PANTOLOC CONTROL Gastro-resistant tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

PANTOLOC Control 20 mg gastro-resistant tablets.

2. Qualitative and quantitative composition

Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Gastro-resistant tablet. Yellow, oval, biconvex film-coated tablets imprinted with P20 in brown ink on one side.

4.1. Therapeutic indications

PANTOLOC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.

4.2. Posology and method of administration

Posology The recommended dose is 20 mg pantoprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Once complete relief of ...

4.3. Contraindications

Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent ...

4.4. Special warnings and precautions for use

Patients should be instructed to consult a doctor if: They have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, since pantoprazole ...

4.5. Interaction with other medicinal products and other forms of interaction

Medicinal products with pH-dependent absorption pharmacokinetics PANTOLOC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole). ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity. Preclinical studies revealed no evidence of impaired fertility ...

4.7. Effects on ability to drive and use machines

PANTOLOC Control has no or negligible influence on the ability to drive and use machines. However, adverse reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, ...

4.8. Undesirable effects

Summary of the safety profile Approximately 5% of patients can be expected to experience adverse reactions. Tabulated list of adverse reactions The following adverse reactions have been reported with pantoprazole. ...

4.9. Overdose

Doses up to 240 mg administered intravenously over 2 minutes were well tolerated. As pantoprazole is extensively protein bound, it is not readily dialysable. In the case of overdose with clinical signs ...

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

Pharmacokinetics do not vary after single or repeated administration. In the dose range of 10 to 80 mg, the plasma kinetics of pantoprazole are linear after both oral and intravenous administration. Absorption ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. In the 2-year carcinogenicity studies in rats, neuroendocrine ...

6.1. List of excipients

Core: Sodium carbonate, anhydrous Mannitol (E421) Crospovidone Povidone K90 Calcium stearate Coating: Hypromellose Povidone K25 Titanium dioxide (E171) Yellow iron oxide (E172) Propylene ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store in the original package in order to protect from moisture.

6.5. Nature and contents of container

Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Takeda GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Germany Telephone: 0800 825332 4 Telefax: 0800 825332 9

8. Marketing authorization number(s)

EU/1/09/519/001-004

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 12 June 2009 Date of latest renewal: 21 February 2014

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