Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Klacid Uno
500 mg, modified-release tablets
Clarithromycinum
Please read the entire 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

What Klacid Uno is and what it is used for
Important information before taking Klacid Uno
How to take Klacid Uno
Possible side effects
How to store Klacid Uno
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 comes 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 to any of the other components 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 such patients, use of Klacid with unmodified 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 severe cardiac arrhythmias.
If the patient is taking astemizole or terfenadine (medicines used for allergies), cisapride or domperidone (medicines used for gastrointestinal motility disorders), pimozide (a medicine used for psychiatric disorders), because concomitant use with Klacid Uno may cause severe 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 (hypokalemia or hypomagnesemia).
If the patient is taking lovastatin or simvastatin (statin-class medicines used to lower blood cholesterol levels).
If the patient has severe hepatic impairment with concomitant renal impairment.
If the patient has previously experienced, or there is a 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 to treat 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 (slow heart rate).
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 edema, or bronchospasm. Immediate medical attention is required, and appropriate treatment should be initiated.
Diarrhea, especially if acute or prolonged. Inform the doctor as soon as possible. If necessary, the doctor will recommend appropriate treatment. Do not use anti-diarrheal medicines.
Symptoms suggesting liver dysfunction, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. Discontinue treatment and consult a doctor.
New infection (superinfection) caused by bacteria resistant to clarithromycin or by fungi, especially during prolonged antibiotic use. The doctor will recommend appropriate treatment.

Additionally, during treatment with Klacid Uno, 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).

If symptoms indicating damage to the hearing organ or vestibular apparatus 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 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 (medicines 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 (medicines that lower blood cholesterol levels)
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 used concomitantly with Klacid Uno:

rifampicin, rifapentine, rifabutin (antibiotics used to treat 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 to treat 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 that reduces gastric acid secretion)
cilostazol (a medicine used for intermittent claudication, characterized by muscle pain in the lower limbs during exertion, 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)
St. John's wort (a herbal medicine used for mild depression)
sulfonylureas, nateglinide, repaglinide, insulin (medicines used for diabetes)

This is also important when using the following medicines:

hydroxychloroquine or chloroquine (used for, among others, rheumatoid arthritis, and for treatment or prevention of malaria). Taking these medicines together with clarithromycin may increase the risk of cardiac arrhythmias and other serious cardiac adverse effects.
corticosteroids administered orally, by injection, or by inhalation (used to suppress immune system activity, which is useful in treating many different conditions)

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 during pregnancy and breastfeeding 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 human milk, breastfeeding women should exercise particular caution when using Klacid Uno.
Driving and operating machinery
The medicine may cause dizziness, confusion, and disorientation, which may affect the ability to
drive or operate machinery.
Klacid Uno contains monohydrate lactose
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 medicine is for oral use.
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.
Klacid Uno is contraindicated in patients with severe renal impairment (creatinine clearance below
30 ml/min), as the dose cannot be reduced (the tablet cannot be divided).
In these patients, a clarithromycin immediate-release formulation should be used.
Taking more Klacid Uno than prescribed
If you take more Klacid Uno than prescribed, contact your doctor or pharmacist immediately.
Taking a higher than prescribed 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 take the next dose at the
scheduled 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 using this medicine, consult your doctor or pharmacist.
Do not stop treatment prematurely, even if you feel better and symptoms resolve after a few days of
taking the medicine.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following adverse reactions occur in the patient at any time during treatment, the patient must stop taking Klacid 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, low urine output, rapid breathing, weakness and fainting
allergic reactions: rash (common), itching, urticaria (not common), angioedema of the face, tongue, lips, eyes and throat, difficulty breathing
severe skin reactions:
- acute generalized exanthematous pustulosis – red, peeling rash with subcutaneous nodules and blisters
- bullous erythema multiforme (Stevens-Johnson syndrome) characterized by sudden onset of fever and blisters, which resolve rapidly and spontaneously after discontinuation of the drug; a severe disease 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 rupturing 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 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 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 concomitantly with other medicines known to cause rhabdomyolysis, such as: drugs used in the treatment of lipid disorders, e.g. statins, fibrates; drugs used in the treatment of gout, e.g. colchicine or allopurinol. These reactions occur with unknown frequency, unless otherwise stated.

Other adverse reactions
In clinical studies and following marketing of clarithromycin, the following adverse reactions were reported commonly (occurring in 1 to 10 out of 100 patients):

insomnia
taste disturbances, 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), gastritis, enteritis, vaginal infection
decreased white blood cell count
hypersensitivity
anorexia, decreased appetite
restlessness
dizziness, somnolence, tremor
loss of balance, hearing loss, tinnitus
palpitations, changes in ECG (prolongation of QT interval)
nosebleed
gastroesophageal reflux disease, gastritis and enteritis, anal pain, stomatitis, glossitis, constipation, dry mouth, belching, flatulence
increased liver enzyme activity: alanine aminotransferase, increased aspartate aminotransferase activity
muscle pain
asthenia (weakness, lack of energy)

Listed below are adverse reactions with unknown frequency (frequency cannot be estimated from the available data), reported after marketing of Klacid tablets and oral suspension:

erythema
agranulocytosis (reduction in granulocyte count), thrombocytopenia (reduction in platelet count)
acne
psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania
seizures, loss of taste, parosmia, anosmia, paresthesia (numbness, tingling)
deafness
cardiac arrhythmias such as torsade de pointes, ventricular tachycardia, ventricular fibrillation
haemorrhage
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, 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, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website:
https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to 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. This will help protect the environment.

6. Contents of the package 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 (E 330), sodium alginate (E 401), sodium-calcium alginate, lactose monohydrate, povidone K 30, talc (E 553b), stearic acid, magnesium stearate; coating ingredients: hypromellose, polyethylene glycol 400, polyethylene glycol 8000, titanium dioxide (E 171), quinoline yellow, lac dye (E 104), 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 in 1 blister,
14 tablets in 2 blisters of 7 tablets each.
Blister packs made of PVC/PVDC/Al, in a cardboard carton.
For further detailed information, please contact the responsible party 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Austrian Marketing Authorisation Number, country of export: 1-22085
Parallel Import Licence Number: 246/16