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Phenoxymethylpenicillin 250mg Tablets

Document: leaflet MAH GENERIC_PL 20416-0126 change

PATIENT INFORMATION LEAFLET


PHENOXYMETHYLPENICILLIN

250mg Tablets


Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See Section 4.


In this leaflet:

1.    What Phenoxymethylpenicillin Tablets are and what they are used for

2.    Before you take Phenoxymethylpenicillin Tablets

3.    How to take Phenoxymethylpenicillin Tablets

4.    Possible side effects

5.    How to store Phenoxymethylpenicillin Tablets

6.    Further information

1.    What Phenoxymethylpenicillin Tablets are and what they are used for

This medicine belongs to the penicillin group of antibiotics. It is an antibacterial drug used in the treatment of mild to moderately severe infections such as chest and throat infections, skin and soft tissue infections, infections of the mouth, gums and teeth, scarlet fever (characterised by high fever, sore throat and skin rashes) and mild erysipelas (a disease marked by red skin eruptions, chills and fever). It is also used in the prevention of rheumatic fever and chorea (a group of disorders characterised by brief rapid involuntary movements of limbs, face, trunk and head).

2.    Before you take Phenoxymethylpenicillin Tablets

Do not take these tablets if:

*    you are allergic to Phenoxymethylpenicillin or to any of the other ingredients (see section 6).

Check with your doctor before taking these tablets if:

*    you have a history of allergic reaction to penicillins, cephalosporins or other allergy causing agents

■    you are suffering from severe illness, nausea, vomiting, stomach bloating/cramping, difficulty swallowing or chest pain

■    you have kidney problems

*    you are pregnant, think you may be pregnant or you are breast feeding. (This medicine is passed into breast milk and may cause an allergic reaction in your baby).

Taking other medicines:

Check with your doctor or pharmacist before taking these tablets if you are taking any other medicines, including any that you can buy without a prescription. This is especially important if you are taking:

■    probenecid (used for the treatment of gout)

■    contraceptive pills containing oestrogen. This medicine may stop the pill from working properly and you should use additional means of contraception whilst taking this medicine and for a full cycle afterwards

*    guar gum (which you may be taking as a supplement).

Other special warnings:

Pregnancy and breast feeding:

Check with your doctor before taking this medicine if you are pregnant, think you may be pregnant or you are breast feeding. This medicine is passed into breast milk and may cause an allergic reaction in your baby.

Driving and using machinery:

This medicine should not affect your ability to drive or to operate machinery. However if you think you are affected do not drive or operate machinery.

Important information about an ingredient of Phenoxymethylpenicillin Tablets:

Contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    How to take Phenoxymethylpenicillin Tablets

Swallow the tablets with water half an hour before or at least three hours after a meal.

The dose will be different for different medical conditions and patients. Your doctor has decided the dose which is best for you. Always follow your doctor’s instructions. The pharmacist's label will tell you how many tablets to take and how often to take them. If you are not sure about anything, ask your doctor or pharmacist.

The usual doses are as follows:

Adults and the Elderly: 125-500 mg every 4 to 6 hours. The dose will be reduced if you are elderly and have kidney problems.

For long-term prevention of rheumatic fever: 125mg twice a day.

Children:

Up to 1 year: This 250mg strength tablet is not suitable 1 - 5 years: 125mg every 6 hours 6-12 years: 250mg every 6 hours

In patients with bacterial infections (such as streptococcal infection), treatment is continued at the full dosage for 10 days to minimise complications.

It is important to finish your prescribed course of this medicine. If you stop taking your medicine too soon, your infection may come back.


If you have taken too many tablets:

Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the container so that the medicine can be identified.

If you forget to take a dose:

Take it as soon as you remember. However if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSES.

4.    Possible side effects

Like all medicines, phenoxymethylpenicillin can cause side effects, although not everybody gets them.

If any of the following occur STOP TAKING the medicine IMMEDIATELY and seek medical help, as these may be signs of an allergic reaction:

■    itchy, red, swollen or flaky skin or raised itchy red lumps (hives)

•    swelling of the face, lips, mouth or throat

•    difficulty in breathing, wheezing or shortness of breath, dizziness

■    a delayed allergic reaction may occur up to 7 to 12 days after taking the tablets. Symptoms may include rash, itching, joint pain, fever, chills, swollen lymph nodes, generally feeling unwell.

If you notice any of the following effects tell your doctor or seek medical attention STRAIGHT AWAY:

■ pale yellow skin, weakness, breathlessness, increased risk of bruising or bleeding, frequent infections (may be signs of a blood disorder)

• burning or stabbing pain, numbness, tingling (may be signs of damage to the nerves)

■    swollen ankles, feet or hands, increased need to pass urine, loss of appetite, feeling tired (may be signs of kidney disease).

These side effects have usually occurred with high doses of injected phenoxymethylpenicillin.

The following side effects have also been reported:

■    feeling or being sick, stomach pain, heartburn, diarrhoea

•    black hairy tongue.

You may develop a yeast/fungal infection if you have been taking this medicine for a long period.

Do not be concerned by this list of side effects, you may not get any of them.

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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Phenoxymethylpenicillin Tablets

Keep this medicine in the pack provided and protect from heat, light and moisture.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6.    Further information

Ingredients:

Each tablet contains 250 mg of Phenoxymethylpenicillin (as potassium salt) as the active ingredient. They also contain the following other ingredients: magnesium stearate, lactose, maize starch and pregelatinised maize starch.

What the medicine looks like:

Phenoxymethylpenicillin Tablets 250mg are white, round tablets, engraved on one side with the company logo and with a breakline and A057 on the other side.

This medicine is available in pack sizes of 9, 10, 14, 15, 20, 21, 28, 30, 50, 56, 84, 100, 250, 500 or 1000 tablets. (Not all pack sizes may be marketed).

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK.

Date leaflet prepared: May 2015

If you would like this leaflet in a different format please contact the licence holder at the above address.