Side Effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them. Some side effects may be minimised by
taking the lowest dose for the shortest time necessary to relieve the
symptoms. If any of the side effects get serious or if you notice any
side effects not listed in this leaflet, tell your doctor or pharmacist.
STOP TAKING the medicine and seek immediate medical help if
you develop:
• signs of intestinal bleeding such as: bright red faeces
(stools/motions), black tarry stools, vomiting blood or dark
particles that look like coffee grounds.
• signs of serious allergic reaction such as:
– difficulties in breathing or unexplained wheezing
– dizziness or faster heartbeat,
– severe forms of skin reactions such as itchiness, skin rash with
redness, peeling, flaking or blistering (e.g.: Steven-Johnson
syndrome)
– swelling of your face, tongue or throat
• signs of kidney problems such as:
– passing less or more urine
– cloudy urine or blood in urine
– pain in the back and/or swelling (particularly in the legs)
• signs of aseptic meningitis with neck stiffness, headache,
feeling sick, being sick, fever or disorientation. Patients with
autoimmune disorders (lupus, mixed connective tissue disease)
may be more likely to be affected.
• a severe skin reaction known as DRESS syndrome can occur.
Symptoms of DRESS include: skin rash, fever, swelling of lymph
nodes and an increase of eosinophils (a type of white blood cells) • A red, scaly widespread rash with bumps under the skin and
blisters mainly localised on the skin folds, trunk, and upper
extremities accompanied by fever at the initiation of treatment
(acute generalised exanthematous pustulosis) (frequency not
known) See also section 2.
STOP TAKING the medicine and tell your doctor if you
experience the following uncommon side effects which may
affect up to 1 in 100 people:
– indigestion, heartburn or feeling sick
– pains in your stomach (abdomen) or other abnormal stomach
problems
TELL YOUR DOCTOR if you have any of the following side
effects, they become worse or you notice any effects not listed:
Uncommon: may affect up to 1 in 100 people:
– allergic reactions, such as skin rashes (urticaria), itching,
peeling
– headaches
Rare: may affect up to 1 in 1,000 people:
– flatulence (wind), diarrhoea, constipation and vomiting
Very rare: may affect up to 1 in 10,000 people:
– blood disorder resulting in unexplained or unusual bruising or
bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and
severe exhaustion
– drop in blood pressure
– stomach or intestinal ulcers, sometimes with bleeding and
perforation, inflammation of the lining of the mouth with
ulceration (ulcerative stomatitis), inflammation of the stomach
(gastritis)
– liver problems
Not known: frequency cannot be estimated from the available data
– worsening of asthma or bronchospasm
– swelling (oedema), high blood pressure, heart failure or attack
– worsening of colitis and Crohn’s disease
– skin becomes sensitive to light
Medicines such as this medicine may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke.
(See Section 2 ’Other warnings’.)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly 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.
By reporting side effects, you can help provide more information
on the safety of this medicine.