Ceclor

Leaflet attached to the packaging: patient information

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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. Package contents 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 from the cephalosporin group. Cephalosporins have a bactericidal effect, as they inhibit the synthesis of bacterial cell walls. Cefaclor is indicated for 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. Cefaclor is usually effective in combating 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 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 allergy may include: rash, itching, swelling, and sudden difficulty breathing
• 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 sugar tests.

Prolonged 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 medications (e.g., warfarin or acenocoumarol) simultaneously, the effect of these medications may be enhanced, and bleeding may occur. The renal excretion of cefaclor, like that of other beta-lactam antibiotics, is inhibited by probenecid. Cases of a positive (sometimes false-positive) Coombs test have been reported during cephalosporin treatment. Ceclor may cause a false-positive result in the glucose test using Benedict's solution or Fehling's 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 medication, consult your doctor or pharmacist. Pregnancy: Women who are pregnant, suspect they may be pregnant, or plan 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 plan to start breastfeeding should inform their doctor. Caution should be exercised when using Ceclor in breastfeeding women.

Driving and operating machinery

The effect of Ceclor on the ability to drive and operate machinery is not known.

Ceclor contains sucrose

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

3. How to take Ceclor

This medicine should always be taken as directed by your doctor or pharmacist. In case of doubts, 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 administered in 2 divided doses every 12 hours. The treatment of streptococcal infections should last at least 10 days. Do not stop taking Ceclor without consulting your doctor. How to prepare the suspension
The suspension should be prepared immediately before taking the medicine, according to the instructions below.
For the 75 ml bottle, add 45 ml of cooled boiled water in two portions (2 × 22.5 ml). After each addition of water, the suspension should be shaken well.
For the 100 ml bottle, add 60 ml of cooled boiled water in two portions (2 × 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. Shake the prepared suspension well before use.
• 2. Press the cap and turn it counterclockwise.
• 3. Insert the syringe tip into the suspension and pull the plunger up. Draw the prescribed volume of suspension.
• 4. If an air bubble forms in the syringe, push the medicine back into 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 syringe tip 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 administering the last dose to the child, discard the syringe and bottle.

Taking more Ceclor than recommended

Do not take more suspension than your doctor has prescribed.
In case of overdose, consult your doctor or go to the nearest hospital immediately.
Symptoms of cefaclor overdose include: nausea, vomiting, gastrointestinal disorders, and diarrhea.

Missing a dose of Ceclor

If a dose is missed, take it as soon as possible.
If several doses are missed, inform your doctor.
In case of 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, during treatment in children, hyperactivity may occur.
If you experience itching, redness, or swelling of the skin, joint pain, headache, sudden difficulty breathing, 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 usually occurs after antibiotic treatment, resulting from the proliferation of Clostridium difficilebacteria 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 urticaria, itching, and rash, have been observed. These symptoms usually disappeared after discontinuation of the medicine. Symptoms similar to those of 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 occurred. Isolated cases of a single symptom, but not as part of a serum sickness-like reaction, have been reported. Serum sickness-like reactions are caused by hypersensitivity and usually occur during cefaclor treatment or after its repeated use. They occur more frequently in children than in adults. Symptoms usually appear within a few days of starting treatment and disappear within a few days of its completion. They can be alleviated by administering antihistamines and corticosteroids. No serious consequences of these reactions have been reported.
Rarely, Stevens-Johnson syndrome (multiform erythema characterized by blisters on mucous membranes, mainly in the mouth and genital organs), toxic epidermal necrolysis (toxic skin necrosis), and anaphylaxis (sudden and severe allergic reaction) have been reported. Anaphylaxis may occur more frequently in patients allergic to penicillin. Anaphylactoid reactions may occur as isolated symptoms, e.g., angioedema, weakness, swelling (including facial and limb swelling), shortness of breath, paresthesia (tingling sensation), fainting, or vasodilation.
Rarely, symptoms of hypersensitivity may persist for several months.
Blood and lymphatic system disorders: Eosinophilia (elevated levels of a type of white blood cell - eosinophils), rarely thrombocytopenia (low platelet count), transient lymphocytosis, and leukopenia (low white blood cell count), rarely anemia, agranulocytosis (low levels of a type of white blood cell - granulocytes), and possibly clinically significant transient neutropenia (low levels of granulocytes).

• transient neutropenia.

Hepatobiliary disorders: Rarely, transient hepatitis and jaundice with bile stasis, slight increases in liver enzyme activity (aspartate aminotransferase and alanine aminotransferase, as well as 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 tension, dizziness, hallucinations, and somnolence.
Other: Genital itching, candidiasis (thrush), and vulvitis, positive Coombs test, urticaria, symptoms similar to those of 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, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceclor

Store out of sight and reach of children.
Granules should be stored at a temperature below 25°C.
The suspension should be stored in the refrigerator (2°C–8°C).
Do not use this medicine after the expiration date stated on the carton after "Expiration date". The expiration 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. Package contents 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, Modified starch, Artificial strawberry flavor (52.312AP05.51), Sucrose, Erythrosine (Aluminum Lake)

What Ceclor looks like and what the package contains

Carton boxes 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: [email protected]

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, contact the representative of the marketing authorization holder.

Date of leaflet approval: April 2022