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Constella 290 micrograms hard capsules

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About the medicine

How to use Constella 290 micrograms hard capsules

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Patient Information: Summary of Product Characteristics

Constella 290micrograms hard capsules

linaclotida

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.

Contents of the pack

  1. What is Constella and what is it used for
  2. What you need to know before you take Constella
  3. How to take Constella
  4. Possible side effects
  5. Storage of Constella
  6. Contents of the pack and other information

1. What is Constella and what is it used for

What Constella is used for

Constella contains the active substance linaclotida. It is used to treat the symptoms of irritable bowel syndrome with constipation (often referred to as IBS-C) of moderate to severe intensity in adult patients.

IBS is a common intestinal disorder. The main symptoms of IBS-C are:

  • stomach or abdominal pain,
  • bloating sensation,
  • infrequent, hard, small or pellet-like stools.

These symptoms can vary from person to person.

How Constella works

Constella acts locally in the intestine, relieving pain and bloating and restoring normal bowel function. It is not absorbed by the body, but binds to a receptor on the surface of the intestine, called guanylate cyclase C. By binding to this receptor, it blocks the sensation of pain and allows fluid to pass from the body into the intestine, softening the stools and increasing bowel movements.

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Constella

Do not take Constella

  • if you are allergic to linaclotida or any of the other ingredients of this medicine (listed in section 6).
  • if you or your doctor know that you have a stomach or intestinal obstruction.

Warnings and precautions

Your doctor has given you this medicine after ruling out other diseases, especially of your intestines, and concluding that you have IBS-C. Since these other diseases can have the same symptoms as IBS, it is important that you inform your doctor immediately of any change or irregularity in your symptoms.

If you experience severe or prolonged diarrhea (frequent passage of liquid stools for 7 days or more), stop treatment with Constella and consult your doctor (see section 4); do not forget to drink plenty of fluids to replace the water and electrolytes, such as potassium, lost with diarrhea.

If you have severe stomach symptoms that persist or worsen, stop treatment with Constella and contact your doctor immediately, as they could be symptoms of a hole in the wall of the intestine (gastrointestinal perforation). See section 4.

Consult your doctor if you experience intestinal or rectal bleeding.

Take special precautions if you are over 65 years old, as you have a higher risk of experiencing diarrhea.

Also, take special precautions if you experience severe or prolonged diarrhea and have an additional disease, such as high blood pressure, a previous heart or blood vessel disease (e.g., previous heart attacks), or diabetes.

Consult your doctor if you have inflammatory bowel diseases 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 or adolescents under 18 years old, as the safety and efficacy of Constella in this age group have 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 properly if you have severe or prolonged diarrhea, such as:
  • Oral contraceptives. If you have very severe diarrhea, the contraceptive pill may not work properly and it is recommended to use an additional contraceptive method. Consult the instructions for the contraceptive pill you are taking.
  • Medicines that require careful and exact administration, such as levothyroxine (a hormone to treat reduced thyroid function).
    • Some medicines may increase the risk of diarrhea when taken with Constella, such as:
  • Medicines for the treatment of stomach ulcers or excessive acid production in the stomach, called proton pump inhibitors.
  • Medicines for the treatment of pain and inflammation, called NSAIDs.
  • Laxatives.

Taking Constella with food

Constella increases the frequency of bowel movements and causes diarrhea (looser stools) to a greater extent when taken with food than when taken on an empty stomach (see section 3).

Pregnancy and breastfeeding

There is limited information on the effects of Constella in pregnant or breastfeeding women.

Do not take this medicine if you are pregnant, think you may be pregnant, or are planning to become pregnant, unless your doctor advises you to do so.

In a lactation study conducted in seven breastfeeding women who were already receiving treatment with linaclotida, no linaclotida or its active metabolite was detected in breast milk. Therefore, it is not expected that breastfeeding will cause exposure of the infant to linaclotida, and Constella can be used during breastfeeding.

Driving and using machines

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

3. How to take Constella

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

If you have not experienced improvement in your symptoms after 4 weeksof treatment, consult your doctor.

If you take more Constella than you should

The most likely effect of taking too much Constella is diarrhea. 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 forgotten doses. Simply take the next dose at the scheduled time and continue with the treatment as usual.

If you stop taking Constella

Before stopping treatment, it is recommended that you consult your doctor; however, you can stop taking Constella at any time with complete safety.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common(may affect more than 1 in 10 people):

  • Diarrhea

Diarrhea is usually short-lived; however, if you experience a severe or prolonged episode (frequent or liquid stools for 7 days or more) and feel dizzy or faint, stop treatment with Constella and contact your doctor.

Common(may affect up to 1 in 10 people):

  • Stomach or abdominal pain
  • Bloating sensation
  • Flatulence
  • Viral gastroenteritis (stomach flu)
  • Dizziness

Uncommon(may affect up to 1 in 100 people):

  • Lack of control over bowel movements (fecal incontinence)
  • Urgent need to have a bowel movement
  • Dizziness when standing up quickly
  • Dehydration
  • Low potassium levels in the blood
  • Decreased appetite
  • Rectal bleeding
  • Intestinal or rectal bleeding, including hemorrhoidal bleeding
  • Nausea
  • Vomiting
  • Hives

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

  • Decreased bicarbonate levels in the blood
  • Development of a hole in the wall of the intestine (gastrointestinal perforation)

Frequency not known(may affect up to 1 in 1,000 people):

  • Skin rash

Reporting of side effects

If you experience 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.

5. Storage of 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 blister after “EXP”. The expiry date refers to the last day of the month shown.

Once the bottle is opened, the capsules should be used within 18 weeks.

Do not store above 30°C. Keep the bottle tightly closed to protect from moisture.

Warning:The bottle contains one or more sealed containers of silica gel intended to preserve the dryness of the capsules; these containers should not be removed from the container or ingested.

Do not use this medicine if you notice that the bottle is damaged or if you notice 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. This will help protect the environment.

6. Contents of the pack and other information

What Constella contains

  • The active substance is linaclotida. Each capsule contains 290 micrograms of linaclotida.
  • The other ingredients are:

Contents of the capsules: microcrystalline cellulose, hypromellose, calcium chloride dihydrate, and leucine.

Coating of the capsules: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), gelatin, and polyethylene glycol.

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

Appearance and packaging

The medicine is presented in white to off-white and orange opaque capsules with the inscription “290” in gray ink.

The product is presented in a white high-density polyethylene (HDPE) bottle with a child-resistant closure and a screw cap, along with one or more silica gel desiccant containers.

Constella is available in packs of 10, 28, or 90 capsules and in multipacks of 112 capsules, which include 4 boxes of 28 capsules each. Not all pack sizes may be marketed.

Marketing authorisation holder

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

Manufacturer

Allergan Pharmaceuticals International Limited

Clonshaugh Business & Technology Park

Dublin 17, D17 E400

Ireland

Forest Laboratories Ireland Limited

Clonshaugh Business and Technology Park

Clonshaugh

Dublin 17, D17 E400

Ireland

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

België/Belgique/Belgien

AbbVie SA

Tél/Tel: +32 10 477811

Lietuva

AbbVie UAB

Tel: + 370 5 205 3023

Text in Bulgarian showing company name ABV EOOD and phone number +359 2 90 30 430

Luxembourg/Luxemburg

AbbVie SA

Belgique/Belgien

Tél/Tel: +32 10 477811

Ceská republika

AbbVie s.r.o.

Tel.: +420 233 098 111

Magyarország

AbbVie Kft.

Tel:+36 1 455 8600

Danmark

AbbVie A/S

Tlf: +45 72 30 20 28

Malta

Vivian Corporation Ltd.

Tel: +356 27780331

Deutschland

AbbVie Deutschland GmbH & Co. KG

Tel.: 00800 222843 33 (gebührenfrei)

Tel.: +49 (0) 611 / 1720-0

Nederland

AbbVie B.V.

Tel: +31 (0)88 322 2843

Eesti

AbbVie OÜ

Tel. +372 6231011

Norge

AbbVie AS

Tlf: +47 67 81 80 00

Ελλάδα

AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.

Τηλ: +30 214 4165 555

Österreich

AbbVie GmbH

Tel: +43 1 20589-0

España

AbbVie Spain, S.L.U.

Tel: +34 913840910

Polska

AbbVie Sp. z o.o.

Tel.: +48 22 372 78 00

France

AbbVie

Tél: +33 (0) 1 45 60 13 00

Portugal

AbbVie, Lda.

Tel.: +351 (0)21 1908400

Hrvatska

AbbVie d.o.o.

Tel: + 385 (0)1 5625 501

România

AbbVie S.R.L.

Tel: +40 21 529 30 35

Ireland

AbbVie Limited

Tel: +353 (0)1 4287900

Slovenija

AbbVie Biofarmacevtska družba d.o.o.

Tel: +386 (1)32 08 060

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

AbbVie s.r.o.

Tel: +421 2 5050 0777

Italia

AbbVie S.r.l.

Tel: +39 06 928921

Suomi/Finland

AbbVie Oy

Puh/Tel: +358 (0)10 2411 200

Κύπρος

Lifepharma (Z.A.M.) Ltd

Τηλ: +357 22 34 74 40

Sverige

AbbVie AB

Tel: +46 (0)8 684 44 600

Latvija

AbbVie SIA

Tel: +371 67605000

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

To listen to or request a copy of this leaflet in Braille, large print, or audio, contact the local representative of the marketing authorisation holder.

Online doctors for Constella 290 micrograms hard capsules

Discuss questions about Constella 290 micrograms hard capsules, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Family medicine 13 years exp.

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Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

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General surgery 12 years exp.

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General medicine 6 years exp.

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Frequently Asked Questions

Is a prescription required for Constella 290 micrograms hard capsules?
Constella 290 micrograms hard capsules requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in Constella 290 micrograms hard capsules?
The active ingredient in Constella 290 micrograms hard capsules is linaclotide. This information helps identify medicines with the same composition but different brand names.
How much does Constella 290 micrograms hard capsules cost in pharmacies?
The average pharmacy price for Constella 290 micrograms hard capsules is around 63.82 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures Constella 290 micrograms hard capsules?
Constella 290 micrograms hard capsules is manufactured by Abbvie Deutschland Gmbh & Co. Kg. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of Constella 290 micrograms hard capsules online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether Constella 290 micrograms hard capsules is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to Constella 290 micrograms hard capsules?
Other medicines with the same active substance (linaclotide) include GLYCILAX ADULT SUPPOSITORIES, GLYCILAX LACTANTES SUPPOSITORIES, GLYCILAX NIÑOS SUPPOSITORIES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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