Ampicillin Tillomed

Package leaflet: Information for the user

Ampicillina Tillomed

1 g powder for injectable/infusion solution
Equivalent medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Ampicillina Tillomed is and what it is used for
2. What you need to know before using Ampicillina Tillomed
3. How to use Ampicillina Tillomed
4. Possible side effects
5. How to store Ampicillina Tillomed
6. Contents of the pack and other information

1. WHAT AMPICILLINA TILLOMED IS AND WHAT IT IS USED FOR

Ampicillina Tillomed contains the active substance ampicillin, which belongs to a group of medicines
called penicillins. This is a medicinal product for the treatment of bacterial infections (antibiotics) that
acts by killing the bacteria causing the infections. Ampicillina Tillomed is used to treat infections
caused by bacteria sensitive to ampicillin.
Ampicillina Tillomed 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 covering the brain)
• Pneumonia (lung infection) when another penicillin is not effective or is inappropriate for other reasons
• Intra-abdominal infections (infection of the stomach and intestine)
• Bacterial blood infection associated with any of the above-mentioned infections.

Ampicillin is also used for the treatment and prevention of endocarditis (infection of the heart valves).

2. WHAT YOU NEED TO KNOW BEFORE USING AMPICILLIN TILLOMED

Do not use Ampicillin Tillomed:

• If you are allergic to ampicillin or to other penicillins.

Do not use Ampicillin Tillomed if any of the above conditions apply to you. If you have any
doubts, consult your doctor, pharmacist, or nurse before using ampicillin.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ampicillin Tillomed:
Hypersensitivity reactions
If you are allergic to cephalosporins (another group of antibacterial medicines). Caution is recommended if you
have had allergies in the past.
If an allergic reaction occurs (e.g. urticaria, anaphylaxis, asthma, hay fever), treatment
with ampicillin must be stopped and appropriate alternative therapy initiated.
Inflammation of the colon
Be alert for symptoms of watery diarrhoea, often with blood and mucus, abdominal pain and/or
fever. This may be a sign of inflammation of the colon. See section 4. This also applies
if diarrhoea develops several months after administration of ampicillin.
Infectious mononucleosis, chronic lymphocytic leukaemia
A significant proportion (up to 90%) of patients with infectious mononucleosis or lymphocytic
leukaemia who receive ampicillin develop skin rashes. Typically, the rash begins 7
to 10 days after starting ampicillin treatment and persists for several days or a week
after discontinuation.
Renal impairment
If you suffer from severe renal impairment, your doctor will adjust the recommended antibiotic dose and
monitor kidney function during therapy.
Anticoagulant therapy
If you are being treated with anticoagulants, a prolonged prothrombin time may occur. In
case of concomitant prescription of anticoagulants, appropriate monitoring is required.
Adjustment of oral anticoagulant dosage may be necessary.
Urine sample
Ampicillin may affect the results of certain types of laboratory tests. If you need to provide urine samples for
glucose measurement, inform your doctor or nurse that you are taking Ampicillin Tillomed.
Ampicillin Tillomed
Administration of intramuscular solutions may cause pain at the injection site.
Other medicines and Ampicillin Tillomed
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Ampicillin may interact with or be affected by certain other medicines, for example:

• Allopurinol (a medicine used to treat gout). The risk of allergic skin rash may increase.
• Methotrexate (a medicine used to treat cancer or rheumatic diseases). Methotrexate side effects may increase.
• Probenecid (a medicine used to treat gout). Your doctor may decide to adjust the dose of Ampicillin Tillomed.
• Anticoagulants (medicines used to thin the blood). Co-administration of anticoagulants may increase the tendency to bleed. Your doctor may decide to perform regular blood tests.
• Oral typhoid live vaccine. At least 3 days should elapse between taking an oral live typhoid vaccine and administration of antibiotics such as ampicillin.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Ampicillin may be used during pregnancy if your doctor considers it necessary.
Breastfeeding
Ampicillin is excreted in human milk in small amounts. Breastfed infants may therefore
experience hypersensitivity reactions, diarrhoea, or yeast colonization of the mucous membranes, which in some
cases may require discontinuation of breastfeeding.
Fertility
In animal studies, ampicillin had no effect on fertility.
Driving and using machines
There is no evidence that Ampicillin Tillomed affects the ability to drive or operate
machinery.
It is your responsibility to assess whether you are fit to drive a motor vehicle or perform tasks
requiring high concentration. One of the factors that may affect your ability in these areas is
the use of medicines due to their effects and/or side effects. Descriptions of these effects and
side effects are provided in other sections. Read all the information contained in this leaflet.
If you are unsure, discuss it with your doctor or pharmacist.
Ampicillin Tillomed 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 daily sodium intake recommended in the diet for an adult.
The maximum daily recommended dose corresponds to 39.48% of the maximum daily sodium intake recommended by the WHO.
Consult your doctor or pharmacist if you need Ampicillin Tillomed daily for a prolonged period,
especially if you have been advised to follow a low-salt (sodium) diet.

3. HOW TO USE AMPICILLIN TILLOMED

This medicine will be administered to you by healthcare personnel as an injection into a muscle or into a blood vessel, or as an intravenous infusion (infusion) into a blood vessel.
Your doctor will determine the appropriate dose for you/for your child. The dose depends on the type of infection, the location of the infection in the body, and its severity.
If you use more Ampicillin Tillomed than you should
If you think you have used too much of this medicine, inform your doctor, nurse, or pharmacist. If you have taken an excessive dose of the medicine or, for example, a child has accidentally ingested it, contact your doctor or the emergency department of the nearest hospital.
Signs that you have been given too much Ampicillin Tillomed may include: nausea, vomiting, diarrhoea, loss of consciousness, involuntary muscle contractions, cramps, seizures, coma, renal failure.
If you have any doubts about how to use this medicine, consult your doctor, nurse, or pharmacist.
If you forget to use Ampicillin Tillomed
Do not use a double dose to make up for a forgotten dose.
If you stop using Ampicillin Tillomed
Do not stop treatment even if symptoms disappear, unless your doctor has advised you to do so, as symptoms may reappear.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Stop taking Ampicillin Tillomed and contact your doctor immediately or go to the nearest hospital
emergency department if you experience any of the following:

• Severe acute allergic reaction (anaphylactic reaction). This reaction may be life-threatening. One or more of the following symptoms may occur: skin redness, itchy rash similar to hives, shortness of breath, and dizziness (rare, may affect up to 1 in 1,000 people).
• Ampicillin may affect white blood cells and thereby impair the body's defense against infections. If you develop an infection with symptoms such as fever accompanied by severe general deterioration or fever with signs of local infection such as sore throat/pharynx/mouth or difficulty urinating, you should consult a doctor as soon as possible so that a blood test can rule out a deficiency of white blood cells (agranulocytosis). It is important to seek medical advice regarding the medications used (less common, may occur in up to 1 in 100 people).
• Inflammation of the colon with symptoms such as watery diarrhoea, often with blood and mucus, abdominal pain and/or fever (uncommon, may affect up to 1 in 100 people).

Other possible adverse reactions include:
Common (may affect up to 1 in 10 people)

• Skin rash, itching
• Soft stools

Uncommon (may affect up to 1 in 100 people)

• Reduction in red blood cells leading to pale skin, weakness, and shortness of breath (anaemia)
• Decreased platelet count (thrombocytopenia)
• Decreased or increased white blood cell count (leucopenia, eosinophilia)
• Inflammation of the tongue and oral mucosa
• Stomatitis, glossitis, abdominal pain
• Nausea and vomiting
• Inflammation of the colon
• Diarrhoea
• Urticaria
• Crystalluria (presence of crystals in urine indicating kidney irritation)

Rare (may affect up to 1 in 1,000 people)

• Severe skin inflammation with peeling (exfoliative dermatitis)
• Skin disorders, sometimes severe (erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome)
• Dizziness, headache, myoclonus, and convulsions
• Hepatitis (liver inflammation) and cholestatic jaundice; elevated liver values may occur
• Acute interstitial nephritis (inflammation of the kidneys)
• Pain and swelling at the site of administration
• Excessive growth of fungi in the oral cavity and gastrointestinal tract may occur

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AMPICILLIN TILLOMED

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton, following
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

After reconstitution:

• The reconstituted solution must be used immediately.
• Solutions should always be prepared immediately before use and checked for clarity. Use only clear solutions. Do not use cloudy solutions or those containing a precipitate.
• For instructions on storage after reconstitution of this medicine, see the section "The following information is intended exclusively for healthcare professionals".
• Unused solution must be discarded.

After dilution:

• The diluted solution must be used immediately.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Ampicillina Tillomed contains

• The active substance is ampicillin.
• There are no other components.

Each vial contains sodium ampicillin equivalent to 1 g of ampicillin.
Description of the appearance of Ampicillina Tillomed and packaging contents
White to off-white powder.
1 g of powder for injectable/infusion solution in colorless glass vials of type III, closed with bromobutyl rubber stoppers and sealed with aluminium flip-off caps, in pack sizes of 1, 5, 10, 50 units.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Tillomed Italia S.r.l.
Viale Giulio Richard 1, Torre A
20143 Milano (MI), Italy
Manufacturer:
Antibiotice S.A.
Str Valea Lupului Nr 1
Iasi, 707410 Judet Iasi, Romania
This medicinal product is authorized in the European Economic Area member states under the following names:
Norway: Amroliv
Sweden: Amroliv
Denmark: Amroliv
Germany: Ampicillin Tillomed 1g Pulver zur Herstellung einer Injektions-/Infusionslösung
Poland: Ampicillin Adamed
Hungary: Ampicillin Antibiotice 1g por oldatos injekcióhoz vagy infúzióhoz
Spain: Ampicillin Tillomed 1g polvo para solución inyectable y para perfusión

The following information is intended exclusively for physicians or healthcare professionals:
Incompatibilities
This medicinal product must not be mixed with other solutions except those mentioned in this section.
If ampicillin is prescribed concomitantly with an aminoglycoside, the antibiotics must not be mixed in the same syringe or intravenous container, as this may result in loss of aminoglycoside activity.

Reconstitution of the injectable solution
Ampicillina Tillomed 1 g can be used for intramuscular and intravenous administration.

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

Intravenous injection
To reconstitute the injectable solution, dissolve the contents of one vial in 7.4 mL of water for injections to obtain a solution with a concentration of 125 mg/mL.
After reconstitution, administer the intravenous injection slowly over 5–10 minutes. Rapid administration may cause seizures.

Intravenous infusion
First reconstitute as specified in the section "Intravenous injection", then dilute with 9 mg/mL (0.9%) sodium chloride solution for injection.
The concentration of the diluted solution must not exceed 30 mg/mL. The infusion rate and volume must be adjusted to ensure the stability of the medicinal product in the solution used.
Only the solutions listed above may be used for intravenous infusion of Ampicillina Tillomed.
Solutions must always be prepared immediately before use and inspected visually for clarity.
Ampicillina Tillomed may be administered by intravenous infusion over 20–30 minutes. For continuous infusion, an infusion pump should be used if possible.
Use only clear solutions practically free from particles.
Do not use cloudy solutions or those containing precipitates.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.