Ampicillin Biopharma

Package leaflet: Information for the user

Ampicillina Biopharma 250 mg/2.5 ml powder and solvent for injectable solution, 500 mg/2.5 ml powder and solvent for injectable solution, 1 g/4 ml powder and solvent for injectable solution, 1 g powder for injectable solution – 100 vials

Sodium ampicillin
Please read this leaflet carefully before using 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 effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Ampicillina Biopharma is a medicine used to treat bacterial infections
(antibiotic) and works by killing the bacteria that cause infections. It contains ampicillin.
Ampicillin belongs to a group of medicines called "penicillins".
Ampicillina Biopharma is used to treat:
respiratory tract infections: pharyngitis, tonsillitis, sinusitis, bronchitis, bronchopneumonia,
pneumonia, pleuropneumonia, infectious complications of influenza
urinary tract infections: acute and chronic cystitis, urethritis, pyelitis, cystopyelitis, pyelonephritis

• intestinal infections: gastroenteritis, bacillary dysentery, salmonellosis
• various infections: otitis, endocarditis and sepsis caused by sensitive organisms
• gonorrhoea
• pre- and post-operative treatment
• surgical infections
• infections caused by Haemophilus influenzae
• biliary tract infections, cholecystitis, angiocholangitis

2. WHAT YOU SHOULD KNOW BEFORE TAKING AMPICILLIN BIOPHARMA

Consult your doctor before taking Ampicillin Biopharma. The doctor will assess whether treatment with Ampicillin is appropriate for your condition.

Do not take Ampicillin Biopharma

• if you are allergic to ampicillin or other penicillins, or to any of the other ingredients of this medicine (listed in section 6), due to the risk of allergic shock.
• if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include skin rash or swelling of the face or neck.

If you are unsure, consult your doctor, pharmacist, or nurse before being administered Ampicillin.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Ampicillin Biopharma if:

• you are a person with allergies (hypersensitivity to multiple allergens, asthma, hay fever, or urticaria), as a severe allergic reaction (anaphylaxis) may occur, especially following parenteral administration.

• In case of allergic reactions to the product, discontinue administration of the drug and consult your doctor for appropriate treatment.

• if you have had allergic reactions to other antibiotics known as beta-lactams (belonging to the group of penicillins and cephalosporins).

• if, particularly after prolonged use, you do not feel better or feel worse: it is possible that infections caused by microorganisms not sensitive to Ampicillin Biopharma have developed. Your doctor may decide on the most appropriate therapy.

• if you are undergoing prolonged treatment with high doses, because your doctor may monitor blood, liver, and kidney values. Do not use Ampicillin Biopharma for ophthalmic purposes. Do not use Ampicillin Biopharma in very early infancy unless the doctor has evaluated the actual need and under their supervision.

Other medicines and Ampicillin Biopharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines.

If you are taking other antibacterial medicines belonging to the aminoglycoside group, these may enhance the therapeutic effect of Ampicillin (as well as other drugs of the same class: semi-synthetic penicillins).

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. If you are breastfeeding, ampicillin may pass into breast milk and could affect the infant. Consult your doctor to evaluate whether to discontinue breastfeeding or to switch to a different medicine.

Driving and using machines

No effects on the ability to drive vehicles or operate machinery are known. However, consider that some possible side effects may affect your ability to drive or use machinery.

Ampicillin Biopharma contains sodium

Ampicillin Biopharma 250 mg contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

Ampicillin Biopharma 500 mg contains 31 mg of sodium (main component of table salt) per vial. This corresponds to 1.6% of the maximum daily recommended dietary intake for an adult.

Ampicillin Biopharma 1 g contains 62 mg of sodium (main component of table salt) per vial. This corresponds to 3.1% of the maximum daily recommended dietary intake for an adult.

3. HOW TO TAKE AMPICILLIN BIOPHARMA

Never administer this medicine yourself. A qualified person, such as a doctor or nurse, will administer this medicine to you.
Adults
Adults: 1 g every 8 hours or 2 g every 12 hours.
Children: 5–11 years: 500 mg every 8 hours. 0–5 years: 100 mg/kg/day divided into 3 doses.
How Ampicillin Biopharma will be administered to you
It will be administered by injection into a vein or by intravenous infusion, or by intramuscular injection.
In severe cases, doses may be increased at the physician's discretion.
If you are given more Ampicillin Biopharma than you should
This is unlikely to happen, but if you think you have been given too much Ampicillin Biopharma, inform your doctor, pharmacist, or nurse immediately.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Conditions to be aware of
Allergic reactions:

• skin rashes such as erythema multiforme or maculopapular rash, itching, urticaria,
• severe, rapidly occurring allergic reactions that may be life-threatening (anaphylactic reactions),
• fever, joint pain, swelling of the glands in the neck, armpits or groin,
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing,
• collapse.

Contact a doctor immediately if you experience any of these symptoms and
discontinue taking Ampicillina Biopharma
Other adverse reactions:
Contact your doctor as soon as possible if you experience any of the following symptoms:
Gastrointestinal disorders:

• acute or chronic inflammation of the tongue (glossitis),
• acute and painful inflammation of the mucous membranes of the mouth affecting the gums, inner cheeks, palate, inner lips and tongue (stomatitis),
• nausea, vomiting and diarrhoea.

Blood or lymphatic system disorders:

• Changes in laboratory test results: anaemia, thrombocytopenic purpura, eosinophilia, leucopenia and agranulocytosis. These symptoms usually resolve upon discontinuation of therapy, but may also be signs of hypersensitivity.

Elevated transaminase levels.
If you experience any adverse reaction, including those not listed in this leaflet, contact your
doctor, pharmacist or nurse.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your
doctor, pharmacist or nurse. You may also report adverse reactions directly via the national reporting system at the website
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 AMPICILLINA BIOPHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after Exp. The expiry date refers to the last day of that month.
Storage conditions
Store in a cool place (not above 25°C) and protect from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Ampicillina Biopharma contains
Ampicillina Biopharma 250 mg/2.5 ml powder and solvent for injectable solution:
One vial of powder for injectable solution contains:
Active substance: sodium ampicillin 265.75 mg equivalent to: ampicillin 250 mg.
One solvent ampoule contains: Excipients: Water for injections 2.5 ml

Ampicillina Biopharma 500 mg/2.5 ml powder and solvent for injectable solution:
One vial of powder for injectable solution contains:
Active substance: sodium ampicillin 531.5 mg equivalent to: ampicillin 500 mg.
One solvent ampoule contains: Excipients: Water for injections 2.5 ml

Ampicillina Biopharma 1 g/4 ml powder and solvent for injectable solution:
One vial of powder for injectable solution contains:
Active substance: sodium ampicillin 1063 mg equivalent to: ampicillin 1000 mg.
One solvent ampoule contains: Excipients: Water for injections 4 ml

Ampicillina Biopharma 1 g powder for injectable solution – 100 vials:
One vial of powder for injectable solution contains:
Active substance: sodium ampicillin 1063 mg equivalent to: ampicillin 1000 mg.

Description of the appearance of Ampicillina Biopharma and pack contents
Ampicillina Biopharma 250 mg/2.5 ml powder and solvent for injectable solution:
The pack contains one colourless glass vial with a butyl rubber stopper and aluminium cap, and one solvent ampoule in colourless glass.

Ampicillina Biopharma 500 mg/2.5 ml powder and solvent for injectable solution:
The pack contains one colourless glass vial with a butyl rubber stopper and aluminium cap, and one solvent ampoule in colourless glass.

Ampicillina Biopharma 1 g/4 ml powder and solvent for injectable solution:
The pack contains one colourless glass vial with a butyl rubber stopper and aluminium cap, and one solvent ampoule in colourless glass.

Ampicillina Biopharma 1 g:
The pack contains one colourless glass vial with a butyl rubber stopper and aluminium cap.

Marketing Authorization Holder
Biopharma S.r.l. – Via Paolo Mercuri, 8 – 00193 Rome - Italy

Responsible manufacturer for batch release
Biopharma S.r.l. – Via delle Gerbere, 22/30 – 00134 S. Palomba (RM) - Italy

The following information is intended exclusively for healthcare professionals:

Preparation of the injection solution:
For intramuscular administration, dissolve the vial contents with the water for injections from the attached ampoule.
For slow intravenous administration, dissolve the vial contents with 10 ml of water for injections.

Solutions for intramuscular use should be used immediately after preparation. Intravenous infusion solutions are stable at room temperature for 8 hours in saline solution; in glucose solutions, they are stable for 4 hours at concentrations not exceeding 2 mg/ml.

Compatibility
For intravenous infusion, Ampicillin may be added to saline or glucose solutions, but not to plasma, plasma derivatives, or protein solutions (e.g., hydrolysates).

Sodium ampicillin may be administered together with sodium heparin in normal saline solution for intravenous infusion.