PACKAGE LEAFLET

GLYCEROL NEW.FA.DEM., New.Fa.Dem. children 2.25 g rectal solution with chamomile and mallow, New.Fa.Dem. adults 6.75 g rectal solution with chamomile and mallow.

THERAPEUTIC CATEGORY
Laxatives, enemas
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 dehydration. PRECAUTIONS FOR USE Laxatives should be used as infrequently as possible and for no more than seven days. Use for longer periods requires medical prescription following appropriate evaluation of the individual case. Treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medication, and monitoring during therapy. Abuse of laxatives may cause persistent diarrhea with consequent loss of water, electrolytes (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, especially if the patient is concurrently being treated with cardiac glycosides, diuretics, or corticosteroids. Abuse of laxatives, particularly contact laxatives (stimulant 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). In episodes of constipation, it is recommended first to correct dietary habits by supplementing the daily diet with an adequate intake of fiber and water. When using laxatives, it is advisable to drink at least 6–8 glasses of water or other liquids per day to help soften stools. INTERACTIONS Inform your doctor or pharmacist if you have recently taken any other medicinal product, including those without a prescription. No specific interaction studies have been conducted.

SPECIAL WARNINGS
Consult a 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. In children under twelve years of age, the medicine should be used only after consulting a doctor. It is also advisable that elderly patients or those in poor health consult a doctor before using the 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 to its use during pregnancy and breastfeeding, it is recommended to take the medicine only when necessary and under medical supervision.
Effects on the 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 be aware of your individual response to the medicine before driving or operating machinery.
Important information about some excipients: none
Health education notes
First of all, it should be borne in mind 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 a large number of individuals. Constipation should instead be considered when bowel movements are reduced compared to one's usual habits 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 smallest amount sufficient to produce an easy bowel movement. It is advisable to start with the lowest recommended doses.
Adults and adolescents (12–18 years): 1 single-dose adult container as needed, up to a maximum of 1 or 2 administrations per day.
Children aged 6–11 years: 1–2 single-dose pediatric containers as needed, up to a maximum of 1 or 2 administrations per day.
Children aged 2–6 years: 1 single-dose pediatric container as needed, up to a maximum of 1 or 2 administrations per day.
Instructions for use
To remove the safety cannula cap from the single-dose container, place your index finger and thumb on the circular ring located above the bulb and, with the other hand, bend the cannula cap until it detaches from the body of the container. During this operation, never squeeze the bulb, otherwise the medicine may leak before use. It may be helpful to lubricate the cannula with a drop of the solution itself before inserting it into the rectum and then compressing the bulb. Withdraw the cannula while keeping the bulb compressed.
Each container is for single use only; any remaining medicine must be discarded. In children under twelve years of age, the medicine should be used only after consulting a doctor.
Laxatives should be used as infrequently as possible and for no more 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 with consequent loss of water, electrolytes (especially potassium), and other essential nutrients. Fluid and electrolyte losses must be replaced.
Electrolyte imbalances are characterized by the following symptoms: 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 if the patient is concurrently being treated with cardiac glycosides, diuretics, or corticosteroids. Abuse of laxatives, particularly contact laxatives (stimulant laxatives), may cause dependence (and therefore a possible need to progressively increase the dose), 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 doubts about the use of glycerol N ew.Fa.Dem. , consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, glycerol may cause undesirable effects, although not everybody experiences them. The following undesirable effects of glycerol are listed below. There are insufficient data to determine the frequency of the individual effects listed.
Gastrointestinal disorders - Isolated cramp-like pains or abdominal colic and diarrhea, with loss of fluids and electrolytes, more frequent in cases of severe constipation, as well as rectal irritation.
Following the instructions in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsen, or if you notice any undesirable effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging. The expiry date refers to the medicine kept in its original, unopened packaging and stored correctly. Caution – Do not use the medicine after the expiry date stated on the packaging.
Store below 30 °C.
Keep in the original packaging to protect the medicine from moisture and away from direct sources of heat.
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 sight and reach of children.
COMPOSITION
GLYCEROL New.Fa.Dem. children 2.25 g rectal solution with chamomile and mallow.
Each single-dose container contains:
active substance: Glycerol 2.25 g
excipients: wheat starch 0.02 g; chamomile fluid extract 0.10 g; mallow fluid extract 0.10 g; purified water q.s. to 3 g.
GLYCEROL New.Fa.Dem. adults 6.75 g rectal solution with chamomile and mallow.
Each single-dose container contains:
active substance: Glycerol 6.75 g
excipients: starch 0.06 g; chamomile fluid extract 0.30 g; mallow fluid extract 0.30 g; purified water q.s. to 9 g.
PHARMACEUTICAL FORM AND CONTENT
Rectal solution

children 2.25 g rectal solution with chamomile and mallow – one micro-enema in PE with cannula of 3 g
adults 6.75 g rectal solution with camomile and mallow – micro-enema in PE with cannula of 9 g

MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
New.Fa.Dem. srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovie dello Stato, zona A.S.I., Giugliano in Campania, NA.
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY: