Clarithromicin Genoptim

Leaflet attached to the packaging: patient information

Clarithromycin Genoptim, 500 mg, film-coated tablets

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 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 side effects 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 pack 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 sensitive 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)
• -disseminated or localized infections caused by mycobacteria

In patients with HIV infection (CD4 cell count <100>In patients with duodenal ulcer and diagnosed Helicobacter pylori infection, it is recommended to use Clarithromycin Genoptim in combination with drugs that reduce gastric acid secretion and another antibiotic, in accordance with national and international guidelines for the eradication of Helicobacter pylori.

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 for migraine), or midazolam orally (used for 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 for allergies), cisapride or domperidone (used for gastrointestinal disorders), pimozide (used for psychiatric disorders), as concomitant use with Clarithromycin Genoptim may cause severe heart rhythm disturbances.
• If the patient is taking ticagrelor or ranolazine (used for 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 or 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 for gout).
• If the patient is taking a medicine containing lomitapide.

Warnings and precautions

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

• -Severe allergic reactions such as: maculopapular rash, urticaria, petechiae, laryngeal edema, 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 use of the antibiotic. The doctor will prescribe appropriate treatment.

In addition, during treatment with 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);
• drug resistance of bacteria (e.g., treatment of Helicobacter pylori infection may lead to the selection of resistant microorganisms).

If symptoms of ototoxicity or vestibular disorders occur (see section 4), it is recommended to perform appropriate control tests after the end of 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 for migraine)
• astemizole or terfenadine (used for allergies)
• cisapride or domperidone (used for gastrointestinal disorders)
• pimozide (used for psychiatric disorders)
• -ticagrelor, ranolazine (used for heart and circulation diseases)
• colchicine (used for gout)
• statins - lovastatin, simvastatin (used to lower cholesterol levels in the blood)
• midazolam orally (used for anxiety or 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 for tuberculosis)
• fluconazole, itraconazole (antifungal medicines)
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used for HIV infection)
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used for heart rhythm disorders or hypertension)
• alprazolam, triazolam, midazolam intravenously or orally (used for anxiety or 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 for intermittent claudication, which is characterized by leg pain during exercise that subsides after a short rest)
• cyclosporine, tacrolimus, sirolimus (used for organ transplantation)
• sildenafil, tadalafil, vardenafil (used for erectile dysfunction)
• vinblastine (used for cancer chemotherapy)
• theophylline (used for asthma)
• tolterodine (used for urinary incontinence)
• phenobarbital (antiepileptic medicine)
• St. John's wort (herbal medicine used for mild depression)
• sulfonylureas, nateglinide, repaglinide, insulin (used for diabetes)
• ototoxic medicines (damaging to hearing), especially aminoglycoside antibiotics used for bacterial infections.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a 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 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 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 a 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. If the patient has any doubts, they should consult a doctor or pharmacist.
The medicine is for oral use.
The tablet should be swallowed whole, with a glass of 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 is the same as for adults.
Children under 12 years
It is recommended to use the medicine in the form of an oral suspension.
Patients with renal impairment
The 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 Clarithromycin Genoptim containing 250 mg of clarithromycin per tablet. Treatment should not last longer 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.
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: 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 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 the eradication of Helicobacter pylori.

Taking a higher dose of Clarithromycin Genoptim than recommended

If the patient takes a higher dose of the medicine than recommended, they should immediately consult a 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

If the patient misses a dose of Clarithromycin Genoptim, they 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 treatment with Clarithromycin Genoptim

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

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 treatment with Clarithromycin Genoptim, they should stop taking the medicine and consult a doctor immediately:

• anaphylactic shock - a life-threatening allergic reaction, which may include confusion, pallor, low blood pressure, sweating, oliguria, tachypnea, weakness, and fainting
• allergic reactions: rash (frequent), itching, urticaria (infrequent), 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, which resolve spontaneously after withdrawal of the medicine; severe disease characterized by blisters and erosions on the skin, in the mouth, eyes, and genital organs, fever, and arthralgia;
• toxic epidermal necrolysis (Lyell's syndrome) - a severe, rapidly progressing disease characterized by large, blistering skin lesions, extensive skin necrosis, and fever;
• DRESS syndrome - a severe (life-threatening) drug rash, which progresses with an increase in eosinophils and involvement of internal organs
• severe or prolonged diarrhea, which may be accompanied by blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even after 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. These reactions occur with an unknown frequency, unless otherwise specified.

Other side effects

In clinical trials and after the medicine was marketed, clarithromycin oftencaused the following side effects (occurring in 1 to 10 out of 100 patients):

• insomnia
• taste disorders, headache
• diarrhea, vomiting, nausea, abdominal pain
• abnormal liver function test results
• excessive sweating

Side effects reported less frequently(occurring in 1 to 10 out of 1,000 patients):

• candidiasis (fungal infection), vaginal infection
• decreased white blood cell count, decreased neutrophil count, and increased eosinophil count
• anorexia, decreased appetite
• anxiety
• dizziness, drowsiness, tremors
• balance disorders, hearing loss, tinnitus
• palpitations, changes in ECG (QT interval prolongation)
• gastritis, oral mucositis, tongue discoloration, tooth discoloration, abdominal distension, constipation, dry mouth, eructation, flatulence
• cholestasis (bile stasis), increased liver enzyme activity
• malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue
• increased blood levels of enzymes: alkaline phosphatase and lactate dehydrogenase

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

• rosacea
• agranulocytosis (decreased neutrophil count), 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, 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
• muscle diseases (myopathies) characterized by muscle weakness, and 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 function
In addition to symptoms related to the course of the disease, the following side effects have been observed in adult patients with impaired immune function:

• 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 any side effects 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, 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 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 pack and other information

What Clarithromycin Genoptim contains

• -The active substance of the medicine is clarithromycin. One film-coated tablet contains 500 mg of clarithromycin. The 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 what the pack contains

Clarithromycin Genoptim is available in the form of film-coated tablets.
The tablet is white, oblong, and biconvex (approximately 18.5 mm x 8.1 mm) with a score line on both sides and the marking K 500 on one side.
The pack contains 10, 14, or 28 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.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer/Importer

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