GlaxoSmithKline UK

Fertility

Some clinical studies have shown that SSRIs (including paroxetine) may affect sperm quality. This effect appears to be reversible following discontinuation of treatment.  These studies have not examined impact on fertility but changes in sperm quality may affect fertility in some men.

Rare: arthralgia, myalgia.

Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.

Adverse events from paediatric clinical trials

The following adverse events were observed:

Increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility.  Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder.  Increased hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age.

Additional events that were seen are: decreased appetite, tremor, sweating, hyperkinesia, agitation, emotional lability (including crying and mood fluctuations), bleeding related adverse events, predominantly of the skin and mucous membranes.

Events seen after discontinuation/tapering of paroxetine are: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, nausea and abdominal pain (see section 4.4 Special Warnings and Special Precautions for use).

See section 5.1 for more information on paediatric clinical trials.

In short-term (up to 10-12 weeks) clinical trials in children and adolescents, the following adverse events were observed in paroxetine treated patients at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility.  Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder.  Increased hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age.  Additional events that were more often seen in the paroxetine compared to placebo group were: decreased appetite, tremor, sweating, hyperkinesia, agitation, emotional lability (including crying and mood fluctuations).

In studies that used a tapering regimen, symptoms reported during the taper phase or upon discontinuation of paroxetine at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, nausea and abdominal pain (see section 4.4 Special Warnings and Special Precautions for use).

In five parallel group studies with a duration of eight weeks up to eight months of treatment, bleeding related adverse events, predominantly of the skin and mucous membranes, were observed in paroxetine treated patients at a frequency of 1.74% compared to 0.74% observed in placebo treated patients.

Tablet cores:  Dibasic calcium phosphate dihydrate (E341), sodium starch glycolate (Type A), Magnesium stearate (E470b).

Tablet coating:  Hypromellose (E464) Macrogol 400 and polysorbate 80 (E433) and Titanium dioxide (E171).

       Excipient – each 10 ml of oral suspension contains:

-          20 mg methyl parahydroxybenzoate

-          6 mg propyl parahydroxybenzoate

-          0.9 mg FD&C Yellow No. 6 (sunset yellow, EEC No. 110)

-          4 g sorbitol (E420).

Seroxat 20/20 has been amended to Seroxat 20 or 20

Epidemiological studies show an increased risk of bone fractures in patients receiving certain antidepressants, including SSRIs, such as paroxetine. The risk occurs during treatment and is greatest in the first months of therapy.

Common: somnolence, insomnia, agitation, abnormal dreams (including nightmares).

Nervous system disorders

Common: dizziness, tremor, headache.

Uncommon: extrapyramidal disorders.

Rare: convulsions, restless legs syndrome (RLS).

Gastrointestinal disorders

Very common: nausea.

Common: constipation, diarrhoea, vomiting, dry mouth.

/ "30" on one side and a break bar on the reverse

Section 6.5 - Pack sizes: 28, 30, 56 and 60 tablets

Section 10 - 22/5/2009

Section 4.6

Pregnancy

Approval date 17.10.2008

Treatment with paroxetine can be initiated:

-           two weeks after discontinuation of an irreversible MAOI, or

-           at least 24hrs after discontinuation of a reversible MAOI e.g.           moclobemide, linezolid).

Ssection 4.4 - Glaucoma
As with other SSRIs, paroxetine can cause mydriasis and should be used with caution in patients with narrow angle glaucoma or history of glaucoma.

Section 4.5 - Serotonergic drugs

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5‑HT associated effects (serotonin syndrome: see Section 4.4 Special Warnings and Special Precautions for Use). Caution should be advised and a closer clinical monitoring is required when serotonergic drugs (such as L‑tryptophan, triptans, tramadol, linezolid, SSRIs, lithium and St. John's Wort – Hypericum perforatum – preparations) are combined with paroxetine. Concomitant use of paroxetine and MAOIs is contraindicated because of the risk of serotonin syndrome (see Section 4.3 Contraindications).

Pimozide

Increased pimozide levels of on average 2.5 times have been demonstrated in a study of a single low dose pimozide (2 mg) when co‑administered with 60 mg paroxetine. This may be explained by the known CYP2D6 inhibitory properties of paroxetine.

Section 4.8 - Nervous system disorders
Common:  dizziness, tremor, headache. 

Eye disorders
Common: blurred vision.
Uncommon: mydriasis (see section 4.4 Special Warnings and Special Precautions for Use). 

Vascular disorders
Uncommon:  transient increases or decreases in blood pressure, postural hypotension.

Transient increases or decreases of blood pressure have been reported following treatment with paroxetine, usually in patients with pre-existing hypertension or anxiety.

Section 4.9 - Experience of paroxetine in overdose has indicated that, in addition to those symptoms mentioned under section 4.8 "Undesirable Effects", vomiting, fever and involuntary muscle contractions have been reported. 

Section 6.1 - Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)