Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - constella

Document Subject

Generated Narrative: MedicinalProductDefinition mp7504582d8c4f390424d8e4bfcd82fbae

identifier: http://ema.europa.eu/identifier/EU/1/12/801/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Constella 290 micrograms hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7504582d8c4f390424d8e4bfcd82fbae

identifier: http://ema.europa.eu/identifier/EU/1/12/801/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - constella

Attesters

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

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.

Do not take Constella

if you are allergic to linaclotide or any of the other ingredients of this medicine (listed in section 6).

if you or your doctor know that you have a blockage in your stomach or bowels. Warnings and precautions Your doctor has given this medicine to you after excluding other diseases, especially of your bowels and concluding that you suffer from IBS with constipation. Because these other diseases may have the same symptoms as IBS, it is important that you report any change or irregularity in symptoms to your doctor promptly. If you experience severe or prolonged diarrhoea (passing of frequent watery stools for 7 days or more), stop taking Constella and contact your doctor (see section 4). Make sure you drink plenty of fluids to replace the water and electrolytes like potassium lost from the diarrhoea. If you have severe stomach symptoms which continue or get worse, stop taking Constella and contact your doctor immediately because these could be symptoms of a hole developing in the bowel wall (gastrointestinal perforation). See section 4. Talk to your doctor if you experience bleeding from the bowel or rectum. Take special care if you are older than 65 years, as there is a higher risk you experience diarrhoea. Take also special care if you have severe or prolonged diarrhoea and an additional disease, such as high blood pressure, previous disease of the heart and blood vessels (e.g. such as previous heart attacks) or diabetes. Talk to your doctor if you suffer from inflammatory diseases of the guts such as Crohn s disease or ulcerative colitis as Constella is not recommended in these patients. Children and adolescents Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy of Constella in this age group has not been established. Other medicines and Constella Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines: Some medicines may not work as effectively if you have severe or prolonged diarrhoea, such as:

Oral contraceptives. If you have very bad diarrhoea, the contraceptive pill may not work properly and the use of an extra method of contraception is recommended. See the instructions in the patient leaflet of the contraceptive pill you are taking.

Medicines that need careful and exact dosing, such as levothyroxine (a hormone to treat reduced function of the thyroid gland). Some medicines may increase the risk of diarrhoea when taken with Constella, such as:

Medicines to treat stomach ulcers or excessive production of stomach acid called Proton Pump Inhibitors.

Medicines to treat pain and inflammation called NSAIDs.

Laxatives. Constella with food Constella produces more frequent bowel movements and diarrhoea (looser stools) when it is taken with food than when it is taken on an empty stomach (see section 3). Pregnancy and breast-feeding Limited information is available on the effects of Constella in pregnant and breast-feeding women. Do not take this medicine if you are pregnant, think you may be pregnant or are planning to have a baby, unless your doctor advises you to do so. In a milk-only lactation study in seven lactating women, who were already taking linaclotide therapeutically, neither linaclotide nor its active metabolite were detected in the milk. Therefore breastfeeding is not expected to result in exposure of the infant to linaclotide and Constella can be used during breast-feeding. Driving and using machines Constella will not affect your ability to drive or use machines

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one capsule (i.e. 290 micrograms of linaclotide) taken orally once a day. The capsule should be taken at least 30 minutes before a meal. If you have not experienced improvement in your symptoms after 4 weeks of treatment, you should contact your doctor. If you take more Constella than you should The most likely effect of taking too much Constella is diarrhoea. Contact your doctor or pharmacist if you have taken too much of this medicine. If you forget to take Constella Do not take a double dose to make up for a forgotten dose. Just take the next dose at the scheduled time and continue as normal. If you stop taking Constella It is preferable to discuss stopping treatment with your doctor before actually doing so. However, treatment with Constella can be safely stopped at any time. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common side effects (may affect more than 1 in 10 people):

diarrhoea
Diarrhoea is normally short lived; however, if you experience severe or prolonged diarrhoea (passing frequent or watery stools for 7 days or more) and feel lightheaded, dizzy or faint, stop taking Constella and contact your doctor. Common side effects (may affect up to 1 in 10 people):

stomach or abdominal pain

feeling bloated

wind

stomach flu (viral gastroenteritis)

feeling dizzy Uncommon side effects (may affect up to 1 in 100 people):

lack of control over passing stools (faecal incontinence)

urgency to pass stools

feeling lightheaded after standing up quickly

dehydration

low level of potassium in your blood

decreased appetite

rectal bleeding

bleeding from the bowel or rectum including bleeding from piles/haemorrhoids

nausea

vomiting

hives (urticaria) Rare side effects (may affect up to 1 in 1,000 people):

bicarbonate decrease in your blood

a hole developing in the bowel wall (gastrointestinal perforation) Side effects with frequency not known (frequency cannot be estimated from the available data):

Rash Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP . The expiry date refers to the last day of that month. Once the bottle is opened, the capsules should be used within 18-weeks. Do not store above 30 C. Keep the bottle tightly closed in order to protect from moisture. Warning: The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry. Keep the canisters in the bottle. Do not swallow them. Do not use this medicine if you notice any signs of damage to the bottle or any change in the appearance of the capsules. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Constella contains

The active substance is linaclotide. Each capsule contains 290 micrograms of linaclotide.

The other ingredients are : Capsule content: microcrystalline cellulose, hypromellose, calcium chloride dihydrate and leucine. Capsule shell: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), gelatin and polyethylene glycol Printing ink: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171) and black iron oxide (E172). What Constella looks like and contents of the pack The capsules are white to off-white-orange opaque hard capsules marked 290 with grey ink. They are packaged in a white, high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant screw cap, together with one or more desiccant canisters containing silica gel. Constella is available in packs containing 10, 28 or 90 capsules and in multipacks of 112 capsules comprising 4 cartons, each containing 28 capsules. Not all pack-sizes may be marketed. Marketing Authorisation Holder AbbVie Deutschland GmbH & Co. KG Knollstra e 67061 Ludwigshafen Deutschland Manufacturer Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 EIreland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AbbVie SA T l/Tel: +32 10 477Lietuva AbbVie UAB Tel: + 370 5 205 3

:+359 2 90 30 Luxembourg/Luxemburg AbbVie SA Belgique/Belgien T l/Tel: +32 10 477 esk republika AbbVie s.r.o. Tel.: +420 233 098 Magyarorsz g AbbVie Kft. Tel:+36 1 455 8Danmark AbbVie A/S Tlf: +45 72 30 20 Malta Vivian Corporation Ltd. Tel: +356 27780Deutschland AbbVie Deutschland GmbH & Co. KG Tel.: 00800 222843 33 (geb hrenfrei) Tel.: +49 (0) 611 / 1720-0 Nederland AbbVie B.V. Tel: +31 (0)88 322 2Eesti AbbVie O Tel. +372 6231Norge AbbVie AS Tlf: +47 67 81 80
AbbVie . . : +30 214 4165 sterreich AbbVie GmbH Tel: +43 1 20589-0 Espa a AbbVie Spain, S.L.U. Tel: +34 913840Polska AbbVie Sp. z o.o. Tel.: +48 22 372 78 France AbbVie T l: +33 (0) 1 45 60 13 Portugal AbbVie, Lda. Tel.: +351 (0)21 1908Hrvatska AbbVie d.o.o. Tel: + 385 (0)1 5625 Rom nia AbbVie S.R.L. Tel: +40 21 529 30 Ireland AbbVie Limited Tel: +353 (0)1 4287Slovenija AbbVie Biofarmacevtska dru ba d.o.o. Tel: +386 (1)32 08 sland Vistor hf. S mi: +354 535 7Slovensk republika AbbVie s.r.o. Tel: +421 2 5050 0Italia AbbVie S.r.l. Tel: +39 06 928Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411
Lifepharma (Z.A.M.) Ltd : +357 22 34 74 Sverige AbbVie AB Tel: +46 (0)8 684 44 Latvija AbbVie SIA Tel: +371 67605United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: