Clarilax for constipation

Patient Information Leaflet: Information for the User

CLARILAX CONSTIPATION

Adults 6.75 g rectal solution
Glycerol
Please 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.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What CLARILAX CONSTIPATION is and what it is used for

CLARILAX CONSTIPATION contains the active substance glycerol, which belongs to the category of laxatives—medicines used to facilitate the expulsion of faeces. This medicine is indicated 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 CLARILAX CONSTIPATION

Do not use CLARILAX CONSTIPATION

• if you are allergic to glycerol or to any of the other ingredients of this medicine (listed in section 6);
• if you have acute abdominal pain or of unknown origin;
• if you have nausea or vomiting;
• if you have intestinal obstruction or narrowing (stenosis);
• if you have rectal bleeding of unknown origin;
• if you have acute hemorrhoidal crisis with pain and bleeding (swelling of blood vessels around the anus);
• if you are severely dehydrated.

Warnings and precautions
Talk to your doctor or pharmacist before using CLARILAX CONSTIPATION.
If you are elderly and/or in poor general health, inform your doctor before using this medicine.
If you suffer from constipation that lasts for long periods (chronic) or occurs frequently, always seek medical advice for diagnosis, prescription of medicines, and monitoring during treatment. Consult your doctor when the need for a laxative arises from a sudden change in 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.
Drink at least 6–8 glasses of water or other fluids daily to help soften stools while using laxatives.
If you use laxatives excessively, frequently, or incorrectly, you may develop prolonged diarrhea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients. In severe cases of abuse, excessive fluid loss (dehydration) or low potassium levels in the blood (hypokalaemia) may occur, which can cause heart problems or muscle dysfunction, especially if you are taking cardiac glycosides, diuretics, or corticosteroids during treatment with this medicine.
Abuse of laxatives, particularly stimulant laxatives (contact laxatives), may lead to dependence (the need to continually increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).

Other medicines and CLARILAX CONSTIPATION
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Laxatives may reduce intestinal transit time, thereby decreasing the absorption of other medicines taken orally at the same time. Therefore, avoid taking this medicine simultaneously with other medicines: wait at least 2 hours after taking another medicine before taking the laxative.

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.
Use this medicine during pregnancy and breastfeeding only if necessary and always under direct medical supervision.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
However, monitor your response to the medicine, as adverse effects may occur that could affect your ability to drive or use machinery (see “Side effects”).

3. How to use CLARILAX CONSTIPATION

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The correct dose is the lowest one that produces easy bowel evacuation. Initially use the minimum recommended doses. When necessary, the dose may be increased, but never exceed the maximum recommended dose.
It is preferable to take the medicine in the evening.
The recommended dose for adults and adolescents is 1 single-dose container for adults (6.75 g) as needed, up to a maximum of 2 single-dose containers per day.

Use in children
This medicine is not recommended for children under 12 years of age.

Instructions for use:

• Open the blister by lifting the unsoldered edge flap
• Remove the cap from the micro-enema and lubricate the cannula with a drop of the product
• Gently insert the cannula into the rectum without squeezing the container
• Firmly press the micro-enema completely
• Withdraw the cannula without releasing pressure, to avoid sucking back the liquid

Use medicines that stimulate bowel evacuation (laxatives) as infrequently as possible and in any case for no longer than 7 days. Prolonged use of laxatives requires a doctor's prescription following an appropriate assessment of the patient's condition.
A diet rich in fluids helps the effect of the medicine.

If you use more CLARILAX CONSTIPATION than you should
In case of accidental ingestion/overdose of CLARILAX CONSTIPATION, inform your doctor immediately or go to the nearest hospital.
If you use excessive amounts of this medicine, abdominal pain and persistent diarrhea may occur, leading to fluid loss, loss of electrolytes (especially potassium), and other essential nutrients that must be replaced.
Symptoms of electrolyte imbalance (electrolyte disturbance) include: thirst, vomiting, weakness, swelling (edema), bone problems (osteomalacia), and decreased levels of the blood protein albumin (hypoalbuminemia).
In more severe cases, dehydration or hypokalemia may occur, which can cause cardiac or neuromuscular dysfunction, especially if the patient is also being treated with cardiac glycosides, diuretics, or corticosteroids.
Laxative abuse may lead to dependence (and thus a possible need to progressively increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
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 everybody gets them.
The following side effects may occur with unknown frequency (frequency cannot be estimated from the available data):

• cramp-like pains (localized or widespread in the abdomen);
• intermittent abdominal pain (colic);
• diarrhoea (with loss of fluids and electrolytes);
• redness with burning or pain (irritation) around the anus.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CLARILAX CONSTIPATION

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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CLARILAX CONSTIPATION contains

• The active substance is glycerol. Each single-dose container contains 6.75 g of glycerol.
• The other components are: chamomile glyceric extract, mallow glyceric extract, soluble starch, purified water.

Description of the appearance of CLARILAX CONSTIPATION and package contents
A single-dose container of CLARILAX CONSTIPATION consists of 9 g of solution for rectal use, contained in a polyethylene squeeze bottle with a nozzle. Each single-dose container is individually sealed.
Pack size: 6 single-dose containers.
Marketing Authorization Holder
Almus S.r.l. – Via Cesarea, 11/10 – 16121 Genoa – Italy
Manufacturer
Zeta Farmaceutici S.p.A. – Via Galvani, 10 – 36066 Sandrigo (VI) – Italy

Health Education Notes
In most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can permanently resolve constipation.
Many people believe they suffer from constipation if they do not have a bowel movement every day. This is a mistaken belief, as going less frequently is completely normal for many individuals.
Constipation is instead defined as a reduction in bowel movements compared to one's usual pattern, associated with the passage of hard stools. Before using laxatives, it is advisable to correct dietary habits by ensuring adequate daily intake of fiber and water.
If the condition is persistent (chronic constipation) or recurrent, it is appropriate to consult a doctor.