Ref: 1517/180615/1/F

Spasmonal ® 60mg 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 any more ingormation 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 60mg Capsules but will be referred to as Spasmonal throughout this leaflet.

What is in this leaflet:

Q What Spasmonal is and what it is used for ^ What you need to know before you take Spasmonal Q How to take Spasmonal Q Possible side effects Q How to store Spasmonal Q Contents of the pack and other information

Q 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.

Q What you need to know 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:

*You are allergic (hypersensitive) to alverine citrate or any of the other ingredients of Spasmonal.

* Your doctor has told you that you have obstruction of 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

*    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 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.

Q How to take Spasmonal

Always take Spasmonal exactly as your doctor has told you.

* 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.

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.

Spasmonal ® 60mg Capsules

(alverine citrate)

Patient Information Leaflet Q 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:

*    Yellowing 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: www.mhra.gov.uk/ yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

Q How to store Spasmonal

*    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

*    Do not store above 25°C.

*    Store in the original container in order to protect from light.

_*    Store in a dry place.

*    Do not take this medicine after the expiry date on the blister or carton label. The expiry refers to the last 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 show 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.

Q Contents of the pack and other information

What Spasmonal contains:

Each capsule contains 60mg alverine citrate.

The other ingredients are: maize starch, magnesium stearate, gelatin, indigo carmine (E132), titanium dioxide (E171) and black iron oxide (E172).

What Spasmonal looks like and contents of the pack:

Spasmonal capsules are opaque capsules with a grey cap and blue body, marked SP 60 in black ink.

Each pack contains 100 hard 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.

[~P|    PL 15184/1517 Spasmonal 60mg Capsules

Spasmonal is a registered trademark of Meda AB.

Revision date: 18/06/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Health tips for you

Try to make your everyday life a bit helthier

_*    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