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SPASMONAL 60 MG CAPSULES

Active substance(s): ALVERINE CITRATE

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Package leaflet: Information for the user

SPASMONAL® 60 mg CAPSULES
(alverine citrate)
This medicine is available as the above name but will be referred to as Spasmonal
throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet:
1. What Spasmonal is and what it is used for
2. What you need to know before you take Spasmonal
3. How to take Spasmonal
4. Possible side effects
5. How to store Spasmonal
6. Contents of the pack and other information
1. WHAT SPASMONAL IS AND WHAT IT IS USED FOR
Spasmonal is an “anti-spasmodic” medicine. It relaxes the muscles in the intestine (gut)
and uterus (womb).
This helps stop the pain you feel when the muscles become tense.
It is used to help people who have Irritable Bowel Syndrome (IBS), some of the
symptoms of IBS are:
• Abdominal pains like cramp which come and go
• Diarrhoea
• Constipation
• Feeling full and bloated
• Wanting to go to the toilet urgently
Sometimes these symptoms are worse if you are worried or under stress.
Spasmonal can also be used for a condition of the large intestine called painful
diverticular disease of the colon and to relieve period pains.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPASMONAL
Do not take Spasmonal if:
• You are allergic (hypersensitive) to alverine citrate or any other ingredients of
Spasmonal.
• Your doctor has told you that you have obstruction of the gut or that your small bowel
is not working properly.
Warnings and precautions
If this is the first time you have had these symptoms, consult your doctor before using
any treatment.
Do not take Spasmonal if any of the following apply to you, it may not be the right
treatment for you. See your doctor as soon as possible if:
• You are aged 40 years or over
• You have passed blood from the bowel
• You are feeling sick or vomiting
• You have lost your appetite or lost weight
• You are looking pale and feeling tired
• You are suffering from severe constipation
• You have a fever
• You have recently travelled abroad
• You are, or may be, pregnant
• You are breast feeding
• You have abnormal vaginal bleeding or discharge
• You have difficulty or pain passing urine
Consult your doctor if you have developed new symptoms, or if your symptoms worsen,
or if they do not improve after 2 weeks treatment.
Children
Spasmonal is not suitable for children under 12 years old.
Other medicines and Spasmonal
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Spasmonal with food and drink
It does not matter if you take Spasmonal with or without food.
Pregnancy and breast-feeding
Do not take Spasmonal during pregnancy or whilst breast-feeding. Ask your doctor or
pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy while taking Spasmonal you should avoid driving or operating
machinery.
Spasmonal contains:
The colours indigotine (E132), iron oxide (E172), and titanium dioxide (E171).
3. HOW TO TAKE SPASMONAL
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you
are not sure.
• The usual dose is 1 or 2 capsules taken up to 3 times a day. You should check with
your doctor or pharmacist if you are not sure.
Use in children
Spasmonal is not suitable for children under 12 years old.

If you take more Spasmonal than you should
If you take more Spasmonal than you should, contact a doctor. Symptoms of an
overdose may be low blood pressure, dizziness, increased heartbeat, dilated pupils,
blurred vision, dry mouth and throat, difficulty breathing, or difficulty passing urine.
If you forget to take Spasmonal
If you forget to take Spasmonal, take it when you remember. If you forget for more than
4 hours, just take the next dose when you remember it is due.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Spasmonal can cause side effects, although not everybody gets
them.
Stop taking Spasmonal and seek urgent medical advice immediately if you notice:
• difficulties in breathing, shortness of breath, wheezing, swelling of your face or other
parts of your body, as serious allergic reactions have been known to occur.
• yellowing of the whites of the eyes and skin, as inflammation of the liver has been
known to occur.
Tell your doctor or pharmacist if any of the following side effects occur or worsen
Not known (frequency cannot be estimated from the available data):
• a feeling of sickness or dizziness,
• headache,
• allergic reactions, which may include itching or skin rash.
• increased levels of some liver enzymes (which would be detected by your doctor
during a blood test).
Reporting of side effects
If you get any side effects, talk to your doctor or 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 SPASMONAL
• Keep out of the sight and reach of children.
• Do not store above 25°C. Store in a dry place.
• Do not use after the expiry date which is printed on the carton and blister as month/
year. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.
• If your medicine become discoloured or show signs of any deterioration, consult your
doctor or pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Spasmonal contains
The active substance is alverine citrate. Each capsule contains 60 mg of alverine
citrate.
The other ingredients are maize starch, magnesium stearate, iron oxide (E172),
indigotine (E132), titanium dioxide (E171) and gelatin.
What Spasmonal looks like and contents of the pack
Spasmonal is a hard, opaque capsule with a grey cap and blue body marked “SP 60”.
Spasmonal is available in blister packs of 40 and 100 capsules.
PL: 15814/1217

P

Manufactured by Norgine Ltd., Mid Glamorgan CF82 8SJ, UK.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref): 13.05.2016
Spasmonal is a registered trademark of Meda AB, Sweden.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332
796.
Health tips for you
Try to make your everyday life a bit healthier:
• Allow plenty of time to do things, and avoid stress
• Do not rush meals
• Try to eat a balanced diet with high fibre foods
• Do not eat foods which seem to make your IBS worse

Package leaflet: Information for the user

ALVERINE CITRATE 60 mg CAPSULES
This medicine is available as any of the above names but will be referred to as Alverine
citrate capsules throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet:
1. What Alverine citrate capsules are and what they are used for
2. What you need to know before you take Alverine citrate capsules
3. How to take Alverine citrate capsules
4. Possible side effects
5. How to store Alverine citrate capsules
6. Contents of the pack and other information
1. WHAT ALVERINE CITRATE CAPSULES ARE AND WHAT THEY ARE USED FOR
Alverine citrate capsules are an “anti-spasmodic” medicine. It relaxes the muscles in
the intestine (gut) and uterus (womb).
This helps stop the pain you feel when the muscles become tense.
It is used to help people who have Irritable Bowel Syndrome (IBS), some of the
symptoms of IBS are:
• Abdominal pains like cramp which come and go
• Diarrhoea
• Constipation
• Feeling full and bloated
• Wanting to go to the toilet urgently
Sometimes these symptoms are worse if you are worried or under stress.
Alverine citrate capsules can also be used for a condition of the large intestine called
painful diverticular disease of the colon and to relieve period pains.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALVERINE CITRATE
CAPSULES
Do not take Alverine citrate capsules if:
• You are allergic (hypersensitive) to Alverine citrate capsules or any other ingredients
of Alverine citrate capsules.
• Your doctor has told you that you have obstruction of the gut or that your small bowel
is not working properly.
Warnings and precautions
If this is the first time you have had these symptoms, consult your doctor before using
any treatment.
Do not take Alverine citrate capsules if any of the following apply to you, it may not be
the right treatment for you. See your doctor as soon as possible if:
• You are aged 40 years or over
• You have passed blood from the bowel
• You are feeling sick or vomiting
• You have lost your appetite or lost weight
• You are looking pale and feeling tired
• You are suffering from severe constipation
• You have a fever
• You have recently travelled abroad
• You are, or may be, pregnant
• You are breast feeding
• You have abnormal vaginal bleeding or discharge
• You have difficulty or pain passing urine
Consult your doctor if you have developed new symptoms, or if your symptoms worsen,
or if they do not improve after 2 weeks treatment.
Children
Alverine citrate capsules are not suitable for children under 12 years old.
Other medicines and Alverine citrate capsules
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Alverine citrate capsules with food and drink
It does not matter if you take Alverine citrate capsules with or without food.
Pregnancy and breast-feeding
Do not take Alverine citrate capsules during pregnancy or whilst breast-feeding. Ask
your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy while taking Alverine citrate capsules you should avoid driving or
operating machinery.
Alverine citrate capsules contain:
The colours indigotine (E132), iron oxide (E172), and titanium dioxide (E171).
3. HOW TO TAKE ALVERINE CITRATE CAPSULES
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you
are not sure.
• The usual dose is 1 or 2 capsules taken up to 3 times a day. You should check with
your doctor or pharmacist if you are not sure.
Use in children
Alverine citrate capsules are not suitable for children under 12 years old.

If you take more Alverine citrate capsules than you should
If you take more Alverine citrate capsules than you should, contact a doctor. Symptoms
of an overdose may be low blood pressure, dizziness, increased heartbeat, dilated
pupils, blurred vision, dry mouth and throat, difficulty breathing, or difficulty passing
urine.
If you forget to take Alverine citrate capsules
If you forget to take Alverine citrate capsules, take it when you remember. If you forget
for more than 4 hours, just take the next dose when you remember it is due.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Alverine citrate capsules can cause side effects, although not
everybody gets them.
Stop taking Alverine citrate capsules and seek urgent medical advice immediately if you
notice:
• difficulties in breathing, shortness of breath, wheezing, swelling of your face or other
parts of your body, as serious allergic reactions have been known to occur.
• yellowing of the whites of the eyes and skin, as inflammation of the liver has been
known to occur.
Tell your doctor or pharmacist if any of the following side effects occur or worsen
Not known (frequency cannot be estimated from the available data):
• a feeling of sickness or dizziness,
• headache,
• allergic reactions, which may include itching or skin rash.
• increased levels of some liver enzymes (which would be detected by your doctor
during a blood test).
Reporting of side effects
If you get any side effects, talk to your doctor or 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 ALVERINE CITRATE CAPSULES
• Keep out of the sight and reach of children.
• Do not store above 25°C. Store in a dry place.
• Do not use after the expiry date which is printed on the carton and blister as month/
year. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.
• If your medicine become discoloured or show signs of any deterioration, consult your
doctor or pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Alverine citrate capsules contain
The active substance is alverine citrate. Each capsule contains 60 mg of alverine
citrate.
The other ingredients are maize starch, magnesium stearate, iron oxide (E172),
indigotine (E132), titanium dioxide (E171) and gelatin.
What Alverine citrate capsules look like and contents of the pack
Alverine citrate capsules are a hard, opaque capsule with a grey cap and blue body
marked “SP 60”.
Alverine citrate capsules are available in blister packs of 40 and 100 capsules.
PL: 15814/1217

P

Manufactured by Norgine Ltd., Mid Glamorgan CF82 8SJ, UK.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref): 13.05.2016
To request a copy of this leaflet in Braille, large print or audio please call 01923 332
796.
Health tips for you
Try to make your everyday life a bit healthier:
• Allow plenty of time to do things, and avoid stress
• Do not rush meals
• Try to eat a balanced diet with high fibre foods
• Do not eat foods which seem to make your IBS worse

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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