Klacid uno

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Klacid Uno
500 mg, modified-release tablets
Clarithromycinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that 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. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Klacid Uno is and what it is used for
2. Important information before taking Klacid Uno
3. How to take Klacid Uno
4. Possible side effects
5. How to store Klacid Uno
6. Contents of the pack and other information

1. What Klacid Uno is and what it is used for

Klacid Uno contains the active substance – clarithromycin. It is a macrolide antibiotic which inhibits the growth of bacteria causing infections. The medicine is in the form of modified-release tablets. The tablet has been specially formulated and contains excipients that allow modification of the rate and duration of release of the active substance.
Klacid Uno 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, erysipelas, abscesses).

2. Important Information Before Using Klacid Uno

When Not to Use Klacid Uno

• 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 has severe renal impairment (creatinine clearance less than 30 ml/min), because dose reduction is not possible (the tablet cannot be divided).
• In these patients, use of Klacid Uno with immediate release of the active substance is recommended.
• 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 serious cardiac arrhythmias.
• 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 Klacid Uno may lead to serious cardiac arrhythmias.
• If the patient is taking ticagrelor, ivabradine, or ranolazine (used in the treatment of angina pectoris or to reduce the risk of myocardial infarction or stroke).
• If the patient has low blood potassium or magnesium levels (hypokalaemia or hypomagnesaemia).
• If the patient is taking lovastatin or simvastatin (statin group medicines used to lower blood cholesterol levels).
• If the patient has severe hepatic impairment with concomitant renal impairment.
• If the patient has a history, 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 following situations apply to the patient, discuss them with a doctor before starting
treatment with Klacid Uno.

• 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.
• The patient is taking any of the medicines listed in the section "Klacid Uno and Other Medicines".

If any of the following occur during treatment with Klacid Uno, inform the doctor immediately.

• Severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, laryngeal oedema, or bronchospasm. Immediate medical attention is required, and appropriate treatment should be initiated.
• Diarrhoea, especially if acute or prolonged. Inform the doctor as soon as possible. If necessary, the doctor will recommend appropriate treatment. Do not use anti-diarrhoeal medicines.
• Symptoms suggesting liver dysfunction, such as loss of appetite, jaundice, dark urine, pruritus, or abdominal pain. Discontinue treatment and consult a doctor.
• New infection (superinfection) with bacteria resistant to clarithromycin or with fungi, particularly during prolonged antibiotic use. The doctor will recommend appropriate treatment.

Additionally, during treatment with Klacid Uno, the following may occur:

• Bacterial cross-resistance (bacteria resistant to clarithromycin may also show resistance to other macrolide antibiotics, as well as to lincomycin and clindamycin).

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

Klacid Uno and Other Medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
It is essential to inform the doctor if the patient is taking any of the following medicines, as their concomitant use with Klacid Uno is contraindicated:

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

Inform the doctor if the patient is taking any of the following medicines, as special caution is required when using them concomitantly with Klacid Uno:

• Rifampicin, rifapentine, rifabutin (antibiotics used in the treatment of tuberculosis)
• Fluconazole, itraconazole (antifungal medicines)
• Atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (medicines used in the treatment of HIV infection)
• Digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (medicines 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, edoxaban (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 muscle pain in the lower limbs during exercise, resolving after brief rest)
• Cyclosporine, tacrolimus, sirolimus (medicines used, among others, after organ transplantation)
• Sildenafil, tadalafil, vardenafil (medicines used for erectile dysfunction)
• Ibrutinib or vinblastine (medicines used in cancer chemotherapy)
• Theophylline (a medicine used for bronchial asthma)
• Tolterodine (a medicine used for urinary incontinence)
• Phenobarbital (an anticonvulsant medicine)
• St. John’s wort (a herbal medicine used for mild depression)
• Sulfonylureas, nateglinide, repaglinide, insulin (medicines used for diabetes)

It is also important when using the following medicines:

• Hydroxychloroquine or chloroquine (used, among others, for rheumatoid arthritis, and for treatment or prevention of malaria). Concomitant use with clarithromycin may increase the risk of cardiac arrhythmias and other serious adverse effects on the heart.
• Corticosteroids administered orally, by injection, or by inhalation (used to suppress immune system activity, useful in treating many different conditions).

Pregnancy and Breast-Feeding
If the patient is pregnant or breast-feeding, 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 breast-feeding has not been established.
Klacid Uno 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 breast-feeding should exercise particular caution when using Klacid Uno.

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

Klacid Uno Contains Lactose Monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.

Klacid Uno Contains Sodium
The medicine contains 15.3 mg of sodium (the main component of table salt) in one tablet. If the patient takes 2 tablets of Klacid Uno per day, the total sodium intake is 30.6 mg.
This corresponds to 1.5% of the maximum recommended daily dietary sodium intake for adults.

Klacid Uno Contains Quinoline Yellow
Quinoline Yellow (a dye) may cause allergic reactions in sensitive individuals.

3. How to use Klacid Uno

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
This is an oral medicine.
The tablet should be swallowed whole with water. Do not chew, divide, or suck the tablet.

Adults
Recommended dose – one 500 mg tablet once daily with food. In severe infections, the dose may be increased to 1 gram once daily (two 500 mg tablets). Treatment usually lasts from 5 to 14 days. Only in cases of pneumonia or sinusitis should the medicine be administered for 6 to 14 days.

Children over 12 years of age
Dosage as in adults.

Children aged 12 years and younger
Use of Klacid in oral suspension form is recommended.

Patients with renal impairment
In patients with moderate renal impairment (creatinine clearance 30 to 60 ml/min), the dose should be halved, i.e. maximum one tablet of Klacid Uno once daily.
In patients with severe renal impairment (creatinine clearance below 30 ml/min), Klacid Uno is contraindicated because the dose cannot be reduced (the tablet cannot be divided).
In these patients, use of a clarithromycin immediate-release formulation is recommended.

Taking more Klacid Uno than recommended
If you take more Klacid Uno than recommended, seek medical advice immediately from your doctor or pharmacist.
Taking a higher than recommended dose of Klacid Uno may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missing a dose of Klacid Uno
If you miss a dose of Klacid Uno, take it as soon as possible, then continue with the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Klacid Uno
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Do not stop treatment prematurely, even if you feel better and symptoms of the illness have resolved after a few days of treatment.

4. Possible adverse reactions

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

• anaphylactic shock – an acute, life-threatening allergic reaction, manifested, among others, 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, breathing difficulties
• severe skin reactions:
  • acute generalized exanthematous pustulosis – red, peeling rash with subcutaneous nodules and blisters
  • bullous erythema multiforme (Stevens-Johnson syndrome), suddenly appearing with fever and blisters, rapidly and spontaneously resolving after discontinuation of the drug; a serious 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) – a severe, rapidly progressing disease characterized by rupturing of large subepidermal blisters, extensive skin erosions, shedding of large epidermal sheets, and fever
  • DRESS syndrome – a severe (life-threatening) drug eruption 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 completing 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 failure
• muscle swelling, cramps, and muscle pain, which may be symptoms of rhabdomyolysis (a syndrome caused by breakdown of muscle tissue).
• In some cases of rhabdomyolysis, clarithromycin was administered concurrently with other drugs known to cause rhabdomyolysis, such as lipid-lowering agents (e.g., statins, fibrates) or drugs used in the treatment of gout (e.g., colchicine or allopurinol). These adverse reactions occur with 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 (occurring 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 (occurring in 1 to 10 out of 1,000 patients):

• candidiasis (fungal infection), gastritis, enteritis, vaginal infection
• decreased white blood cell count
• hypersensitivity
• aversion to food, decreased appetite
• restlessness
• dizziness, somnolence, tremor
• imbalance, hearing loss, tinnitus
• palpitations, changes in ECG (prolongation of QT interval)
• nosebleeds
• gastroesophageal reflux disease, gastritis and enteritis, anal pain, stomatitis, glossitis, constipation, dry mouth, belching, bloating with gas release
• increased liver enzyme activity: alanine aminotransferase, increased aspartate aminotransferase activity
• muscle pain
• asthenia (weakness, lack of energy)

The following adverse reactions have been reported after marketing of Klacid tablets and oral suspension, with unknown frequency (frequency cannot be estimated from available data):

• erythema
• agranulocytosis (decreased granulocyte count in blood), thrombocytopenia (decreased platelet count)
• acne
• psychotic disorder, 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 such as torsade de pointes, ventricular tachycardia, ventricular fibrillation
• hemorrhage
• acute pancreatitis, tongue discoloration, tooth discoloration
• myopathy (muscle disease with muscle weakness)
• 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, bloating with gas release, 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Klacid Uno

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store in the original outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Klacid Uno contains

• The active substance is clarithromycin. One modified-release tablet contains 500 mg of clarithromycin.
• Other ingredients are: citric acid, sodium alginate, sodium-calcium alginate, lactose monohydrate, povidone K 30, talc, stearic acid, magnesium stearate; coating ingredients: hypromellose, polyethylene glycol 400, polyethylene glycol 8000, titanium dioxide (E 171), quinoline yellow E 104 (aluminium lake), sorbic acid.

What Klacid Uno looks like and contents of the pack
Klacid Uno is available as modified-release tablets.
The tablet is yellow and oval-shaped.
Pack contents: 7 tablets or 14 tablets.
PVC/PVdC/Aluminium blisters in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Austria, country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin
Ireland
Manufacturer:
AbbVie S.r.L.
04011 Campoverde di Aprilia
Italy
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Austria, country of export: 1-22085
Parallel import authorisation number: 54/22