NURIKA Hard capsule (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

NURIKA 25 (capsule). NURIKA 50 (capsule). NURIKA 75 (capsule). NURIKA 150 (capsule).

2. Qualitative and quantitative composition

Each hard capsule contains 25 mg, 50 mg, 75 mg, or 150 mg of pregabalin. Contains sugar (mannitol). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

NURIKA hard gelatin capsules contain a white to off-white, granulated powder. NURIKA 25: Ivory opaque hard gelatin capsule imprinted in black with 25 on the capsule body. NURIKA 50: Ivory ...

4.1. Therapeutic indications

Neuropathic pain NURIKA is indicated for the treatment of adult patients with neuropathic pain due to Herpes zoster infections and diabetes.

4.2. Posology and method of administration

The recommended starting dose for NURIKA is 75 mg twice daily (150 mg/day), with or without food. Based on individual patient response and tolerability, the dose may be increased to 150 mg twice daily ...

4.3. Contraindications

NURIKA is contraindicated in patients who are hypersensitive to pregabalin or to any of the excipients.

4.4. Special warnings and precautions for use

Hypersensitivity reactions There have been reports of hypersensitivity reactions, including cases of angioedema and urticaria. NURIKA should be discontinued immediately if symptoms of angioedema, such ...

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

Since NURIKA is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans, does not inhibit medicine metabolism in vitro and is not bound to plasma proteins, NURIKA is unlikely ...

4.6. Pregnancy and lactation

Pregnancy NURIKA should not be used during pregnancy since safety and efficacy has not been established, therefore effective contraception must be used in women of childbearing potential. Breastfeeding ...

4.7. Effects on ability to drive and use machines

NURIKA frequently causes dizziness and somnolence. Therefore, patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether ...

4.8. Undesirable effects

The most frequently reported adverse reactions are dizziness and somnolence. Infections and infestations Frequent: Nasopharyngitis Immune system disorders Frequency unknown: Hypersensitivity ...

4.9. Overdose

Post-marketing reports of pregabalin overdose included affective disorder, somnolence, confusional state, depression, agitation, restlessness, seizures and coma. Treatment of NURIKA overdose should include ...

5.1. Pharmacodynamic properties

A 2.5 Central nervous system depressants – Anticonvulsants, including anti-epileptics ATC code: N03AX16 The active substance, pregabalin, is a gamma-aminobutyric acid (GABA) analogue (S) 3-(aminomethyl) ...

5.2. Pharmacokinetic properties

Absorption Pregabalin is absorbed after oral administration in the fasted state. Peak plasma concentrations are achieved within 1 hour and is independent of dose. Pregabalin oral bioavailability is estimated ...

6.1. List of excipients

Maize starch Mannitol Talc Capsule shell contains: Colourants (titanium dioxide, yellow iron oxide and red iron oxide) Gelatin

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store at or below 25°C in the original container. Keep blisters in the outer carton until required for use. Keep bottles well closed. STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

6.5. Nature and contents of container

NURIKA 25, 50, 75 & 150 are packed in PVC/aluminium blisters. The blister consists of a silver/grey aluminum foil with a transparent, colourless PVC foil. Blisters are contained in an outer carton. ...

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Teva Pharmaceuticals (Pty) Ltd, Maxwell Office Park, Magwa Crescent West, Waterfall City, Midrand, Gauteng, 2090, South Africa Tel: (011) 055 0200

8. Marketing authorization number(s)

NURIKA 25: 46/2.5/0772.764 NURIKA 50: 46/2.5/0773.765 NURIKA 75: 46/2.5/0774.766 NURIKA 150: 46/2.5/0775.767

9. Date of first authorization / renewal of the authorization

23 November 2017

10. Date of revision of the text

29 March 2021

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