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V PNC film coated tabl. 250mg, 500mg, 750mg, 1000mg

Summary of Product Characteristics

1.  NAME OF THE MEDICAL PRODUCT

V PNC 250
V PNC 500
V PNC 750
V PNC 1000 

film-coated tablets

2.   QUALITATIVE AND QUANTITATIVE COMPOSITION

Phenoxymethylpenicillinum potassium 250 mg in 1 film-coated tablets
or
Phenoxymethylpenicillinum potassium 500 mg in 1 film-coated tablets
or
Phenoxymethylpenicillinum potassium 750 mg in 1 film-coated tablet
or
Phenoxymethylpenicillinum potassium 1000 mg in 1 film-coated tablets

For a full list of excipients, see section 6.1.

3.   PHARMACEUTICAL FORM
film-coated tablets

Description of:

The PNC 250:     White to yellowish round biconvex film-coated tablets.
                        
The PNC 500:     White to yellowish round biconvex film-coated tablets scored.
                         The tablet can be halved dose
The PNC 750:     White to yellowish oblong film-coated tablets.

PNC In 1000:     White to yellowish oblong film-coated tablets scored.
                        The tablet can be halved dose.

4.  CLINICAL PARTICULARS

4.1. Therapeutic indications

Treatment from mild to moderate infections caused by organisms susceptible to penicillin. They are respiratory infections (bronchitis, bronchopneumonia, pneumonia), infections in the throat, nose and ears (pharyngitis, tonsillitis, sinusitis, otitis media) infections in the face and mouth based on teeth, skin infections (rose, robin, migrant erythema), inflammation of lymph nodes and lymph vessels, scarlet fever (and preventive).
V PNC can be used as prevention of endocarditic during action in the teeth area, mouth and jaws, or upper respiratory tract and as prevention of acute rheumatic fever. 

4.2. Posology and method of administration

Dosage is individualized according to the nature and severity of infection. According to recent empirical experience phenoxymethylpenicillin is also effective when it was administered 3 times daily.

The V PNC is usually used as follows:
    Children from 3 years to 25 kg body weight of 250 mg every 6-8 hours.
    Children 25 to 40 kg body weight, 250 mg - 500 mg every 6 -8 hours.
    Adolescents and adults up to 70 kg body weight of 750 mg every 6-8 hours.
    Adults over 70 kg body weight of 750 mg - 1000 mg every 6-8 hours.
According to the sensitivity of the disease agent and the type and severity of the disease physician benefits may be adjusted accordingly.

The tablets are best taken one hour before food, preferably swallowed unchewed and rinse down a glass of water (200-250 ml). For use after a meal can be delayed transfer of the active substance into the bloodstream and possibly its reduction.

The duration of treatment with penicillin is always decided by the treating physician. Phenoxymethylpenicillin is usually taken 7-10 days, at least 2-3 days after the subsidence of the symptoms of the disease. Therapy must not be interrupted in any way or arbitrarily terminated after resolution of clinical signs of disease, because it is associated with the risk of disease recurrence and later complications (rheumatic fever, glomerulonephritis). 

Adults good tolerate daily dose up to 4000 mg, because penicillin has a low toxicity and with wide therapeutic index.
In elderly patients with renal insufficiency is prolonged biological half-life of phenoxymethylpenicillin for about 4 hours, it is appropriate to extend the time interval between doses.

4.3 Contraindications

Absolute: Known hypersensitivity to penicillins and cephalosporins. Patients should be informed that symptoms (hives, fever, joint pain) can occur suddenly after initiation of therapy and these symptoms should immediately notify your doctor.

Relative: Use in patients with urticaria, bronchial asthma and hay fever.

4.4. Special warnings and precautions for use 

The patients with any type of allergy are more likely to develop allergic reactions during administration of penicillin. Light signs of hypersensitivity reactions may occur after initiation of medication (itching, hives, inflammation of the lining of the mouth and face),  and subsequently dysfunction of stomach and intestines which appear as feeling sick, vomiting,  pain in the abdominal cavity, loose stools or diarrhea. They are usually mild and often disappear already during treatment or after interrupted. The most difficult and exceptional manifestation of hypersensitivity is anaphylactic shock, which usually occurs a few minutes after administration of penicillin. It causes a failure to heart and breathing and patients needed immediate medical help in respect the principles of the first medical aid for anaphylactic shock (epinephrine, norepinephrine, hydrocortisone, antihistamines, calcium). Each patient, who has experienced with an anaphylactic shock, is in acute danger of life and requires intensive care in hospital facilities.

4.5. Interaction with other medicinal products

Penicillin and other medicines may be mutually interact in their effectiveness. Parallel administration of V PNC tablets is contraindicated in chemotherapeutics with a bacteriostatic effect (tetracyclines, sulfonamides, chloramphenicol, etc.) because there is a decrease of antimicrobial effect.
Bacteriostatic drugs (tetracyclines, sulfonamides, chloramphenicol, etc.) may interfere with the bactericidal effect of penicillin and there are decline antimicrobial effects.
Salicylates, indomethacin, phenylbutazone, sulfinpyrazone increase levels of penicillin in blood serum and prolong its effect. Penicillin can temporarily reduce the effectiveness of contraceptives and is therefore recommended contraceptives to ensure otherwise.

4.6. Pregnancy and lactation

In penicillin V was not found any teratogenic properties. The V PNC tablets is therefore possible administered throughout pregnancy in case of infections caused by pathogens susceptible to penicillin. The active substance passes into breast milk. Maximum level in milk is about 50% of the maximum concentration in serum. Infants fed by breast milk were not showed any adverse effects, but there cannot be eliminated the risk of sensitization or affection of intestinal flora. Concentration of penicillin V in human milk during breastfeeding is about 0.1% of maternal dose. 

4.7. Effects on ability to drive and use machines

No known evidence of impairment of attention in driving vehicles or operating machinery while taking the PNC.

4.8. Undesirable effects

The penicillin is usually well tolerated, but may also occur adverse symptoms.

Disorders of the gastrointestinal tract accounts for about 5 to 10% most frequent adverse effects which can occure. These are nausea, vomiting, loss of appetite, tightness in the stomach, bloating and diarrhea. In the case of severe and persistent diarrhea during treatment associated with fever and abdominal pain, or after treatment there is necessary to envisage with the emergence pseudomembranous enterocolitis caused with peniciliin , which must be immediately treated with vancomycin (250 mg 4 times daily per os). Some inhibit peristalsis preparations are contraindicated. Occasionally you may experience skin rashes and inflammation, especially in the mouth (glossitis, stomatitis). Very rarely appears so. "Black hairy tongue."

After taking of V PNC, may emerge transient phenomena as dry mouth or/and taste disturbance. Occasionally allergic reactions may occur, usually in the form of skin reactions (rash, pruritus). In an anaphylactic reaction that can occur as a failure of heartbeat and breathing is needed immediate medical attention.

4.9. Overdose

Toxicity of Phenoxymethylpenicillin is very low, therapeutic width is extremely large. As with other penicillins, single oral ingestion of several doses of phenoxymethylpenicillin do not cause any acute toxicity. During oral administration cannot be practically achieved concentrations that could cause neurotoxic symptoms.
In overdose, no need for special measures, in addition to interruption of medication. Phenoxymethylpenicillin can be eliminated by hemodialysis.

5.  Pharmacological properties

5.1. Pharmacodynamic properties

Pharmacotherapeutic group:         antibiotic.
ATC classification:                       J01CE02 
Phenoxymethylpenicillin (penicillin V) is an biosyntetic antibiotic, unstable against beta-lactamases, stable in acidic media, acting bactericide.

It works by inhibiting bacterial cell wall synthesis (growth phase) by blocking transpeptidases.
Spectrum of antibacterial effects of penicillin V corresponds to the spectrum of penicillin G and includes the following pathogens:

Actinomyces, Bacillus anthracis, Bacteroides, Clostridium, Corynebacterium diphtheriae, Erysipelothrix rhusiopathiae, Fusobacterium, Leptospira, Neisseria gonorrhoeae, Neisseria meningitis, Pasteurella multocida, Spirillum minus, Staphylococcus aureus, Streptobacillus moniliformis, Streptococcus pneumoniae (pneumococcus), Streptoccus pyogenes (type A), Streptococcus (type B and C), Streptococcus bovis (type D), Streptococcus viridans, anaerobic streptococci, Treponema, Veillonella.

Penicillin V is not fault-lactamases and therefore V PNC does not effect on the pathogens, which these enzymes form (such as staphylococcus or gonococcus). Enterococcus (Streptococcus faecalis and faecium) are particularly sensitive.

In Staphylococcus aureus there is an increased resistance up on 70%. In pneumococcus and gonococcus is still low proportion of their resistance, but there is observed upward trend. Gram-positive bacteria are differently sensitive. There is cross-resistance between penicillin V and other oral penicillins, partly with ampicillin. The therapeutic spectrum of penicillin V does not include  the Enterobacteriaceae (eg Escherichia coli, Klebsiella, Enterobacter, and others). Nocardia and Pseudomonas aeruginosa are resistant.

Pathogens with variable sensitivity are:
Bacteroides fragilis and other Bacteroides spp. Brucella, Clostridium perfringens (some strains), Clostridium ramosum (some strains), Fusobacterium varium and Fusobacterium mortiferum.

5.2. Pharmacokinetic Properties

Phenoxymethylpenicillin is stable to gastric acid, and after passing through the stomach is absorbed in the upper small intestine. Absorbtion is from 50 to 60%. The current food intake leads to reduce the absorption.

Maximum serum concentrations are reached after 30 to 60 minutes. The biological serum half-life is 30 to 45 minutes. In neonates and patients with impaired renal function elimination is slow. Phenoxymethylpenicillin is mainly excreted by the kidneys and also a small part by bile. Penicillin V is eliminated by glomerular filtration and renal tubular secretion in kidneys. In urine, which was sampling in time 0-12 hours after the application of antibiotics is approximately 25% of the dose unchanged, microbiologically active form. Approximately 30 to 55% of the dose of Penicillin V is found in the urine as inactive metabolites. Phenoxymethylpenicillin penetrates well into tissues and therapeutic concentrations are achieved in different organs and body fluids. Permeability of the cerebrospinal fluid is low even when meningeal inflammation. Binding to serum proteins is approximately 60% (55-70%).

5.3. Preclinical safety data

Tests for acute toxicity in mice and rats and chronic toxicity studies in rats and dogs did not detect any evidence about toxic effect of penicillin. In published trials have not been described any mutagenic potential of penicillin. Even testing different species of animals did not submit evidence of teratogenic effects. Levels of penicillin in the blood of the fetus reached 44% concentration in maternal blood. Safety of the product has been verified during sufficiently prolonged use in clinical practice.

A quotient between the levels of milk and serum in tests lay in the range 0.05 to 1.02
(mean is 0.15) after a single oral dose of phenoxymethylpenicillin.

6.  PHARMACEUTICAL PARTICULARS

6.1. List of excipients:

calcium hydrogen phosphate, maize starch, microcrystalline cellulose, magnesium stearate, basic butylated methacrylate copolymer, polyethylene glycol 6000, sodium lauryl sulphate, titanium dioxide and stearic acid

6.2. Incompatibilities
They are not.

6.3. Shelf life
5 years

6.4.  Special precautions for storage method

PVC/Aluminum blister: Store in original container in a dry place to store up to 25 ° C.
HDPE bottle with a child-resistant closure: Store in original container in a dry place to store up to 25 ° C.

6.5. Type and contents of container

PVC / Aluminum blister, leaflet, carton
Package size: 
The  V PNC 250: blister PVC / Al (a 10 tablets): 10,20 or 30 film-coated tablets
The  V PNC 500: blister PVC / Al (a 10 tablets):  10,20 or 30 film-coated tablets
The  V PNC 750: blister PVC / Al  (a 10 tablets): 10,20 or 30 film-coated tablets
The V PNC  1000: blister PVC / Al  (a 10 tablets): 10,20 or 30 film-coated tablets

HDPE bottle with a child-resistant closure, leaflet, carton
Package size: 
The V PNC 250: HDPE bottle with a child-resistant closure: 30 film-coated tablets
The V PNC 500: HDPE bottle with a child-resistant closure: 30 film-coated tablets
The V PNC 750: HDPE bottle with a child-resistant closure: 30 film-coated tablets
The V PNC 1000: HDPE bottle with a child-resistant closure: film-coated tablets

In the market may not be all pack sizes.

6.6. Precautions for disposal of a used medicinal product and other handling of the product

The PNC is a preparation for oral administration. The tablets are best taken one hour before food, preferably swallowed unchewed and rinse down a glass of water or fruit juice. 

7.  MARKETING AUTHORISATION HOLDER
G.V. Pharma, a.s.,Štúrova 55, 920 01 Hlohovec
Slovak Republic
8. MARKETING AUTHORISATION NUMBERS
   V PNC 250  tbl fim
   V PNC 500  tbl fim 15/0262/08-S
   V PNC 750  tbl fim 15/0263/08-S
   V PNC 1000  tbl fim 15/0264/08-S
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION     
13.06.2008
10.  DATE OF THE REVISION
 July 2011