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ALVERINE CITRATE 120MG HARD CAPSULES

Active substance(s): ALVERINE CITRATE

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Package leaflet: Information for the user

Spasmonal® Forte 120mg 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.
• The name of this medicine is Spasmonal® Forte 120mg Hard Capsules
but will be referred to as Spasmonal Forte throughout the remainder of
this leaflet.
What is in this leaflet:
1) What Spasmonal Forte is and what it is used for
2) What you need to know before you take Spasmonal Forte
3) How to take Spasmonal Forte
4) Possible side effects
5) How to store Spasmonal Forte
6) Contents of the pack and other information
1) WHAT SPASMONAL FORTE IS AND WHAT IT IS USED FOR
Spasmonal Forte 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 Forte 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 FORTE
Do not take Spasmonal Forte if:
• You are allergic (hypersensitive) to alverine citrate or any of the other
ingredients of Spasmonal Forte.
• 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 Forte 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 Forte is not suitable for children under 12 years old.

Other medicines and Spasmonal Forte
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Spasmonal Forte with food and drink
It does not matter if you take Spasmonal Forte with or without food.
Pregnancy and breast-feeding
Do not take Spasmonal Forte during pregnancy or whilst breastfeeding. Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
If you feel dizzy while taking Spasmonal Forte you should avoid
driving or operating machinery.
Spasmonal Forte contains:
The colours Indigo Carmine (E132), Black Iron Oxide (E172), and
Titanium Dioxide (E171).
3) HOW TO TAKE SPASMONAL FORTE
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 capsule taken up to 3 times a day.
You should check with your doctor or pharmacist if you are not sure.
Use in children
Spasmonal Forte is not suitable for children under 12 years old.
If you take more Spasmonal Forte than you should
If you take more Spasmonal Forte than you should, contact a doctor
immediately. 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 Forte
If you forget to take Spasmonal Forte, 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 Forte can cause side effects, although not
everybody gets them.
Stop taking Spasmonal Forte 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 or 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. 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 FORTE






Keep out of the sight and reach of children.
Do not store above 25oC.
Store in a dry place.
Store in the original package.
Do not use your capsules after the expiry date which is stated on the
box, blisters and labels. The expiry date refers to the last day of the
month.
• If your capsules become discoloured or show any sign of deterioration,
return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are no
longer required. This will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION

What Spasmonal Forte contains:
Each capsule contains 120mg alverine citrate.
The other ingredients are: maize starch, magnesium stearate, gelatin and
the colours indigo carmine (E132), titanium dioxide (E171) and black iron
oxide (E172).
The printing ink contains: shellac, black iron oxide (E172) and propylene
glycol.
What Spasmonal Forte looks like and contents of the pack
Spasmonal Forte 120mg Hard Capsules are opaque, size 1, hard gelatin
capsules with a grey cap and a blue body, marked ‘SP120’.
Spasmonal Forte comes in a blister pack containing 60 capsules.
Manufactured by
Norgine Ltd, Hengoed, Mid Glamorgan, CF82 8SJ, UK.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0640

P
nd

Leaflet dated 22 February 2016
Leaflet coded XXXXXXXXXX
Spasmonal® is a registered trademark of Meda AB.

Package leaflet: Information for the user

Alverine Citrate 120mg 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.
• The name of this medicine is Alverine Citrate 120mg Hard Capsules
but will be referred to as Alverine Citrate throughout the remainder of
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 of the other
ingredients of Alverine Citrate.
• 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 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 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 breastfeeding. 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.
• The usual dose is 1 capsule 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
immediately. 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 or 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. 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






Keep out of the sight and reach of children.
Do not store above 25oC.
Store in a dry place.
Store in the original package.
Do not use your capsules after the expiry date which is stated on the
box, blisters and labels. The expiry date refers to the last day of the
month.
• If your capsules become discoloured or show any sign of deterioration,
return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are no
longer required. This will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION

What Alverine Citrate contains:
Each capsule contains 120mg alverine citrate.
The other ingredients are: maize starch, magnesium stearate, gelatin and
the colours indigo carmine (E132), titanium dioxide (E171) and black iron
oxide (E172).
The printing ink contains: shellac, black iron oxide (E172) and propylene
glycol.
What Alverine Citrate looks like and contents of the pack
Alverine Citrate 120mg Hard Capsules are opaque, size 1, hard gelatin
capsules with a grey cap and a blue body, marked ‘SP120’.
Alverine Citrate comes in a blister pack containing 60 capsules.
Manufactured by
Norgine Ltd, Hengoed, Mid Glamorgan, CF82 8SJ, UK.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0640

P
nd

Leaflet dated 22 February 2016
Leaflet coded XXXXXXXXXX

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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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