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AMITIZA 24 MICROGRAM SOFT CAPSULES

Active substance(s): LUBIPROSTONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
AMITIZA 24 MICROGRAM SOFT CAPSULES
Lubiprostone





This medicine is subject to additional monitoring. This will
allow quick identification of new safety information. You can
help by reporting any side effects you may get. See the end
of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this
medicine.
- 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

PCR-750-07143-1

PCR-750-07143-1

In this leaflet:
1. What AMITIZA is and what it is used for?
2. Before you take AMITIZA
3. How to take AMITIZA
4. Possible side effects
5. How to store AMITIZA
6. Further information
1. WHAT AMITIZA IS AND WHAT IT IS USED FOR?
AMITIZA capsules work by increasing the amount of fluids into
the bowels. This helps the passage of stool and reduces the
feeling of uncomfortable and difficult bowel movements that
occurs with constipation.
AMITIZA is used to treat chronic constipation.
2. BEFORE YOU TAKE AMITIZA
Do not take AMITIZA:
- If you are allergic (hypersensitive) to lubiprostone or any of the
other ingredients of AMITIZA.
- If you have a blockage in your bowels (intestine).
- If you are less than 18 years of age. There is no information
available on the use of AMITIZA in people under 18 years of age.
This medicinal product contains the sugar sorbitol, if you have
been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

Take special care with AMITIZA:
- It is possible that you may feel like getting sick (nausea) whilst
taking AMITIZA. Taking AMITIZA with food will help to reduce
this feeling.
- If you have certain symptoms such as severe stomach pain or
cramps your doctor may need to check if you have a blockage
or inflammation in your bowels. If you have any of these
problems AMITIZA may not be suitable for you.
- You should not take AMITIZA if you have severe diarrhoea.
You may get diarrhoea while taking AMITIZA. If you get severe
diarrhoea tell your doctor.
- It is possible that sometimes, shortly after taking AMITIZA, that
you may feel short of breath, or have a feeling of tightness in
your chest. This usually stops within a few hours, but if you are
worried please contact your doctor, who will help you, before
taking any more AMITIZA.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. This includes treatments
that you might buy in a pharmacy or in a supermarket.
Taking AMITIZA with food and drink
AMITIZA should be taken with food and the capsules should be
swallowed whole with a sufficient amount of water.
Taking AMITIZA with food may reduce symptoms of nausea.
Pregnancy and breast-feeding
AMITIZA has not been studied in pregnant women and should
not be used during pregnancy and in women of childbearing
potential not using contraception.
It is not known whether AMITIZA is excreted in human milk.
Because many drugs are excreted in human milk and because of
the potential for serious adverse reactions in nursing infants from
AMITIZA, it should not be used whilst breastfeeding.

Important information about some of the ingredients of
AMITIZA
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking AMITIZA, this
is because AMITIZA contains sorbitol.
3. HOW TO TAKE AMITIZA
Always use AMITIZA exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
For adults only: The usual dose is one 24 microgram capsule
twice a day. You should only take AMITIZA for 2 to 4 weeks. If
you do not respond to AMITIZA at least after 2 weeks talk to your
doctor.
Take AMITIZA with water at mealtimes. AMITIZA may make you
feel nauseous and taking it with food may help. The capsules
should be swallowed whole and should not be broken apart or
chewed.
Your doctor should regularly assess the need for you to continue
treatment.
If you take more AMITIZA than you should
If you accidentally take too many capsules you are more likely
to experience side effects. You should contact your doctor or
pharmacist immediately. If possible, take your bottle of capsules
with you to show the doctor or pharmacist.
If you forget to take AMITIZA
If you miss a dose of AMITIZA, just skip that dose. Do not take
two capsules to make up for the missed dose. Instead, just wait
until the next time you are supposed to take it, and then take
your normal dose.
If you stop taking AMITIZA
Take AMITIZA as prescribed by your doctor, if you stop taking
AMITIZA your symptoms may return.

Ask your doctor or pharmacist for advice before taking any
medication.

If you think you are suffering from a side effect of AMITIZA, ask
your doctor or pharmacist for advice.

Driving and using machines
No studies on the effects on the ability to drive and use machines
have been performed.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

If you experience a side effect of AMITIZA that may affect your
ability to drive or operate machinery, do not drive or operate
machinery.

4. POSSIBLE SIDE EFFECTS
Like all medicines, AMITIZA can cause side effects, although not
everybody gets them.

Do not take AMITIZA if you think any of these apply to you.
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Colours

Proof no

Initials – Date

7. proof dk-pth 18.02.2016
File name

black

LFT Amitiza 24 mcg caps - GBR
Market

United Kingdom

Technical approved
by (initials)

Date

Approved by
(initials)

Date

Format

519,1 x 260,35 mm (20 7/16 x 10 1/4 inch)
Created by

Pia Thorndahl
Department

Takeda OES

Title



Graphical specialist

The most common (more than 1 in 10 patients) side effects
reported by people taking AMITIZA was nausea, with diarrhoea
and headache, also being commonly reported.
Tell your doctor if you experience severe nausea. Your doctor
may be able to suggest other ways to manage your nausea.
If you do get nausea, taking AMITIZA with food may reduce
the symptoms.
If you get severe diarrhoea during treatment or your diarrhoea
worsens, tell your doctor immediately.

6. FURTHER INFORMATION
What AMITIZA contains
- The active substance is lubiprostone
- One soft capsule contains 24 micrograms of lubiprostone
- The other ingredients are medium-chain triglycerides, gelatin,
sorbitol (E420), and purified water.
- The outside of each soft capsule has black ink printing.
The black ink consists of propylene glycol, black iron oxide,
polyvinyl acetate phthalate and polyethylene glycol.

Other common (greater than 1 in 100 patients) side effects
reported by people taking AMITIZA included abdominal pain,
abdominal swelling, flatulence, loose stools, dizziness, increased
heart rate, oedema, tiredness, chest discomfort/pain, shortness
of breath, abdominal discomfort, upset stomach, dry mouth,
excessive sweating, hot flushes and stomach discomfort.

What AMITIZA looks like and contents of the bottle
AMITIZA is available as an oval, soft gelatin capsule with an
amber appearance with SPI printed on one side. Each capsule
contains 24 micrograms of lubiprostone.

Uncommon (affecting more than 1 in 1000 patients) side effects
have been reported: vomiting, occasional fainting and muscle
spasms.

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder of AMITIZA is:
Takeda UK Limited
Building 3,
Glory Park,
Glory Park Avenue,
Wooburn Green,
BUCKS,
HP10 0DF,
UK

Also, some reports of flu-like symptoms, throat tightness, allergic
reaction/rash, low blood pressure, and insufficient blood supply
to the large intestine causing inflammation (ischaemic colitis)
have been received but it is not possible to accurately estimate
their frequency.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet. You can
also report side effects directly via the national reporting system
listed in United Kingdom as Yellow Card Scheme Website:
www.mhra.gov.uk/ yellowcard. By reporting side effects, you can
help provide more information on the safety of this medicine.
5. HOW TO STORE AMITIZA
Keep out of the reach and sight of children.
Keep the container tightly closed.
Store in the original container. Once opened, use within 4 weeks.
Do not store above 30°C. Do not freeze.
Do not use AMITIZA after the expiry date, which is stated on the
bottle and carton as “EXP” followed by the date. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Each bottle contains 28 or 56 capsules of AMITIZA.

The manufacturer of AMITIZA is:
Catalent UK Packaging Ltd.
Lancaster Way
Wingates Industrial Estate
Westhoughton
Bolton
Lancashire
BL5 3XX
United Kingdom
and
Takeda GmbH (Plant Singen)
Robert Bosch Strasse 8
78224 Singen
Germany
For any information about this medicine, reporting an undesired
effect or a product defect, please contact the Marketing
Authorisation Holder.
This leaflet was last approved in 04/2016.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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