CONSTELLA 290 MICROGRAMS Kapsułka twarda
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Treść ulotki
Constella 290 micrograms hard capsules
linaclotide
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even 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 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
1. What is Constella and what is it used for
What is Constella used for
Constella contains the active ingredient linaclotide. It is used for the treatment of symptoms of irritable bowel syndrome (often simply called “IBS”) from moderate to severe with constipation in adult patients.
IBS is a common intestinal disorder. The main symptoms of IBS with constipation include:
- abdominal or stomach pain,
- feeling of bloating,
- infrequent bowel movements with hard, small or pellet-like stools.
These symptoms can vary from person to person.
How Constella works
Constella works 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 stool in the intestine by increasing intestinal movements (peristalsis).
2. What you need to know before taking Constella
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 knows you have a gastric or intestinal blockage.
Warnings and precautions
Your doctor has prescribed this medicine after excluding other diseases, particularly of the intestine and
after concluding that you suffer from IBS with constipation. Since other diseases can
present the same symptoms as IBS, it is important that you promptly inform your doctor of any
change or irregularity in your symptoms.
In case of severe or prolonged diarrhea (frequent and 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
compensate for the loss of fluids and electrolytes such as potassium due to diarrhea.
If you experience severe stomach symptoms that persist or worsen, stop taking
Constella and contact your doctor immediately, as these may be symptoms of perforation of the
intestinal wall (gastrointestinal perforation). See section 4.
Contact your doctor if you experience intestinal or rectal bleeding.
Be particularly careful if you are over 65 years of age, as you are at greater risk of developing
diarrhea.
Also, be particularly careful if you experience severe or prolonged diarrhea and have
another condition, such as high blood pressure, previous heart and blood vessel disease (e.g.
previous heart attacks) or diabetes.
Consult your doctor if you suffer from inflammatory bowel diseases such as Crohn's disease or ulcerative colitis, as
Constella is not recommended in 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 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 do not work effectively in case of severe or prolonged diarrhea, such as:
- Oral contraceptives: in case of severe diarrhea, the effectiveness of oral contraceptives may be reduced and you
are taking
- Medicines that require a precise and accurate dosage, such as levothyroxine (a hormone to treat reduced thyroid function)
- Some medicines may increase the risk of diarrhea if taken with Constella, such as:
- Medicines to treat stomach ulcers or excessive stomach acidity, known as proton pump inhibitors
- Medicines to treat pain and inflammation, known as NSAIDs
- Laxatives
Constella with food
Constella produces more frequent bowel movements (peristalsis) and diarrhea if taken with food rather
than 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 are pregnant, or are planning a pregnancy, unless
your doctor tells you to do so.
In a study of exclusive breastfeeding in seven women who were breastfeeding and already taking
linaclotide for therapeutic purposes, neither linaclotide nor its active metabolite were detected in breast milk. Therefore, it is
believed that breastfeeding does not lead to exposure of the infant to linaclotide and that Constella can
be used during breastfeeding.
Driving and using machines
Constella does not impair the ability to drive or operate machinery.
3. How to take Constella
Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one capsule (i.e. 290 micrograms of linaclotide) orally once a day.
The capsule must be taken at least 30 minutes before a meal.
If after 4 weeksof treatment you do not notice an improvement in symptoms, consult your doctor.
If you take more Constella than you should
The most likely effect if you take more Constella than you should 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 a missed dose. Take the next dose at the scheduled time
and continue as usual.
If you stop taking Constella
Before stopping treatment it is preferable to discuss it with your doctor. However, treatment with
Constella can be stopped safely at any time.
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 side effects (may affect more than 1 in 10 people)
diarrhoea
Diarrhoea is usually short-lived; however, if you experience severe or prolonged diarrhoea
(frequent, watery stools for 7 days or more) and feel dizzy, lightheaded or faint,
stop taking Constella and contact your doctor.
Common side effects (may affect up to 1 in 10 people)
abdominal or stomach pains
feeling bloated
wind
gastrointestinal infection (viral gastroenteritis)
feeling of spinning
Uncommon side effects (may affect up to 1 in 100 people)
loss of bowel control (faecal incontinence)
urgency to defecate
feeling lightheaded when standing up quickly
dehydration
low level of potassium in the blood
decreased appetite
rectal bleeding
intestinal or rectal bleeding including bleeding haemorrhoids
nausea
vomiting
hives
Rare side effects (may affect up to 1 in 1,000)
reduced bicarbonate in the blood
formation of a hole in the intestinal wall (gastrointestinal perforation)
Side effects of unknown frequency (frequency cannot be estimated from available data):
rash (skin eruption)
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system listed in Annex V. By reporting side effects 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 which is stated on the pack and bottle after “Exp.”.
The expiry date refers to the last day of that month.
Once opened, the capsules must be used within 18 weeks.
Do not store at a temperature above 30ºC. Keep the bottle tightly closed to protect the medicine
from humidity.
Warning:the bottle contains one or more sealed containers containing silica gel to keep the capsules dry.
Keep these containers in the bottle. Do not ingest them.
Do not use this medicine if you notice signs of deterioration on the bottle or any change in the appearance
of the capsules.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Constella contains
- The active ingredient 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 titanium oxide
(E172), gelatin and polyethylene glycol.
Printing ink: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171) and black iron oxide (E172).
Description of Constella and package contents
The capsules are opaque, hard capsules ranging from white to orange-white, marked with “290” in grey ink.
They are packaged in a white bottle, made of high-density polyethylene (HDPE) with a tamper-evident seal and a child-resistant cap, together with one or more desiccant containers containing silica gel.
Constella is available in packs containing 10, 28 or 90 capsules and in a multi-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
For further information on this medicine, contact the local representative of the marketing authorisation holder:
België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811
Lietuva
AbbVie UAB
Tel: + 370 5 205 3023
България
Алерган България ЕООД
Тел.: + 359 (0) 800 20 280
Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811
Česká republika
Allergan CZ s.r.o.
Tel: + 420 800 188 818
Magyarország
Allergan Hungary Kft.
Tel.: + 36 80 100 101
Danmark
AbbVie A/S
Tlf: +45 72 30 20 28
Malta
Allergan Pharmaceuticals Ireland
+356 27780331 (MT)
Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel.: 00800 222843 33 (gebührenfrei)
Tel.: +49 (0) 611 / 1720-0
Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843
Eesti
AbbVie OÜ
Tel: + 372 623 1011
Norge
AbbVie AS
Tlf: +47 67 81 80 00
Ελλάδα/Κύπρος
Allergan Hellas Pharmaceuticals S.A.
Τηλ: + 30 210 74 73 300
Österreich
AbbVie GmbH
Tel: +43 1 20589-0
España
AbbVie Spain, S.L.U.
Tel: +34 913840910
Polska
Allergan Sp. z o.o.
Tel: + 48 22 256 37 00
France
Allergan France SAS
Tél: + 33 (0)1 49 07 83 00
Portugal
AbbVie, Lda.
Tel.: +351 (0)21 1908400
Hrvatska
AbbVie d.o.o.
Tel: + 385 (0)1 5625 501
România
Allergan S.R.L.
Tel: + 40 21 301 53 02
Ireland
AbbVie Limited
Tel: +353 (0)1 4287900
Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: + 386 (1)32 08 060
Ísland
Vistor hf.
Sími: +354 535 7000
Slovenská republika
Allergan SK s.r.o.
Tel: + 421 2 593 961 00
Italia
Allergan S.p.A
Tel: + 39 06 509 562 90
Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200
Latvija
AbbVie SIA
Tel: +371 676 05000
Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600
United Kingdom (Northern Ireland)
AbbVie Deutschland GmbH & Co. KG
Tel: +44 (0)1628 561090
Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 290 MICROGRAMS
- Kod ATCA06AX04
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KONSTELLAPostać farmaceutyczna: Suppository, 675 MGSubstancja czynna: glycerolProducent: ALMUS S.R.L.Bez receptyPostać farmaceutyczna: Suppository, 1375 MGSubstancja czynna: glycerolProducent: AEFFE FARMACEUTICI SRLBez receptyPostać farmaceutyczna: Suppository, 900 MGSubstancja czynna: glycerolProducent: CARLO ERBA O.T.C. S.R.L.Bez recepty
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Substancją czynną w KONSTELLA jest linaclotide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KONSTELLA jest produkowany przez ABBVIE DEUTSCHLAND GMBH & CO. KG. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
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Inne leki zawierające tę samą substancję czynną (linaclotide) to m.in. KLARILAXINA STITIKETSTSA, LYKEROLO AFOM, LYKEROLO KARLO ERBA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
