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 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. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 performed to demonstrate the susceptibility of microorganisms to cefaclor.

2. Important information before taking Ceclor MR

When not to take Ceclor MR

• 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 to take Ceclor MR, the patient should discuss it with their doctor or pharmacist

• if the patient is 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 the patient has kidney disease and 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. The patient should not take anti-diarrheal medications
• if the patient has diabetes, as Ceclor MR may affect the results of urine sugar tests.

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

Ceclor MR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Rarely, in patients taking cefaclor and anticoagulant medicines (including 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 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, the patient should consult their 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 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 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 prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Ceclor MR is an oral medicine.
Recommended dose
Adults, including the elderly

• Pharyngitis, tonsillitis, bronchitis, skin and soft tissue infections - 375 mg twice a day.
• Uncomplicated lower urinary tract infections - 375 mg twice a day or 500 mg once a day.
• Pneumonia - 750 mg twice a day.
• Sinusitis - 750 mg twice a day.

In elderly patients with normal renal function, no dose adjustment 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.

Overdose of Ceclor MR

The patient should not take more tablets than prescribed by their doctor.
In case of overdose, the patient should immediately consult their doctor or go to the nearest hospital.
Symptoms of cefaclor overdose include: nausea, vomiting, gastrointestinal disturbances, and diarrhea.

Missed dose of Ceclor MR

If a dose is missed, the patient should take it as soon as possible.
If several doses are missed, the patient should inform their doctor.
In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ceclor MR can cause side effects, although not everybody gets them.
If the patient experiences itching, redness, or swelling of the skin, joint pain, headache, sudden difficulty breathing, or a feeling of weakness, they should stop taking the medicine and contact their doctor immediately.
During clinical trials with cefaclor, most of the observed side effects were transient and mild. In 1.7% of patients, side effects occurred that 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
Common side effects included: diarrhea, nausea, vomiting, and indigestion.
Immune system disorders
Common 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 (polymorphic rash, rash, and other skin symptoms with concurrent arthritis or arthralgia, with or without fever) have been observed. Rare cases of lymphadenopathy and proteinuria have been reported. 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 levels of a type of white blood cell - eosinophils).
Reproductive system and breast disorders
Common side effects included: candidiasis (thrush) and vulvovaginitis.
The following symptoms have also been reported, although their relationship to treatment has not been confirmed:
Nervous system disorders
Headache, dizziness, and 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 symptoms have been observed in patients taking cefaclor: polymorphic rash, fever, anaphylaxis (may occur more frequently in patients allergic to penicillin), Stevens-Johnson syndrome (polymorphic rash characterized by blisters on mucous membranes, mainly in the mouth and genital areas), positive Coombs test, and genital itching.
Symptoms of pseudomembranous colitis (a disease that usually occurs after antibiotic treatment, resulting from the multiplication of Clostridium difficilebacteria in the intestine and the action of toxins produced by them) may occur during or after antibiotic treatment. Anaphylactoid reactions may occur as isolated 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.
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:
colitis, renal function disorders, and toxic nephropathy. Some β-lactam antibiotics have been reported to cause seizures, especially in patients with impaired renal function taking standard doses of cefaclor. If seizures occur during cefaclor treatment, the patient should stop taking the medicine and contact their doctor immediately, who may prescribe anticonvulsant medications.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety 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. The patient should ask their 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 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, the patient should contact the representative of the marketing authorization holder.

Date of leaflet approval: April 2022