TACLAR 500 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Taclar, 500 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
4. Important information before taking Taclar
   1. When not to take Taclar
   2. Warnings and precautions
   3. Taclar and other medicines
   4. You should tell your doctor if you are taking any of the following medicines, as special caution is required when taking them with Taclar:
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Taclar contains sodium
5. How to take Taclar
   1. If you take more Taclar than you should
   2. If you forget to take Taclar
   3. If you stop taking Taclar
6. Possible side effects
   1. Reporting side effects
7. How to store Taclar
8. Contents of the pack and other information
   1. What Taclar contains
   2. What Taclar looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Taclar, 500 mg, Film-Coated Tablets

Clarithromycin

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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. 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 use in adults and children over 12 years of age for the treatment of infections caused by susceptible organisms. 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)
• -disseminated or localized infections caused by mycobacteria

In patients with HIV infection (CD4 cell 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 confirmed diagnostic infection with Helicobacter pylori, it is recommended to use Taclar in combination with drugs that inhibit 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:
• medicines that can cause severe heart rhythm disturbances, including:
• astemizole or terfenadine (medicines used in allergies)
• cisapride (a medicine used in gastrointestinal disorders)
• pimozide (a medicine used in psychiatric disorders)
• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used in migraines)
• lovastatin, simvastatin (statins used to lower cholesterol levels)
• oral midazolam (a medicine used in anxiety and insomnia)
• colchicine (a medicine used in gout)
• a medicine containing lomitapide (a medicine used in patients with high cholesterol to lower it)
• If you are taking medicines called ticagrelor, ivabradine or ranolazine (for angina or to reduce the risk of heart attack or stroke).
• If you have low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• If you or a family member have a history of heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or abnormalities in the electrocardiogram (ECG, a recording of the heart's electrical activity) called "long QT syndrome".
• If you have severe liver failure with concomitant kidney failure.

Warnings and precautions

If you are in any of the following situations, you should discuss this with your doctor before taking Taclar.

• You are pregnant or think you may be pregnant.
• You have kidney or liver problems.
• You have coronary artery disease, severe heart failure, 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 allergic reactions, such as a rash, hives, swelling of the throat, or difficulty breathing. You should immediatelysee a doctor, who will provide appropriate treatment.
• 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.
• Signs of liver problems, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. You should stop taking the medicine and see a doctor.
• New infections (superinfections) with bacteria or fungi, especially during long-term use of the antibiotic. 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 and clindamycin);
• Antibiotic resistance (e.g., treatment of Helicobacter pylori infection may lead to the development of resistant microorganisms).

Taclar and other medicines

Tell your doctor about all the medicines you are taking now or recently, and about any medicines you plan to take.
You must tell your doctor if you are taking any of the following medicines, as their use with Taclar is contraindicated:

• astemizole or terfenadine (medicines used in allergies)
• cisapride (a medicine used in gastrointestinal disorders)
• pimozide (a medicine used in psychiatric disorders)
• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used in migraines)
• statins - lovastatin, simvastatin (medicines used to lower cholesterol levels)
• oral midazolam (a medicine used in anxiety or insomnia)
• colchicine (a medicine used in gout)

You should tell your doctor if you are taking any of the following medicines, as special caution is required when taking them with Taclar:

as their use with Taclar requires special caution:

• rifampicin, rifapentine, rifabutin (antibiotics used in the treatment of tuberculosis)
• fluconazole, itraconazole (antifungal medicines)
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used in the treatment of HIV infection)
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used in the treatment of heart rhythm disorders or hypertension)
• alprazolam, triazolam, midazolam (given intravenously or orally, medicines used in anxiety or insomnia)
• warfarin or other anticoagulant medicines, e.g. dabigatran, rivaroxaban, apixaban, edoxaban (medicines used to thin the blood)
• quetiapine or other atypical antipsychotic medicines
• carbamazepine, valproate, phenytoin (antiepileptic medicines)
• atorvastatin, rosuvastatin (statins - medicines used to lower cholesterol levels)
• methylprednisolone (an anti-inflammatory medicine)
• omeprazole (a medicine that reduces stomach acid production)
• cilostazol (a medicine used in intermittent claudication, which is characterized by leg pain during exercise that disappears after a short rest)
• cyclosporin, tacrolimus, sirolimus (medicines used, among other things, after transplants)
• sildenafil, tadalafil, vardenafil (medicines used in erectile dysfunction)
• vinblastine (a medicine used in cancer chemotherapy)
• theophylline (a medicine used in asthma)
• tolterodine (a medicine used in urinary incontinence)
• phenobarbital (an antiepileptic medicine)
• St. John's Wort (a herbal medicine used in mild depression)
• sulfonylurea, nateglinide, repaglinide, insulin (medicines used in diabetes)

It is also important if you are taking the following medicines:

• hydroxychloroquine or chloroquine (used in the treatment of rheumatoid arthritis, or in the treatment or prevention of malaria). Taking these medicines with clarithromycin may increase the risk of heart rhythm disturbances and other serious side effects affecting the heart.
• oral, injectable, or inhaled corticosteroids (used to suppress the immune system, which is useful in the treatment of many different diseases).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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.
As 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.

Taclar contains sodium

Taclar contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is essentially "sodium-free".

3. How to take Taclar

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is for oral use.
Swallow the tablet whole with water. Do not chew or suck the tablet.
The tablets can be taken with or without food.
Respiratory tract infections, skin and soft tissue infections, acute otitis media
Adults
In severe infections - one 500 mg tablet 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
Dosage as for adults.
Children under 12 years
Taclar oral suspension is recommended.
Patients with renal impairment
Your doctor may recommend reducing the dose of the medicine by half, which means taking one 250 mg tablet once a day.
In severe infections - one 250 mg tablet twice a day.
It is recommended to use Taclar containing 250 mg of clarithromycin per tablet. Treatment should not last more than 14 days.
Infections caused by mycobacteria
Recommended dose for adults: one 500 mg tablet 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 are effective 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: one 500 mg tablet twice a day.
Helicobacter pylori infections
In patients with gastric or duodenal ulcer caused by Helicobacter pylori infection, clarithromycin can be given for 7 to 14 days at a dose of 500 mg twice a day, in combination with other appropriate antibacterial treatment and proton pump inhibitors, in accordance with national and international guidelines for the eradication of Helicobacter pylori.

If you take more Taclar than you should

If you have taken more Taclar than you should, contact your doctor or pharmacist immediately.
Taking more Taclar than prescribed by your doctor may cause gastrointestinal symptoms (vomiting, stomach pain).

If you forget to take 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 a missed dose.

If you stop taking Taclar

If you have any further questions about taking this medicine, ask your doctor or pharmacist.
Do not stop treatment, even if you feel better and the symptoms of the disease disappear after a few days of taking the medicine.

4. Possible side effects

Like all medicines, Taclar can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop takingTaclar and consult your doctor immediately:

• severe or prolonged diarrhea, which may be bloody or contain mucus (pseudomembranous colitis). Diarrhea may occur even after two months after the end of treatment with clarithromycin. In this case, you should also contact your doctor.
• allergic reactions:
• rash, difficulty breathing, fainting, or swelling of the face, tongue, lips, eyes, and throat (anaphylactoid reaction, hypersensitivity)
• anaphylactic reaction (a life-threatening allergic reaction that can cause, among other things, circulatory and respiratory disorders), angioedema
• severe skin reactions:
• painful skin peeling, mouth, lips, eyes, and genital lesions (these are symptoms of an allergic reaction called Stevens-Johnson syndrome or toxic epidermal necrolysis [Lyell's syndrome])
• red, peeling rash with nodules under the skin and blisters (symptoms of acute generalized exanthematous pustulosis [AGEP])
• rare skin reaction causing severe illness with mouth ulcers, skin rash, fever, and inflammation of internal organs (DRESS syndrome)
• yellowing of the skin (jaundice), skin irritation, light-colored stools, dark urine, abdominal tenderness, or loss of appetite. These may be signs of liver inflammation or liver failure
• muscle pain or muscle weakness called rhabdomyolysis (a syndrome of muscle symptoms caused by muscle tissue breakdown, which can lead to kidney damage).

In clinical trials and after the marketing of clarithromycin in the form of powder for solution for infusion, very common(more than 1 in 10 patients) phlebitis at the injection site was reported.
In patients taking clarithromycin in the form of intravenous or oral administration, the following side effects were common(occurring in 1 to 10 out of 100 patients):

• injection site pain, injection site inflammation
• insomnia
• taste disturbances, headache, change in taste perception
• vasodilation
• diarrhea, vomiting, nausea, abdominal pain
• abnormal liver function tests
• rash, excessive sweating

The following side effects were reported uncommonly(occurring in 1 to 10 out of 1,000 patients):

• inflammation of the connective tissue, candidiasis (fungal infection), vaginal infection
• decreased white blood cell count, increased platelet count
• loss of appetite, decreased appetite
• restlessness
• loss of consciousness, dyskinesia (involuntary, uncoordinated movements of the limbs or the whole body), dizziness, drowsiness, tremors
• balance disorders, hearing disturbances, tinnitus
• cardiac arrest, ventricular tachycardia, ventricular fibrillation, palpitations, changes in ECG (QT interval prolongation)
• asthma, pulmonary embolism, nosebleeds
• esophagitis, gastritis, oral inflammation, tongue inflammation, abdominal distension, constipation, dry mouth, belching, flatulence
• increased liver enzyme activity
• blisters, itching, hives
• musculoskeletal stiffness
• increased creatinine levels in the blood, increased urea levels in the blood, abnormal albumin-to-globulin ratio
• asthenia (weakness, lack of strength), feeling unwell, fever, chest pain, chills

The following side effects have been reported with an unknown frequency(frequency cannot be estimated from the available data) after the marketing of different forms of the medicine with the active substance clarithromycin (tablets, granules for oral suspension, powder for solution for infusion):

• pseudomembranous colitis
• rosacea
• agranulocytosis (decreased granulocyte count in the blood), thrombocytopenia (decreased platelet count)
• acne
• psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania
• seizures, loss of taste, abnormal smell, loss of smell, paresthesia (numbness, tingling)
• deafness
• heart rhythm disturbances, ventricular tachycardia, ventricular fibrillation
• bleeding and changes in blood clotting parameters (especially if you are taking oral anticoagulant medicines at the same time)
• acute pancreatitis, tongue discoloration, tooth discoloration
• liver failure, jaundice
• muscle diseases (myopathies) characterized by muscle weakness, in some cases - difficulty relaxing muscles, muscle atrophy
• kidney failure, interstitial nephritis
• changes in laboratory test results (increased INR, prolonged prothrombin time, abnormal urine color).

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

• nausea, vomiting, changes in taste, constipation, abdominal pain, diarrhea, flatulence, dry mouth
• headache, hearing disturbances
• rash
• shortness of breath, 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: 22 49 21 301
Fax: 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 this medicine.

5. How to store Taclar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store in a temperature not exceeding 25°C.
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 Taclar contains

The active substance of Taclar is clarithromycin.

• -One film-coated tablet contains 500 mg of clarithromycin.

The other ingredients are: maize starch, povidone, microcrystalline cellulose type 102, sodium croscarmellose, magnesium stearate;
Coating: hypromellose, macrogol 6000, titanium dioxide.

What Taclar looks like and contents of the pack

Taclar is available in the form of film-coated tablets
The tablets are oval, 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 number: (22) 811-18-14
To obtain more detailed information about this medicine, contact the marketing authorization holder.

Date of last revision of the leaflet: