Ampicillin adamed

Package leaflet: Information for the user

Ampicillin Adamed, 1 g, powder for solution for injection/infusion
Ampicillinum
Please read all of this leaflet carefully before you are given this medicine, because it contains
important information for you.

• 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 personally. 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 leaflet

1. What Ampicillin Adamed is and what it is used for
2. What you need to know before you are given Ampicillin Adamed
3. How to be given 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 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 (infection of the upper urinary tract)
• 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)
• Bacteraemia (bacterial infection of the blood) associated with any of the above infections

Ampicillin is also used in the treatment and prevention 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
administration.
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 an allergic reaction occurs (e.g. urticaria, anaphylactic shock, asthma, hay fever), treatment with ampicillin must be discontinued and appropriate alternative therapy initiated.
Colitis
Be alert for watery diarrhoea, 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 ampicillin administration.
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 drugs, prolongation of prothrombin time may occur. When anticoagulants are used concomitantly, appropriate monitoring of the patient is required.
Dosage adjustment of the oral anticoagulant may be necessary.
Urine testing
Ampicillin may affect the results of certain laboratory tests. If the patient provides a urine sample for testing glucose, 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 interacts with other medicines, such as:

• Allopurinol (a medicine used in the treatment of gout). The risk of developing an allergic skin rash may increase.
• Methotrexate (a medicine used in the treatment of cancer or rheumatism). 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.
• Anticoagulant medicines (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. At least 3 days should elapse between administration of antibiotics such as ampicillin and intake of the oral live typhoid vaccine.

Pregnancy, breastfeeding, and effects on 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. Hypersensitivity reactions, diarrhoea, or fungal infection (mucocutaneous candidiasis) may therefore occur in breastfed infants. For this reason, breastfeeding may need to be discontinued in some cases.
Fertility
In animal studies, ampicillin has shown no effect on fertility.
Driving and operating machinery
There is no evidence indicating that Ampicillin Adamed affects the ability to drive
motor vehicles 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 that may affect the ability to perform these activities are 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 66 mg of sodium (the main component of table salt) per vial. This corresponds to
3.30% 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 the WHO (World Health Organization).
If the patient needs to take Ampicillin Adamed for a prolonged period, they should speak with 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 the muscle or into a 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, the site of infection, and its severity.

Administration of a higher than recommended dose of Ampicillin Adamed
If the patient thinks that too high a dose of the medicine has been administered, they should inform the doctor, nurse, or pharmacist.
If the patient has taken an overdose, 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 with Ampicillin Adamed may include: nausea, vomiting, diarrhoea, loss of consciousness, involuntary muscle twitching, convulsions, seizures, coma, kidney failure.

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

Missed dose of Ampicillin Adamed
Do not take a double dose to make up for a missed dose.

Stopping Ampicillin Adamed treatment
Unless otherwise directed by the doctor, do not stop treatment even if symptoms improve, as the infection symptoms may recur.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
If any of the adverse effects listed below occur,
discontinue use of Ampicillin Adamed immediately and contact your doctor without delay
or go directly to 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 defence mechanisms against infection. If an infection occurs with symptoms such as fever accompanied by a serious deterioration in general health, or fever with local infection symptoms such as sore throat and (or) larynx and (or) oral cavity or difficulty urinating, 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 (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, no more than 1 in 100 people).

Other adverse effects include:
Common (no more than 1 in 10 people)

• Skin rash, itching
• Loose stools

Uncommon (no more than 1 in 100 people)

• Decrease in red blood cells, which may cause paleness of the skin, weakness and shortness of breath (anaemia)
• Decrease in platelet count (thrombocytopenia)
• Decrease or increase in white blood cell count (leukopenia, eosinophilia)
• Inflammation of the tongue and oral mucosa
• Inflammation of the oral cavity, inflammation of the tongue, abdominal pain
• Nausea and vomiting
• Colitis
• 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 lesions, sometimes severe (erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome)
• Dizziness, headache, myoclonus and convulsions
• Inflammation of the liver and cholestatic jaundice; increased liver enzyme activity
• Acute interstitial nephritis (kidney inflammation)
• Pain and swelling at the injection site
• Fungal infections in the oral cavity and abdominal cavity may occur

Reporting of adverse effects
If any adverse symptoms occur in the patient, including any adverse effects
not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse effects 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation 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 required.

After reconstitution:

• The prepared solution should be administered immediately.
• Solutions should be prepared immediately before use and checked for clarity. Use only clear solutions. Do not use solutions that are cloudy or contain sediment.
• 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 must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ampicillin Adamed contains

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

Each vial contains sodium ampicillin 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 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 medicinal product has been authorised in the European Economic Area countries 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: Ampicilina Antibiotice 1 g polvo para solución inyectable y para perfusión EFG

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 with aminoglycosides in the same syringe or infusion bottle due to the risk of inactivation of the aminoglycosides.

Preparation of injection solution

Intramuscular injection
To reconstitute the injection solution, dissolve the contents of the vial in 4 mL of water for injections to obtain a solution with a concentration of 250 mg/mL. Shake until the solution becomes clear and transparent.
After reconstitution, administer the solution immediately and discard any unused portion.
The solution should be administered by deep intramuscular injection.

Intravenous injection
To reconstitute the injection solution, dissolve the contents of the vial in 7.4 mL of water for injections to obtain a solution with a concentration of 125 mg/mL.
After preparation, inject intravenously slowly 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 infusion rate and volume should be adjusted to maintain the stability of the drug 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 inspected visually 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 without visible particulate matter should be used.
Do not use solutions that are cloudy or contain a precipitate.

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