SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL    PRODUCT

Econocil / Penicillin VK Tablets 125mg

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Phenoxymethylpenicillin Potassium BP 138.90mg

Also contains lactose; for a full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Phenoxymethylpenicillin potassium is indicated in the treatment of mild to severe infections associated with micro-organisms whose susceptibility to penicillin is within the range of serum levels attained with these dosage forms.

The drug exerts high activity in vitro against staphylococci (except penicillinase-producing strains), streptococci (groups A, C, G, H, L and M), pneumococci. Corynebacterium diphtheriae, bacillus anthracis, clostiria, actinomyces bovis, streptobacillusmoniliformis, listeriamonocytogenes, leptospira, neisseria gonorrhoeae, treponema pallidum.

The following infections (without bacteraemia); Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas.

NOTE: Streptococci in groups A, C, G, H, L and M are very sensitive to Penicillin. Other groups, including group D (enterococcous) are resistant.

Pneumococcal infections: Mild to moderately severe infections of the respiratory tract.

Staphylococcal infections sensitive to Penicillin. Mild infections of the skin and soft tissues.

Fusospirochaetosis (Vincent's gingivitis and pharyngitis). Mild to moderately severe infections of the oropharynx.

Prophylactic usage: Prophylaxis with oral Penicillin has proved effective in preventing recurrence of rheumatic fever and chorea.

Patients with a past history of rheumatic fever receiving continuous prophylaxis may harbour penicillin-resistant organisms. In these patients the use of another prophylactic agent should be considered.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Adults: 125 mg or 250 mg every four to six hours, depending on the severity of the condition.

Elderly:    As for adults. Reduce dosage if renal function is markedly impaired.

Children:    Over 5 years - The adult dose

1 to 5 years - 125 mg every six hours Up to 1 year - 62.5 mg every six hours

Prophylactic use: 125 mg twice daily is recommended for long term prophylaxis of rheumatic fever and chorea.

In all but the most serious cases, the last dose of the day may be doubled to avoid disturbing sleep. Ideally each dose should be given half-an-hour before (or at least three hours after) a meal.

To avoid late complications (rheumatic fever), infections with P-haemolytic streptococci should be treated for 10 days.

To be taken by mouth.

4.3 Contraindications

A previous hypersensitivity reaction to any penicillin

4.4 Special warnings and precautions for use

All degrees of hypersensitivity, including fatal anaphylaxis, have been observed with oral penicillin. These reactions are more likely to occur in individuals with a history of sensitivity to penicillins, cephalosporins and other allergens. Enquiry should be made for such a history before therapy with a penicillin is begun. If an allergic reaction occurs, the drug should be discontinued and the patient treated with the usual agents (e.g. adrenaline and other pressor amines, antihistamines and corticosteroids).

Severe empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with Penicillin V during the acute phase.

Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma.

Oral therapy should not be relied upon in patients with severe illness, or with nausea, vomiting, gastric dilatation, cardiospasm or intestinal hypermotility. Occasionally patients do not absorb therapeutic amounts of orally administered penicillin.

Administer with caution in the presence of markedly impaired renal function, as safe dosage may be lower than that usually recommended.

Streptoccal infections should be treated for a minimum of 10 days, and posttherapy cultures should be performed to confirm the eradication of the organisms.

Prolonged use of antibiotics may promote the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate measures should be taken.

Patients with a past history of rheumatic fever receiving continuous prophylaxis may harbour penicillin-resistant organisms. In these patients the use of another prophylactic agent should be considered.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of neomycin or guar gum reduces the absorption of phenoxymethylpenicillin.

Penicillins may decrease the removal of methotrexate from the body, increasing the risk of toxicity.

Probenecid may decrease the rate of removal of penicillins from the body.

Penicillins may decrease the effectiveness of oestrogen containing contraceptive pills.

Sulfinpyrazone may reduce the excretion of penicillin.

Penicillin should be avoided for 3 days before and after oral typhoid vaccine.

4.6 Pregnancy and lactation

There are no or limited reports of data from the use of Penicillins in pregnant women however Penicillins are not known to be harmful when used during pregnancy but caution should be exercised when prescribing for the pregnant patient.

4.7 Effects on ability to drive and use machines

No known effects

4.8 Undesirable effects

Reactions have been reported much less frequently after oral than after parenteral therapy.

Blood and the lymphatic system disorders

Haemolytic anaemia, leucopenia, thrombocytopenia and coagulation disorders

Nervous system disorders Neuropathy

Immune system disorders

Hypersensitivity reactions, skin eruptions (ranging from maculopapular to exfoliative dermatitis), urticaria, reactions resembling serum sickness, including chills, angioedema, arthralgia and prostration; oedema and laryngeal oedema; interstitial nephritis and fatal anaphylaxis.

Gastrointestinal disorders

Nausea and vomiting, epigastric distress, diarrhoea and black, hairy tongue

Renal and urinary disorders Nephropathy

Skin and subcutaneous tissue disorders Rashes, urticaria

General disorders Fever and eosinophilia

4.9 Overdose

Treatment is symptomatic, but unlikely to be required

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Penicillin is bactericidal to susceptible micro-organisms during the stage of their active multiplication.

5.2    Pharmacokinetic properties

Absorption of Phenoxymethylpenicillin from the gastro-intestinal tract is usually rapid, but peak serum concentrations are variable; peak serum concentrations of about 0.7pg per mo have been observed following a dose of 125mg and 3 to 5pg per ml following 250 to 500mg. The biological half-life of Phenoxymethylpenicillin in serum is about 30 minutes and about 55%-80% is protein bound. Phenoxymethylpenicillin diffuses across the placenta; it also diffuses into ascitic, pericardial, pleural and synovial fluids. There is little diffusion into the cerebrospinal fluid unless the meninges are inflamed. Some 20%-30% of a dose appears in the urine within 24 hours. Only small concentrations are excreted in the bile.

5.3    Preclinical safety data

Not applicable

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Lactose, maize starch, pregelatinised maize starch, sodium starch glycolate, magnesium stearate, IMS

6.2    Incompatibilities

None known

Shelf life

36 months

6.4    Special precautions for storage

Store below 25°C in a dry place in well closed containers Protect from light

6.5    Nature and contents of container

Pack sizes

Polypropylene or high density polystyrene 100 and 500 containers with polythene closures and polyurethane wads or polythene inserts

6.6    Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

Chelonia Healthcare Limited

rd

Boumpoulinas 11, 3 Floor

Nicosia

Cyprus

PC. 1060

Cyprus

8    MARKETING AUTHORISATION NUMBER(S)

PL 33414/0078

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08/08/1986 / 24/02/2009

10 DATE OF REVISION OF THE TEXT

26/06/2012