Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
linaclotide
AbbVie Deutschland GmbH & Co. KG
A06AX04
linaclotide
Drugs for constipation
Irritable Bowel Syndrome
Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.
Revision: 25
Authorised
2012-11-26
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CONSTELLA 290 MICROGRAMS HARD CAPSULES linaclotide 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. - 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 Constella is and what it is used for 2. What you need to know before you take Constella 3. How to take Constella 4. Possible side effects 5. How to store Constella 6. Contents of the pack and other information 1. WHAT CONSTELLA IS AND WHAT IT IS USED FOR WHAT CONSTELLA IS USED FOR Constella contains the active substance linaclotide. It is used to treat the symptoms of moderate to severe irritable bowel syndrome (often just called “IBS”) with constipation in adult patients. IBS is a common gut disorder. The main symptoms of IBS with constipation include: stomach or abdominal pain, feeling bloated, infrequent, hard, small or pellet-like stools (faeces). These symptoms may vary from person to person. HOW CONSTELLA WORKS Constella acts locally in your gut, helping you to feel less pain and less bloated, and to restore the normal functioning of your bowels. It is not absorbed into the body, but attaches to receptor called guanylate cyclase C on the surface of your gut. By attaching to this receptor, it blocks the sensation of pain and allows liquid to enter from the body into the gut, thereby loosening the stools and increasing your bowel movements. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CONSTELLA DO NOT TAKE CONSTELLA - if you are allergic to linaclotide or any of the other ingredients of this medicine (listed in se Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Constella 290 micrograms hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 290 micrograms of linaclotide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. White to off-white-orange opaque capsule (18 mm x 6.35 mm) marked “290” with grey ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one capsule (290 micrograms) once daily. Physicians should periodically assess the need for continued treatment. The efficacy of linaclotide has been established in double-blind placebo-controlled studies for up to 6 months. If patients have not experienced improvement in their symptoms after 4 weeks of treatment, the patient should be re-examined and the benefit and risks of continuing treatment reconsidered. _Special populations_ _Patients with renal or hepatic impairment_ No dose adjustments are required for patients with hepatic or renal impairment (see section 5.2). _Elderly patients_ For elderly patients, although no dose adjustment is required, the treatment should be carefully monitored and periodically re-assessed (see section 4.4). _Paediatric population _ The safety and efficacy of Constella in children aged 0 to18 years have not yet been established. No data are available. This medicinal product should not be used in children and adolescents (see sections 4.4 and 5.1). Method of administration Oral use. The capsule should be taken at least 30 minutes before a meal (see section 4.5). 4.3 CONTRAINDICATIONS 3 Hypersensitivity to linaclotide or to any of the excipients listed in section 6.1. Patients with known or suspected mechanical gastrointestinal obstruction. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Constella should be used after organic diseases have Aqra d-dokument sħiħ