CITRAFLEET POWDER FOR ORAL SOLUTION IN SACHET

Active substance: SODIUM PICOSULFATE

View full screen / Print PDF » Download PDF ⇩

Transcript
CitraFleet

®

Powder for oral solution in sachet

Sodium picosulfate, light magnesium oxide, citric acid anhydrous.

Read all of this leaflet carefully before you start
using this medicine.
This medicine is available without prescription.
However, you still need to take CitraFleet carefully to
get the best results from it.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• If you get any of the side effects listed in this
leaflet whilst using CitraFleet and they become
troublesome, or if you notice any side effects not
listed in this leaflet, please tell your doctor.

In this leaflet:
1.
2.
3.
4.
5.
6.

What CitraFleet is and what it is used for
Before you take CitraFleet
How to take CitraFleet
Possible side effects
How to store CitraFleet
Further information

1. WHAT CITRAFLEET IS AND WHAT
IT IS USED FOR
You are taking CitraFleet to clean your bowels (also known
as intestines and colon) before having any diagnostic
procedure that requires a clean bowel, for example a
colonoscopy (procedure that looks inside your bowel using
a long, flexible instrument that the doctor inserts through
your anus) or x-ray examination. CitraFleet is a powder
that smells and tastes of lemons. It contains two types
of laxatives mixed in each sachet which, when dissolved
in water and drunk, wash-out and clean the bowels. It
is important to have an empty, clean bowel so that your
doctor or surgeon can see it clearly.

2. BEFORE YOU TAKE CITRAFLEET
Do not take CitraFleet and tell your doctor if you:
• are allergic (hypersensitive) to sodium picosulfate,
magnesium oxide, citric acid or any of the other
ingredients of CitraFleet
• have congestive heart failure (your heart is unable to
properly pump blood round the body)
• have a condition called gastric retention (your stomach
does not empty properly)
• have a stomach ulcer (sometimes called gastric or
duodenal ulcers)
• have blockage of the gut or failure of normal bowel
movements (sometimes called ileus)
• have been told by a doctor that you have a damaged
gut wall (also called toxic colitis)
• have a swollen large bowel (also known as toxic
megacolon)
• have recently been sick or feel sick (nausea or
vomiting)
• are very thirsty or think you may be severely dehydrated
• have been told by your doctor that you have a swollen
abdomen due to the collection of fluid (called ascites)
• have recently had surgery on your abdomen e.g. for
appendicitis
• may have a pierced/damaged or blocked gut
(perforated or obstructed bowel)
• have been told by your doctor that you suffer from active
inflammatory bowel disease (such as Crohn’s disease
or ulcerative colitis)
• have been told by your doctor that you have damaged
muscles that are leaking their contents into your blood
(rhabdomyolysis)
• have severe kidney problems or have been told by
your doctor that you have too much magnesium in your
blood (hypermagnesaemia).
Take special care and check with your doctor before
taking CitraFleet if you:
• have had recent surgery on your gut
• have kidney or heart trouble
• have water and/or electrolyte (sodium or potassium)
imbalance or are taking medicines that might affect
water and/or electrolyte (sodium or potassium)
balance in the body, such as diuretics, corticosteroids
or lithium
• have epilepsy or a history of fits
• have low blood pressure (hypotension)
• are thirsty or think you may be mildly to moderately
dehydrated
• are elderly or physically weak
• have ever suffered from low sodium or potassium
in the blood (also known as hyponatraemia or
hypokalaemia).
Taking CitraFleet with other medicines
CitraFleet may affect or be affected by other medicines if
you take them concomitantly. If you are taking any of the
types of medicines listed below, your doctor might decide
that you should be given a different medicine or that the
dose should be adjusted. So, if you have not already
spoken with your doctor about these go back to your
doctor and ask what to do:
• Oral contraceptives, as their effects may be reduced
• Diabetic medicines or medicines used to treat epilepsy
(fits), as their effects may be reduced

• Antibiotic medicines, as their effects may be reduced
• Other laxatives, including bran
• Diuretics, such as furosemide used to control fluid
retention in the body
• Corticosteroids such as prednisone, used to treat
inflammation in diseases such as arthritis, asthma, hay
fever, dermatitis and inflammatory bowel disease
• Digoxin, used to treat heart failure
• Non-steroidal anti-inflammatory drugs (NSAIDs)
such as aspirin and ibuprofen used to treat pain and
inflammation
• Tricyclic antidepressants such as imipramine,
and amtryptiline and selective serotonin reuptake
inhibitors (SSRIs) such as fluoxetine, paroxetine and
citalopram used to treat depression and anxiety
• Antipsychotic drugs such as haloperidol, clozapine
and risperidone used to treat schizophrenia
• Lithium used to treat manic depression (bipolar disorder)
• Carbamazepine used to treat epilepsy
• Pencillamine used to treat rheumatoid arthritis and
other conditions
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast feeding
Talk to your doctor before taking this medicine if you are
pregnant, planning to get pregnant or breast-feeding.
Driving and using machines
Do not drive, or use tools or machines, if you start to feel
tired or dizzy after taking CitraFleet.
Important information about some of the other
ingredients of CitraFleet
Each sachet contains 5 mmol (or 195 mg) potassium. You
should discuss this with your doctor if you have kidney
problems or you have been put on a low potassium diet.

3. HOW TO TAKE CITRAFLEET
Always take CitraFleet exactly as your doctor has told you,
as the hospital procedure may have to be repeated if you
do not wash-out your bowels completely. If you have been
given no instructions the treatment plan below shows you
how to take CitraFleet so that it is safe and effective.
Be prepared to expect frequent, loose bowel
movements at any time after taking a dose of
CitraFleet. This is normal and shows that the medicine is
working. It would be sensible to make sure that you have
access to a toilet until the effects have worn off.
Drink plenty of clear fluids e.g. water, clear soups,
herbal tea, black tea or coffee, or diluted cordials/
fruit juice to avoid dehydration. In general, you should try
to drink 250 ml (a small tumbler-sized glass) every hour
until the effects of CitraFleet have worn off. After this drink
clear fluids, preferably water, to satisfy thirst until after
your hospital procedure, or as directed by your doctor.
Unless directed by your doctor, you should not take more
than the recommended dose in any 24 hour period.
Treatment plan
You should have been given two sachets of CitraFleet.
Each sachet contains one adult dose. Each dose should
be taken 6 - 8 hours apart on the day before the hospital
procedure.

DIRECTIONS FOR USE:
Adults (including the elderly) aged 18 years and over:
Dose 1 – to be taken before 8 am BEFORE BREAKFAST
in the morning of the day before the procedure:
• Step 1 - Mix the contents of 1 sachet in a cup of cold tap
water (approximately 150 ml).
• Step 2 - Stir for 2 - 3 minutes. If it becomes hot when
you stir it, wait until it has cooled down before drinking
the whole solution. Once the solution is ready, drink it
immediately. The solution will appear cloudy.
Dose 2 – to be taken between 2 pm and 4 pm on the
same day as dose 1:
• Take as directed above in steps 1 and 2.
On the day that you take CitraFleet it is best to only have
small meals made up of foods called “low residue foods”.
This is to help CitraFleet work properly. These include:
• Fats such as, butter and margarine – these should be
used sparingly
• Eggs, especially boiled and poached
• Cereals including cornflakes and crisped rice cereal, but
not bran
• Cream or cottage cheese, or cheese sauce
• Potatoes without the skins, boiled, creamed, mashed or
baked, but not roasted or deep fried
• Plain white pasta, noodles or rice, boiled
A016011/04/uk

• Meat or fish e.g. minced, well cooked,
tender, lean beef, lamb, ham, veal,
pork, poultry, fish and shellfish
• Gravy made from stock cubes (white
flour or corn flour can be used to
thicken)
• White bread/toast
• Sugar or sweetener
• Clear jelly
The table below gives an example of how
you should eat these foods and drink
during the day you are taking CitraFleet:
However you should always follow the
advice given to you by your doctor.
8.00 am BEFORE BREAKFAST
• Take the first CitraFleet dose in water as directed
above.
8.00 – 9.00 am BREAKFAST
• Tea/coffee (with milk and sugar/sweetener, if
required) or other clear fluids such as water, clear
soups, herbal tea, black tea or coffee, or diluted
cordials/fruit juice
Choose ONE of the following:
• 30 g crisped rice cereal or cornflakes with 100 ml of
milk
• 2 slices of white bread/toast with a small spread of
butter/margarine and honey
• 1 boiled/poached egg and 1 slice of white toast/
bread with a thin spread of butter/margarine
• 50 g cottage or cream cheese and 1 slice of white
toast/bread with a thin spread of butter/margarine
MID MORNING
• Tea/coffee (with milk and sugar/sweetener, if
required)
12.00 – 1.30 pm LUNCH
Choose ONE of the following:
• 75 g meat/fish with gravy
• 2 boiled/poached eggs
• 100 g cream or cottage cheese
ADD one of the following:
• 2 slices of white bread/toast with a small spread of
butter/margarine
• 2 egg-sized potatoes without skins with a small
amount of butter/margarine
• 2 tablespoons of plain white pasta/rice
Drink plenty of clear fluids, preferably water. Tea
and coffee should now only be black.
AFTER LUNCH YOU MUST NOT HAVE ANY SOLID
FOOD OR MILK OR OTHER DAIRY PRODUCTS
UNTIL AFTER YOUR HOSPITAL PROCEDURE.
2.00 – 4.00 pm MID AFTERNOON
• Take the second CitraFleet dose in water as directed
above.
7.00 – 9.00 pm EARLY EVENING
• No solid food is allowed
• Clear soup or a meat extract drink and clear jelly is
allowed.
AFTER 9.00 pm
NO FURTHER FOOD IS ALLOWED UNTIL AFTER
THE HOSPITAL PROCEDURE.
If you take more CitraFleet than you should, talk to
your doctor or pharmacist immediately.

4. POSSIBLE SIDE EFFECTS
Like all medicines, CitraFleet can cause side effects,
although not everybody gets them. The known side effects
of CitraFleet are described below and are listed according
to the frequency with which they occur:

taking this medicine your bowel movements become
troublesome or give you concern, you should talk to your
doctor.
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.

5. HOW TO STORE CITRAFLEET
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not take CitraFleet after the expiry date which is stated
on the sachet. 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.

6. FURTHER INFORMATION
What CitraFleet contains
• The active substances are sodium picosulfate 10.0 mg,
light magnesium oxide 3.5 g, citric acid anhydrous
10.97 g per sachet.
• The other ingredients are potassium hydrogen
carbonate, saccharin sodium, lemon flavour (lemon
flavour, maltodextrin, tocopherol E307).
What CitraFleet looks like and contents of the pack
CitraFleet is a powder for oral solution in sachet supplied
in packs of 2, 50, 100, 200, 500 or 1000 sachets containing
white powder crystals. Each sachet contains one adult
dose. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Laboratorios Casen-Fleet S.L.U.
Autovía de Logroño Km 13,300
50180 UTEBO
Zaragoza
Spain
You can get more information on CitraFleet by
contacting the following e-mail address:
enquiries@casenfleet.com
AN AUDIO, LARGE PRINT OR BRAILLE VERSION OF
THIS LEAFLET IS AVAILABLE ON REQUEST.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Name of the
Member State

Name of the Medicinal
Product

Denmark
Finland

Citrafleet
CitraFleet, Jauhe oraaliliuosta
varten, annospussissa
France
CitraFleet, Poudre
pour solution buvable en
sachet-dose
Germany
CitraFleet Pulver zur
Herstellung einer Lösung zum
Einnehmen in einem Beutel
United Kingdom / Ireland CitraFleet, Powder for oral
solution in sachet
Italy
CitraFleet Polvere per
soluzione orale in bustina
Norway
Citrafleet, pulver til mikstur,
oppløsning i dosepose
Portugal
CitraFleet, Pó para solução
oral em saqueta
Spain
CitraFleet, Polvo para solución
oral
Sweden
CitraFleet, Pulver till oral
lösning i dospåse

This leaflet was last approved in 07/2010.

Very common (more than 1 in 10 patients):
Abdominal pain.
Common (less than 1 in 10, but more than 1 in 100
patients):
Abdominal distension (swollen abdomen), feeling thirsty,
anal discomfort and proctalgia (anal or bottom pain),
fatigue (tiredness), sleep disorders, headache, dry mouth,
nausea (feeling sick).
Uncommon (less than 1 in 100, but more than 1 in
1,000 patients):
Dizziness, vomiting (being sick), inability to control your
bowel movements (faecal incontinence).
Other side effects for which the frequency of
occurrence is not known:
Anaphylaxis or hypersensitivity which are serious allergic
reactions. You should go straight to hospital if you have
difficulty in breathing, start to look flushed, or have any
other symptom that you think might mean you are having
a serious allergic reaction.
Hyponatraemia (low levels of sodium in the blood),
epilepsy, convulsions (fits), orthostatic hypotension (low
blood pressure upon standing up which may make you feel
dizzy or unsteady), feeling of confusion, rashes including
urticaria (hives), pruritis (itching) and purpura (bleeding
under the skin).
Flatulence (wind) and pain.
This medicine is intended to give you very regular, loose
bowel movements, similar to diarrhoea. However, if after
A016011/04/uk

Expand view ⇕

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.

Hide
(web4)