Powder for oral solution in sachet Sodium picosulphate
, light magnesium oxide and citric acid

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What CitraFleet is and what it is used for 
2. What you need to know before taking Citra Fleet 
3. How to take Citra Fleet 
4. Possible side effects 
5. How to store CitraFleet 
6. Contents of the packaging and other information 

1. What CitraFleet is and what it is used for

You take CitraFleet to clean the intestines (small and large intestine) before undergoing a diagnostic examination that requires a clean bowel, such as a colonoscopy (an examination that looks at the inside of the intestine using a long, flexible instrument that the doctor inserts through the anal opening) or X-ray examination. CitraFleet is a powder that smells and tastes like lemon. It contains two types of laxatives in each sachet. When the powder is dissolved in water and drunk, it rinses out and cleanses the intestines. It is important to have an empty and cleansed bowel so that the doctor or surgeon can see clearly.

CitraFleet is intended for use by adults (including the elderly) who are 18 years of age or older.

Sodium picosulphate, light magnesium oxide, and citric acid contained in CitraFleet may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before taking Citra Fleet

Do not take CitraFleet if you:

  • is allergic to sodium picosulphate, magnesium oxide, citric acid, or any of the other ingredients of this medicine (listed in section 6).
  • have chronic heart failure (your heart can not pump around the blood in the body properly).
  • have a condition called gastric retention (your stomach is not emptied properly).
  • have stomach ulcers (sometimes called ventricular or duodenal ulcers ).
  • have bowel obstruction or non-functioning normal bowel movements(sometimes called bowel movements).
  • have been told by your doctor that you have a damaged intestinal wall (also called toxic colitis ).
  • has a swollen colon (also called toxic megacolon).
  • recently vomited or felt unwell.
  • is very thirsty or thinks you may be severely dehydrated .
  • have been told by your doctor that you have a swollen abdomen due to an increased amount of fluid in the abdominal cavity ( called ascites ).
  • has recently undergone abdominal surgery , e.g. appendix surgery.
  • may have a perforated/damaged or blocked intestine.
  • have been told by your doctor that you suffer from an active inflammatory bowel disease (for example, Crohn’s disease or ulcerative colitis ).
  • have been told by your doctor that you have damaged muscles and that their contents are leaking into the blood ( rhabdomyolysis ).
  • have severe kidney problems or have been told by your doctor that you have too much magnesium in your blood ( hypermagnesemia ).

Warnings and cautions

Talk to your doctor or pharmacist before taking CitraFleet if you:

  • has recently undergone bowel surgery .
  • have kidney or heart problems.
  • have water and/or electrolyte balance ( sodium or potassium ) or take medicines that can affect water and/or the electrolyte balance ( sodium or potassium ) in the body, such as diuretics, corticosteroids, or lithium.
  • have had epilepsy or a previous seizure.
  • have low blood pressure ( hypotension ).
  • are thirsty or think you may be mild to moderately dehydrated.
  • is elderly or physically weak .
  • have ever had low sodium or potassium in their blood (also called hyponatremia or hypokalaemia ).

Be prepared for frequent loose stools after taking CitraFleet. You should drink copious amounts of clear liquids (see section 3) to compensate for the loss of fluids and salts. Otherwise, you may suffer from dehydration and low blood pressure, which can cause fainting.

Other medicines and CitraFleet

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

CitraFleet can affect or be affected by other medicines if you take them at the same time. If you are taking any of the medicines listed below, your doctor may decide that you should be given another medicine or that your dose should be adjusted. Therefore, if you have not already talked to your doctor about these, go back and ask him/her what to do:

  • Oral contraceptives, as their effect may be reduced.
  • Diabetes drugs or drugs used to treat epilepsy (seizures), as their effect may be reduced.
  • Antibiotics, as their effect may be reduced.
  • Other laxatives, including bran.
  • Diuretic agents such as furosemide used to control fluid retention in the body.
  • Corticosteroids are, e.g. prednisone, which is used to treat inflammation in diseases such as arthritis, asthma, hay fever, dermatitis, and inflammatory bowel disease.
  • Digoxin, which is used to treat heart failure.
  • Non-steroidal anti-inflammatory drugs ( NSAIDs ), such as acetylsalicylic acid and ibuprofen, are used to treat pain and inflammation.
  • Tricyclic antidepressant drugs, such as imipramine and amitryptiline, and selective serotonin reuptake inhibitors ( SSRIs ), such as fluoxetine,paroxetine, and citalopram, are used to treat depression and anxiety.
  • Antipsychotic drugs, such as haloperidol, clozapine, and risperidone, are used to treat schizophrenia.
  • Lithium used to treat manic depression (bipolar disorder).
  • Carbamazepine used to treat epilepsy.
  • Penicillamine used to treat chronic rheumatoid arthritis and other medical conditions.

Pregnancy, breastfeeding, 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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

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

CitraFleet contains potassium and sodium

This medicine contains 5 mmol (or 195 mg) potassium per sachet. This should be considered by patients with impaired renal function or patients on a low-potassium diet.

This medicine contains less than 1 mmol (23 mg) sodium per sachet, ie essentially ‘sodium-free ‘.

3. How to take Citra Fleet

Always take this medicine exactly as your doctor or pharmacist has told you, as the test may need to be repeated if you do not flush your bowels completely. Ask your doctor or pharmacist if you are unsure.

Be prepared for frequent and loose bowel movements at any time after taking a dose of CitraFleet. This is normal and indicates that the medicine is working. It is wise to make sure that you have access to a toilet until the effect has subsided.

It is very important that you adhere to a special diet (low percentage of solid foods) the day before your planned examination. From the time you start taking CitraFleet until the end of the study, you should avoid solid foods. You should always follow your doctor’s dietary instructions. If you have any further questions, ask your doctor or pharmacist.

Unless your doctor tells you otherwise, do not take more than the recommended dose over a 24-hour period.

Treatment plan

You should have received two sacks of CitraFleet. Each sachet contains an adult dose.

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

  • One sachet in the evening before the examination and the other sachet in the morning on the same day as the examination,
  • One sachet in the afternoon and the other sachet in the evening the day before the examination. This method is recommended when the examination is to be performed early in the morning, or
  • Both sachets are taken in the morning on the same day as the examination is to be done. This method is only suitable when the examination is planned for the afternoon/evening.

The two sachets should be taken at least five hours apart.

Mix the contents of a sachet in a glass of water. Do not dilute the product further by drinking immediately after taking a sachet.

Wait about ten minutes after taking a sachet and then drink about 1.5-2 liters of different clear drinks. Drink about 2.5 dl (a small drinking glass) to 4 dl (a large drinking glass) per hour. Clear soups and/or balanced electrolyte solutions (sports drinks) are recommended to avoid dehydration. It is not advisable to drink water alone.

After taking the second sachet and drinking 1.5-2 liters of fluid, you must not eat or drink anything else for at least two hours before the examination, or according to your doctor’s instructions.

INSTRUCTIONS FOR USE :

ulna (including the elderly) aged 18 years or older :

  • Step 1 – mix the contents of a sachet in a glass of cold tap water (about 150 ml).
  • Step 2 – Stir for 2 to 3 minutes. If it gets hot when you stir it, wait until it has cooled before drinking the whole solution. When the solution is ready, drink it immediately. The solution will look cloudy.

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 reported in descending frequency according to their occurrence:

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

Abdominal pain.

Common (may affect up to 1 in 100 people):

Abdominal tension, thirst, anal discomfort, and proctalgia (pain in the rectum and anus), fatigue (fatigue), sleep disorders, headaches, dry mouth, and nausea.

Uncommon (may affect up to 1 in 1,000 people):

Dizziness, vomiting, inability to control bowel movements (stool incontinence).

Other side effects where the frequency is not known (can not be calculated from the available data):

Anaphylaxis or hypersensitivity is severe allergic reactions. You should go to the hospital immediately if you have difficulty breathing, start to turn red in the face, or have other symptoms that you think may cause you to have a severe allergic reaction.

Hyponatremia (low levels of sodium in the blood), hypokalaemia (low levels of potassium in the blood), epilepsy, convulsions (seizures), orthostatic low blood pressure (low blood pressure when you get up which can make you feel dizzy and unstable), feeling confused, rash including hives, itching and purpura (bleeding under the skin).

Flatulence (gas formation) and pain.

The purpose of this medicine is for you to have very regular, loose bowel movements similar to diarrhea. However, if your bowel movements become awkward or if they worry you after taking this medicine, 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

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. The expiration date is the last day of the specified 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. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and the contents of the pack

CitraFleet is a powder for oral solution in a sachet that is available in packs of 2, 50, 50 (25×2), 100, 100 (50×2), 200, 200 (100×2), 500, 500 (250×2), or 1000 sachets containing a white crystalline powder. Each sachet contains an adult dose of 15.08 g. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Caseen Recordati, SL

Autovia de Logroño Km 13,300

50180 Utebo

Zaragoza

Spain

Agent:

Recordati AB,

Tel: +46 8 545 80 230

You can get more information about CitraFleet by writing to the following email address: info@casenrecordati.com

This medicinal product is authorized under the European Economic Area under the names:

Name of Member State Name of the medicine
Denmark Citrafleet
Finland CitraFleet, Jauhe oraaliliuosta varten, annospussissa
France CitraFleet, Powder for buvable solution in sachet dose
Germany CitraFleet powder for making a solution for taking in a bag
Great Britain / Ireland / Malta CitraFleet, Powder for oral solution in sachet
Italy CitraFleet Powder for oral solution in the bust
Norway Citrafleet, powder for oral solution, solution in a sachet
Portugal CitraFleet, Po for oral solution in the bag
Spain CitraFleet, Polvo for oral solution
Austria CitraFleet Powder for the manufacture of a solution for ingestion
Belgium CitraFleet, powder for beverage
Holland Citrafleet, powder for beverage
Hungary CitraFleet, Por belsőleges oldathoz
Iceland CitraFleet, oral powder, sachet solution
Luxembourg CitraFleet, powder for buvable solution
Poland CitraFleet, (0,01 g + 3,50 g + 10,97 g)
Czech Republic Citrafleet prášek pro perorální roztok
Romania CitraFleet puller for oral solution
Slovakia CitraFleet works in the interior of the city
Greece / Cyprus CitraFleet, I’m not sure if I’m going to

Muhammad Nadeem

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