Clarithromycin genoptim

Package leaflet: Information for the patient

Clarithromycin Genoptim, 500 mg, film-coated tablets
Clarithromycinum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not give it to others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Clarithromycin Genoptim is and what it is 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 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)
• disseminated or localized infections caused by mycobacteria

In patients infected with HIV (CD4 lymphocyte count < 100/mm³), Clarithromycin Genoptim is indicated for the prevention of disseminated infections caused by Mycobacterium avium complex (MAC).
In patients with duodenal ulcer and confirmed Helicobacter pylori infection, Clarithromycin Genoptim should be used concomitantly with agents that inhibit 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 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, in migraine) or oral midazolam (a medicine used in anxiety states and insomnia).
• If the patient is taking medicines that may cause severe heart rhythm disorders.
• If the patient is taking astemizole or terfenadine (medicines used in allergy), cisapride or domperidone (a medicine used in gastrointestinal motility disorders), pimozide (a medicine used in psychiatric disorders), because concomitant use with Clarithromycin Genoptim may lead to severe heart rhythm disturbances.
• If the patient is taking ticagrelor (an antiplatelet agent) 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 (medicines belonging to the statin group, used to reduce blood cholesterol levels).
• If the patient has severe hepatic impairment with concomitant renal impairment.
• If the patient or a family member has previously experienced heart rhythm disorders (ventricular arrhythmias, including torsade de pointes) or abnormalities in the electrocardiogram (ECG, recording of the heart's electrical activity) 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 following situations apply to the patient, they should discuss them with a 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 their doctor.

• Severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, laryngeal oedema, 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 indicating 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) with bacteria resistant to clarithromycin or fungi, particularly 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 be resistant 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 after completion of treatment are recommended.

Clarithromycin Genoptim and other medicines
The patient should inform the doctor about all medicines currently or recently taken, as well as any medicines they plan to take.
The patient must inform the doctor if they are 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, in migraine)
• astemizole or terfenadine (medicines used in the treatment of allergy)
• cisapride or domperidone (a medicine used in gastrointestinal motility disorders)
• pimozide (a medicine used in psychiatric disorders)
• ticagrelor, ranolazine (medicines used in heart and circulatory diseases)
• colchicine (a medicine used in the treatment of gout)
• statins – lovastatin, simvastatin (medicines lowering blood cholesterol levels)
• oral midazolam (a medicine used in anxiety states or insomnia)

The patient should inform the doctor if they are taking any of the following medicines,
as special caution is required during concomitant use 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 in the treatment of cardiac arrhythmias or hypertension)
• alprazolam, triazolam, intravenous or oral mucosal midazolam (medicines used in anxiety states 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 in intermittent claudication, characterised by leg muscle pain during exertion that resolves with short rest)
• cyclosporine, tacrolimus, sirolimus (medicines used, among others, after organ transplantation)
• sildenafil, tadalafil, vardenafil (medicines used in erectile dysfunction)
• vinblastine (a medicine used in cancer chemotherapy)
• theophylline (a medicine used in bronchial asthma)
• tolterodine (a medicine used in urinary incontinence)
• phenobarbital (an anticonvulsant medicine)
• St John’s wort (a herbal medicine used in mild depression)
• sulfonylureas, nateglinide, repaglinide, insulin (medicines used in diabetes)
• 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 become pregnant, 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 doctor’s opinion, the benefit to the mother outweighs the potential risk to the foetus.
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, they 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, meaning the medicine is considered "sodium-free".

3. How to take Clarithromycin Genoptim

This medicine should always be taken exactly as directed by your doctor. 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.
Tablets may be taken with or without food.

Respiratory, skin and soft tissue infections, acute otitis media
Adults
For severe infections – one 500 mg tablet twice daily (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 of age
Dosage as for adults.

Children aged 12 years and younger
Use of the oral suspension formulation is recommended.

Patients with renal impairment
The doctor may recommend reducing the dose by half, i.e. one 250 mg tablet once daily.
For severe infections – one 250 mg tablet twice daily.
In such cases, Clarithromycin Genoptim 250 mg tablets are recommended. Treatment should not exceed 14 days.

Mycobacterial infections
Recommended dose for adults: one 500 mg tablet twice daily.
Treatment of disseminated infection caused by Mycobacterium avium complex (MAC) in AIDS patients should be continued as long as directed by the physician.
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 physician.

Prevention of MAC infections
Recommended dose for adults: one 500 mg tablet twice daily.

Helicobacter pylori infections
In patients with peptic ulcer disease of the stomach or duodenum caused by Helicobacter pylori, 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 prescribed
If you take more medicine than prescribed, contact your doctor or pharmacist immediately.
Taking more Clarithromycin Genoptim than prescribed 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 scheduled time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Clarithromycin Genoptim
If you have any further questions about using this medicine, consult your doctor or pharmacist.
Do not stop treatment, even if you start to feel better and symptoms improve within a few days of starting 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 taking the medicine, any of the following adverse reactions,
the patient should stop taking Clarithromycin Genoptim and immediately consult a doctor:

• Anaphylactic shock – acute, life-threatening allergic reaction characterized by confusion, pale skin, drop in blood pressure, sweating, reduced urine output, rapid breathing, 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 – red, scaly rash with subcutaneous papules and vesicles, vesicular erythema multiforme
  • Stevens-Johnson syndrome – sudden onset of fever and blistering rash, which resolves rapidly after discontinuation of the drug; severe condition characterized 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) – severe, rapidly progressing disease characterized by rupturing of large subepidermal blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever
  • DRESS syndrome – severe (life-threatening) drug-induced rash associated with increased eosinophil count and internal organ involvement
• Severe or prolonged diarrhoea, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhoea may occur even up to two months after completion of clarithromycin treatment. In such cases, the patient should also contact a doctor
• Yellowing of the skin (jaundice), skin irritation, pale stool, dark 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 studies and post-marketing surveillance of clarithromycin, the following adverse reactions were reported commonly (occurring in 1 to 10 out of 100 patients):

• Insomnia
• Disturbances in taste, headache
• Diarrhoea, vomiting, dyspepsia, nausea, abdominal pain
• Abnormal liver function test results
• Excessive sweating

Adverse reactions reported uncommonly (occurring in 1 to 10 out of 1,000 patients):

• Candidiasis (fungal infection), vaginal infection
• Decreased white blood cell count, decreased neutrophil count, increased eosinophil count
• Anorexia, decreased appetite
• Restlessness
• Dizziness, somnolence, tremor
• Disturbances in balance, hearing loss, tinnitus
• Palpitations, ECG changes (prolongation of QT interval)
• Gastritis, stomatitis, glossitis, abdominal distension, constipation, dry mouth, belching, flatulence
• Cholestasis (bile stasis), increased liver enzyme activity
• Malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue
• Increased blood levels of alkaline phosphatase and lactate dehydrogenase

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

• Erythema
• Agranulocytosis (reduced granulocyte count in blood), thrombocytopenia (reduced platelet count)
• Acne
• Psychotic disorders, confusion, depersonalization, depression, disorientation, hallucinations, abnormal dreams, mania
• Seizures, ageusia (loss of taste), parosmia (distorted sense of smell), anosmia (loss of smell), paresthesia (numbness, tingling)
• Deafness
• Cardiac arrhythmias, 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 disorders (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, altered taste perception, constipation, abdominal pain, diarrhoea, flatulence, dry mouth
• Headache, hearing disturbances
• Rash
• Dyspnoea, 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 any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 Clarithromycin Genoptim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following "EXP". The expiry date refers to the last day of the stated month.
No special storage precautions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Clarithromycin Genoptim contains

• The active substance is clarithromycin. One coated tablet contains 500 mg of clarithromycin.
  Other ingredients are: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous 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 pack
Clarithromycin Genoptim is available as film-coated tablets.
White, elongated, biconvex tablets (approximately 18.5 mm x 8.1 mm) with a score line on both sides and the marking "K 500" on one side.
Pack contains 10, 14 or 28 tablets.
Aluminium/PVC blister in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland

Manufacturer/Importer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland