Patient Information Leaflet

Constella 290microgram hard capsules

linaclotida

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What Constella is used for

Constella contains the active ingredient linaclotide. It is used to treat the symptoms of moderate to severe irritable bowel syndrome (often simply referred to as “IBS”) with constipation in adult patients.

Irritable bowel syndrome (IBS) is a common intestinal disorder. The main symptoms of IBS with constipation are:

• abdominal or stomach pain,
• feeling bloated,
• infrequent, hard, small, or pellet-like bowel movements.

These symptoms can vary from person to person.

How Constella works

Constella acts locally in the intestine, relieving pain and bloating and restoring normal intestinal function. It is not absorbed by the body, but binds to a receptor on the intestinal surface, 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 stool and increasing intestinal movements.

Do not take Constella

• if you are allergic to linaclotide or any of the other components of this medication (listed in section6).
• if you or your doctor know that you have intestinal or stomach obstruction.

Warnings and precautions

Your doctor has given you this medication after ruling out other diseases, especially those affecting your intestines, and concluding that you have SII with constipation. Since these other diseases may have the same symptoms as SII, it is essential to inform your doctor immediately of any changes or irregularities in your symptoms.

If you experience severe or prolonged diarrhea (frequent expulsion of liquid stools for 7 days or more), discontinue treatment with Constella and consult your doctor (see section4); do not forget to drink plenty of liquids to replenish water and electrolytes, such as potassium, lost with diarrhea.

If you have severe stomach symptoms that persist or worsen, discontinue treatment with Constella and contact your doctor immediately, as they may be symptoms of a hole in the intestinal wall (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 have severe or prolonged diarrhea and an additional disease, such as high blood pressure, a previous heart disease, and vascular 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 for these patients.

Children and adolescents

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

Other medications and Constella

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication:

• Some medications may not work properly if you have severe or prolonged diarrhea, such as:

- Oral contraceptives. If you have severe diarrhea, the birth control pill may not work properly, and an additional contraceptive method is recommended. See the instructions in the birth control pill prospectus you are taking.

- Medications that require careful and exact administration, such as levothyroxine (a hormone to treat reduced thyroid function).

• Some medications may increase the risk of diarrhea when taken with Constella, such as:

- Medications for treating stomach ulcers or excessive stomach acid production, known as proton pump inhibitors.

- Medications for treating pain and inflammation, known as NSAIDs.

- Laxatives.

Constella with food

Constella increases bowel movements and causes diarrhea (softer 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 available on the effects of Constella in pregnant women and those breastfeeding.

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

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

Driving and operating machinery

Constella will not affect your ability to drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule (that is, 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, 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 ingested too much of this medication.

If you forget to take Constella

Do not take a double dose to make up for the missed dose. Simply take the next one at the correct time and continue treatment as usual.

If you interrupt treatment with Constella

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

• Diarrhea

Diarrhea is usually of short duration; however, if you experience a severe or prolonged episode (frequent bowel movements or liquid consistency for 7 days or more) and feel dizzy or lightheaded or faint, discontinue treatment with Constella and contact your doctor.

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

• Stomach or abdominal pain
• Feeling of bloating
• Flatulence
• Viral gastroenteritis (stomach flu)
• Feeling of dizziness

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

• Loss of bowel control (fecal incontinence)
• Urgency to defecate
• Feeling of dizziness when standing up quickly
• Dehydration
• Low potassium levels in the blood
• Decreased appetite
• Rectal bleeding
• Intestinal or rectal bleeding, including hemorrhoids
• Nausea
• Vomiting
• Urticarial rash (hives)

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

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

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

• Skin rash

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly throughthenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Once the bottle is opened, the capsules must be taken within an 18-week period.

Do not store at a temperature above30°C. Keep the bottle perfectly closed to protect it from humidity.

Do not use this medication if you observe that the bottle is damaged or notice any change in the appearance of the capsules.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Constella

• The active ingredient is linaclotide. Each capsule contains 290micrograms of linaclotide.
• The other components are:

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

Capsule coating: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), gelatin, and polyethylene glycol.

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

Appearance of the product and contents of the package

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

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

Constella is available in packaging containing 10, 28, or 90 capsules and in multiple packaging of 112 capsules, which includes 4 boxes of 28 capsules each. Only some package sizes may be marketed.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

Responsible for manufacturing

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

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

For a braille, large print, or audio version of this leaflet, please contact the local representative of the marketing authorization holder.