CitraFleet® Powder for oral solution in sachet

Sodium picosulfate, light magnesium oxide, citric acid anhydrous

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

What is in this leaflet

1.    What CitraFleet is and what it is used for

2.    What you need to know before you take CitraFleet

3.    How to take CitraFleet

4.    Possible side effects

5.    How to store CitraFleet

6.    Contents of the pack and other 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.

CitraFleet is indicated in adults (including the elderly) aged 18 years and over.

2.    What you need to know before you take CitraFleet

Do not take CitraFleet if you:

•    are allergic to sodium picosulfate, magnesium oxide, citric acid or any of the other ingredients of this medicine (listed in section 6).

•    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 (rhabdo-myolysis).

•    have severe kidney problems or have been told by your doctor that you have too much magnesium in your blood (hypermagnesaemia).

Warnings and precautions

Talk to your doctor or pharmacist before taking CitraFleet.

•    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). Other medicines and CitraFleet

Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Do not drive, or use tools or machines, if you start to feel tired or dizzy after taking CitraFleet.

CitraFleet contains potassium

CitraFleet 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 this medicine exactly as your doctor or pharmacist has told you, as the hospital procedure may have to be repeated if you do not wash-out your bowels completely. Check with your doctor or pharmacist if you are not sure.

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.

It is important you follow a special (low solids) diet on the day before your procedure is planned. When you start taking the sachets of this medicine, you should not have any solid food until after your procedure is finished. You should always follow the dietary instructions given by your doctor. If you have any questions contact your doctor or pharmacist. 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.

The treatment can be administered in one of the following ways:

•    One sachet on the evening prior to the procedure and the second sachet in the morning of the day of the procedure, or

•    One sachet in the afternoon and the second sachet in the evening prior to the procedure. This schedule is recommended when the procedure is planned for early in the morning.

The time elapsed between the two sachets should be at least 5 hours.

Each sachet should be reconstituted in a cup of water. Do not further dilute the product by drinking liquid immediately after the intake of each sachet.

Wait about ten minutes after taking each sachet, and then drink approximately 1.5-2 litres of a variety of clear fluids, at a rate of approximately 250 ml (a small tumbler sized glass) to 400 ml (a large tumbler sized glass) every hour. Clear soups and/or balanced electrolyte solutions are recommended to avoid dehydration. It is advisable not to drink water alone.

After you have taken the second sachet and drunk the 1.5-2 litres of fluid, do not eat or drink anything for at least 2 hours prior to the procedure, or as instructed by your doctor.

Directions for use:

Adults (including the elderly) aged 18 years and over:

•    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.

If you take more CitraFleet than you should, talk to your doctor or pharmacist immediately.

4.    Possible side effects

Like all medicines, this medicine 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:

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

Abdominal pain.

Common (may affect up to 1 in 10 people):

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 (may affect up to 1 in 100 people):

Dizziness, vomiting (being sick), inability to control your bowel movements (faecal incontinence).

Other side effects for which the frequency of occurrence is not known (cannot be estimated from the available data): 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 taking this medicine your bowel movements become troublesome or give you concern, you should talk to your doctor.

Reporting of side effects

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 the 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 CitraFleet

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the sachet after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other 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, maltodex-trin, tocopherol E307). See section 2.

What CitraFleet looks like and contents of the pack

CitraFleet is a powder for oral solution in sachet supplied in packs of 2, 50, 50 (25x2), 100, 100 (50x2), 200, 200 (100x2), 500, 500 (250x2), 1000 sachets or 50 and 50 (25x2) sachets (hospital pack). The sachets contain white powder crystals with single dose of 15.08g. Each sachet contains one adult dose. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Casen Recordati, S.L.

Autovia de Logrono, Km 13,300 • 50180 Zaragoza - Spain

You can get more information on CitraFleet by contacting the following e-mail address: info@casenrecordati.com

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

Citrafleet

CitraFleet, Jauhe oraaliliuosta varten, annospussi

CitraFleet, Poudre pour solution buvable en sachet-dose

CitraFleet Pulver zur Herstellung einer Losung zum Einnehmen in einem Beutel

CitraFleet, Powder for oral solution in sachet

CitraFleet Polvere per soluzione orale in bustina

Citrafleet, pulver til mikstur, opplosning i dosepose

CitraFleet, Po para solugao oral em saqueta

CitraFleet, Polvo para solucion oral

CitraFleet, Pulver till oral losning i dospase

CitraFleet Pulver zur Herstellung einer Losung zum Einnehmen

CitraFleet, poeder voor drank

CitraFleet, poeder voor drank

CitraFleet, Por belsoleges oldathoz

CitraFleet, mixturuduft, lausn i skammtapoka

CitraFleet, poudre pour solution buvable

CitraFleet, (0,01 g + 3,50 g + 10,97 g)/saszetk§, proszek do sporzqdzania roztworu doustnego

Citrafleet prasek pro peroralni roztok

CitraFleet pulbere pentru solufle orala

CitraFleet, prasok na peroralny roztok vo vrecku

CitraFleet, Kovig yia noaipo SiaAupa as qiaKsAiaKO

This leaflet was last revised in 02/2016.

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