Friday, September 30, 2016

Spasmonal Forte 120mg





SPASMONAL Forte 120 mg, hard capsules



Alverine citrate




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.

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





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.





Before You Take Spasmonal Forte



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




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 paralytic ileus (obstruction of the gut)




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



SPASMONAL Forte should not affect your ability to drive or use machines.






How To Take Spasmonal Forte



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.

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.





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:



  • Yellowing of the whites of the eyes and the skin, as inflammation of the liver has been known to occur.

  • Difficulties in breathing, as allergic reactions (including anaphylaxis) have also been known to occur.




Other side effects may include:



  • a feeling of sickness or dizziness,

  • headache,

  • itching or skin rash.



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





How To Store Spasmonal Forte



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



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.





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).





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 “120” in blisters.





Marketing Authorisation Holder and Manufacturer



The Marketing Authorisation Holder is




Norgine Ltd

Moorhall Road

Harefield

Middlesex

UB9 6NS

UK



It is made by




Norgine Ltd

Hengoed

Mid Glamorgan

CF82 8SJ

UK





UK Marketing Authorisation Number:



PL 00322/0075





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 April 2008