Each film-coated tablet contains 50 mg of pinaverium bromide.
Excipients/Inactive Ingredients (non-medicinal ingredients): Core: microcrystalline cellulose, pregelatinised starch, lactose monohydrate, hydrophobic colloidal silica, talc, magnesium stearate.
Coating: basic butylated metacrylate copolymer, sodium laurylsulfate, stearic acid, talc, hydroxypropyl methylcellulose, iron oxide yellow, iron oxide red.
Pharmacotherapeutic Group: Other drugs for functional bowel disorders.
Pharmacology: Pharmacodynamics: The following is a detailed description of how the active ingredients of Dicetel work. For further explanations please consult a doctor.
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.
Paediatric Population: Pharmacodynamic and efficacy studies have mainly been conducted in adults. In one open, baseline-controlled clinical study the efficacy and safety have been assessed in 29 children aged 5 to 15 over a period of 7-15 days with a daily dose of 100-150 mg. The safety and tolerability was shown to be good. Efficacy was analyzed only for the subset of patients (N=17) suffering from abdominal pain associated to an organic lesion or to previous pathological symptomatology. Overall clinical responses were considered good in 9 patients (53%), partial in 6 patients (35%) and nil in 2 patients (12%).
Pharmacokinetics: The following is a detailed description of how the active ingredients of Dicetel are metabolized by the body. For further explanations please consult a doctor.
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 hours.
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%).
Toxicology: Preclinical safety data: Toxicity: Toxicity of pinaverium bromide after oral administration was low. Signs of toxicity were mostly limited to general signs of toxicity, gastrointestinal symptoms and CNS symptoms.
Genotoxicity, carcinogenic potential, teratogenicity: Pinaverium bromide did not display genotoxic or carcinogenic properties. At doses 2 fold the maximal recommended clinical dose pinaverium had no teratogenic potential.
Reproductive toxicity: At doses 2 fold the maximal recommended clinical dose pinaverium bromide decreased gravidity performance, but had no relevant effect on the pre- or post-natal development. Placental transfer of pinaverium bromide and transfer into the milk were not studied.
Symptomatic treatment of pain, transitory disorders and intestinal discomfort related to functional intestinal disturbances; Symptomatic treatment of pain related to functional disturbances of the biliary tract; Preparation for a barium enema.
Always take Dicetel exactly as the doctor has prescribed. For any questions, contact a doctor or pharmacist.
If the patient forgets to take the tablet(s), do not take a double dose to compensate for it. For further information, ask a doctor or pharmacist for advice.
Posology: Dicetel 50 mg, film-coated tablets: Adults: The recommended dosage is one tablet three times a day up to two tablets twice a day.
If necessary, this dosage may be increased to 2 tablets three times a day.
In preparation for a barium enema, the dosage is 2 tablets twice a day, for the 3 days before the examination.
Method of administration: The tablet must be swallowed without being chewed or sucked, with a glass of water in the middle of a meal in order to avoid contact of pinaverium with oesophageal mucosa (risk of oesophageal lesion, see Adverse Reactions).
Paediatric population: The safety and efficacy of Dicetel have not sufficiently been established in children and experience is limited (see Precautions).
Currently available data are described in Pharmacology: Pharmacodynamics under Actions but no recommendation on a posology can be made.
Overdose may lead to gastrointestinal complaints, such as flatulence and diarrhoea. No specific antidote is known; symptomatic treatment is recommended.
Do not take Dicetel if the patient is hypersensitive to the active substance or to any of the excipients.
Because of a risk of oesophageal lesion, instructions on the methods of administration should be carefully adhered to. Patients with pre-existing oesophageal lesion and/or hiatus hernia should pay special attention to correct application of Dicetel.
The safety and efficacy of Dicetel have not sufficiently been established in children and experience is limited. Therefore, Dicetel is not recommended for use in children.
This medicinal product contains lactose. Patients with rare hereditary problems: of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, do not take this medicine.
Important information about the ingredients: If the patient has an intolerance to some sugars, especially lactose, glucose or galactose, contact a doctor before taking this medicinal product.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Ask the doctor or pharmacist for advice before taking any medicine during pregnancy.
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 (giving birth) or postnatal (following birth) development. The potential risk for humans is unknown. Dicetel should not be used during pregnancy unless clearly necessary.
Furthermore, the presence of bromine should be taken into account. Administration of pinaverium bromide at the end of pregnancy can affect the new-born neurologically (hypotony (decreased muscle tone), sedation (sleepiness)).
There is insufficient information on the excretion of Dicetel in human or animal breast milk. Physico-chemical and available pharmacodynamic/toxicological data on Dicetel point to excretions in breast milk and a risk to the suckling child cannot be excluded. Dicetel should not be used during breast-feeding.
Like all medicines, Dicetel may cause side effects, although not everybody experiences them. If the patient notices any side effects not mentioned, or if any of the side effects gets serious, please inform the doctor or pharmacist.
The following adverse reactions have been reported spontaneously during post-marketing use. A precise frequency can not be estimated form available data (not known).
Gastro-intestinal disturbances have been observed, e.g. abdominal pain, diarrhea, nausea, vomiting, and dysphagia (difficulty swallowing). Oesophageal lesion may occur when not applied as advised (see Dosage & Administration).
Skin and subcutaneous tissue disorders:
Cutaneous (skin) effects have been observed, e.g. rash, pruritus (itchiness), urticaria (hives), and erythema (reddening of the skin).
Immune system disorders:
Hypersensitivity reactions may occur.
Please tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines including medicines obtained without a prescription. Furthermore, if the patient is taking any type of the medications listed as follows, or if unsure of the class of medication being taken, inform the doctor before starting treatment with Dicetel.
Clinical trials have demonstrated the absence of any interaction between pinaverium bromide and digitalis drugs (heart medications), oral anti-diabetics, insulin, oral anticoagulants and heparin.
Co-administration of an anticholinergic drug may enhance spasmolysis.
No interference with laboratory tests for drug level detection was observed.
Any unused product or waste material should be disposed of in accordance with local requirements.
The information in this monograph is limited. For further information, please contact the doctor or pharmacist.
Incompatibilities: Not applicable.
This product can be stored for up to 3 years.
Do not store above 30°C.
A03AX04 - pinaverium ; Belongs to the class of other drugs used for functional bowel disorders.
Coated tab 50 mg (round, biconvex, yellowish-orange coloured film-coated tablets for oral administration, engraved with "50" on one side and 8 mm in diameter) x 1 x 30's.