Nausicalm

Main information

  • Trade name:
  • Nausicalm 50 mg Tablet
  • Dosage:
  • 50 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, Al-PVC blisters, Dispensary Only Pack, 10 tablets
  • Class:
  • Restricted
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Srikem Laboratories Pvt Ltd

Documents

Localization

  • Available in:
  • Nausicalm 50 mg Tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Nausicalm is indicated for the prevention and treatment of nausea and vomiting including motion sickness, nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period and radiotherapy, especially for breast cancer since cyclizine does not elevate prolactin levels. Nausicalm may be of value in relieving vomiting and attacks of vertigo associated with Meniere's disease and other forms of vestibular disturbance.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 11987
  • Authorization date:
  • 07-02-2005
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

NEW ZEALAND DATA SHEET

NAUSICALM Tablets SPC v 1.0 January 2017

Page 1 of 7

1 PRODUCT NAME

NAUSICALM

Cyclizine hydrochloride 50 mg tablet

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 50 mg cyclizine hydrochloride

Excipient with known effect: Lactose monohydrate

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

White, circular, biconvex, uncoated tablets with a score line on one side, plain on the

other.

The tablets can be divided into two halves.

4 CLINICAL PARTICULARS

4.1

Therapeutic indications

NAUSICALM is indicated for the prevention and treatment of nausea and vomiting

including

motion sickness.

nausea and vomiting caused by narcotic analgesics and by general anaesthetics in

the post-operative period.

nausea and vomiting associated with radiotherapy, especially for breast cancer

since cyclizine does not elevate prolactin levels.

NAUSICALM may be of value in relieving vomiting and attacks of vertigo associated

with Meniere’s disease and other forms of vestibular disturbance.

Dose and method of administration

Route of administration: Oral

Adults and children over 12 years: one tablet up to three times daily

Children 6 – 12 years: half a tablet up to three times daily

Children under 6 years: Not recommended

Use in the Elderly: There have been no specific studies of cyclizine in the elderly.

Experience has indicated that normal adult dosage is appropriate.

NEW ZEALAND DATA SHEET

NAUSICALM Tablets SPC v 1.0 January 2017

Page 2 of 7

4.3

Contraindications

NAUSICALM should not be given to individuals with known hypersensitivity to

cyclizine or to any of the excipients listed in section 6.1.

4.4

Special warnings and precautions for use

Potential anticholinergic effects

As with other anticholinergic agents, cyclizine should be used with caution and

appropriate monitoring in patients with glaucoma, obstructive disease of the

gastrointestinal tract and in males with possible prostatic hypertrophy.

Heart failure

Cyclizine should be used with caution in patients with severe heart failure. In such

patients, cyclizine may cause a fall in cardiac output associated with increases in heart

rate, mean arterial pressure and pulmonary wedge pressure.

Hereditary enzyme deficiency

Patients with rare hereditary problems of galactose insufficiency, the Lapp lactase

deficiency or glucose-galactose malabsorption should not take this medicine.

Renal and hepatic impairment

There have been no specific studies in hepatic and/or renal dysfunction.

Porphyria

Cyclizine should be avoided in porphyria

Epilepsy

Cyclizine should be administered with caution in patients with epilepsy

Sunlight

Cyclizine may increase sensitivity to sunlight

Abuse

There have been reports of abuse of cyclizine, either oral or intravenous, for its

euphoric or hallucinatory effects. The concomitant misuse of cyclizine with large

amounts of alcohol is particularly dangerous, since the antiemetic effect of cyclizine

may increase the toxicity of alcohol (see also Section 4.5 Interactions).

4.5

Interaction with other medicines and other forms of interaction

Cyclizine may have additive effects with alcohol and other central nervous system

depressants e.g. hypnotics, tranquillisers. Cyclizine enhances the soporific effect of

pethidine. Because of its anticholinergic activity cyclizine may enhance the side-

effects of other anticholinergic drugs.

NEW ZEALAND DATA SHEET

NAUSICALM Tablets SPC v 1.0 January 2017

Page 3 of 7

4.6

Fertility, pregnancy and lactation

Pregnancy

Pregnancy Category B3

. Some animal studies are interpreted as indicating that

cyclizine may be teratogenic. In the absence of any definitive data, the use of

cyclizine in pregnancy is not advised.

Breast-feeding

It is not known whether cyclizine or its metabolite are excreted in human milk.

Fertility

There is no experience of the effect of cyclizine on human fertility.

4.7

Effects on ability to drive and use machines

Studies designed to detect drowsiness did not reveal sedation in healthy adults who

took a single oral therapeutic dose (50 mg) of cyclizine.

Patients should not drive or operate machinery until they have determined their own

response.

Although there are no data available, patients should be cautioned that cyclizine may

have additive effects with alcohol and other central nervous system depressants (e.g.

hypnotics and tranquillisers).

4.8

Undesirable effects

a.

Summary of the Safety Profiles

Urticaria, drug rash, drowsiness, dryness of the mouth, nose and throat,

blurred vision,

tachycardia, urinary retention, constipation, restlessness,

nervousness, insomnia and

auditory and visual hallucinations have been

reported, particularly when dosage

recommendations have been exceeded.

b.

Summary of Adverse Reactions

Blood and lymphatic system disorders

Agranulocytosis

Psychiatric disorders

Disorientation, agitation

Nervous system disorders

Somnolence,

headache,

dystonia,

dyskinesia,

extrapyramindal

motor

disturbances,

tremor,

convulsions,

dizziness,

decreased

consciousness,

transient

speech disorders, paraesthesia, generalised chorea.

Eye disorders

Oculogyric crisis

NEW ZEALAND DATA SHEET

NAUSICALM Tablets SPC v 1.0 January 2017

Page 4 of 7

Vascular disorders

Hypertension, hypotension

Respiratory, thoracic and mediastinal disorders

Bronchospasm, apnoea

Hepatobiliary disorders

Hepatic dysfunction, hypersensitivity hepatitis, cholestatic jaundice

cholestatic hepatitis.

Skin and subcutaneous tissue disorders

Urticaria, drug rash, angioedema, fixed drug eruption.

Musculoskeletal and connective tissue disorders

Twitching, muscle spasms

General disorders and administration site conditions

Asthenia. Injection site reactions

including vein tracking, erythema, pain,

thrombophlebitis and blisters. A sensation of

heaviness, chills and pruritus

have been reported rarely.

c.

Description of selected adverse reactions

Single

case

reports

have

been

documented

fixed

drug

eruption,

generalised chorea, hypersensitivity hepatitis and agranulocytosis.

4.9

Overdose

Symptoms:

Symptoms of acute toxicity from cyclizine arise from peripheral anticholinergic

effects and effects on the central nervous system.

Peripheral

anticholinergic

symptoms

include,

mouth,

nose

throat,

blurred vision,

tachycardia and urinary retention. Central nervous system effects

include

drowsiness,

dizziness,

incoordination,

ataxia,

weakness,

hyperexcitability,

disorientation,

impaired

judgement,

hallucinations,

hyperkinesia,

extrapyramidal

motor

disturbances,

convulsions,

hyperpyrexia

and respiratory depression.

An oral dose of 5 mg/kg is likely to be associated with at least one of the

clinical symptoms

stated

above.

Younger

children

more

susceptible

convulsions. The incidence of

convulsions, in children less than 5 years, is

about 60% when the oral dose ingested

exceeds 40 mg/kg.

Treatment:

In the management of acute overdosage with cyclizine, gastric lavage and

supportive

measures for respiration and circulation should be performed if

necessary.

Convulsions should be controlled in the usual way with parenteral

anticonvulsant therapy.

NEW ZEALAND DATA SHEET

NAUSICALM Tablets SPC v 1.0 January 2017

Page 5 of 7

5 PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

ATC Code: R60AE03

Pharmacotherapeutic Group: Piperazine derivatives

Mode of Action:

active

ingredient-cyclizine

piperazine

derivative

with

general

properties of H

blocking drugs but is used as an anti-emetic in a variety of

clinical situations including drug-

induced and motion sickness, vertigo, post-

operative vomiting and radiation sickness. The

mechanism of the anti-emetic

effect is unclear. Cyclizine also possesses anticholinergic

activity but does not

have marked sedative effects.

5.2

Pharmacokinetic properties

Absorption

H1-blockers are well absorbed from the GI tract. Following oral administration

effects develop

within 30 minutes, are maximal within 1-2 hours and last,

for cyclizine, for 4-6 hours.

Biotransformation

Cyclizine is extensively N-demethylated to norcyclizine

in vivo

Distribution

Norcyclizine is widely distributed throughout

the tissues and has a plasma half-life

of less than 1 day.

Elimination

After a single dose of 50 mg cyclizine given to a single adult male volunteer, urine

collected over the following 24 hours contained less than 1% of the total dose

administered.

5.3

Preclinical safety data

Mutagenicity

Cyclizine was not mutagenic in a full Ames test, including use of S9-

microsomes but can nitrosate

in vitro

to form mutagenic products.

Carcinogenicity

No long term studies have been conducted in animals to determine whether

cyclizine has a potential for carcinogenesis. However, long-term studies with

cyclizine administered with nitrate have indicated no carcinogenicity.

Teratogenicity

Some animal studies are interpreted as

indicating

that cyclizine may

NEW ZEALAND DATA SHEET

NAUSICALM Tablets SPC v 1.0 January 2017

Page 6 of 7

teratogenic. The relevance of these studies to the human situation is not known.

Fertility

In a study involving prolonged administration of cyclizine to male and

female rats there was

no evidence of impaired fertility after continuous

treatment for

90 to

100 days.

There

experience of the effect of

cyclizine on human fertility.

6 PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Potato starch

Lactose monohydrate

Gum acacia

Magnesium stearate

6.2

Incompatibilities

Not applicable

6.3

Shelf life

36 months

6.4

Special precautions for storage

Store below 30

6.5

Nature and contents of container

PVC/PVDC/Al blister strips.

Pack sizes of 6, 10, 50 and 100 tablets

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

No special requirements

7 MEDICINE SCHEDULE

Pharmacist Only Medicine

Blister packs of 6

Prescription Only Medicine

Blister packs of 10

Blister packs of 50

NEW ZEALAND DATA SHEET

NAUSICALM Tablets SPC v 1.0 January 2017

Page 7 of 7

Blister packs of 100

8 SPONSOR

AFT Pharmaceuticals Ltd

PO Box 33-203

Takapuna

AUCKLAND

Telephone: (09) 488-0232

Facsimile: (09) 488-0234

9 DATE OF FIRST APPROVAL

13/04/2006

10 DATE OF REVISION OF THE TEXT

January 2017

SUMMARY TABLE OF CHANGES

Version

Date

Change

Approval Date

01/2017

Reformat.

07/02/2017

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Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety