Citrafleet

Package leaflet: information for the patient

CitraFleet oral solution

sodium picosulfate / light magnesium oxide / citric acid
Read this leaflet carefully before taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What CitraFleet oral solution is and what it is used for
2. What you need to know before taking CitraFleet oral solution
3. How to take CitraFleet oral solution
4. Possible side effects
5. How to store CitraFleet oral solution
6. Contents of the pack and other information

1. What CitraFleet oral solution is and what it is used for

You are taking CitraFleet oral solution to clean your bowel (also known as intestine and colon) before undergoing any diagnostic procedure requiring a clean intestine, for example, a colonoscopy (a procedure that examines the inside of the bowel using a long flexible instrument inserted by the doctor through the anus) or radiographic examination. CitraFleet is an oral solution with a pleasant taste and smell resembling pomegranate. It contains two types of laxatives mixed in each bottle, which, when consumed, flush and clean the bowel. It is important that the bowel is empty and clean so that the doctor or surgeon can see clearly.
CitraFleet oral solution is indicated in adults (including elderly patients) aged 18 years and older.

2. What you should know before taking CitraFleet oral solution

Do not take CitraFleet oral solution if:

• you are allergic to sodium picosulfate, magnesium oxide, citric acid, or any of the other ingredients of this medicine (listed in section 6).
• you have congestive heart failure (the heart is unable to pump blood adequately throughout the body).
• you have a condition called gastric retention (the stomach does not empty properly).
• you have a stomach ulcer (sometimes called gastric or duodenal ulcer).
• you have intestinal obstruction or impaired normal intestinal motility (sometimes called ileus).
• your doctor has told you that you have a damaged intestinal wall (also known as toxic colitis).
• you have an enlarged colon (also known as toxic megacolon).
• you have recently become ill or feel unwell (nausea or vomiting).
• you are very thirsty or think you may be severely dehydrated.
• your doctor has told you that you have abdominal swelling due to fluid retention (called ascites).
• you have recently undergone abdominal surgery, e.g. for appendicitis.
• you may have a perforated/damaged or blocked intestine (intestinal perforation or obstruction).
• your doctor has told you that you have active inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis).
• your doctor has told you that you have damaged muscles, causing their contents to be released into the blood (rhabdomyolysis).
• you have severe kidney problems or your doctor has told you that you have too much magnesium in your blood (hypermagnesemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking CitraFleet oral solution if:

• you have recently undergone intestinal surgery.
• you have kidney or heart problems.
• you have fluid and/or electrolyte imbalance (sodium or potassium), or you are taking medicines that may affect your body’s fluid and/or electrolyte balance (sodium or potassium), such as diuretics, corticosteroids, or lithium.
• you have epilepsy or a history of seizures.
• you have low blood pressure (hypotension).
• you are thirsty or think you may be mildly or moderately dehydrated.
• you are elderly or physically frail.
• you have previously had low levels of sodium or potassium in your blood (also known as hyponatremia or hypokalemia).
• you experience severe or persistent abdominal pain and/or rectal bleeding after treatment with CitraFleet, inform your doctor. This is because CitraFleet has been rarely associated with intestinal inflammation (colitis).

Please keep in mind that after taking CitraFleet oral solution, you will have frequent loose stools. You must drink plenty of clear fluids (see section 3) to replace lost fluids and salts. Otherwise, you may become dehydrated and develop low blood pressure, which could cause you to faint.

Other medicines and CitraFleet oral solution
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
CitraFleet oral solution may affect or be affected by other medicines taken at the same time. If you are taking a medicine of the type listed below, your doctor may prescribe a different medicine or adjust your dose. Therefore, if you have not already discussed this with your doctor, contact your doctor for instructions:

• Oral contraceptives, as their effects may be reduced.
• Medicines for diabetes or medicines for treating epilepsy (seizures), as their effects may be reduced.
• Antibiotics, 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 conditions 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 amitriptyline, and selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, paroxetine, and citalopram, used to treat depression and anxiety.
• Antipsychotic medicines, 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 disorders.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Do not drive or operate tools or machinery if you begin to feel tired or experience dizziness after taking CitraFleet oral solution.

CitraFleet oral solution contains sodium, sodium metabisulfite (E 223), sodium methylhydroxybenzoate (E 219), ethanol, and sodium propylhydroxybenzoate (E 217)
This medicine contains sodium metabisulfite (E 223). Rarely, it may cause severe hypersensitivity reactions and bronchospasm.
This medicine contains sodium methylhydroxybenzoate (E 219) and sodium propylhydroxybenzoate (E 217). It may cause allergic reactions (including delayed reactions).
This medicine contains 66 mg of alcohol (ethanol) per bottle. The amount in 160 ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains 3.4 g of sodium (the main component of table salt) per bottle. This corresponds to 173.6% of the maximum recommended daily dietary intake for an adult.

3. How to take CitraFleet oral solution

Take this medicine exactly as instructed by your doctor or pharmacist, because if the bowel is not completely cleaned, the hospital procedure may need to be repeated. If you have any doubts, consult your doctor or pharmacist.
Be prepared for frequent bowel movements with loose stools after taking each dose of CitraFleet oral solution. This is normal and indicates that the medicine is working. You should ensure easy access to a toilet until these effects subside.
It is important to follow a special diet (low in fibre) the day before the procedure. From the time you start taking this medicine, you must not eat solid foods until after the procedure is completed. You must always follow your doctor’s dietary instructions. If you have any questions, contact your doctor or pharmacist.
Unless otherwise instructed by your doctor, do not take more than the recommended dose within any 24-hour period.

Treatment schedule
You should have received two bottles of CitraFleet oral solution. Each bottle contains one adult dose.
CitraFleet oral solution is ready to drink directly from the bottle. It does not need to be mixed or diluted.
The treatment can be administered in one of the following ways:

• One bottle the evening before the procedure and the second bottle on the morning of the procedure.
• One bottle in the afternoon and the second bottle in the evening before the procedure. This schedule is recommended when the procedure is scheduled for early morning, or
• Both bottles on the morning of the procedure. This schedule is suitable only when the procedure is scheduled for the afternoon/evening.

The interval between the two bottles must be at least 5 hours.
Do not further dilute the product by drinking fluids immediately after taking each bottle.
Wait approximately 10 minutes after taking each bottle, then drink about 1.5–2 litres of clear fluids, at a rate of 250 ml (a small glass) to 400 ml (a large glass) per hour. Clear broth and/or balanced electrolyte solutions are recommended to prevent dehydration. Drinking water alone is not advised.
After taking the second bottle and consuming 1.5–2 litres of fluids, do not eat or drink anything else for at least 2 hours before the procedure, or as directed by your doctor.

If you take more CitraFleet oral solution than you should, contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone experiences them. The known side effects of CitraFleet oral
solution are described below and listed according to how often 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 (bloating), feeling of thirst, anal discomfort and
proctalgia (pain in the anus or buttocks), fatigue (tiredness), sleep disturbances, headache, dry mouth, nausea (feeling unwell).
Uncommon (may affect up to 1 in 100 people):
Dizziness, vomiting (being sick), inability to control bowel movements
(fecal incontinence).
Other side effects for which frequency is unknown (frequency cannot be estimated from the available data):
Anaphylaxis or hypersensitivity, which are severe allergic reactions. If you have difficulty breathing, develop redness or any other symptom you think may indicate a severe allergic reaction, go to hospital immediately.
Hyponatremia (low sodium levels in the blood), hypokalemia (low potassium levels in the blood), epilepsy, seizures, orthostatic hypotension (drop in blood pressure upon standing, which may cause dizziness or instability), confusion, skin rashes such as urticaria, pruritus and purpura (bleeding under the skin).
Flatulence and pain.
This medicine is intended to cause very regular bowel movements, with soft stools resembling diarrhoea. However, if after taking this medicine your bowel movements become bothersome or cause concern, speak to your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CitraFleet oral solution

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the bottle after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help
protect the environment.

6. Package contents and other information

What CitraFleet oral solution contains

• The active substances are sodium picosulfate 10.0 mg, light magnesium oxide 3.5 g, citric acid 10.97 g per bottle (160 ml).
• The other components are malic acid, sodium metabisulfite (E 223), sodium methylhydroxybenzoate (E 219), sodium propylhydroxybenzoate (E 217), sucralose, flavour masking agent (sweetness modulator), pomegranate flavour (containing ethanol and propylene glycol (E 1520)), sodium hydroxide (for pH adjustment) and purified water. See section 2.

Description of the appearance of CitraFleet oral solution and contents of the pack
CitraFleet is a transparent, colourless or slightly yellowish oral solution with a pomegranate flavour, supplied in:

• packs containing 2, 20, 40 or 80 bottles, or
• multipacks containing 20 (10x2), 40 (20x2) or 80 (40x2) bottles. The bottles contain a single dose of 160 ml. Each bottle contains one adult dose. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Casen Recordati, S.L.
Autovía de Logroño Km 13,300
50180 Utebo - Zaragoza
Spain
Sole Distributor:
RECORDATI Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1 – 20148 Milano
For further information on CitraFleet oral solution, please contact the following
email address: [email protected]
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
CitraFleet: France, Finland, Germany, Greece, Ireland, Italy, Norway, Poland,
Portugal, Spain, Sweden.

Patient Information Leaflet

CitraFleet, Effervescent Powder for Oral Solution in Sachet

Sodium picosulfate, light magnesium oxide, citric acid
Please read this leaflet carefully before taking this medicine because
it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. However, take CitraFleet by carefully following these instructions to achieve the best results.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What CitraFleet is and what it is used for
2. What you need to know before taking CitraFleet
3. How to take CitraFleet
4. Possible side effects
5. How to store CitraFleet
6. Package contents and other information

2. What CitraFleet is and what it is used for

CitraFleet is taken to clean the bowel before undergoing any diagnostic procedure requiring a clean intestine, for example, a colonoscopy (a procedure that examines the inside of the bowel using a long flexible instrument inserted by the doctor through the anus) or radiographic examination. CitraFleet is a powder with a lemon flavour and odour. It contains two types of laxatives mixed in each sachet, which, when dissolved in water and drunk, wash and clean the bowel. It is important that the bowel is empty and clean so that the doctor or surgeon can see clearly.
CitraFleet is indicated in adults (including the elderly) aged 18 years and over.

4. What you need to know before taking 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).
• you suffer from congestive heart failure (the heart is unable to adequately pump blood throughout the body).
• you have a condition called gastric retention (the stomach does not empty properly).
• you have a stomach ulcer (sometimes called gastric or duodenal ulcer).
• you have intestinal blockage or impaired normal intestinal motility (sometimes referred to as ileus).
• your doctor has told you that you have damage to the intestinal wall (also known as toxic colitis).
• you have an enlarged colon (also known as toxic megacolon).
• you have recently experienced nausea or vomiting.
• you are very thirsty or think you may be severely dehydrated.
• your doctor has told you that you have abdominal swelling due to fluid retention (called ascites).
• you have recently undergone abdominal surgery, e.g. for appendicitis.
• you may have a perforated, damaged, or blocked intestine (intestinal perforation or obstruction).
• your doctor has told you that you have active inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).
• your doctor has told you that you have damaged muscles, causing their contents to be released into the blood (rhabdomyolysis).
• you have severe kidney problems or your doctor has told you that you have too much magnesium in your blood (hypermagnesemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking CitraFleet if:

• you have recently undergone intestinal surgery.
• you have kidney or heart problems.
• you have a fluid and/or electrolyte imbalance (sodium or potassium), or you are taking medicines that may affect your body’s fluid and/or electrolyte balance (sodium or potassium), such as diuretics, corticosteroids, or lithium.
• you have epilepsy or a history of seizures.
• you have low blood pressure (hypotension).
• you are thirsty or think you may be mildly or moderately dehydrated.
• you are elderly or physically frail.
• you have previously had low levels of sodium or potassium in your blood (also known as hyponatremia or hypokalemia).

Please keep in mind that after taking CitraFleet, you will experience frequent liquid bowel movements. You must
drink plenty of clear fluids (see section 3) to replace lost fluids and salts.
Otherwise, you may become dehydrated and develop low blood pressure, which could cause you
to faint.
Other medicines and CitraFleet
Inform your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines.
CitraFleet may interact with or be affected by other medicines taken concomitantly.
If you are taking a medicine of the type listed below, your doctor may
prescribe a different medicine or adjust your dose. Therefore, if you have not
already discussed this with your doctor, contact your doctor for instructions:

• Oral contraceptives, as their effects may be reduced.
• Medicines for diabetes or medicines for treating epilepsy (seizures), as their effects may be reduced.
• Antibiotics, 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 conditions 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 amitriptyline, and selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, paroxetine, and citalopram, used to treat depression and anxiety.
• Antipsychotic medicines, 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 disorders.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Do not drive or operate tools or machinery if you begin to feel tired or experience dizziness after taking CitraFleet.
CitraFleet contains potassium and sodium
This medicine contains 5 mmol (or 195 mg) of potassium per sachet. This should be taken into
account in patients with impaired kidney function or those on a low-potassium diet.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e.
essentially "sodium-free".

5. How to take CitraFleet

Take this medicine exactly as instructed by your doctor or pharmacist, because if the bowel is not completely emptied, the hospital procedure may need to be repeated. If you have any doubts, consult your doctor or pharmacist.
Be prepared for frequent bowel movements with loose stools following the intake of each dose of CitraFleet. This is normal and indicates that the medicine is working. You should ensure access to a toilet until these effects have passed.
It is important to follow a special low-residue diet the day before the procedure. From the time you start taking the sachets of this medicine, you must not eat solid foods until after the procedure is completed. You must always follow your doctor’s dietary instructions. If you have any questions, contact your doctor or pharmacist.
Unless otherwise instructed by your doctor, do not take a higher dose than recommended within any 24-hour period.

Treatment schedule
You should have received two sachets of CitraFleet. Each sachet contains one adult dose.
The treatment can be administered in one of the following ways:

• One sachet the evening before the procedure and the second sachet on the morning of the day of the procedure.
• One sachet in the afternoon and the second sachet the evening before the procedure. This schedule is recommended when the procedure is scheduled for early morning, or
• Both sachets on the morning of the day of the procedure. This schedule is only suitable when the procedure is scheduled for the afternoon/evening.

There must be an interval of at least 5 hours between the two sachets.
Each sachet must be reconstituted in a glass of water. Do not further dilute the product by drinking fluids immediately after taking each sachet.
Wait approximately 10 minutes after taking each sachet, then drink about 1.5–2 litres of various clear fluids, at a rate of 250 ml (a small glass) to 400 ml (a large glass) per hour. Broth and/or balanced electrolyte solutions are recommended to prevent dehydration. It is advised not to drink plain water alone.
After taking the second sachet and drinking 1.5–2 litres of fluids, do not eat or drink anything else for at least 2 hours before the procedure, or as directed by your doctor.

INSTRUCTIONS FOR USE
Adults (including elderly) aged 18 years and over.

• Step 1 – Mix the contents of 1 sachet into a glass of cold tap water (approximately 150 ml).
• Step 2 – Stir for 2–3 minutes. If the solution warms during mixing, wait until it has cooled before drinking. Once the solution is ready, drink it immediately. The solution will appear cloudy.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone will experience them. The known side effects of CitraFleet are
described below and listed according to how often 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 (bloating), feeling of thirst, anal discomfort and
proctalgia (anal or buttock pain), fatigue (tiredness), sleep disturbances, headache, dry mouth, nausea.
Uncommon (may affect up to 1 in 100 people):
Dizziness, vomiting, inability to control bowel movements (fecal incontinence).
Other side effects for which frequency is unknown (frequency cannot be estimated from the available data):
Anaphylaxis or hypersensitivity, which are severe allergic reactions. If you have difficulty breathing, develop redness or any other symptom you think could indicate a severe allergic reaction, you must go to hospital immediately.
Hyponatremia (low sodium levels in the blood), hypokalemia (low potassium levels in the blood), epilepsy, seizures, orthostatic hypotension (drop in blood pressure upon standing, which may cause dizziness or instability), confusion, skin rashes such as urticaria, pruritus and purpura (bleeding under the skin).
Flatulence and pain.
This medicine is intended to cause very frequent bowel movements, with soft stools resembling diarrhea. However, if after taking this medicine bowel movements become bothersome or cause concern, speak to your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
www.aifa.gov.it/content/segnalazioni-reazioni-avverse . 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 stated on the sachet after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help
protect the environment.

6. Package contents and other information

What CitraFleet contains

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

Description of the appearance of CitraFleet and the contents of the pack
CitraFleet is an oral solution powder in sachets, 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 crystals of powder weighing 15.08 g each. Each sachet contains one adult dose. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Casen Recordati, S.L.
Autovía de Logroño Km 13,300
50180 Utebo - Zaragoza
Spain

Marketing Authorisation Holder:
RECORDATI Industria Chimica e Farmaceutica S.p.A.
Via M. Civitali, 1 – 20148 Milano

For further information on CitraFleet, please contact the following email address:
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

| Member State | Name of the medicinal product | |------------------|-----------------------------------| | Denmark | Citrafleet | | Finland | CitraFleet, Jauhe oraaliliuosta varten, annospussi | | France | CitraFleet, Poudre pour solution buvable en sachet-dose | | Germany | CitraFleet Pulver zur Herstellung einer Lösung zum Einnehmen in einem Beutel | | United Kingdom / Ireland / Malta | 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 | | Austria | CitraFleet Pulver zur Herstellung einer Lösung zum Einnehmen | | Belgium | CitraFleet, poeder voor drank | | Netherlands | CitraFleet, poeder voor drank | | Hungary | CitraFleet, Por belsőleges oldathoz | | Iceland | CitraFleet, mixtúruduft, lausn í skammtapoka | | Luxembourg | CitraFleet, poudre pour solution buvable | | Poland | CitraFleet, (0.01 g + 3.50 g + 10.97 g)/saszetkę, proszek do sporządzania roztworu doustnego | | Czech Republic | Citrafleet prášek pro perorální roztok | | Romania | CitraFleet pulbere pentru soluţie orală | | Slovakia | CitraFleet, prášok na perorálny roztok vo vrecku | | Greece / Cyprus | CitraFleet, Κόνις για πόσιμο διάλυμα σε φακελίσκο |