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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
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