Patient leaflet - PHENOXYMETHYLPENICILLIN POTASSIUM SOLUTION 125 MG / 5ML
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:
- 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.
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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
- Jaundice- yellowing of skin or whites of the eyes
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 informationwhat 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.
Marketing Authorisation Holder and Manufacturer Mmedreich plc
[POM]
0038/O/PIL/001/I
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail :
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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Colours:
H Red 032 C
Black
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| Arial – Bold |
| Heading – 11 pts | |
| Body – 9 pts | |
| RA artwork code | 0038/O/PIL/001/I |
| Version | V-2 |
Unit 3
| MEDREICH LIMITED | Title: Art Work Approval Form | |||||||
| Product | Phenoxymethylpenicillin Potassium – OS – 125 mg / 5 ml – S/L – English – PIL | Specification: | Printed on 56 – 60 GSM, Maplitho paper | |||||
| Customer | MEDREICH PLC, UK | |||||||
| Reason for Issue | AWR No.: (Old Code: 1213340) 2) Safety update | Colours: |
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| Dimensions: | 220 × 195 mm (Open size) (Folded size 110 × 49 mm) | |||||||
| Related FG Codes | 1301406 Pharmacode No | 134 | ||||||
| No. of Folds (only for PIL) | 3 | Artwork made to | 100% | |||||
| Item Code | 121XXXX-V1 (WOA) Layout No.: NA | |||||||
| Verified By | Approved By | |||||||
| PDC: | PDC: | Regulatory: | QC: | CQA: | ||||
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Format No.: CO-QA005-F03–03 Internal Approval issued on CD issued on 19(MA)/24.11.20(MA)/07(MA)/
19.01.21(MA)