RIDAQ 25 mg / 50 mg Tablet (2023)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

RIDAQ-25 tablets. RIDAQ-50 tablets.

2. Qualitative and quantitative composition

RIDAQ-25 Each tablet of RIDAQ-25 contains 25 mg of hydrochlorothiazide. Contains sugar: Lactose monohydrate 48,59 mg. RIDAQ-50 Each tablet of RIDAQ-50 contains 50 mg hydrochlorothiazide. Contains ...

3. Pharmaceutical form

RIDAQ-25 is a round flat pale peach tablet with bevelled edges and bisected on one side, with a diameter of 6,5 mm. RIDAQ-50 is a round flat pale peach tablet with bevelled edges and bisected on one side, ...

4.1. Therapeutic indications

RIDAQ is indicated for: Oedema due to sodium and water retention. Paradoxically, RIDAQ appears to have an antidiuretic effect on patients with diabetes insipidus and may be of value in the management of ...

4.2. Posology and method of administration

Posology Adults For the treatment of oedema: An initial dose of 25 mg to 100 mg is usually given, and later reduced to a smaller maintenance dose, often given on alternative days. An initial dose ...

4.3. Contraindications

RIDAQ is contraindicated in: Patients with hypersensitivity to hydrochlorothiazide, other sulphonamide-derived medicines or to any of the excipients in RIDAQ (see section 6.1). Patients with anuria or ...

4.4. Special warnings and precautions for use

Hypersensitivity reactions Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma. Hepatobiliary disorders RIDAQ should be used with caution in patients with ...

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

Calcium salts Increased serum calcium levels due to decreased excretion may occur when administered concurrently with thiazide diuretics such as RIDAQ. Antidiabetic medicines (insulin and oral antidiabetics) ...

4.6. Fertility, pregnancy and lactation

The safety of RIDAQ in pregnancy and lactation has not been established (see section 4.3). Pregnancy There is limited experience with RIDAQ during pregnancy, especially during the first trimester. RIDAQ ...

4.7. Effects on ability to drive and use machines

RIDAQ has moderate influence on the ability to drive and use machines. Since adverse reactions such as dizziness, drowsiness and visual disturbance have been reported in patients receiving RIDAQ, patients ...

4.8. Undesirable effects

a) Summary of the safety profile System organ class Frequency unknown (cannot be estimated from the available data) Infections and infestations Sialadenitis Neoplasm benign, malignant ...

4.9. Overdose

Symptoms RIDAQ can produce acute renal failure either from overdosage, producing saline depletion and hypovolaemia or, occasionally, as a result of a hypersensitivity reaction. The most frequent signs ...

5.1. Pharmacodynamic properties

Category and Class: A 18.1 Diuretics Pharmacotherapeutic group: Medicines acting on reno-urinary and genital system ATC code: C03AA03 Mechanism of action Hydrochlorothiazide is a diuretic ...

5.2. Pharmacokinetic properties

Absorption Hydrochlorothiazide is absorbed from the gastrointestinal tract, distributed throughout the extracellular space and diffuses across the placenta. Distribution Hydrochlorothiazide is distributed ...

6.1. List of excipients

RIDAQ-25: Dye P/B orange, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate, purified talc, sodium starch glycollate, starch maize. RIDAQ-50: Dye lennon lake ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

48 months.

6.4. Special precautions for storage

Store at or below 25°C. Keep in the original packaging until required for use.

6.5. Nature and contents of container

RIDAQ-25: 14 or 28 tablets are packed in a printed, metallised, low-density polyethylene lay-flat bag and sealed with a lay-flat zip. 500 tablets are packed in a white polypropylene container, together ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead; 2191

8. Marketing authorization number(s)

RIDAQ-25: M/18.1/35 RIDAQ-50: M/18.1/36

9. Date of first authorization / renewal of the authorization

Date of first authorization: RIDAQ-25: 28 January 1981 RIDAQ-50: 28 January 1981

10. Date of revision of the text

04 March 2023

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