Stugeron 15mg Tablets

Section 4.8 –  New text added as introductory paragraph as per below –

 

The safety of Stugeron was evaluated in 372 cinnarizine treated subjects who participated in 7 placebo-controlled, double-blind clinical trials for the indications peripheral circulatory disorders, cerebral circulatory disorders, vertigo and seasickness; and in 668 cinnarizine treated subjects who participated in 6 comparator and 13-open label clinical trials for the indications of peripheral circulatory disorders, cerebral circulatory disorders and vertigo. Based on pooled safety data from these clinical trials, the most commonly reported (>2% incidence) Adverse Drug Reactions (ADRs) were: Somnolence (8.3%) and Weight Increased (2.1%).

 

Deleted below texts –

 

The safety of STUGERON was evaluated in 167 cinnarizine-treated subjects who participated in 1 placebo controlled trial (166 placebo-treated subjects) in the prophylaxis of seasickness. In this trial, only Somnolence has been included as an ADR with an incidence of 8.4% in the cinnarizine group compared to 4.8% in the placebo group.

 

Updated with blue texts as per below as applicable

 

Including the above mentioned ADR, the following ADRs have been observed from clinical trials and post-marketing experiences reported with the use of STUGERON. Frequencies displayed use the following convention:

 

Tabulated presentation of section 4.8 updated as per below – Uncommon frequency column has been added.

Nausea, Hypersomnia, Lethargy, Hyperhidrosis, Stomach Discomfort, Vomiting; Abdominal Pain Upper; Dyspepsia, Fatigue, weight increased has been added.

Lichenoid Keratosis moved from Not known to Uncommon frequency.

Hypersensitivity, Headache, Dry mouth and Gastrointestinal disorder were deleted.

 

 

Section 10: date of revision of text is updated with 06 December 2017.

Addition of the following text to Section 4.8

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Section 4.4:

FROM:

As with other antihistamines, Stugeron may cause epigastric upset, which may be diminished if taken after meals.

 

Cinnarizine is a vasodilator.  While it has not been found to reduce blood pressure significantly, it should be used with caution in those with coronary artery disease or in patients with hypotension.

 

In patients with Parkinson's disease, Stugeron should only be given if the advantages outweigh the possible risk of aggravating this disease.

 

Stugeron may cause somnolence, especially at the start of treatment.  Therefore, caution should be taken when alcohol or CNS depressants are used concomitantly.

 

Because of its antihistamine effect, Stugeron may prevent otherwise positive reactions to dermal reactivity indicators if used up to 4 days prior to skin testing.

 

Use of cinnarizine should be avoided in porphyria.

 

There have been no specific studies in hepatic or renal dysfunction. Stugeron should be used with care in patients with hepatic or renal insufficiency.

 

Patients with rare hereditary problems of galactose intolerance, fructose intolerance, LAPP lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

 

Avoid alcoholic drink.

 

Warning:  Do not exceed the stated dose.

TO:

As with other antihistamines, Stugeron may cause epigastric upset, which may be diminished if taken after meals.

 

Cinnarizine is a vasodilator.  While it has not been found to reduce blood pressure significantly, it should be used with caution in those with coronary artery disease or in patients with hypotension.

 

In patients with Parkinson's disease, Stugeron should only be given if the advantages outweigh the possible risk of aggravating this disease.

 

Stugeron may cause somnolence, especially at the start of treatment.  Therefore, caution should be taken when alcohol or CNS depressants or tricyclic antidepressants are used concomitantly. (See section 4.5).

 

Diagnostic Interference:

Because of its antihistamine effect, Stugeron may prevent otherwise positive reactions to dermal reactivity indicators if used up to 4 days prior to skin testing. (See section 4.5).

 

Use of cinnarizine should be avoided in porphyria.

 

There have been no specific studies in hepatic or renal dysfunction. Stugeron should be used with care in patients with hepatic or renal insufficiency.

 

Patients with rare hereditary problems of galactose intolerance, fructose intolerance, LAPP lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

 

Avoid alcoholic drink.

 

Warning:  Do not exceed the stated dose.

Section 4.5:

added:

Diagnostic interference:

Because of its antihistamine effect, Stugeron may prevent otherwise positive reactions to dermal reactivity indicators if used up to 4 days prior to skin testing.

Section 4.6:

'Fertility' added to title.

Section 4.9:

Deleted:

Within the first hour after ingestion, gastric lavage may be performed.

Section 4.8:

Side effects listed in table along with frequency

Section 5.1:

ATC code added

Section 5.2

More detiled information added for Distribution, Metabolism and Elimination

Section 5.3
Information added where previously no information was available.

Section 6.3: Shelf life chnaged from 5 to 3 years

None provided