Side Effects

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have any of the following symptoms of a severe allergic reaction stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital The frequency of the these reactions is not known (frequency cannot be estimated from the available data) • Sudden difficulty in breathing, speaking and swallowing • Swelling of lips, tongue, face and neck • Extreme dizziness or collapse • Severe or itchy skin rash, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs. • Serious skin reactions: − blistering of the skin, mouth, eyes and genitals (StevensJohnson Syndrome (SJS)) − blistering of the skin, severe skin reaction (Toxic Epidermal Necrosis (TEN)) − skin rash accompanied by other symptoms such as fever, swollen glands and an increase of eosinophils (a type of white blood cell). A rash appears as small, itchy red bumps (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)) If you experience any of the following side effects contact your doctor as soon as possible Rare (may affect up to 1 in 1,000 people): • Increased or reduced urine output, or traces of blood in your urine • Skin eruption that is characterised by the rapid Package leaflet: Information for the user Azithromycin 250 mg film-coated tablets Azithromycin 500 mg film-coated tablets Azithromycin P15XXXXX Black Version: 10 Date & Time: 11.01.2023 & 1.00 PM Submission Code: N07860_u7f Half Fold : 340 mm appearance of areas of red skin studded with small pustules (small blisters filled with white/ yellow fluid) Not known (frequency cannot be estimated from the available data) • Diarrhoea that is serious, lasts a long time or has blood in it, with stomach pain or fever. This can be a sign of a serious bowel inflammation. This is something that can rarely happen after taking antibiotics • Yellowing of the skin or whites of the eyes (jaundice) caused by liver problems • Inflammation of the pancreas (pancreatitis), which causes severe pain in the abdomen and back • Increased or reduced urine output, or traces of blood in your urine • Skin rash caused by sensitivity to sunlight • Unusual bruising or bleeding • Irregular heart beat. These are all serious side effects. You may need urgent medical attention. Other side effects include: Very common (may affect more than 1 in 10 people) • diarrhoea • abdominal pain • feeling sick (nausea) • loose wind (flatulence) Common (may affect up to 1 in 10 people) • lack of appetite (anorexia) • headache • feeling dizzy • sensation of pins and needles or numbness (paraesthesia) • changes in your sense of taste • visual impairment • deafness • being sick (vomiting), stomach pain or cramps, loss of appetite, problems digesting your food • skin rashes and itching • joint pain (arthralgia) • fatigue • change in the quantity of the white blood cells and the concentration of bicarbonate in the blood. Uncommon (may affect up to 1 in 100 people) • thrush (candidiasis) – a fungal infection • bacterial infection • inflammation of the throat (pharyngitis) • breathlessness, chest pain, wheeze and cough (respiratory disorder) • inflammation of the mucous membrane inside the nose (rhinitis) • stomach flu (gastroenteritis) • inflammation inside your vagina (vaginitis) • pneumonia • reduction in the number of white blood cells • angioedema • hypersensitivity • nervousness • reduced sense of touch (hypoaesthesia) • feeling drowsy (somnolence) • having difficulty sleeping (insomnia) • ear disorder • dizziness • spinning sensation (vertigo) • palpitations • hot flushes • shortness of breath • nosebleed • inflammation of the lining of the stomach (gastritis) • constipation • difficulty swallowing • swollen abdomen • dry mouth • belching • mouth ulcer • increased salivary flow • liver problems such as hepatitis • allergic skin reactions such as being sensitive to sunlight, red, flaking and swollen skin • skin rash • itching • inflammation of the skin (dermatitis) • dry skin • increased sweating • pain, swelling and reduced motion in your joints (osteoarthritis) • muscle pain • back pain • neck pain • increase in blood urea levels • painful or difficult urination • pain in the upper back (renal pain) • spotting • testicular disorder • urticaria • chest pain • face swelling • fever • pain • swelling of extremities(peripheral edema) • swelling (oedema) • general feeling of being unwell (malaise) • weakness (asthenia) • change in liver enzyme levels and blood levels • post procedural complications • skin more sensitive to sunlight than normal • abnormal laboratory test values (e.g. blood or liver tests). Rare (may affect up to 1 in 1,000 people) • feeling agitated, feeling of unreality to the self and own feeling • abnormal hepatic function, • allergic skin reactions • skin eruption that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid). • swelling of the hands, feet, lips, genitals or throat (angioneurotic oedema) • kidney problems Not known (frequency cannot be estimated from the available data) • gut (colon) infection (pseudomembranous colitis) • reduced number of red blood cells due to destruction (haemolytic anaemia); reduction in number of platelets (thrombocytopenia) • anaphylactic reaction • feeling angry, aggressive • anxiety • confusion • hallucination • fainting (syncope) • fits (convulsions) • reduced sense of touch (hypoaesthesia) • feeling hyperactive • change in your sense of smell (anosmia, parosmia) • change in your sense of taste (ageusia) • exacerbation or aggravation of muscle weakness (myasthenia gravis) • blurred vision • impaired hearing including loss of hearing, ringing in your ears • rapid (ventricular tachycardia) or irregular heart beat, sometimes being life-threatening, changes of the heart rhythm found by an electro-cardiogram (QT prolongation and torsade de pointes) • low blood pressure • inflammation of the pancreas (pancreatitis) • your tongue changes colour • liver failure • severe allergic skin reactions • inflammation within the kidneys. The following side effects have been reported in prophylactic treatment against Mycobacterium Avium complex (MAC): Very common (may affect more than 1 in 10 people) • diarrhoea • abdominal pain • feeling sick (nausea) • loose wind (flatulence) • abdominal discomfort • loose stools Common (may affect up to 1 in 10 people): • lack of appetite (anorexia) • feeling dizzy • headache • sensation of pins and needles or numbness (paraesthesia) • changes in your sense of taste • visual impairment • deafness • being sick (vomiting), stomach pain or cramps, loss of appetite, problems digesting your food • skin rashes and itching • joint pain (arthralgia) • fatigue Uncommon (may affect up to 1 in 100 people): • reduced sense of touch (hypoaesthesia) • hearing loss or ringing in your ears • palpitations • liver problems such as hepatitis • severe form of skin flushing • allergic skin reactions such as being sensitive to sunlight, red, flaking and swollen skin • general feeling of being unwell (malaise) • weakness (asthenia) Reporting of side effects If you get any side effects,talk to your doctor or pharmacist. This includesany possible side effects notlisted in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: 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.