Taclar

Package leaflet: Information for the patient

Taclar, 250 mg, coated tablets
Clarithromycin - Clarithromycinum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm
another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, you should inform your
doctor or pharmacist. See section 4.
Table of contents of the leaflet
What Taclar is and what it is used for
Important information before taking Taclar
How to take Taclar
Possible side effects
How to store Taclar
Contents of the pack and other information
What Taclar is and what it is used for
Taclar contains the active substance - clarithromycin. It is a macrolide antibiotic that inhibits the growth of bacteria causing infections.
Taclar is indicated for the treatment of infections caused by microorganisms sensitive to clarithromycin.
These infections include:
infections of the upper respiratory tract (e.g. streptococcal pharyngitis, sinusitis),
infections of the lower respiratory tract (e.g. bronchitis, pneumonia),
acute otitis media,
skin and soft tissue infections (e.g. impetigo, folliculitis, cellulitis, abscesses),
dental and oral infections (e.g. periapical abscess, periodontitis),
disseminated or localized infections caused by mycobacteria.
In patients infected with HIV (CD4 lymphocyte count ≤100/mm³), Taclar is indicated for the prevention of disseminated infections caused by the Mycobacterium avium complex (MAC).
In patients with duodenal ulcer and a confirmed Helicobacter pylori infection, treatment with Taclar is recommended in combination with acid secretion inhibitors and another antibiotic.

2. Important information before taking Taclar

When not to take Taclar
If you are allergic to clarithromycin or other macrolide antibiotics (such as
azithromycin, erythromycin) or any of the other ingredients of this medicine (listed in
section 6).
If you are taking any of the following medicines:
astemizole or terfenadine (medicines used to treat allergies),
cisapride (a medicine used for gastrointestinal motility disorders),
pimozide (a medicine used for psychiatric disorders),
ticagrelor (an antiplatelet agent),
ranolazine (a heart medicine),
ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, for migraine),
lovastatin, simvastatin (statins used to reduce blood cholesterol levels),
midazolam administered orally (a medicine used for anxiety and insomnia),
colchicine (a medicine used to treat gout).
If you have low blood potassium levels.
If you have previously experienced ECG abnormalities (prolonged QT interval) or cardiac arrhythmias.
If you have severe hepatic insufficiency with concomitant renal insufficiency.
Warnings and precautions
If any of the following situations apply to you, discuss them with your doctor before starting Taclar.
You are pregnant or suspect you may be pregnant.
You have impaired kidney or liver function.
You have coronary artery disease, severe heart failure, low blood magnesium levels, or bradycardia.
You are taking any of the medicines listed in the section "Taclar with other medicines".
If any of the following occur during treatment with Taclar, inform your doctor immediately.
Severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, laryngeal edema, or bronchospasm. Seek immediate medical attention. Appropriate treatment will be initiated.
Diarrhea, especially if acute or prolonged. Inform your doctor as soon as possible. If necessary, your doctor will recommend appropriate treatment. Do not use anti-diarrheal medicines.
Symptoms suggesting liver dysfunction, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. Discontinue treatment and consult your doctor.
New infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially during prolonged antibiotic use. Your doctor will recommend appropriate treatment.
Additionally, during treatment with Taclar the following may occur:
cross-resistance of bacteria (bacteria resistant to clarithromycin may also be resistant to other macrolide antibiotics, as well as to lincomycin and clindamycin);
bacterial resistance (e.g. treatment of Helicobacter pylori infection may lead to the emergence of drug-resistant microorganisms).
Taclar with other medicines
You must inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You must inform your doctor if you are taking any of the following medicines, as their use with Taclar is contraindicated:
astemizole or terfenadine (medicines used to treat allergies),
cisapride (a medicine used for gastrointestinal motility disorders),
pimozide (a medicine used for psychiatric disorders),
ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, for migraine),
statins - lovastatin, simvastatin (medicines that lower blood cholesterol levels),
midazolam administered orally (a medicine used for anxiety or insomnia),
colchicine (a medicine used to treat gout).
You should inform your doctor if you are taking any of the following medicines, as special caution is required when using them with Taclar:
rifampicin, rifapentine, rifabutin (antibiotics used to treat tuberculosis),
fluconazole, itraconazole (antifungal medicines),
atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (medicines used to treat HIV infection),
digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (medicines used to treat cardiac arrhythmias or hypertension),
alprazolam, triazolam (medicines used for anxiety or insomnia),
warfarin or other oral anticoagulants,
carbamazepine, valproate, phenytoin (antiepileptic medicines),
atorvastatin, rosuvastatin (statins - medicines that lower blood cholesterol levels),
methylprednisolone (an anti-inflammatory medicine),
omeprazole (a medicine that reduces gastric acid secretion),
cilostazol (a medicine used to treat intermittent claudication - leg pain occurring during walking and resolving with rest),
cyclosporine, tacrolimus, sirolimus (medicines used, among others, after organ transplantation),
sildenafil, tadalafil, vardenafil (medicines used for erectile dysfunction),
vinblastine (a medicine used in cancer chemotherapy),
theophylline (a medicine used to treat bronchial asthma),
tolterodine (a medicine used to treat urinary incontinence),
phenobarbital (an anticonvulsant medicine),
St. John's wort (a herbal medicine used to treat mild depression),
sulfonylureas, nateglinide, repaglinide, insulin (medicines used to treat diabetes),
aminoglycosides (a group of antibiotics).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
The safety of clarithromycin during pregnancy and breastfeeding has not been established.
Taclar may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
Since clarithromycin passes into breast milk, women who are breastfeeding should exercise particular caution when using Taclar.
Driving and operating machinery
This medicine may cause dizziness, confusion, and disorientation, which may affect the ability to drive or operate machinery.

3. How to take Taclar

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
This medicine is for oral administration.
If a single dose of 500 mg is required, use of Taclar tablets containing 500 mg of clarithromycin per tablet is recommended.

Respiratory tract, skin and soft tissue infections, acute otitis media
Adults
For severe infections – one tablet (250 mg) twice daily (every 12 hours).
In severe infections, your doctor may recommend increasing the dose to two 250 mg tablets (500 mg) twice daily (every 12 hours).
Treatment usually lasts from 5 to 14 days, except for pneumonia and sinusitis, for which treatment lasts 6 to 14 days.

Children over 12 years of age
Dosage as for adults.

Children under 12 years of age
Use of Taclar oral suspension is recommended.

Patients with renal impairment
Your doctor may recommend reducing the dose by half, meaning one 250 mg tablet once daily.
For severe infections – one 250 mg tablet twice daily.
Treatment should not last longer than 14 days.

Dental and oral infections
One tablet (250 mg) twice daily (every 12 hours). Treatment usually lasts 5 days.

Infections caused by mycobacteria
Recommended dose for adults: two 250 mg tablets (500 mg) twice daily.
Treatment of disseminated infection caused by Mycobacterium avium complex (MAC) in patients with AIDS should be continued as long as directed by your doctor. Taclar should be used concomitantly with other anti-Mycobacterium agents.
Treatment of other non-tuberculous Mycobacterium infections should be continued according to your doctor's instructions.

Prevention of MAC infections
Recommended dose for adults: two 250 mg tablets (500 mg) twice daily.

Helicobacter pylori infections
For patients infected with Helicobacter pylori, your doctor will recommend one of the following treatment regimens.

Triple therapy:

• clarithromycin 500 mg twice daily (every 12 hours) with amoxicillin 1 g twice daily and lanzoprazole 30 mg twice daily for 10 days; or
• clarithromycin 500 mg twice daily with amoxicillin 1 g twice daily and omeprazole 20 mg once daily for 7 to 10 days.

Dual therapy:

• clarithromycin 500 mg three times daily and omeprazole 40 mg once daily for 14 days. Omeprazole 20 mg or 40 mg once daily should be continued for the next 14 days; or
• clarithromycin 500 mg three times daily and lanzoprazole 60 mg once daily for 14 days. Additional acid-reducing therapy may be necessary to achieve complete ulcer healing.

Administration instructions
Swallow the tablet whole with water. Do not chew or suck the tablet.
Tablets may be taken with or without food.

If you take more Taclar than you should
If you take more Taclar than recommended, contact your doctor or pharmacist immediately.
Taking more Taclar than prescribed may cause gastrointestinal symptoms (e.g. vomiting, abdominal pain).

If you forget to take Taclar
If you miss a dose of Taclar, take it as soon as possible, then take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.

If you stop taking Taclar
It is important to take the medicine exactly as prescribed for the recommended duration. Do not stop treatment even if you start to feel better and symptoms improve after a few days of treatment.
If you feel worse during treatment or do not feel well after completing the recommended course, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient develops a severe skin reaction: red, peeling rash with nodules under the skin and
blisters (erythema multiforme), contact a doctor immediately. The frequency of occurrence of
these adverse effects is unknown (cannot be estimated from available data).
In clinical trials and after the marketing of clarithromycin, the following adverse reactions were reported frequently (occur in 1 to 10 out of 100 patients):

• insomnia,
• taste disturbances, headache, altered sense of taste,
• diarrhoea, vomiting, dyspepsia, nausea, abdominal pain,
• abnormal liver function test results,
• rash, excessive sweating.

Adverse reactions reported uncommonly (occur in 1 to 10 out of 1,000 patients):

• candidiasis (fungal infection), vaginal infection,
• decreased white blood cell count, decreased neutrophil count, and increased eosinophil count,
• hypersensitivity,
• anorexia, decreased appetite,
• anxiety,
• dizziness, somnolence, tremor,
• loss of balance, deafness, tinnitus,
• palpitations, changes in ECG recording (prolongation of QT interval),
• gastritis, oral inflammation, glossitis, abdominal distension, constipation, dry mouth, belching, flatulence,
• cholestasis (increased bile components in blood), hepatitis, increased liver enzyme activity,
• pruritus, urticaria,
• malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue,
• increased blood levels of alkaline phosphatase and lactate dehydrogenase enzyme activity.

The following adverse reactions have been reported after marketing of clarithromycin in tablet and suspension forms, with unknown frequency:

• pseudomembranous colitis, erythema,
• agranulocytosis (reduced neutrophil count in blood), thrombocytopenia (reduced platelet count),
• anaphylactic reaction (acute, life-threatening allergic reaction, manifesting e.g. as circulatory and respiratory disturbances), angioedema,
• psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania,
• convulsions, ageusia (loss of taste), parosmia (distorted sense of smell), anosmia (loss of smell), paresthesia (numbness, tingling),
• deafness,
• cardiac arrhythmias, ventricular tachycardia,
• bleeding and changes in blood coagulation parameters (especially if the patient is concurrently taking oral anticoagulants),
• acute pancreatitis, tongue discoloration, tooth discoloration,
• liver failure, hepatocellular jaundice,
• skin reactions with peeling or blisters (Stevens-Johnson syndrome, toxic epidermal necrolysis), drug eruption with eosinophilia and systemic symptoms (DRESS), acne,
• muscle pain, rhabdomyolysis (syndrome of disease symptoms caused by breakdown of muscle tissue) – may occur if the patient is taking drugs used in the treatment of lipid disorders (statins, fibrates) or allopurinol (a drug used in gout),
• renal failure, interstitial nephritis, abnormal urine color.

Patients with impaired immunity
In addition to symptoms resulting from the course of the disease, the following adverse reactions have been observed in adult patients with impaired immunity:

• nausea, vomiting, altered sense of taste, constipation, abdominal pain, diarrhoea, flatulence, dry mouth,
• headache, hearing disturbances,
• rash,
• dyspnoea, insomnia,
• abnormal laboratory test results: increased aspartate aminotransferase (AspAT) and alanine aminotransferase (AlAT) activity, increased blood urea nitrogen concentration, and decreased platelet and white blood cell counts.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Taclar

Keep out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

The active substance is clarithromycin.
One coated tablet contains 250 mg of clarithromycin.
The other ingredients are: pregelatinized corn starch, povidone, microcrystalline cellulose ph 102,
sodium croscarmellose, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide.
What Taclar looks like and contents of the pack
White or almost white, round tablets.
Pack: 14 coated tablets.
Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint-Stock Company
A. Fleminga Street 2
03-176 Warsaw
Telephone number: (22) 811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.