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Antibiotic

CLAMODIA

                                         Amoxicillin (as trihydrate) & clavulanic acid (as potassium clavulanate)

Clamodia 375  Film-Coated Tablets 375mg

Clamodia 625  Film-Coated Tablets 625mg

Please read this leaflet carefully before you start taking the medicine.

  • Keep this leaflet in a safe place. You may need to read it again.
  • If you have any questions ask your doctor or your pharmacist.
  • This medicine was prescribed for you personally and you should not pass it on to others. It can be harmful, even when their symptoms are the same as yours.

Composition:

Active substances: Amoxicillin (as trihydrate) and Clavulanic Acid (as Potassium Clavulanate)

Excipients: Microcrystalline Cellulose, Sodium Lauryl Sulphate, Sodium Starch Glycolate, Colloidal Silicon Dioxide, Magnesium Stearate, Hypromellose, Propylene Glycol, Titanium Dioxide, Purified Talc.

Marketing License Holder & Manufacturer

Remedica Ltd, Limassol Industrial Estate,

Limassol, Cyprus, EU.

 

1.           WHAT IS CLAMODIA AND ITS USES

Clamodia contains a combination of two active substances, Amoxicillin trihydrate with Clavulanic acid, Amoxicillin is an antibiotic belonging to the semi-synthetic derivatives of penicillin. Clavulanic acid belongs to the β-lactamase inhibitors i.e. it inhibits the action of staphylococcal lactamases. Penicillins are used for the treatment of bacterial infections. By their action they cause the death of germs or they inhibit their development. Therefore they help our body to get rid of the germs that cause infections.

Indications

Clamodia is indicated for the short term treatment of bacterial infections caused by bacteria resistant to amoxicillin because of the production of β-lactamases.

Upper respiratory tract infections: – ears, nose and throat – especially sinusitis (infection of the sinuses), otitis media (infection of the medium ear), recurrent tonsillitis (infection of the tonsils).

Lower respiratory tract infections: especially acute exacerbations of chronic bronchitis (especially in severe cases), bronchopneumonia.

Genito-urinary tract and abdominal infections: in particular cystitis (especially when recurrent or complicated (excluding prostatitis), septic abortion, pelvic or puerperal sepsis and intra-abdominal sepsis.

Skin and soft tissue infections: in particular cellulitis, animal bites and severe dental abscesses with spreading cellulitis.

2.           WHAT YOU SHOULD KNOW BEFORE YOU TAKE CLAMODIA

Be particularly careful with Clamodia:

Since it is either contra-indicated or it should be used cautiously in the following cases, please inform your doctor,

  • if you are allergic to the active substances or any of the excipients of the product
  • if you are pregnant or intend to get pregnant or if you are breast feeding
  • if you suffer from jaundice or hepatic insufficiency
  • if you suffer from renal insufficiency

Contra-indications:

Hypersensitivity to the active substances or the excipients of the product, history of jaundice associated with the use of Clamodia or the use of penicillin or cephalosporins, hepatic insufficiency, mononucleosis, children under 12 years.

Interactions

A number of medicines interact with Clamodia and should not be used concomitantly. However, a few of them can be used concomitantly. In this case, your doctor can change the dose or take other cautions if needed. If you are going to take Clamodia it is important to inform your doctor or pharmacist if you are taking any other medication and particularly any of the following:

Probenecid, bacteriostatic drugs (tetracycline), allopurinol, contraceptives, and anticoagulants.

Other forms of interaction: When testing for urine glucose using copper sulphate reagents there is a possibility of getting wrongly positive results. It is recommended to use glucose tests based on enzymatic reactions with oxidase (clinistix or Tes-Tape).

Special precautions:

Special caution in administration is necessary in people with a history of hypersensitivity to the drug or to any other penicillin derivative, as well as in people with a history of asthma.

Pregnancy:

There are no adequate or controlled studies on the use of amoxicillin and Clavulanic acid in pregnant women. As with all medicines Clamodia should be avoided during pregnancy, particularly during the first trimester, unless there is a clear indication that the ratio between benefit and risk is high.

Consult your doctor or pharmacist before taking any medication.

Lactation:

As amoxicillin and clavulanic acid are excreted into human milk, Clamodia should be used cautiously during lactation. Consult your doctor or pharmacist before taking any medication.

Effects on ability to drive or operate machinery

Clamodia is unlikely to affect the ability of driving and machinery operation.

3.           HOW TO TAKE CLAMODIA

Follow your doctor’s instructions.

Adults and Children over 12 years: One tablet of Clamodia 375 mg three times daily. In severe infections one tablet of Clamodia 625mg three times daily.

Elderly: the same as the adult dose but see dosage under renal and hepatic insufficiency.

Tablets of 375 mg and 625 mg are not recommended for children under 12 years.

Dosage in dental infections (e.g. dentoalveolar abscess):

Adults and Children over 12 years: One tablet of Clamodia 375 three times daily for 5 days.

Dosage in renal insufficiency:

Adults:

Mild impairment (creatinine clearance > 30ml/minute): No change in the dosage.

Moderate impairment (creatinine clearance 10 – 30ml/minute): One tablet of 375 mg or one tablet of 625 mg every 12 hours.

Severe impairment (creatinine clearance < 10ml/minute: Not more than one tablet of 375mg every 12 hours. Tablets of 625mg are not recommended.

Dosage in hepatic insufficiency: Give with caution.

Monitoring of hepatic function at regular intervals. There are insufficient data on which to base a dosage pattern.

Every Clamodia tablet of 375mg contains 0,63mmol (25 mg) of Potassium.

Administration of tablets and suspension: To minimise potential gastrointestinal intolerance, administer at the start of a meal.

The duration of therapy depends on the severity of the infection. However the therapy should not exceed 14 days without a review by the doctor.

In case you receive a dose of Clamodia larger than that recommended:

In case of overdose contact your doctor immediately.

Overdose symptoms: Gastrointestinal symptoms (stomach and abdominal pain, vomiting, diarrhoea) and disturbances of fluid and electrolyte balances. Skin rash, hypermotility or drowsiness appeared in a small number of patients.

Treatment: Treatment is symptomatic with particular attention in correcting the disturbances in the fluid and water electrolytes balance.

Amoxicillin and clavulanic acid may be removed from circulation by haemodialysis.

What should you know if you forger to take a dose:

If you have to take the medicine continuously and you forgot to take a dose, you should take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for the missed one.

Consult your doctor in case you missed more than one dose.

4.           POSSIBLE UNDESIRABLE EFFECTS

As with all medicines Clamodia can cause undesirable effects. Most of the undesirable effects, which were manifested during clinical studies, were of a mild and transient nature.

The most common are:

Diarrhoea, nausea, vomiting, skin rashes, pruritus and vaginitis, abdominal discomfort, flatulence and headache.

Gastrointestinal system: Diarrhoea, nausea, vomiting, dyspepsia, gastritis, stomatitis, glossitis, black hairy tongue, mucocutaneous candidiasis, colitis, and haemorrhagic pseudomembranous colitis.

Hypersensitivity reactions: Skin rashes, pruritus, urticaria, angioedema, serum sickness-like reactions, (pruritus or skin rash accompanied by arthritis, arthralgia, myalgia, and often fever), erythema multiforme (rarely Steven-Johnson syndrome) and sporadically exfoliative dermatitis (including toxic epidermal necrolysis). Severe and sporadically fatal hypersensitivity reactions may appear with oral penicillin.

Liver: Hepatic insufficiency with an increase of serum transaminases AST (SGOT and/or ALT (SGPT)), bilirubin and/or alkaline phosphatases, hepatic and cholestatic jaundice. Hepatic disturbances particularly in the elderly.

Kidneys: Interstitial nephritis and haematuria.

Haemopoetic and lymphatic system: Anaemia including haemolytic anaemia, thrombocytopenia, trombopenic purpura, eosinophilia, leucopenia, and agranulocytosis thrombocytosis. Prolongation of prothrombin time has also been reported in patients receiving concomitantly Clamodia and anticoagulants.

Central Nervous System: Rarely restlessness, anxiety, behavioural changes, confusion, convulsions, dizziness, insomnia, headaches and reversible hyperactivity have been observed.

Genito-urinary system: Discharge and sore vaginal itching.

If you have observed undesirable effects that are not mentioned above, please inform your doctor immediately.

5.           SHELF LIFE & STORAGE OF CLAMODIA

Product expiry date:

Shown on the inner and outer packaging. In case the expiry date has lapsed, do not use.

Special precautions for storage of the product:

Clamodia Tablets should be kept at below 25oC, in a safe, cool, dry place, away from light and moisture and out of the reach of children. After opening the container the medicament should be used within 30 days.

6.           OTHER INFORMATION

For any information regarding this pharmaceutical product, contact the Marketing License Holder.

Date of last revision of the leaflet:

November 2012

Legal Category:

Prescription only medicine.

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