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SPC, UK: MACROBID Prolonged-release capsules (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Macrobid 100mg Prolonged-release Capsules.

Qualitative and quantitative composition

Macrobid is a modified release, hard gelatin capsule containing the equivalent of 100mg of Nitrofurantoin in the form of nitrofurantoin macrocrystals and nitrofurantoin monohydrate. Excipient(s) with known ...

Pharmaceutical form

The 100mg capsule has an opaque blue cap and opaque yellow body and bears the monogram GS 100.

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. It is indicated in adults, ...

Posology and method of administration

Posology Adults and children over 12 years of age. The dose should be taken with food or milk (e.g. at meal times). Acute or recurrent uncomplicated UTI and pyelitis: 100mg twice daily for seven days. ...

Contraindications

Hypersensitivity to nitrofurantoin, other nitrofurans or to any of the excipients listed in section 6.1. Patients suffering from renal dysfunction with an eGFR below 45 ml/minute. G6PD deficiency (see ...

Special warnings and precautions for use

Nitrofurantoin is not effective for the treatment of parenchymal infections of a unilaterally 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

Macrobid may cause dizziness and drowsiness. Patients should be advised not to drive or operate machinery if affected in this way until such symptoms go away.

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 specific antidote. However, Nitrofurantoin can be haemodialysed. Standard treatment is by ...

Pharmacodynamic properties

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

Pharmacokinetic properties

Absorption Each Macrobid capsule contains two forms of nitrofurantoin. 25% of the dose is macrocrystalline nitrofurantoin which has slower dissolution and absorption than nitrofurantoin microcrystals. ...

Preclinical safety data

None stated.

List of excipients

Macrobid Capsules contain: Talc Corn starch Lactose carbopol Povidone Sugar Magnesium stearate Gelatin Colouring agents (E104, E171, E132) Printing ink contains: Shellac Propylene glycol (E1520) Titanium ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: The expiry date for the product should not exceed 2 years from the date of its manufacture.

Special precautions for storage

Capsules should be stored in light and moisture resistant containers. Storage temperature should not exceed 30°C (aluminium/ aluminium). Do not store above 25°C (For PVC/ polyethylene/aclar/aluminium blisters). ...

Nature and contents of container

There are two pack sizes, one consists of 14 capsules and the other is a sample pack containing 2 capsules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

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

Marketing authorization holder

Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization number(s)

PL 12762/0052

Date of first authorization / renewal of the authorization

31/03/2000

Date of revision of the text

18/03/2019

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