4.1. Therapeutic indications
 Symptomatic treatment of pain, transit disorders and intestinal discomfort relating to functional intestinal disorders
 Symptomatic treatment of pain related to functional disturbances of the biliary tract
 Preparation for a barium enema

DICETEL 50 mg
Adults:
The recommended dosage is 3 to 4 tablets per day.
Rarely, this dosage can be increased to 6 tablets per day.
In preparation for a barium enema, the dosage is 4 tablets a day, for the 3 days before examination.
Method of administration
The tablets must be swallowed whole with a glass of water in the middle of a meal. They must not be chewed or sucked in order to
avoid contact of pinaverium with the oesophageal mucosa (risk of oesophageal lesion, see section 4.8)..
The tablets must not be swallowed neither when the patient is lying down, nor just before going to bed.
Paediatric population:
The safety and efficacy of pinaverium bromide have not been established in children (see section 4.4).

DICETEL 50 mg
This medicinal product contains Lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency
or glucose-galactose malabsorption (rare hereditary diseases) should not take this medicine.
Because of a risk of upper gastrointestinal damage including esophageal ulcers, instructions on the methods of administration should
be carefully adhered to. Patients with pre-existing esophageal lesion and/or hiatus hernia should pay special attention to correct
methods of administration (see headings 4.2 and 4.8).
DICETEL 50 mg, film-coated tablet, is not recommended for use in children as its safety and efficacy have not sufficiently been
established.

Combinations to be taken into:
+ Atropinic drugs : Co-administration of an anticholinergic drug may enhance spasmolysis.

Fertility
Studies in rats evaluating the effect of pinaverium bromide on fertility and reproductive functions have shown adverse effects on
female fertility at a dose of 50 mg / kg and the no-effect dose (NOAEL) Was 25 mg / kg. The no-effect level (NOAEL) on male fertility
was 50 mg / kg.
Pregnancy
In preclinical studies, no embryotoxic or teratogenic effects of the product has been demonstrated.
Clinically, there are currently insufficient data to help evaluate the teratogenic or fetotoxic of pinaverium bromide when administered
during pregnancy.
Therefore, as a precaution, it is best to avoid the use of pinaverium bromide during pregnancy.

In addition, the presence of bromine in late pregnancy should be taken into account. Indeed, the administration of Pinaverium
bromide at the end of pregnancy can affect the newborn neurologically, because of the presence of bromide, although the reported
cases have been observed with specialties including the intake of bromide was about 20 times higher.
There are no adequate data from the use of pinaverium bromide in pregnant women. Animal studies are insufficient with respect to
effects on pregnancy or embryonal/foetal development or parturition or postnatal development. The potential risk for humans is
unknown. DICETEL should not be used during pregnancy unless clearly necessary.
Moreover, the presence of bromide must be taken into account. In fact, the administration of pinaverium bromide at the end of
pregnancy could affect the neurological newborn (hypotonia, sedation).

Lactation
There is insufficient information on the excretion of Trademark in human or animal breast milk. Physico-chemical and available
pharmacodynamic/toxicological data on Trademark point to excretions in breast milk and a risk to the suckling child cannot be
excluded. DICETEL should not be used during breast-feeding.

No studies on the effects on the ability to drive and use machines have been performed.

Risk of dysphagia, esophagitis or even upper gastrointestinal ulceration including esophageal ulcers that can be aggravated by the
failure to comply with recommendations for administration (see rubrics 4.2 and 4.4)
The following adverse reactions have been reported spontaneously during post-marketing use of DICETEL 50 mg, film-coated table.
A precise frequency can not be estimated from available data.
Gastrointestinal disorders
Gastro-intestinal disturbances e.g. abdominal pain, diarrhea, nausea, vomiting, and dysphagia.
Skin and subcutaneous tissue disorders
Rash, pruritus, urticaria, and erythema.
Immune system disorders
Hypersensitivity.

Reporting suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the
benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions.

To report any side effect(s):

-National Pharmacovigilance Center (NPC)

o Fax: +966-11-205-7662

o SFDA Call Center: 19999

oE-mail: npc.drug@sfda.gov.sa

oWebsite: https://ade.sfda.gov.sa

Gastrointestinal complaints, such as diarrhea, nausea, vomiting and abdominal pain may occur at dosages above 600 mg. In the
post-marketing pharmacovigilance, only one case of accidental overdose has been reported. No specific antidote is known;
symptomatic treatment is recommended.

5.1. Pharmacodynamic properties
Pharmacotherapeutic group: OTHERS MEDICINES FOR FUNCTIONAL BOWEL DISORDERS, ATC CODE:A03 AX04
(A: gastrointestinal tract and metabolism)
Pinaverium bromide is an antispasmodic which selectively acts on the gastro-intestinal tract. It is a calcium antagonist which inhibits
the influx of calcium into intestinal smooth muscle cells. In animal pinaverium directly or indirectly reduces the effects of the
stimulation of the sensitive afferences. It is free from anticholinergic effects. It is also devoid of effects on the cardiovascular system.

After oral administration pinaverium bromide is rapidly absorbed with peak plasma concentrations occurring within one hour. The
drug is extensively metabolized and eliminated via the liver. The elimination half-life is 1.5 hour.
Absolute bioavailability for the oral formulation is very low (< 1%). Major route of excretion is via the feces.
Plasma protein binding of pinaverium bromide is high (95-97%).

Toxicity

Toxicity of pinaverium bromide after oral administration is low. Signs of toxicity were mostly limited to general signs of toxicity,
gastrointestinal symptoms and CNS symptoms.
Genotoxicity and carcinogenic potential
At higher doses pinaverium bromide decreased gravidity performance, but had no relevant effect on the pre- or post-natal
development.
Placental transfer of pinaverium bromide was not studied.
Reproductive Toxicity
Studies in rats evaluating the effect of pinaverium bromide on fertility and reproductive functions have shown adverse effects on
female fertility at a dose of 50 mg / kg and the no-effect dose (NOAEL) Was 25 mg / kg. The no-effect level (NOAEL) on male fertility
was 50 mg / kg. Pinaverium bromide did not show any significant effect on pre- or postnatal development. Embryofetal development
studies in rats and rabbits did not show teratogenic effects. The NOAEL was 50 mg / kg in the rat and 60 mg / kg in the rabbit. Doses
of 150 mg / kg in rats and 180 mg / kg in rabbits showed marked maternal toxicity. The passage of the Pinaverium bromide in the
placenta and in the milk has not been studied.

Core: microcrystalline cellulose, pre-gelatinised starch, lactose monohydrate, anhydrous colloidal silica, talc, magnesium stearate.
Coating: basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, talc, microcrystalline cellulose, iron oxide yellow
(E172), iron oxide red (E172), hydroxypropyl methylcellulose.

Not applicable.

Store below 30°C
Keep the blister in the outer carton in order to protect from light.

20 tablets in blister strips (PVC/Aluminium).
40 tablets in blister strips (PVC/Aluminium).
Not all pack sizes may be marketed.

No particular requirements.