Constella 290 micrograms hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Constella 290 micrograms hard capsules

linaclotide

Read the entire leaflet carefully before you start taking this medicine, because 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Constella is and what it is used for
2. What you need to know before taking 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 simply referred to as "IBS") with constipation in adult patients.

IBS is a common gastrointestinal disorder. The main symptoms of IBS with constipation are:

• abdominal pain or discomfort,
• a sensation of bloating,
• infrequent, hard, small, or pellet-like bowel movements (stools).

These symptoms may vary from person to person.

How Constella works

Constella works locally in the intestine, relieving pain and bloating and restoring normal bowel function. It is not absorbed into the body, but instead 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, thereby softening the stools and increasing intestinal motility.

2. What you need to know before taking Constella

Do not take Constella

• if you are allergic to linaclotide or to 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 blockage.

Warnings and precautions

Your doctor has prescribed this medicine for you after ruling out other diseases, especially those affecting your intestines, and determining that you have irritable bowel syndrome with constipation (IBS-C). Since these other conditions may have similar symptoms to IBS, it is important that you inform your doctor immediately of any changes or irregularities 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); remember to drink plenty of fluids to replace water and electrolytes, such as potassium, lost due to diarrhea.

If you experience severe stomach symptoms that persist or worsen, stop taking Constella and contact your doctor immediately, as these could be signs of a hole developing 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 of age, as you have a higher risk of developing diarrhea.

Also take special precautions if you have severe or prolonged diarrhea and an additional medical condition such as high blood pressure, a previous heart or vascular disease (e.g., prior 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 patients with these conditions.

Children and adolescents

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

Other medicines and Constella

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

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

• Oral contraceptives. If you have severe diarrhea, the oral contraceptive pill may not work effectively and use of an additional contraceptive method is recommended. Refer to the instructions in the leaflet of the contraceptive pill you are taking.

• Medicines that require careful and precise dosing, such as levothyroxine (a hormone used to treat reduced thyroid gland function).

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

• Medicines used to treat stomach ulcers or excessive stomach acid production, known as proton pump inhibitors.

• Medicines used to treat pain and inflammation, known as 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 available on the effects of Constella in pregnant or breastfeeding women.

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

In a breastfeeding study conducted in seven lactating women who were already receiving linaclotide treatment, neither linaclotide nor its active metabolite was detected in breast milk. Therefore, breastfeeding is not expected to result in exposure of the infant to linaclotide, and Constella may be used during breastfeeding.

Driving and using machines

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

3. How to take Constella

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule (i.e., 290 micrograms of linaclotide) taken 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 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 taken an excessive amount of this medicine.

If you forget to take Constella

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

If you stop taking Constella

It is advisable to consult your doctor before stopping treatment; however, you may discontinue taking Constella at any time with complete safety.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 bowel movements lasting 7 days or more) and feel dizzy, lightheaded, or faint, stop treatment with Constella and contact your doctor immediately.

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):

• Loss of bowel control (fecal incontinence)
• Urgency to defecate
• Dizziness when standing up quickly
• Dehydration
• Low blood potassium levels
• Decreased appetite
• Rectal bleeding
• Intestinal or rectal bleeding, including hemorrhoidal bleeding
• Nausea
• Vomiting
• Hives (urticaria)

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

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

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

• Skin rash

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton and container after "EXP". The expiry date refers to the last day of the month indicated.

After opening the bottle, the capsules should be taken within 18 weeks.

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

Do not use this medicine if you notice that the container is damaged or if you observe any changes in the appearance of the capsules.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Constella

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

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

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

Capsule 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 container

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

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

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

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG
Knollstraße
67061 Ludwigshafen
Germany

Manufacturer

Forest Laboratories Ireland Limited
Clonshaugh Business and Technology Park
Clonshaugh
Dublin 17, D17 E400
Ireland

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

Date of the most recent review 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, please contact the local representative of the marketing authorization holder.