Skip to Content

SPASMONAL CAPSULES

Active substance(s): ALVERINE CITRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
6. Contents of the pack and
other 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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
This leaflet was last approved in February 2015.
If this leaflet is difficult to see or read and you would like it
in a different format, please contact Meda
Pharmaceuticals Ltd, Skyway House, Parsonage Road,
Takeley, Bishops Stortford, CM22 6PU,
United Kingdom.

Spasmonal

60 mg

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.
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

647

Keep this medicine 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 ºC and store in a dry place.
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.

Package leaflet: Information for the user
®

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 or 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.
78616105

56UK2060120-03

647

5. How to store 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 Indigo Carmine (E132), Black 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.
78616105

56UK2060120-03

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.

Hide