TACLAR 250 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Taclar, 250 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
   3. What is Taclar and what is it used for
3. Important Information Before Taking Taclar
   1. When Not to Take Taclar
   2. Warnings and Precautions
   3. Taclar and Other Medicines
   4. You must inform your doctor if you are taking any of the following medicines, as their use with Taclar is contraindicated:
   5. You should inform your doctor if you are taking any of the following medicines, as special caution is required when using them with Taclar:
   6. Taclar:
   7. Pregnancy and Breastfeeding
   8. Driving and Using Machines
4. How to Take Taclar
   1. Method of Administration
   2. Overdose of Taclar
   3. Missed Dose of Taclar
   4. Stopping Taclar Treatment
5. Possible Side Effects
   1. Reporting Side Effects
6. How to Store Taclar
7. Contents of the Pack and Other Information
   1. Marketing Authorization Holder and Manufacturer
   2. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

Taclar, 250 mg, Film-Coated Tablets

Clarithromycin - Clarithromycinum

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.
In case of any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

What is Taclar and what is it 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 is Taclar and what is it used for

Taclar contains the active substance clarithromycin. It is a macrolide antibiotic that inhibits the growth of bacteria that cause infections.
Taclar is indicated for the treatment of infections caused by susceptible microorganisms.
These infections include:
upper respiratory tract infections (e.g. streptococcal pharyngitis, sinusitis),
lower respiratory tract infections (e.g. bronchitis, pneumonia),
acute otitis media,
skin and soft tissue infections (e.g. infectious eczema, folliculitis, cellulitis, abscesses),
dental and oral infections (e.g. periapical abscess, periodontitis),
disseminated or localized infections caused by mycobacteria.
In patients with HIV infection (CD4 cell count ≤100/mm), Taclar is indicated for the prevention of disseminated infections caused by the Mycobacterium avium complex (MAC).
In patients with duodenal ulcer and diagnosed Helicobacter pylori infection, it is recommended to use Taclar in combination with drugs that reduce gastric acid secretion 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 to treat gastrointestinal disorders),
pimozide (a medicine used to treat psychiatric disorders),
tikagrelor (a medicine that inhibits platelet aggregation),
ranolazine (a medicine used to treat angina),
ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used to treat migraines),
lovastatin, simvastatin (statins used to lower blood cholesterol levels),
oral midazolam (a medicine used to treat anxiety and insomnia),
colchicine (a medicine used to treat gout).
If you have a low potassium level in your blood.
If you have a history of QT interval prolongation and heart rhythm disorders.
If you have severe liver failure with concomitant renal failure.

Warnings and Precautions

If you have any of the following conditions, you should discuss them with your doctor before taking Taclar.
You are pregnant or think you may be pregnant.
You have kidney or liver function disorders.
You have coronary artery disease, severe heart failure, low magnesium levels, or slow heart rate.
You are taking any of the medicines listed in the "Taclar and other medicines" section.
If you experience any of the following while taking Taclar, tell your doctor:
Severe hypersensitivity reactions, such as rash, urticaria, angioedema, bronchospasm. You should seek medical attention immediately.
Diarrhea, especially severe or prolonged. You should tell your doctor as soon as possible. If necessary, your doctor will prescribe appropriate treatment. Do not take anti-diarrheal medicines.
Symptoms of liver function disorders, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. You should stop treatment and consult your doctor.
New infections (superinfections) with bacteria or fungi, especially during long-term antibiotic use. Your doctor will prescribe appropriate treatment.
In addition, while taking Taclar, you may experience:
cross-resistance of bacteria (bacteria resistant to clarithromycin may also be resistant to other macrolide antibiotics and lincosamides);
bacterial resistance (e.g. treatment of Helicobacter pylori infection may lead to the selection of resistant microorganisms).

Taclar and Other Medicines

Tell your doctor about all the medicines you are 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 to treat gastrointestinal disorders),
pimozide (a medicine used to treat psychiatric disorders),
ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used to treat migraines),
statins - lovastatin, simvastatin (medicines that lower blood cholesterol levels),
oral midazolam (a medicine used to treat 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:

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 heart rhythm disorders or hypertension),
alprazolam, triazolam (medicines used to treat 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 that occurs when walking and disappears after rest),
cyclosporin, tacrolimus, sirolimus (medicines used after transplants),
sildenafil, tadalafil, vardenafil (medicines used to treat erectile dysfunction),
vinblastine (a medicine used in cancer chemotherapy),
theophylline (a medicine used to treat asthma),
tolterodine (a medicine used to treat urinary incontinence),
phenobarbital (an antiepileptic 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 plan to have a child, 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 the doctor considers that the benefits to the mother outweigh the potential risks to the fetus.
Since clarithromycin passes into breast milk, breastfeeding women should exercise caution when taking Taclar.

Driving and Using Machines

The medicine may cause dizziness, confusion, and disorientation, which may affect your ability to drive and use machines.

3. How to Take Taclar

Always take this medicine exactly as your doctor has told you.
In case of doubts, consult your doctor or pharmacist.
The medicine is for oral use.
If a single dose of 500 mg is necessary, it is recommended to use Taclar containing 500 mg of clarithromycin per tablet.
Respiratory tract infections, skin and soft tissue infections, acute otitis media
Adults
In severe infections - one tablet (250 mg) twice a day (every 12 hours).
In severe infections, the doctor may recommend increasing the dose to two tablets of 250 mg (500 mg) twice a day (every 12 hours).
Treatment usually lasts 5 to 14 days, except for pneumonia and sinusitis, when treatment lasts 6 to 14 days.
Children over 12 years old
Dosage as for adults.
Children under 12 years old
Taclar oral suspension is recommended.
Patients with renal impairment
The doctor may recommend reducing the dose by half, which means taking one 250 mg tablet once a day.
In severe infections - one 250 mg tablet twice a day.
Treatment should not last more than 14 days.
Dental and oral infections
One tablet (250 mg) twice a day (every 12 hours). Treatment usually lasts 5 days.
Infections caused by mycobacteria
Recommended dose for adults: two tablets of 250 mg (500 mg) twice a day.
Treatment of disseminated Mycobacterium avium complex (MAC) infection in patients with AIDS should be continued for as long as the doctor recommends. Taclar should be used in combination with other medicines that act against Mycobacterium.
Treatment of other non-tuberculous mycobacterial infections should be continued according to the doctor's recommendations.
Prevention of MAC infections
Recommended dose for adults: two tablets of 250 mg (500 mg) twice a day.
Helicobacter pyloriinfections
In patients with Helicobacter pylori infection, the doctor will recommend one of the following treatment regimens.

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

Treatment with 2 medicines:

• clarithromycin 500 mg three times a day and omeprazole 40 mg once a day for 14 days. Omeprazole 20 mg or 40 mg once a day should be continued for the next 14 days; or
• clarithromycin 500 mg three times a day and lansoprazole 60 mg once a day for 14 days. To achieve complete healing of the ulcer, further use of acid-reducing medicines may be necessary.

Method of Administration

Swallow the tablet whole with water. Do not chew or suck the tablet.
The tablets can be taken with or without food.

Overdose of Taclar

In case of overdose, consult your doctor or pharmacist immediately.
Taking more Taclar than prescribed by your doctor may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missed Dose of Taclar

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

Stopping Taclar Treatment

It is important to use the medicine according to the recommended treatment cycle. Do not stop treatment, even if you feel better and symptoms disappear after a few days of taking the medicine.
If you feel worse during treatment or do not feel well after completing the recommended treatment cycle, consult your doctor.
In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Taclar can cause side effects, although not everybody gets them.
If you experience a severe skin reaction: red, scaly rash with bumps under the skin and blisters (pustular psoriasis), you should contact your doctor immediately. The frequency of these side effects is unknown (cannot be estimated from the available data).
In clinical trials and after marketing, clarithromycin has commonly been reported to cause the following side effects (occurring in 1 to 10 out of 100 patients):

• insomnia,
• taste disorders, headache, change in taste,
• diarrhea, vomiting, nausea, abdominal pain,
• abnormal liver function test results,
• rash, excessive sweating.

Side effects reported not very commonly (occurring in 1 to 10 out of 1000 patients):

• candidiasis (fungal infection), vaginal infection,
• decreased white blood cell count, decreased neutrophil count and increased eosinophil count,
• hypersensitivity,
• anorexia, decreased appetite,
• restlessness,
• dizziness, somnolence, tremors,
• balance disorders, hearing loss, tinnitus,
• palpitations, QT interval prolongation, changes in ECG,
• gastritis, oral mucositis, tongue discoloration, abdominal distension, constipation, dry mouth, belching, flatulence,
• cholestasis (increased bile components in the 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.

The following side effects have been reported with an unknown frequency (cannot be estimated from the available data) after marketing of clarithromycin in tablet and oral suspension form:

• pseudomembranous colitis, erythema multiforme,
• agranulocytosis (decreased granulocyte count in the blood), thrombocytopenia (decreased platelet count),
• anaphylactic reaction (severe, life-threatening allergic reaction, manifested by, among other things, circulatory and respiratory disorders), angioedema,
• psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania,
• seizures, ageusia, parosmia, anosmia, paresthesia (numbness, tingling),
• deafness,
• arrhythmias, ventricular tachycardia,
• bleeding and changes in blood coagulation parameters (especially if you are taking oral anticoagulants at the same time),
• acute pancreatitis, tongue discoloration, tooth discoloration,
• liver failure, jaundice,
• skin reactions with exfoliation or blisters (Stevens-Johnson syndrome, toxic epidermal necrolysis), drug rash with eosinophilia and systemic symptoms, acne,
• muscle pain, rhabdomyolysis (a condition characterized by muscle tissue breakdown) - may occur if you are taking statins or fibrates (medicines used to treat lipid disorders) or allopurinol (a medicine used to treat gout),
• renal failure, interstitial nephritis, abnormal urine color.

Patients with impaired immune systems
In addition to symptoms related to the course of the disease, the following side effects have been observed in adult patients with impaired immune systems:

• nausea, vomiting, change in taste, constipation, abdominal pain, diarrhea, flatulence, dry mouth,
• headache, hearing disorders,
• rash,
• dyspnea, insomnia,
• abnormal laboratory test results: increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity, increased blood urea nitrogen levels, and decreased platelet and white blood cell counts.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell 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, e-mail: [email protected]. 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 Taclar

Keep out of the sight and reach of children.
Store in 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 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

The active substance of Taclar is clarithromycin.
One film-coated tablet contains 250 mg of clarithromycin.
The other ingredients are: cornstarch, povidone, microcrystalline cellulose ph 102, sodium croscarmellose, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide.
What Taclar looks like and what the pack contains
The tablets are round, white or almost white.
Packaging:14 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, Phone: (22) 811-18-14. For more detailed information, please contact the representative of the marketing authorization holder.

Date of Last Revision of the Leaflet: