Ampitar

Leaflet attached to the packaging: information for the user

Ampitar, 1 g, powder for solution for injection/infusion

Ampitar, 2 g, powder for solution for injection/infusion

Ampicillin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Ampitar and what is it used for
• 2. Important information before using Ampitar
• 3. How to use Ampitar
• 4. Possible side effects
• 5. How to store Ampitar
• 6. Contents of the packaging and other information

1. What is Ampitar and what is it used for

Ampitar contains the active substance ampicillin, which belongs to a group of medicines called penicillins. It is a medicine used to treat bacterial infections (antibiotic), which works by killing the bacteria that cause the infections. Ampitar is used to treat infections caused by bacteria that are sensitive to ampicillin.

Ampitar is used to treat the following diseases:

• Acute exacerbation of chronic bronchitis (respiratory tract infections)
• Pyelonephritis (upper urinary tract infection)
• Bacterial meningitis (infection of the membranes surrounding the brain)
• Pneumonia, when another penicillin is not effective or is contraindicated for other reasons
• Infections in the abdominal cavity (stomach and intestine infections)
• Blood infections associated with any of the above infections
• Treatment and prevention of endocarditis. Ampitar is also used for the treatment and prevention of endocarditis (infection of the heart valves).

2. Important information before using Ampitar

When not to use Ampitar

• if the patient is allergic (hypersensitive) to ampicillin, other antibiotics called beta-lactams (e.g. penicillin or cephalosporin) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Ampitar, the patient should discuss the following with their doctor:

• if the patient has had an allergic reaction to any antibiotic in the past;
• if the patient has had any other allergic reaction in the past. Allergic reactions to ampicillin may occur more frequently in people with a tendency to allergic reactions to various substances. These reactions can cause various symptoms and have different severity - from skin changes to anaphylactic shock (severe allergic reaction);
• if the patient has kidney failure. The doctor will adjust the dose of the medicine according to the degree of kidney failure;
• if the patient has had gastrointestinal diseases in the past, especially colitis.

Before starting treatment with Ampitar, the patient should discuss the following with their doctor, pharmacist, or nurse:

• if the patient is allergic to cephalosporins (another group of antibacterial medicines).
• if the patient experiences symptoms such as watery diarrhea, often with blood and mucus, abdominal pain, and/or fever during or after treatment with ampicillin, they should tell their doctor. This may be a sign of pseudomembranous colitis. See section 4.

Urinalysis

In patients treated with ampicillin, urine glucose test results may be false positive. In this case, if glucose measurement is required, the patient should inform their doctor or nurse about taking Ampitar.

Ampitar and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Allopurinol (a medicine used to treat gout) taken at the same time as Ampitar increases the risk of skin allergic reactions.
• Methotrexate (a medicine used to treat cancer or rheumatism) - Ampitar taken at the same time may enhance the side effects of methotrexate.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Pregnancy

Ampicillin can be used during pregnancy if the doctor considers it necessary.

Breastfeeding

Ampicillin is excreted into human milk in small amounts. Therefore, breastfed infants may experience allergic reactions, diarrhea, or colonization of the mucous membrane with fungi, which in some cases may require discontinuation of breastfeeding.

Fertility

In animal studies, ampicillin did not affect fertility.

Driving and using machines

Ampitar has no or negligible influence on the ability to drive and use machines. However, if side effects occur that have a negative impact on concentration (e.g. drowsiness, see section 4. Possible side effects), driving and using machines is not recommended. In case of doubt, the patient should consult their doctor or pharmacist.

Ampitar contains sodium

Ampitar, 1 g:

The medicine contains 70.2 mg of sodium (the main component of common salt) per vial. This corresponds to 3.51% of the maximum recommended daily intake of sodium in the diet for adults.

The maximum recommended daily dose of Ampitar contains 842.4 mg of sodium (the main component of common salt). This corresponds to 42.1% of the maximum recommended daily intake of sodium in the diet for adults.

The patient should inform their doctor or pharmacist if Ampitar is to be administered daily for a longer period, especially if the patient has a low-sodium diet.

If the medicinal product is dissolved or diluted with isotonic sodium chloride solution, the additional amount of sodium from the solvent should also be taken into account.

Ampitar, 2 g:

The medicine contains 140.4 mg of sodium (the main component of common salt) per vial. This corresponds to 7.02% of the maximum recommended daily intake of sodium in the diet for adults.

The maximum recommended daily dose of Ampitar contains 842.4 mg of sodium (the main component of common salt). This corresponds to 42.1% of the maximum recommended daily intake of sodium in the diet for adults.

The patient should inform their doctor or pharmacist if Ampitar is to be administered daily for a longer period, especially if the patient has a low-sodium diet.

If the medicinal product is dissolved or diluted with isotonic sodium chloride solution, the additional amount of sodium from the solvent should also be taken into account.

3. How to use Ampitar

This medicine will be administered to the patient by medical staff in the form of an intramuscular injection or an injection into one of the blood vessels or in a drip (as an intravenous infusion).

The doctor will determine the dose for the adult or child patient. The dosage depends on the severity of the infection, the type of microorganism causing the infection, the patient's age, and weight.

Overdose of Ampitar

In case of overdose or if, for example, a child has accidentally taken the medicine, the patient should contact their doctor, hospital, or Poison Information Center (tel. 112) to assess the risk and obtain advice.

In case of overdose, the following symptoms may occur: nausea, vomiting, diarrhea, loss of consciousness, involuntary muscle twitching, convulsions, coma, kidney failure. In exceptional cases, a severe acute allergic reaction (anaphylactic reaction) may occur within 20-40 minutes.

Missed dose of Ampitar

If the patient thinks they have missed a dose of Ampitar, they should tell their doctor or nurse immediately. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Ampitar

Stopping treatment too early may worsen the treatment outcome or lead to a relapse that is more difficult to treat. The patient should follow their doctor's instructions.

The instructions for preparing the medicine for use are at the end of the leaflet in the section "Information intended for healthcare professionals only".

In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

In case of any of the following serious side effects, the patient should contact their doctor immediately:

• Severe allergic reaction (anaphylactic reaction), which can be life-threatening. Symptoms may include itching and skin rash (hives), swelling of the face, lips, tongue, body, or difficulty breathing. These symptoms can be severe and, in rare cases, may lead to death - they occur rarely (less than 1 in 1000 people).
• Ampitar may affect white blood cells, leading to weakened immunity. If the patient experiences an infection with symptoms such as fever with severe deterioration of general condition or fever with local symptoms of infection, such as throat and mouth pain or difficulty urinating, they should contact their doctor as soon as possible to confirm or rule out agranulocytosis using an appropriate test. It is essential to tell the doctor about all medicines being taken. These reactions occur not very often (less than 1 in 100 people)
• Pseudomembranous colitis with symptoms such as watery diarrhea, often with blood and mucus, abdominal pain, and/or fever. This reaction occurs not very often (less than 1 in 100 people)

Other side effects that may occur during treatment

The following side effects are common(occur in less than 1 in 10 people):
diarrhea
skin rash
The following side effects are uncommon(occur in less than 1 in 100 people):
decrease in red blood cell count, which can lead to pale skin, weakness, and shortness of breath (anemia)
decrease in platelet count (thrombocytopenia)
decrease or increase in white blood cell count (leukopenia, eosinophilia)
inflammation of the tongue and mucous membrane of the mouth
nausea and vomiting
inflammation of the large intestine
diarrhea
hives
The following side effects are rare(occur in less than 1 in 1000 people):
severe skin inflammation with peeling (exfoliative dermatitis)
skin changes, sometimes severe (erythema multiforme)
Candidiasis
When administered intramuscularly, pain may occur at the injection site.
Elevated liver parameters may occur.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ampitar

There are no special precautions for storing the medicine.

The medicine should be stored out of sight and reach of children.

The solution should be used immediately after preparation.

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

Lot means batch number.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ampitar contains

• The active substance of the medicine is ampicillin (in the form of ampicillin sodium). Ampitar, 1 g: 1 vial contains 1 g of ampicillin (in the form of ampicillin sodium). Ampitar, 2 g: 1 vial contains 2 g of ampicillin (in the form of ampicillin sodium). (Ampitar contains sodium. More information about sodium can be found at the end of section 2).
• The medicine does not contain any other ingredients.

What Ampitar looks like and contents of the pack

Ampitar is a white to light yellow powder. The pH of the reconstituted solution is 8.0-10.0.

Packaging: 1 or 10 vials in a carton.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna

ul. A. Fleminga 2

03-176 Warsaw

Phone number: (22) 811 18 14

To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder.

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

Poland

Ampitar

Denmark

Ampitar

Sweden

Ampitar

Finland

Ampitar 1 g injektio-/infuusiokuiva-aine liuosta varten

Ampitar 2 g injektio-/infuusiokuiva-aine liuosta varten

Norway

Ampitar

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Dosage

Adults:

Intramuscularly: 500 mg 4 times a day.

Intravenously: 500 mg to 2 g 4-6 times a day. Administer slowly over at least 3-4 minutes.

Continuous intravenous infusion: 6 to 12 g per day. Whenever possible, an infusion pump should be used.

Intermittent intravenous infusion: 2 g 4-6 times a day.

Prophylaxis of endocarditis - 2 g can be administered intravenously as a single dose 30 to 60 minutes before the procedure.

In case of need, higher doses than recommended can be administered intravenously.

Children:

Intramuscularly: 50 mg/kg body weight per day. The daily dose should be divided into four doses administered at 6-hour intervals. In newborns and premature infants, 25-50 mg/kg is recommended in two divided doses.

Intravenously: 100-200 mg/kg body weight per day in severe infections. In bacterial meningitis, the intravenous dose in children can be increased to 400 mg/kg body weight per day (divided into four doses).

Prophylaxis of endocarditis - in children, 50 mg/kg can be administered intravenously as a single dose 30 to 60 minutes before the procedure.

Monitoring of treatment

In case of long-term treatment (more than 2-3 weeks), liver and kidney function, as well as blood morphology, should be monitored.

In case of acute meningitis caused by Listeria monocytogenes and sepsis in newborns, ampicillin is administered in combination with another antibiotic.

In abdominal infections, ampicillin should be used in combination with other appropriate antibacterial medicines when it is known or suspected that anaerobic and/or Gram-negative pathogens contribute to the infectious process.

Special patient groups

Patients with renal impairment

No dose adjustment is necessary in patients with a creatinine clearance (CrCl) >30 mL/min.

In case of severe renal impairment with a glomerular filtration rate of 30 mL/min or less, the dose should be reduced, as accumulation of ampicillin is expected:

• at a creatinine clearance of 20-30 mL/min, the usual dose should be reduced to 2/3,
• at a creatinine clearance below 20 mL/min, the usual dose should be reduced to 1/3. Generally, in patients with severe renal impairment, the dose of ampicillin should not exceed 1 g every 8 hours.

Overdose

Toxicity:High doses are usually well tolerated. However, for example, in patients with impaired renal function and disrupted blood-brain barrier, parenteral administration of high doses of the product has caused toxic symptoms. Acute reactions are mainly caused by allergic reactions.

Symptoms:Toxic reactions; nausea, vomiting, diarrhea, electrolyte disturbances, decreased consciousness, muscle twitching, myoclonus, convulsions, coma. Hemolytic reactions, kidney dysfunction, acidosis.

In exceptional cases, an anaphylactic reaction may occur within 20-40 minutes.

Treatment:Symptomatic treatment. In severe cases, hemoperfusion or hemodialysis.

In case of anaphylactic reaction:Epinephrine (adrenaline) 0.1-0.5 mg slowly intravenously. Hydrocortisone 200 mg intravenously, optionally promethazine 25 mg intravenously. Fluids. Acidosis correction.

Special precautions for disposal

The solution should be used immediately after preparation.

Before administration, the appearance of the solution should be checked. The solution should be clear and practically free from particles.

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Preparation of the solution

Intramuscular injections

Dissolve 1 g in 4 mL of water for injections.

Intravenous injections

Dissolve 1 g in 10 mL of water for injections.

Dissolve 2 g in 20 mL of water for injections.

Intermittent infusion

Dissolve 1 g in 100 mL of isotonic sodium chloride solution (0.9%). The solution is prepared in polyolefin containers.

Dissolve 2 g in 100 mL of isotonic sodium chloride solution (0.9%) or water for injections. The solution is prepared in a polyolefin container.

Continuous infusion

Dissolve 2 g in 15 mL of water for injections. The resulting solution should be added to 500 mL of isotonic sodium chloride solution (0.9%). The solution is prepared in a polyolefin container.

Incompatibilities

Penicillin solutions should not be mixed with substances for which compatibility has not been established.