Phenoxymethylpenicillin Tablets BP 500mg Taj Pharma

  1. Name of the medicinal product

Phenoxymethylpenicillin Tablets BP 250mg Taj Pharma
Phenoxymethylpenicillin Tablets BP 500mg Taj Pharma

  1. Qualitative and quantitative composition

a) Phenoxymethylpenicillin Tablets BP 250mg Taj Pharma
Each film coated tablet contains:
Phenoxymethylpenicillin BP
Equivalent to Phenoxymethylpenicillin potassium Tablets 250mg

b) Phenoxymethylpenicillin Tablets BP 500mg Taj Pharma
Each film coated tablet contains:
Phenoxymethylpenicillin BP
Equivalent to Phenoxymethylpenicillin potassium Tablets 500mg

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film-coated tablet.

  1. Clinical particulars
  • Therapeutic indications

For use in the treatment of mild to moderately severe infections caused by penicillin sensitive organisms.

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

  • Posology and method of administration

Posology

Adults: The dosage is 250-500mg every six hours.

Elderly: The dosage is as for adults. The dosage should be reduced if renal function is markedly impaired.

Prophylactic Use: The dosage is 250mg daily for long term prophylaxis of rheumatic fever.

Paediatric population

Children 1-5 years: 125mg every six hours

6-12 years: 250mg every six hours

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

The treatment of acute otitis media with penicillin V should be limited to 5 days. However, 5-10 days treatment may be recommended in patients with potential for complications.

Method of administration

/Phenoxymethylpenicillin 250mg Film-Coated Tablets are for oral use.

Each tablet should be swallowed whole with water, at least 30 minutes before food, as ingestion of phenoxymethylpenicillin with meals slightly reduces the absorption of the drug.

  • Contraindications

Phenoxymethylpenicillin is contraindicated in patients with known penicillin hypersensitivity.

Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Severe acute infections should not be treated with phenoxymethylpenicillin.

  • Special warnings and precautions for use

Phenoxymethylpenicillin should be given with caution to patients with a history of allergy, especially to other drugs. Phenoxymethylpenicillin should also be given cautiously to cephalosporin-sensitive patients, as there is some evidence of partial cross-allergenicity between the cephalosporins and penicillins. Patients have had severe reactions (including anaphylaxis) to both drugs. If the patient experiences an allergic reaction phenoxymethylpenicillin should be discontinued and treatment with the appropriate agents initiated (e.g. adrenaline and other pressor amines, antihistamines and other corticosteroids).

Particular caution should be exercised in prescribing phenoxymethylpenicillin to patients with an allergic diathesis or with bronchial asthma

Oral penicillins are not indicated in patients with severe illness or with a gastrointestinal disease that causes persistent nausea, vomiting gastric dilation, cardiospasm, intestinal hypermotility or diarrhoea because absorption may be reduced. Occasionally, patients do not absorb therapeutic amounts of orally administered penicillin.

Streptococcal infections should be treated for a minimum of 10 days and post-therapy cultures should be performed to confirm the eradication of the organisms.

In patients undergoing long-term phenoxymethylpenicillin treatment the complete and differential blood count, as well as the liver and kidney function, should be monitored.

During long-term treatment attention should also be paid to the potential overgrowth of resistant organisms including Pseudomonas or Candida. If super-infection occurs, appropriate measures should be taken.

Caution should be used when treating patients with a history of antibiotic-associated colitis.

Each tablet of /Phenoxymethylpenicillin 250mg Film-Coated Tablets contains 28mg of potassium, which may be harmful to people on low potassium diets and may cause stomach upset, diarrhoea and hyperkalaemia. High doses should be used with caution in patients receiving potassium-containing drugs or potassium sparing-diuretics.

In renal impairment the safe dosage may be lower than usually recommended.

During treatment with phenoxymethylpenicillin non-enzymatic glucose tests may be false-positive.

  • Interaction with other medicinal products and other forms of interaction

As penicillins like phenoxymethylpenicillin are only active against proliferating microorganisms, phenoxymethylpenicillin should not be combined with bacteriostatic antibiotics such as tetracycline, erythromycin, chloramphenicol and sulphonamides.

Concomitant use of uricosuric drugs (e.g. probenecid and sulfinpyrazone) reduces the excretion of phenoxymethylpenicillin resulting in increased plasma levels and thus prolongs its action.

Phenoxymethylpenicillin may reduce the excretion of methotrexate causing an increased risk of toxicity.

During treatment with phenoxymethylpenicillin non-enzymatic urinary glucose tests may be false-positive.

Guar gum may slow the speed of absorption of phenoxymethylpenicillin.

Phenoxymethylpenicillin has the following interaction information:

Neomycin – absorption of phenoxymethylpenicillin reduced by neomycin.

Combined use of phenoxymethylpenicillin and oral anticoagulants (e.g. warfarin) may prolong prothrombin time.

Coumarin – common experience in anticoagulant clinics is that INR can be altered by a course of broad-spectrum penicillins such as ampicillin, although studies have failed to demonstrate an interaction with coumarins.

Phenindione – common experience in anticoagulant clinics is that INR can be altered by a course of broad-spectrum penicillins such as ampicillin, although studies have failed to demonstrate an interaction with phenindione.

Thyphoid Vaccines – antibacterials inactive oral typhoid vaccine.

  • Pregnancy and lactation

Pregnancy

Animal studies with phenoxymethylpenicillin potassium have shown no teratogenic effects.

Phenoxymethylpenicillin potassium has been in extensive clinical use and suitability in human pregnancy has been well documented in clinical trials. However, as with other drugs, caution should be exercised when prescribing to pregnant patients.

Lactation

Breast feeding is not contraindicated with phenoxymethylpenicillin potassium. Trace quantities of phenoxymethylpenicillin potassium can be detected in breast milk. While adverse effects are apparently rare, two potential problems exist for nursing infant:

  • modification of bowel flora
  • direct effects on the infant such as allergy/sensitisation

Caution should therefore be exercised when prescribing for the nursing mother.

  • Effects on ability to drive and use machines

None known.

  • Undesirable effects

Hypersensitivity

Potential allergic reactions include urticaria, angioneurotic oedema, erythema multiforme, exfoliative dermatitis, fever, joint pain, serum sickness-like reactions, haemolytic anaemia, interstitial nephritis or anaphylactic shock (which could be fatal) with collapse and anaphylactoid reactions (asthma, purpura, gastrointestinal symptoms). Although these are less common, and take a milder course, in oral treatment than during parenteral penicillin treatment, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been observed with oral penicillin.

Gastro-intestinal tract

Phenoxymethylpenicillin potassium is generally well tolerated. Occasionally soft stools occur and they do not require the interruption of the treatment.

Nausea, diarrhoea, vomiting, stomatitis and glossitis are sometimes seen.

Sustained severe diarrhoea should prompt suspicion of pseudomembranous colitis. As this condition may be life-threatening phenoxymethylpenicillin should be withdrawn immediately and treatment guided by bacteriologic studies with appropriate antibiotherapy (i.e. vancomycin)..

Blood

Eosinophilia, haemolytic anaemia, leukopenia, thrombocytopenia and agranulocytosis are extremely rare. Other possible effects on the blood composition include: neutropenia, haemolytic anaemia and coagulation disorders.

Central nervous system

Central nervous system toxicity, including convulsions, has been reported, especially following high doses or in severe renal impairment. Paraesthesia has been reported with prolonged use.

As with other broad-spectrum antibiotics prolonged use may result in the overgrowth of non-susceptible organisms, e.g. candida. This may present a vulvo-vaginitis.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

  • Overdose

A large overdose may cause nausea, vomiting and diarrhoea. Rarely major motor seizures may occur. There is no known antidote. Symptomatic and supportive therapy is recommended. It is advisable to monitor blood levels in patients with renal malfunction. Phenoxymethylpenicillin may be removed by haemodialysis.

  1. Pharmacological properties
  • Pharmacodynamic properties

Mechanism of action

Phenoxymethylpenicillin is a broad spectrum beta-lactam antibiotic with bactericidal action against Gram-positive bacteria and Gram-negative cocci. Its antimicrobial action is similar to that of benzyl penicillin. Phenoxymethylpenicillin is usually active against the following organisms:

Gram-positive aerobes and anaerobes including

Bacillus anthracis

Clostridium perfringens

Clostridium tetani

Corynebacterium diphtheriae

Erysipelothrix rhusiopathiae

Listeria monocytogenes

Peptostreptococcus spp.

Streptococcus agalactiae (Group B)

Streptococcus pneumoniae

Streptococcus pyogenes (Group A)

Gram-negative including

Neisseria meningitidis

Neisseria gonorrhoeae

Phenoxymethylpenicillin is inactivated by penicillinase and other beta-lactamases.

Phenoxymethylpenicillin binds to penicillin-binding proteins located on the inner membrane of the bacterial cell wall. Phenoxymethylpenicillin binds to and inactivates these proteins resulting in weakening of the bacterial cell wall and lysis.

  • Pharmacokinetic properties

Absorption

Phenoxymethylpenicillin is stable under acidic conditions so it can be administered by oral route.

Phenoxymethylpenicillin is rapidly, but incompletely absorbed after oral administration and the absorption level is around 60%. The simultaneous administration of food slightly decreases the peak plasma concentration of phenoxymethylpenicillin, but does not appear to affect the extent of absorption. Peak plasma concentrations are reached in about 45 minutes. The peak plasma concentration increases approximately in proportion with increased doses. Peak serum concentrations of 3-6 jig per ml have been seen following dosage of 250mg to 500mg by mouth.

Distribution

Phenoxymethylpenicillin is widely distributed round the body tissues and fluids (volume of distribution about 0.2 1 kg-1 of body weight) and more readily penetrates inflamed tissues. It also diffuses across the placenta into foetal circulation and small amounts appear in the milk of nursing mothers. Eighty per cent is reported to be protein bound.

Biotransformation

Phenoxymethylpenicillin is partially metabolised to inactive penicilloic acid by hydrolysis of the lactam ring. This metabolism occurs in the liver.

Elimination

The plasma half-life of phenoxymethylpenicillin is about 45 minutes which may increase to four hours in renal failure.

Excretion is by tubular secretion into urine. About 40% of the dose is eliminated in the urine either as under unchanged or as penicilloic acid in the first 10 hours after oral administration. Small excretion occurs in bile.

Impaired absorption is seen in patients with coeliac disease.

  • Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this SPC.

  1. Pharmaceutical particulars
  • List of excipients

Tablet core, Magnesium stearate, Talc, Macrogol 6000, Povidone, Maltodextrin

Tablet coating

Titanium dioxide, Hypromellose, Talc

  • Incompatibilities

There are no known incompatibilities.

  • Shelf life

This medicinal product as packaged for sale has a shelf life of two years.

  • Special precautions for storage

The following applies to the storage of Phenoxymethylpenicillin 250mg &500mg Film-Coated Tablets:

  • “Do not store above 25°C”
  • ‘Store in the original packaging” (when packaged in blisters)
  • ‘Keep the container tightly closed” (when packaged in securitainers)

Nature and contents of container

The 250mg & 500mg film coated tablets are presented in the following containers

  • Polypropylene containers with polyethylene snap on caps containing 50, 500 tablets.
  • Blister strips of 10, 14, 20, 21, 28 or 30 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Phenoxymethylpenicillin Tablets BP 500mg Taj Pharma

Package leaflet: Information for the user

(Phenoxymethylpenicillin)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Phenoxymethylpenicillin Tablets are and what they are used for
  2. What you need to know before you take Phenoxymethylpenicillin Tablets
  3. How to take Phenoxymethylpenicillin Tablets
  4. Possible side effects
  5. How to store Phenoxymethylpenicillin Tablets
  6. Contents of the pack and other information
  7. What Phenoxymethylpenicillin Tablets are and what they are used for

Phenoxymethylpenicillin is an antibiotic (antibacterial medicine) for treating infections. It belongs to a group of antibiotics called “Penicillins”. Phenoxymethylpenicillin works by killing the bacteria that can cause infections. Phenoxymethylpenicillin can also be used to prevent infections.

Your doctor has prescribed Phenoxymethylpenicillin Tablets because it can treat a range of bacterial infections of the ear, throat, lungs, skin and soft tissues. It may also be used to prevent infections such as rheumatic fever and prevention of infection in patients without a spleen or patients with sickle cell disease.

  1. What you need to know before you take Phenoxymethylpenicillin Tablets

Do not take Phenoxymethylpenicillin Tablets

  • If you are allergic (hypersensitive) to phenoxymethylpenicillin or any of the other ingredients of Phenoxymethylpenicillin Tablets (see section 6 Contents of the pack and other informations).
  • if you know that you are allergic to penicillin

Warning and precautions

Talk to your doctor, pharmacist or nurse before taking Phenoxymethylpenicillin Tablets:

  • if you know that you are allergic to cephalosporins, or any other antibiotic or any of the ingredients in your medicine.
  • if you suffer from kidney problems.
  • if you suffer from liver problems.
  • if you suffer any blood disorders.
  • if you are pregnant, trying for a baby or breast-feeding.
  • if you suffer from bronchial asthma or suffer from a tendency to develop allergic conditions such as hay fever or eczema.
  • if you suffer with persistent diarrhoea or vomiting caused by stomach or intestinal problems or being sick, or are suffering from any gut disorder which may affect the way your body absorbs the medicine .
  • if you have suffered severe diarrhoea following previous treatment with antibiotics.
  • You are on a low potassium diet. Each Phenoxymethylpenicillin 250mg tablet contains 28mg of potassium. This potassium content needs to be taken into consideration by patients with kidney problems or patients on a controlled potassium diet.
  • if you have severe illness.
  • if you are on long term treatment with Penicillin.

Other Medicines and Phenoxymethylpenicillin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular tell your doctor if you are using the following:

  • Uricosuric drugs (medicines used to treat gout and other conditions which require lowering of blood uric acid levels, e.g. probenecid and sulfinpyrazone).
  • Anticoagulants (medicines that prevent the clotting of blood, e.g. warfarin, coumarin and phenindione).
  • Potassium-sparing diuretics (medicines used to treat high blood pressure, water retention, or some heart, liver or kidney conditions, e.g. Amiloride, spirolactone).
  • Any other antibiotics (such as tetracycline, erythromycin, chloramphenicol, sulphonamide).
  • Methotrexate (a medicine used to treat cancer, psoriasis and rheumatoid arthritis).
  • Guar gum (a medicine used to treat some types of diabetes).
  • Neomycin (anti-fungal).
  • Phenoxymethylpenicillin tablets may reduce the efficacy of oral contraceptives (“the pill”). Your doctor or pharmacist will be able to advise you on whether additional contraceptive measures are necessary whilst taking Phenoxymethylpenicillin tablets, such as using a condom or a diaphragm with spermicide.

Please tell your doctor or pharmacist if you have recently been given or are due to receive a typhoid vaccination.

You should also note that if you test your urine for glucose using a non-enzymatic test,

Phenoxymethylpenicillin Tablets may give a false positive result. Please ask your pharmacist for advice on this.

Long term treatment should be monitored as overgrowth of resistant organisms including Pseudomonas or

Candida may occur.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Phenoxymethylpenicillin Tablets with food and drink

Phenoxymethylpenicillin Tablets are best absorbed when taken on an empty stomach.

Pregnancy and breast-feeding

The effects of phenoxymethylpenicillin in pregnancy have not been adequately studied. If you are pregnant or planning to become pregnant, inform your doctor immediately. Phenoxymethylpenicillin

Tablets should be used during pregnancy only if your doctor determines that the potential benefit justifies the potential risk to the unborn baby. Since phenoxymethylpenicillin appears in breast milk, you should consult with your doctor if you plan to breast feed your baby. If this medication is essential to your health, your doctor may advise you to discontinue breast feeding until your treatment is finished.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Phenoxymethylpenicillin Tablets have not been shown to have any effect on ability to drive and use machines.

Phenoxymethylpenicillin Tablets contains potassium

Each Phenoxymethylpenicillin 250mg tablet contains 28mg of potassium. This potassium content may be harmful to people on low potassium diets or reduced kidney function.

  1. How to take phenoxymethylpenicillin tablets

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

Each dose should be swallowed with a drink of water, at least 30 minutes before food. Try to space the doses as early as possible throughout the day.

The recommended dose is:

Adults

The usual dosage is 250 milligrams or 500 milligrams (one to two tablets) every 6 hours. This may vary depending on the type of infection you have. If you have poor kidney function the dose may be lowered.

To prevent recurring rheumatic fever

The usual dosage is 250 milligrams (one tablet) daily on a continuing basis.

To prevent pneumococcal infection (e.g. in aspleenia and in sickle cell disease)

The usual dosage is 500mg (two tablets) every 12 hours.

Children (under 12)

For children aged between 6 and 12 years of age the usual dosage is 250 milligrams (one tablets) every 6 hours.

For infants and children under the age of 6 an oral solution containing phenoxymethylpenicillin is recommended.

To prevent pneumococcal infection (e.g. in aspleenia and in sickle cell disease)

The usual dosage is 250mg (one tablet) every 12 hours.

Patients with kidney and liver problems

  • If you have kidney problems the dose might be changed by your doctor.
  • Dosage might be changed by your doctor if you have liver problems along with kidney problem.

If you take more Phenoxymethylpenicillin Tablets than you should

Always take your medicine as recommended by your doctor.

Never take more than the recommended dose each day. If you or someone else swallows several of these tablets all together or if you think a child has swallowed any of the tablets, contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablet left over with you and also the box, as this will allow easier identification of the tablets.

Symptoms of overdose may include: Diarrhoea, nausea, vomiting and rarely seizures (fits) may occur.

If you forget to take Phenoxymethylpenicillin Tablets

If you miss a dose, just carry on with the next one as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Phenoxymethylpenicillin Tablets

Continue taking Phenoxymethylpenicillin Tablets for the full time of treatment, even if you begin to feel better after a few days. Failure to take a full course of therapy may prevent complete elimination of the infection and infection may start up again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, Phenoxymethylpenicillin Tablets can cause side effects, although not everybody gets them. If you experience any of the following, stop taking the tablets and tell your doctor immediately:

  • An allergic reaction- symptoms such as shortness of breath, skin rash or itching, skin eruptions, swelling of your lips, face or tongue, chills or fever or painful joints, dizziness, allergic reactions may also cause effects to the blood and kidneys.

The following side effects have been reported in patients treated with Phenoxymethylpenicillin Tablets.

However, frequency estimates for these effects are not available:

Diarrhoea (which may contain blood)

Should the diarrhoea be persistent and severe, stop taking your tablets and tell your doctor Immediately or go to your local hospital emergency department.

  • Vomiting or nausea (a feeling of sickness).
  • Inflammation of the tongue or mouth.
  • Redness of the skin, often itchy, similar to the rash of measles,
  • Thrush or inflammation of the vaginal area
  • Changes in white blood cell count, reduction in red blood cell count, reduction in blood platelets, which increases risk of bleeding or bruising.
  • Fits or convulsion (usually following high doses or if you suffer from severe kidney damage)
  • Numbness or tingling of the hands and feet.
  • Soft stools.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet tell your doctor or pharmacist.

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.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Phenoxymethylpenicillin

Keep out of the sight and reach of children.

Do not store above 25º C. Store in the original packaging.

Do not use this medicine after the expiry date which is stated on the individual blister and on the carton after EXP. The expiry date refers to the last day of that month.

Do not use phenoxymethylpenicillin film-coated tablets if you notice any visible signs of deteriorations such as colour change of the tablet from white to off-white or yellowish or if patches appear on the tablet.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

  1. Contents of the pack and other information

What Phenoxymethylpenicillin contains

The active substance is Phenoxymethylpenicillin. Each tablet contains 250mg of

Phenoxymethylpenicillin (as Phenoxymethylpenicillin Potassium).

The other ingredients are:

Calcium Hydrogen Phosphate Dihydrate

Maize Starch

Cellulose, Microcrystalline

Magnesium Stearate

Film Coat

Basic Butylated Methacrylate

Macrogol 6000

Sodium Laurylsulfate

Stearic acid

Titanium Dioxide

What Phenoxymethylpenicillin Tablets look like and contents of the pack

Blisters (aluminium – PVC) of 14 tablets. Packs containing 14, 28, 42, 56, 70, 140 tablets are available.

Not all pack sizes may be marketed

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

 

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