Bacampicillin Eurogenerici

Package leaflet: Information for the patient

Bacampicillin Eurogenerici 1200 mg film-coated tablets

Bacampicillin hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start taking 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Bacampicillin Eurogenerici is and what it is used for
2. What you need to know before taking Bacampicillin Eurogenerici
3. How to take Bacampicillin Eurogenerici
4. Possible side effects
5. How to store Bacampicillin Eurogenerici
6. Contents of the pack and other information

1. What Bacampicillina Eurogenerici is and what it is used for

Bacampicillina Eurogenerici is an antibiotic; its active substance, called bacampicillin,
belongs to a group of medicines known as "penicillins".
Bacampicillina Eurogenerici is used to treat bacterial infections in various parts of the
body.
Bacampicillina Eurogenerici is used to treat the following infections:

• Lower respiratory tract infections: bronchitis and pneumonia
• Upper respiratory tract infections: pharyngitis, tonsillitis, laryngitis and epiglottitis
• Ear and sinus infections: otitis media, sinusitis
• Genitourinary tract infections: bladder infection (acute and recurrent cystitis), urethra (urethritis), kidneys (pyelonephritis), and prostate (prostatitis)
• Skin and soft tissue infections: impetigo, erysipelas, pyoderma, cellulitis, abscesses, traumatic and post-surgical wounds
• Intestinal infections
• Oral and dental infections

2. What you need to know before taking Bacampicillin Eurogenerici

Do not take Bacampicillin Eurogenerici

• if you are allergic to bacampicillin or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to penicillins or cephalosporins or to other allergens,
• if you have infections caused by bacteria that are not susceptible to the action of the class of antibiotics to which Bacampicillin Eurogenerici belongs (penicillins),
• if you are taking disulfiram, a medicine used in the treatment of alcoholism,
• if you are pregnant,
• if you have infectious mononucleosis, because there is a high probability of developing a skin rash (exanthema).

Do not take Bacampicillin Eurogenerici if any of the above situations apply to you. If you have any doubts, consult your doctor or pharmacist before taking Bacampicillin Eurogenerici.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Bacampicillin Eurogenerici.

As with any antibiotic-containing preparation, constant monitoring for the emergence of non-susceptible microorganisms, including fungi, is essential. If a superinfection occurs, the drug should be discontinued and/or appropriate therapy initiated.

If you take Bacampicillin Eurogenerici for a prolonged period, you may need to undergo regular tests to monitor liver, kidney, and blood function.

Children and adolescents

In early infancy, this medicine should be administered only when strictly necessary and under direct medical supervision.

Other medicines and Bacampicillin Eurogenerici

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• allopurinol (a medicine used to treat gout); when allopurinol and ampicillins are taken together, the incidence of skin reactions (exanthema) increases compared to patients treated with the antibiotic alone;
• disulfiram (a medicine used in the treatment of alcoholism).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. During pregnancy, this medicine should be administered only when clearly necessary and under direct medical supervision.

Driving and using machines

Bacampicillin Eurogenerici does not impair the ability to drive or operate machinery.

Bacampicillin Eurogenerici contains lactose

One tablet of Bacampicillin Eurogenerici contains 75 mg of lactose. If your doctor has diagnosed you with an intolerance to certain sugars, please consult him before taking this medicine.

3. How to take Bacampicillin Eurogenerici

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults and children over 7 years
Take 1 tablet of 1200 mg every 12 hours.
This medicine can be taken with or without food, as food does not affect the absorption of the antibiotic.
If you take more Bacampicillin Eurogenerici than you should
If you take too much Bacampicillin Eurogenerici, inform your doctor immediately and/or go to the nearest hospital.
Your doctor will determine appropriate treatment and take necessary supportive measures.
If you forget to take Bacampicillin Eurogenerici
Do not take a double dose (two tablets together) to make up for a missed dose.
If you stop taking Bacampicillin Eurogenerici
Do not stop taking Bacampicillin Eurogenerici unless instructed by your doctor.
Interrupted use is strongly discouraged, as it may render the treatment ineffective.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience a severe allergic reaction (including anaphylactic shock), which may be life-threatening, while receiving Bacampicillin Eurogenerici, stop treatment immediately and contact your doctor without delay.

The following side effects may occur with this medicine. However, there are insufficient data available to determine the frequency of the individual adverse reactions listed below.

As with all penicillins, adverse reactions are mainly related to hypersensitivity phenomena. Such reactions are more likely to occur in patients with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported with oral broad-spectrum penicillins.

Allergic reactions:

• Skin irritation with redness and/or swelling (cutaneous rush),
• Appearance of red patches on the skin with blisters (maculopapular erythema),
• Skin lesions with widespread redness (erythema multiforme),
• Raised areas of varying shape and size, accompanied by itching (urticaria),
• Skin inflammation with shedding of the superficial layer in flakes (exfoliative dermatitis),
• A reaction known as “serum sickness”.

Effects on the gastrointestinal system (mouth, stomach, and intestine):

• Inflammation of the tongue (glossitis),
• Inflammation of the mucous membrane lining the oral cavity (stomatitis),
• Pain in the upper abdomen (epigastric pain),
• Nausea,
• Vomiting,
• Diarrhea.

Effects on the liver:

• Mild increase in one type of transaminase (SGOT), particularly in infants.

Effects on blood and lymphatic system:

• Decrease in the amount of hemoglobin, the protein that carries oxygen in the blood, and in red blood cells (anemia),
• Reduction in the number of platelets in the blood (thrombocytopenia),
• Purple or reddish-brown spots visible under the skin due to reduced platelet count (thrombocytopenic purpura),
• Increased concentration in the blood of eosinophils, a type of white blood cell (eosinophilia),
• Reduction in the number of white blood cells in the blood (leukopenia),
• Reduction in granulocytes in the blood (agranulocytosis).

Effects on laboratory tests:

• Bacampicillin Eurogenerici may interfere with certain types of urine glucose tests (glycosuria): please consult your doctor. High urinary concentrations of bacampicillin may lead to false-positive results when Clinitest or certain reagents such as Benedict's or Fehling's solutions are used; therefore, enzymatic reagents based on glucose oxidase are recommended.

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

5. How to store Bacampicillin Eurogenerici

Store below 25°C.
Keep in the original packaging to protect the medicine from light and moisture. Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Bacampicillina Eurogenerici contains
The active substance is bacampicillin hydrochloride 1200 mg.
The other excipients are lactose, microcrystalline cellulose, magnesium stearate,
hydroxypropylmethylcellulose, titanium dioxide, polyethylene glycol 400, polyethylene glycol 6000.
Description of the appearance of Bacampicillina Eurogenerici and package contents
Film-coated divisible tablets. Carton containing 12 tablets in blister packs.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
K24 Pharmaceuticals S.r.l. – Via Generale Orsini, 46 – 80132 Naples – Italy
Manufacturer
BIOPHARMA S.r.l. - Via delle Gerbere - S. Palomba (Rome)
Selling Licensee for Italy:
EG S.p.A. Via Pavia 6 - 20136 Milan