Ceclor Mr

CECLOR MR, 375 mg, prolonged-release tablets

CECLOR MR, 500 mg, prolonged-release tablets

CECLOR MR, 750 mg, prolonged-release tablets

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

1. What is Ceclor MR and what is it used for

Ceclor MR contains the active substance cefaclor, which is an oral semi-synthetic antibiotic belonging to the cephalosporin group. Cephalosporins have a bactericidal effect, as they inhibit the synthesis of the bacterial cell wall.
Cefaclor is indicated for the treatment of the following infections caused by susceptible bacterial strains:

• Acute bronchitis and exacerbation of chronic bronchitis caused by Streptococcus pneumoniae(strains with reduced susceptibility to penicillin are resistant), Haemophilus influenzae(including strains producing β-lactamases), Haemophilus parainfluenzae, Moraxella catarrhalis(including strains producing β-lactamases), Staphylococcus aureus(methicillin-resistant strains are resistant).
• Pharyngitis and tonsillitis caused by Streptococcus pyogenes(group A streptococci).
• Pneumonia caused by Streptococcus pneumoniae(strains with reduced susceptibility to penicillin are resistant), Haemophilus influenzae(including strains producing β-lactamase) and Moraxella catarrhalis(including strains producing β-lactamase).
• Sinusitis caused by Streptococcus pneumoniae(only penicillin-susceptible strains), Haemophilus influenzae(including strains producing β-lactamase), Moraxella catarrhalis(including strains producing β-lactamase).
• Uncomplicated lower urinary tract infections, including cystitis and asymptomatic bacteriuria, caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilisand Staphylococcus saprophyticus.
• Skin and soft tissue infections caused by Streptococcus pyogenes(group A streptococci), Staphylococcus aureus(including β-lactamase-producing strains, methicillin-resistant strains are resistant) and Staphylococcus epidermidis(including β-lactamase-producing strains, methicillin-resistant strains are resistant).

Before starting treatment, appropriate tests should be carried out to demonstrate the susceptibility of the microorganisms to cefaclor.

2. Important information before taking Ceclor MR

When not to take Ceclor MR

• if you are 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 taking Ceclor MR, discuss it with your doctor or pharmacist

• if you are allergic to antibiotics, including penicillins and cephalosporins, as well as any other medicines. Symptoms of an allergic reaction may include: rash, itching, swelling and sudden difficulty breathing
• if you have kidney disease and are undergoing dialysis
• if you have had colitis (a type of severe diarrhea) in the past. If you experience diarrhea during treatment, you should inform your doctor, as it may be a sign of pseudomembranous colitis. The doctor will decide on further action. You should not take anti-diarrheal medicines
• if you have diabetes, as Ceclor MR may affect the results of urine tests for sugar.

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

Ceclor MR and other medicines

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

Children

The safety and efficacy of Ceclor MR in children have not been established. A cephalosporin antibiotic is available for children in the form of an oral suspension.

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 MR. Ceclor MR may be used in pregnant women only if absolutely necessary.
Breastfeeding
Women who are breastfeeding or planning to breastfeed should inform their doctor. Particular caution should be exercised when using Ceclor MR in breastfeeding women.

Childbirth

Ceclor MR can be used during childbirth only if absolutely necessary.

Driving and using machines

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

3. How to take Ceclor MR

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Ceclor MR is for oral use.
Recommended dose
Adults, including the elderly

• Pharyngitis, tonsillitis, bronchitis, skin and soft tissue infections - 375 mg twice daily.
• Lower urinary tract infections - 375 mg twice daily or 500 mg once daily.
• Pneumonia - 750 mg twice daily.
• Sinusitis - 750 mg twice daily.

In the elderly with normal renal function, no dose adjustment of Ceclor MR is necessary.

Use in children

The safety and efficacy of Ceclor MR in children have not been established. A cephalosporin antibiotic is available for children in the form of an oral suspension.
Method of administration
Cefaclor is well absorbed from the gastrointestinal tract. Better absorption of the active substance occurs in the presence of food, so Ceclor MR should be taken during meals.
Tablets should not be divided, crushed, or chewed.

Taking a higher dose of Ceclor MR than recommended

Do not take more tablets than your doctor has advised.
If you have taken more than the recommended dose of Ceclor MR, seek medical attention immediately.
Symptoms of cefaclor overdose include: nausea, vomiting, gastrointestinal disturbances, and diarrhea.

Missing a dose of Ceclor MR

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 MR can cause side effects, although not everybody gets them.
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.
During clinical trials with cefaclor, most of the observed side effects were transient and mild. In 1.7% of patients, side effects related to the use of the medicine occurred, which required discontinuation of treatment. The following side effects have been reported during clinical trials. The frequency of side effects was less than 1% (less than 1 in 100 patients), except for those listed below:
Gastrointestinal disorders
Frequent side effects included: diarrhea, nausea, vomiting, and indigestion.
Immune system disorders
Frequent side effects included: rash, urticaria, or itching.
Very rare cases of a reaction similar to serum sickness have been reported.
During treatment with cefaclor, symptoms similar to serum sickness (multiform erythema, rash, and other skin symptoms with concurrent arthritis or arthralgia, with or without fever) have been observed. Rarely, lymphadenopathy and proteinuria occurred. Isolated symptoms may occur, but they are not due to a serum sickness-like reaction. Serum sickness-like reactions are due to hypersensitivity and usually occur during or after cefaclor treatment. They can be alleviated by administering antihistamines and corticosteroids. No serious consequences of these reactions have been reported.
Blood and lymphatic system disorders
Eosinophilia (elevated count of one type of white blood cell - eosinophils).
Reproductive system and breast disorders
Frequent cases of candidiasis (thrush) and vulvovaginitis.
Other side effects have also been reported, but their relationship to the treatment has not been confirmed:
Nervous system disorders
Headache, dizziness, drowsiness.
Hepatobiliary disorders
Transient elevation of liver enzymes (aspartate aminotransferase and alanine aminotransferase, and alkaline phosphatase).
Renal and urinary disorders
Transient elevation of blood urea nitrogen and creatinine levels.
Investigations
Transient thrombocytopenia (low platelet count), leukopenia, and lymphocytosis (low white blood cell count), neutropenia (low granulocyte count), and abnormal urine test results.
In addition to the side effects reported by patients taking Ceclor MR, the following side effects have been observed in patients taking cefaclor: erythema multiforme, fever, anaphylaxis (may occur more frequently in patients allergic to penicillin), Stevens-Johnson syndrome (erythema multiforme characterized by blisters on mucous membranes, mainly in the mouth and genital organs), positive Coombs test, and genital itching. Symptoms of pseudomembranous colitis (a disease that usually occurs after antibiotic treatment, resulting from the proliferation of Clostridium difficilein the intestine and the action of toxins produced by it) may occur during or after antibiotic treatment. 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.
In patients taking cefaclor, the following side effects have been reported rarely:
Toxic epidermal necrolysis (toxic skin necrosis), transient interstitial nephritis, liver function disorders, cholestatic jaundice, increased prothrombin time in patients taking cefaclor and warfarin, transient hyperactivity, excitement, nervousness, insomnia, hallucinations, increased tension, aplastic anemia, agranulocytosis, and hemolytic anemia.
Side effects reported by patients taking other β-lactam antibiotics:
pseudomembranous colitis, renal function disorders, and toxic nephropathy. Some β-lactam antibiotics have been associated with the ability to cause seizures, especially in patients with impaired renal function taking standard doses of cefaclor. If seizures occur during treatment with cefaclor, discontinue the medicinal product and contact your doctor immediately, who may prescribe antiepileptic drugs.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 the medicine.

5. How to store Ceclor MR

Keep out of the sight and reach of children.
Store in a temperature below 30°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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ceclor MR contains

• The active substance is cefaclor. One prolonged-release tablet contains 375 mg, 500 mg, or 750 mg of cefaclor.
• Other ingredients are: Tablet core: Mannitol, Methylhydroxypropylcellulose, Hydroxypropylcellulose, Hydroxypropylcellulose EF (Extra Fine), Methacrylic acid copolymer (type C), Stearic acid, Magnesium stearate

Coating:
Color mixture "Dark Blue YS-1-4273"
Propylene glycol
Talc

What Ceclor MR looks like and contents of the pack

Prolonged-release tablets.
10 tablets (10 units) or 14 tablets (14 units) in a cardboard box.
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, please contact the marketing authorization holder's representative.

Date of approval of the leaflet: April 2022