Ampicillin adamed

Package leaflet: Information for the user

Ampicillin Adamed, 500 mg, powder for solution for injection/infusion
Ampicillinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Ampicillin Adamed is and what it is used for
2. What you need to know 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 Ampicillin Adamed is and what it is 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 by killing the bacteria causing the infection. Ampicillin Adamed is used to treat bacterial infections caused by organisms 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)
• Bacterial bloodstream infection associated with any of the above infections

Ampicillin is also used in the treatment and prophylaxis of bacterial endocarditis (infection of the heart valves).

2. Important information before using Ampicillin Adamed

When not to use Ampicillin Adamed

• if the patient is allergic to ampicillin or other penicillins.

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, consult a doctor, pharmacist, or nurse before use.

Warnings and precautions

Before starting treatment with Ampicillin Adamed, discuss this 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 previously experienced any other allergic reaction. If a hypersensitivity reaction occurs (e.g. urticaria, anaphylactic shock, asthma, hay fever), treatment with ampicillin must be discontinued and appropriate alternative treatment initiated.

Colitis
Be alert for 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 diarrhoea occurring several months after administration of ampicillin.

Infectious mononucleosis, chronic lymphocytic leukaemia
A skin rash develops in a significant proportion of patients (up to 90%) with infectious mononucleosis or chronic lymphocytic leukaemia who take ampicillin. The rash usually appears 7 to 10 days after starting ampicillin treatment and may persist for several days to a week after treatment ends.

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

Anticoagulant therapy
If the patient is taking anticoagulant medicines, prolongation of prothrombin time may occur. Appropriate monitoring of the patient is required when anticoagulants are used concomitantly. Dose adjustment of oral anticoagulant therapy may be necessary.

Urine testing
Ampicillin may affect the results of certain laboratory tests. If the patient provides a urine sample for glucose testing, they should inform the doctor or nurse that they are taking Ampicillin Adamed.

Intramuscular injection of solutions may cause pain at the injection site.

Ampicillin Adamed with other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Ampicillin may interact with other medicines, such as:

• Allopurinol (a medicine used in the treatment of gout). The risk of allergic skin rash may increase.
• Methotrexate (a medicine used in the treatment of cancer or rheumatic diseases). The adverse effects of methotrexate may be enhanced.
• Probenecid (a medicine used in the treatment of gout). The doctor may decide to adjust the dose of Ampicillin Adamed.
• Anticoagulants (medicines used to thin the blood). Concomitant administration may increase the tendency to bleed. The doctor may order regular blood tests.
• Oral live typhoid vaccine. A minimum interval of 3 days should be maintained between administration of antibiotics such as ampicillin and oral live typhoid vaccine.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

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

Breastfeeding
Ampicillin passes into human milk in small amounts. Breastfed infants may therefore experience hypersensitivity reactions, diarrhoea, or fungal infection (mucosal candidiasis). For this reason, in some cases, discontinuation of breastfeeding may be necessary.

Fertility
Animal studies have shown no effect of ampicillin on fertility.

Driving and operating machinery
There is no evidence indicating that Ampicillin Adamed affects the ability to drive or operate machinery.
The patient is responsible for assessing whether their condition allows driving motor vehicles or performing work requiring concentration. One of the factors affecting the ability to perform these activities may be the effects of taking medicines and/or their adverse effects. A description of these effects and adverse reactions is provided in other sections of this leaflet. Please read the entire leaflet carefully.
If in doubt, consult a doctor or pharmacist.

Ampicillin Adamed contains sodium
This medicine contains approximately 33 mg of sodium (the main component of table salt) per vial. This corresponds to 1.65% of the maximum recommended daily dietary intake of sodium.
The maximum recommended daily dose corresponds to 39.48% of the maximum daily sodium intake recommended by WHO (World Health Organization).
If the patient needs to take Ampicillin Adamed for a prolonged period, they should consult their doctor or pharmacist, especially if they are on a low-salt (low-sodium) diet.

3. How to use Ampicillin Adamed

This medicine will be administered by medical personnel as an injection into a muscle or blood vessel, or as an intravenous infusion (drip) into a blood vessel.
The doctor will determine the appropriate dose for the patient or child. The dose depends on the type of infection, its location, and severity.
Use of a higher than recommended dose of Ampicillin Adamed
If the patient thinks they have been given too much medicine, they should inform their doctor, nurse, or pharmacist immediately.
If the patient has taken too much medicine, or for example a child has accidentally swallowed the medicine, they should immediately inform a doctor or go to the emergency department of the nearest hospital.
Symptoms of an overdose of Ampicillin Adamed may include: nausea, vomiting, diarrhoea, loss of consciousness, involuntary muscle tremors, cramps, convulsions, coma, and kidney failure.
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.
Missed dose of Ampicillin Adamed
Do not use a double dose to make up for a missed dose.
Stopping treatment with Ampicillin Adamed
Unless otherwise advised by the doctor, do not stop treatment even if symptoms improve, as the infection may otherwise recur.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below occur, you must
stop taking Ampicillin Adamed immediately and contact your doctor
or go directly to a hospital:

• Acute severe allergic reaction (anaphylactic reaction). Such a reaction may be life-threatening. One or more of the following symptoms may occur: skin redness, itchy rash (urticaria), shortness of breath, and dizziness (rare, less than 1 in 1,000 people).
• Ampicillin may affect white blood cells, leading to weakened mechanisms responsible for protection against infection. If an infection occurs with symptoms such as fever and associated serious deterioration in general health, or fever with signs of local infection such as sore throat and/or larynx and/or oral cavity or difficulty urinating, you should seek medical advice immediately. The doctor may order a blood test to rule out a deficiency of white blood cells (agranulocytosis). It is important to inform the doctor about taking this medicine at that time (uncommon, less than 1 in 100 people).
• Inflammation of the large intestine (colitis), accompanied by symptoms such as watery diarrhoea, often with blood and mucus, abdominal pain and/or fever (uncommon, less than 1 in 100 people).

Other adverse reactions include:
Common (not more than 1 in 10 people)

• Skin rash, itching
• Loose stools

Uncommon (not more than 1 in 100 people)

• Decrease in red blood cells, which may cause pale skin, weakness, and shortness of breath (anaemia)
• Decrease in platelets (thrombocytopenia)
• Decrease or increase in white blood cells (leukopenia, eosinophilia)
• Inflammation of the tongue and oral mucosa
• Inflammation of the oral cavity, inflammation of the tongue, abdominal pain
• Nausea and vomiting
• Inflammation of the large intestine
• Diarrhoea
• Urticaria (rash)
• Crystalluria (presence of crystals in urine, indicating kidney irritation)

Rare (less than 1 in 1,000 people)

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

Reporting of adverse reactions
If any adverse symptoms occur in a patient, including any adverse symptoms not listed in this leaflet, they should be reported to a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Ampicillin Adamed
Keep the medicine out of the 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 stated month.
No special storage conditions apply.

After reconstitution:

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

After dilution:

• The diluted solution should be administered immediately.

Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ampicillin Adamed contains

• The active substance is ampicillin.
• The medicine contains no other ingredients.

Each vial contains sodium ampicillin equivalent to 500 mg of ampicillin.
What Ampicillin Adamed looks like and contents of the pack
White or almost white powder.
500 mg of powder for solution for injection/infusion is packed in vials made of colourless glass type III, closed with a bromobutyl rubber stopper type I and an aluminium flip-off cap, placed in a cardboard box containing 1 or 10 single units.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Denmark: Amroliv
Norway: Amroliv
Finland: Amroliv
Czech Republic: Ampicillin Ardez
Germany: Ampicillin Antibiotice 500 mg Pulver zur Herstellung einer Injektions-/Infusionslösung
Poland: Ampicillin Adamed
Spain: Ampicilina Antibiotice 500 mg polvo para solución inyectable y para perfusión

Information intended exclusively for healthcare professionals:

Pharmaceutical incompatibilities
Do not mix this medicinal product with other medicinal products, except those mentioned in this section.
If ampicillin has been prescribed simultaneously with aminoglycosides, do not mix the antibiotics in the same syringe or infusion bottle due to the risk of inactivating the aminoglycosides.

Preparation of injection solution
Ampicillin Adamed 500 mg can be administered intramuscularly or intravenously.

Intramuscular injection
To reconstitute the injection solution, dissolve the contents of the vial in 1.8 mL of water for injections to obtain a solution with a concentration of 250 mg/mL. Shake until the solution becomes clear.
After reconstitution, the solution should be administered immediately and any unused portion must be discarded.
The solution should be administered by deep intramuscular injection.

Intravenous injection
To reconstitute the injection solution, dissolve the contents of the vial in 5 mL of water for injections to obtain a solution with a concentration of 100 mg/mL.
After preparation, administer the solution slowly intravenously over 5–10 minutes. Rapid administration may cause seizures.

Intravenous infusion
First prepare as described in the section "Intravenous injection", then dilute with sodium chloride solution 9 mg/mL (0.9%).
The concentration of the prepared solution should not exceed 30 mg/mL. The rate and volume of infusion should be adjusted to ensure the drug remains stable in the solution used.
For intravenous infusion, only the solutions mentioned above may be used with Ampicillin Adamed.
Solutions should be prepared immediately before use and checked for clarity.

Ampicillin Adamed may be administered as intravenous infusions over 20–30 minutes. In the case of continuous infusions, an infusion pump should be used whenever possible.
Only clear solutions that are practically free of particulate matter should be used.
Do not use solutions that are cloudy or contain precipitate.

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