Clisma lax

Package leaflet: Information for the user

Clisma lax, rectal solution

Monosodium phosphate monobasic anhydrous, disodium phosphate
Read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any adverse reactions occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days of treatment.

Contents of this leaflet:

1. What Clisma lax is and what it is used for
2. What you need to know before using Clisma lax
3. How to use Clisma lax
4. Possible side effects
5. How to store Clisma lax
6. Contents of the pack and other information

1. What Clisma lax is and what it is used for

Clisma lax contains the active substances anhydrous monobasic sodium phosphate and dibasic sodium phosphate, which belong to a group of medicines called osmotic laxatives.
Clisma lax is a highly concentrated rectal solution that works by drawing water into the site of administration, thereby increasing the volume of intestinal contents. This stimulates peristaltic movements in the intestine and thus promotes the elimination of faeces.
Clisma lax is used for the short-term treatment of occasional constipation.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

2. What you need to know before using Clisma lax

Do not use Clisma lax:

• if you are allergic to sodium phosphate or to any of the other ingredients of this medicine (listed in section 6)
• if you have acute abdominal pain or any pain of unknown origin
• if you have nausea or vomiting
• if you have intestinal or anorectal obstruction or narrowing (stenosis)
• if you have a bowel blockage due to a physical obstruction (mechanical ileus) or a partial blockage (intestinal sub-occlusion)
• if you have a bowel blockage or impaired normal bowel emptying (paralytic ileus)
• if you suffer from inflammatory intestinal disorders or other conditions that may increase absorption of the medicine
• if you have perforation of the anal wall
• if you suffer from specific intestinal problems (colon abnormalities such as Hirschsprung's disease or congenital or acquired megacolon)
• if you have unexplained rectal bleeding
• if you have an acute hemorrhoidal crisis with pain and bleeding
• if you are severely dehydrated
• if you suffer from heart disorders or problems
• if you have severe kidney problems (severe renal insufficiency) or elevated levels of phosphate in the blood (hyperphosphatemia)
• in children under 12 years of age
• if you are taking other medicines containing sodium phosphate (such as oral solutions or tablets)

Warnings and precautions
Talk to your doctor or pharmacist before using Clisma lax:

• if the need for a laxative arises from a sudden change in your previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when use of the laxative fails to produce an effect
• if you are elderly or in poor general health
• if you suffer from high blood pressure, heart problems, increased volume of abdominal fluid (ascites), or ulcers and fissures of the rectal mucosa
• if you frequently have difficulty evacuating or suffer from chronic constipation.

What you should know about laxatives:

• prolonged use of a laxative for the treatment of constipation is not recommended
• to treat constipation, medicines should only be an aid to dietary and lifestyle measures (e.g. increasing dietary fiber and fluid intake, regular physical activity)
• you should drink at least 6–8 glasses of water or other fluids during laxative treatment to help soften the stools
• it is advisable to correct dietary habits by increasing fiber and water intake during episodes of constipation.

Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause:

• persistent diarrhea leading to loss of water, minerals, and other essential substances
• in more severe cases, dehydration or a severe drop in blood potassium levels may occur, which can lead to heart, nerve, or muscle dysfunction, especially if you are also taking heart medications (digitalis), drugs that increase urine production (diuretics), or corticosteroids (anti-inflammatory agents)
• a state of dehydration, particularly if you are also taking medicines that affect kidney filtration, such as diuretics, ACE inhibitors, sartans (antihypertensive drugs acting on angiotensin), or NSAIDs (anti-inflammatory agents)
• disturbances in blood levels of certain minerals, potentially leading to serious kidney problems (renal failure) and muscle stiffness (tetany)
• the need to progressively increase the dose (dependence)
• chronic constipation
• loss of normal bowel function (decreased intestinal tone).

Health education notes
First and foremost, it should be remembered that in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can provide a lasting solution to constipation.
Many people believe they suffer from constipation if they do not have a bowel movement every day. This is a mistaken belief, as this condition is entirely normal for many individuals.
Constipation should instead be considered present when bowel movements are less frequent than your usual pattern and are associated with the passage of hard stools.
Consult your doctor if episodes of constipation occur repeatedly.
Children
Do not use Clisma lax in children under 12 years of age.
Other medicines and Clisma lax
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor before using Clisma lax if you are taking:

• medicines that increase urine elimination (diuretics), cortisone-based medicines (corticosteroids), certain medicines that lower blood pressure (calcium channel blockers), or lithium-containing medicines
• medicines that affect heart rhythm (prolongation of the QT interval)
• calcium supplements and calcium-containing antacids
• other medicines containing sodium phosphate (such as oral solutions or tablets)

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use Clisma lax only if necessary and under direct medical supervision; your doctor will assess whether the benefits to you outweigh the potential risks to the fetus or nursing infant.
Driving and using machines
Clisma lax does not affect the ability to drive or operate machinery.
However, undesirable effects may occur during treatment; therefore, it is advisable to understand your response to the medicine before driving or operating machinery.
Clisma lax contains 133 mg per dose of sodium benzoate, which may cause local irritation.
Clisma lax contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use Clisma lax

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses.
Use laxatives intermittently, as infrequently as possible, and for no longer than 7 days.
If used for longer periods, contact your doctor, who will assess whether you should continue or discontinue treatment.

Use in adults and adolescents
The recommended dose is the entire contents of the bottle, preferably in the evening.
Please note:

• Do not use more than one bottle per day.
• Each bottle is intended for single administration only: discard any remaining medicine.
• Stop administration immediately if you encounter resistance during cannula insertion to avoid causing injury.

Instructions for using Clisma lax
You may administer Clisma lax rectal solution at room temperature. If you prefer a warm solution, place the bottle in contact with warm water by immersing it or holding it under a warm tap.

To administer Clisma lax correctly:

1. Lie on your left side (Figure 1). After administering Clisma lax, assume the knee-chest position for a few minutes (Figure 2).
2. Remove the cap protecting the rectal cannula (Figure 3).
3. Hold the bottle and gently insert the cannula into the rectum (Figure 4), then firmly squeeze the bottle; some solution will remain in the bottle. When administering to a child, insert the cannula only halfway along its length.
4. After administration, remove the cannula and dispose of the empty bottle in its original carton (Figure 5).
5. Remain lying down until you feel the urge to defecate, which usually occurs within 5 minutes. In any case, it is not necessary to retain the enema for more than 10–15 minutes.

Figure 1      Figure 3
            Figure 4

Figure 2
Figure 5

If you use more Clisma lax than you should
In case of accidental ingestion or overdose of Clisma lax, contact your doctor immediately or go to the nearest hospital emergency department.
Undesirable effects that may occur following overdose or rectal administration include:

• abdominal pain
• nausea
• vomiting
• persistent diarrhea, leading to loss of water, electrolytes (especially potassium), and other essential nutrients. These losses should be replaced by drinking water or other fluids. Excessive absorption of phosphate from the enema may cause:
• elevated phosphate levels in the blood (hyperphosphatemia)
• low calcium levels in the blood (hypocalcemia)
• low magnesium levels in the blood (hypomagnesemia)

If you take an excessive dose of Clisma lax, you may experience abdominal pain and diarrhea, and you should replace lost fluids and electrolytes (see also section 2 “Warnings and precautions”).

If you forget to use Clisma lax
Do not use a double dose to make up for a missed dose. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects that may occur with the use of Clisma Lax are:

• isolated cramp-like abdominal pains
• intermittent abdominal pain (abdominal colic)
• diarrhoea with loss of fluids and salts, more frequent in cases of severe constipation (difficulty passing stools)
• redness, burning or pain (irritation) at the rectal level
• nausea and vomiting
• hypersensitivity reactions (e.g. urticaria)
• blisters, itching and burning on the skin

The following side effects occur rarely:

• increased levels of phosphate in the blood (hyperphosphataemia)
• increased levels of sodium in the blood (hypernatraemia)
• low levels of calcium in the blood (hypocalcaemia)
• low levels of potassium in the blood (hypokalaemia)
• calcium accumulation (calcification) in tissues

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clisma lax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Clisma Lax contains

• The active substances are anhydrous monobasic sodium phosphate and dibasic sodium phosphate. 100 ml of Clisma Lax contain: 13.91 g of anhydrous monobasic sodium phosphate (NaH₂PO₄); 3.18 g of dibasic sodium phosphate (Na₂HPO₄).
• The other components are: sodium hydroxide, sodium benzoate, methylparahydroxybenzoate, purified water.

Description of the appearance of Clisma Lax and package contents
Clisma Lax is a clear, colourless, hyperosmotic rectal solution contained in a soft PE bottle of 133 ml or 260 ml.
Clisma Lax in 133 ml bottles is available in packs containing 1, 4 or 20 bottles.
Clisma Lax in 260 ml bottles is available in packs containing 4 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer:
SOFAR S.p.A. - Via Firenze, n. 40 - 20060 Trezzano Rosa (MI)