Spasmonal Forte 120mg Hard Capsules
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Spasmonal ® Forte 120mg Hard Capsules
(alverine citrate)
Patient Information Leaflet
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 Forte 120mg Hard Capsules but will be referred to as Spasmonal Forte throughout this leaflet.
What is in this leaflet:
^ What is Spasmonal Forte is and what it is used for
What you need to know before you take Spasmonal Forte How to take Spasmonal Forte ^ Possible side effects
How to store Spasmonal Forte Contents of the pack and other information
^ 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.
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 breast-feeding. 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).
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.
Spasmonal ® Forte 120mg Hard Capsules
(alverine citrate)
PL 15184/1520
P
Patient Information Leaflet
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
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).
Further information
What Spasmonal Forte contains:
Each capsule contains 120mg alverine citrate.
The other ingredients are: maize starch, magnesium stearate, gelatin, indigo carmine (E132), titanium dioxide (E171) and black iron oxide (E172). The printing ink contains: shellac, black iron oxide (E172), propylene glycol
What Spasmonal Forte looks like and contents of the pack:
Spasmonal capsules are opaque capsules with a grey cap and blue body, marked SP 120.
Each pack contains 60 capsules.
Manufacturer and Licence Holder
Manufactured by Norgine Ltd, Hengoed, Mid Glamorgan CF82 8SJ, UK and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
Spasmonal Forte 120mg Hard Capsules
Spasmonal Forte is a registered trademark of Meda AB.
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.
How to store Spasmonal
Revision date: 21/05/15
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* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Store in the original package.
* Store in a dry place.
* Do not take this medicine after the expiry date on the blister or carton label. The expiry date refers to the last day of the month. If your doctor tells you to stop taking the medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
* If your medicine becomes discoloured or shows any other signs of deterioration, ask your pharmacist who will advise you what to do.
* Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.