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SPASMONAL 60 MG HARD CAPSULES

Active substance(s): ALVERINE CITRATE

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PAGE 4

5. How to store SPASMONAL
Keep out of the sight and reach of children.
Do not use SPASMONAL after the expiry date which is printed or
embossed on the carton and blister as month/year.
The expiry date refers to the last day of the month.
Do not store above 25°C. Store in a dry place.
If your 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.
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 to protect the environment.

6. Contents of the pack and
other information
What SPASMONAL contains
Each capsule contains 60 mg alverine citrate.
The other ingredients are maize starch, magnesium stearate, iron
oxide (E172), indigo carmine (E132), titanium dioxide (E171),
gelatine, printing ink.
What SPASMONAL looks like and contents of the pack
Spasmonal hard capsules have a blue body and grey cap, and
are marked 'SP 60'.
The capsules come in a blister pack containing 100 capsules.
Manufactured by:
Norgine Limited, New Road, Tir-y-berth, Hengoed CF82 8SJ, UK.
Procured from within the EU by the Product Licence Holder:
Expono Ltd, Smethwick, Birmingham, B66 2JT, UK.
Repackaged by:
N.G. Ltd, Birmingham, B66 2JT, UK.
PL 22961/0142 - Spasmonal® 60 mg Hard Capsules
Revision Date: 16.05.2016
P
Ref: 821
Spasmonal® is a registered trademark of Meda AB.
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

PAGE 1
Package leaflet: Information for the user

Spasmonal

®

60 mg

Hard Capsules (alverine citrate)

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.
Your medicine is called Spasmonal 60 mg Hard Capsules but will
be referred to as SPASMONAL throughout this leaflet.
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.

PAGE 2

PAGE 3

– 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 difficultly 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 Indigo Carmine (E132), Black Iron Oxide (E172),
and Titanium Dioxide (E171).

– 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.

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.

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, 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.

PAGE 4

5. How to store Alverine citrate
Keep out of the sight and reach of children.
Do not use Alverine citrate after the expiry date which is printed
or embossed on the carton and blister as month/year.
The expiry date refers to the last day of the month.
Do not store above 25°C. Store in a dry place.
If your 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.
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 to protect the environment.

6. Contents of the pack and
other information
What Alverine citrate contains
Each capsule contains 60 mg alverine citrate.
The other ingredients are maize starch, magnesium stearate, iron
oxide (E172), indigo carmine (E132), titanium dioxide (E171),
gelatine, printing ink.
What Alverine citrate looks like and contents of the pack
Alverine citrate hard capsules have a blue body and grey cap,
and are marked 'SP 60'.
The capsules come in a blister pack containing 100 capsules.
Manufactured by:
Norgine Limited, New Road, Tir-y-berth, Hengoed CF82 8SJ, UK.
Procured from within the EU by the Product Licence Holder:
Expono Ltd, Smethwick, Birmingham, B66 2JT, UK.
Repackaged by:
N.G. Ltd, Birmingham, B66 2JT, UK.
PL 22961/0142 - Alverine citrate 60 mg Hard Capsules
P
Revision Date: 16.05.2016
Ref: 820
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

PAGE 1
Package leaflet: Information for the user

Alverine citrate 60 mg
Hard Capsules

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.
Your medicine is called Alverine citrate 60 mg Hard Capsules but
will be referred to as Alverine citrate throughout this leaflet.
What is in this leaflet:
1. What Alverine citrate is and what it is used for
2. What you need to know before you take Alverine citrate
3. How to take Alverine citrate
4. Possible side effects
5. How to store Alverine citrate
6. Contents of the pack and other information

1. What Alverine citrate is
and what it is used for
Alverine citrate 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.
Alverine citrate 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
Do not take Alverine citrate if:
– You are allergic (hypersensitive) to alverine citrate or any other
ingredients of Alverine citrate.

PAGE 2
– 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 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 difficultly 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 is not suitable for children under 12 years old.
Other medicines and Alverine citrate
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 with food and drink
It does not matter if you take Alverine citrate with or without food.
Pregnancy and breast-feeding
Do not take Alverine citrate 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 you should avoid
driving or operating machinery.
Alverine citrate contains:
The colours Indigo Carmine (E132), Black Iron Oxide (E172),
and Titanium Dioxide (E171).

3. How to take Alverine citrate
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.

PAGE 3
– 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 is not suitable for children under 12 years old.
If you take more Alverine citrate than you should
If you take more Alverine citrate 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
If you forget to take Alverine citrate, 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 can cause side effects,
although not everybody gets them.
Stop taking Alverine citrate 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, 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.

Expand view ⇕

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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