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Active substance: ALVERINE CITRATE

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Spasmonal Forte
alverine citrate

Do not store above 25°C. Store in a dry place.
Do not use SPASMONAL Forte 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 Forte contains
The active substance is alverine citrate. Each hard capsule
contains 120 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 Forte looks like and contents of the pack
Each carton contains 2, 10, 20, 30, 60 or 90 blue/grey hard
capsules marked “SP 120” in blisters.
The Marketing Authorisation Holder in the UK is Meda
Pharmaceuticals Ltd, Skyway House, Parsonage Road,
Takeley, CM22 6PU, United Kingdom.
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.

SPASMONAL is a registered trademark.

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120 mg

Hard capsules

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 become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.


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 Forte is and what it is used for
2. Before you take SPASMONAL Forte
3. How to take SPASMONAL Forte
4. Possible side effects
5. How to store SPASMONAL Forte
6. Further 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.


5. How to store SPASMONAL Forte

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2. Before you take SPASMONAL Forte

3. How to take SPASMONAL Forte

If this is the first time you have had these symptoms, consult
your doctor before using any treatment.

Always take SPASMONAL Forte exactly as your doctor has
told you.
* 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.

Do not take SPASMONAL Forte if:
*   ou are allergic (hypersensitive) to alverine citrate or any
of the other ingredients of SPASMONAL Forte.
*   our doctor has told you that you have obstruction of
the gut or that your small bowel is not working properly.
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.
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.
Taking 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
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 Forte is not suitable for children under
12 years old.
If you take more SPASMONAL Forte than you should,
contact a doctor immediately.
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 see your doctor as soon
as possible if you notice:
*   ellowing of the whites of the eyes and the skin,
as inflammation of the liver has been known to occur.
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.
Other side effects may include:
* a feeling of sickness or dizziness,
* headache,
* allergic reactions, which may include itching or skin rash
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:
By reporting side effects you can help provide more
information 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:

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

Colours used:


Spasmonal Forte

Pantone 300

120 mg Kapseln


Meda-No.: 56UK2060260-01

Mfs-No.: 80604204

Laetus-Code: 594

United Kingdom UK

Language: english
Pack Size:

198 x 159 mm

Correction: 3.

Font Size:

7,0 x 7,5 pt


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.