Constella 290 micrograms hard capsules

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.

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.

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.

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:

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.