Clarithromycin genoptim

Patient Information Leaflet

Clarithromycin Genoptim, 250 mg, film-coated tablets
Clarithromycinum
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

1. What Clarithromycin Genoptim is and what it is used for
2. What you need to know 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 Clarithromycin Genoptim is and what it is used for

Clarithromycin Genoptim contains the active substance clarithromycin. It is a macrolide antibiotic that inhibits the growth of bacteria causing 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. impetigo, folliculitis, cellulitis, abscesses)
• Dental and oral infections (e.g. periapical abscess, periodontitis)
• Disseminated or localized infections caused by mycobacteria

In HIV-infected patients (CD4 lymphocyte count ≤100/mm³), Clarithromycin Genoptim is indicated for the prevention of disseminated infections caused by Mycobacterium avium complex (MAC) organisms.

In patients with duodenal ulcer and confirmed Helicobacter pylori infection, Clarithromycin Genoptim should be used concomitantly with agents that suppress gastric acid secretion and another antibiotic.

2. Important information before using Clarithromycin Genoptim

When not to use Clarithromycin Genoptim

• If the patient is allergic to clarithromycin or other macrolide antibiotics (such as azithromycin, erythromycin) or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, for migraine) or oral midazolam (a medicine used for anxiety and insomnia).
• If the patient is taking medicines that may cause severe heart rhythm disturbances.
• If the patient is taking astemizole or terfenadine (medicines used for allergies), cisapride or domperidone (a medicine used for gastrointestinal motility disorders), pimozide (a medicine used for psychiatric disorders), because concomitant use with Clarithromycin Genoptim may lead to severe heart rhythm disturbances.
• If the patient is taking ticagrelor (a platelet aggregation inhibitor) or ranolazine (a heart medicine).
• If the patient has low blood potassium or magnesium levels (hypokalaemia or hypomagnesaemia).
• If the patient is taking lovastatin, simvastatin (statin group medicines used to reduce blood cholesterol levels).
• If the patient has severe hepatic insufficiency with concomitant renal insufficiency.
• If the patient has a history of, or family history of, cardiac arrhythmias (ventricular arrhythmias, including torsade de pointes) or electrocardiogram (ECG) abnormalities known as "long QT syndrome".
• If the patient is taking colchicine (a medicine used in the treatment of gout).
• If the patient is taking a medicine containing lomitapide.

Warnings and precautions
If any of the situations described below apply to the patient, they should be discussed with the doctor before starting treatment with Clarithromycin Genoptim.

• The patient is pregnant or suspects she may be pregnant.
• The patient has impaired kidney or liver function.
• The patient has coronary artery disease, severe heart failure, or bradycardia (slow heart rate).
• The patient is taking any of the medicines listed in the section "Clarithromycin Genoptim and other medicines".

If any of the following situations occur during treatment with Clarithromycin Genoptim, the patient should inform the doctor immediately.

• Severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, laryngeal oedema, or bronchospasm. The patient should immediately consult a doctor who will initiate appropriate treatment.
• Diarrhoea, especially if acute or prolonged. The patient should inform the doctor as soon as possible. If necessary, the doctor will recommend appropriate treatment. Antidiarrhoeal medicines should not be used.
• Symptoms suggesting liver dysfunction, such as loss of appetite, jaundice, dark urine, pruritus, or abdominal pain. Treatment should be discontinued and the patient should consult a doctor.
• New infection (superinfection) caused by bacteria resistant to clarithromycin or fungi, especially during prolonged antibiotic use. The doctor will recommend appropriate treatment.

Additionally, during treatment with Clarithromycin Genoptim, the following may occur:

• Cross-resistance of bacteria (bacteria resistant to clarithromycin may also show resistance to other macrolide antibiotics, as well as to lincomycin and clindamycin);
• Bacterial resistance (e.g. treatment of Helicobacter pylori infection may lead to emergence of drug-resistant microorganisms).

If symptoms indicating damage to the hearing organ or vestibular system occur (see section 4), appropriate follow-up examinations are recommended after completion of treatment.

Clarithromycin Genoptim and other medicines
The patient should inform the doctor about all medicines currently or recently taken, as well as any medicines planned for future use.

The patient must inform the doctor if taking any of the following medicines, as concomitant use with Clarithromycin Genoptim is contraindicated:

• Ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, for migraine)
• Astemizole or terfenadine (medicines used for the treatment of allergies)
• Cisapride or domperidone (a medicine used for gastrointestinal motility disorders)
• Pimozide (a medicine used for psychiatric disorders)
• Ticagrelor, ranolazine (medicines used for heart and circulatory diseases)
• Colchicine (a medicine used for the treatment of gout)
• Statins – lovastatin, simvastatin (medicines lowering blood cholesterol levels)
• Oral midazolam (a medicine used for anxiety or insomnia)

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

• 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 for cardiac arrhythmias or hypertension)
• Alprazolam, triazolam, intravenous or oral mucosal midazolam (medicines used for anxiety or insomnia)
• Warfarin or any other anticoagulant, e.g. dabigatran, rivaroxaban, apixaban (medicines used to thin the blood)
• Quetiapine or other atypical antipsychotics
• Carbamazepine, valproate, phenytoin (antiepileptic medicines)
• Methylprednisolone (an anti-inflammatory medicine)
• Omeprazole (a medicine reducing gastric acid secretion)
• Cilostazol (a medicine used for intermittent claudication, characterised by pain in the lower limb muscles during exercise, resolving after short rest)
• Cyclosporine, tacrolimus, sirolimus (medicines used, among others, after organ transplantation)
• Sildenafil, tadalafil, vardenafil (medicines used for erectile dysfunction)
• Vinblastine (a medicine used in cancer chemotherapy)
• Theophylline (a medicine used in the treatment of bronchial asthma)
• Tolterodine (a medicine used for urinary incontinence)
• Phenobarbital (an anticonvulsant medicine)
• St. John’s wort (an herbal medicine used for the treatment of mild depression)
• Sulfonylureas, nateglinide, repaglinide, insulin (medicines used for diabetes treatment)
• Ototoxic medicines (damaging hearing), particularly aminoglycoside antibiotics used in bacterial infections.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The safety of clarithromycin use during pregnancy and breastfeeding has not been established.
Clarithromycin Genoptim may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
Since clarithromycin passes into breast milk, women who are breastfeeding should exercise particular caution when using Clarithromycin Genoptim.

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

Clarithromycin Genoptim contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Clarithromycin Genoptim contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Clarithromycin Genoptim

This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your
doctor or pharmacist.
This is an oral medicine.
Swallow the tablet whole with water. Do not chew or suck the tablet.
The tablets may be taken with or without food.
If a single dose of 500 mg is required, it is recommended to use Clarithromycin Genoptim tablets
containing 500 mg of clarithromycin per tablet.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing in
cases where swallowing the whole tablet is difficult.

Respiratory, skin and soft tissue infections, acute otitis media
Adults
One tablet (250 mg) twice daily (every 12 hours).
In severe infections, your doctor may recommend increasing the dose to two 250 mg tablets (i.e. 500 mg)
twice daily (every 12 hours).
Treatment usually lasts from 5 to 14 days, except for pneumonia and sinusitis, for which treatment lasts 6 to 14
days.

Children over 12 years of age
Dosage as in adults.

Children 12 years of age and younger
It is recommended to use Clarithromycin Genoptim in the form of an oral suspension.

Patients with renal impairment
Your doctor may recommend reducing the dose by half, meaning one 250 mg tablet once daily.
In severe infections – one 250 mg tablet twice daily.
Treatment should not last longer than 14 days.

Dental and oral infections
One 250 mg tablet twice daily (every 12 hours). Treatment usually lasts 5 days.

Infections caused by mycobacteria
Recommended dose in adults: two 250 mg tablets (i.e. 500 mg) twice daily.
Treatment of disseminated infection caused by Mycobacterium avium complex (MAC) in AIDS patients should
be continued as long as directed by the doctor.
Clarithromycin Genoptim should be used concomitantly with other anti-Mycobacterium agents.
Treatment of other non-tuberculous Mycobacterium infections should be continued as directed by the doctor.

Prevention of MAC infections
Recommended dose in adults: two 250 mg tablets (i.e. 500 mg) twice daily.

Helicobacter pylori infections
In patients with gastric or duodenal ulcer disease associated with Helicobacter pylori infection, clarithromycin
may be administered for 7 to 14 days at a dose of 500 mg twice daily, in combination with other appropriate
antibacterial therapy and proton pump inhibitors, in accordance with national and international guidelines for
Helicobacter pylori eradication.

Taking more Clarithromycin Genoptim than recommended
If you take more Clarithromycin Genoptim than recommended, contact your doctor or pharmacist immediately.
Taking more than the recommended dose of Clarithromycin Genoptim may cause gastrointestinal symptoms
(vomiting, abdominal pain).

Missing a dose of Clarithromycin Genoptim
If you miss a dose of Clarithromycin Genoptim, take it as soon as possible, then take the next dose at the
regularly scheduled time.
Do not take a double dose to make up for a missed dose.

Stopping Clarithromycin Genoptim
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Do not stop treatment, even if you feel better and symptoms improve after a few days of taking the medicine.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences, at any stage of treatment, any of the following adverse reactions,
stop taking Clarithromycin Genoptim and consult a doctor immediately:

• anaphylactic shock – an acute, life-threatening allergic reaction, manifested, among others, by confusion, skin pallor, drop in blood pressure, sweating, reduced urine output, rapid breathing, weakness, and fainting
• allergic reactions: rash (common), itching, urticaria (not common), angioedema of the face, tongue, lips, eyes, and throat, breathing difficulties
• severe skin reactions:
  • acute generalized exanthematous pustulosis – red, scaly rash with subcutaneous nodules and vesicles, vesicular erythema multiforme
  • Stevens-Johnson syndrome, characterized by sudden onset of fever and blisters, which resolve rapidly after discontinuation of the drug; a severe condition manifested by blisters and erosions on the skin, in the oral cavity, eyes, and genital organs, accompanied by fever and joint pain
  • toxic epidermal necrolysis (Lyell's syndrome) – a severe, rapidly progressing disease characterized by rupture of giant subepidermal blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever
  • DRESS syndrome – a severe (life-threatening) drug-induced rash associated with increased eosinophil count and internal organ involvement
• severe or prolonged diarrhea, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even up to two months after completion of clarithromycin treatment. In such cases, contact a doctor immediately
• yellowing of the skin (jaundice), skin irritation, pale-colored stools, dark-colored urine, abdominal tenderness, or loss of appetite. These may be symptoms of liver inflammation or liver failure. These reactions occur at an unknown frequency unless otherwise stated.

Other adverse reactions
In clinical trials and post-marketing surveillance of clarithromycin, the following adverse reactions have been reported commonly (occur in 1 to 10 out of 100 patients):

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

Adverse reactions reported uncommonly (occur in 1 to 10 out of 1000 patients):

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

The following adverse reactions have been reported after marketing authorization of various clarithromycin-containing formulations (tablets, oral suspension, intravenous injection powder), with frequency not known (frequency cannot be estimated from available data):

• erythema
• agranulocytosis (decreased granulocyte count in blood), thrombocytopenia (decreased platelet count)
• acne
• psychotic disorders, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania
• seizures, loss of taste, parosmia, anosmia, paresthesia (numbness, tingling)
• deafness
• cardiac arrhythmias of the torsade de pointes type, ventricular tachycardia, ventricular fibrillation
• bleeding and changes in blood coagulation parameters (especially if the patient is concurrently taking oral anticoagulants)
• acute pancreatitis, tongue discoloration, tooth discoloration
• muscle diseases (myopathies) manifested by muscle weakness, in some cases difficulty in muscle relaxation, muscle atrophy
• renal failure, interstitial nephritis
• changes in diagnostic test results (increased international normalized ratio (INR), prolonged prothrombin time, abnormal urine color)

Patients with impaired immunity
In addition to symptoms related to the underlying disease, the following adverse reactions have been observed in adult patients with impaired immunity:

• nausea, vomiting, taste disturbances, constipation, abdominal pain, diarrhea, flatulence, dry mouth
• headache, hearing disturbances
• rash
• dyspnea, insomnia
• abnormal laboratory test results: increased aspartate aminotransferase (AspAT) and alanine aminotransferase (AlAT) activity, increased blood urea nitrogen, decreased platelet and white blood cell counts

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Clarithromycin Genoptim

Keep this medicine 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 stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Clarithromycin Genoptim contains

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

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

Marketing Authorisation 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