CLARITHROMYCIN 500 mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Clarithromycin Adamed, 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 Clarithromycin Adamed and what is it used for
4. Important information before taking Clarithromycin Adamed
   1. When not to take Clarithromycin Adamed
   2. Warnings and precautions
   3. Clarithromycin Adamed and other medicines
   4. The patient must inform their doctor if they are taking any of the following medicines, as their use with Clarithromycin Adamed is contraindicated:
   5. The patient should inform their doctor if they are taking any of the following medicines, as caution is required when using them with Clarithromycin Adamed:
   6. Clarithromycin Adamed:
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Clarithromycin Adamed contains sodium
5. How to take Clarithromycin Adamed
   1. Using a higher dose of Clarithromycin Adamed than recommended
   2. Missing a dose of Clarithromycin Adamed
6. Possible side effects
   1. If the patient experiences any of the following side effects at any stage of taking the medicine, they should stop taking Clarithromycin Adamed and consult their doctor immediately:
   2. Other side effects
   3. Reporting side effects
7. How to store Clarithromycin Adamed
8. Contents of the pack and other information
   1. What Clarithromycin Adamed contains
   2. What Clarithromycin Adamed looks like and what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: 06.2024
   6. Information intended for healthcare professionals only
   7. The dose of the medicine should be administered intravenously in an infusion lasting at least 60 minutes (in the form of a solution with a concentration of 2 mg/ml). The medicine should not be administered in a single, rapid injection (bolus), or intramuscularly.
   8. PREPARATION OF THE INFUSION SOLUTION

Leaflet attached to the packaging: patient information

Clarithromycin Adamed, 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, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Clarithromycin Adamed and what is it used for

Clarithromycin Adamed contains the active substance clarithromycin. It is a macrolide antibiotic that inhibits the growth of bacteria that cause infections.
Clarithromycin Adamed in the form of powder for solution for infusion is indicated for use in adults and adolescents 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,
• widespread or localized infections caused by mycobacteria.

2. Important information before taking Clarithromycin Adamed

When not to take Clarithromycin Adamed

• 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 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);
• tikagrelor, ivabradine or ranolazine (used in the treatment of angina or to reduce the risk of heart attack or stroke);
• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, in migraine);
• lovastatin, simvastatin (statins used to lower blood cholesterol levels);

cholesterol-lowering medicines);

• midazolam given orally (a medicine used in anxiety and insomnia);
• colchicine (a medicine used in the treatment of gout).
• a medicine containing lomitapide.
• if the patient has too low a level of potassium or magnesium in the blood (hypokalemia or hypomagnesemia).
• if the patient or their family has a history of heart rhythm disorders (ventricular arrhythmias, including torsades de pointes) or abnormalities in the electrocardiogram (ECG, a record of the heart's electrical activity) called "long QT syndrome".
• if the patient has severe liver failure with concomitant kidney failure.

Warnings and precautions

Before starting treatment with Clarithromycin Adamed, the patient should discuss it with their doctor.

• if the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child.
• if the patient has kidney or liver problems;
• if the patient has coronary artery disease, severe heart failure, or slow heart rate;
• if the patient is taking any of the medicines listed in the section "Clarithromycin Adamed and other medicines".

If any of the following situations occur during treatment with Clarithromycin Adamed, the patient should tell their doctor.

• Severe hypersensitivity reactions, such as rash, hives, itching, swelling of the face, lips, eyes, and throat, difficulty breathing. The patient should immediatelyconsult a doctor, who will provide appropriate treatment.
• Diarrhea, especially acute 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 dysfunction, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. The patient should stop treatment and consult a doctor.
• New infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially during prolonged use of antibiotics. The doctor will prescribe appropriate treatment.

In addition, during treatment with Clarithromycin Adamed, the following may occur:

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

Clarithromycin Adamed 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 Clarithromycin Adamed 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 - lovastatin, simvastatin (medicines that lower blood cholesterol levels);
• midazolam given orally (a medicine used in anxiety or insomnia);
• colchicine (a medicine used in the treatment of gout);
• tikagrelor (a medicine that inhibits platelet aggregation);
• ranolazine (a cardiac medicine).

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

Clarithromycin Adamed:

• 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 any other anticoagulant, 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 that lower blood 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 and relieved by rest);
• cyclosporin, 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);
• sulfonylurea, nateglinide, repaglinide, insulin (medicines used in diabetes).

This is also important in the case of medicines with the following names:

• hydroxychloroquine or chloroquine (used in the treatment of, among others, rheumatoid arthritis, or to prevent or treat 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 before taking this medicine.
The safety of clarithromycin during pregnancy and breastfeeding has not been established.
Clarithromycin 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 caution when taking Clarithromycin Adamed.

Driving and using machines

The medicine may cause dizziness, confusion, and disorientation, which may affect the ability to drive and use machines. If these symptoms occur, the patient should not drive or operate any machinery that requires concentration.

Clarithromycin Adamed contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free".

3. How to take Clarithromycin Adamed

This medicine is administered to the patient only by medical personnel.
The medicine is for intravenous use.
Adults
The recommended daily dose of clarithromycin for infusion is 1 gram, given 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 given at the end of the leaflet in the section for medical personnel). The dose of the medicine is administered intravenously in an infusion lasting at least 60 minutes.
The medicine should not be administered 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. As soon as possible, oral administration of the medicine should be started, according to the doctor's instructions..
Children and adolescents
There is a lack of sufficiently documented data on the use and dosage of Clarithromycin Adamed in the form of infusion in children under 12 years of age.
In adolescents between 12 and 18 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
So far, there are no clinical data on the use of Clarithromycin Adamed 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 widespread or localized infections caused by mycobacteria, the recommended daily dose in adults is 500 mg of clarithromycin twice a day.

Using a higher dose of Clarithromycin Adamed than recommended

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

Missing a dose of Clarithromycin Adamed

The medicine is administered to the patient by medical personnel. If the patient suspects that a dose has been missed, they should inform their doctor or nurse.
If the patient has any further questions about the use of this medicine, they should consult 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 taking Clarithromycin Adamed and consult their doctor immediately:

• anaphylactic shock or pseudo-anaphylactic reaction - a severe, life-threatening allergic reaction, characterized by, among other things, confusion, pallor, low blood pressure, sweating, oliguria, tachypnea, weakness, and fainting
• allergic reactions: rash (frequent), itching, hives (uncommon), angioedema of the face, lips, eyes, and throat, difficulty breathing
• severe skin reactions:
• acute generalized exanthematous pustulosis - a red, scaly rash with bumps under the skin and blisters, bullous dermatitis (uncommon)
• Stevens-Johnson syndrome - a severe disease characterized by a sudden onset of fever and blisters, which resolve quickly and spontaneously after discontinuation of the medicine; a severe disease characterized by blisters and ulcers on the skin, in the mouth, eyes, and genitals, fever, and joint pain
• toxic epidermal necrolysis - a severe, rapidly progressing disease characterized by bursting of large subcutaneous blisters, extensive skin ulcers, and peeling of large skin flakes, as well as fever
• DRESS syndrome - a severe (life-threatening) drug rash that occurs with an increased number of eosinophils and involvement of internal organs
• severe or prolonged diarrhea, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even two months after the end of treatment with clarithromycin. In this case, the patient should also consult a doctor
• jaundice, skin irritation, pale stools, dark urine, abdominal tenderness or loss of appetite. These may be symptoms of liver inflammation or liver failure
• cardiac arrest, atrial fibrillation, ventricular extrasystoles, palpitations, changes in the ECG (prolonged QT interval) (uncommon)
• loss of consciousness (uncommon)
• pulmonary embolism (uncommon; characterized by shortness of breath, chest pain, cough, cyanosis)

Other side effects

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 infusion or orally, the following side effects have been commonlyreported (less than 1 in 10 patients):

• injection site pain, injection site inflammation, phlebitis at the injection site;
• insomnia;
• taste disturbances, headache, changes in taste perception;
• vasodilation;
• diarrhea, vomiting, nausea, abdominal pain;
• abnormal liver function test results;
• excessive sweating.

Side effects reported uncommonly(less than 1 in 100 patients):

• connective tissue disorders, candidiasis (fungal infection), vaginal infection;
• decreased white blood cell count;
• anorexia, decreased appetite;
• restlessness;
• dyskinesia (involuntary, uncoordinated movements of the limbs or the whole body), dizziness, drowsiness, tremors;
• balance disorders, hearing loss, tinnitus;
• asthma;
• esophagitis, gastritis, stomatitis, glossitis, constipation, dry mouth, belching, flatulence;
• increased liver enzyme activity: alanine aminotransferase, increased aspartate aminotransferase activity;
• musculoskeletal stiffness;
• increased creatinine and urea levels in the blood, abnormal albumin/globulin ratio;
• asthenia (weakness, lack of strength).

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

• 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, such as torsades de pointes, ventricular tachycardia, atrial fibrillation;
• bleeding;
• acute pancreatitis, tooth discoloration, tongue discoloration;
• myopathy (muscle disease with muscle weakness)
• rhabdomyolysis (a condition characterized by muscle tissue breakdown) kidney failure, interstitial nephritis;
• changes in laboratory test results (increased INR, prolonged prothrombin time, abnormal urine color).

Patients with impaired immunity
In addition to symptoms related to 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, dry mouth;
• headache, hearing disturbances;
• rash;
• shortness of breath, insomnia;
• abnormal laboratory test results: increased aspartate aminotransferase and alanine aminotransferase activity, increased urea levels in the blood, and decreased platelet and white blood cell count.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych,
Al. Jerozolimskie 181C, 02-222 Warszawa,
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 Clarithromycin Adamed

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the term "EXP". The expiry date refers to the last day of the month stated.
Store at a temperature below 30°C.
The infusion solution should not be stored for more than 24 hours at a temperature of 2°C to 8°C, unless it has been prepared and diluted under controlled and validated aseptic conditions.
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 Clarithromycin Adamed contains

• The active substance of the medicine is clarithromycin. One vial contains 500 mg of clarithromycin in the form of clarithromycin lactobionate.
• The other ingredients are: lactobionic acid and sodium hydroxide (to adjust the pH).

What Clarithromycin Adamed looks like and what the pack contains

Clarithromycin Adamed is a powder for solution for infusion, white or almost white in color. After dissolution in water for injection, a clear, colorless solution is formed.
The packaging is a 15 ml vial made of type I colorless glass, sealed with a bromobutyl rubber stopper with an aluminum seal and a plastic flip-off cap, in a cardboard box.
Pack size: 1 vial in a cardboard box.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
ANFARM HELLAS S.A
53-57 Perikleous str., Gerakas
15344, Attiki,
Greece
To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
phone: +48 22 732 77 00

Date of last revision of the leaflet: 06.2024

Information intended for healthcare professionals only

Clarithromycin Adamed, 500 mg, powder for solution for infusion
Clarithromycin
The powder in the vial should be dissolved and then diluted in an appropriate solvent (see below: Method of preparing the infusion solution).

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

PREPARATION OF THE INFUSION SOLUTION

• A.Preparation of the basic solution for infusion

10 ml of water for injection should be injected into the vial with the medicine. Shake until the contents of the vial are dissolved. Onlywater for injection should be used for dissolution. Other solvents may cause precipitation. Do not use salt solutions or solutions containing preservatives.
1 ml of the basic solution, prepared as described above, contains 50 mg of clarithromycin.
The basic solution shows chemical and physical stability for 24 hours at a temperature below 25°C or for 48 hours at a temperature of 2°C to 8°C. From a microbiological point of view, the product should be used immediately after preparation. Otherwise, the user is responsible for the storage conditions and time. The solution should not be stored for more than 24 hours at a temperature of 2°C to 8°C, unless it has been prepared and diluted under controlled and validated aseptic conditions.

• B.Preparation of the infusion solution

The basic solution (500 mg in 10 ml of water for injection) should be diluted to 250 ml using one of the following solutions:

• 5% glucose solution in Ringer's solution with lactate,
• 5% glucose solution, Ringer's solution with lactate,
• 5% glucose solution in 0.3% sodium chloride solution,
• 5% glucose solution in 0.45% sodium chloride solution,
• 0.9% sodium chloride solution.

1 ml of the resulting infusion solution contains 2 mg of clarithromycin.
The infusion solution shows chemical and physical stability for 6 hours at a temperature below 25°C or for 48 hours at a temperature of 2°C to 8°C.
From a microbiological point of view, the infusion solution should be used immediately after preparation. Otherwise, the user is responsible for the storage conditions and time. The solution should not be stored for more than 24 hours at a temperature of 2°C to 8°C, unless it has been prepared and diluted under controlled and validated aseptic conditions.
Note.There are no clinical data on the compatibility of clarithromycin with other intravenous solutions.
Any unused product or waste material should be disposed of in accordance with local regulations.