Kliacef

Package leaflet: Information for the user

KLIACEF 500 mg effervescent tablets

Cefaclor
Equivalent medicine
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See Section 4.

Contents of this leaflet:

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

1. What KLIACEF is and what it is used for

KLIACEF contains the active substance cefaclor.
Cefaclor is an antibacterial agent belonging to the cephalosporin family. These
antibiotics have a bactericidal effect against pathogenic bacteria that are susceptible to their
action. Their bactericidal effect consists in preventing the formation of the cell wall in certain bacterial strains.
KLIACEF is indicated for the treatment of the following infections caused by susceptible strains:

• respiratory tract infections (pneumonia, bronchitis, acute exacerbations of bronchitis, pharyngitis and tonsillitis);
• middle ear infection (otitis media);
• skin and soft tissue infections;
• urinary tract infections (pyelonephritis and cystitis);
• paranasal sinus infections (sinusitis);
• urethral infections (the canal allowing urine to pass from the bladder to the outside) caused by bacteria responsible for gonorrhoea (a sexually transmitted disease).

2. What you need to know before taking KLIACEF

Do not take KLIACEF:

• if you are allergic to cefaclor, to other similar substances (cephalosporins), or to any of the other ingredients of this medicine listed in section 6;
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking KLIACEF:

• if you are allergic to antibiotics of the cephalosporin or penicillin class. There have been patients who experienced severe reactions (including anaphylaxis) following administration of penicillins and cephalosporins, including KLIACEF, with IgE-mediated reactions usually manifesting at the cutaneous, gastrointestinal, respiratory, and cardiovascular levels. Symptoms may include: severe and sudden hypotension, increased or decreased heart rate, unusual fatigue or weakness, anxiety, restlessness, dizziness, loss of consciousness, breathing or swallowing difficulties, generalized itching especially on the soles of the feet and palms of the hands, urticaria with or without angioedema (swollen and itchy skin areas most frequently located on the extremities, external genitalia, and face, especially around the eyes and lips), skin redness particularly around the ears, cyanosis, profuse sweating, nausea, vomiting, cramp-like abdominal pain, diarrhea.
• if you suffer from severe impairment of kidney function. Your doctor will determine the appropriate dose of KLIACEF for your condition;
• if you have had or currently have intestinal disorders, particularly colitis. Take KLIACEF as prescribed by your doctor.

During treatment with KLIACEF, keep in mind that:

• episodes of diarrhea may occur, as the use of broad-spectrum antibiotics (including macrolides, semisynthetic penicillins, and cephalosporins) is often associated with pseudomembranous colitis (antibiotic-associated colitis);
• the medicine must be kept out of the reach of children;
• in case of an allergic reaction due to the use of cefaclor, stop treatment immediately and inform your doctor or go to the nearest hospital;
• prolonged use of cefaclor may lead to the development of antibiotic-resistant bacteria;
• if you develop additional infections beyond the one for which you are taking KLIACEF, inform your doctor immediately, who will initiate the most appropriate treatment for your condition;
• if you undergo urine tests using Benedict's or Fehling's solutions or Clinitest®, false positive results may occur, indicating falsely elevated glucose levels in the urine. This phenomenon has not been observed with Tes-Tape® (enzymatic test for glycosuria, Lilly).

Other medicines and KLIACEF
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Inform your doctor if you are taking:

• probenecid (used in the treatment of gout). Concomitant use inhibits renal elimination of cefaclor.

KLIACEF with food, drinks and alcohol
KLIACEF can be taken independently of meals.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take KLIACEF if you are pregnant or breastfeeding, unless your doctor, after evaluating the potential benefits versus the possible risks for you and your baby, considers it strictly necessary.
Driving and using machines
This medicine does not affect your ability to drive or operate machinery.
KLIACEF contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take KLIACEF

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
KLIACEF is administered orally and may be taken regardless of meals.

Use in adults
The recommended dose in adults is 250 mg every 8 hours.
In more severe infections or those caused by less sensitive organisms, higher doses may be indicated. The maximum recommended dose is 2 g per day, although doses of up to 4 g per day have been administered to healthy subjects for 28 days without adverse effects.
For the treatment of acute gonococcal urethritis in both sexes, a single dose of 3 g of cefaclor, possibly in combination with 1 g of probenecid, is recommended.

Use in children
The recommended daily dose for children is 20 mg/kg, divided into doses every 8 hours. In more severe infections, otitis media, or infections caused by less sensitive organisms, a dosage of 40 mg/kg per day is recommended, up to a maximum daily dose of 1 g.

Alternative dosing and administration regimen
In otitis media and pharyngitis, the total daily dose may be administered in divided doses every 12 hours.

For children, a preferred formulation is KLIACEF 250 mg/5 ml oral suspension granules, for which dosing schedules are provided in the package leaflet.

Instructions for use
Effervescent tablets should be taken after dissolving in half a glass of water.

If you take more KLIACEF than you should
If you take an excessive dose of KLIACEF, inform your doctor immediately or go to the nearest hospital. Always bring the package with you so that the medicine can be easily identified.
If you take too much KLIACEF, symptoms such as nausea, vomiting, epigastric disturbances, and diarrhoea may occur. The severity of epigastric discomfort and diarrhoea is related to the dose taken.
If other symptoms occur, they are likely secondary to the underlying disease, an allergic reaction, or another intoxication.

If you forget to take KLIACEF
Do not take a double dose to make up for the forgotten dose.

If you stop taking KLIACEF
If you have any questions about using this medicine, consult your doctor or pharmacist.
Do not stop taking this medicine without first consulting your doctor. Take KLIACEF exactly as prescribed by your doctor.
It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop taking this medicine too early, the infection may not be completely cured, symptoms may recur or worsen, and you may develop resistance to the antibiotic.

4. Possible side effects

Like all medicines, KLIACEF can cause side effects, although not everyone experiences them.

If you experience any of the following side effects, stop taking KLIACEF and contact your doctor immediately or go to the nearest hospital:

• severe skin reaction with peeling and swelling of the skin, skin blisters, affecting mouth, eyes, genitals, frequent rashes with inflammation (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• severe allergic reaction with sudden onset (anaphylaxis);
• sudden swelling of one or more of the following parts: hands, feet, lips, tongue, throat, which may cause difficulty in breathing and/or itching, rash, due to an allergic reaction (angioedema);
• serious kidney problems (interstitial nephritis).

Other side effects that may occur with the use of KLIACEF

• allergic reactions, rare (affects up to 1 in 1,000 people): itching, urticaria, positive Coombs test;
• erythema multiforme, rash and other skin manifestations, accompanied by joint pain and inflammation (arthritis/arthralgia), with or without fever, known as serum-sickness-like illness;
• diarrhoea, antibiotic-associated colitis (pseudomembranous colitis), nausea, vomiting;
• genital itching, vaginal fungal infections and vaginitis;
• changes in blood cell count (eosinophilia, thrombocytopenia);

Side effects that may occur with the use of antibiotics of the cephalosporin class:

• liver problems and yellowing of the skin and whites of the eyes (cholestatic jaundice);
• anaemia;

For the following side effects, a relationship with KLIACEF use is uncertain:

• hyperactivity, restlessness, insomnia, mental confusion, increased muscle tone, hallucinations, sensation of instability and staggering, drowsiness;
• transient changes in blood test values such as:
• mild increases in liver enzyme levels (SGOT and SGPT, or alkaline phosphatase) (1 in 40);
• changes in blood cell count (transient lymphocytosis, leucopenia and, rarely, haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia possibly of clinical significance), prolonged prothrombin time, with or without clinical bleeding, in patients receiving cefaclor and sodium warfarin concurrently;
• mild increases in blood urea nitrogen or serum creatinine (less than 1 in 500), or abnormalities in urine analysis (less than 1 in 200).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 KLIACEF

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after 'Exp'.
The expiry date refers to the last day of that month. This date applies to the product in its original
packaging, correctly stored.
This medicine does not require any special storage conditions.
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 KLIACEF contains
The active substance is cefaclor.
One tablet contains cefaclor monohydrate equivalent to 500 mg of anhydrous cefaclor.
The other components are: calcium carbonate, sodium carboxymethylcellulose, sodium carboxymethylcellulose,
sodium stearate, sodium saccharin, strawberry flavour.
Description of the appearance of KLIACEF and package contents
Effervescent tablets.
KLIACEF 500 mg effervescent tablets are packaged in blisters within a printed cardboard carton
containing 8 tablets.
Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia
Italy
MANUFACTURER
Francia Farmaceutici Industria Farmaco Biologica S.r.l.
Via dei Pestagalli, 7
20138 Milano (MI)
Italy

Package leaflet: Information for the user

KLIACEF 250 mg/5 ml granules for oral suspension

Cefaclor
Generic medicine
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, consult 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See Section 4.

Contents of this leaflet:

7. What KLIACEF is and what it is used for
8. What you need to know before taking KLIACEF
9. How to take KLIACEF
10. Possible side effects
11. How to store KLIACEF
12. Package contents and other information

1. What KLIACEF is and what it is used for

KLIACEF contains the active substance cefaclor.
Cefaclor is an antibacterial agent belonging to the cephalosporin family. These
antibiotics have a bactericidal effect against pathogenic bacteria that are susceptible to their
action. Their bactericidal effect consists in preventing the formation of the cell wall in certain
bacterial strains.
KLIACEF is indicated for the treatment of the following infections caused by susceptible strains:

• respiratory tract infections (pneumonia, bronchitis, acute exacerbations of bronchitis, pharyngitis and tonsillitis);
• middle ear infection (otitis media);
• skin and soft tissue infections;
• urinary tract infections (pyelonephritis and cystitis);
• paranasal sinus infections (sinusitis);
• urethral infections (the canal allowing the passage of urine from the bladder to the outside) caused by bacteria responsible for gonorrhoea (a sexually transmitted disease).

2. What you need to know before taking KLIACEF

Do not take KLIACEF:

• if you are allergic to cefaclor, to other similar substances (cephalosporins), or to any of the other ingredients of this medicine listed in section 6;
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions:
Talk to your doctor or pharmacist before taking KLIACEF:

• if you are allergic to antibiotics of the cephalosporin or penicillin classes. There have been patients who experienced severe reactions (including anaphylaxis) following administration of penicillins or cephalosporins, including KLIACEF, with IgE-mediated reactions typically manifesting at the cutaneous, gastrointestinal, respiratory, and cardiovascular levels.
  Symptoms may include: severe and sudden hypotension, accelerated or slowed heartbeat, unusual fatigue or weakness, anxiety, restlessness, dizziness, loss of consciousness, difficulty breathing or swallowing, generalized itching especially on the soles of the feet and palms of the hands, urticaria with or without angioedema (swollen and itchy skin areas most frequently located on extremities, external genitalia, and face, especially around eyes and lips), skin redness particularly around the ears, cyanosis, excessive sweating, nausea, vomiting, cramp-like abdominal pain, diarrhea.

• if you have severe impairment of kidney function. Your doctor will determine the appropriate dose of KLIACEF for your condition;

• if you have had or currently suffer from intestinal disorders, particularly colitis. Take KLIACEF exactly as prescribed by your doctor.

During treatment with KLIACEF, keep in mind that:

• episodes of diarrhea may occur, as the use of broad-spectrum antibiotics (including macrolides, semisynthetic penicillins, and cephalosporins) is often associated with pseudomembranous colitis (antibiotic-associated colitis);
• the medicine must be kept out of the reach of children;
• in case of an allergic reaction due to cefaclor use, stop treatment immediately and inform your doctor or go to the nearest hospital;
• prolonged use of cefaclor may lead to the development of antibiotic-resistant bacteria;
• if you develop additional infections beyond the one for which you are taking KLIACEF, inform your doctor immediately so that appropriate treatment can be initiated;
• if you undergo urine tests using Benedict's or Fehling's solutions or with Clinitest®, false positive results indicating the presence of glucose in urine may occur. This has not been observed with Tes-Tape® (enzymatic test for glycosuria, Lilly).

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

• probenecid (used in the treatment of gout). Concomitant use inhibits renal elimination of cefaclor.

KLIACEF with food, beverages and alcohol
KLIACEF can be taken independently of meals.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take KLIACEF if you are pregnant or breastfeeding, unless your doctor, after evaluating the potential benefits versus possible risks for you and your child, considers it strictly necessary.
Driving and using machines
This medicine does not affect your ability to drive vehicles or operate machinery.
KLIACEF contains sucrose and sodium.
This medicine contains:

• sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• less than 1 mmol (23 mg) of sodium per ml, i.e. essentially 'sodium-free'.

3. How to take KLIACEF

Take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
KLIACEF is administered orally and may be taken regardless of meals.

Use in adults
The recommended dose in adults is 250 mg every 8 hours.
In more severe infections or those caused by less sensitive organisms, higher doses may be indicated. The maximum recommended dose is 2 g per day, although doses of 4 g per day have been administered to healthy subjects for 28 days without adverse effects.
For the treatment of acute gonococcal urethritis in both sexes, a single dose of 3 g of cefaclor, possibly associated with 1 g of probenecid, is recommended.

Use in children
The recommended daily dose for children is 20 mg/kg divided every 8 hours. In more severe infections, otitis media, and infections caused by less sensitive organisms, a dosage of 40 mg/kg per day is recommended, up to a maximum daily dose of 1 g.
For children, the preferred formulation is KLIACEF 250 mg/5 ml granules for oral suspension
with the dosing schedule indicated in the tables below.

Alternative dosing and administration schedule: in otitis media and pharyngitis, the total daily dose may be administered in divided doses every 12 hours.
The amount of reconstituted product should be taken according to the following schedule.

NOTE
The tables refer to the maximum daily dose of 40 mg/kg. The doses of 20 mg/kg
correspond to half of the values reported above.

Instructions for use

Instructions for preparing the suspension
Shake the bottle well before preparation; then add water up to the level indicated on the bottle, close and shake the suspension well. Add water again up to the level indicated on the bottle and shake well until a uniform suspension is obtained.
If prepared according to these instructions, 5 ml of suspension will contain:
cefaclor monohydrate equivalent to 250 mg of cefaclor.
Shake well before each administration.

If you take more KLIACEF than you should
If you take an excessive dose of KLIACEF, inform your doctor immediately or go to the nearest hospital. Always bring the packaging with you so that the medicine can be easily identified.
If you take an excessive dose of KLIACEF, symptoms such as nausea, vomiting, epigastric disturbances, and diarrhoea may occur. The severity of epigastric disturbances and diarrhoea is related to the dose taken.
If other symptoms occur, they may likely be secondary to the underlying disease, an allergic reaction, or another intoxication.

If you forget to take KLIACEF
Do not take a double dose to make up for the forgotten dose.

If you stop taking KLIACEF
If you have any doubts about using this medicine, consult your doctor or pharmacist.
Do not stop taking this medicine without first consulting your doctor. Take KLIACEF exactly as prescribed by your doctor.
It is important that you complete the full course of treatment, even if you start to feel better after a few days.
If you stop taking this medicine too early, the infection may not be completely cured and symptoms may return or worsen. You may also develop resistance to the antibiotic.

4. Possible side effects

Like all medicines, KLIACEF may cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking KLIACEF and contact your doctor immediately or go to the nearest hospital:

• severe skin reactions with peeling and swelling of the skin, skin blisters, affecting the mouth, eyes, genitals, frequent skin rashes with inflammation (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• severe sudden-onset allergic reaction (anaphylaxis);
• sudden swelling of one or more of the following parts: hands, feet, lips, tongue, throat, which may cause breathing difficulties and/or itching, rash, due to an allergic reaction (angioedema);
• serious kidney problems (interstitial nephritis).

Other side effects that may occur with the use of KLIACEF

• allergic reactions, rare (affects up to 1 in 1,000 people): itching, urticaria, positive Coombs test;
• erythema multiforme, rash and other skin manifestations, accompanied by joint pain and inflammation (arthritis/ararthralgia), with or without fever, known as serum-sickness-like reactions;
• diarrhoea, antibiotic-associated colitis (pseudomembranous colitis), nausea, vomiting;
• genital itching, vaginal fungal infections and vaginitis;
• changes in blood cell counts (eosinophilia, thrombocytopenia);

Side effects that may occur with the use of antibiotics of the cephalosporin class:

• liver problems and yellowing of the skin and whites of the eyes (cholestatic jaundice);
• anaemia;

For the following side effects, it is not certain whether there is a correlation with the use of KLIACEF:

• hyperactivity, restlessness, insomnia, confusion, increased muscle tone, hallucinations, sensation of instability and staggering, drowsiness;
• transient alterations in blood test values such as:
• mild increases in liver enzyme levels (SGOT and SGPT, or alkaline phosphatase) (1 in 40);
• changes in blood cell counts (transient lymphocytosis, leucopenia and, rarely, haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia, possibly of clinical significance), prolonged prothrombin time, with or without clinical bleeding, in patients receiving cefaclor and sodium warfarin concurrently;
• mild increases in blood urea nitrogen or serum creatinine (less than 1 in 500), or abnormalities in urine analysis (less than 1 in 200).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through 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 KLIACEF

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after 'Exp'.
The expiry date refers to the last day of that month. This date applies to the product in its original
packaging, correctly stored and unopened.
The reconstituted suspension must be stored in the refrigerator (+2°C  +8°C) for no longer than
14 days.
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 KLIACEF contains
The active substance is cefaclor.
5 ml of suspension contain cefaclor monohydrate equivalent to 250 mg of cefaclor.
The other components are: modified starch, dimethicone 350 cs, erythrosine E127, methylcellulose, sodium lauryl sulfate, xanthan gum, sucrose, strawberry flavouring.

Description of the appearance of KLIACEF and contents of the pack
Granules for oral suspension.
KLIACEF 250 mg/5 ml granules for oral suspension is supplied in a 100 ml polyethylene bottle, with measuring spoon and dosing syringe, contained in a printed cardboard carton.

Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040 Pomezia
Italy

MANUFACTURER
Via Laurentina Km 24, 730
00071 Pomezia (RM)
Italy