Ampicillin Adamed

Package Leaflet: Information for the User

Ampicillin Adamed, 2 g, Powder for Solution for Injection/Infusion

Ampicillin

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Ampicillin Adamed and what is it used for

Ampicillin Adamed contains the active substance ampicillin, which belongs to a group of medicines called "penicillins". It is an antibiotic used to treat bacterial infections, which works by killing the bacteria that cause the infection. Ampicillin Adamed is used to treat infections caused by bacteria that are sensitive to ampicillin.

Ampicillin Adamed is used to treat the following diseases:

• Acute exacerbation of chronic bronchitis (respiratory tract infection)
• Pyelonephritis (upper urinary tract infection)
• Bacterial meningitis (infection of the membranes covering the brain)
• Pneumonia (lung infection) when other penicillins are ineffective or inappropriate for other reasons
• Infections in the abdominal cavity (stomach and intestine infection)
• Blood infections associated with any of the above infections

Ampicillin is also used to treat and prevent endocarditis (infection of the heart valves).

2. Important information before using Ampicillin Adamed

When not to use Ampicillin Adamed

Do not use Ampicillin Adamed if any of the above situations apply to the patient. If in doubt, whether any of the above situations apply to the patient, consult a doctor, pharmacist, or nurse before using.

Warnings and precautions

Before starting treatment with Ampicillin Adamed, discuss it with your doctor, pharmacist, or nurse:

Hypersensitivity reactions

If the patient is allergic to cephalosporins (another group of antibiotics), they should consult a doctor or pharmacist. Caution is advised if the patient has had another allergic reaction in the past.

If the patient experiences an allergic reaction (e.g., hives, anaphylactic shock, asthma, hay fever), discontinue ampicillin treatment and initiate alternative treatment.

Colitis

Pay attention to watery stools, often with blood and mucus, abdominal pain, and (or) fever. These may be signs of colitis. See section 4. This also applies to diarrhea that occurs several months after ampicillin administration.

Infectious mononucleosis, chronic lymphocytic leukemia

In a significant proportion of patients (up to 90%) with infectious mononucleosis or chronic lymphocytic leukemia who take ampicillin, a skin rash appears. The rash usually starts 7 to 10 days after starting ampicillin treatment and lasts for several days to a week after its completion.

Kidney problems

If the patient has kidney failure, the doctor will adjust the dose according to the degree of kidney failure and will monitor kidney function during treatment.

Anticoagulant therapy

If the patient is taking anticoagulant medications, there may be an increased risk of bleeding. The doctor may order regular blood tests.

Oral live typhoid vaccine

There should be an interval of at least 3 days between the administration of antibiotics such as ampicillin and the oral live typhoid vaccine.

Ampicillin Adamed and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Ampicillin interacts with other medicines, such as:

• Allopurinol (a medicine used to treat gout). The risk of an allergic rash may increase.
• Methotrexate (a medicine used to treat cancer or rheumatism). Methotrexate side effects may worsen.
• Probenecid (a medicine used to treat gout). The doctor may decide to adjust the dose of Ampicillin Adamed.
• Anticoagulant medications (medicines used to thin the blood). Concurrent administration of anticoagulant medications may increase the risk of bleeding. The doctor may order regular blood tests.
• Oral live typhoid vaccine. There should be an interval of at least 3 days between the administration of antibiotics such as ampicillin and the oral live typhoid vaccine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

Ampicillin passes into breast milk in small amounts. Breastfed infants may therefore experience allergic reactions, diarrhea, or infection (colonization of the mucous membranes). In some cases, it may be necessary to stop breastfeeding.

Fertility

Animal studies have shown no effect of ampicillin on fertility.

Driving and using machines

There is no evidence to suggest that Ampicillin Adamed affects the ability to drive or use machines.

The patient is responsible for assessing whether their condition allows them to drive or perform work that requires attention. One of the factors that may affect this ability is the effect of taking medicines and (or) their side effects. A description of these effects and side effects is provided in other sections of the leaflet. Read the entire leaflet carefully.

In case of doubt, consult a doctor or pharmacist.

Ampicillin Adamed contains sodium

The medicine contains about 132 mg of sodium (the main component of common salt) per vial. This corresponds to 6.60% of the maximum recommended daily dose of sodium in the diet.

The maximum recommended daily dose corresponds to 39.48% of the WHO (World Health Organization) recommended maximum daily dose of sodium.

If the patient needs to take Ampicillin Adamed for a long time, they should talk to their doctor or pharmacist, especially if they have a low-sodium diet.

3. How to use Ampicillin Adamed

This medicine will be administered by medical personnel as an injection into a blood vessel or as an intravenous infusion.

The doctor will determine the appropriate dose for the patient or child. The dose depends on the type of infection, its location, and severity.

Using a higher dose of Ampicillin Adamed than recommended

If the patient thinks they have been given too much medicine, they should inform their doctor, nurse, or pharmacist.

If the patient has taken too much medicine or, for example, a child has accidentally swallowed the medicine, they should immediately tell their doctor or go to the emergency department of the nearest hospital.

Signs of taking too much Ampicillin Adamed may include: nausea, vomiting, diarrhea, loss of consciousness, involuntary muscle twitching, convulsions, seizures, coma, kidney failure.

In case of any further doubts about using this medicine, consult a doctor, pharmacist, or nurse.

Missing a dose of Ampicillin Adamed

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

Stopping treatment with Ampicillin Adamed

Unless advised by a doctor, do not stop treatment even if symptoms disappear, as the infection may recur.

In case of any further doubts about using the medicine, consult a doctor.

4. Possible side effects

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

If you experience any of the following side effects, stop taking Ampicillin Adamed and contact your doctor or go to the hospital immediately:

• Severe allergic reaction (anaphylactic reaction). This reaction can be life-threatening. It may include one or more of the following symptoms: skin redness, itching rash (hives), shortness of breath, and dizziness (rare, less than 1 in 1000 people).
• Ampicillin may affect white blood cells, which can lead to weakened mechanisms responsible for protecting against infection. If an infection occurs with symptoms such as fever and a significant worsening of the overall health condition or fever with symptoms of local infection, such as sore throat and (or) tonsils and (or) mouth or difficulty urinating, seek medical attention immediately. It is essential to inform the doctor about taking the medicine (not very common, less than 1 in 100 people).
• Colitis, which may be accompanied by symptoms such as watery diarrhea, often with blood and mucus, abdominal pain, and (or) fever (not very common, less than 1 in 100 people).

Other side effects include:

Common (less than 1 in 10 people)

• Skin rash, itching
• Diarrhea

Uncommon (less than 1 in 100 people)

• Decreased red blood cell count, which can cause pale skin, weakness, and shortness of breath (anemia)
• Decreased platelet count (thrombocytopenia)
• Decreased or increased white blood cell count (leukopenia, eosinophilia)
• Tongue and mouth inflammation
• Mouth inflammation, tongue inflammation, abdominal pain
• Nausea and vomiting
• Colitis
• Diarrhea
• Hives (rash)
• Crystalluria (presence of crystals in the urine, indicating kidney irritation)

Rare (less than 1 in 1000 people)

• Severe skin peeling (exfoliative dermatitis)
• Skin changes, sometimes severe (erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome)
• Dizziness, headache, myoclonus, and seizures
• Hepatitis and cholestatic jaundice; elevated liver enzyme activity
• Acute interstitial nephritis (kidney inflammation)
• Pain and swelling at the injection site
• Fungal infections may occur in the mouth and abdominal cavity

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Jerozolimskie Avenue 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

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

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

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

5. How to store Ampicillin Adamed

Store the medicine out of sight and reach of children.

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 stated.

No special precautions for storage.

After reconstitution:

• The prepared solution should be administered immediately.
• Solutions should be prepared just before use and checked for clarity. Only clear solutions should be used. Do not use solutions that are cloudy or contain sediment.
• Instructions for storing this medicine after reconstitution are provided in the section "Information intended for healthcare professionals only".
• Any unused solution should be discarded.

After dilution:

• The diluted solution should be administered immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ampicillin Adamed contains

• The active substance is ampicillin.
• The medicine does not contain any other ingredients.

Each vial contains ampicillin sodium equivalent to 2 g of ampicillin.

What Ampicillin Adamed looks like and contents of the pack

White or almost white powder.

2 g of powder for solution for injection/infusion is packed in vials made of colorless glass type III, closed with a bromobutyl rubber stopper type I and an aluminum flip-off cap, placed in a cardboard box containing 1 or 10 single-dose units.

Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Phone: 22 732 77 00

Manufacturer

Adamed Pharma S.A.

ul. Marszałka Józefa Piłsudskiego 5

95-200 Pabianice

Antibiotice S.A.

1 Valea Lupului Street

707410 Iasi

Romania

This medicine has been authorized for use in the Member States of the European Economic Area under the following names:

Denmark: Amroliv

Norway: Amroliv

Sweden: Amroliv

Iceland:

Amroliv

Finland: Amroliv

Czech Republic: Ampicillin Ardez

Germany: Ampicillin Antibiotice 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung

Poland: Ampicillin Adamed

Date of last revision of the leaflet: 07.2025

Information intended for healthcare professionals only:

Incompatibilities

Do not mix this medicinal product with other medicinal products, except those mentioned in this section.

If ampicillin has been prescribed concurrently with aminoglycosides, do not mix the antibiotics in the same syringe or infusion bottle due to the possibility of inactivation of aminoglycosides.

Preparation of the solution for injection

Ampicillin Adamed 2 g can only be administered intravenously.

Intravenous injection

To reconstitute the solution for injection, the contents of the vial should be dissolved in 14.8 mL of water for injection to obtain a solution for injection with a concentration of 125 mg/mL.

After preparation, the solution should be administered intravenously slowly, over 5-10 minutes. Rapid administration may cause seizures.

Intravenous infusion

First, prepare as described in the "intravenous injection" paragraph, and then dilute with a 9 mg/mL (0.9%) sodium chloride solution.

The concentration of the prepared solution should not exceed 30 mg/mL. The rate and volume of infusion should be determined so that the medicine does not lose stability in the solution used.

For intravenous infusion, Ampicillin Adamed can only be used with the above-mentioned solutions.

Solutions should be prepared just before use and checked for clarity. Only clear solutions should be used. Do not use solutions that are cloudy or contain sediment.

Ampicillin Adamed can be administered as an intravenous infusion over 20-30 minutes. In the case of continuous infusions, it is recommended to use an infusion pump whenever possible.

Use only clear solutions with virtually no solid particles. Do not use solutions that are cloudy or contain sediment.

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