AMPICILLIN 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

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

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

What is in this leaflet

• 1. What Ampicillin powder for solution for injection/infusion is and what it is used for

• 2. What you need to know before you are given Ampicillin powder for solution for injection/infusion

• 3. How to use Ampicillin powder for solution for injection/infusion

• 4. Possible side effects

• 5. How to store Ampicillin powder for solution for injection/infusion

• 6. Contents of the pack and other information

1. what ampicillin powder for solution for injection/infusion is and what it is used for

Ampicillin powder for solution for injection/infusion is a medicine for the treatment of bacterial infections (antibiotic), and works by killing bacteria that cause infections. It contains the active substance ampicillin.

Ampicillin belongs to a group of medicines called ‘penicillins’.

Ampicillin powder for solution for injection/infusion is used to treat the following:

• complicated acute bacterial sinusitis
• meningitis caused by the listeria bacteria
• infections of the heart
• kidney infections
• female genital organ infections
• infections inside the abdomen
• urinary bladder infections

2. what you need to know before you are given ampicillin powder for solution for injection/infusion

Do not use ampicillin powder for solution for injection/infusion

• – if you are allergic to ampicillin or other penicillins, or any of the other ingredients of this

medicine (listed in section 6), because of the risk of allergic shock.

• – if you have ever had a severe allergic reaction to any other antibiotic.

This can include a skin rash or swelling of the face or neck.

• – if you have ever had jaundice or other liver problems due to ampicillin.

Do not take Ampicillin powder for solution for injection/infusion if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before using ampicillin

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Ampicillin powder for solution for injection/infusion if you:

• – have glandular fever, cytomegalovirus infection or lymphoid leukaemia

• – have kidney problems

Duringtreatment

Ampicillin powder for solution for injection/infusion can make some existing conditions worse or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation of the intestine with some diarrhoea. You must look out for certain symptoms while taking Ampicillin powder for solution for injection/infusion, to reduce the risk of any problems (see section 4).

Bloodandurinetests

Your doctor may want to check your blood to see how your liver and kidneys are working or your blood cell levels during treatment. If you are having urine tests for glucose let your doctor or nurse know that you are taking Ampicillin powder for solution for injection/infusion. This is because Ampicillin powder for solution for injection/infusion can affect the results of these types of tests.

Other medicines and Ampicillin powder for solution for injection/infusion

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking allopurinol (a medicine used for gout), it may be more likely that you will have an allergic skin reaction.

If you are taking probenecid (a medicine used for gout); your doctor may decide to adjust your dose of Ampicillin powder for solution for injection/infusion.

Other antibiotics

If you are taking other antibiotic medicines such as chloramphenicol or tetracycline as they may affect how ampicillin works.

Blood anticlotting medicines:

If you are taking medicines to stop your bloodfrom clotting such as warfarin at the same time as Ampicillin powder for solution for injection/infusion, your doctor may decide to test your blood regularly.

Medicines that strengthen the action of the heart (digoxin)

Ampicillin can increase the amount of digoxin that is absorbed by the body. Your doctor can adjust the prescribed dose of digoxin.

Methotrexate (a medicine drug used to treat cancer or rheumatism)

Ampicillin powder for solution for injection/infusion can affect how methotrexate works.

Pregnancy, breast-feeding and fertility

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.

Ampicillin should only be used during pregnancy if the doctor recommends this as there is limited data from use during pregnancy.

Ampicillin is present in breast milk and may cause some side effects in the breast-fed infant.

Your doctor will discuss with you whether or not it is more beneficial to take this medicine or to continue to breast-feeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines. Do not drive or use machinery if you experience these side effects.

Ampicillin powder for solution for injection/infusion contains sodium

Ampicillin 250 mg

This medicine contains less than 1 mmol sodium (23 mg) per vial. To be taken into consideration by patients on a controlled sodium/low-salt diet.

Ampicillin 500 mg

This medicine contains 1.43 mmol (or 32.9 mg) sodium per vial. To be taken into consideration by patients on a controlled sodium/low-salt diet.

Ampicillin 1 g

This medicine contains contains 2.86 mmol (or 65.8 mg) sodium per vial. To be taken into consideration by patients on a controlled sodium/low-salt diet.

Ampicillin 2 g

This medicine contains 5.72 mmol (or 131.6 mg) sodium per vial. To be taken into consideration by patients on a controlled sodium/low-salt diet.

3. how to use ampicillin powder for solution for injection/infusion

You will never give yourself this medicine. A qualified person, such as a doctor or nurse, will give you this medicine.

Useinadultsan­dadolescents

The recommended dose is 500mg every 4 to 6 hours (the daily dose can be increased to 6 g in case of severe infection)

Use in children Intravenous

inj ectionorinfusion Child 1

month –12 years

The recommended dose is 25 mg/kg (max 1g) every 6 hours (the dose can be increased to 50 mg/kg (max 2 g) every 6 hours in case of severe infection).

Neonate 21 – 28days

The recommended dose is 30mg/kg every 6 hours (the dose can be doubled in case of severe infection).

Neonate 7 – 21 days

The recommended dose is 30mg/kg every 8 hours (the dose can be doubled in case of severe infection).

Neonate under 7 days

The recommended dose is 30mg/kg every 12 hours (the dose can be doubled in case of severe infection).

Dosage for patients with impaired kidney function

No dose adjustment is required in patients mild to moderate kidney problems

For severely impaired renal function with a glomerular filtration rate of 30 ml/min and less, a reduction in the dose (administered amount) is recommended, since an accumulation of ampicillin is to be expected:

• – at a creatinine clearance of 20 to 30 ml/min, the normal dose should be reduced to %, – at a creatinine clearance below 20 ml/min, the normal dose should be reduced to %.

As a general rule, a dose of 1 g ampicillin in 8 hours should not be exceeded in patients with severe renal insufficiency.

HowAmpicillin­powderforsolu­tionforinjecti­on/infusionwi­llbegiventoyou

It will be given as an injection into a vein, or by intravenous infusion, or into a muscle in your body.

Durationoftre­atment

The duration of treatment depends on the course of the disease. As a general rule, ampicillin is used for 7 to 10 days, but for at least another 2 to 3 days after the signs of disease have subsided.

If you use more Ampicillin powder for solution for injection/infusion than you should

It is unlikely you will be given too much, but if you think you have been given too much Ampicillin powder for solution for injection/infusion tell your doctor, pharmacist or nurse immediately.

Signs may be an upset stomach (feeling sick (nausea), being sick (vomiting) or diarrhoea), muscle twitching, nervousness, tingling around the mouth, tinnitus, tremor, dizziness, blurred vision, altered consciousness including coma, a change in levels of sodium or potassium in your blood, other problems with your blood, kidney failure or an increase of acid in the blood or convulsions (fits).

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

nurse.

4. possible side effects

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

Stop taking Ampicillin powder for solution for injection/infusion and immediately contact your doctor or go to your nearest hospital emergency department if you get the following:

• An increase in the number of infections causing fever, severe chills, sore throat, mouth ulcers, chest infections or you may feel tired, short of breath, have pale skin, yellowing of the skin or whites of the eyes, unexplained bruising or bleeding more easily than normal. These may be signs of changes to the type or number of blood cells in the blood.
• An allergic reaction: such as a rash, hives, redness, itching or swelling of the face, mouth, lips, tongue or throat that may cause difficulty breathing, fever and lymph node swellings (serum sickness).
• Widespread red skin rash which may have small pus-containing blisters (exfoliative dermatitis).
• Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge (exudative erythema multiforme).
• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface (toxic epidermal necrolysis or Lyell’s syndrome)).
• Seizures (fits). You are more likely to experience this if you have kidney problems or are receiving high doses by intravenous injection.
• Severe watery diarrhoea with mucus or blood, stomach pain or fever. You may have a bacterial infection that can cause inflammation of the gut.
• Produce little or no urine, cloudy, crystals or blood in the urine, have pain when passing urine or lower back pain. You may have serious kidney problems.

Other possible side effects include:

Very common: may affect more than 1 in 10 people

• – Stomach pain

• – Feeling sick (nausea)

• – Being sick (vomiting)

• – Bloating of the gut- Soft stools

• – Diarrhoea

Common: may affect up to 1 in 10 people

• – Measles-like rash (develops several days (5 to 11) after the start of the treatment).

• – Skin rash ) and rash in the area around and or inside the mouth. This may be more likely if you have glandular fever or lymphatic leukaemia.

• – Swelling and pain at the injection site.

• – Swelling and redness along a vein which is extremely tender when touched after an intravenous injection.

Uncommon: may affect up to 1 in 100 people

• – Infection with fungi or resistant bacteria especially during prolonged and/or repeated use, such as thrush (candida – a yeast infection of the vagina, mouth or skin folds).

• – Other allergic reactions such as:

o Drug fever.

o Inflammation of the blood vessels of the skin (allergic vasculitis)

o Swollen red, sore tongue

o Mouth ulcers or cold sores

• - Increase in certain enzymes produced by the liver (transaminases)

• - An increase in the number of white blood cells

Rare: may affect up to 1 in 1,000 people

• – Dizziness

• – Headache

• – Sudden, abrupt, brief, involuntary, twitching of a muscle or muscle group (myoclonus)

Not known (frequency cannot be estimated from the available data)

• – Black hairy tongue

• – Joint pain

• – Fever

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:y reporting side effects you can help provide more information on the safety of this medicine.

5. how to store ampicillin powder for solution for injection/infusion

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

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

Do not store above 25 °C.

Reconstituted/di­luted solution should be used immediately.

Do not use this medicine if you notice cloudiness or precipitations.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information- the active substance is ampicillin (as ampicillin sodium).

• – There are no other ingredients.

What Ampicillin powder for solution for injection/infusion looks like and contents of the pack

White to off white crystalline powder

Ampicillin 250 mg powder for solution for injection/infu­sion:

Pack with 1 glass vial with dark grey bromobutyl rubber stopper and light yellow flip off aluminium seal containing 266 mg powder for solution for injection/infusion.

Ampicillin 500 mg powder for solution for injection/infu­sion:

Pack with 1 glass vial with dark grey bromobutyl rubber stopper and blue flip off aluminium seal containing 531 mg powder for solution for injection/infusion.

Ampicillin 1 g powder for solution for injection/infu­sion:

Pack with 1 glass vial with dark grey bromobutyl rubber stopper and green flip off aluminium seal containing 1063 mg powder for solution for injection/infusion.

Ampicillin 2 g powder for solution for injection/infu­sion:

Pack with 1 glass vial with dark grey bromobutyl rubber stopper and brown flip off aluminium seal containing 2126 mg powder for solution for injection/infusion.

Marketing Authorisation Holder and Manufacturer

Mylan

Potters Bar

Hertfordshire

EN6 1TL

United Kingdom

Manufacturer

Mylan S.A.S.

117 Allee des Parcs

69800 Saint-Priest

France

Wessling Hungary KFT

Foti ut 56

1046 Budapest

Hungary

This leaflet was last revised in 04/2016

The following information is intended for healthcare professionals only:

Preparati onoftheinj ection solution:

Ampicillin 250 mg powder for solution for injection/infusion

The 10 % injection/infusion solution is prepared by dissolving 0,26 g powder in 2,5 ml water for injections.

Ampicillin 500mg powder for solution for injection/infusion

The 10 % injection/infusion solution is prepared by dissolving 0.53 g powder in 5 ml water for injections.

Ampicillin 1 g powder for solution for injection/infusion

The 10 % injection/infusion solution is prepared by dissolving 1.06 g powder in 10 ml water for injections.

Ampicillin 2 g powder for solution for injection/infusion

The 10 % injection/infusion solution is prepared by dissolving 2.12 g powder in 20 ml water for injections.

The solutions should always be prepared freshly before use and checked for clarity.

Use only clear solutions for injection or infusion! Do not use solutions with cloudiness or precipitation.

Compatibility

Ampicillin solutions should always be administered separately, unless the compatibility with other infusion solutions or medicines has been established.

Ampicillin solutions are compatible with 0.9% (9 mg/ml) sodium chloride solution, 5% (50mg/ml) glucose solution and Ringer solution.

Ampicillin solutions should not be mixed with aminoglycosides, metronidazole and injectable tetracycline derivatives such as oxytetracycline, rolitetracycline and doxycycline. Visual signs of incompatibility are precipitation, clouding and discolouration.