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SPC, UK: MOXONIDINE Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Moxonidine 200 microgram film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 0.2 mg moxonidine. Excipient: lactose monohydrate For a full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Appearance: All tablets are round, approximately 6 mm in diameter. The tablets are light pink.

Therapeutic indications

Mild to moderate essential hypertension.

Posology and method of administration

Posology Adults Treatment must be instituted with the lowest dosage of Moxonidine. This means a daily dose of 0.2 mg moxonidine in the morning. If the therapeutic effect is insufficient, the dose can be ...

Contraindications

Moxonidine must not be used in cases of Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. History of angioneurotic oedema. Sick sinus syndrome or sino-atrial block. ...

Special warnings and precautions for use

Cases of varying degrees of AV block have been reported in the post-marketing setting in patients undergoing moxonidine treatment. Based on these case reports, the causative role of moxonidine in delaying ...

Interaction with other medicinal products and other forms of interaction

Concomitant administration of moxonidine and other antihypertensive agents result in an additive effect. Since tricyclic antidepressants may reduce the effectiveness of centrally acting antihypertensive ...

Pregnancy and lactation

Pregnancy There are no adequate data from use of moxonidine in pregnant women. Studies in animals have shown embryo-toxocological effects (see section 5.3). The potential risk for humans is unknown. Moxonidine ...

Effects on ability to drive and use machines

The effect of moxonidine on the ability to drive or use machines has not been studied. Since, however, there have been reports of drowsiness and dizziness, the patient should exercise caution with regard ...

Undesirable effects

Especially at the beginning of treatment dry mouth, headache, somnolence, asthenia and dizziness have been described frequently. The frequency and intensity of these symptoms often disappear in the course ...

Overdose

Symptoms of overdose In the few cases of overdose that have been reported, a dose of 19.6 mg was ingested acutely without fatality. Signs and symptoms reported included: headache, sedation, somnolence, ...

Pharmacodynamic properties

Pharmacotherapeutic group: antihypertensives, antiadrenergic agents, centrally acting, imidazoline receptor agonists ATC code: C02AC05 In various animal models moxonidine has been shown to be a potent ...

Pharmacokinetic properties

Absorption In humans, about 90% of an oral dose of moxonidine is absorbed; there is no first-pass effect and the bioavailability is 88%. Food intake does not affect moxonidine. Distribution The peak plasma ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. Chronic oral treatment for 52 ...

List of excipients

Tablet core: Lactose monohydrate Crospovidone Povidone K25 Magnesium stearate Film-coating: Hypromellose Titanium dioxide (E171) Macrogol 400 Colouring agents ferric(III) oxide (E172)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

PVC/PVDC/Al blister pack with 10, 20, 28, 30, 50, 60, 98, 100, 400 (20 20, 10 40, as hospital pack sizes only) film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization number(s)

PL 04416/1287

Date of first authorization / renewal of the authorization

05<sup>th</sup> August 2008

Date of revision of the text

24/05/2018

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