CitraFleet, Powder for oral solution in sachet

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Talk to your doctor or pharmacist 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).
• If severe or persistent abdominal pain and/or bleeding from the anus occurs after treatment with CitraFleet, notify your doctor. This is because CitraFleet has been associated in rare cases with intestinal inflammation (colitis).

You should keep in mind that after taking CitraFleet you will have frequent fluid stools. You should drink plenty of clear liquids (see Section 3) to replenish the loss of fluids and salts. Otherwise, you may suffer from dehydration and low blood pressure, which might cause you to faint.

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 acetylsalicylic acid 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.
• Penicillamine used to treat rheumatoid arthritis and other conditions.

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.

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

This medicine contains 5 mmol (or 195 mg) potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.

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,
• 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, or
• Both sachets in the morning of the day of the procedure. This regimen is only suitable when the procedure is planned in the afternoon/evening.

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.

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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances are sodium picosulfate 10.0 mg, light magnesium oxide 3.5 g, citric acid 10.97 g per sachet.
• The other ingredients are potassium hydrogen carbonate, saccharin sodium, lemon flavour (lemon flavour, maltodextrin, tocopherol E307). See section 2.

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.