• 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.

1. What Constella is and what it is used for
2. What you need to know before you take Constella
3. How to take Constella
4. Possible side effects
5. How to store Constella
6. Contents of the pack and other information

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

IBS is a common gut disorder. The main symptoms of IBS with constipation include:

• stomach or abdominal pain,
• feeling bloated,
• infrequent, hard, small or pellet-like stools (faeces).

These symptoms may vary from person to person.

Constella acts locally in your gut, helping you to feel less pain and less bloated, and to restore the normal functioning of your bowels. It is not absorbed into the body, but attaches to receptor called guanylate cyclase C on the surface of your gut. By attaching to this receptor, it blocks the sensation of pain and allows liquid to enter from the body into the gut, thereby loosening the stools and increasing your bowel movements.

• 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.

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.

If you have severe stomach symptoms which continue or get worse, stop taking Constella and contact your doctor immediately because these could be symptoms of a hole developing in the bowel wall (gastrointestinal perforation). See section 4.

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.

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.

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 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).

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.

In a milk-only lactation study in seven lactating women, who were already taking linaclotide therapeutically, neither linaclotide nor its active metabolite were detected in the milk. Therefore breastfeeding is not expected to result in exposure of the infant to linaclotide and Constella can be used during breast-feeding.

Constella will not affect your ability to drive or use machines

The most likely effect of taking too much Constella is diarrhoea. Contact your doctor or pharmacist if you have taken too much of this medicine.

Do not take a double dose to make up for a forgotten dose. Just take the next dose at the scheduled time and continue as normal.

It is preferable to discuss stopping treatment with your doctor before actually doing so. However, treatment with Constella can be safely stopped at any time.

If you get 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:

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

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

Capsule content: microcrystalline cellulose, hypromellose, calcium chloride dihydrate and leucine.

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

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

The capsules are white to off-white-orange opaque hard capsules marked “290” with grey ink.

They are packaged in a white, high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant screw cap, together with one or more desiccant canisters containing silica gel.

Constella is available in packs containing 10, 28 or 90 capsules and in multipacks of 112 capsules comprising 4 cartons, each containing 28 capsules. Not all pack-sizes may be marketed.

or

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: