Penbritin

250 mg and 500 mg Capsules

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.

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In this leaflet:

1.    What this medicine is and 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 capsules contain ampicillin which belongs to the penicillin group of antibiotics.

Ampicillin works by killing bacteria that 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.

• 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 capsules are unlikely to affect your ability to operate machinery or to drive.

3. How to take

2. Before you take

Do NOT take Penbritin capsules if you:

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

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

Take special care with Penbritin capsules

Before taking the capsules, 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 another antibiotic

•    have glandular fever or low immune system

•    have leukaemia

•    have kidney problems.

Taking other medicines

Please tell your 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

Always take Penbritin capsules exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition.

Ask your doctor or pharmacist if you are not sure.

• Swallow the capsules whole with water, half an hour to one hour before food.

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 dose 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 capsules than you should you may get nausea, vomiting and diarrhoea.

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

2.    Take the container and any remaining capsules with you so that people can see what you have taken.

3.    Do this even if you feel well.

Continued over page

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 your capsules until the prescribed course is finished.

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

If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store

•    Keep out of the reach and sight of children.

•    Do not use after the expiry date which is stated on the blisters and on the carton, or on the container label. The expiry date refers to the last day of that month.

•    Do not store above 25°C.

•    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.

4. Possible side effects

6. Further information

Like all medicines, Penbritin capsules 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 capsules 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.

Some of these reactions may happen several weeks after finishing the treatment.

The following side effects usually settle without changing the dose:

• upset stomach, nausea or diarrhoea.

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

What Penbritin Capsules contain

•    The active ingredient is ampicillin (250 mg or 500 mg) as ampicillin trihydrate.

•    The other ingredients are:

magnesium stearate.

The capsule shell contains: gelatin, red and black iron oxides, erythrosine and titanium dioxide.

What Penbritin Capsules look like and contents of the pack

•    Penbritin 250 mg Capsules are black and red hard gelatin capsules, marked 'Penbritin 250'.

They are available in pack sizes of 28 and 100 capsules. Not all pack sizes may be marketed.

•    Penbritin 500 mg Capsules are black and red hard gelatin capsules, marked 'Penbritin 500'.

They are available in pack sizes of 28 capsules.

Marketing Authorisation Holder

Chemidex Pharma Ltd, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB.

Manufacturer

Famar SA, Avlonas Industrial Site, 48 km of National Road Athens-Lamia, 19011 Avlonas, Attiki, Greece.

This leaflet was last revised in

April 2009

'Penbritin' and 'Chemidex' are trade marks.

CHEMIDEX PHARMA

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