SPASMONAL CAPSULES

Active substance: ALVERINE CITRATE

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Do not store above 25°C and store in a dry place.
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.

6. Further information
What SPASMONAL contains
The active substance is alverine citrate. Each capsule
contains 60 milligrams of alverine citrate.
The other ingredients are maize starch, magnesium
stearate, gelatin and colours (E132, E171 and E172).
The printing ink contains: Shellac, Black Iron Oxide (E172),
Propylene Glycol.
What SPASMONAL looks like and contents of the pack
Each carton contains 3, 10, 12, 20, 90 or 100 blue/grey
capsules marked “SP 60” in blisters.
The Marketing Authorisation Holder in the UK is Meda
Pharmaceuticals Ltd, Skyway House, Parsonage Road,
Takeley, CM22 6PU, United Kingdom.
Manufacturer:
Norgine Ltd, Hengoed, Mid Glamorgan CF82 8SJ, UK.

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
The leaflet was last approved in November 2013

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Spasmonal
alverine citrate

60 mg

Read all of this leaflet carefully before you start taking
this medicine.
* Keep this leaflet. You may need to read it again.
* f you have any further questions, ask your doctor
I
or pharmacist.
*  his medicine has been prescribed for you. Do not
T
pass it on to others. It may harm them, even if
their symptoms are the same as yours.
*  f any of the side effects become serious, or if you
I
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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Keep all medicines out of the reach and sight of children.

®

If you need the information on this leaflet in
an alternative format, such as large text, or
Braille please ring from the UK: 0800 198 5000.
In this leaflet:
1. What SPASMONAL is and what it is used for
2. Before you take SPASMONAL
3. How to take SPASMONAL
4. Possible side effects
5. How to store SPASMONAL
6. Further 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.

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5. How to store SPASMONAL

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2. Before you take SPASMONAL
If this is the first time you have had these symptoms,
consult your doctor before using any treatment.
Do not take SPASMONAL if:
*  ou are allergic (hypersensitive) to alverine citrate or
Y
any of the other ingredients of SPASMONAL.
*   our doctor has told you that you have obstruction of
Y
the gut or that your small bowel is not working properly.
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
*  ou have difficulty or pain passing urine
Y
Consult your doctor if you have developed new symptoms,
or if your symptoms worsen, or if they do not improve after
2 weeks treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.

3. How to take SPASMONAL
Always take SPASMONAL exactly as your doctor has told you.
*   he usual dose is 1 or 2 capsules taken up to 3 times a
T
day. You should check with your doctor or pharmacist if
you are not sure.
SPASMONAL is not suitable for children under 12 years old.
If you take more SPASMONAL than you should, contact
a doctor.
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 see your doctor as soon as
possible if you notice:
*   ellowing of the whites of the eyes and the skin,
Y
as inflammation of the liver has been known to occur.
*   ifficulties in breathing, shortness of breath, wheezing,
D
swelling of your face or other parts of your body,
as ­ erious allergic reactions have been known to occur.
s
Other side effects may include:

Taking SPASMONAL with food and drink
It does not matter if you take SPASMONAL with or
without food.

* a feeling of sickness or dizziness,
* headache,
* allergic reactions, which may include itching or skin rash.

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.

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

Driving and using machines
If you feel dizzy while taking SPASMONAL you should
a
­ void driving or operating machinery.

By reporting side effects you can help provide more
i
­nformation on the safety of this medicine.
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Studio Oberländer GmbH · Rubensstr.  33 · 60596 Frankfurt a. M. · Germany
Phone: +49 69 631520-85  ·  Fax: - 87  ·  E-Mail: info@studio-oberlaender.de

Specification Box: Leaflet
Manufacturer: Meda Pharma GmbH & Co. KG

Colours used:

Product: Spasmonal

Pantone 300



Black

60 mg

Meda-No.: 56UK2060120-02



Mfs-No.: 78616104



Laetus-Code: 593
Country:



United Kingdom UK

Language: english
Pack Size:

198 x 159 mm

Correction: 2.

Font Size:

7,0 x 8,25 pt

Date:

18. 11. 2013

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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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