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Clarithromycin film-coated tablets

 
Maximum Quantity Allowed:
250 mg
500 mg
14 tablets
£

Clarithromycin Film-Coated Tablets contains the active ingredient clarithromycin, which is an
macrolide antibiotic which stop the growth of bacteria which cause infections.

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Description

Clarithromycin Film-Coated Tablets is indicated for use in adults and adolescents over 12 years of
age for the treatment of infections caused by micro-organisms sensitive to clarithromycin. These
infections include:


• Upper respiratory tract infections (e.g. pharyngitis, sinusitis)
• Lower respiratory tract infections (e.g. bronchitis, pneumonia)
• Acute otitis media
• Skin and soft tissue infections (e.g. impetigo, folliculitis, cellulitis, abscesses)
• Tooth and mouth infections (e.g. periapical abscess, periodontitis)
• Disseminated or localised mycobacterial infections

In HIV-infected patients (CD4 cell count ≤100/mm3), clarithromycin is indicated for the prevention
of disseminated infections caused by the Mycobacterium avium (MAC) complex.

In patients with duodenal ulceration and diagnostically confirmed Helicobacter pylori infection,
clarithromycin treatment is recommended simultaneously with preparations that suppress gastric
acid secretion and other antibiotics

Warnings

Talk to your doctor or pharmacist before you start taking Clarithromycin Film-Coated Tablets:

  • if you are pregnant or you think that you may be pregnant
  • if you have a liver or kidney disorder
  • if you have been diagnosed with coronary artery disease, severe heart failure or slowed heart rate

You must inform your doctor, if you are taking one of the following medicines, as it is
contraindicated to use them with Clarithromycin Film-Coated Tablets:

  • ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, to treat migraines)
  • astemizole or terfenadine (medicines used to treat allergy)
  • cisapride or domperidone (a medicine used to treat gastrointestinal tract disorders)
  • pimozide (a medicine used to treat mental disorders)
  • ticagrelor, ranolazine (a medicine used to treat heart and circulatory diseases)
  • colchicine (a medicine used to treat gout)
  • statins – lovastatin, simvastatin (medicines used to lower blood cholesterol)
  • midazolam administered orally (a medicine used to treat anxiety or insomnia)

Directions

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.

Medicine for oral use.

Swallow the tablet whole with water. Do not chew or suck the tablet. The tablets may be taken with or without food.

The usual dose for adults is one 250 mg tablet twice daily (every 12 hours).

In the case of severe infections your doctor may recommend to increase the dose to two 250 mg tablets (that is 500 mg) twice daily (every 12 hours).

The treatment usually takes from 5 to 14 days. 

Ingredients

Each film-coated tablet contains clarithromycin 250mg.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, magnesium
stearate, talc, colloidal anhydrous silica, stearic acid and the coating material Opadry 20H 52875
containing: hypromellose, hydroxypropylcellulose, propylene glycol, vanillin, titanium dioxide, talc
and quinoline yellow lake (E 104)

Side Effects

The following side effects (occur in 1 to 10 patients out of 100) were often reported in clinical
studies and in post-marketing experience with clarithromycin:

  • insomnia
  • taste disturbances, headache
  • diarrhoea, vomiting, indigestion, nausea, abdominal pain
    abnormal liver function results
  • excessive sweating

Uncommon side effects (occur in 1 to 10 patients in 1000):

  • candidiasis (fungal infection), vaginal infection
  • decrease in white blood cells, decrease in neutrophils and increase of eosinophils
  • anorexia, decreased appetite
  • restlessness
  • dizziness, sleepiness, shaking
  • balance disorder, hearing loss, ringing in the ears
  • palpitations, ECG trace changes (QT interval prolongation)
  • inflammation of the stomach, inflammation of the mouth, inflammation of the tongue, bloating, constipation, dry mouth, burping, wind
  • increased liver enzymes activity: alanine aminotransferase, increased aspartate aminotransferase
  • activity, increased gamma-glutamyl transferase activity
  • malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue
  • increased blood enzyme activity: alkaline phosphatase and lactate dehydrogenase

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