TACLAR 500 mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Taclar, 500 mg, powder for solution for infusion
   1. Read the 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. The patient must inform their doctor if they are taking any of the following medicines, as their use with Taclar is contraindicated:
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to take Taclar
   1. Using more than the recommended dose or missing a dose of Taclar
6. Possible side effects
7. How to store Taclar
8. Contents of the packaging and other information
   1. What Taclar looks like and what the packaging contains
   2. Marketing authorization holder and manufacturer
   3. Date of the last update of the leaflet:
   4. Information intended only for healthcare professionals

Leaflet attached to the packaging: patient information

Taclar, 500 mg, powder for solution for infusion

Clarithromycin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 packaging 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 in the form of powder for solution for infusion is indicated for use in adults and children over 12 years of age for the treatment of infections caused by microorganisms susceptible to clarithromycin, when intravenous administration of an antibiotic is necessary. These infections include:

• upper respiratory tract infections
• lower respiratory tract infections
• skin and soft tissue infections
• disseminated or localized infections caused by mycobacteria

2. Important information before taking Taclar

When not to take Taclar

• If the patient is 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 the patient is taking any of the following medicines:
• medicines that may 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, among others, in migraine)
• lowastatin, simvastatin (statins used to lower blood cholesterol levels)
• midazolam given orally (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 the patient is taking medicines called ticagrelor, ivabradine, or ranolazine (for the treatment of angina or to reduce the risk of heart attack or stroke).
• If the patient has too low levels of potassium or magnesium in the blood (hypokalemia or hypomagnesemia).
• If the patient or their family members have a history of heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or electrocardiogram (ECG) abnormalities called "long QT interval syndrome".
• If the patient has severe liver failure with concurrent kidney failure.

Warnings and precautions

If the patient has any of the following conditions, they should discuss it with their doctor before starting Taclar.

• The patient is pregnant or thinks they may be pregnant.
• The patient has kidney or liver function disorders.
• The patient has coronary artery disease, severe heart failure, or slow heart rate.
• The patient is taking any of the medicines listed in the "Taclar and other medicines" section.

If any of the following situations occur while taking Taclar, the patient should tell their doctor.

• Severe allergic reactions, such as rash, hives, bruising, throat swelling, bronchospasm. The patient should immediatelyconsult a doctor, who will provide appropriate treatment.
• Diarrhea, especially severe or prolonged. The patient should tell their doctor as soon as possible. If necessary, the doctor will prescribe appropriate treatment. The patient should not take anti-diarrheal medicines.
• Symptoms of liver function disorders, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. The patient should stop treatment and consult a doctor.
• New infections (superinfections) with bacteria resistant to clarithromycin or fungi, especially during prolonged use of antibiotics. The doctor will prescribe appropriate treatment.

In addition, while taking Taclar, the following may occur:

• Cross-resistance of bacteria (bacteria resistant to clarithromycin may also be resistant to other macrolide antibiotics and lincosamides and clindamycin)

Taclar and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The patient must inform their doctor if they 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, among others, in migraine)
• statins - lowastatin, simvastatin (medicines used to lower blood cholesterol levels)
• midazolam given orally (a medicine used in anxiety and insomnia)
• colchicine (a medicine used in gout)

The patient should inform their doctor if they are taking any of the following medicines, as special caution is required when using them with Taclar:

• rifampicin, rifapentine, rifabutin (antibiotics used in tuberculosis treatment)
• fluconazole, itraconazole (antifungal medicines)
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used in HIV treatment)
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used in heart rhythm disorders or hypertension)
• alprazolam, triazolam, midazolam given intravenously or orally, (medicines used in anxiety or insomnia)
• warfarin or other anticoagulant medicines, such as 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 blood cholesterol levels)
• methylprednisolone (an anti-inflammatory medicine)
• omeprazole (a medicine used to reduce stomach acid production)
• cilostazol (a medicine used in intermittent claudication, which is characterized by leg pain during exercise that disappears after a short rest)
• cyclosporine, tacrolimus, sirolimus (medicines used, among others, 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)
• sulfonylureas, nateglinide, repaglinide, insulin (medicines used in diabetes)

This is also important for the following medicines:

• hydroxychloroquine or chloroquine (used in the treatment of, among others, 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Since clarithromycin passes into breast milk, breastfeeding women should exercise special caution when taking Taclar.

Driving and using machines

The medicine may cause dizziness, confusion, and disorientation, which may affect the ability to drive vehicles and operate machinery.

3. How to take Taclar

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.
The medicine is given intravenously.
Adults
The recommended daily dose of clarithromycin for infusion is 1 gram, in two divided doses of 500 mg each.
The powder in the vial is dissolved and then diluted in an appropriate solvent (the method of preparing the infusion solution is described in the part of the leaflet intended for medical staff). The dose is administered intravenously in an infusion lasting at least 60 minutes.
The medicine should not be given in a single, rapid injection (bolus), or intramuscularly.
Depending on the severity of the infection, the administration of clarithromycin in intravenous infusion is limited to 2-5 days, and oral administration of the medicine should be started as soon as possible.
Children and adolescents
There is a lack of adequately documented data on the use and dosage of Taclar in the form of infusion in patients under 12 years of age.
In adolescents over 12 years of age, the dosage is the same as for adults.
Patients with renal impairment
Depending on the degree of renal impairment, the doctor may recommend reducing the dose of the medicine by half, i.e., to 500 mg per day.
Patients with impaired immunity infected with mycobacteria
There is currently a lack of clinical data on the use of Taclar in the form of infusion in patients with impaired immunity, but there are data on the use of oral forms of clarithromycin in patients infected with HIV. In the treatment of disseminated or localized infections caused by mycobacteria, the recommended daily dose for adults is 500 mg of clarithromycin twice a day.

Using more than the recommended dose or missing a dose of Taclar

The medicine is administered to the patient by medical staff. If the patient suspects that a higher dose than recommended has been used or a dose has been missed, they should tell their doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects at any stage of taking the medicine, they should stop takingTaclar and consult their doctor immediately:

• severe or prolonged diarrhea, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even two months after the end of clarithromycin treatment. In this case, the patient should also consult their 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 characterized by, among others, circulatory and respiratory disorders), angioedema
• severe skin reactions:
• painful skin peeling, oral, lip, eye, 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])
• a rare skin allergic reaction causing severe disease characterized by oral, lip, and skin ulcers, rash, fever, and inflammation of internal organs (DRESS syndrome)
• jaundice (yellowing of the skin), skin irritation, light-colored stools, dark urine, abdominal tenderness, or loss of appetite. These may be symptoms of liver inflammation or liver failure
• muscle pain or muscle weakness called rhabdomyolysis (a syndrome of disease symptoms caused by muscle tissue breakdown, which can lead to kidney damage).

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

• injection site pain, injection site inflammation
• insomnia
• taste disorders, headache, changes in taste perception
• vasodilation
• diarrhea, vomiting, nausea, abdominal pain
• abnormal liver function test results
• rash, excessive sweating

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

• connective tissue disorders, 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 limbs or the whole body), dizziness, drowsiness, tremors
• balance disorders, hearing impairment, tinnitus
• cardiac arrest, atrial fibrillation, ventricular extrasystoles, palpitations, changes in ECG (QT interval prolongation)
• asthma, pulmonary embolism, nosebleeds
• esophagitis, gastritis, oral inflammation, tongue discoloration, abdominal distension, constipation, dry mouth, belching, flatulence
• increased liver enzyme activity
• bullous skin rash, 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 determined from available data), after the introduction of various forms of 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 disorders, ventricular tachycardia, ventricular fibrillation
• bleeding and changes in blood coagulation parameters (especially if the patient is taking oral anticoagulant medicines at the same time)
• acute pancreatitis, tongue discoloration, tooth discoloration
• liver failure, hepatocellular jaundice
• muscle diseases (myopathies) characterized by muscle weakness, in some cases - difficulty in relaxing muscles, muscle atrophy
• kidney failure, interstitial nephritis
• changes in diagnostic test results (increased INR, prolonged prothrombin time, abnormal urine color)

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

• nausea, vomiting, changes in taste perception, constipation, abdominal pain, diarrhea, flatulence with gas, dry mouth
• headache, hearing disorders
• rash
• shortness of breath, insomnia
• abnormal laboratory test results: increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity, increased urea levels in the blood, and decreased platelet and white blood cell count.

Reporting side effects
If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 can help gather more information on the safety of the medicine.

5. How to store Taclar

The medicine should be stored out of sight and reach of children.
Store at a temperature not exceeding 25°C. Protect from light.
Do not use the medicine after the expiration date (EXP) stated on the packaging. The expiration date refers to the last day of the specified 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 packaging and other information

The active substance of the medicine is clarithromycin in the form of clarithromycin lactobionate.
One vial contains 500 mg of clarithromycin.
The medicine does not contain other ingredients.

What Taclar looks like and what the packaging contains

White or almost white lyophilizate in the form of a disk or its fragments of different sizes, after dissolution in water for injection, a colorless, clear solution is formed.
Packaging:1 vial or 10 vials in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Phone number: 22-811-18-14
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder.

Date of the last update of the leaflet:

Information intended only for healthcare professionals

• Method of administration

Clarithromycin in the form of a solution with a concentration of 2 mg/ml should be administered in an intravenous infusion lasting at least 60 minutes.
The medicine should not be given in a single, rapid injection (bolus), or intramuscularly.

• Instructions for preparing solutions

Basic solution for preparing the infusion solution
10 ml of water for injection should be injected into a vial containing 500 mg of clarithromycin. Shake until the contents of the vial are dissolved.
1 ml of the prepared basic solution contains 50 mg of clarithromycin.
The solution should be stored at a temperature between 2°C and 8°C and used within 24 hours.
Intravenous infusion solution
The basic solution (500 mg in 10 ml of water for injection) should be diluted to 250 ml of 5% glucose solution or 0.9% sodium chloride solution.
1 ml of the resulting intravenous infusion solution contains 2 mg of clarithromycin.
The solution should be stored at a temperature between 2°C and 8°C and used within 24 hours.
Solutions for intravenous infusion prepared in 5% glucose solution or 0.9% sodium chloride solution remain stable for 6 hours at 25°C.
Any unused product or waste should be disposed of in accordance with local regulations.

• Incompatibilities

None have been found.
Taclar, powder for solution for infusion, should be dissolved and then diluted only in solvents recommended by the manufacturer.
There is currently a lack of clinically documented studies on the compatibility of Taclar with other infusion solutions.
No other medicines or chemical substances should be added to the clarithromycin solution unless their effect on the physicochemical properties of the infusion solution has been previously tested.