Ampicillin Ethypharm

Package leaflet: Information for the patient

Ampicillina Ethypharm 1 g powder for injection/infusion solution, 2 m powder for injection/infusion solution

ampicillin
Equivalent medicine
Please 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 questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Ampicillina Ethypharm is and what it is used for
2. What you need to know before using Ampicillina Ethypharm
3. How to use Ampicillina Ethypharm
4. Possible side effects
5. How to store Ampicillina Ethypharm
6. Contents of the pack and other information

1. What Ampicillina Ethypharm is and what it is used for

Ampicillina Ethypharm contains the active substance ampicillin, which belongs to a group of medicines called penicillins. This is a medicinal product for the treatment of bacterial infections (antibiotics) that works by killing the bacteria causing the infections. Ampicillina Ethypharm is used to treat infections caused by bacteria sensitive to ampicillin.

Ampicillina Ethypharm is used to treat the following conditions:

• Acute exacerbation of chronic bronchitis (respiratory tract infection)
• Pyelonephritis (infection of the upper urinary tract)
• Bacterial meningitis (infection of the membranes covering the brain)
• Pneumonia (lung infection) when another penicillin is not effective or is inappropriate for other reasons
• Intra-abdominal infections (infection of the stomach and intestine)
• Bacteraemia (bacterial infection of the blood) associated with any of the above-mentioned infections

Ampicillina Ethypharm is also used for the treatment and prevention of endocarditis (infection of the heart valves).

2. What you need to know before using Ampicillina Ethypharm

Do not use Ampicillina Ethypharm:

• if you are allergic to ampicillin or to other antibiotics known as beta-lactams (e.g. penicillin or cephalosporins).

Warnings and precautions
Talk to your doctor before using Ampicillina Ethypharm:

• if you have experienced an allergic reaction to any antibiotic;
• if you have had any other allergic reactions. Hypersensitivity reactions to ampicillin may develop more commonly in individuals prone to allergic reactions to various substances. These reactions may manifest in different ways and may vary in severity – from skin changes to anaphylactic shock (a severe allergic reaction);
• if you have been diagnosed with renal impairment. Your doctor will adjust the dose of the medicine according to the degree of impairment;
• if you have had gastrointestinal disorders (stomach and intestine), particularly colitis;
• if you have been diagnosed with myasthenia gravis (a disease characterized by marked fatigue and muscle weakness).

Talk to your doctor, pharmacist or nurse before being administered Ampicillina Ethypharm:

• if you are allergic to cephalosporins (another group of antibacterial medicines);
• if you have experienced symptoms of watery diarrhoea, often with blood and mucus, abdominal pain and/or fever during or after treatment with ampicillin, inform your doctor. This may be a sign of inflammation of the colon (pseudomembranous enterocolitis). See section 4.

Urine testing
Patients receiving ampicillin may have false positive results in urine glucose tests. If you need to provide urine samples for glucose testing, inform your doctor or nurse that you are taking Ampicillina Ethypharm.
Other medicines and Ampicillina Ethypharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Allopurinol (a medicine used to treat gout) when given together with ampicillin increases the risk of allergic skin rash.
• Methotrexate (a medicine used to treat cancer or rheumatic diseases) – ampicillin given together with methotrexate may increase the side effects of methotrexate.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, please consult your doctor or pharmacist before this medicine is administered.
Pregnancy
Ampicillin may be used during pregnancy if your doctor considers it necessary.
Breastfeeding
Ampicillin is excreted in human milk in small amounts. Breastfed infants may therefore experience hypersensitivity reactions, diarrhoea or fungal colonization of the mucous membranes, which in some cases may require discontinuation of breastfeeding.
Fertility
In animal studies, ampicillin had no effect on fertility.
Driving and using machines
Ampicillina Ethypharm has no effect or a negligible effect on the ability to drive or use machines. However, driving or operating machinery is not recommended if you experience adverse effects that impair concentration (such as drowsiness, see section 4. Possible side effects). If in doubt, discuss this with your doctor or pharmacist.
Ampicillina Ethypharm contains sodium
Ampicillina Ethypharm 1 g contains 70 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 3.5% of the maximum daily recommended dietary intake of sodium for an adult.
Ampicillina Ethypharm 2 g contains 140 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 7% of the maximum daily recommended dietary intake of sodium for an adult.
Consult your doctor or pharmacist if you need Ampicillina Ethypharm daily for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.
If the product is dissolved or diluted with an isotonic sodium chloride solution, the additional sodium content from the solvent must also be taken into account.

3. How to use Ampicillina Ethypharm

This medicine will be administered to you by healthcare personnel as an injection into a muscle or into a blood vessel, or as an intravenous infusion (drip) into a blood vessel.
Your doctor will determine the appropriate dose for you/for your child. The dose depends on the type of infection, the location of the infection in the body, and its severity.

If you use more Ampicillina Ethypharm than you should
If you have taken an excessive dose of Ampicillina Ethypharm or, for example, a child has accidentally ingested the medicine, contact your doctor, hospital, or emergency department immediately to assess the risk and obtain advice.
Symptoms of having received too much ampicillin may include: nausea, vomiting, diarrhoea, loss of consciousness, involuntary muscle contractions, seizures (fits), coma, and kidney failure. In rare cases, a severe allergic reaction (anaphylactic reaction) may occur within 20–40 minutes.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

If you forget to use Ampicillina Ethypharm
If you think you may have missed a dose of Ampicillina Ethypharm, speak to your doctor or nurse immediately. Do not use a double dose to make up for the missed dose.

If you stop using Ampicillina Ethypharm
Stopping treatment too early may compromise the effectiveness of therapy and lead to a relapse, which may be more difficult to treat. Please follow your doctor's instructions.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you experience any of the following side effects:

• Severe acute allergic reaction (anaphylactic reaction), which may be life-threatening. Symptoms may include: itching and skin rash (urticaria), swelling of the face, lips, tongue, or body, and difficulty breathing. These symptoms can be severe and, in rare cases, may lead to death (rare: may affect up to 1 in 1,000 people).
• Ampicillin may affect white blood cells and thereby impair the body's defence against infections. If you develop an infection with symptoms such as fever accompanied by severe deterioration in general condition, or fever with signs of local infection such as sore throat/mouth or difficulty urinating, you should consult a doctor as soon as possible to confirm or exclude agranulocytosis with an appropriate test. It is important to provide information about any medicines you are taking. These reactions are not common (may occur in up to 1 in 100 people).
• Inflammation of the colon with symptoms such as watery diarrhoea, often with blood and mucus, abdominal pain and/or fever (pseudomembranous enterocolitis). This reaction is not common (may affect up to 1 in 100 people).

Other side effects that may occur during treatment

Common (may affect up to 1 in 10 people):

• Soft stools
• Skin rash

Uncommon (may affect up to 1 in 100 people):

• Reduction in red blood cells, which may lead to pale skin, weakness, and shortness of breath (anaemia)
• Decrease in platelet count (thrombocytopenia)
• Decrease or increase in white blood cell count (leucopenia, eosinophilia)
• Inflammation of the tongue and oral mucosa
• Nausea and vomiting
• Inflammation of the colon
• Diarrhoea
• Urticaria

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

• Severe skin inflammation with peeling (exfoliative dermatitis)
• Skin disorders, sometimes severe (erythema multiforme)
• Candidiasis (fungal infection caused by Candida)
• Local pain may occur at the site of intramuscular injections (into the muscle)
• Elevated liver parameters

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ampicillina Ethypharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After reconstitution, the reconstituted solution must be used according to the instructions provided
in the section below for healthcare professionals.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ampicillina Ethypharm contains

• The active substance is ampicillin. Each vial contains 1 g or 2 g of ampicillin as sodium ampicillin.
• There are no other ingredients.

Description of the appearance of Ampicillina Ethypharm and contents of the pack
White or almost white powder.
Colorless glass vials (type III) with a nominal capacity of 8 ml or 20 ml (only for the 2 g strength), sealed with a chlorobutyl rubber stopper and an aluminium cap.
Pack sizes of 10 or 100 vials (for the 1 g strength) or 10 vials (for the 2 g strength) are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Ethypharm
194 Bureaux de la Colline, Building D
92 213 Saint Cloud cedex
France

Manufacturer
Medochemie Ltd. Factory B - Agios Athanassios Industrial Area, 48 Iapetou Street, Agios
Athanassios, Limassol 4101, Cyprus

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

The following information is intended exclusively for healthcare professionals:

Dosage
Adults
Intramuscular: 500 mg four times daily.
Intravenous injection: 500 mg to 2 g four to six times daily. Inject 2 g slowly over at least 3–4 minutes.
Continuous intravenous infusion: 6 to 12 g daily. If possible, use an infusion pump.
Intermittent intravenous infusion: 2 g four to six times daily.
For prophylaxis of endocarditis, 2 g may be administered intravenously as a single dose 30 to 60 minutes before the procedure.
If necessary, a higher dose than recommended may be administered intravenously.

Children
Intramuscular: 50 mg/kg body weight per day. The daily dose should be divided into four doses administered at 6-hour intervals.
For neonates and premature infants: 25–50 mg/kg divided into two doses is recommended.
Intravenous: 100–200 mg/kg body weight per day in case of severe infection. In bacterial meningitis, the intravenous dose for children may be increased up to 400 mg/kg body weight per day (divided into four doses) if necessary.
For prophylaxis of endocarditis, 50 mg/kg may be administered intravenously as a single dose 30 to 60 minutes before the procedure.

Monitoring during treatment
During long-term treatment (beyond 2–3 weeks), liver and kidney function and blood counts should be monitored.
In cases of acute meningitis caused by Listeria monocytogenes and neonatal sepsis, ampicillin must be administered in combination with other antibiotics.
In intra-abdominal infections, ampicillin should be used in combination with other appropriate antibacterial agents when anaerobic and/or Gram-negative pathogens are known or suspected to contribute to the infectious process.

Special populations
Renal impairment
No dose adjustment is necessary in patients with creatinine clearance (CrCl) >30 mL/min.
In case of severe renal impairment with glomerular filtration rate ≤30 mL/min, dose reduction is recommended due to the expected accumulation of ampicillin:

• With creatinine clearance between 20 and 30 mL/min, the normal dose should be reduced to 2/3,
• With creatinine clearance <20 mL/min, the normal dose should be reduced to 1/3.
  As a general rule, in patients with severe renal impairment, the dose of 1 g of ampicillin every 8 hours should not be exceeded.

Method of administration
Ampicillina Ethypharm 250 mg, 500 mg, 1 g: for intramuscular and intravenous use after reconstitution.
Ampicillina Ethypharm 2 g: for intravenous use after reconstitution.
Only freshly prepared, clear solutions should be used, prepared immediately before use. Care must be taken to ensure complete dissolution.

Overdose
Toxicity: High doses are generally well tolerated. However, for example, in cases of impaired renal function and/or impaired blood-cerebrospinal fluid barrier, high parenteral doses may produce toxic symptoms. Acute reactions are primarily due to allergic reactions.
Symptoms: Toxic reactions, nausea, vomiting, diarrhea, electrolyte disturbances, loss of consciousness, muscle fasciculations, myoclonus, cramps, coma. Hemolytic reactions, renal failure, acidosis.
In rare cases, an anaphylactic reaction may occur within 20–40 minutes.
Treatment: Symptomatic treatment. In severe cases, hemoperfusion or hemodialysis.
In anaphylactic reactions: Epinephrine (adrenaline) 0.1–0.5 mg slowly intravenously.
Hydrocortisone 200 mg intravenously, optionally promethazine 25 mg intravenously.
Administration of fluids. Electrolyte correction.

Special precautions for disposal
Only freshly prepared, clear solutions should be used, prepared immediately before use. Care must be taken to ensure complete dissolution. Reconstituted solutions are clear and slightly yellow.
For single use only.

Ampicillina Ethypharm 1 g:

• Solution for intramuscular injection:
  The content of the 1 g vial is dissolved in 3.4 mL of solvent (water for injections). The solution must be used immediately after reconstitution.
• Solution for intravenous injection:
  Dissolve the content of the 1 g vial in 7.4 mL of solvent (water for injections). Chemical and physical stability under use conditions has been demonstrated for 30 minutes at 25°C.
• Solution for intravenous infusion:
  Dissolve the content of the 1 g vial in 7.4 mL of solvent (water for injections). The final solution may be diluted with the infusion fluids listed below to the desired volume to achieve the final concentration, as indicated in the table below.

Ampicillina Ethypharm 2 g:

• Solution for intravenous injection:
  Dissolve the content of the 2 g vial in 10 mL of solvent (water for injections). The solution must be used immediately after reconstitution.
• Solution for intravenous infusion:
  Dissolve the content of the 2 g vial in 10 mL of solvent (water for injections). The final solution may be diluted with the infusion fluids listed below to the desired volume to achieve the final concentration, as indicated in the table below.

Chemical and physical stability during use has been demonstrated for 1 hour at 25°C and for 4 hours at 2°-8°C when diluted in Sodium Chloride 0.9%, Lactated Ringer's, and M/6 Sodium Lactate.
From a microbiological standpoint, diluted and reconstituted solutions should be used immediately, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination. If not used immediately, the storage times and conditions during use are the responsibility of the user.
Unused medicinal product and waste materials derived from such medicinal product must be disposed of in accordance with local regulations.
Incompatibilities
Additions to the penicillin solution should not be made with substances for which compatibility studies are lacking.