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CLISMA-LAX, 133 ml

Gastroenterology
 

Single-use medical device
QUICK-ACTING, READY-TO-USE, EVACUATION ENEMA

COMPOSITION
Each 133 ml bottle-dose contains a solution with the following composition per 100 ml: 13.91 g sodium acid phosphate (NaH2PO4); 3.18 g sodium phosphate (Na2HPO4); sodium hydroxide; sodium benzoate, methylparahydroxybenzoate, purified water q.s. at 100 ml.
PRESENTATION
CLISMA-LAX is a medical device designed to practice lower bowel cleansing enemas in an easy, fast, safe and hygienic way; it is a ready-to-use device and its application does not require any additional device. CLISMA-LAX contains an aqueous saline solution and is formed of a handy soft plastic bottle that also has the function of delivery apparatus, provided with a lubricated atraumatic rectal cannula. Both the active saline solution contained in the bottle, and the bottle itself which is also a tool of administration make CLISMA-LAX a ready-to-use device. Indeed, using CLISMA-LAX, evacuation enema is no more unpleasant and cumbersome experience. Its administration is highly fast, workable both at home and elsewhere, under conditions of high security and hygiene, without the discomfort, risks, costs and expenditure time of traditional methods.
It comes in boxes of one or twenty bottles of 133 ml.

MECHANISM OF ACTION
CLISMA-LAX contains a hyperosmotic solution of sodium phosphates, stabilized and buffered at Ph 5.5, widely used in US and Europe. The evacuative effect of the solution is specifically mechanical and derives above all from its hyperosmotic property, which is a common feature of saline laxatives. After introducing into the rectum, the solution recalls water by osmosis from the surrounding tissues, increasing the volume of the intestinal content. The increased volume boosts intestinal peristalsis in a smooth, effortless and nearly physiologic way.
Ready-to-Use Enema is a bowel cleanser that acts by increasing the water content of your stools and in this way helps relieving constipation and clearing the bowel. It can be used in the relief of occasional constipation and where bowel cleansing is required, such as prior to your endoscopy, bowel surgery or X-ray examination, before and after lower bowel surgery, delivery and post partum, before proctoscopy, sigmoidoscopy or colonoscopy and mainly before radiological examinations of the lower bowel. Due to its quick and limited to-lower-bowel action, CLISMA-LAX is the preferred choice especially in heart patients who need to evacuate effortlessly, paraplegic and some neurologic patients where oral laxatives are contraindicated.
THERAPEUTIC INDICATIONS and POSOLOGY
CLISMA-LAX is indicated in constipation and in evacuating the rectum prior to diagnostic, radiological, urological, gynecological and colonscopic examinations.
Adults and Children over 12 years old: 1 bottle (133 ml delivered dose) daily or as directed by a physician. For some particular clinical needs, up to 2-3 bottles can be administered.
Children aged 3 years to less than 12 years: ½ a bottle or as directed by a physician. Do not administer to children under 3 years of age. CLISMA-LAX helps treating constipation and irregular bowel movements but repeated and prolonged use of CLISMA-LAX Ready-to-Use Enema is not recommended as it may cause habituation.Unless indicated by a physician, enema should not be used for more than 7 days.

METHOD OF ADMINISTRATION
CLISMA-LAX can be performed at room temperature. If preferred warm, simply put it in contact with hot water (by emerging or under the tap). For best results apply CLISMA-LAX lying on your left side (fig. 1).
For a greater cleansing effect assume the kneechest position for a few minutes, immediately after administration (see fig. 2).
1. Remove the cap from the rectal cannula (fig. 3).
2. Take the bottle and gently introduce the cannula into the rectum in the direction of the navel (fig. 4). Press the bottle to the bottom. A residue of the solution remains in the bottle. In children the cannula must not penetrate beyond half its length.
3. With the injection terminated, remove the cannula.
4. Remain lying down until the urgent need to evacuate arises, (usually within 5 minutes). Do not retain enema for more than 5 minutes.

CONTRAINDICATIONS
Like all evacuation enemas, CLISMA-LAX is contraindicated in dialysis patients; in all patients with megacolon, bowel obstruction or intestinal stenosis; fecaloma and hemorrhoid patients. CLISMA-LAX is also contraindicated in acute or chronic inflammatory bowel disease; in presence of nausea, vomiting or abdominal pain.
PRECAUTIONS
Do not use CLISMA-LAX ready-to-use enema for long periods unless directed by a physician. Not to be used when nausea, vomiting or abdominal pain is present, in bowel obstruction or intestinal stenosis, rectal bleeding. Consult a physician before using CLISMA-LAX in children under 12 and elderly or debilitated. Use only if solution is clear, coloreless and correctly stored. Keep this leaflet always available and ready to consult.
SIDE EFFECTS
The correct and short-term use of CLISMA-LAX riduces the risk of any side effect. However, especially in excessive doses, CLISMA-LAX can lead to dehydration and electrolytes equilibrium unbalance with symptoms like tachycardia, hypotensione, thirst, dizziness, vomiting, urinating less often than usual, sleepness, itching, muscle soreness and stiff arms sensation. No further administrations should be given and the condition of the patient should be assessed by a physician. Stop using CLISMA-LAX enema when nausea, vomiting or abdominal pain is present unless directed by a physician.

Notes on health education
Mainly, a balanced diet rich with water and fibre (bran, vegetables and fruit) can be the long-term answer to constipation. Many people wrongly think they suffer constipation when they are unable to evacuate daily. Instead, constipation occurs when the evacuation activity is reduced compared to individual habits and associated to hard stools. International guidelines consider constipation, whenever evacuation activity is reduced to less than 3 per week. If episodes of constipation are frequent physician should be consulted.
Manufacturer: Sofar S. p. A, via Firenze 40, 20060 Trezzano Rosa (MI), Italy
Representative: Genba Pharma,Veiveriu str. 150, LT-46391, Kaunas - Lithuania
EXPIRY DATE AND STORAGE
CLISMA-LAX should be stored below 30°C. Do not use CLISMA-LAX after the expiry date indicated on the box. The date refers to the unused product, correctly stored.
KEEP OUT OF REACH OF CHILDREN