Phosphates Enema BP Formula B (Short Tube)

• 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 Phosphates Enema BP Formula B is and what it is used for
2. What you need to know before you use Phosphates Enema BP Formula B
3. How to use Phosphates Enema BP Formula B
4. Possible side effects
5. How to store Phosphates Enema BP Formula B
6. Contents of the pack and other information

• you are allergic to sodium dihydrogen phosphate dihydrate or disodium phosphate dodecahydrate or any of the other ingredients of this medicine (listed in section 6)
• you have a swollen large bowel (also known as megacolon)
• you have a narrowing or incomplete opening of the anus or rectum
• you have a blockage of the lower colon (Hirschsprung’s disease)
• you have a suspected blockage of the gut
• you have blockage of the gut or failure of normal bowel movements (sometimes called paralytic ileus)
• you have been told by your doctor that you may have:
  • appendicitis
  • a pierced/damaged or blocked gut
  • an active inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis)
• you have bleeding of the back passage
• you have congestive heart failure (your heart is unable to properly pump blood around the body)
• you have recently been sick or feel sick or thirsty
• the patient is under 3 years of age
• you have kidney problems.

Talk to your doctor or pharmacist before using Phosphates Enema BP Formula B if you:

• suffer from electrolyte disturbances (change of salt levels in the body such as low calcium, low potassium, high phosphate or high sodium levels)
• have a blockage in the gut (bowel obstruction)
• are elderly, frail (debilitated) or have a neurological disorder such as paralysis of the lower part of the body or a stroke
• are taking other medicines
• have a heart or kidney condition
• have uncontrolled blood pressure
• suffer from ascites (excess fluid in the belly)
• suffer from rectal ulceration (ulceration of the back passage) or fissures (tears in the skin of the back passage)
• have had a colostomy
• are pregnant or breast-feeding.

Do not give this medicine to children under 3 years of age because it is unlikely to be safe.

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

• medicines for the treatment of high blood pressure (hypertension) such as angiotensin-converting enzyme-inhibitors (ACE-inhibitors) (e.g. enalapril, ramipril, lisinopril) and angiotensin receptor blockers (e.g. losartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan, valsartan) or angina (calcium channel blockers).
• medicines to empty the bladder (diuretics).
• certain medicines for mental disorders (lithium).
• any other medicines that could make you dehydrated or alter the salt levels (potassium, sodium, phosphate or water) in your body, known as your electrolyte balance.
• certain medicines for cleaning the bowel (sodium phosphates).
• medicines that alter the rhythm of your heart (prolong the QT interval); such as amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide.
• non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin or ibuprofen.

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.

Whilst there are no direct effects of Phosphates Enema BP Formula B on your ability to drive or use machinery, you should remain near toilet facilities after using this medicine.

Phosphates Enema BP Formula B contains benzalkonium chloride. This may cause irritation.

Use one enema no more than once daily or as directed by your doctor.

Reduce the dose in proportion to the child's weight, i.e. for a 35 kg (5½ stone) child give half the contents of the bottle. If unsure, check the dose with your doctor or pharmacist.

Do not administer to children under 3 years of age.

For rectal use only

Unless directed by your doctor, Phosphates Enema BP Formula B should not be used for more than one week. Administration of more than one enema in a 24-hour period can be harmful.

Phosphates Enema BP Formula B is available in a long tube version and a short tube version, which can be identified on the carton. The administration is different betweeen the versions as indicated below.

SHORT TUBE VERSION

1. Warm the bottle before use, in warm water.
2. Remove the cap. If required, apply a lubricant (e.g. petroleum jelly) to the nozzle.
3. Lie on a towel, on your side with both knees bent towards the chest.
4. Insert the full length of the nozzle into the rectum and squeeze the bottle gently until empty. For a young child, the nozzle should only be inserted to half its length. Do not use force especially in children, the elderly or frail, if the lower body is paralysed, or in stroke patients.
5. Put the used bottle back into the carton for disposal.

LONG TUBE VERSION

1. Warm the bottle before use, in warm water.
2. Remove the cap, and screw on the applicator tube. If required, apply a lubricant (e.g. petroleum jelly) to the nozzle.
3. Lie on a towel, on your side with both knees bent towards the chest.
4. Insert the full length of the nozzle into the rectum and squeeze the bottle gently until empty. For a young child, the nozzle should only be inserted to half its length. Do not use force especially in children, the elderly or frail, if the lower body is paralysed, or in stroke patients.
5. Put the used bottle back into the carton for disposal.

If rectal bleeding is noticed, administration must be discontinued immediately, and you must contact a doctor immediately.

After using the enema, if you have not had a bowel movement (usually within 5 to 10 minutes), contact your doctor for advice. Do NOT use another enema.

Drink plenty of clear fluids e.g. water, clear soups, tea or diluted cordials/fruit juice without pulp (but not red or purple coloured juices) to avoid dehydration. In general, you should drink 250 ml (a small tumbler-sized glass) every hour until the effect of the Phosphates Enema BP Formula B has worn off. After this, drink clear fluids, preferably water, to satisfy your thirst until after your hospital procedure, or as directed by your doctor.

If you use more Phosphates Enema BP Formula B than you should or swallow some by mistake, seek medical advice.

Very common: may affect more than 1 in 10 people

• high levels of phosphorus in the blood (hyperphosphataemia)
• anal discomfort and pain
• abdominal pain
• abdominal cramping
• vomiting
• rectal irritation (redness, itching, pain, discomfort)

Common: may affect up to 1 in 10 people

• low levels of calcium in the blood (hypocalcaemia)
• dizziness
• nausea
• diarrhoea
• general malaise
• chills

Very rare: may affect up to 1 in 10 000 people

• blister
• pruritus
• stinging

Not known: frequency cannot be estimated from the available data

• hypersensitivity: allergic reactions (with or without rash)
• high levels of sodium in the blood (hypernatremia)
• low levels of potassium in the blood (hypokalaemia)
• dehydration
• metabolic acidosis (when acids build up in your body)
• muscle twitches and spasms due to changes in the amounts of salts (electrolytes) in the blood.

Long term use of the enema may irritate the anal passage, or the bowel may become lazy. It may also affect the amount of salts in your blood, your doctor may check for this.

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 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 dihydrogen phosphate dihydrate 10% w/v and disodium phosphate dodecahydrate 8% w/v
• The other ingredients are disodium edetate, benzalkonium chloride and purified water

The rectal solution is a clear liquid in a plastic bottle for single dose use.