Ampicillin Adamed

Package Leaflet: Information for the User

Ampicillin Adamed, 1 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package 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 conditions:

• Acute exacerbation of chronic bronchitis (respiratory tract infection)
• Pyelonephritis (upper urinary tract infection)
• Bacterial meningitis (infection of the membranes surrounding the brain)
• Pneumonia (lung infection) when other penicillins are ineffective or inappropriate for other reasons
• Intra-abdominal infections (infection of the stomach and intestines)
• Bloodstream 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

• if you are allergic to ampicillin or other penicillins.

Do not use Ampicillin Adamed if any of the above situations apply to you. If you are unsure whether any of the above situations apply to you, consult your doctor, pharmacist, or nurse before using the medicine.

Warnings and precautions

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

Hypersensitivity reactions

If you are allergic to cephalosporins (another group of antibiotics), you should consult your doctor or pharmacist. Caution is advised if you have had a previous hypersensitivity reaction.

If you experience a hypersensitivity reaction (e.g., hives, anaphylactic shock, asthma, hay fever), discontinue ampicillin treatment and initiate alternative treatment.

Colitis

Be aware of 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.

Mononucleosis, chronic lymphocytic leukemia

In a significant proportion of patients (up to 90%) with 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 you have kidney failure, your doctor will adjust the dose according to the degree of kidney failure and monitor kidney function during treatment.

Anticoagulant therapy

If you are taking anticoagulant medications, there may be an increased risk of bleeding. If you are taking anticoagulant medications, your doctor will monitor you closely. It may be necessary to modify the dose of oral anticoagulant medication.

Urinalysis

Ampicillin may affect the results of some tests. If you are providing a urine sample for glucose testing, inform your doctor or nurse that you are taking Ampicillin Adamed.

Intramuscular injection may cause pain at the injection site.

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 hypersensitivity reactions may increase.
• Methotrexate (a medicine used to treat cancer or rheumatism). Methotrexate side effects may worsen.
• Probenecid (a medicine used to treat gout). Your 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. Your 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, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

Ampicillin passes into breast milk in small amounts. Breastfed infants may therefore experience hypersensitivity reactions, diarrhea, or infection (mucosal colonization) with yeast, and in some cases, breastfeeding may need to be discontinued.

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.

You are responsible for assessing whether your condition allows you to drive or perform work that requires attention. One of the factors that may affect this ability is the effect of taking medicines and their side effects. The description of these effects and side effects is given in other sections of the leaflet. Read the entire leaflet carefully.

If you are unsure, consult your doctor or pharmacist.

Ampicillin Adamed contains sodium

The medicine contains approximately 66 mg of sodium (the main component of common salt) per vial, which is 3.30% of the maximum recommended daily intake of sodium.

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

If you need to take Ampicillin Adamed for a long time, talk to your doctor or pharmacist, especially if you are on a low-sodium diet.

3. How to use Ampicillin Adamed

This medicine will be administered by medical personnel as an intramuscular or intravenous injection or as an intravenous infusion.

Your doctor will determine the appropriate dose for you or your child. The dose depends on the type of infection, the site of infection, and its severity.

Using a higher dose of Ampicillin Adamed than recommended

If you think you have been given too much medicine, tell your doctor, nurse, or pharmacist.

If you have taken too much medicine or, for example, a child has accidentally swallowed the medicine, tell your doctor or go to the emergency department of the nearest hospital immediately.

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

If you have any further questions about using this medicine, ask your 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

Do not stop treatment unless your doctor tells you to, even if your symptoms have improved, as this may lead to a recurrence of infection symptoms.

If you have any further questions about using the medicine, ask your 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 hypersensitivity reaction (anaphylactic reaction). This reaction can be life-threatening. One or more of the following symptoms may occur: 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 you experience an infection with symptoms such as fever and a significant deterioration in general health or fever with symptoms of local infection, such as sore throat and/or tonsillitis and/or oral cavity or difficulty urinating, seek medical attention immediately. Your doctor will order a blood test to rule out a lack of white blood cells (agranulocytosis). It is essential to inform your doctor that you are 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 oral mucosa inflammation
• Oral 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 abdomen

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 Adverse Reaction Monitoring 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

Reporting side effects will help to 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.

No special storage precautions are required.

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 given in the section "Information intended for healthcare professionals only".
• 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 1 g of ampicillin.

What Ampicillin Adamed looks like and contents of the pack

White or almost white powder.

1 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

tel. 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 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 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung

Hungary: Ampicillin Antibiotice 1 g por oldatos injekcióhoz vagy infúzióhoz

Poland: Ampicillin Adamed

Italy: Ampicillina Tillomed

Spain: Ampicillin Tillomed 1 g polvo para solución inyectable y para perfusión

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 is prescribed concurrently with aminoglycosides, do not mix the antibiotics in the same syringe or infusion bottle due to the possibility of inactivating the aminoglycosides.

Preparation of the solution for injection

Ampicillin Adamed 1 g can be administered intramuscularly or intravenously.

Intramuscular injection

To reconstitute the solution for injection, the contents of the vial should be dissolved in 4 mL of water for injections to obtain a solution for injection with a concentration of 250 mg/mL. Shake until the solution is clear.

After reconstitution, the solution should be administered immediately, and any remaining solution should be discarded.

The solution should be administered by deep intramuscular injection.

Intravenous injection

To reconstitute the solution for injection, the contents of the vial should be dissolved in 7.4 mL of water for injections to obtain a solution for injection with a concentration of 125 mg/mL.

After preparation of the solution, administer slowly intravenously over 5-10 minutes. Rapid administration may cause seizures.

Intravenous infusion

Prepare first as described in the "intravenous injection" paragraph, then dilute with sodium chloride 9 mg/mL (0.9%) 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 intravenous infusions over 20-30 minutes. For 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.