Section 10: change of date top September 2006

Section 4.4 Special warnings and precautions for use

This section now includes the additional warnings:

PERIOSTAT therapy has been associated with diarrhoea, colitis and vaginal moniliasis which may suggest overgrowth of non-susceptible micro-organisms

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Section 4.7 Effects on ability to drive and use machines

This section now includes the additional warning:

PERIOSTAT therapy has been associated with nausea and dizziness. 

Section 4.8 Undesirable effects

This section now includes the additional warnings:

The following adverse reactions have been observed in patients receiving tetracyclines, including doxycycline:

… Stevens-Johnson syndrome … porphyria … Musculoskeletal: Arthralgia

The following adverse events have been reported during post-marketing:

(Frequency estimate: very common > 1 in 10; common >1 in 100 to <1 in 10; uncommon >1 in 1000 to <1 in 100; rare >1 in 10,000 to <1 in 1000; very rare <1 in 10,000)

Infections

Rare: Vaginal moniliasis, Anogenital moniliasis

Immune system disorders

Rare: Mild allergic reactions

Nervous system disorders

Rare: Headache

Very rare: Dizziness

Gastrointestinal disorders

Rare: Nausea, diarrhoea, dyspepsia

Very rare: Abdominal pain, constipation, dry mouth, superficial tooth discolouration

There have been isolated case reports of bloody diarrhoea, colitis and pseudomembranous colitis.

Skin and subcutaneous tissue disorders

Rare: Rash

Very rare: Urticaria, pruritus, skin photosensitivity

Musculoskeletal disorders

Very rare: Arthralgia

General disorders

Very rare: Asthenia

Section 4.4 Special warnings and precautions for use

This section now includes the additional warnings:

PERIOSTAT therapy has been associated with diarrhoea, colitis and vaginal moniliasis which may suggest overgrowth of non-susceptible micro-organisms

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The galactose intolerance warning is because the film coat on the tablets contains minute quantities of lactose.

Section 4.7 Effects on ability to drive and use machines

This section now includes the additional warning:

PERIOSTAT therapy has been associated with nausea and dizziness. 

Section 4.8 Undesirable effects

This section now includes the additional warnings:

The following adverse reactions have been observed in patients receiving tetracyclines, including doxycycline:

… Stevens-Johnson syndrome … porphyria … Musculoskeletal: Arthralgia

 The following adverse events have been reported during post-marketing:

 (Frequency estimate: very common > 1 in 10; common >1 in 100 to <1 in 10; uncommon >1 in 1000 to <1 in 100; rare >1 in 10,000 to <1 in 1000; very rare <1 in 10,000)

Infections

Rare: Vaginal moniliasis, Anogenital moniliasis

 Immune system disorders

Rare: Mild allergic reactions

 Nervous system disorders

Rare: Headache

Very rare: Dizziness

 Gastrointestinal disorders

Rare: Nausea, diarrhoea, dyspepsia

Very rare: Abdominal pain, constipation, dry mouth, superficial tooth discolouration

 There have been isolated case reports of bloody diarrhoea, colitis and pseudomembranous colitis.

 Skin and subcutaneous tissue disorders

Rare: Rash

Very rare: Urticaria, pruritus, skin photosensitivity

 Musculoskeletal disorders

Very rare: Arthralgia

General disorders

Very rare: Asthenia