Biaxin
(Clarithromycin)

What Biaxin is and what it is used for

Clarithromycin belongs to a group of medicine called macrolide antibiotics. Antibiotics stop the growth of bacteria which cause infections. Clarithromycin is used to treat following infections:
• Chest infections such as bronchitis and pneumonia,
• Throat and sinus infections,
• Skin and soft tissue infections,
• Helicobacter pylori infections associated with duodenal ulcers.

How to take Biaxin

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Clarithromycin may be taken with or without food Clarithromycin 500 mg film-coated tablet is not suitable for doses below 500 mg. There are other options for this strength available on the market. The recommendations for the usual doses are given below: Adults including the elderly and adolescents (children over 12 years) The usual dose is 250 mg twice a day. The usual dose is 250 mg twice daily. In severe infections, your doctor may increase the dose to 500 mg twice daily. The treatment takes 7-14 days and should last at least two days after the disappearance of the symptoms. Package leaflet: Information for the user Clarithromycin 250 mg film-coated tablets Clarithromycin 500 mg film-coated tablets Clarithromycin P1519136 Half Fold: 290 mm Black A/s: 135 x 580 mm Component Item Code Date & Time Customer / Country Version No. Reason Of Issue Reviewed / Approved by Sign / Date Product Name Clarithromycin Leaflet P1519136 Milpharm_Unit 3 02 Revision 30.07.2018 & 10.00 AM Dimensions Pharmacode Team Leader Initiator Additional Information : Artist: No. of Colours : 01 135 x 580 mm Arjun Arief 19136 Packaging Development Supersede item Code: P1516205 Use in infections with H. pylori: In adult patients with ulcers of stomach and duodenum by infection with H. Pylori, as a part of triple combination therapy administered usual dose is 500 mg twice a day. Patients with kidney problems If you have severe kidney problems your doctor may need to reduce your dose by half, i.e. once daily and restrict treatment to 14 days at the most. Children under 12 years Use of Clarithromycin tablets for children under the age of 12 years (under 30 kg bodyweight) is not recommended. Your doctor will prescribe another medication that is appropriate for your chlid. For children with a body weight of more than 30 kg, the same dose as for adults is used. If you feel that the effect of this medicine is too strong or too weak? Please contact your doctor or pharmacist. If you take more Clarithromycin than you should If you have taken too much of Clarithromycin, contact your doctor or nearest hospital emergency department as soon as possible. Overdose can cause gastrointestinal discomfort and possibly other complaints. If you forget to take Clarithromycin If you forget to take a dose of Clarithromycin, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and just carry on as before. Do not take a double dose to make up for a forgotten dose. If you stop taking Clarithromycin It is important that you take your medicine in accordance with the doctor’s instructions. Do not suddenly stop using Clarithromycin without discussing it first with your doctor. Otherwise symptoms may return. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects: If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:
• allergic reactions such as sudden difficulty in breathing, speaking and swallowing
• extreme dizziness or fainting
• severe or itchy skin rash, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs Take as soon as possible, contact your doctor if the following symptoms develop:
• 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. Your doctor may discontinue treatment. Do not take medicines that reduce bowel movements.
• Liver function with following possible symptoms
• loss of appetite
• yellowing of the skin or whites of the eyes (jaundice),
• pale stools, dark urine
• Itchy rash
• Abdominal pain
• Palpitations or irregular heartbeat
• severe pain in the abdomen and back, caused by pancreas inflammation Other possible side effects:

Common (may affect up to 1 in 10 people):
• difficulty sleeping
• headache
• changes in sense of taste
• abdominal pain, nausea, vomiting, diarrhoea, indigestion
• abnormal liver function test results
• skin rash
• excessive sweating.

Uncommon (may affect up to 1 in 100 people):
• yeast infections (candidiasis) (Eg: in the mouth)
• infections of the vagina
• reduction in the level of certain white blood cells, which can make infections more likely ( leucopenia and neutropenia)
• increased number of certain white blood cells (eosinophilia)
• loss of appetite
• anxiety, dizziness, difficulty sleeping, chills
• spinning sensation
• impaired hearing, ringing in the ears (tinnitus)
• palpitations
• inflammation of the stomach, mouth and tongue
• Flatulence, constipation and indigestion
• dry mouth
• chlolestasis
• increase of liver enzymes in the blood
• itching, hives
• muscle pain
• generally feeling unwell
• weakness
• chest pain
• chills
• fatigue Frequency not known [frequency cannot be estimated from the available data]:
• Inflammation of the gut with severe diarrhea called Pseudomembranous collitus,
• Saint Anthony’s fire (erysipelas), acne
• severe reduction of white blood cells associated with sudden high fever, severe sore throat and mouth ulcers (agranulocytosis)
• unusual bruising or bleeding caused by low blood platelets
• Serious allergic reaction which causes swelling of the face or throat (angioedema)
• psychosis, a feeling of loss of identity
• confusion, change in sense of reality or panicking,
• depression, nightmares, disorientation, hallucinations, mania
• convulsions
• disturbed sense of smell, loss of sense of smell or taste
• deafness
• tingling or numbness in the hands or feet
• difficulty with your blood clotting
• discoloration of the teeth and tongue
• acne
• pain or weakness in muscles
• Inflammation of the kidneys, renal failure
• abnormal urine colour. Contact a doctor immediately if you experience a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this side effect is not known (cannot be estimated from the available data).

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Malta ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D’Argens GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt e-mail: [email protected] gov.mt The United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

How to Store Biaxin

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment