CLARITHROMYCIN 500 mg Powder

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Clarithromycin Hameln, 500 mg, Powder for Concentrate for Solution for Infusion
   1. Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
3. What is Clarithromycin Hameln and what is it used for
4. Important information before using Clarithromycin Hameln
   1. When not to use Clarithromycin Hameln, if
   2. Warnings and precautions
   3. Children
   4. Clarithromycin Hameln and other medications
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Clarithromycin Hameln contains sodium
5. How to use Clarithromycin Hameln
   1. Use in children
   2. Patients with kidney function disorders
   3. Using a higher dose of Clarithromycin Hameln than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store Clarithromycin Hameln
8. Contents of the package and other information
   1. What Clarithromycin Hameln contains
   2. What Clarithromycin Hameln looks like and what the package contains
   3. Marketing authorization holder
   4. This medication is authorized in European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:
   5. Date of last revision of the package leaflet:
   6. Information intended for healthcare professionals only:
   7. Clarithromycin Hameln, 500 mg, Powder for Concentrate for Solution for Infusion
   8. Refer to the Summary of Product Characteristics for full information on the product.
   9. Instructions for reconstitution and dilution of Clarithromycin Hameln
   10. Recommended solvents for Stage 2:
   11. Method of administration
   12. Do not use if:
   13. Shelf life of the medicinal product after reconstitution and dilution:

Package Leaflet: Information for the Patient

Clarithromycin Hameln, 500 mg, Powder for Concentrate for Solution for Infusion

Clarithromycin

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any not listed in this package leaflet, inform the doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Clarithromycin Hameln and what is it used for
• 2. Important information before using Clarithromycin Hameln
• 3. How to use Clarithromycin Hameln
• 4. Possible side effects
• 5. How to store Clarithromycin Hameln
• 6. Contents of the package and other information

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

Clarithromycin Hameln contains the active substance clarithromycin. Clarithromycin Hameln belongs to a group of medicines called macrolide antibiotics. Antibiotics inhibit the growth of bacteria that cause infections.
Clarithromycin Hameln, as an intravenous antibiotic (injection into a vein), is used to treat severe infections or, alternatively, when the patient cannot swallow tablets.
This medicine is used to treat infections caused by bacteria, such as:

• 1. Recurrence of chronic bronchitis and lung infections (pneumonia)
• 2. Severe sinus infection (sinusitis), throat infection (pharyngitis), and tonsillitis
• 3. Skin and tissue infections Clarithromycin Hameln is used in adults and children over 12 years of age.

2. Important information before using Clarithromycin Hameln

When not to use Clarithromycin Hameln, 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).
• the patient is taking ergot alkaloids (such as ergotamine or dihydroergotamine) or uses an ergotamine inhaler to treat migraines.
• the patient is taking certain medications such as terfenadine or astemizole (commonly used for hay fever or allergies), cisapride or domperidone (for stomach disorders), pimozide (used for mental disorders), as combining these medications may cause serious heart rhythm disturbances. Consult a doctor to determine alternative therapies.
• the patient is taking other medications known to cause serious heart rhythm disturbances.
• the patient is taking lovastatin or simvastatin [HMG-CoA reductase inhibitors, commonly known as statins, used to lower cholesterol levels (a type of fat) in the blood].
• the patient is taking oral midazolam (a sedative).
• the patient has low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia).
• the patient has severe liver failure with concurrent kidney failure.
• the patient or their family has a history of heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or electrocardiogram (ECG, recording of the heart's electrical activity) abnormalities known as "prolonged QT interval".
• the patient is taking ticagrelor, ivabradine, or ranolazine (used to treat heart attack, chest pain, or angina).
• the patient is using colchicine (a medication used to treat gout).
• the patient is taking a medicine containing lomitapide.

Warnings and precautions

Before starting Clarithromycin Hameln, discuss with your doctor or pharmacist if:

• the patient has heart problems (heart disease, heart failure, slow heart rate).
• the patient has kidney or liver function disorders.
• the patient has or is prone to fungal infections (e.g., thrush).
• the patient is pregnant or breastfeeding.
• the patient is taking midazolam intravenously or orally.
• the patient is taking medications that can harm the ears and hearing, such as certain types of antibiotics known as aminoglycosides

Inform your doctor immediately if you experience severe or prolonged diarrhea during or after treatment with clarithromycin, as this may be a sign of a more serious condition, such as pseudomembranous colitis or Clostridium difficile-associated diarrhea.
If you experience any symptoms of liver function disorders, such as loss of appetite (loss of appetite), yellowing of the skin or whites of the eyes, dark urine, itching, or abdominal tenderness, inform your doctor immediately.
Long-term use of clarithromycin may lead to infection with resistant bacteria and fungi.

Children

Clarithromycin Hameln should not be used in children under 12 years of age.

Clarithromycin Hameln and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. It may be necessary to adjust the dosage or perform additional tests.
Clarithromycin should not be administered with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain cholesterol-lowering medications, or medications known to cause serious heart rhythm disturbances.
In particular, inform your doctor if you are taking any of the following medications:

• digoxin, quinidine, disopyramide (used for heart disorders)
• ibrutinib (used to treat cancer)
• warfarin or any other anticoagulant, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (medications used to thin the blood)
• omeprazole (used to treat heartburn and stomach ulcers), unless prescribed by a doctor to treat Helicobacter pylori infection associated with duodenal ulcer disease
• carbamazepine, valproate, phenobarbital, or phenytoin (antiepileptic medications)
• atorvastatin or rosuvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to lower cholesterol levels in the blood). Statins may cause rhabdomyolysis (a condition that causes muscle tissue to break down, which can lead to kidney damage), so monitor for symptoms of myopathy (muscle pain or weakness).
• nateglinide, pioglitazone, repaglinide, rosiglitazone, or insulin (used to lower blood glucose levels)
• gliclazide or glimepiride (sulfonylurea derivatives used to treat type 2 diabetes)
• theophylline (used in patients with breathing difficulties, such as asthma)
• triazolam, alprazolam, or intravenous midazolam (sedatives)
• cilostazol (for poor circulation)
• methylprednisolone (a corticosteroid)
• vinblastine (used to treat cancer)
• cyclosporin, sirolimus, and tacrolimus (immunosuppressive medications)
• etravirine, efavirenz, nevirapine, ritonavir, nelfinavir, zidovudine, atazanavir, saquinavir (antiviral medications used to treat HIV infection)
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole, ketokonazol (medications used to treat certain bacterial or fungal infections)
• tolterodine (for overactive bladder)
• verapamil, amlodipine, diltiazem, nifedipine (medications used to treat high blood pressure)
• sildenafil, vardenafil, and tadalafil [medications used to treat erectile dysfunction or pulmonary arterial hypertension (high blood pressure in the blood vessels of the lungs)]
• St. John's Wort (a herbal medicine used to treat depression - Hypericum perforatum L.)
• fluoxetine (an antidepressant)
• quetiapine or other antipsychotic medications
• other macrolide antibiotics
• lincomycin and clindamycin (lincosamides - a type of antibiotic)
• hydroxychloroquine or chloroquine (used to treat, among other things, rheumatoid arthritis, or to prevent or treat malaria). Taking these medications 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 body's immune system, which is useful in treating many different diseases)

Inform your doctor about taking oral contraceptives and experiencing diarrhea or vomiting, as additional contraceptive measures may be necessary, such as a condom.

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 using this medication, as the safety of clarithromycin during pregnancy or breastfeeding is not known.

Driving and using machines

Clarithromycin Hameln may cause dizziness or drowsiness. If these symptoms occur, do not drive, operate machinery, or perform any work that requires attention.

Clarithromycin Hameln contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per vial, which means the medication is considered "sodium-free".

3. How to use Clarithromycin Hameln

Clarithromycin Hameln is prepared by a doctor or nurse - the powder in the vial is dissolved in water for injection. Then, it is diluted to the appropriate volume in an appropriate solvent. Clarithromycin Hameln is administered slowly through a needle into a vein over at least one hour.
The recommended dose of Clarithromycin Hameln for adults and children over 12 years of age is 1.0 g per day, in two divided doses, for 2 to 5 days. The total treatment duration with clarithromycin should not exceed 14 days. The doctor will prescribe the appropriate dosage.

Use in children

Clarithromycin Hameln should not be used in children under 12 years of age. Consult a doctor to prescribe another suitable medication.
If a child accidentally swallows part of this medication, consult a doctor immediately.

Patients with kidney function disorders

The dose of clarithromycin should be reduced to half of the recommended dose.

Using a higher dose of Clarithromycin Hameln than recommended

Since Clarithromycin Hameln is administered by a doctor, overdose is unlikely, but symptoms may include vomiting and abdominal pain.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.
If you experience any of the following symptoms at any time during treatment, inform your doctor immediately, as it may be necessary to stop treatment:

• severe or prolonged diarrhea, which may contain blood or mucus. Diarrhea may occur even two months after treatment with clarithromycin, in which case you should also consult a doctor.
• rash, difficulty breathing, fainting, or swelling of the face, lips, eyes, and throat. This is a sign of an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, itching, or abdominal tenderness. These may be symptoms of liver inflammation or liver failure
• severe skin reactions, such as blisters on the skin, in the mouth, lips, eyes, and genitals [symptoms of a rare allergic reaction called Stevens-Johnson syndrome and (or) toxic epidermal necrolysis (Lyell's syndrome)].
• red, scaly rash with bumps under the skin and blisters (symptoms of acute generalized exanthematous pustulosis). The frequency of this side effect is unknown (cannot be estimated from available data).
• rare allergic skin reaction causing severe illness with mouth, lip, and skin ulcers, which causes severe illness with rash, fever, and inflammation of internal organs (DRESS, Drug Rash with Eosinophilia and Systemic Symptoms).
• muscle pain or weakness called rhabdomyolysis (a condition that causes muscle tissue to break down, which can lead to kidney damage).

Common side effects(occurring in no more than 1 in 10 patients) include:

• inflammation, tenderness, or pain at the injection site
• sleep disorders
• change in taste
• change in sense of smell
• headache
• vasodilation
• stomach problems, such as nausea, vomiting, abdominal pain, indigestion, diarrhea
• abnormal liver function test results
• excessive sweating
• oral thrush
• increased blood urea levels

Uncommon side effects(occurring in no more than 1 in 100 patients) include:

• high temperature
• rash, swelling, redness, or itching of the skin
• vaginal thrush (fungal infection)
• gastritis
• decreased platelet count (platelets help stop bleeding)
• decreased white blood cell count (leukopenia)
• decreased neutrophil count (neutropenia)
• allergic reactions
• joint stiffness or pain
• chills
• increased eosinophil count (a type of white blood cell related to immunity)
• exaggerated immune response
• loss of appetite or decreased appetite
• anxiety, nervousness
• drowsiness, fatigue, dizziness of peripheral origin, or tremors
• involuntary muscle movements
• vertigo of peripheral origin
• tinnitus, hearing loss
• chest pain or changes in heart rhythm, such as palpitations or irregular heartbeat
• asthma: a lung disease characterized by constriction of the airways, making breathing difficult
• nosebleeds
• blood clots that cause sudden blockage of a pulmonary artery (pulmonary embolism)
• inflammation of the esophageal mucosa (esophagitis) and stomach lining
• anal pain
• bloating, constipation, gas, belching
• dry mouth
• cholestasis, when bile (a fluid produced by the liver and stored in the gallbladder) cannot flow from the gallbladder to the duodenum
• skin inflammation characterized by the presence of blisters filled with fluid, itching, and painful rash
• muscle spasms, muscle pain, or muscle loss. If you have myasthenia (a condition where muscles become weak and easily tired), clarithromycin may worsen these symptoms.
• abnormal kidney and liver function test results and elevated blood test results

Rare side effects(occurring in no more than 1 in 1,000 patients) include:

• reversible hearing loss

Very rare side effects(occurring in no more than 1 in 10,000 patients) include:

• confusional state
• kidney failure

Side effects with unknown frequency(frequency cannot be estimated from available data):

• colitis
• bacterial infection of the outer skin layers
• skin swelling around the face and throat, which can cause breathing difficulties (angioedema)
• decreased count of certain blood cells (which can increase the risk of infections or increase the risk of bruising or bleeding)
• confusion, disorientation, hallucinations (seeing things), change in sense of reality, or panic, depression, unusual dreams or nightmares, and mania (feeling of elation or excessive excitement)
• seizures (seizure attacks)
• paresthesia, also known as "tingling"
• deafness
• loss of taste or smell or inability to smell properly
• a type of heart rhythm disorder (torsades de pointes, ventricular tachycardia, atrial fibrillation)
• blood loss (bleeding)
• pancreatitis
• discoloration of the tongue or teeth
• liver failure, jaundice (yellowing of the skin) associated with liver failure
• feeling of weakness, fatigue, and lack of energy
• increased creatinine levels in the blood

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, inform your doctor, pharmacist, or nurse. 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 will help gather more information on the safety of this medication.

5. How to store Clarithromycin Hameln

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the label or carton after EXP. The expiration date refers to the last day of the specified month.
This medicinal product does not require special storage conditions.
Medications should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the package and other information

What Clarithromycin Hameln contains

• The active substance is clarithromycin. Each vial contains 500 mg of clarithromycin in the form of clarithromycin lactobionate.
• The other ingredient (excipient) is: sodium hydroxide (to adjust pH).

What Clarithromycin Hameln looks like and what the package contains

Clarithromycin Hameln is a white or off-white granular powder or powder in a 15 ml glass vial, sealed with a rubber stopper and an aluminum cap and a plastic flip-off cap.
Clarithromycin Hameln is available in packs of:
1, 5, or 10 vials of 500 mg of clarithromycin .
Not all pack sizes may be marketed.

Marketing authorization holder

hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany
Phone: +49 171 766 2789
Manufacturer:
ANFARM HELLAS S.A.
61st km National Road Athens-Lamia
320 09 Schimatari
Greece
hameln rds s.r.o
Horná 36
900 01 Modra
Slovakia

This medication is authorized in European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the package leaflet:

• 28.08.2024

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Information intended for healthcare professionals only:

Clarithromycin Hameln, 500 mg, Powder for Concentrate for Solution for Infusion

Refer to the Summary of Product Characteristics for full information on the product.

For single use only.
Aseptic techniques should be used when preparing solutions.

Instructions for reconstitution and dilution of Clarithromycin Hameln

Stage 1 - Reconstitution
Add 10 ml of sterile Water for Injections and shake to dissolve the contents of the vial.
The resulting solution has a concentration of 50 mg/ml. The reconstitution time should not exceed 7 minutes,
and the resulting solution is clear to slightly opalescent, colorless to slightly yellow.
Only water should be used for injection, as other solutions may cause precipitation during dissolution. Do not use solutions containing preservatives or inorganic salts. Use within 24 hours of preparation if the solution is stored at 25°C or within 48 hours if stored at 2°C to 8°C.
Stage 2 - Dilution
Add the primary solution from Stage 1 to 250 ml of an appropriate infusion solvent before infusion (see below). This yields a final infusion solution with a concentration of 2 mg/ml. The resulting solution after dilution is clear to slightly opalescent, colorless to slightly yellow.
Use within 6 hours if the solution is stored at 25°C or within 48 hours if stored at 2°C to 8°C.
IMPORTANT: BOTH STAGES (1 AND 2) MUST BE COMPLETED BEFORE USE.

Recommended solvents for Stage 2:

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

Method of administration

Clarithromycin should not be administered as a bolus or intramuscular injection.
Clarithromycin Hameln should be administered into one of the larger proximal veins as an intravenous infusion over 60 minutes, using a solution with a concentration of approximately 2 mg/ml.

Do not use if:

The solution concentration is greater than 2 mg/ml (0.2%).
The infusion rate is less than 60 minutes (<60 minutes).
Failure to follow these precautions may cause pain along the vein.

Shelf life of the medicinal product after reconstitution and dilution:

The reconstituted primary solution shows chemical and physical stability for 24 hours at up to 25°C or 48 hours at 2°C to 8°C.
The final infusion solution shows chemical and physical stability for 6 hours at up to 25°C or 48 hours at 2°C to 8°C.
From a microbiological point of view, the infusion solution should be used immediately after preparation. Otherwise, the responsibility for the storage time and conditions lies with the user, and the solution should not be stored for more than 24 hours at 2°C to 8°C, unless it has been prepared and diluted under controlled and validated conditions.