Package leaflet: Information for the patient

CEFACLOR EG 750 mg modified-release tablets

Generic medicine
Read this leaflet carefully before 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CEFACLOR EG is and what it is used for
What you need to know before taking CEFACLOR EG
How to take CEFACLOR EG
Possible side effects
How to store CEFACLOR EG
Contents of the pack and other information

1. What CEFACLOR EG is and what it is used for

CEFACLOR EG contains the active substance cefaclor, which belongs to a group of medicines called cephalosporins. Cephalosporins are antibiotics used to treat infections caused by bacteria.
CEFACLOR EG is indicated for the treatment of:

infections of the bronchi (bronchitis, including acute exacerbations of chronic bronchitis), throat (pharyngitis), and tonsils (tonsillitis);
skin and soft tissue infections;
non-severe urinary tract infections.

2. What you need to know before taking CEFACLOR EG

Do not take CEFACLOR EG

if you are allergic to cefaclor, cephalosporins, other similar antibiotics (such as penicillins), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking CEFACLOR EG.
Inform your doctor if you or a member of your family has ever experienced allergic reactions after taking
medicines containing cefaclor or other similar medicines (cephalosporins, penicillins), as this
medicine may cause allergic reactions (affecting the skin, gastrointestinal system, respiratory system,
heart, and circulatory system), which can be severe, including anaphylactic shock.
Your doctor will carefully evaluate whether it is appropriate to prescribe this medicine to you and, if necessary,
will take precautions to prevent unwanted reactions.
If you experience symptoms of an allergic reaction, stop taking this medicine immediately
and contact a doctor without delay.
Symptoms of an allergic reaction may include:

severe and sudden drop in blood pressure (hypotension);
rapid or irregular heartbeat;
unusual tiredness or weakness;
anxiety, restlessness;
dizziness;
fainting (loss of consciousness);
difficulty breathing or swallowing;
generalized itching, especially in hands and feet;
skin irritation (urticaria), with or without swelling of the extremities, external genitalia, face, particularly around the eyes and lips (angioedema);
skin redness, especially around the ears;
bluish discoloration of the skin (cyanosis);
excessive sweating;
nausea, vomiting;
stomach ache (abdominal cramps);
diarrhea.

Inform your doctor if:

you experience episodes of diarrhea during treatment with this medicine, as this may indicate the onset of an intestinal problem (pseudomembranous colitis); inform your doctor if you have previously suffered from intestinal disorders, as you may be more likely to develop such antibiotic-associated intestinal disturbances;
you have kidney problems, as your doctor may need to reduce the dose;
you are due to have blood or urine tests, as this medicine may cause test results to be inaccurate.

Children
There are no data available to establish the safety of CEFACLOR EG in children.
Other medicines and CEFACLOR EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Inform your doctor if you are taking a medicine called probenecid (used to treat gout), as your doctor may need to adjust the dose of CEFACLOR EG, or if you are taking medicines used to treat stomach problems (antacids containing aluminium or magnesium hydroxide).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, your doctor will prescribe CEFACLOR EG only if strictly necessary and under close medical supervision.
Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.
CEFACLOR EG contains propylene glycol (E1520)
This medicine contains 0.688 mg of propylene glycol per tablet.

3. How to take CEFACLOR EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablets whole without chewing them; do not crush them before taking. You may take
CEFACLOR EG independently of meals.
Use in adults
The recommended dose is 1 tablet twice daily.
For infections caused by a specific type of bacterium ( S. pyogenes ), it is recommended to continue
treatment for up to 10 days.
If you take more CEFACLOR EG than you should
In case of overdose, the following symptoms may occur: nausea, vomiting, stomach disturbances, and
diarrhea.
If you accidentally take too high a dose of CEFACLOR EG, inform your doctor immediately or go to the
nearest hospital.
If you forget to take CEFACLOR EG
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:

Common (may affect up to 1 in 10 people)

Increase in white blood cell levels (eosinophilia);
Allergic reactions (hypersensitivity) characterized by skin lesions similar to measles (morbilliform rashes);
Diarrhea;
Swelling of the face, lips, mouth, tongue, or throat due to fluid accumulation (angioedema);
Changes in liver function with increased levels of liver enzymes (SGOT, SGPT, alkaline phosphatase).

Uncommon (may affect up to 1 in 100 people)

Itching, skin irritation (urticaria);
Changes in results of certain blood tests (positive Coombs test);
Genital itching, fungal infection of the vagina (vaginal moniliasis), inflammation of the vagina;
Changes in kidney function with increased levels of certain substances in the blood (azotemia and creatininemia) and changes in urine tests.

Frequency not known (frequency cannot be determined from the available data)

Generalized allergic reactions (serum-sickness-like), occurring mainly in children, characterized by various skin lesions (erythema multiforme, skin rash), joint inflammation and pain (arthritis, arthralgia), with or without fever;
Severe skin disorders characterized by skin lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis) and severe, life-threatening allergic reaction (anaphylaxis);
Nausea and vomiting;
Inflammation of the intestine (pseudomembranous colitis), which may occur during or after treatment;
With some penicillins and other cephalosporins, rare cases of liver inflammation (hepatitis) and yellowing of the skin due to excessive levels of a substance called bilirubin in the blood (cholestatic jaundice) have been observed;
Kidney problems (reversible interstitial nephritis);
Changes in white blood cell count (transient lymphocytosis, agranulocytosis, reversible neutropenia, leukopenia), decreased red blood cell levels (hemolytic anemia); reduction in all blood cells (aplastic anemia);
Low platelet levels (thrombocytopenia);
Blood clotting problems (increased prothrombin time), with or without bleeding, in patients taking anticoagulant medicines (e.g., warfarin);
Hyperactivity, restlessness, sleep disturbances (insomnia), confusion, involuntary muscle contractions (hypertonia), hallucinations (seeing or hearing things that are not real), sensation of unsteadiness and staggering, drowsiness;
Anaphylactoid reactions, including angioedema, asthenia, edema (both facial and in limbs), dyspnea, paresthesia, syncope, and vasodilation (following the use of broad-spectrum antibiotics).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 CEFACLOR EG

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

6. Package contents and other information

What CEFACLOR EG contains

The active substance is cefaclor. Each modified-release tablet contains 750 mg of cefaclor;
The other components are: hypromellose, mannitol (E421), povidone, magnesium stearate, colloidal silicon dioxide, propylene glycol (E1520), titanium dioxide.

Description of the appearance of CEFACLOR EG and contents of the pack
Pack containing 6 or 12 modified-release tablets.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan
Manufacturer
ACS DOBFAR S.p.A., Via Laurentina Km 24,730 – 00071 – Pomezia (Rome)