What Constella is used for and how to use it
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Constella - Consumer Medicine Information

Manufacture: Actavis
Country: Canada
Condition: Constipation, Chronic, Constipation, Irritable Bowel Syndrome
Class: Guanylate cyclase-C agonists
Form: Capsules
Ingredients: linaclotide, calcium chloride dihydrate, gelatin, hypromellose, iron oxide black, iron oxide yellow, L-leucine, microcrystalline cellulose, shellac glaze, titanium dioxide

About this medication

What the medication is used for in adults:

CONSTELLA has been prescribed to you by your doctor to treat your:

  • Irritable bowel syndrome with constipation (IBS-C).
  • Chronic idiopathic constipation (CIC). “Idiopathic” means the cause of the constipation is unknown.

What it does:

CONSTELLA is a medication in a class called guanylate cyclase type C (GC-C) agonist. CONSTELLA is believed to relieve constipation by adding fluid to the bowels, making bowel movements (BMs) softer, and helping them occur more often. It is also believed to decrease abdominal pain by acting on pain-sensing nerves in the intestines.

IBS-C

IBS-C is a bowel disorder in which abdominal (stomach area) symptoms, including pain, discomfort and bloating are experienced along with constipation. CONSTELLA may help you feel less pain, discomfort, and bloating in your abdomen. It may also help your constipation by causing you to have more BMs, softer BMs, and less straining to pass the BM. You may notice improvement of bowel symptoms within the first week; the pain or discomfort in your abdomen may take longer to improve.

CIC

CIC is a bowel disorder with many bowel and abdominal symptoms including constipation, straining, hard stools, discomfort, bloating and a sense of incomplete BM. CONSTELLA may help you have more BMs, softer BMs, and less straining to pass the BM. You may also feel less discomfort and bloating in your abdomen. You may notice improvement of bowel symptoms within the first week.

CONSTELLA may help your IBS-C or CIC symptoms, but CONSTELLA is not a cure for either condition. If you stop taking CONSTELLA, your symptoms may return within 1 week.

When it should not be used:

Do not give CONSTELLA to children under 6 years of age. Do not take CONSTELLA if:

  • you are allergic to it or any of the other ingredients in CONSTELLA or component of the container (see What the nonmedicinal ingredients are section).
  • a doctor has told you recently that you have a bowel blockage (intestinal obstruction).

What the medicinal ingredient is:

linaclotide

What the nonmedicinal ingredients are:

Nonmedicinal ingredients include: calcium chloride dihydrate, gelatin, hypromellose, iron oxide black, iron oxide yellow, L-leucine, microcrystalline cellulose, shellac glaze, and titanium dioxide.

What dosage forms it comes in:

CONSTELLA comes in 2 capsule strengths: 145 mcg and 290 mcg.

Warnings and precautions

Read this information before you start taking CONSTELLA and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

If you have any questions about CONSTELLA, ask your doctor.

CONSTELLA must not be used in children under 6 years of age and is not recommended for use in children and adolescents between 6 and 18 years of age. The safety and efficacy of CONSTELLA in children and adolescents (less than 18 years of age) have not been established.

BEFORE you use CONSTELLA talk to your doctor or pharmacist if:

  • You have any other medical conditions.
  • You are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if CONSTELLA will harm your unborn baby.
  • You are breast-feeding or planning to breastfeed. It is not known if CONSTELLA passes into your breast milk. Talk with your doctor about the best way to feed your baby, if you take CONSTELLA.
  • You are taking or planning to take any other medicines, including prescription and non-prescription drugs, vitamins and herbal supplements.

Interactions with this medication

As very little linaclotide is absorbed from the intestines, no drug interaction studies have been conducted with CONSTELLA.

Your doctor or pharmacist can tell you if it is safe to take CONSTELLA with your other medicines. Do not start or stop any medicine while taking CONSTELLA without talking to your healthcare provider first.

Proper use of this medication

Usual Adult Dose:

  • Take CONSTELLA exactly as your doctor tells you to take it.
  • Take CONSTELLA one time each day on an empty stomach, at least 30 minutes before your first meal of the day.
  • Swallow the capsule whole with water. Do not break the capsule apart or chew it.

If no improvement in symptoms is seen within 6 weeks, contact your doctor.

Overdose:

In case of drug overdose, contact a health care provider, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of CONSTELLA, just skip that dose. Do not take two capsules to make up the missed dose. Instead, wait until the next time you are supposed to take it and then take your normal dose on an empty stomach, at least 30 minutes before your first meal of the day.

Side effects and what to do about them

The most common side effects reported with CONSTELLA are:

  • Diarrhea
  • Passing gas
  • Abdominal (stomach-area) pain
  • Swelling, or a feeling of fullness or pressure in your abdomen (bloating)
  • Nausea
  • Vomiting

Some side effects can be serious.

Mild to moderate diarrhea often begins within the first two weeks of taking CONSTELLA. Stop taking CONSTELLA and call your doctor right away if you get severe diarrhea (for example persistent watery stools) during treatment with CONSTELLA.

Call your doctor or go to the nearest hospital emergency room right away, if you develop unusual or severe abdominal pain.

This is not a complete list of side effects. If you have other unexpected side effects, side effects that bother you or do not go away, contact your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacist
Only if severe In all cases
Uncommon Severe diarrhea
Rare New or worsening abdominal pain not typical of your IBS-C or CIC symptoms

How to store it

  • Store CONSTELLA at room temperature between 15oC and 25oC.
  • Keep CONSTELLA in the bottle that it comes in.
  • The CONSTELLA bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle.
  • Keep the container of CONSTELLA tightly closed and in a dry place.

Keep CONSTELLA and all medicines out of the reach of children.

Do not use CONSTELLA past the expiration date shown on the package.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                        Health Canada
                        Postal Locator 0701D
                        Ottawa, Ontario
                        K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.


NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This Consumer Information Leaflet provides you with the most current information at the time of printing. For the most current information, the Consumer Information Leaflet plus the full product monograph, prepared for health professionals can be found at:

http://www.frx.ca

or by contacting the sponsor, Forest Laboratories Canada Inc., at: 1-855-894-1747