290 microgram hard capsules 
linaclotide

1. What Constella is and what it is used for

What Constella is used for 
Constella contains the active substance linaclotide and is used to treat the symptoms of moderate to severe irritable bowel syndrome (often called IBS) with constipation in adult patients.

IBS is a common intestinal disease. The main symptoms of constipation IBS include:

  • abdominal or abdominal pain
  • feeling of bloating
  • irregular, hard, small, or pellet-like stools.

These symptoms may vary from person to person.

How Constella works 
Constella acts locally in the intestine to relieve pain and swelling and to restore normal bowel function. It is not absorbed into the body but attaches to a receptor on the surface of the intestine called guanylate cyclase C. By attaching to this receptor, the drug blocks the sensation of pain and allows fluid from the body to enter the intestine to thereby relieve constipation by dissolving the contents of the intestines. and increase bowel movements.

2. What you need to know before using Constella

Do not use 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 intestines.

Warnings and cautions

Your doctor has given you this medicine after ruling out other diseases, especially in the intestines, and has determined that you are suffering from IBS with constipation. Other diseases can have the same symptoms like IBS and it is important that you quickly report changes or irregularities in symptoms to your doctor.

If you experience severe or prolonged diarrhea (frequent, watery bowel movements for 7 days or longer), stop taking Constella and contact your doctor (see section 4). Make sure you drink plenty of fluids to replace the water and electrolytes, e.g. potassium, which is lost through diarrhea.

Tell your doctor if you experience bleeding from the gastrointestinal tract or rectum.

Take special care if you are older than 65 years as you are at higher risk of developing diarrhea.

Also take special care if you have severe or prolonged diarrhea and another illness, e.g. high blood pressure, previous illness involving the heart and blood vessels (eg previous heart attacks), or diabetes.

Tell your doctor if you suffer from intestinal inflammation such as Crohn’s disease or ulcerative colitis, as Constella is not recommended for these patients.

Children and young people

Do not give this medicine to children and adolescents under 18 years of age, as the safety and efficacy of Constella for this age group have not been established.

Other drugs and Constella

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:

  • Some medicines may work less effectively if you have severe or prolonged diarrhea:
    • contraceptives in tablet form – if you have very severe diarrhea, birth control pills may not work as they should and the use of another method of contraception is recommended. See the instructions in the package leaflet for the contraceptive pill you are using.
    • drugs that require careful and accurate dosing, e.g. levothyroxine (a hormone used to treat hypothyroidism).
  • Some medicines may increase the risk of diarrhea when taken with Constella:
    • drugs called proton pump inhibitors used to treat stomach ulcers or excess stomach acid
    • drugs called non-steroidal anti-inflammatory drugs ( NSAIDs ) used to treat pain and inflammation
    • laxatives.

Constella with food

Constella causes more frequent bowel movements and diarrhea (loose stools) when taken with food compared to when taken on an empty stomach (see section 3).

Pregnancy and breastfeeding

There is only limited information on the effects of Constella in pregnant and lactating women.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In a breast-only breast-feeding study involving seven breastfeeding women who had already been treated with linaclotide, neither linaclotide nor its active metabolite was detected in breast milk. Therefore, breast-feeding is not expected to cause the baby to be exposed to linaclotide and Constella can be used during breast-feeding.

Driving and using machines

Constella does not affect your ability to drive or use machines.

3. How to use Constella

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one capsule (ie 290 micrograms of linaclotide) taken orally once daily. The capsule should be taken at least 30 minutes before a meal.

If you do not experience any improvement in your symptoms after 4 weeks of treatment, you should contact your doctor.

If you use more Constella then you should

The most likely effect of taking too much Constella is diarrhea. Contact your doctor or pharmacist if you have used too much of this medicine.

If you forget to use Constella

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time and continue as usual.

If you stop using Constella

Preferably discuss with a doctor before ending treatment. However, treatment with Constella can be safely discontinued at any time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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)

  • Diarrhea

Diarrhea is usually short-lived. If you experience severe or prolonged diarrhea (frequent or watery stools for 7 days or longer) and feel dizzy or weak, stop taking Constella and consult a doctor.

Common side effects (may affect up to 1 in 10 people)

  • Stomach or abdominal pain
  • Feeling of bloating
  • Gases
  • Stomach flu (viral gastroenteritis )
  • Dizziness

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

  • Accidental bowel movements ( fecal incontinence )
  • Urgent need to empty the bowel
  • Fainting when you get up quickly
  • Dehydration
  • Low levels of potassium in the blood
  • Decreased appetite
  • Bleeding from the rectum
  • Bleeding from the gastrointestinal tract or rectum including bleeding from hemorrhoids
  • Nausea
  • Vomiting
  • Hives ( urticaria )

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

  • Decreased level of bicarbonate in the blood

Adverse reactions without known frequency (frequency can not be calculated from the available data)

  • 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Constella

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 jar after “EXP”. The expiration date is the last day of the specified month. Once opened, the capsules should be used within 18 weeks.

Do not store above 30 ° C. Close the jar tightly, the contents are moisture sensitive. Show larger

Warning: The jar contains one or more sealed pads with silica gel to keep the capsules dry. Store the pillows in the jar. Do not swallow.

Do not use this medicine if you notice signs of damage to the jar or any change in the appearance of the capsules.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is linaclotide. Each capsule contains 290 micrograms of linaclotide.
  • Other ingredients are:

Capsule contents: microcrystalline cellulose, hypromellose, calcium chloride dihydrate, and leucine

Capsule housing: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), and gelatin

Ink: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171), and black iron oxide (E172)

What the medicine looks like and the contents of the pack

The capsules are white to off-white-orange, opaque and hard, marked with “290” in gray ink.

They are packaged in a white high-density polyethylene (HDPE) jar, with a guarantee seal and a childproof screw cap, along with one or more desiccant pads with silica gel.

Constella is available in packs containing 10, 28, or 90 capsules and in a multi-pack of 112 capsules divided into 4 cartons with 28 capsules in each. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Allergan Pharmaceuticals International Limited

Clonshaugh Business & Technology Park

Dublin 17, D17 E400

Ireland

Manufacturer 
Allergan Pharmaceuticals International Limited

Clonshaugh Business & Technology Park

Dublin 17, D17 E400

Ireland

Contact the representative of the marketing authorization holder to find out more about this medicine: Show larger

Belgium / Belgium / Belgium / Luxembourg / Luxembourg / NetherlandsAllergan nvTel: +32 (0) 2 351 2424
BulgariaAllergan Bulgaria ЕООДTel: +359 (0) 800 20 280
Czech RepublicAllergan CZ sroTel: +420 800 188 818 HungaryAllergan Hungary Kft.Tel .: +36 80 100 101
GermanyPharm-Allergan GmbHTel: + 49 69 92038-1050
Λλάδα ΚύπροςAllergan Hellas Pharmaceuticals SA 
Τηλ: +30 210 74 73 300
AustriaPharm-Allergan GmbHTel: +43 1 99460 6355
SpainAllergan SATel: + 34 91 807 6130 PolandAllergan Sp. z ooTel: +48 22 256 37 00
FranceAllergan France SASTel: +33 (0) 1 49 07 83 00 PortugalProfarin Lda.Tel: + 351 21 425 3242
CroatiaEwopharma dooTel: +385 1 6646 563 RomaniaAllergan SRLTel: +40 21 301 53 02

SloveniaEwopharma dooTel: + 386 (0) 590 848 40
IcelandActavis Pharmaceuticals Iceland ehf.Phone: +354 550 3300 Slovak RepublicAllergan SK sroTel: +421 2 593 961 00
ItalyAllergan SpATel: + 39 06 509 562 90
Latvia Lithuania / EstoniaAllergan Baltics UABTel: + 371 676 60 831 (LT); + 37 052 ​​072 777 (LV); + 37 2634 6109 (ET)
United KingdomAllergan LtdTel: + 44 (0) 1628 494026

Muhammad Nadeem

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