Ceclor

Package Leaflet: Information for the Patient

CECLOR, 125 mg/5 ml, Granules for Oral Suspension

CECLOR, 250 mg/5 ml, Granules for Oral Suspension

CECLOR, 375 mg/5 ml, Granules for Oral Suspension

(Cefaclor)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Ceclor and what is it used for

Ceclor contains the active substance cefaclor, which is an oral semi-synthetic antibiotic belonging to the cephalosporin group. Cephalosporins exhibit bactericidal activity by inhibiting the synthesis of bacterial cell walls.
Cefaclor is indicated in the following infections caused by susceptible strains of the listed bacteria:
Upper respiratory tract infections
including pharyngitis and tonsillitis caused by Streptococcus pyogenes(beta-hemolytic group A streptococci) and Moraxella catarrhalis.
Otitis media and sinusitis
caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, Streptococcus pyogenes(beta-hemolytic group A streptococci) and Moraxella catarrhalis.
Lower respiratory tract infections
including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes(beta-hemolytic group A streptococci) and Moraxella catarrhalis.
Note
The drug of choice for the treatment and prevention of streptococcal infections, including the prevention of rheumatic fever, is penicillin.
Usually, cefaclor is effective against streptococci in the nasopharynx, but there is no data on its effectiveness in preventing the consequences of streptococcal infections, i.e. rheumatic disease and endocarditis.
Urinary tract infections
including pyelonephritis and cystitis caused by Escherichia coli, Proteus mirabilis, Klebsiella sp.and coagulase-negative staphylococci.
Cefaclor has been shown to be effective in both acute and chronic infections, e.g. gonococcal urethritis.
Skin and soft tissue infections
caused by Staphylococcus aureusand Streptococcus pyogenes.
Before starting treatment, appropriate tests should be performed to demonstrate the susceptibility of microorganisms to cefaclor.

2. Important information before taking Ceclor

When not to take Ceclor

• if the patient is allergic to the active substance - cefaclor (or other cephalosporins) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Ceclor, discuss it with your doctor or pharmacist.

• if the patient is allergic to antibiotics, including penicillins or cephalosporins, as well as any other medicines. Symptoms of an allergic reaction may include: rash, itching, swelling, and sudden increase in breathing difficulties
• if the patient has kidney disease or is undergoing dialysis
• if the patient has a history of colitis (a type of severe diarrhea). If the patient experiences diarrhea during treatment, they should inform their doctor, as it may be a sign of pseudomembranous colitis. The doctor will decide on further action. Do not take anti-diarrheal medications
• if the patient has diabetes, as Ceclor may affect the results of urine tests for sugar.

Long-term use of cefaclor may lead to the proliferation of resistant microorganisms. If a secondary infection occurs during treatment, inform your doctor, who will decide on further action and prescribe appropriate treatment.
Before performing a blood test, inform your doctor that you are taking Ceclor, as it may affect the results of some tests.
Consult your doctor if the above warnings apply to your past situation.

Children and adolescents

Ceclor should not be used in children under one month of age, as its safety and efficacy in this age group have not been established.

Ceclor and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Rarely, in patients taking cefaclor and anticoagulant medicines (e.g. warfarin or acenocoumarol) at the same time, the effect of these medicines may be enhanced, and bleeding may occur.
The excretion of cefaclor by the kidneys, like that of other beta-lactam antibiotics, is inhibited by probenecid.
During treatment with cephalosporins, cases of a positive (sometimes false-positive) Coombs test have been reported.
Ceclor may cause a false-positive result in the glucose test using Benedict's solution or Fehling's solution and copper sulfate tablets.

Using Ceclor in patients with renal impairment

Ceclor can be used in patients with impaired renal function. Usually, the same doses are recommended as for patients with normal renal function.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist.
Pregnancy
Women who are pregnant, think they may be pregnant, or are planning to become pregnant should inform their doctor before starting treatment with Ceclor. Ceclor may be used in pregnant women only if absolutely necessary.
Breastfeeding
Women who are breastfeeding or planning to start breastfeeding should inform their doctor. Caution should be exercised when using Ceclor in breastfeeding women.

Driving and using machines

The effect of Ceclor on the ability to drive and use machines is not known.

Ceclor contains sucrose

The medicine contains sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Ceclor

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Ceclor is an oral medicine.
Recommended dose
The recommended dose for children is 20 mg/kg body weight per day, divided into doses every 8 hours. For bronchitis and pneumonia, the dose is 20 mg/kg body weight per day, divided into 3 doses. For more severe infections, otitis media, and infections caused by less susceptible bacteria, the dose is 40 mg/kg body weight per day, divided into doses. The maximum daily dose is 1 g.

In the treatment of otitis media and pharyngitis, the daily dose can be given in 2 divided doses every 12 hours.
Treatment of streptococcal infections should last at least 10 days.
Do not stop taking Ceclor without consulting your doctor.
Preparation of the suspension
The suspension should be prepared immediately before taking the medicine, according to the instructions below.
To the granules in a 75 ml bottle, add 45 ml of cooled boiled water in two portions (2 times 22.5 ml). After each addition of water, the suspension should be shaken well.
To the granules in a 100 ml bottle, add 60 ml of cooled boiled water in two portions (2 times 30 ml). After each addition of water, the suspension should be shaken well.
After preparation, the suspension should be stored in the refrigerator (2°C–8°C) for no longer than 14 days. After this time, the medicine should be discarded.
A measuring spoon is included with the 75 ml bottle packaging to administer the suspension.
A measuring spoon and a dosing syringe are included with the 100 ml bottle packaging to administer the suspension.
Instructions for using the dosing syringe
Filling the syringe with medicine

• 1. The prepared suspension should be shaken well before use.
• 2. Press the cap and turn it counterclockwise.
• 3. Insert the tip of the syringe into the suspension and pull the plunger up. Draw the prescribed volume of suspension.
• 4. If an air bubble forms in the syringe, return the medicine to the bottle and repeat the process from step 3. Administering the medicine to a child
• 1. Place or sit the child in a feeding position.
• 2. Insert the tip of the syringe into the child's mouth.
• 3. Slowly press the plunger so that the child can swallow the medicine gradually.
• 4. After the child has swallowed the medicine, give them a small amount of liquid to drink. Cleaning and storage
• 1. After each use, disassemble the syringe, wash it under running water, dry, and store it in a clean place with the medicine.
• 2. After the last dose has been given to the child, discard the syringe and bottle.

Taking a higher dose of Ceclor than recommended

Do not take more of the oral suspension than your doctor has prescribed.
If you have taken more than the recommended dose of Ceclor, contact your doctor or go to the nearest hospital immediately.
Symptoms of cefaclor overdose include: nausea, vomiting, gastrointestinal disturbances, and diarrhea.

Missing a dose of Ceclor

If you miss a dose, take it as soon as possible.
If you miss several doses, inform your doctor.
If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ceclor can cause side effects, although not everybody gets them.
Possible side effects include: diarrhea (sometimes with blood or mucus), nausea or vomiting, vaginal discharge or itching, dizziness. Sometimes, in children taking Ceclor, hyperactivity may occur.
If you experience itching, redness, or swelling of the skin, joint pain, headache, sudden increase in breathing difficulties, or a feeling of weakness, stop taking the medicine and contact your doctor immediately.
Gastrointestinal disorders
The most common side effect was diarrhea. Rarely, it was severe enough to require discontinuation of the medicine. Cases of colitis, including pseudomembranous colitis (a disease that occurs usually as a result of antibiotic use, resulting from the proliferation of Clostridium difficilebacteria in the intestine and the action of toxins produced by them), have been reported. Nausea and vomiting have also been reported.
Immune system disorders
Allergic reactions such as rash, itching, and urticaria have been observed. These symptoms usually resolve after discontinuation of the medicine. Symptoms similar to serum sickness (multiform erythema, rash, and other skin symptoms with concurrent arthritis or joint pain, with or without fever) have been reported. Rarely, lymphadenopathy and proteinuria have occurred.
Rarely, anaphylaxis (a sudden and severe allergic reaction) may occur. Anaphylaxis may occur more frequently in patients allergic to penicillin. Anaphylactoid reactions may occur as single symptoms, such as angioedema, weakness, swelling (including facial and limb swelling), shortness of breath, paresthesia (tingling or numbness), fainting, or vasodilation.
Rarely, symptoms of hypersensitivity may persist for several months.
Blood and lymphatic system disorders
Eosinophilia (an increased number of one type of white blood cell - eosinophils), rarely thrombocytopenia (a decrease in platelet count), transient lymphocytosis and leukopenia (a decrease in white blood cell count), rarely anemia, agranulocytosis (a decrease in one type of white blood cell - granulocytes), and possibly clinically significant transient neutropenia (a decrease in granulocytes).

• transient neutropenia.

Hepatobiliary disorders
Rarely, transient hepatitis and jaundice with bile stasis, slight increases in liver enzyme activity (aspartate aminotransferase and alanine aminotransferase, and alkaline phosphatase) have been reported.
Renal and urinary disorders
Rarely, transient interstitial nephritis, slight increases in blood urea and serum creatinine, and abnormal urine test results have been reported.
Nervous system disorders
Rarely, the following side effects have been reported: transient hyperactivity, excitement, nervousness, insomnia, confusion, increased muscle tone, dizziness, hallucinations, and somnolence.
Other
Genital itching, candidiasis (thrush), and vulvovaginitis, positive Coombs test, rash, urticaria, symptoms similar to serum sickness (multiform erythema, rash, and other skin symptoms with concurrent arthritis or joint pain, with or without fever), lymphadenopathy, and proteinuria.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ceclor

Keep out of the sight and reach of children.
Store the granules below 25°C.
Store the suspension in the refrigerator (2°C–8°C).
Do not use this medicine after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ceclor contains

• The active substance of Ceclor is cefaclor. Granules for oral suspension 125 mg/5 ml: 5 ml of suspension contains 125 mg of cefaclor (Cefaclor). Granules for oral suspension 250 mg/5 ml: 5 ml of suspension contains 250 mg of cefaclor (Cefaclor). Granules for oral suspension 375 mg/5 ml: 5 ml of suspension contains 375 mg of cefaclor (Cefaclor).
• Other ingredients of the medicine are: Methylcellulose Sodium lauryl sulfate Dimethicone Xanthan gum A Modified starch A Strawberry flavor (52.312AP05.51) Sucrose Erythrosine (Aluminum Lake)

What Ceclor looks like and contents of the pack

Cartons containing:

• 1 bottle containing granules for the preparation of 75 ml of oral suspension, and a measuring spoon or
• 1 bottle containing granules for the preparation of 100 ml of oral suspension, and a measuring spoon and a dosing syringe.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Poland
tel: (22) 345 93 00
fax: (22) 345 93 01
e-mail: teva.polska@teva.pl

Manufacturer

ACS Dobfar S.P.A.
Via Laurentina Km 24.730
00071 Pomezia (Rome)
Italy
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow
To obtain detailed information about the medicine, please contact the representative of the marketing authorization holder.

Date of approval of the leaflet: April 2022