Consumer medicine information

Klyx Enema

Docusate sodium; Sorbitol solution (70 per cent) (crystallising)

BRAND INFORMATION

Brand name

Klyx Enema

Active ingredient

Docusate sodium; Sorbitol solution (70 per cent) (crystallising)

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Klyx Enema.

What is in this leaflet

This leaflet answers some common questions about KLYX Enema. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about taking this medicine, ask your doctor, nurse or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What KLYX Enema is used for

KLYX Enema is used when oral therapies are not suitable, for:

  • Treatment of faecal impaction or constipation
  • Colon evacuation prior medical procedures.

It acts by increasing water content in the stools, thereby softening hard stools, facilitating opening of the bowels and cleansing the bowel area. It starts to work approximately 5-20 minutes after application.

If you have constipation it is important to also drink plenty of water and to increase fibre in diet, except if the constipation is caused by certain medications such as codeine.

Before you use KLYX Enema

Do not use KLYX Enema if:

  • you are hypersensitive (allergic) to the active substances or any other ingredients found in KLYX Enema
  • you are suffering from active inflammatory bowel disease
  • you have intestinal bleeding (including haemorrhoids or anal fissures)
  • you are suffering from abdominal pain of unknown origin
  • you have a bowel obstruction.

Take special care with KLYX Enema

KLYX Enema should only be used on a short-term basis. Do not use for more than one week. KLYX Enema should not be used regularly. Regular use may cause irritation in the bowel, lead to dehydration and cause chemical imbalances in your blood.

Prolonged use of laxatives is undesirable and may lead to dependence.

Seek medical advice if your constipation persists.

Tell your doctor if you are taking other medications or have a particular diet or allergies to any, foods, preservatives or dyes.

Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. No untoward effects on the fetus have been seen.

Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. No untoward effects of KLYX Enema have been seen in the suckling infant.

Driving and using machinery
KLYX Enema is not expected to affect your ability to drive a car or operate machinery.

After using KLYX Enema, ensure you have an available toilet nearby.

How to use KLYX Enema

KLYX enema is used rectally as directed by your health professional. If requested by your healthcare professional KLYX enema can be repeated once a day for up to maximum of 2 days for bowel cleansing and 6 days for difficult to treat constipation.

How much to use

Adults and children 12 years and over: Normally 120 mL is effective.

Children from 4 to 6 years:
Normally 60 mL (half of the contents of KLYX enema 120 mL) is effective.

Children from 7 to 11 years:
60 mL (half of the contents of KLYX Enema 120 mL) may be effective. Up to one KLYX 120 mL may be administered (see How to administer KLYX Enema below).

The use of more than one enema should be strictly under the supervision of your healthcare professional.

If you believe that the effects of KLYX Enema on your bowel movement is too strong, or the product has not had the desired effect, speak with your doctor, nurse or pharmacist.

If you do not understand the instructions in this leaflet, ask your doctor, nurse or pharmacist for help.

How to administer KLYX Enema

Do not attempt to use KLYX Enema until you have checked the following illustrations, and have read and understood the accompanying instructions.

KLYX Enema may be warmed up to body temperature in a water-bath before it is used.

Left-side position:
Lie on left side with knee bent, arms resting comfortable.

Knee-chest position:
Kneel, then lower head and chest forward until left side of face resting on surface with left arm folded comfortable.

Follow these simple steps:

CAUTION: REMOVE THE PROTECTIVE CAP FROM THE APPLICATOR BEFORE INSERTING.

  1. Hold bottle upright. Closely examine the applicator and bottle. For protection, the applicator is provided with a cap.
  1. Grasp the applicator cap with other hand, pull gently to remove it.
  1. Twist to remove the upper-most end of the applicator.
  1. The applicator is now ready to use.
  1. Lubricate the tip of the enema with small amounts of Vaseline or KY jelly, or by pressing out some drops of KLYX Enema, and letting them run down the tip.
  2. While laying on your side or in the 'knee-chest position', gently insert the tip of the enema into the rectum with steady pressure, then slowly squeeze the bottle until nearly all liquid is expelled. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
  1. Discontinue use if resistance is encountered. Forcing the enema can result in injury.
  2. Gently remove the tip while keeping the bottle compressed in order to prevent black-flow.
  3. Try to retain the solution for approximately 5-10 minutes or until you have a strong urge to defecate, so that it has time to exert its effect.
    Stay near a toilet because most people have a bowel movement within 5-20 minutes.
  4. Throw away the used bottle.

It is important to use KLYX Enema exactly as your doctor, nurse or pharmacist has described. KLYX should be used at times of the day as directed by your doctor, or at times that are best suited for your situation.

If you are using KLYX prior to a medical procedure, administration in the evening before the procedure and again on the day of your procedure, about 1 to 2 hours before your procedure, may be suitable.

Using it more often than recommended may not improve your problem any faster but may cause side effects, or increase the intensity of side effects.

Seek medical advice if symptoms persist.

If you are not sure how long to use KLYX Enema, talk to your doctor, nurse or pharmacist.

If you use too much (overdose)

If you may have administered too much KLYX Enema, immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital.

You may need urgent medical attention.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after using KLYX.

This medicine helps most people who require a bowel preparation but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not.

You may need medical attention if you get some of the following side effects:

  • pain when pinching the rectum with the tip
  • abdominal pain & discomfort
  • effects from imbalance in the amount of salt in the body, such as irregular heartbeat, tiredness, nausea, vomiting, diarrhoea, convulsions
  • dizziness or light-headedness, which may be due to low blood pressure
  • slow heart beat (bradycardia).

Rare: Isolated cases of skin-rash and more severe types of allergy, with fall in blood-pressure and difficulty in breathing, have been reported.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

After using KLYX Enema

Storage

Keep your medicine in the pack until it is time to use it.

Keep KLYX Enema in a cool dry place where the temperature stays below 25°C. Do not refrigerate, burn or pierce KLYX.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not use KLYX Enema after the expiry date stated on the label.

If it has expired or is damaged, return it to your pharmacist for disposal.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

KLYX Enema is supplied in a plastic bottle, of nominal volume 120 mL with a plastic applicator. The applicator is covered with a cap.

Ingredients

Your KLYX Enema contains:

Active Ingredients:

  • docusate sodium 1 mg/mL and
  • sorbitol solution (70 per cent) (crystallising) 357 mg/mL.

Inactive Ingredients:

  • sodium methyl hydroxybenzoate (as a preservative)
  • sodium propyl hydroxybenzoate (as a preservative)
  • sodium hydroxide
  • hydrochloric acid
  • water-purified.

Sponsor

KLYX is supplied in Australia by:

Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble NSW 2073
Australia

AUST R 287769 - KLYX 120 mL Enema

This leaflet was revised in March 2017. #38851-v3A

KLYX® is a registered trademark of Ferring B.V.

® = Registered trademark

BRAND INFORMATION

Brand name

Klyx Enema

Active ingredient

Docusate sodium; Sorbitol solution (70 per cent) (crystallising)

Schedule

Unscheduled

 

1 Name of Medicine

Docusate sodium.
Sorbitol solution (70%) (crystallising).

6.7 Physicochemical Properties

Docusate.

C20H37NaO7S. MW: 444.56.

Chemical structure.


CAS number.

577-11-7.

Sorbitol.

C6H14O6. MW: 182.2.

Chemical structure.


CAS number.

50-70-4.

2 Qualitative and Quantitative Composition

Active ingredients.

Docusate sodium 1 mg/mL, sorbitol solution (70%) (crystallising) 357 mg/mL.

Excipients.

Excipients with known effect.

Methyl hydroxybenzoate, propyl hydroxybenzoate.
Also contains sodium hydroxide, hydrochloric acid and purified water.

3 Pharmaceutical Form

It is a clear, colourless, slightly foamy solution.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Klyx Enema is a dual action laxative enema that works locally in the colon. It contains the osmotic laxative sorbitol, which increases the water content of the distal large bowel lumen, and the stool softener laxative docusate, which acts by facilitating fluid penetration into faeces which soften stools, promotes defecation and bowel cleansing. The onset of action of Klyx Enema is rapid, normally within 5-10 minutes, with the full effect usually occurring within 20 minutes. The enema acts locally. There is no interference with normal reflexes.

Clinical trials.

Faecal impaction/ constipation.

Bekkali, et al., (2009) assessed the efficacy and safety of Klyx Enema verses orally administered polyethylene glycol (PEG) 3350 with electrolytes in a randomised, controlled trial in 90 children and adolescents (4 to 16 years) with evidence rectal faecal impaction (RFI) on rectal examination and functional constipation persisting for ≥ 8 weeks. Patients were randomised to receive Klyx Enema once daily for 6 consecutive days (60 mL for children < 6 years of age and 120 mL for children ≥ 6 years of age) (n = 46) or orally administered PEG 3350 with electrolytes once daily for 6 consecutive days (1.5 g/kg) (n = 44). The primary outcome, successful disimpaction, was achieved in 80% of patients receiving Klyx and 68% of patients receiving PEG 3350 with electrolytes (P = 0.28, not significant). Bowel habits and gastrointestinal symptoms information is provided in Table 1.

Colon evacuation.

Ormarsson, et al., 2014 assessed the efficacy and safety of free fatty acids (FFA) suppositories (not available in Australia) for colon evacuation using Klyx Enema as a control treatment in a noninferiority, single blind, randomised study in 53 outpatients undergoing flexible sigmoidoscopy. Patients were randomised to self administer Klyx Enema (n = 25), 120 mL the evening before and then again 2 hours before the sigmoidoscopy or FFA suppositories (n = 28), two suppositories, the evening before, and then again 2 hours before the sigmoidoscopy. The main outcomes measured were quality of the bowel cleansing, height of scope insertion and safety. The mean height of scope insertion for the Klyx group was 48 cm (SD = 10.4) compared to the 43 cm (SD = 13.4) for the FFA group (p = 0.09, not significant). The overall endoscopic view as rated by the physician is shown in Figure 1. Time until urge for bowel movement and time until bowel movement (min) are listed in Table 2. No serious side effects such as toxic reaction or irritation were observed in either group.

5.2 Pharmacokinetic Properties

Sorbitol, a sugar alcohol, is poorly absorbed from the gastrointestinal tract after oral or rectal use. Docusate sodium is a surfactant and its absorption from rectal preparations is also expected to be limited.
Klyx Enema is typically retained in the rectum for only 5 to 10 minutes before defecation occurs. Therefore, the short contact time of the enema in the rectum further limits the scope for absorption of the two active ingredients.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of faecal impaction/ constipation, on the recommendation of a medical practitioner, where oral therapies have been found to be inadequate or inappropriate.
Colon evacuation prior to medical procedures such as surgery or endoscopy, where oral therapies are inappropriate.

4.3 Contraindications

Known hypersensitivity to any ingredients of the product.
Bleeding or inflammation of the intestinal tract including haemorrhoids or anal fissures.
Abdominal pain of unknown origin.
Intestinal obstruction.

4.4 Special Warnings and Precautions for Use

Patients should be advised to drink plenty of water and to increase fibre in diet except in cases of medication-induced constipation (e.g. with codeine).
Patients should be advised to seek medical advice if symptoms persist.
The use of enemas may damage the intestinal wall. Long-term frequent use of Klyx Enema could lead to electrolyte disturbances. Therefore, Klyx Enema should only be used on a short-term basis for up to one week.
Prolonged use of laxatives is undesirable and may lead to dependence.

Use in the elderly.

Falls in blood pressure and bradycardia have been reported in the elderly.

Paediatric use.

Use only in children 4 years of age and over.

Effect on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Based on long-term clinical experience, no effect has been demonstrated.
(Category A)
Based on long-term clinical experience, no effect has been demonstrated.
 Based on long-term clinical experience, no effect has been demonstrated.

4.8 Adverse Effects (Undesirable Effects)

Long-term frequent use may lead to irritation of the intestinal tract for a longer period and electrolyte disturbances. Isolated cases of urticaria and anaphylactic reaction have been reported. Abdominal pain and discomfort has also been reported. Slight discomfort and fatigue may occur in a few subjects. Fall in blood pressure and bradycardia have been seen in the elderly. Anorectal pain or bleeding have occasionally occurred after rectal doses.
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems

4.2 Dose and Method of Administration

Dosage.

Klyx Enema should be administered rectally when required. If clinically required, treatment can be repeated once a day for up to maximum of 2 days for colon evacuation and 6 days for constipation or faecal impaction.

Adults and children 12 years and over.

Normally 120 mL is effective.

Children from 4 to 6 years.

Normally 60 mL is effective.

Children from 7 to 11 years.

60 mL may be effective but up to a maximum 120 mL may be necessary.

Administration.

The solution is recommended for use at a time of the day recommended by the treating doctor, or when best suited for the intended indication. When used prior to medical procedures, administration 1-2 hours before the procedure is suitable.
Remove the protective cap from the Klyx Enema before inserting. Gently insert the enema tip deep into the rectum. Empty the required dose into the colon by squeezing the bottle. The bottle should remain compressed while the tip is removed from the rectum.
Discontinue use if resistance is encountered. Forcing the enema can result in injury. Klyx Enema should be retained in the rectum until defecation occurs. Defecation usually occurs within 5-20 minutes.
Any unused portion of the enema solution should be discarded.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

References

Bekkali NL, van den Berg MM, Dijkgraaf MG, van Wijk MP, Bongers ME, Liem O, Benninga MA: Rectal fecal impaction treatment in childhood constipation: enemas versus high doses oral PEG. Pediatrics. 2009; 124(6): e1108-15.
Ormarsson OT, Asgrimsdottir GM, Loftsson T, Stefansson E, Kristinsson JO, Lund SH, Bjornsson ES: Clinical trial: free fatty acid suppositories compared with enema as bowel preparation for flexible sigmoidoscopy. Frontline Gastroenterol. 2015; 6(4): 278-283.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Do not refrigerate.

6.5 Nature and Contents of Container

Klyx is a single patient use enema supplied in a one piece plastic bottle. It is available in 120 mL in packs of 1 and 10*.
*Not all presentations may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes