Clarilaxina for constipation

Italy
Brand name Clarilaxina for constipation
Form suppositories
Active substance / Dosage
GLYCEROL
Prescription type Over-the-counter
ATC code
A06AX01
Registration number 031330
Manufacturer ALMUS S.R.L.
Clarilaxina for constipation suppositories

CLARILAXINA CONSTIPATION early infancy 675 mg suppositories
CLARILAXINA CONSTIPATION early infancy 900 mg suppositories
CLARILAXINA CONSTIPATION children 1350 mg suppositories
CLARILAXINA CONSTIPATION adults 2250 mg suppositories
GLYCEROL

THERAPEUTIC PHARMACOLOGICAL CATEGORY
Other laxatives

THERAPEUTIC INDICATIONS
Short-term treatment of occasional constipation

CONTRAINDICATIONS

  • Hypersensitivity to the active substance or to any of the excipients
  • Acute or unknown origin abdominal pain
  • Nausea or vomiting
  • Intestinal obstruction or stenosis
  • Rectal bleeding of unknown origin
  • Acute hemorrhoidal crisis with pain and bleeding
  • Severe state of dehydration

PRECAUTIONS FOR USE
Laxatives should be used as infrequently as possible and for no longer than seven days. Use for longer periods requires medical prescription following adequate evaluation of the individual case.
The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medications, and monitoring during therapy.
Laxative abuse may cause persistent diarrhea leading to loss of water, minerals (especially potassium), and other essential nutrients. In more severe cases of abuse, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, particularly when used concomitantly with cardiac glycosides, diuretics, or corticosteroids.
Abuse of laxatives, especially stimulant (contact) laxatives, may lead to dependence (and thus possible need for progressive dose increases), chronic constipation, and loss of normal intestinal function (intestinal atony).
In episodes of constipation, it is first recommended to correct dietary habits by increasing daily intake of adequate fiber and water.
When using laxatives, it is advisable to drink at least 6–8 glasses of water or other fluids per day to help soften stools.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
No specific interaction studies have been conducted.

SPECIAL WARNINGS
Consult your doctor if 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 if the laxative fails to produce an effect.
In children under twelve years of age, this medicine should only be used after consulting a doctor.
Elderly patients or those in poor health should also consult a doctor before using this medicine.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Adequate and well-controlled studies on the use of this medicine during pregnancy or breastfeeding have not been conducted.
Although there are no evident contraindications for using this medicine during pregnancy or breastfeeding, its use is recommended only when necessary and under medical supervision.

Effects on ability to drive vehicles and use machinery
This medicine does not impair the ability to drive vehicles or operate machinery. However, adverse effects may occur during treatment; therefore, it is advisable to assess your response to the medicine before driving or operating machinery.

Health education notes
First of all, it should be noted 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 when bowel movements are reduced compared to one’s usual pattern and are associated with the passage of hard stools.
If episodes of constipation recur frequently, a doctor should be consulted.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The correct dose is the lowest dose sufficient to produce easy defecation.
It is advisable to start with the lowest recommended doses.

Adults and adolescents (12–18 years): 1 adult suppository as needed, up to a maximum of 1 or 2 administrations per day.
Children aged 2–11 years: 1 children’s suppository as needed, up to a maximum of 1 or 2 administrations per day.
Children aged 1 month to 2 years: 1 early infancy suppository as needed, up to a maximum of 1 or 2 administrations per day.

Instructions for use
Remove the suppository from its container and, if necessary, moisten it slightly to facilitate rectal insertion.
If the suppositories appear softened, immerse the containers in cold water before opening them.
In children under twelve years of age, this medicine should only be used after consulting a doctor.
Laxatives should be used as infrequently as possible and for no longer than seven days (see Precautions for use). A diet rich in fluids enhances the effect of the medicine.

OVERDOSE
No cases of overdose have been reported. However, excessive doses (laxative abuse – frequent or prolonged use or excessive doses) may cause abdominal pain, persistent diarrhea, and consequent loss of water, minerals (especially potassium), and other essential nutrients. Fluid and electrolyte losses should be replaced.
Electrolyte imbalances are characterized by symptoms such as thirst, vomiting, weakness, edema, bone pain (osteomalacia), and hypoalbuminemia.
In more severe cases, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially when used concomitantly with cardiac glycosides, diuretics, or corticosteroids.
Abuse of laxatives, especially stimulant (contact) laxatives, may lead to dependence (and thus possible need for progressive dose increases), chronic constipation, and loss of normal intestinal function (intestinal atony).
In case of accidental ingestion/absorption of an excessive dose of GLYCEROL, contact a doctor immediately or go to the nearest hospital.

IF YOU HAVE ANY DOUBT ABOUT THE USE OF CLARILAXINA CONSTIPATION, CONSULT YOUR DOCTOR OR PHARMACIST.

UNDESIRABLE EFFECTS
Like all medicines, GLYCEROL can cause adverse effects, although not everyone experiences them.
The following are the adverse effects associated with GLYCEROL. There are insufficient data to determine the frequency of individual listed effects.

Gastrointestinal disorders
Isolated cramp-like pains or abdominal colic and diarrhea, with loss of fluids and electrolytes—more common in cases of severe constipation—as well as rectal irritation.

Following the instructions in this leaflet reduces the risk of adverse effects.
If any of the adverse effects worsen, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE
Expiry date: see the date indicated on the packaging
The expiry date refers to the medicine kept in its original, undamaged packaging and stored correctly.

WARNING: Do not use the medicine after the expiry date stated on the packaging.

Storage conditions
Store in the original packaging to protect the medicine from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Keep the medicine out of the reach and sight of children.

COMPOSITION

CLARILAXINA CONSTIPATION early infancy 675 mg suppositories
Each suppository contains:
Active substance: Glycerol 675 mg
Excipients: sodium stearate, anhydrous sodium carbonate

CLARILAXINA CONSTIPATION early infancy 900 mg suppositories
Each suppository contains:
Active substance: Glycerol 900 mg
Excipients: sodium stearate, anhydrous sodium carbonate

CLARILAXINA CONSTIPATION children 1350 mg suppositories
Each suppository contains:
Active substance: Glycerol 1350 mg
Excipients: sodium stearate, anhydrous sodium carbonate

CLARILAXINA CONSTIPATION adults 2250 mg suppositories
Each suppository contains:
Active substance: Glycerol 2250 mg
Excipients: sodium stearate, anhydrous sodium carbonate

PHARMACEUTICAL FORM AND CONTENT
Suppositories
CLARILAXINA CONSTIPATION early infancy 675 mg suppositories – 6 suppositories
CLARILAXINA CONSTIPATION early infancy 900 mg suppositories – 6 suppositories
CLARILAXINA CONSTIPATION early infancy 900 mg suppositories – 12 suppositories
CLARILAXINA CONSTIPATION children 1350 mg suppositories – 6 suppositories
CLARILAXINA CONSTIPATION adults 1350 mg suppositories – 18 suppositories
CLARILAXINA CONSTIPATION adults 2250 mg suppositories – 6 suppositories
CLARILAXINA CONSTIPATION adults 2250 mg suppositories – 18 suppositories

MARKETING AUTHORISATION HOLDER
Almus S.r.l. – Via Cesarea 11/10 – 16121 Genoa (GE)

LOT RELEASE RESPONSIBLE MANUFACTURER
Zeta Farmaceutici S.p.A.
Via Galvani, 10 – 36066 Sandrigo (VI)