Patient leaflet - Manxolax powder for oral solution

1. What Manxolax is and what it is used for

Manxolax is a powder that contains sodium picosulfate, a laxative that works by increasing the activity of the intestine.

Manxolax also contains magnesium citrate, another type of laxative that works by holding back fluid in the bowel to provide a wash-out effect. Manxolax is used in adults, adolescents and children from the age of 9 years to clear the bowel before an x-ray examination, endoscopy or surgery when judged clinical necessary.

2. What you need to know before you take Manxolax

Do not take Manxolax 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 reduced ability of the stomach to empty (gastric retention)
have stomach or intestinal ulcers
have severe problems with your kidneys
have a blockage or perforation of your bowel
are currently suffering from feeling or being sick
have a condition requiring abdominal surgery such as acute appendicitis
have been told by a doctor that you have congestive heart failure (the heart is unable to pump blood efficiently around the body)
have active inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
have been told by your doctor that you have too much magnesium in your blood
are very thirsty or may be severely dehydrated
have been told by your doctor that you have damaged muscles that are leaking their contents to your blood
have a condition called:
- ileus (intestinal blockage or failure of normal bowel movements),
- toxic colitis (damage to the intestinal wall)
- toxic megacolon (expansion of the large bowel)

In these conditions, the movement of the contents of the bowel may be impaired or prevented. Symptoms include nausea, vomiting, diarrhoea, abdominal pain, tenderness or swelling, colicky pain and fever.

Warnings and precautions

Talk to your doctor or pharmacist before taking Manxolax:

if you have recently had abdominal surgery
if you have a heart disease or kidney problems
if you have inflammatory bowel disease such as ulcerative colitis or Crohn’s Disease
if you are taking Manxolax prior to surgery involving the bowel

You should make sure to drink a sufficient amount of fluid and electrolytes during the course of the treatment. This is particularly important if you are younger than 18 years, elderly or physically weak.

If you have an early time of the day procedure, you might need to take the second dose during night and possible sleep disturbance may occur.

Other medicines and Manxolax:

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

It is especially important to tell your doctor if you are taking:

bulk forming laxatives e.g. bran
prescribed oral medication, especially if it is regularly prescribed as their effects may be modified e.g. contraceptives, antibiotics, antidiabetics, iron, penicillamine or antiepileptics. These medicines should be taken at least 2 hours before and not less than 6 hours after administration of Manxolax
prescribed medication that may affect water and/or electrolyte balance e.g. water tablets, steroids, lithium, digoxin, antidepressants, carbamazepine or anti-psychotics

Pregnancy and breast-feeding

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

Driving and using machines

Manxolax has no effect on the ability to drive and use machines. However, you should make sure that you have access to a toilet at all times following each dose, until the effect wears off.

Manxolax contain lactose and potassium

Each sachet contains 7.24 mmol (or 283 mg) potassium. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

This medicine also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Manxolax

Always take Manxolax exactly as your doctor has told you. Check with your doctor if you are not sure.

Manxolax powder should be dissolved in a cup of cold water (approximately 150ml). Stir for 2-3 minutes and then drink the solution. Sometimes the solution becomes hot as Manxolax dissolves. If this happens, wait until it cools sufficiently before drinking it.

Adults (including elderly) and children 9 and over:

The recommended dose is one sachet taken 10 to 18 hours before your procedure and one sachet taken 4 to 6 hours before your procedure. The first sachet taken, should be followed by at least five 250 ml drinks of clear liquids spread over several hours and the second sachet taken, should be followed by at least three 250 ml drinks of clear liquids spread over several hours.

You may drink clear liquids until 2 hours before your procedure.

You should expect frequent, loose bowel motions to start at any time after taking a dose of Manxolax. Please ensure that you have access to a toilet at all times following each dose, until the effects wear off.

In order to replace fluid lost from the body, it is important to drink plenty of clear liquids throughout the treatment with Manxolax until the bowel movements have ceased. In general, you should try to drink clear liquids when you are thirsty.

Clear liquids should include a variety of fruit juice without pulp, soft drinks, clear soup, tea, coffee (without milk, soy or cream) and water. Do not drink only water.

The success of your hospital procedure that you undergo depends on the bowel being as clear as possible. The procedure may need to be repeated if you do not achieve a clear bowel. You should always follow the dietary instructions given by your doctor.

If you take more Manxolax than you should

If you have taken more Manxolax than you should, contact your doctor immediately or go to the casualty department at your nearest hospital.

If you forget to take Manxolax

Please consult your doctor, nurse or pharmacist for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately in case of the following side effects as these might be severe:

allergic reaction including such as rash, redness of skin, hives, itching, swelling of the throat, and/or difficulty breathing (uncommon)
change in consciousness, such as loss or reduced level of consciousness (uncommon)
confusion/disorientation (uncommon)
syncope/fainting (uncommon)
dizziness/light-headedness (uncommon)
seizures (uncommon)
abdominal pain (common)
vomiting (common)

Other known side effects of Manxolax are described below:

Common (affects less than 1 in 10 but more than 1 in 100 patients):

Headache
Nausea

Uncommon (affects less than 1 in 100 but more than 1 in 1,000 patients):

Low levels of potassium in the blood (‘hypokalaemia’)
As the primary clinical effect, very regular, loose bowel movements, or diarrhoea may happen. However, if your bowel movements become troublesome or give you concern, you should contact your doctor

Rare (affects less than 1 in 1,000 but more than 1 in 10,000 patients):

Low levels of sodium in the blood (‘hyponatraemia’)
Ulcers of the bowel
Involuntary/accidental loss of bowel contents (‘anal incontinence’) •
Anal pain

If any of the side effects gets serious contact your doctor or nurse. If you notice any side effects not listed in this leaflet, please tell your doctor, nurse 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 via the Yellow Card Scheme at: 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.

5. How to store Manxolax

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

Do not store above 30°C.

Single use only. Discard any unused contents.

Do not use this medicine after the expiry date which is stated on the carton and sachet. 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 Manxolax contains

The active substances of 1 sachet are 10.0 mg sodium picosulfate, 3.5 g magnesium oxide heavy and 12.0 g anhydrous citric acid

The other ingredients are lactose anhydrous, polyvinyl pyrollidone (E1201), potassium carbonate (E501) and sucralose (E955).

What Manxolax looks like and contents of the pack

Your medicine is called Manxolax. It is a powder for oral solution. It is supplied in packs of 2 sachets.

Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL,

United Kingdom

Manufacturer

Manx Healthcare Limited

Taylor Group House, Wedgnock Lane

Warwick CV34 5YA