms if you have a sensitive digestive tract. You may also feel bloated, with excess wind and abdominal discomfort.
2. BEFORE YOU TAKE BUSCOPAN TABLETS
Do not take Buscopan Tablets if:
• You are allergic to hyoscine butylbromide or any of the other ingredients of Buscopan Tablets (listed in Section 6)
• You are intolerant to or cannot digest some sugars (as the tablet coating contains a small amount of sucrose)
• You have glaucoma (an eye problem)
• You have megacolon (a very enlarged bowel)
• You have something called ‘myasthenia gravis' (a very rare muscle weakness problem)
• You are pregnant, likely to get pregnant, or are breast-feeding
Do not take this medicine if any of the above applies to you. If you
are not sure, talk to your pharmacist or doctor before taking this
medicine.
Take special care with Buscopan Tablets
Check with your pharmacist or doctor before taking your medicine if any of the following apply to you:
• You are 40 years or over
• You have recently passed blood from the bowel
• You have severe constipation
• You are feeling sick or vomiting
• You have lost your appetite or lost weight
• You are looking pale and feeling tired
• You have difficulty or pain passing water (urine)
• You have a fever
• You have abnormal vaginal bleeding or discharge
• You have recently travelled abroad (in case you have picked up a stomach bug)
• You have a very fast heart rate or other heart problems
• You have been treated by a doctor for a severe sweating problem
If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking this medicine.
Check with your pharmacist or doctor straight away if you have unexplained abdominal pain which persists or worsens or occurs with:
• fever
• feeling sick
• being sick
• changes in your bowel movements
• abdominal tenderness
• low blood pressure
• feeling faint or,
• blood in your bowel movements
Taking other medicines
Please tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Buscopan Tablets can affect the way some other medicines work. Also some other medicines can affect the way Buscopan Tablets work.
In particular tell your pharmacist or doctor if you are taking any of the following medicines:
• Antihistamines - used to treat hay fever and other allergies
• Tetracyclic or tricyclic medicines - used to treat depression and some types of pain
• Antipsychotic medicines such as butyrophenones or phenothiazines - used to treat severe mental illness such as schizophrenia
• Dopamine antagonists such as metoclopramide for feeling sick
• Beta 2 adrenergic medicines such as salbutamol inhalers for asthma
• Quinidine or disopyramide - used to control your heart beat
• Amantadine - used for Parkinson's disease and flu
• Anticholinergic medicines such as tiotropium, ipratropium or atropine-like medicines - usually inhaled to treat breathing problems
If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking this medicine.
Pregnancy and breast-feeding
Do not take Buscopan Tablets if you are pregnant, likely to get pregnant or are breast-feeding.
Driving and using machines
Some people may have temporary blurring of vision while taking this medicine. If this happens to you, wait until your vision returns to normal before driving or using any tools or machines.
3. HOW TO TAKE BUSCOPAN TABLETS
Always take this medicine exactly as your pharmacist or doctor has told you. You should check with them if you are not sure. Buscopan Tablets should not be taken continuously for more than two weeks. Talk to your pharmacist or doctor if you develop new symptoms or if your symptoms get worse or have not improved over two weeks.
Taking this medicine
• Swallow the tablet whole with water
• Do not crush or chew the tablet
How much to take
For relief of painful spasm of the stomach, bowel or bladder and urinary tubes (urinary tract).
Adults, and children 12 years or over:
• 2 tablets four times a day Children 6 to 12 years:
• 1 tablet three times a day
Not recommended for children under 6 years
For the relief of abdominal pain in Irritable Bowel Syndrome (IBS)
Adults, and children 12 years or over:
• Start by taking 1 tablet three times a day
• You can increase your dose to a maximum of 2 tablets four times a day, if needed
Not recommended for children under 12 years
If you take more Buscopan Tablets than you should
If you take more than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you have any further questions on the use of this product, ask your pharmacist or doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Buscopan Tablets can cause side effects in some people. The following side effects may happen with this medicine:
Mild side effects that do not normally require medical treatment:
Uncommon - affects fewer than 1 in 100 people
• Dry mouth
• Dyshidrosis (outbreaks of sweat and dryness of skin)
If any of these side effects get troublesome or seem serious to you please tell your pharmacist or doctor.
If you get any of the side effects described below stop taking this medicine and tell your doctor straight away. You may need urgent medical treatment:
Uncommon - affects fewer than 1 in 100 people
• Skin reactions such as urticaria and pruritus (itching)
• Tachycardia (increased heart rate)
Rare - affects fewer than 1 in 1,000 people • Problems emptying the bladder Isolated events - some side effects are so rare that it is not known how many people may be affected
• Anaphylactic reaction and shock - this is a severe type of allergic reaction. An itchy rash may spread all over the body, as well as swelling. You may have difficulty in breathing and may lose consciousness
• Dyspnoea (difficult or laboured breathing)
• Allergic reactions (hypersensitivity) such as skin rash and erythema (patchy red skin)
• If you experience a painful red eye with loss of vision after taking this medicine, stop taking it and tell your doctor straight away. You may have an eye problem called glaucoma and need urgent medical attention
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE BUSCOPAN TABLETS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Buscopan Tablets should not be stored above 25°C and should be stored in a dry place and protected from light.
• Do not use after the expiry date printed on the carton label or blister strip.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Buscopan Tablets contain
• Each tablet contains 10mg of the active ingredient, hyoscine-N-butylbromide.
• Buscopan Tablets also contain the following: calcium hydrogen phosphate, dried maize starch, soluble maize starch, colloidal silica, stearic/palmitic acid, tartaric acid, sucrose, talc, acacia, macrogol 6000, carnauba wax, beeswax, povidone and titanium dioxide (E171).
What Buscopan Tablets look like and contents of the pack
Buscopan Tablets are round, white, biconvex, coated, unmarked
tablet.
Buscopan Tablets are available in blister packs of 20 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1Dx.
Manufacturer
This product is manufactured by Boehringer Ingelheim Hellas S.A.,
5 km Paiania - Markopoulou, Koropi, Attica, Greece.
[P] PL No: 19488/0496 Leaflet revision date: 14 May 2014
Buscopan is a registered trade mark of Boehringer Ingelheim Pharma GmbH & Co. KG, Germany.
S496 LEAFLET P Buscopan 20140514
S496 LEAFLET P Hyoscine 20140514
PACKAGE LEAFLET: INFORMATION FOR THE USER HYOSCINE-N-BUTYLBROMIDE 10mg TABLETS
The name of your medicine is Hyoscine-N-butylbromide 10mg Tablets but will be referred to as Hyoscine Tablets throughout the following leaflet.
Read all of this leaflet carefully before you start taking Hyoscine Tablets, because it contains important information for you to get the best results.
• Keep this leaflet. You may need to use it again
• Ask your pharmacist if you need more information or advice
• You must contact a doctor if your symptoms worsen or do not improve after two weeks
• If a side effect occurs and gets troublesome, or seems serious to you, or if you experience a side effect not listed in this leaflet, please tell your pharmacist or doctor
In this leaflet:
1. What Hyoscine Tablets are and what they are used for
2. Before you take Hyoscine Tablets
3. How to take Hyoscine Tablets
4. Possible side effects
5. How to store Hyoscine Tablets
6. Further information
1. WHAT HYOSCINE TABLETS ARE AND WHAT THEY ARE USED FOR
• Hyoscine Tablets contain a medicine called “hyoscine butylbromide”. It belongs to a group of medicines called antispasmodics.
• It is used to relieve stomach and bowel cramps which cause pain and discomfort associated with your digestive tract, and in Irritable Bowel Syndrome.
• It may also be recommended by your doctor for spasm of the bladder and urinary tubes (urinary tract).
• It works by relaxing the cramping muscles of your stomach and bowel, or urinary tract.
What are abdominal cramps?
Abdominal cramps (or spasm) are due to the sudden, irregular tightening up of muscles in the wall of your stomach or bowel. While the precise cause is unknown, the muscles of the stomach and bowel appear to be very sensitive to things like:
• Stress, eating and drinking habits
• Food allergies or intolerances
• Stimulants such as coffee
• Hormonal factors
Such things can trigger painful abdominal cramps or spasms if you have a sensitive digestive tract. You may also feel bloated, with excess wind and abdominal discomfort.
2. BEFORE YOU TAKE HYOSCINE TABLETS
Do not take Hyoscine Tablets if:
• You are allergic to hyoscine butylbromide or any of the other ingredients of Hyoscine Tablets (listed in Section 6)
• You are intolerant to or cannot digest some sugars (as the tablet coating contains a small amount of sucrose)
• You have glaucoma (an eye problem)
• You have megacolon (a very enlarged bowel)
• You have something called ‘myasthenia gravis' (a very rare muscle weakness problem)
• You are pregnant, likely to get pregnant, or are breast-feeding
Do not take this medicine if any of the above applies to you. If you
are not sure, talk to your pharmacist or doctor before taking this
medicine.
Take special care with Hyoscine Tablets
Check with your pharmacist or doctor before taking your medicine if any of the following apply to you:
• You are 40 years or over
• You have recently passed blood from the bowel
• You have severe constipation
• You are feeling sick or vomiting
• You have lost your appetite or lost weight
• You are looking pale and feeling tired
• You have difficulty or pain passing water (urine)
• You have a fever
• You have abnormal vaginal bleeding or discharge
• You have recently travelled abroad (in case you have picked up a stomach bug)
• You have a very fast heart rate or other heart problems
• You have been treated by a doctor for a severe sweating problem
If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking this medicine.
Check with your pharmacist or doctor straight away if you have unexplained abdominal pain which persists or worsens or occurs with:
• fever
• feeling sick
• being sick
• changes in your bowel movements
• abdominal tenderness
• low blood pressure
• feeling faint or,
• blood in your bowel movements
Taking other medicines
Please tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Hyoscine Tablets can affect the way some other medicines work. Also some other medicines can affect the way Hyoscine Tablets work.
In particular tell your pharmacist or doctor if you are taking any of the following medicines:
• Antihistamines - used to treat hay fever and other allergies
• Tetracyclic or tricyclic medicines - used to treat depression and some types of pain
• Antipsychotic medicines such as butyrophenones or phenothiazines - used to treat severe mental illness such as schizophrenia
• Dopamine antagonists such as metoclopramide for feeling sick
• Beta 2 adrenergic medicines such as salbutamol inhalers for asthma
• Quinidine or disopyramide - used to control your heart beat
• Amantadine - used for Parkinson's disease and flu
• Anticholinergic medicines such as tiotropium, ipratropium or atropine-like medicines - usually inhaled to treat breathing problems
If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking this medicine.
Pregnancy and breast-feeding
Do not take Hyoscine Tablets if you are pregnant, likely to get pregnant or are breast-feeding.
Driving and using machines
Some people may have temporary blurring of vision while taking this medicine. If this happens to you, wait until your vision returns to normal before driving or using any tools or machines.
3. HOW TO TAKE HYOSCINE TABLETS
Always take this medicine exactly as your pharmacist or doctor has told you. You should check with them if you are not sure. Hyoscine Tablets should not be taken continuously for more than two weeks. Talk to your pharmacist or doctor if you develop new symptoms or if your symptoms get worse or have not improved over two weeks.
Taking this medicine
• Swallow the tablet whole with water
• Do not crush or chew the tablet
How much to take
For relief of painful spasm of the stomach, bowel or bladder and urinary tubes (urinary tract).
Adults, and children 12 years or over:
• 2 tablets four times a day Children 6 to 12 years:
• 1 tablet three times a day
Not recommended for children under 6 years
For the relief of abdominal pain in Irritable Bowel Syndrome (IBS)
Adults, and children 12 years or over:
• Start by taking 1 tablet three times a day
• You can increase your dose to a maximum of 2 tablets four times a day, if needed
Not recommended for children under 12 years
If you take more Hyoscine Tablets than you should
If you take more than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you have any further questions on the use of this product, ask your pharmacist or doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Hyoscine Tablets can cause side effects in some people. The following side effects may happen with this medicine:
Mild side effects that do not normally require medical treatment:
Uncommon - affects fewer than 1 in 100 people
• Dry mouth
• Dyshidrosis (outbreaks of sweat and dryness of skin)
If any of these side effects get troublesome or seem serious to you please tell your pharmacist or doctor.
If you get any of the side effects described below stop taking this medicine and tell your doctor straight away. You may need urgent medical treatment:
Uncommon - affects fewer than 1 in 100 people
• Skin reactions such as urticaria and pruritus (itching)
• Tachycardia (increased heart rate)
Rare - affects fewer than 1 in 1,000 people
• Problems emptying the bladder
Isolated events - some side effects are so rare that it is not known how many people may be affected
• Anaphylactic reaction and shock - this is a severe type of allergic reaction. An itchy rash may spread all over the body, as well as swelling. You may have difficulty in breathing and may lose consciousness
• Dyspnoea (difficult or laboured breathing)
• Allergic reactions (hypersensitivity) such as skin rash and erythema (patchy red skin)
• If you experience a painful red eye with loss of vision after taking this medicine, stop taking it and tell your doctor straight away. You may have an eye problem called glaucoma and need urgent medical attention
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE HYOSCINE TABLETS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Hyoscine Tablets should not be stored above 25°C and should be stored in a dry place and protected from light.
• Do not use after the expiry date printed on the carton label or blister strip.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Hyoscine Tablets contain
• Each tablet contains 10mg of the active ingredient, hyoscine-N-butylbromide.
• Hyoscine Tablets also contain the following: calcium hydrogen phosphate, dried maize starch, soluble maize starch, colloidal silica, stearic/palmitic acid, tartaric acid, sucrose, talc, acacia, macrogol 6000, carnauba wax, beeswax, povidone and titanium dioxide (E171).
What Hyoscine Tablets look like and contents of the pack
Hyoscine Tablets are round, white, biconvex, coated, unmarked
tablet.
Hyoscine Tablets are available in blister packs of 20 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1Dx.
Manufacturer
This product is manufactured by Boehringer Ingelheim Hellas S.A.,
5 km Paiania - Markopoulou, Koropi, Attica, Greece.
[P] PL No: 19488/0496 Leaflet revision date: 14 May 2014
S496 LEAFLET P Hyoscine 20140514
S496 LEAFLET POM Buscopan 20140514
PACKAGE LEAFLET: INFORMATION FOR THE USER BUSCOPAN 10mg TABLETS (hyoscine-N-butylbromide)
The name of your medicine is Buscopan 10mg Tablets but will be referred to as Buscopan Tablets throughout the following leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Buscopan Tablets are and what they are used for
2. Before you take Buscopan Tablets
3. How to take Buscopan Tablets
4. Possible side effects
5. How to store Buscopan Tablets
6. Further information
1. WHAT BUSCOPAN TABLETS ARE AND WHAT THEY ARE USED FOR
Buscopan Tablets contain a medicine called “hyoscine butylbromide”. This belongs to a group of medicines called “antispasmodics”.
Buscopan Tablets are used to relieve cramps in the muscles of your:
• Stomach
• Gut (intestine)
• Bladder and the tubes that lead to the outside of your body (urinary system)
It can also be used to relieve the symptoms of Irritable Bowel Syndrome (IBS).
2. BEFORE YOU TAKE BUSCOPAN TABLETS
Do not take Buscopan Tablets if:
• You are allergic (hypersensitive) to hyoscine butylbromide or any of the other ingredients (listed in section 6)
• You have glaucoma (an eye problem)
• You have megacolon (a very enlarged bowel)
• You have something called “myasthenia gravis” (a very rare muscle weakness problem)
• You are pregnant, likely to get pregnant, or are breast-feeding
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Take special care with Buscopan Tablets
Check with your doctor or pharmacist before taking your medicine if:
• You have a very fast heart rate or other heart problems
• You have a problem with your thyroid gland such as an overactive thyroid gland
• You have difficulty or pain passing water (urine) such as men with prostate problems
• You have constipation
• You have a fever
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Buscopan Tablets.
Check with your doctor or pharmacist straight away if you have unexplained abdominal pain which persists or worsens or occurs with:
• fever
• feeling sick
• being sick
• changes in your bowel movements
• abdominal tenderness
• low blood pressure
• feeling faint or,
• blood in your bowel movements
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Buscopan Tablets can affect the way some other medicines work.
Also some other medicines can affect the way Buscopan Tablets work.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• Medicines for depression called “tetracyclic antidepressants” or “tricyclic antidepressants” such as doxepin
• Medicines for allergies and travel sickness called “antihistamines”
• Medicines to control your heart beat such as quinidine or disopyramide
• Medicines for severe mental illness called ‘antipsychotics' such as haloperidol or fluphenazine
• Medicines usually used for breathing problems such as tiotropium, ipratropium or atropine-like medicines
• Amantadine - for Parkinson's disease and flu
• Metoclopramide - for feeling sick (nausea)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Buscopan Tablets.
Pregnancy and breast-feeding
Do not take Buscopan Tablets if you are pregnant, likely to get pregnant or are breast-feeding.
Some people may have sight problems while taking this medicine. If this happens to you, wait until your sight returns to normal before driving or using any tools or machines.
Important information about some of the ingredients of Buscopan Tablets
Buscopan Tablets contain sucrose. Talk to your doctor before taking this medicine if they have told you that you cannot tolerate or digest some sugars.
3. HOW TO TAKE BUSCOPAN TABLETS
Always take your medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Buscopan Tablets should not be taken continuously for long periods of time.
Taking this medicine
• Take your tablets with water
• Do not break, crush or chew the tablets How much to take
Adults and children over 12 years
• The usual dose is two tablets 4 times a day
• For Irritable Bowel Syndrome, your doctor may give you a lower starting dose of one tablet 3 times a day. This dose may be increased, if further relief is necessary
Children 6 - 12 years:
• The usual dose is one tablet 3 times a day
Buscopan Tablets are not recommended for children under 6 years.
If you take more Buscopan Tablets than you should
If you take more Buscopan Tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you even if there are no Buscopan Tablets left.
If you forget to take Buscopan Tablets
• If you forget a dose, take it as soon as you remember.
However, if it is time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Buscopan Tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Stop taking your medicine and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
• Allergic reactions such as skin reactions e.g. nettle rash, itching (affects fewer than 1 in 100 people), rash, redness of the skin
• Severe allergic reactions (anaphylactic shock) such as difficulty breathing, feeling faint or dizzy (shock)
• Painful red eye with loss of vision
Other side effects
• Dry mouth (affects fewer than 1 in 100 people)
• Small blisters on hands and feet (affects fewer than 1 in 100 people)
• Increased heart rate (affects fewer than 1 in 100 people)
• Being unable to pass water (urine) (affects fewer than 1 in 1,000 people)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE BUSCOPAN TABLETS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Buscopan Tablets should not be stored above 25°C and should be stored in a dry place and protected from light.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Buscopan Tablets contain
• Each tablet contains 10mg of the active ingredient, hyoscine-N-butylbromide.
• Buscopan also contains the following: calcium hydrogen phosphate, dried maize starch, soluble maize starch, colloidal silica, stearic/palmitic acid, tartaric acid, sucrose, talc, acacia, macrogol 6000, carnauba wax, beeswax, povidone and titanium dioxide (E171).
What Buscopan Tablets look like and contents of the pack
Buscopan Tablets are round, white, biconvex, coated, unmarked tablet.
Buscopan Tablets are available in blister packs of 40 and 60 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1Dx.
Manufacturer
This product is manufactured by Boehringer Ingelheim Hellas S.A., 5 km Paiania - Markopoulou, Koropi, Attica, Greece.
POMl PL No: 19488/0496
Leaflet revision date: 14 May 2014
Buscopan is a registered trade mark of Boehringer Ingelheim Pharma GmbH & Co. KG, Germany.
S496 LEAFLET POM Buscopan 20140514
S496 LEAFLET POM Hyoscine 20140415
PACKAGE LEAFLET: INFORMATION FOR THE USER HYOSCINE-N-BUTYLBROMIDE 10mg TABLETS
The name of your medicine is Hyoscine-N-butylbromide 10mg Tablets but will be referred to as Hyoscine Tablets throughout the following leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Hyoscine Tablets are and what they are used for
2. Before you take Hyoscine Tablets
3. How to take Hyoscine Tablets
4. Possible side effects
5. How to store Hyoscine Tablets
6. Further information
1. WHAT HYOSCINE TABLETS ARE AND WHAT THEY ARE USED FOR
Hyoscine Tablets contain a medicine called “hyoscine butylbromide”. This belongs to a group of medicines called “antispasmodics”.
Hyoscine Tablets are used to relieve cramps in the muscles of your:
• Stomach
• Gut (intestine)
• Bladder and the tubes that lead to the outside of your body (urinary system)
It can also be used to relieve the symptoms of Irritable Bowel Syndrome (IBS).
2. BEFORE YOU TAKE HYOSCINE TABLETS
Do not take Hyoscine Tablets if:
• You are allergic (hypersensitive) to hyoscine butylbromide or any of the other ingredients (listed in section 6)
• You have glaucoma (an eye problem)
• You have megacolon (a very enlarged bowel)
• You have something called “myasthenia gravis” (a very rare muscle weakness problem)
• You are pregnant, likely to get pregnant, or are breast-feeding
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Take special care with Hyoscine Tablets
Check with your doctor or pharmacist before taking your medicine if:
• You have a very fast heart rate or other heart problems
• You have a problem with your thyroid gland such as an overactive thyroid gland
• You have difficulty or pain passing water (urine) such as men with prostate problems
• You have constipation
• You have a fever
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hyoscine Tablets.
Check with your doctor or pharmacist straight away if you have unexplained abdominal pain which persists or worsens or occurs with:
• fever
• feeling sick
• being sick
• changes in your bowel movements
• abdominal tenderness
• low blood pressure
• feeling faint or,
• blood in your bowel movements
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Hyoscine Tablets can affect the way some other medicines work.
Also some other medicines can affect the way Hyoscine Tablets work.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• Medicines for depression called “tetracyclic antidepressants” or “tricyclic antidepressants” such as doxepin
• Medicines for allergies and travel sickness called “antihistamines”
• Medicines to control your heart beat such as quinidine or disopyramide
• Medicines for severe mental illness called ‘antipsychotics' such as haloperidol or fluphenazine
• Medicines usually used for breathing problems such as tiotropium, ipratropium or atropine-like medicines
• Amantadine - for Parkinson's disease and flu
• Metoclopramide - for feeling sick (nausea)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hyoscine Tablets.
Pregnancy and breast-feeding
Do not take Hyoscine Tablets if you are pregnant, likely to get pregnant or are breast-feeding.
Some people may have sight problems while taking this medicine. If this happens to you, wait until your sight returns to normal before driving or using any tools or machines.
Important information about some of the ingredients of Hyoscine Tablets
Hyoscine Tablets contain sucrose. Talk to your doctor before taking this medicine if they have told you that you cannot tolerate or digest some sugars.
3. HOW TO TAKE HYOSCINE TABLETS
Always take your medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Hyoscine Tablets should not be taken continuously for long periods of time.
Taking this medicine
• Take your tablets with water
• Do not break, crush or chew the tablets How much to take
Adults and children over 12 years
• The usual dose is two tablets 4 times a day
• For Irritable Bowel Syndrome, your doctor may give you a lower starting dose of one tablet 3 times a day. This dose may be increased, if further relief is necessary
Children 6 - 12 years:
• The usual dose is one tablet 3 times a day
Hyoscine Tablets are not recommended for children under 6 years.
If you take more Hyoscine Tablets than you should
If you take more Hyoscine Tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you even if there are no Hyoscine Tablets left.
If you forget to take Hyoscine Tablets
• If you forget a dose, take it as soon as you remember.
However, if it is time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Hyoscine Tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Stop taking your medicine and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
• Allergic reactions such as skin reactions e.g. nettle rash, itching (affects fewer than 1 in 100 people), rash, redness of the skin
• Severe allergic reactions (anaphylactic shock) such as difficulty breathing, feeling faint or dizzy (shock)
• Painful red eye with loss of vision
Other side effects
• Dry mouth (affects fewer than 1 in 100 people)
• Small blisters on hands and feet (affects fewer than 1 in 100 people)
• Increased heart rate (affects fewer than 1 in 100 people)
• Being unable to pass water (urine) (affects fewer than 1 in 1,000 people)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE HYOSCINE TABLETS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Hyoscine Tablets should not be stored above 25°C and should be stored in a dry place and protected from light.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Hyoscine Tablets contain
• Each tablet contains 10mg of the active ingredient, hyoscine-N-butylbromide.
• Hyoscine Tablets also contain the following: calcium hydrogen phosphate, dried maize starch, soluble maize starch, colloidal silica, stearic/palmitic acid, tartaric acid, sucrose, talc, acacia, macrogol 6000, carnauba wax, beeswax, povidone and titanium dioxide (E171).
What Hyoscine Tablets look like and contents of the pack
Hyoscine Tablets are round, white, biconvex, coated, unmarked
tablet.
Hyoscine Tablets are available in blister packs of 40 and 60 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1Dx.
Manufacturer
This product is manufactured by Boehringer Ingelheim Hellas S.A.,
5 km Paiania - Markopoulou, Koropi, Attica, Greece.
| POM | PL No: 19488/0496 Leaflet revision date: 15 April 2014
S496 LEAFLET POM Hyoscine 20140514