Phenoxymethylpenicillin potassium solution 125mg/5ml – patient leaflet, side effects, dosage

1. What Phenoxymethylpenicillin potassium is and what it is used for

Phenoxymethylpeniciliin Potassium is one of a group of antibiotic medicines called penicillins. They are used to treat infections caused by bacteria that are sensitive to penicillins.

Phenoxymethyipenicillin Potassium is used to treat a range of bacterial infections:

• Chest (bronchitis or pneumonia) infections
• Ear and throat infections (such as otitis media and pharyngitis)
• Skin and soft tissue infections such as scarlet fever and erysipelas
• To prevent recurrent attacks of rheumatic fever
• To prevent lung infections in patients with no spleen or sickie cell disease.

2. What you need to know before you take Phenoxymethylpenicillin potassium:

Do not take Phenoxymethylpenicillin potassium if:

• you are allergic (hypersensitive) to Phenoxymethyipeniciliin Potassium or cephalosporin antibiotics or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions

Talk to your doctor before taking this medicine if you:

• Have a history of allergies
• Have been treated for kidney problems
• Have suffered severe diarrhoea following previous treatment with antibiotics
• Have a severe illness

• If you have your urine tested for glucose using a non-enzymatic test, then

  Phenoxymethylpenicillin Potassium Solution may give a false positive result.

Other medicines and Phenoxymethylpenicillin potassium

Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:

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• Other antibiotics (such as tetracyclines, erythromycin, chloramphenicol, sulphonamides, neomycin).
• Coumarin or phenindione used to thin the blood. Sulfinpyrazone or probenecid used to treat gout.
• Oral Typhoid vaccine (penicillin can stop this from working)
• Methotrexate used in the treatment of severe rheumatoid arthritis, severe psoriasis and cancer
• Guar gum used in the treatment of diabetes.

Pregnancy and Breast feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Phenoxymethylpenicillin metabolites are excreted in human milk to such an extent that effects on breastfed newborns are likely.

Phenoxymethylpenicillin Potassium contains sodium benzoate (E211) and sucrose

• Sodium benzoate (E211) - This medicine contains 25mg of sodium benzoate

  (E211) in each 5ml dosage unit which is equivalent to 3.99mg sodium.

• Sucrose - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Phenoxymethylpenicillin potassium

Always take Phenoxymethylpenicillin potassium exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should take your medicine half an hour before food, use the cup provided. In general the treatment must be continued 2-3 days after improvement of the symptoms. It is important that you complete the entire course of medicine your doctor had prescribed for you.

The usual oral dose:

All doses are measured out using the cup provided.

Adults dose including elderly patients:

10-20 ml every 6 hours

Prevention of infection in patients with no spleen or sickle cell disease: Adults: 20 ml every 12 hours

Children 6-12 years old: 10 ml every 12 hours

Children under 5 years old: 5 ml every 12 hours

Prevention of recurrence of rheumatic fever:

10 ml twice a day.

Children Dosage (up to 12 years of age):

Children under 1 year old: 2.5 ml every 6 hours

Children aged 1-5 years old: 5 ml every 6 hours

Children aged 6-12 years old: 5-10 ml every 6 hours.

Patients with kidney problems may have a lower dose recommended by their doctor.

If you take more Phenoxymethylpenlcillin Potassium than you should

If you (or someone else) swallow a lot of the solution all at once, or if you think a child has swallowed any of the solution, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining solution and the container with you to the hospital or doctor so that they know which solution was consumed.

122XXXX-V1 3 If you forget to take Phenoxymethylpencillin Potassium

If you forget to take your medicine take it as soon as you remember. Do NOT take a double dose lo make up for a forgotten dose.

If you stop taking Phenoxymethylpenlclllln Potassium

Do not stop taking Phenoxymethylpenicillin Potassium just because you feel better. If you stop before the end of the course the infection may come back. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

STOP taking the medicine and tell your doctor IMMEDIATELY if you experience any of the following.

• An allergic reaction- symptoms may include: shortness of breath, skin rash or itching, hives, swelling of the skin (especially of the lips, face or tongue), chills or fever, painful joints
• Severe peeling/blistering of the skin
• Seizures
• Profuse watery diarrhoea usually with blood and mucus, stomach pain and fever

The following are the more common effects. Tell your doctor or pharmacist if they worry you.

• Stomach pain or cramps, nausea (feeling sick), vomiting (being sick) and diarrhoea

The following are other possible side effects:

Mouth

• Sore mouth
• Black hairy tongue
• Sore throat

Skin

• Pins and needles or numbness

Blood

• Problems with blood clotting (unusual bleeding or brushing)
• Infection or fever (may be caused by low white blood cells)
• Anaemia (may cause lack of energy or tiredness)

Kidney

• Kidney problems, which might cause blood in the urine or reduced amount of urine

Liver

• Jaundice- yellowing of skin or whites of the eyes

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. Marketing Authorisation Holder and Manufacturer

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK

E-mail : info@medreich.co.uk

POM

0038/O/PIL/001/I

This leaflet was last revised in January 2021

To listen to or request a copy of this leaflet in Braille, large print or audio please call,

02088311580 (UK only)

Please be ready to give the following information:

Product name Reference number

Phenoxymethylpenicillin PL 21880/0038 potassium solution 125mg/5ml

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5. How to store Phenoxymethylpenicillin potassium

Keep this medicine out of the sight and reach of children.

Store in the original packaging.

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

Storage Conditions:

Phenoxymethylpenicillin potassium powder: Do not store above 25°C. Keep in a dry place.

The reconstituted solution: Store in a refrigerator (2-8°C) and use within 7 days after reconstitution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Phenoxymethylpenlcillln potassium contains:

The active ingredient is phenoxymethylpenicillin potassium. 5ml of the reconstituted solution contains 125 mg of phenoxymethylpenicillin. The other ingredients are sodium saccharin, citric acid, sodium citrate, sucrose, banana flavour, E211 sodium benzoate (preservative) and E 127 erythrosine (colouring).

What Phenoxymethylpenlclilln potassium looks like and contents of the pack:

The product comes in 60ml or 100ml bottles either as a powder or as a solution after reconstituted.

Not all pack sizes may be marketed.

122XXXX-V1

Red 032 C

MED/PHE/PIL/07 16(MA)/17(MA)/26.02.15(MA)/

19(MA)/24.11.20(MA)/07(MA)/

19.01.21(MA)

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