This information is intended for use by health professionals
1. name of the medicative product Stugeron 15 magnesium tablets
2. qualitative and quantitative composition

Each pad contains 15 magnesium cinnarizine .
Excipients with know consequence :
Each pad contains 160 milligram lactose monohydrate and 15 magnesium sucrose .
For the full list of excipients, see section 6.1
3. pharmaceutical form White circular pill with S/15 on one english and JANSSEN on the other side .
4. clinical particulars 4.1 remedy indications Disorders of balance – maintenance therapy for symptoms of labyrinthine disorders, including dizziness, tinnitus, nystagmus, nausea and vomiting such as is seen in Meniere ‘s Disease .
Prophylaxis of gesture sickness
4.2 Posology and method of administration Method of governmentOral. The tablets may be chewed, sucked or swallowed whole.
Oral. The tablets may be chewed, sucked or swallowed solid. posologyStugeron should preferably be taken after meals.
Stugeron should preferably be taken after meals. vestibular symptomsAdults, elderly and children over 12 years: 2 tablets three times a day.
Adults, aged and children over 12 years : 2 tablets three times a day. Children 5 to 12 years : One half the adult drug .
These doses should not be exceeded .
motion sicknessAdults, elderly and children over 12 years: 2 tablets 2 hours before you travel and 1 tablet every 8 hours during your journey.
Adults, aged and children over 12 years : 2 tablets 2 hours before you travel and 1 pad every 8 hours during your travel. Children 5 to 12 years : One half the adult drug .
4.3 Contraindications Stugeron should not be given to patients with known hypersensitivity to cinnarizine .
4.4 particular warnings and precautions for use As with other antihistamines, Stugeron may cause epigastric discomfort ; taking it after meals may diminish the gastric discomfort .
In patients with Parkinson ‘s Disease, Stugeron should merely be given if the advantages outweigh the possible risk of aggravating this disease .
Because of its antihistamine effect, Stugeron may prevent an otherwise positivist reaction to cutaneous responsiveness indicators if used within 4 days prior to testing .
Use of cinnarizine should be avoided in porphyria .
There have been no specific studies in hepatic or nephritic dysfunction. Stugeron should be used with worry in patients with liverwort or nephritic insufficiency .
Patients with rare ancestral problems of fructose or galactose intolerance, Lapp lactase insufficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency, should not take this medicine because it contains lactose and sucrose .
4.5 interaction with other medicative products and other forms of interaction Concurrent use of alcohol, CNS depressants or tricyclic antidepressants may potentiate the ataractic effects of either these drugs or of Stugeron .
4.6 Fertility, pregnancy and lactation The safety of Stugeron in homo pregnancy has not been established although studies in animals have not demonstrated teratogenic effects. As with other drugs it is not advisable to administer Stugeron in pregnancy .
There are no data on the body waste of Stugeron in human breast milk. habit of Stugeron is not recommended in nursing mothers .
4.7 Effects on ability to drive and use machines Stugeron may cause sleepiness, particularly at the beginning of treatment ; patients affected in this way should not drive or operate machinery .
4.8 undesirable effects The safety of Stugeron was evaluated in 303 cinnarizine-treated subjects who participated in 6 placebo-controlled trials for the indications peripheral circulatory disorders, cerebral circulative disorders, dizziness and control of apparent motion illness ; and in 937 cinnarizine-treated subjects who participated in six comparator and 13 open label clinical trials for the indications peripheral circulatory disorders, cerebral circulative disorders and dizziness. Based on pool base hit data from these clinical trials, the most normally reported ( > 1 % incidence ) Adverse Drug Reactions ( ADRs ) were : sleepiness ( 9.9 ), nausea ( 3.0 ) and increase weight ( 1.5 ) .
Including the above mentioned ADRs, the following ADRs have been observed from clinical trials and post-marketing experiences reported with the use of Stugeron. Frequencies displayed use the pursuit convention :
identical park ( ≥ 1/10 ) ; common ( ≥ 1/100 to < 1/10 ) ; uncommon ( ≥ 1/1,000 to < 1/100 ) ; rare ( ≥ 1/10,000 to < 1/1,000 ) ; very rare ( < 1/10,000 ), not known ( can not be estimated from the available data ) .

System Organ Class Adverse Drug Reactions
Frequency Category
Common
( ≥ 1/100 to < 1/10 )
Uncommon
( ≥ 1/1,000 to < 1/100 )
Rare
( ≥ 1/10,000 to < 1/1,000 )
Not Known

Nervous System Disorders sleepiness Hypersomnia

Dyskinesia ; Extrapyramidal disorder ; Parkinsonism ; Tremor
Gastrointestinal Disorders nausea ;

Vomiting ;

Upper abdominal annoyance Dyspepsia ;
Hepato-biliary disorders Cholestatic jaundice
Skin and subcutaneous tissue disorders Hyperhydrosis ;

Lichenoid keratosis including Lichen planus

Subacute cutaneous lupus erythematosus

Musculoskeletal and Connective Tissue Disorders Muscle inflexibility
General Disorders and Administration Site Conditions fatigue duty
Investigations Weight increased

Cases of hypersensitivity, headache and dry mouth have been reported .
report of suspect adverse reactions
Reporting suspect adverse reactions after authority of the medicative intersection is authoritative. It allows proceed monitor of the benefit/risk poise of the medicative product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at : www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store .
4.9 Overdose Symptoms
The signs and symptoms are chiefly due to the anticholinergic ( atropine-like ) activity of cinnarizine .
Acute cinnarizine overdoses have been reported with doses ranging from 90 to 2,250 milligram. The most normally reported signs and symptoms associated with overdose of cinnarizine include : alterations in consciousness ranging from sleepiness to stupor and coma, vomiting, extrapyramidal symptoms, and hypotonia. In a little number of young children, seizures developed. clinical consequences were not severe in most cases, but deaths have been reported after single and polydrug overdoses involving cinnarizine .
Treatment
There is no specific antidote. For any overdose, the treatment is symptomatic and supportive care .
It is advisable to contact a poison operate center to obtain the latest recommendations for the management of an overdose .
5. pharmacological properties 5.1 Pharmacodynamic properties ATC Code N07CA02 .
Cinnarizine has been shown to be a non-competitive adversary of the smooth muscle contractions caused by diverse vasoactive agents including histamine .
Cinnarizine besides acts on vascular fluent muscle by selectively inhibiting the calcium inflow into depolarize cells, thereby reducing the handiness of dislodge Ca2+ ions for the initiation and maintenance of contraction .
vestibular eye reflexes induced by caloric stimulation of the inner ear in wop pigs are markedly depressed by cinnarizine .
Cinnarizine has been shown to inhibit nystagmus .
5.2 Pharmacokinetic properties In animals, cinnarizine is extensively metabolised, N-dealkylation being the major nerve pathway. approximately two thirds of the metabolites are excreted with the faeces, the rest in the urine, chiefly during the first gear five days after a individual dose .
absorption
In man, after oral administration, assimilation is relatively slow, flower serum concentrations occurring after 2.5 to 4 hours .
distribution
The plasma protein tie of cinnarizine is 91 % .
metabolism
Cinnarizine is extensively metabolised chiefly via CYP2D6, but there is considerable interindividual variation in the extent of metabolism .
elimination
The reported elimination half life for cinnarizine ranges from 4 to 24 hours .
The elimination of metabolites occurs as follows : one third in the urine ( unaltered as metabolites and glucuronide conjugates ) and two thirds in the faeces .
5.3 preclinical safety data Nonclinical condom studies showed that effects were observed only after chronic exposures that were 10 – 160 times the recommend maximum daily homo acid of 100 mg/day calculated on a body open area basis, calculated as 2 mg/kg as based on a 50 kilogram person. Cinnarizine blocked the cardiac hERG duct in vitro, however in isolate cardiac tissue and following intravenous lotion in guinea-pigs, no QTc prolongation or proarrhythmic effects were observed at substantially higher exposures than those expected clinically .
In generative studies in the rotter, rabbit, and chase, there was no tell of adverse effects on richness and no teratogenicity. At senior high school doses associated with enate perniciousness in the denounce there was a decrease litter size, an increase in resorptions and a decrease in fetal birth weight .
In vitro mutagenicity studies indicated that the rear compound is not mutagenic however, after reacting with nitrite and forming the nitrosation product, a weak mutagenic activeness was observed. Carcinogenicity studies have not been conducted however, no pre-neoplastic changes were apparent during chronic 18-month oral administration in rats up to approximately 35 times the maximal human dose level .
6. pharmaceutical particulars 6.1 list of excipients lactose monohydrateMaize starch Maize starchSucrose SucroseTalc talcMagnesium stearate magnesium stearatePolyvidone K90
Polyvidone K90 6.2 Incompatibilities none known .
6.3 Shelf biography 3 years .
6.4 special precautions for storage This medicative intersection does not require any particular storehouse conditions .
6.5 nature and contents of container PVC/Aluminium foil blisters
or
Polystyrene tub with polyethylene caps
Each backpack containing 15, 25, 100, 250 or 1000 tablets .
not all battalion sizes may be marketed .
6.6 special precautions for disposal and other handling No particular requirements .
7. Marketing authorization holder Janssen-Cilag Limited50-100 Holmers Farm Way 50-100 Holmers Farm WayHigh Wycombe high WycombeBuckinghamshire BuckinghamshireHP12 4EG HP12 4EGUK
united kingdom 8. Marketing authority number ( s ) PL 00242/5009R
9. date of foremost authorisation/renewal of the mandate Date of first authorization : 14 September 1989

Date of latest renewal: 21 August 2001
Date of latest renewal : 21 August 2001 10. Date of rewrite of the text May 2020

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