Clarithromicin Genoptim

Leaflet accompanying the packaging: patient information

Clarithromycin Genoptim, 250 mg, film-coated tablets

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.
• In case of any doubts, consult a 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.
• 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 Clarithromycin Genoptim and what is it used for
• 2. Important information before taking Clarithromycin Genoptim
• 3. How to take Clarithromycin Genoptim
• 4. Possible side effects
• 5. How to store Clarithromycin Genoptim
• 6. Contents of the packaging and other information

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

Clarithromycin Genoptim contains the active substance – clarithromycin. It is a macrolide antibiotic that inhibits the growth of bacteria that cause infections.
Clarithromycin Genoptim is indicated for use in adults and children over 12 years of age for the treatment of infections caused by microorganisms susceptible to clarithromycin. 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 lymphocyte count ≤100/mm), Clarithromycin Genoptim is indicated for the prevention of disseminated infections caused by bacteria of the Mycobacterium avium complex (MAC).

In patients with duodenal ulcer and diagnosed Helicobacter pylori infection, it is recommended to use Clarithromycin Genoptim simultaneously with drugs that inhibit gastric acid secretion and another antibiotic.

2. Important information before taking Clarithromycin Genoptim

When not to take Clarithromycin Genoptim

• 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 ergot alkaloids, such as ergotamine or dihydroergotamine (used in migraine) or oral midazolam (used in anxiety and insomnia).
• If the patient is taking drugs that may cause severe heart rhythm disturbances.
• If the patient is taking astemizole or terfenadine (used in allergy), cisapride or domperidone (used in gastrointestinal disorders), pimozide (used in psychiatric disorders), as concomitant use with Clarithromycin Genoptim may cause severe heart rhythm disturbances.
• If the patient is taking ticagrelor or ranolazine (used in heart and circulation diseases)
• If the patient has low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia).
• If the patient is taking lovastatin, simvastatin (statins used to lower cholesterol levels in the blood).
• If the patient has severe liver failure with concomitant kidney failure.
• If the patient or their family members have a history of heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or electrocardiogram (ECG) abnormalities known as "prolonged QT interval".
• If the patient is taking colchicine (used in gout treatment).
• If the patient is taking a medicine containing lomitapide.

Warnings and precautions

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

• 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 bradycardia.
• The patient is taking any of the medicines listed in the "Clarithromycin Genoptim and other medicines" section.

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

• Severe allergic reactions, such as rash, urticaria, angioedema, bronchospasm. 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 function disorders, 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 long-term antibiotic use. The doctor will prescribe appropriate treatment.

In addition, while taking Clarithromycin Genoptim, the following may occur:

• 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 selection of resistant microorganisms).

If symptoms of hearing or balance organ damage occur (see section 4), it is recommended to perform relevant control tests after completing treatment.

Clarithromycin Genoptim 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 Genoptim is contraindicated:

• Ergot alkaloids, such as ergotamine or dihydroergotamine (used in migraine)
• Astemizole or terfenadine (used in allergy treatment)
• Cisapride or domperidone (used in gastrointestinal disorders)
• Pimozide (used in psychiatric disorders)
• Ticagrelor, ranolazine (used in heart and circulation diseases)
• Colchicine (used in gout treatment)
• Statins - lovastatin, simvastatin (used to lower cholesterol levels in the blood)
• Oral midazolam (used in anxiety and insomnia)

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

Clarithromycin Genoptim:

• 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 (used in anxiety and insomnia)
• Warfarin or other anticoagulant medicines, e.g. dabigatran, rivaroxaban, apixaban (used to thin the blood)
• Quetiapine or other atypical antipsychotic medicines
• Carbamazepine, valproate, phenytoin (antiepileptic medicines)
• Methylprednisolone (anti-inflammatory medicine)
• Omeprazole (medicine that reduces gastric acid secretion)
• Cilostazol (used in intermittent claudication, which is characterized by leg pain during exercise and relieved by rest)
• Cyclosporin, tacrolimus, sirolimus (used in organ transplantation)
• Sildenafil, tadalafil, vardenafil (used in erectile dysfunction)
• Vinblastine (used in cancer chemotherapy)
• Theophylline (used in asthma treatment)
• Tolterodine (used in urinary incontinence treatment)
• Phenobarbital (antiepileptic medicine)
• St. John's Wort (herbal medicine used in mild depression)
• Sulfonylurea, nateglinide, repaglinide, insulin (used in diabetes treatment)
• Ototoxic medicines (damaging hearing), especially aminoglycoside antibiotics used in bacterial infections.

The patient should also report any side effects, including those not listed in this leaflet, to their doctor or pharmacist.

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.
Clarithromycin Genoptim may be used during pregnancy only if the doctor believes 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 Clarithromycin Genoptim.

Driving and using machines

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

Clarithromycin Genoptim contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Clarithromycin Genoptim contains sodium

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

3. How to take Clarithromycin Genoptim

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is for oral use.
The tablet should be swallowed whole with water. Do not chew or suck the tablet.
Tablets can be taken with or without food.
If a single dose of 500 mg is required, it is recommended to use Clarithromycin Genoptim containing 500 mg of clarithromycin per tablet.
The dividing line is intended only to facilitate breaking the tablet for easier swallowing, in case of swallowing difficulties.
Respiratory tract infections, skin and soft tissue infections, acute otitis media
Adults
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 (i.e., 500 mg) twice a day (every 12 hours).
Treatment usually lasts from 5 to 14 days, except for pneumonia and sinusitis, where treatment lasts 6 to 14 days.
Children over 12 years old
Dosage is the same as for adults.
Children under 12 years old
It is recommended to use Clarithromycin Genoptim in the form of an oral suspension.
Patients with kidney failure
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 longer than 14 days.
Dental and oral infections
One 250 mg tablet twice a day (every 12 hours). Treatment usually lasts 5 days.
Mycobacterial infections
Recommended dose for adults: two 250 mg tablets (i.e., 500 mg) twice a day.
Treatment of disseminated Mycobacterium avium complex (MAC) infection in AIDS patients should be continued for as long as the doctor recommends.
Clarithromycin Genoptim 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: two 250 mg tablets (i.e., 500 mg) twice a day.
Helicobacter pylori infections
In patients with gastric or duodenal ulcer caused by Helicobacter pylori infection, clarithromycin can be administered 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 Helicobacter pylori eradication.

Taking a higher dose of Clarithromycin Genoptim than recommended

In case of taking a higher dose of Clarithromycin Genoptim than recommended, the patient should immediately consult their doctor or pharmacist.
Taking a higher dose of Clarithromycin Genoptim than recommended by the doctor may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missing a dose of Clarithromycin Genoptim

In case of missing a dose of Clarithromycin Genoptim, the patient should take it as soon as possible, and then take the next dose at the scheduled time.
The patient should not take a double dose to make up for the missed dose.

Stopping Clarithromycin Genoptim treatment

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.
The patient should not stop treatment, even if they feel better and the symptoms of the disease have disappeared after a few days of taking the medicine.

4. Possible side effects

Like all medicines, Clarithromycin Genoptim 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 Genoptim and consult their

doctor:

• Anaphylactic shock - a life-threatening allergic reaction, which may include confusion, pallor, low blood pressure, sweating, oliguria, tachypnea, weakness, and fainting
• Allergic reactions: rash (common), itching, urticaria (uncommon), angioedema of the face, tongue, lips, eyes, and throat, difficulty breathing
• Severe skin reactions:
• Acute generalized exanthematous pustulosis - a red, scaly rash with bumps under the skin and pustules, toxic epidermal necrolysis, Stevens-Johnson syndrome, characterized by sudden onset of fever and blisters, rapidly and spontaneously resolving after discontinuation of the medicine; severe disease characterized by blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain;
• Toxic epidermal necrolysis (Lyell's syndrome) - a severe, rapidly progressing disease characterized by large, bursting subepidermal blisters, extensive skin erosions, and fever;
• DRESS syndrome - a severe (life-threatening) drug rash, which may include an increased number of eosinophils and involvement of internal organs
• Severe or prolonged diarrhea, which may include blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even after two months after completing treatment with clarithromycin. In such cases, the patient should also consult their doctor
• Jaundice, skin irritation, pale stools, dark urine, itching, or abdominal pain. These may be symptoms of liver inflammation or liver failure. These reactions are rare, and their frequency is unknown.

Other side effects

In clinical trials and after marketing, the following side effects were frequentlyreported (occurring in 1 to 10 out of 100 patients):

• Insomnia
• Taste disorders, headache
• Diarrhea, vomiting, nausea, abdominal pain
• Abnormal liver function tests
• Excessive sweating

The following side effects were reported uncommonly(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
• Anorexia, decreased appetite
• Restlessness
• Dizziness, drowsiness, tremors
• Balance disorders, hearing loss, tinnitus
• Palpitations, changes in ECG (QT interval prolongation)
• Gastritis, stomatitis, glossitis, abdominal distension, constipation, dry mouth, eructation, flatulence
• Cholestasis (bile stasis), increased liver enzyme activity: alanine aminotransferase, increased aspartate aminotransferase activity, increased gamma-glutamyltransferase activity
• Fatigue, asthenia (weakness, lack of energy), chest pain, chills, fatigue
• Increased activity of enzymes: alkaline phosphatase and lactate dehydrogenase

The following side effects have been reported with an unknown frequency(frequency cannot be estimated from available data) after marketing of various forms of clarithromycin (tablets, oral suspension, powder for intravenous injection):

• Rash
• Agranulocytosis (decreased granulocyte count in the blood), thrombocytopenia (decreased platelet count)
• Acne
• Psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania
• Seizures, ageusia, parosmia, anosmia, paresthesia (numbness, tingling)
• Deafness
• Heart rhythm disorders, such as torsades de pointes, ventricular tachycardia, atrial fibrillation
• Bleeding and changes in blood coagulation parameters (especially if the patient is taking oral anticoagulant medicines at the same time)
• Acute pancreatitis, tooth discoloration, tongue discoloration
• Muscle diseases (myopathies) characterized by muscle weakness, in some cases - difficulty in 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 symptoms related to the course of the 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 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 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 the medicine.

5. How to store Clarithromycin Genoptim

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 "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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

What Clarithromycin Genoptim contains

• The active substance of the medicine is clarithromycin. One film-coated tablet contains 250 mg of clarithromycin.
• Other ingredients are: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, cellulose powder, magnesium stearate, Opadry White OY-L-28900 coating containing: hypromellose 15 mPas, titanium dioxide (E 171), macrogol 4000, lactose monohydrate.

What Clarithromycin Genoptim looks like and contents of the packaging

Clarithromycin Genoptim is available in the form of film-coated tablets.
The tablet is white, oblong, and biconvex (approximately 15.3 mm x 6.4 mm in size) with a dividing line on both sides and the marking K 250 on one side.
The packaging contains 10, 14, or 28 film-coated tablets.
Aluminum/PVC blister pack in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
Krakowiaków 65
02-255 Warsaw

Manufacturer/Importer

Synoptis Industrial Sp. z o.o.
Rabowicka 15
62-020 Swarzędz
Date of last revision of the leaflet:03.2021