Do not take Constella

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

Warnings and precautions

Your doctor has given this medicine to you after excluding other diseases, especially of your bowels and concluding that you suffer from IBS with constipation. Because these other diseases may have the same symptoms as IBS, it is important that you report any change or irregularity in symptoms to your doctor promptly.

If you experience severe or prolonged diarrhoea (passing of frequent watery stools for 7 days or more), stop taking Constella and contact your doctor (see section 4). Make sure you drink plenty of fluids to replace the water and electrolytes like potassium lost from the diarrhoea.

Talk to your doctor if you experience bleeding from the bowel or rectum.

Take special care if you are older than 65 years, as there is a higher risk you experience diarrhoea.

Take also special care if you have severe or prolonged diarrhoea and an additional disease, such as high blood pressure, previous disease of the heart and blood vessels (e.g. such as previous heart attacks) or diabetes.

Talk to your doctor if you suffer from inflammatory diseases of the guts 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 and adolescents under the age of 18 years because the safety and efficacy of Constella in this age group has 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 as effectively if you have severe or prolonged diarrhoea, such as:
  • Oral contraceptives. If you have very bad diarrhoea, the contraceptive pill may not work properly and the use of an extra method of contraception is recommended. See the instructions in the patient leaflet of the contraceptive pill you are taking.
  • Medicines that need careful and exact dosing, such as levothyroxine (a hormone to treat reduced function of the thyroid gland).
• Some medicines may increase the risk of diarrhoea when taken with Constella, such as:
  • Medicines to treat stomach ulcers or excessive production of stomach acid called Proton Pump Inhibitors.
  • Medicines to treat pain and inflammation called NSAIDs.
  • Laxatives.

Constella with food

Constella produces more frequent bowel movements and diarrhoea (looser stools) when it is taken with food than when it is taken on an empty stomach (see section 3).

Pregnancy and breast-feeding

Limited information is available on the effects of Constella in pregnant and breast-feeding women.

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

If you are breast-feeding, do not take Constella unless your doctor advises to do so.

Driving and using machines

Constella will not affect your ability to drive or use machines