FREKA CLYSS

FREKA CLYSS enemas individually packaged

Important notes (mandatory information)

Freka-Clyss, ready-to-use disposable enema. Areas of application: for constipation (obstipation); for rapid and sustained emptying of the rectum before operations; for preparation of urological, radiological and gynaecological examinations, rectoscopy.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Freka-Clyss, ready-to-use disposable enema

WHAT IS FREKA-CLYSS AND WHAT IS IT USED FOR?

Freka-Clyss is a ready-to-use disposable enema on a salt basis.

Freka-Clyss is used

• for constipation (obstipation).
• for rapid and sustained emptying of the rectum before operations.
• for preparation of urological, radiological and gynaecological examinations, rectoscopy.

WHAT SHOULD YOU CONSIDER BEFORE USING FREKA-CLYSS?

Freka-Clyss must not be used:

• if you are hypersensitive (allergic) to any of the ingredients of Freka–Clyss.
• if you suffer from impaired kidney function (renal insufficiency) (especially if you are a dialysis patient).
• if you suffer from intestinal changes that lead to a longer retention time of the agent in the intestine, e.g. in the case of severe enlargement of the colon (colonic dilatation), congenital enlargement of the colon (congenital megacolon, Hirschsprung's disease) or in the case of occlusion of the lower part of the rectum (anal canal) by a membrane (anal atresia).
• if you suffer from an inflammatory bowel disease such as acute appendicitis, diverticulitis, localised intestinal inflammation (regional enteritis), colitis, the chronic inflammatory bowel disease ulcerative colitis.
• if there is a tear in the mucous membrane of the rectum (fissure in the rectum or anal canal).
• if you have haemorrhoids.
• if there is faecal impaction in the colon (coprostasis) or if it is suspected.
• if nausea, vomiting and abdominal pain are present, unless expressly prescribed by a doctor.
• in infants, toddlers and children.
• in pregnant and breastfeeding women.

Special care should be taken when using Freka-Clyss:

• if you have had an artificial anus created.
• if you are taking medicines that increase urine output (diuretics).

In these cases, you may only use Freka-Clyss after consulting your doctor.

Please also inform your doctor before using the enema:

• if you suffer from heart disease.
• if you suffer from disorders of the water and salt balance.

In these cases, the phosphate level in the blood may increase, the calcium concentration may decrease, the sodium concentration may increase and the blood may become acidic (acidosis).

Freka-Clyss should be used with caution in elderly patients, especially in the case of hypertension, type 2 diabetes and intestinal motility disorders. Discontinue use of Freka-Clyss if you feel resistance. Administering the enema against resistance can lead to injury. In any case, you should proceed with extreme caution when using enemas. If you have known or suspected damage to the mucous membrane in the anus or rectum, you should not use Freka-Clyss.

Children

Freka-Clyss must not be used in infants, toddlers and children under 12 years of age.

When using Freka-Clyss with other agents

There are no known interactions of Freka-Clyss with other agents.

Pregnancy and breastfeeding

Freka-Clyss must not be used in pregnant or breastfeeding women.

Driving and operating machinery

No special precautions are required.

HOW SHOULD FREKA-CLYSS BE USED?

Always use Freka-Clyss exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: in general, 1 Freka-Clyss (120 ml) is sufficient for adults per application. For special clinical requirements, 2 - 3 bags in succession.

For use via the anus (for rectal use)

1. Lubricate the closure and tube with Vaseline.
2. Open the closure by breaking off the tip manually and carefully insert the tube - as far as possible - into the rectum, with the patient lying on their side with their legs raised.
3. Slowly empty Freka–Clyss under slight pressure. The 15 cm long insertion tube ensures a high penetration depth of the enema fluid, which results in a reliable and rapid (usually within 10 - 20 minutes) emptying of the bowel. The flexibility of the tube and the rounded cone of the closure piece prevent injury to the intestinal mucosa.

Note

The bag does not need to be completely emptied. It contains more fluid than is required for effective use. Therefore, a small amount of fluid remains in the bag. For single use only! Risk of microbiological contamination of the solution if reused. This product contains DEHP. The enema can be warmed before use; to body temperature at most (e.g. in a water bath).

How long should you use Freka-Clyss?
Unless otherwise prescribed by your doctor, Freka-Clyss should only be used once.

If you have used more Freka-Clyss than you should, or if you have made an application error

Incorrect use of Freka-Clyss can injure the intestinal mucosa. The phosphate solution can then cause inflammation and tissue damage. A perforation of the intestine (perforation) can also occur. If your general condition changes, if you experience pain or if you experience bleeding from the anus after administering Freka-Clyss, you should consult a doctor immediately. In the event of an overdose, electrolyte imbalances may occur, which may lead to an increase in the phosphate level in the blood, a decrease in the calcium concentration, an increase in the sodium concentration and an acidification of the blood (acidosis). This can lead to a disturbance in the water balance (dehydration), to convulsive disturbances of movements and skin sensation (hypocalcaemic tetany) and to disturbances of consciousness (lethargy). Signs of these disorders can be: increased heart rate (tachycardia), drop in blood pressure, reduced urine output, thirst, convulsive muscle cramps, especially of the hands, feet (carpopedal spasms), face, paraesthesia, e.g. tingling or numbness (paraesthesia), especially in the arms, drowsiness. Treatment with calcium supplements is recommended. Other treatment measures may include fluid replacement, correction of other electrolyte imbalances and the acid-base balance.

If you have any further questions on the use of Freka-Clyss, ask your doctor or pharmacist.

WHAT SIDE EFFECTS ARE POSSIBLE?

Like almost all medicines, Freka-Clyss can have side effects, although not everybody gets them.

Possible side effects:

• Cramps may occur after administration of Freka–Clyss.
• Phosphate enemas such as Freka–Clyss can cause changes in the appearance of the rectal mucosa (chemically induced mucosal damage).
• If nausea, vomiting or abdominal pain occur when using Freka–Clyss, you must stop using the enema and consult a doctor.
• Bleeding from the rectum (rectal bleeding) and bowel problems such as failure to have a bowel movement after administration of Freka–Clyss may indicate serious problems. In such cases, you must stop using Freka–Clyss and consult a doctor.
• Under Freka–Clyss, particularly in the case of application errors and non-observance of contraindications, elevated phosphate levels or reduced calcium levels in the blood (hyperphosphataemia and hypocalcaemia) may occur (see "If you have used more Freka–Clyss than you should, or if you have made an application error").

Other possible side effects

p-hydroxybenzoic acid methyl ester and p-hydroxybenzoic acid propyl ester may cause hypersensitivity reactions, including delayed reactions. Please inform your doctor or pharmacist if any of the listed side effects affect you severely or if you notice any side effects not listed in this package leaflet.

HOW SHOULD FREKA-CLYSS BE STORED?

Keep Freka-Clyss out of the reach of children. Do not use Freka-Clyss after the expiry date stated on the bag. You may only use Freka-Clyss if the solution is clear and the container is undamaged. Storage conditions: No special storage conditions are required for Freka-Clyss.

FURTHER INFORMATION

What Freka-Clyss contains

100 ml solution contains: Sodium dihydrogen phosphate 2H20 16.00 g, sodium monohydrogen phosphate 12 H20 6.00 g, p-hydroxybenzoic acid methyl ester 0.10 g, p-hydroxybenzoic acid propyl ester 0.01 g, water for injections.

What Freka-Clyss looks like and contents of the pack

Freka-Clyss is a clear, colourless solution. Freka-Clyss is available in the following packs: Bag with 120 ml solution, packs with 10 x 120 ml solution.

Distributor

Fresenius Kabi Deutschland GmbH
61346 Bad Homburg v.d.H.
Telephone: 06172/686-0

Manufacturer

Fresenius Kabi France
5, place du Marivel
F-92316 Sèvres Cedex

This package leaflet was last revised in April 2018.

Source: Information from the package leaflet
Status: 12/2018
Areas of application: for constipation (obstipation); for rapid and sustained emptying of the rectum before operations; for preparation of urological, radiological and gynaecological examinations, rectoscopy.