Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alverine citrate
A A H Pharmaceuticals Ltd
A03AX08
Alverine citrate
120mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01020000; GTIN: 5025903009184
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • 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. What is in this leaflet: 1. What Alverine Citrate Capsules are and what they are used for 2. What you need to know before you take Alverine Citrate Capsules 3. How to take Alverine Citrate Capsules 4. Possible side effects 5. How to store Alverine Citrate Capsules 6. Contents of the pack and other information 1. What Alverine Citrate Capsules are and what they are used for Alverine Citrate Capsules are 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. Sometime these symptoms are worse if you are worried or under stress. Alverine Citrate Capsules 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 Alverine Citrate Capsules Do not take Alverine Citrate Capsules if: • you are allergic to alverine citrate or any of the other ingredients of this medicine (listed in section 6). • 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 Alverine Citrate Capsules if any of the following apply to you, it may not be the right Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alverine Citrate 120mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 120mg alverine citrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules Hard gelatin capsules, size 1 with opaque blue colour body and opaque grey colour cap marked ‘I 65’ containing white to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The relief of smooth muscle spasm in conditions such as irritable bowel syndrome, painful diverticular disease of the colon and primary dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ADULTS AND THE ELDERLY _ 1 or 2 capsules of 60mg or 1 capsule of 120mg, one to three times daily. _CHILDREN BELOW THE AGE OF 12 YEARS _ Not recommended. Method of administration For oral use. 4.3 CONTRAINDICATIONS • Paralytic ileus • Intestinal obstruction • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Additional warnings to be included in the Patient Information Leaflet: If this is the first time you have had these symptoms, consult your doctor before using any treatment. If any of the following apply do not use Alverine Citrate Hard Capsules, 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 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. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INT Olvassa el a teljes dokumentumot