NOLPAZA Gastro-resistant tablet (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Nolpaza 20 mg Gastro-Resistant Tablets.

2. Qualitative and quantitative composition

Each gastro-resistant tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate). Excipient with known effect: sorbitol 18 mg/tablet. For the full list of excipients, see section ...

3. Pharmaceutical form

Gastro-resistant tablet. A light brownish yellow, oval, slightly biconvex tablet.

4.1. Therapeutic indications

Adults and adolescents 12 years of age and above Symptomatic gastro-oesophageal reflux disease. For long-term management and prevention of relapse in reflux oesophagitis. Adults Prevention of gastroduodenal ...

4.2. Posology and method of administration

Posology Adults and adolescents 12 years of age and above Symptomatic gastro-oesophageal reflux disease The recommended oral dose is one gastro-resistant tablet Nolpaza 20 mg per day. Symptom relief is ...

4.3. Contraindications

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

4.4. Special warnings and precautions for use

Hepatic impairment In patients with severe liver impairment the liver enzymes should be monitored regularly during treatment with pantoprazole, particularly on long-term use. In the case of a rise of the ...

4.5. 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, pantoprazole may interfere with the absorption of other medicinal ...

4.6. 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 ...

4.7. Effects on ability to drive and use machines

Pantoprazole has no or negligible influence on the ability to drive and use machines. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients ...

4.8. Undesirable effects

Approximately 5% of patients can be expected to experience adverse drug reactions (ADRs). The table below lists adverse reactions reported with pantoprazole, ranked under the following frequency classification: ...

4.9. Overdose

Symptoms There are no known symptoms of overdose in man. Systemic exposure with up to 240 mg administered intravenously over 2 minutes were well tolerated. Management As pantoprazole is extensively protein ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Proton pump inhibitors ATC code: A02BC02 Mechanism of action Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the ...

5.2. Pharmacokinetic properties

Absorption Pantoprazole is rapidly absorbed and the maximal plasma concentration is achieved even after one single 20 mg oral dose. On average at about 2.0 h 2.5 h p.a. the maximum serum concentrations ...

5.3. Preclinical safety data

Preclinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. In the two-year carcinogenicity studies in rats neuroendocrine ...

6.1. List of excipients

Tablet core: Mannitol Crospovidone (type A, type B) Sodium carbonate Sorbitol (E420) Calcium stearate Film coating: Hypromellose Povidone (K25) Titanium dioxide (E171) Iron oxide, yellow ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years HDPE container: After first opening of the container, the product should be used within 3 months.

6.4. Special precautions for storage

Blister pack: Store in the original package in order to protect from moisture. Container: Keep the container tightly closed in order to protect from moisture.

6.5. Nature and contents of container

Blister pack (OPA/Aluminium/PVC film and aluminium foil) in a carton box. Pack-sizes of 7, 14, 15, 28, 30, 56, 60, 84, 100, 100 1, 112 or 140 gastro-resistant tablets. HDPE containers with a silica gel ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

8. Marketing authorization number(s)

PA1347/006/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 13th March 2009 Date of last renewal: 15th August 2016

10. Date of revision of the text

April 2022

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