Constella

Package leaflet: Information for the patient

Constella 290 micrograms hard capsules

linaclotide
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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 for the treatment of symptoms of irritable bowel syndrome (often simply referred to as "IBS") with constipation, in adult patients.
IBS is a common intestinal disorder. The main symptoms of IBS with constipation include:

• abdominal or stomach pain,
• a sensation of bloating,
• infrequent bowel movements with hard, small or pellet-like stools.

These symptoms may vary from person to person.
How Constella works
Constella acts locally in the intestine, helping to relieve pain and bloating and to restore normal bowel function. It is not absorbed by the body but binds to the guanylate cyclase-C receptor on the surface of the intestine. By binding to this receptor, it blocks the sensation of pain and allows fluids to soften the stools in the intestine, increasing intestinal motility (peristalsis).

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 gastric or intestinal obstruction.

Warnings and precautions
Your doctor has prescribed this medicine after ruling out other diseases, particularly of the intestine, and after determining that you have irritable bowel syndrome (IBS) with constipation. Since other conditions may have symptoms similar to IBS, it is important that you promptly inform your doctor of any changes or irregularities in your symptoms.
If you experience severe or prolonged diarrhoea (frequent bowel movements with liquid stools for 7 days or longer), stop taking Constella and contact your doctor (see section 4). Make sure you drink plenty of fluids to replace fluid and electrolyte losses, such as potassium, caused by diarrhoea.
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 in the intestinal wall (gastrointestinal perforation). See section 4.
Contact your doctor if you experience intestinal or rectal bleeding.
Exercise particular caution if you are over 65 years of age, as you are at higher risk of developing diarrhoea.
Also, pay special attention if you experience severe or prolonged diarrhoea and you have another medical condition, such as hypertension, previous heart or vascular disease (e.g. previous heart attacks), or diabetes.
Consult your doctor if you suffer from intestinal inflammatory disorders such as Crohn’s disease or ulcerative colitis, as Constella is not recommended for these patients.
Children and adolescents
Do not administer to children and adolescents under 18 years of age, as the safety and efficacy of Constella in this age group have not been established.
Other medicines and Constella
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Some medicines may not work effectively during severe or prolonged diarrhoea, such as:
  • Oral contraceptives: in case of severe diarrhoea, the effectiveness of oral contraceptives may be reduced, and use of an alternative contraceptive method is recommended. Read the patient leaflet of the oral contraceptive you are taking.
  • Medicines requiring precise and accurate dosing, such as levothyroxine (a hormone used to treat reduced thyroid gland function)
• Some medicines may increase the risk of diarrhoea when taken with Constella, such as:
  • Medicines used to treat stomach ulcers or excessive stomach acid, known as proton pump inhibitors
  • Medicines used to treat pain and inflammation, known as NSAIDs
  • Laxatives

Constella with food
Constella causes more frequent intestinal movements (peristalsis) and diarrhoea when taken with food compared to taking it on an empty stomach (see section 3).
Pregnancy and breastfeeding
Data on the use of Constella in pregnant or breastfeeding women are limited.
Do not take this medicine if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, unless your doctor specifically prescribes it.
In a study on exclusive breastfeeding in seven women who were breastfeeding while receiving linaclotide for therapeutic purposes, neither linaclotide nor its active metabolite were detected in breast milk. Therefore, breastfeeding is not expected to expose the infant to linaclotide, and Constella may be used during breastfeeding.
Driving and using machines
Constella does not affect the ability to drive or operate machinery.

3. How to take Constella

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
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 do not notice an 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 more Constella than prescribed is diarrhoea. Contact your doctor or pharmacist if you have taken more medicine than you should.
If you forget to take Constella
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time and continue as usual.
If you stop taking Constella
It is advisable to discuss stopping treatment with your doctor beforehand. However, treatment with Constella can be safely stopped at any time.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very common (may affect more than 1 in 10 people)

• diarrhoea

Diarrhoea is usually short-lived; however, if you experience severe or prolonged diarrhoea (frequent passage of liquid stools for 7 days or longer) and feel lightheaded, dizzy, or faint, stop taking Constella and contact your doctor.

Common (may affect up to 1 in 10 people)

• abdominal or stomach pain
• bloating sensation
• flatulence
• gastroenteritis (viral gastroenteritis)
• dizziness

Uncommon (may affect up to 1 in 100 people)

• loss of bowel control (faecal incontinence)
• urgency to defecate
• dizziness upon standing up quickly
• dehydration
• low blood potassium levels
• reduced appetite
• rectal bleeding
• intestinal or rectal bleeding, including bleeding haemorrhoids
• nausea
• vomiting
• hives (urticaria)

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

• reduced bicarbonate levels in the blood
• formation of a hole in the intestinal wall (gastrointestinal perforation)

Not known (frequency cannot be estimated from the available data):

• rash (skin eruption)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system listed in Annex V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store 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 on the bottle after “Exp.”.
The expiry date refers to the last day of that month.
Once the bottle has been opened, the capsules must be used within 18 weeks.
Do not store above 30 ºC. Keep the bottle tightly closed to protect the medicine from moisture.
Warning: the bottle contains one or more sealed containers with silica gel to keep the capsules dry. Keep these containers in the bottle. Do not swallow them.
Do not use this medicine if you notice any signs of deterioration on the bottle or any changes in the appearance of the capsules.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Constella contains

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

Contents of the capsule: microcrystalline cellulose, hypromellose, calcium chloride dihydrate and leucine.
Capsule coating: red iron oxide (E172), titanium dioxide (E171), yellow titanium oxide (E172), gelatin and polyethylene glycol.
Capsule ink: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171) and black iron oxide (E172).

Description of the appearance of Constella and package contents
The capsules are white to off-white opaque hard capsules, printed with "290" in grey ink.
They are packaged in a white high-density polyethylene (HDPE) bottle with a tamper-evident seal and child-resistant cap, together with one or more desiccant containers containing silica gel.
Constella is available in packages containing 10, 28 or 90 capsules, and in a multiple pack of 112 capsules consisting of 4 cartons, each containing 28 capsules. 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: +370 5 205 3023

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел:+359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel.: +420 233 098 111 Tel:+36 1 455 8600

Danmark Malta
AbbVie A/S Vivian Corporation Ltd.
Tlf: +45 72 30 20 28 Tel: +356 27780331

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel.: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel.: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel. +372 6231011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 913840910 Tel.: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel.: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: + 385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Sími: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

To listen to or request a copy of this patient information leaflet in ,
print> or , please contact the local representative of the Marketing Authorisation Holder.