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AMPICILLIN 125 MG / 5ML POWDER FOR ORAL SUSPENSION, PENBRITIN SYRUP 125 MG / 5ML - patient leaflet, side effects, dosage

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Patient leaflet - AMPICILLIN 125 MG / 5ML POWDER FOR ORAL SUSPENSION, PENBRITIN SYRUP 125 MG / 5ML

Penbritin Syrup 125 mg/5 ml and

Ampicillin

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What this medicine is and what it is used for

  • 2. Before you take

3. How to take

4. Possible side effects

5. How to store

  • 6. Further information

1. what this medicine is and what it is used for

Penbritin syrup contains ampicillin which belongs to the penicillin group of antibiotics.

Ampicillin works by killing bacteria which cause infections such as:

  • ear, nose and throat infections
  • bronchitis, pneumonia, chest infections
  • urinary tract infections
  • sexually transmitted infections
  • skin and soft tissue infections
  • gastrointestinal infections
  • blood poisoning
  • 2. Before you take

    Do NOT take Penbritin syrup if you:

  • are allergic to ampicillin, other antibiotics called beta-lactams (e.g. penicillin or cephalosporin) or any of the ingredients (see Section 6).

If this applies to you, speak to your doctor or pharmacist.

Take special care with Penbritin syrup

Before taking the syrup, tell your doctor if you:

  • have ever had a skin rash or swelling of the face or neck when taking any antibiotic
  • are already being treated with any other antibiotic
  • have glandular fever or low immune system
  • leukaemia
  • have kidney problems.

Taking other medicines

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

Some medicines may be affected by Penbritin or they may affect how well Penbritin will work. Tell your doctor or pharmacist if you are taking:

  • any other antibiotics
  • allopurinol or probenecid for conditions such as gout
  • oral contraceptives (the pill) You will need an additional method of contraception, such as condoms. Speak to your doctor or pharmacist about how long you need to take extra precautions for.

Urine tests : Tell the doctor if you are having urine tests for glucose, as your medicine may affect the results.

Pregnancy and breast-feeding

Penbritin will not harm your unborn baby. Small quantities of the medicine may be present in breast milk.

Ask your doctor for advice before taking any medicine.

Driving and using machines

Penbritin syrup is unlikely to affect your ability to operate machinery orto drive.

Important information about some of the ingredients of Penbritin syrup

sodium

Each 5 ml Penbritin syrup contains 16.7mg of sodium.

This should be taken into consideration by patients on a controlled sodium diet.

  • sucrose

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

Each 5ml Penbritin syrup contains 3.6g sucrose.

This should be taken into account in patients with diabetes mellitus.

3. how to take

Always take Penbritin syrup exactly as your doctor has told you and always read the label.

Your doctor will decide what dose on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.

  • Shake the bottle before taking the medicine.
  • Take the syrup half an hour to one hour before food.
  • After taking Penbritin syrup, rinse the mouth – the syrup contains sucrose which may be

harmful to the teeth.

  • Space the doses as evenly as possible through the day – for example before meal times and at bedtime.

Doses

Adults and children over 10 years: the usual dose is 250 mg to 750 mg four times a

day

Children under 10 years : half the adult doses four times a day.

In severe infections the above doses may be increased by your doctor.

Patients with kidney problems: if your kidneys are not working very well, your doctor may change the dose.

Your doctor will give you special instructions if you are on kidney dialysis.

If you take more than you should

If you take more syrup than you should you may get nausea, vomiting and diarrhoea.

  • 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.

  • 2. Take the bottle and any remaining syrup with you so that people can see what you have taken.

  • 3. Do this even if you feel well.

If you forget to take

If you forget to take a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.

Do not take a double dose to make up for a missed dose.

If you stop taking

Do not stop just because you feel better. If you stop too soon, the infection may come back.

Keep taking the syrup until the prescribed course is finished.

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

4. P

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

Do not be alarmed by this list of possible side effects. You may not experience any of them.

STOP taking the syrup and seek medical help immediately if you have any of the following allergic reactions :

  • difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
  • severe itching of the skin, with a red rash or raised lumps
  • blistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin.

Seek immediate medical attention if you have any of the following rare symptoms:

  • severe stomach cramps, watery and severe diarrhoea which may be bloody, fever
  • yellowing of your skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness
  • unusual bleeding or bruising
  • fever, sore throat, mouth ulcers, repeated infections or infections that will not go away
  • feeling tired, breathless, and looking pale
  • fever, rash, nausea, aches and pains, passing more or less urine than usual or passing urine at night.
  • upset stomach, nausea or diarrhoea.

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Blood tests: tell your doctor if you are having blood tests as your medicine can cause short-term changes in blood cell counts.

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. H

  • Keep out of the reach and sight of children.
  • Do not use after the expiry date which is stated on the bottle label and on the carton. The expiry date refers to the last day of that month.
  • Store in a refrigerator (2°C-8°C).
  • Do not use after 14 days from the date of dispensing.
  • Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.

6. F

What Penbritin syrups contain

  • The active ingredient is ampicillin (125 mg per 5 ml or 250 mg per 5 ml) as ampicillin trihydrate.
  • The other ingredients are:

sodium benzoate (E211), sodium chloride, methyl polysiloxane, sodium citrate anhydrous, sucrose and apricot, caramel and peppermint flavours.

(See end of Section 2 for further information on sodium and sucrose).

What Penbritin syrups look like and contents of the packs

Penbritin syrups are pale cream-coloured liquids.

They are available in plastic bottles of 100ml.

Marketing Authorisation Holder

Essential Pharma Liquids Limited, Unit 8a, Crabtree Road, Egham, Surrey, TW20 8RN, United Kingdom.

Manufacturer

Lelypharma, Zuiveringweg 42, 8243PZ Lelystad, The Netherlands.

This leaflet was last revised in

June 2021

73–74/L/x/2