Confetto Falqui C.M.

Package leaflet: Information for the patient

CONFETTO FALQUI C.M. 5 mg coated tablets

Bisacodyl
Read this leaflet carefully before you take/give this medicine to your child
because it contains important information for you.
Always take/give 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.
• Consult your doctor if you do not notice improvement or if symptoms worsen after 7 days.

Contents of this leaflet:

1. What CONFETTO FALQUI C.M. is and what it is used for
2. What you need to know before taking/giving CONFETTO FALQUI C.M. to your child
3. How to take/give CONFETTO FALQUI C.M. to your child
4. Possible side effects
5. How to store CONFETTO FALQUI C.M.
6. Contents of the pack and other information

1. What CONFETTO FALQUI C.M. is and what it is used for

CONFETTO FALQUI C.M. contains bisacodyl. It belongs to a group of medicines called
stimulant laxatives.
CONFETTO FALQUI C.M. works by stimulating intestinal movements, accelerating the passage
of intestinal contents.
CONFETTO FALQUI C.M. is used in adults, children and adolescents aged between 2 and
18 years for the short-term treatment of occasional constipation.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you should know before taking/giving CONFETTO FALQUI C.M. to your child

Do not take/do not give your child CONFETTO FALQUI C.M.

• If you and/or your child are allergic to bisacodyl or to any of the other ingredients of this medicine (listed in section 6);
• if you and/or your child have intestinal paralysis causing a stoppage of intestinal content movement (paralytic ileus);
• if you and/or your child have acute abdominal conditions, such as inflammation of the appendix (appendicitis), or severe abdominal pain associated with nausea and vomiting, which may be signs indicating serious diseases;
• if you and/or your child have intestinal obstruction or narrowing (intestinal stenosis);
• if you and/or your child have acute inflammation of the stomach and intestines;
• if you and/or your child have rectal bleeding of unknown origin;
• if you and/or your child have severe loss of body water (dehydration state);
• if your child is under 2 years of age;
  If you are pregnant or breastfeeding, see section “Pregnancy and breastfeeding”.

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving your child CONFETTO FALQUI C.M.
Cases of dizziness and/or fainting (syncope) have been reported after taking CONFETTO FALQUI C.M. Data from these cases suggest that such events, rather than being related to the intake of CONFETTO FALQUI C.M., may be interpreted as manifestations of "defecation syncope" (caused by the effort of defecation), or as a reflex response to abdominal pain related to constipation itself.
Like all laxatives, do not take/do not give your child CONFETTO FALQUI C.M. daily or for prolonged periods without first having the cause of constipation evaluated by a doctor. Treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medications, and monitoring during therapy.
In particular, 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 results;
• if you are elderly or in poor health;
• if you/your child have diabetes mellitus, high blood pressure (hypertension), or heart disease (cardiopathy);
• if you/your child have shown intolerance to sugars (See section “CONFETTO FALQUI C.M. contains sucrose and sorbitol”);

Laxative abuse
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhoea, leading to fluid loss (dehydration) or decreased potassium levels in the blood (hypokalaemia).
In more severe cases, low potassium levels may cause heart or muscle disorders, especially if you are also being treated with certain heart medications (cardiac glycosides), medications that increase urine production (diuretics), or those used to treat inflammation (corticosteroids).
Symptoms of intestinal fluid loss (dehydration) may include thirst and reduced urine output (oliguria).
Fluid loss (dehydration) can be dangerous if you/your child have reduced kidney function (renal insufficiency) or if you are elderly; in such cases, stop treatment with CONFETTO FALQUI C.M. and consult your doctor.
Presence of blood in the stool (haematochezia) may also occur, which is usually mild and resolves spontaneously.
Avoid frequent or prolonged use of this medicine, as it may lead to habituation and dependence (i.e. the need to progressively increase the dose and inability to do without the medicine), as well as chronic constipation and loss of normal intestinal function (intestinal atony).
Stimulant laxatives, including CONFETTO FALQUI C.M., do not contribute to weight loss.

Children
This medicine must not be taken by children under 2 years of age (See section “Do not take CONFETTO FALQUI C.M.”).
In children aged between 2 and 10 years, CONFETTO FALQUI C.M. may be taken only after consulting a doctor.

Other medicines and CONFETTO FALQUI C.M.
Inform your doctor or pharmacist if you/your child are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking:

• diuretics (medicines that increase urinary excretion) or adrenocorticosteroids (medicines used to treat inflammation). If you take these medicines and excessive doses of CONFETTO FALQUI C.M., the risk of imbalance in blood electrolytes may increase. This imbalance, in turn, may increase sensitivity to cardioactive glycosides (medicines used to treat heart disorders);
• antacids (medicines used to treat heartburn). These may alter the effect of the medicine; wait at least one hour before taking the laxative.

Laxatives may reduce intestinal transit time, and therefore the absorption of other medicines taken simultaneously by oral route.
Therefore, avoid taking/giving your child laxatives and other medicines at the same time: after taking/giving another medicine to your child, wait at least two hours before taking the laxative.
Concomitant use of other laxatives may enhance gastrointestinal side effects of CONFETTO FALQUI C.M.

CONFETTO FALQUI C.M. with drinks
Milk may alter the effect of the medicine; wait at least one hour before taking/giving your child the laxative.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
There are no adequate and well-controlled studies on the use of this medicine during pregnancy. Therefore, although no adverse or toxic effects have ever been reported during pregnancy, as with all medicines, use CONFETTO FALQUI C.M. during pregnancy only if necessary, under direct medical supervision, after the doctor has evaluated the expected benefit to you against the potential risk to the fetus.

Breastfeeding
Clinical data show that the active form of bisacodyl and its glucuronide derivatives do not pass into breast milk. However, use the medicine only if necessary, under direct medical supervision, after the doctor has evaluated the expected benefit to you against the potential risk to the nursing infant.

Fertility
No studies have been conducted to investigate effects on human fertility.

Driving and using machines
No studies have been conducted on the effects on the ability to drive or use machinery.
Due to reflex responses to abdominal pain caused by constipation itself (e.g. abdominal spasms), dizziness and/or fainting (syncope) may occur. If you/your child experience abdominal pain (abdominal spasms), avoid potentially dangerous activities such as driving vehicles or operating machinery.

CONFETTO FALQUI C.M. contains sucrose and sorbitol
CONFETTO FALQUI C.M. contains sucrose and sorbitol, two types of sugars. If your doctor has diagnosed you/your child with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 0.400 mg of sorbitol per tablet, equivalent to 0.004 mg/mg.

3. How to take CONFETTO FALQUI C.M.

Take/give this medicine to your child exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is as follows:
Adults
1-2 coated tablets per day.
Use in children and adolescents
Children over 10 years: 1-2 coated tablets per day.
Children aged 2 to 10 years: 1 coated tablet per day.
Children aged 10 years or younger with chronic or persistent constipation should take CONFETTO FALQUI C.M. only after consulting a doctor. CONFETTO FALQUI C.M. must not be used in children under 2 years of age.
It is advisable to start with the lowest recommended dose.
The dose may then be increased up to the maximum recommended dose to achieve regular bowel evacuation.
The maximum daily dose must never be exceeded.
Take/give the coated tablets preferably in the evening to achieve evacuation the following morning (after approximately 10 hours). When administered in the morning on an empty stomach, the effect occurs after about five hours.
Do not take/give the coated tablets together with milk, bicarbonate, or medicines for heartburn (antacids).
The coated tablets should be swallowed whole, with an adequate amount of water (a generous glass). A diet rich in fluids enhances the effect of the medicine.
Duration of treatment
Use laxatives as infrequently as possible and for no longer than 7 days. Use for longer periods requires a doctor's prescription following appropriate evaluation of the individual case.
Consult your doctor if the condition recurs or if you notice any recent changes in its characteristics.
As a laxative acting on the intestine (colon), bisacodyl stimulates the natural process of evacuation. Therefore, bisacodyl does not alter digestion or absorption of calories or essential nutrients in the intestine.
If you/your child take(s) more CONFETTO FALQUI C.M. than you/they should
In case of accidental ingestion/overdose of CONFETTO FALQUI C.M., contact your doctor immediately or go to the nearest hospital.
Symptoms
If you/your child take(s) excessive doses of CONFETTO FALQUI C.M., symptoms may include abdominal pain and diarrhea, and significant losses of substances present in the blood (potassium and other electrolytes).
If you/your child chronically abuse CONFETTO FALQUI C.M., as with other laxatives, symptoms may include chronic diarrhea, abdominal pain, decreased potassium levels in the blood (hypokalemia), increased production of a hormone (aldosterone) by the adrenal gland, which may lead to decreased potassium levels in the blood (secondary hyperaldosteronism), and formation of kidney stones (renal calculi). Additionally, kidney damage, reduced acidity in the blood (metabolic alkalosis), and muscle weakness due to low potassium levels in the blood (hypokalemia) may occur. See also the information in section "Warnings and precautions" regarding laxative abuse.
Treatment
If treatment is initiated shortly after ingestion of CONFETTO FALQUI C.M. tablets, absorption may be reduced or prevented by inducing vomiting or performing gastric lavage (emptying of stomach contents, to be performed in hospital). The doctor will replace lost fluids and blood components (electrolytes). This is particularly important in elderly patients or children.
Additionally, the doctor may administer medicines to relieve intestinal muscle contractions (spasmolytics) to you/your child.
If you forget to take/give CONFETTO FALQUI C.M. to your child
Do not take/give a double dose to make up for the forgotten tablet.
If you stop treatment with CONFETTO FALQUI C.M.
If you have any doubts about using 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 following side effects are listed by frequency:
Common (may affect up to 1 in 10 people)

• Abdominal cramps, abdominal pain, diarrhoea, nausea
  Uncommon (may affect up to 1 in 100 people)

• Dizziness (vertigo)

• Blood in stools (haematochezia), vomiting, stomach discomfort, anorectal discomfort
  Rare (may affect up to 1 in 1,000 people)

• Anaphylactic reactions, swelling of the skin and mucous membranes of the face, lips and throat (angioedema), hypersensitivity

• Fluid loss (dehydration)

• Fainting (syncope)

• Inflammation of the intestine (colitis, including ischaemic colitis)

Reporting of side effects
If you and/or your child experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 CONFETTO FALQUI C.M.

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 "expiry".
The expiry date refers to the last day of that month.
Store below 30 °C.
Do not dispose of any medicine 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 CONFETTO FALQUI C.M. contains

• The active substance is bisacodyl. Each coated tablet contains 5 mg of bisacodyl.
• The other components are: microcrystalline cellulose, talc, pregelatinized starch, titanium dioxide, ethyl phthalate, sucrose, glyceryl benzoate, povidone, sorbitol, methacrylic acid copolymer, triethyl citrate, shellac gum, macrogol 6000, sepifilm 002.

Description of the appearance of CONFETTO FALQUI C.M. and package contents
Carton pack containing 20 coated tablets.
Marketing Authorization Holder
Falqui Prodotti Farmaceutici S.r.l. – Via Fabio Filzi, 8 – 20124 Milan – Italy
Manufacturers
DOPPEL FARMACEUTICI S.r.l. – Via Volturno, 48 – Quinto De ‘Stampi’ 20089 Rozzano (MI) – Italy
VAMFARMA S.r.l. - Via Kennedy 5 - Comazzo 26833 Lodi, Italy