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SPC, UK: NITROFURANTOIN Tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Nitrofurantoin 50 mg Tablets. Aratoin 50 mg Tablets.

Qualitative and quantitative composition

Nitrofurantoin 50.00 mg. For the full list of excipients see section 6.1.

Pharmaceutical form

Tablet to be taken orally. Flat yellow, bevelled and scored tablets.

Therapeutic indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures. Nitrofurantoin is specifically ...

Posology and method of administration

Posology Adults Acute Uncomplicated Urinary Tract Infections: 50mg four times daily for seven days. Severe Chronic Recurrence: 100mg four times a day for seven days. Long Term Suppression: 50mg-100mg once ...

Contraindications

Hypersensitivity to the active substance, other nitrofurans or to any of the excipients listed in section 6.1. Patients suffering from renal dysfunction with an eGFR of less than 45 ml/minute. G6PD deficiency ...

Special warnings and precautions for use

Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally non-functioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases. Nitrofurantoin ...

Interaction with other medicinal products and other forms of interaction

Increased absorption with food or agents delaying gastric emptying. Decreased absorption with magnesium trisilicate. Decreased renal excretion of Nitrofurantoin by probenecid and sulfinpyrazone. Decreased ...

Pregnancy and lactation

Pregnancy Animal studies with nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in extensive clinical use since 1952 and its suitability in human pregnancy has been well documented. ...

Effects on ability to drive and use machines

Nitrofurantoin may cause dizziness and drowsiness and the patient should not drive or operate machinery if affected this way.

Undesirable effects

A tabulated list of undesirable effects is outlined below: The undesirable effects are listed according to organ systems and following frequencies: Rare (≥1/10,000 to <1/1,000), Not known (cannot be estimated ...

Overdose

Symptoms Symptoms and signs of overdose include gastric irritation, nausea and vomiting. Management There is no known specific antidote. However, Nitrofurantoin can be haemodialysed in cases of recent ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, nitrofurantoin derivatives ATC code: J01XE01 Mechanism of action Nitrofurantoin is a broad spectrum antibacterial agent, active against the majority ...

Pharmacokinetic properties

Absorption Orally administered nitrofurantoin is readily absorbed in the upper gastrointestinal tract and is rapidly excreted in the urine. Blood concentrations at therapeutic dosages are usually low. ...

Preclinical safety data

Carcinogenic effect of nitrofurantoin in animal studies was observed. However, human data and extensive use of nitrofurantoin over 50 years do not support such suggestion.

List of excipients

Lactose Maize starch Pregelatinised maize starch Sodium starch glycollate Magnesium stearate Purified water

Incompatibilities

None stated.

Shelf life

Shelf life: 36 months.

Special precautions for storage

Do not store above 25˚C. Store in the original package. Keep blister in the outer carton/keep container tightly closed.

Nature and contents of container

High density polystyrene containers with polythene lids and/or polypropylene containers with polypropylene or polythene lids. Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000. 250 micron, pharmaceutical ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

Dr Reddys Laboratories (UK) Limited, 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

Marketing authorization number(s)

08553/0087

Date of first authorization / renewal of the authorization

14/03/2011

Date of revision of the text

20/03/2019

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