ERACID belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections. ERACID tablets are used to treat infections such as: □ Chest infections such as bronchitis and pneumonia □ Throat and sinus infections □ Skin and soft tissue infections □ Helicobacter pylori infection associated with duodenal ulcer. ERACID Tablets are indicated in adults and children 12 years and older

□ Know that you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients in the tablets. □ Are taking medicines called ergot alkaloids (e.g. ergotamine or dihydroergotamine) or use ergotamine inhalers for migraine. □ Are taking medicines called terfenadine or astemizole (widely taken for hay fever or allergies) or cisapride or domperidone (for stomach disorders) or pimozide (for mental health problems) as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines. □ Are taking other medicines which are known to cause serious disturbances in heart rhythm. □ Are taking lovastatin or simvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to lower levels of cholesterol (a type of fat) in the blood). □ Are taking oral midazolam (a sedative). □ Are taking a medicine containing lomitapide □ Have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia). □ Have severe liver disease with kidney disease. □ Or someone in your family has a history of heart rhythm disorders (ventricular cardia arrhythmia, including torsades de pointes) or abnormality of electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome”. □ Are taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina) □ Are taking colchicine (usually taken for gout) Take special care with ERACID: Talk to your doctor, pharmacist or nurse before taking ERACID Tablets: □ If you have heart problems (e.g. heart disease, heart failure, an unusually slow heart rate) □ If you have any liver or kidney problems □ If you have, or are prone to, fungal infections (e.g. thrush) □ If you are pregnant or breast feeding Children ERACID tablets are not suitable for use in children under 12 years of age. Taking other medicines with ERACID: You should not take ERACID tablets if you are taking any of the medicines listed in the section above “Do not take ERACID tablets if you;” Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines as your dose may need to be changed or you may need to have regular tests performed: □ Digoxin, quinidine or disopyramide (for heart problems). □ Ibrutinib (for cancer treatment) □ Warfarin, or any other anticoagulant e.g. dabigatran, rivaroxaban, apixaban (for blood thinning) □ Carbamazepine, valproate, phenobarbital or phenytoin (for epilepsy) □ Atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors, commonly known as statins, and used to lower levels of cholesterol (a type of fat) in the blood). Statins can cause rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage) and signs of myopathy (muscle pain or muscle weakness) should be monitored. □ Nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used to lower blood glucose levels) □ Gliclazide or glimepiride (sulphonylureas used in the treatment of type II diabetes) □ Theophylline (used in patients with breathing difficulties such as asthma) □ Triazolam, alprazolam or intravenous or oromucosal midazolam (sedatives) □ Cilostazol (for poor circulation) □ Methadone (used in the treatment of opioid addiction) □ Methylprednisolone (a corticosteroid) □ Vinblastine (for treatment of cancer) □ Ciclosporin, sirolimus and tacrolimus (immune suppressants) □ Etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (anti-viral drugs used in the treatment of HIV) □ Rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used in the treatment of certain bacterial infections) □ Tolterodine (for overactive bladder) □ Verapamil, amlodipine, diltiazem (for high blood pressure) □ Sildenafil, vardenafil and tadalafil (for impotence in adult males or for use in pulmonary arterial hypertension (highblood pressure in the blood vessels of the lung)) □ St John’s Wort (a herbal product used to treat depression) □ Quetiapine or other antipsychotic medicines. □ other macrolide medicines □ lincomycin and clindamycin (lincosamides – a type of antibiotic) Please tell your doctor if you are taking oral contraceptive pills and diarrhoea or vomiting occurs, as you may need to take extra contraceptive precautions such as using a condom. Pregnancy and breast-feeding: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine as the safety of ERACID tablets in pregnancy and breast-feeding is not known. Driving and using machines: ERACID tablets may make you feel dizzy or drowsy. If they affect you in this way do not drive, operate machinery or do anything that requires you to be alert.

Do not give these tablets to children under 12 years. Your doctor will prescribe another suitable medicine for your child. Always take ERACID tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is; For chest infections, throat or sinus infections and skin and soft tissue infections: Usual dose of ERACID tablets for adults and children over 12 years is 250 mg twice daily for 6 to 14 days, e.g. one 250 mg tablet in the morning and one in the early evening. Your doctor may increase the dose to 500 mg twice daily in severe infections. ERACID tablets should be swallowed with at least half a glass of water. For the treatment of Helicobacter pylori infection associated with duodenal ulcers: There are a number of effective treatment combinations available to treat Helicobacter pylori in which ERACID tablets are taken together with one or two other drugs. These combinations include the following and are usually taken for 6 to 14 days: a) One ERACID 500 mg tablet taken twice a day together with amoxycillin, 1000 mg taken twice a day plus lansoprazole, 30 mg twice a day. b) One ERACID 500 mg tablet taken twice a day together with metronidazole, 400 mg taken twice a day plus lansoprazole, 30 mg twice a day. c) One ERACID 500 mg tablet taken twice a day together with amoxycillin, 1000 mg taken twice a day or metronidazole, 400 mg taken twice a day plus omeprazole, 40 mg a day. d) One ERACID 500 mg tablet taken twice a day together with amoxycillin, 1000 mg taken twice a day plus omeprazole, 20 mg taken once a day. The treatment combination which you receive may differ slightly from the above. Your doctor will decide which treatment combination is the most suitable for you. If you are unsure which tablets you should be taking or how long you should be taking them for, please consult your doctor for advice. If you take more ERACID than you should: If you accidentally take more tablets in one day than your doctor has told you to or if a child accidentally swallows some tablets, contact your doctor or nearest hospital emergency department immediately. An overdose of ERACID tablets is likely to cause vomiting and stomach pains. If you forget to take ERACID: If you forget to take a dose of your tablets, take one as soon as you remember. Do not take more tablets in one day than your doctor has told you to. If you stop taking ERACID: Do not stop taking your tablets, even if you feel better. It is important to take the tablets for as long as the doctor has told you to, otherwise the problem might come back. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, ERACID can cause side effects although not everybody gets them. If you suffer from any of the following at any time during your treatment STOP TAKING your tablets and contact your doctor immediately: □ Severe or prolonged diarrhoea, which may have blood or mucus in it. Diarrhoea may occur over two months after treatment with clarithromycin, in which case you should still contact your doctor. □ A rash, difficulty breathing, fainting or swelling of the face, tongue, lips, eyes and throat.This is a sign that you may have developed an allergic reaction. □ Yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tender abdomen or loss of appetite. These are signs that your liver may have inflammation and not be working properly. □ Severe skin reactions such as painful blistering of the skin, mouth, lips, eyes and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis). □ A red, scaly rash with bumps under the skin and blisters (symptoms of exanthematous pustulosis). The frequency of this side effect is not known (cannot be estimated from the available data). □ Rare allergic skin reactions which cause severe illness with ulceration of the mouth, lips and skin which causes severe illness with rash, fever and inflammation of internal organs (DRESS). □ Muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage). Other side effects Common side effects (may affect up to 1 in 10 people) include; □ Difficulty sleeping □ Changes in sense of taste □ Headache □ Widening of blood vessels □ Stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea □ Increased sweating Uncommon side effects (may include up to 1 in 100 people) include: □ High temperature □ Swelling, redness or itchiness of the skin □ Oral or vaginal ‘thrush’ (a fungal infection) □ Inflammation of the stomach and intestines □ Decrease of the levels of blood platelets (blood platelets help stop bleeding) □ Decrease in white blood cells (leukopenia) □ Decrease in neutrophils (neutropenia) □ Stiffness □ Chills □ Increase of eosinophils (white blood cells involved in immunity) □ Exaggerated immune response to a foreign agent □ Lack or loss of appetite □ Anxiety, nervousness □ Drowsiness, tiredness, dizziness or shaking □ Involuntary muscle movements □ Vertigo □ Ringing in the ears or hearing loss □ Chest pain or changes in heart rhythm such as palpitations or an irregular heartbeat □ Asthma: lung disease associated with tightening of air passages, making breathing difficult □ Nosebleed □ Blood clot that causes sudden blockage in a lung artery (pulmonary embolism) □ Inflammation of the lining of the gullet (oesophagus) and lining of the stomach □ Anal pain □ Bloating, constipation, wind, burping □ Dry mouth □ Situation where the bile (fluid made by the liver and stored in the gallbladder) cannot flow from the gallbladder to the duodenum (cholestasis) □ Inflammation of the skin characterized by the presence of the bullae which are filled with fluid, itchy and painful rash □ Muscle spasms, muscle pain or loss of muscle tissue. If your child suffers from myasthenia gravis (a condition in which the muscles become weak and tire easily), clarithromycin may worsen these symptoms. □ Raised abnormal kidney and liver function blood test and raised blood tests □ Feeling weak, tired and having no energy Not known side effects (frequency cannot be estimated from the available data): □ Inflammation of the colon □ Bacterial infection of the outer layers of the skin □ Reduction in the level of certain blood cells (which can make infections more likely or increase the risk of bruising or bleeding) □ Confusion, loss of bearings, hallucinations (seeing things), change in sense of reality or panicking, depression, abnormal dreams or nightmares and mania (feeling of elation or over-excitement) □ Convulsion (fits) □ Paraesthesia, more commonly known as ‘pins and needles’ □ Loss of taste or smell or inability to smell properly □ Type of heart rhythm disorder (Torsade de pointes, ventricular tachycardia) □ Loss of blood (haemorrhage) □ Inflammation of the pancreas □ Discolouration of the tongue or teeth □ Acne □ Change in the levels of products produced by the kidney, inflammation of the kidney or an inability of the kidney to function properly (you may notice tiredness, swelling or puffiness in the face, abdomen, thighs or ankles or problems with urination)

□ Keep out of the reach and sight of children. □ Do not store above 30°C, protected from light. □ Do not use ERACID after the expiry date which is stated on the carton and on the blister, after (EXP).Date. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.