Stixenil

BEFORE USE
READ CAREFULLY ALL THE INFORMATION CONTAINED IN THE PACKAGE LEAFLET
This is a self-medication medicine that you can use to treat mild and transient disorders which are easily recognizable and resolvable without medical intervention.
It may therefore be purchased without a prescription, but must be used correctly to ensure its effectiveness and reduce unwanted effects.
For further information and advice, consult your pharmacist.
Consult a doctor if the condition does not resolve after the short treatment period indicated.

Stixenil 5 mg coated tablets
Bisacodyl

WHAT IT IS
STIXENIL is a stimulant laxative

WHY IT IS USED
Short-term treatment of occasional constipation.

WHEN IT MUST NOT BE USED
Hypersensitivity to the active substance or to any of the excipients.
Laxatives are contraindicated in patients with acute or unknown origin abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, or severe dehydration.
Generally contraindicated during pregnancy and breastfeeding (see section "What to do during pregnancy and breastfeeding").
Generally contraindicated in pediatric age (see section "Important information").

PRECAUTIONS FOR USE

WHICH MEDICINES OR FOODS CAN AFFECT THE MEDICINE'S EFFECT
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Laxatives may reduce the intestinal transit time, and thus the absorption, of other drugs taken orally at the same time. Therefore, avoid taking laxatives and other medicines simultaneously: wait at least 2 hours after taking another medicine before taking the laxative.
Concomitant use of diuretics or corticosteroids may increase the risk of electrolyte imbalance if bisacodyl is taken in excessive amounts.
Electrolyte imbalance may increase sensitivity to cardiac glycosides.
Milk and antacids may alter the effect of the medicine; wait at least one hour before taking the laxative.

IMPORTANT INFORMATION
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhea, resulting in loss of water, minerals (especially potassium), and other essential nutrients.
In severe cases, dehydration or hypokalemia (low potassium levels in the blood) may occur, which can lead to cardiac or neuromuscular dysfunction, particularly if the patient is also being treated with cardiac glycosides, diuretics, or corticosteroids.
Abuse of laxatives, especially stimulant laxatives (contact laxatives), may lead to dependence (and therefore a possible need to progressively increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
Cases of dizziness or syncope during defecation have been reported with bisacodyl use, consistent with defecation syncope (attributable to the effort of defecation) or a vasovagal response to abdominal pain associated with constipation.

When use is permitted only after consulting a doctor
Treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medication, and monitoring during therapy.
In children under 12 years of age.
In the presence of abdominal pain, nausea or vomiting, or inflammatory bowel diseases.
In case of sudden change in previous bowel habits (frequency of bowel movements) lasting more than two weeks, or when laxative use fails to produce an effect, or when the patient has diabetes mellitus, hypertension, or heart disease.
When the patient has diabetes mellitus, hypertension, or heart disease.
During pregnancy and breastfeeding.
Elderly patients or those in poor health should also consult a doctor before using this medicine.

What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
During pregnancy and breastfeeding, STIXENIL should be used only after consulting a doctor and evaluating the individual risk/benefit ratio.
Consult your doctor if you suspect you are pregnant or wish to plan a pregnancy.

Important information about certain excipients
This medicine contains lactose and sucrose; therefore, if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Effects on the ability to drive vehicles and use machinery
No effects on the ability to drive or use machinery are known. However, caution should be exercised by individuals performing activities requiring alertness. Patients should be informed that dizziness and/or syncope may occur due to a vasovagal response (e.g., following abdominal cramping). If abdominal cramping occurs, patients should avoid potentially dangerous activities such as driving or operating machinery.

Health education notes
First of all, it should be remembered that in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can durably 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 such a pattern is entirely normal for many individuals. Constipation should instead be considered when bowel movements are reduced compared to one's usual habits and are associated with hard stools. If episodes of constipation recur frequently, a doctor should be consulted.

How to use this medicine
Children aged 10 years or younger with chronic constipation should be treated under strict medical supervision. Bisacodyl must not be used in children aged 2 years or younger.

Dosage
Short-term treatment of constipation
Adults and children over 10 years:
1–2 coated tablets (5–10 mg) daily, taken before bedtime
Children aged 2 to 10 years:
1 coated tablet (5 mg) daily, taken before bedtime
The correct dose is the minimum required to produce easy evacuation of soft stools. It is advisable to start with the lowest recommended dose.
If necessary, the dose may be increased, but must never exceed the maximum recommended dose.
Warning: Do not exceed the indicated doses.

When and for how long
Preferably take in the evening.
Laxatives should be used as infrequently as possible and for no longer than seven days. Use beyond this period requires a doctor's prescription following adequate individual assessment.

How to take
Take with an adequate amount of water (a full glass). A diet rich in fluids enhances the medicine's effect.
Coated tablets must be swallowed whole, if necessary with an adequate amount of liquid (not milk).

WHAT TO DO IF YOU HAVE TAKEN AN EXCESSIVE DOSE OF THE MEDICINE
Excessive doses may cause abdominal pain and diarrhea; subsequent losses of fluids and electrolytes must be replaced. See also the section "Important information" regarding laxative abuse.
It is important to consult your doctor or pharmacist for appropriate advice on the use of Stixenil.
In case of accidental ingestion/overdose of Stixenil, contact your doctor immediately or go to the nearest hospital.

S ' S,
UNDESIRABLE EFFECTS
Like all medicines, Stixenil can cause undesirable effects, although not everyone experiences them.
The most commonly reported undesirable effects during treatment with Stixenil are abdominal pain and diarrhea.
Immune system disorders: anaphylactic reactions, angioedema, and other hypersensitivity reactions.
Nervous system disorders: dizziness, syncope (episodes of dizziness and syncope occurring after bisacodyl intake appear attributable to a vasovagal response, for example, following abdominal pain or defecation).
Metabolism and nutrition disorders: dehydration.
Gastrointestinal disorders: colitis, abdominal cramps, abdominal pain, diarrhea, vomiting, nausea, hematochezia (blood in stool), abdominal discomfort, anorectal discomfort.
Inform your doctor or pharmacist if any other undesirable effects occur.
Following the instructions in the package leaflet reduces the risk of undesirable effects. These effects are generally transient. However, if they occur, it is advisable to consult your doctor or pharmacist. If any of the undesirable effects worsen, or if you notice any not listed in this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE
Expiry date: See the date on the packaging
The expiry date refers to the product stored in its original unopened packaging, correctly stored
Warning: Do not use the medicine after the expiry date stated on the packaging.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicine out of the reach and sight of children

COMPOSITION
One coated tablet contains:
Active substance: bisacodyl 5 mg
Excipients: lactose, maize starch, talc, glyceryl behenate, magnesium carbonate, methacrylic copolymers, polyethylene glycol 4000, sucrose, titanium dioxide

PRESENTATION
Stixenil is available as coated tablets. The pack contains 20 or 30 coated tablets.

MARKETING AUTHORIZATION HOLDER
Laboratori Alter S.r.l., via Egadi, 7 – 20144 Milan

MANUFACTURER
Officina Farmaceutica FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A - Via R. Follereau, 25 - 24027 Nembro (BG)
December 2012