NAUTISOL Tablet (2017)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

1. Name of the medicinal product

Nautisol 5mg tablets.

2. Qualitative and quantitative composition

Each tablet contains 5mg prochlorperazine maleate. Excipient with known effect: lactose monohydrate. Each tablet contains 155.00 mg lactose monohydrate. For the full list of excipients, see section ...

3. Pharmaceutical form

Tablet. White, round, flat, scored embossed MC immediate release tablets.

4.1. Therapeutic indications

Vertigo due to Menieres Syndrome, labyrinthis and other causes, and for nausea and vomiting from whatever cause including that associated with migraine. It may also be used for schizophrenia (particularly ...

4.2. Posology and method of administration

Posology Adults Prevention of nausea and vomiting: 5 mg to 10 mg two or three times a day. Treatment of nausea and vomiting: 20 mg stat, followed if necessary by 10 mg two hourslater. Vertigo ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Nautisol should be avoided in patients with liver or renal dysfunction, Parkinsons disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy. It should be avoided ...

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

Adrenaline must not be used in patients overdosed with prochlorperazine.(see section 4.9). The CNS depressant actions of neuroleptic agents may be intensified (additively) by alcohol, barbiturates and ...

4.6. Fertility, pregnancy and lactation

Pregnancy There is inadequate evidence of safety in pregnancy. There is evidence of harmful effects in animals. Prochlorperazine should be avoided in pregnancy unless the physician considers it essential. ...

4.7. Effects on ability to drive and use machines

Patients should be warned about drowsiness during the early days of treatment and advised not to drive or operate machinery.

4.8. Undesirable effects

Generally, adverse reactions occur at a low frequency; the most common reported adverse reactions are nervous system disorders. Adverse reactions are listed below, by system organ class and by frequency. ...

4.9. Overdose

Symptoms Symptoms of phenothiazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extrapyramidal dyskinesias ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antipsychotics -Phenothiazines with piperazine structure ATC code: N05AB04 Prochlorperazine is a potent phenothiazine neuroleptic.

5.2. Pharmacokinetic properties

There is little information about blood levels, distribution and excretion in humans. The rate of metabolism and excretion of phenothiazines decreases in old age.

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.1. List of excipients

The tablets also contain: lactose monohydrate, microcrystalline cellulose, sodium starch glycollate and magnesium stearate.

6.2. Incompatibilities

None known.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Tablets are packed in aluminium foil polyvinylchloride film blisters, with a patient information leaflet, in cartons of 20, 50 or 60 tablets. Tablets are also packed in polyvinylchloride securitainers ...

6.6. Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

6550

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 16/11/1977 Date of renewal: 27/01/2010

10. Date of revision of the text

04/2017

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf