Pantopi 40 mg

Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the other excipients listed in section 6.1.

Interaction with other medicinal products

Interaction with other medicinal products and other forms of interaction     Medicinal products with pH-Dependent Absorption Pharmacokinetics Because of profound and long lasting inhibition of gastric acid secretion, pantopimay reduce the absorption of drugs with a gastric pH dependent bioavailability, e.g some azole antifungals as ketoconazole, itraconazole, posaconazole and other medicine such as erlotinib.   HIV protease inhibitors Co-administration of pantopiis not recommended with  HIV  protease inhibitors for which absorption is dependent on acidicintragastric pH such as atazanavir due to significant  reduction in their bioavailability (see section 4.4). If the combination of HIV protease inhibitors with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g virus load) is recommended. A pantopidose of 20 mg per day should not be exceeded. Dosage of the HIV protease inhibitor may need to be adjusted.   Coumarin anticoagulants (phenprocoumon or warfarin) Methotrexate Other interactions studies Medicinal products that inhibit or induce CYP2C19:

Fertility, pregnancy and lactation

Pregnancy A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of Pantoprazole. Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Pantopi  during.   Breast-feeding Animal studies have shown excretion of pantoprazole in breast milk.       Excretion into human milk has been reported in pantopi 40 mg  . Therefore a decision on whether to discontinue breast-feeding or to discontinue/abstain   Fertility There was no evidence of impaired fertility following the administration of pantopiin animal studies (see section 5.3). Pregnancy A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of Pantoprazole. Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Pantopi  during.   Breast-feeding Animal studies have shown excretion of pantoprazole in breast milk.       Excretion into human milk has been reported in pantopi 40 mg  . Therefore a decision on whether to discontinue breast-feeding or to discontinue/abstain   Fertility There was no evidence of impaired fertility following the administration of pantopiin animal studies (see section 5.3).  

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties Pharmacotherapeutic group: Proton pump inhibitors Mechanism of action Pantopi is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells. Pantopi is converted to its active form in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i. e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose- dependent and affects both basal and stimulated acid secretion. In most patients, freedom from symptoms is achieved within 2 weeks. As with other proton pump inhibitors and H2 receptor inhibitors, treatment with pantopi reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible. Since pantopibinds to the enzyme distal to the cell receptor level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously.

PHARMACEUTICAL PARTICULARS

List of excipients Sodium carbonate Decahydrate, Mannitol, Crospovidone(Type XL), Povidone ( Type K90), Calcium stearate, Hydroxypropyl Methyl Cellulose, Povidone(Type K25), Titanium Dioxide, Iron Oxide Yellow, Propylene Glycol, Methacrylic acid copolymer, Triethyl citrate 6.2       Incompatibilities Not applicable. 6.3       Shelf life 2 years for pantopi 40 mg 3 years for pantopi 20 mg 6.4       Special precautions for storage Store at  temp not exceeding 30  c in dry place This medicinal product does not require any special storage conditions. 6.5       Nature and contents of container For pantopi 20 mg : Carton box containing 1, 2 or 3 (AL/PVC) Strips each of 10 tablets and inner leaflet. For pantopi 40 mg : Carton box  containing 1 or 2  (ALAL) blisters each of 7 enteric coated tablets with insert leaflet .