Klacid uno

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Klacid Uno (Klacid SR), 500 mg, modified-release tablets
Clarithromycinum
Klacid Uno and Klacid SR are different brand names for the same medicine.
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, 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 someone else, 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.

Table of 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 belongs to a class of antibiotics known as macrolides, which inhibit the growth of bacteria causing infections. Klacid Uno is formulated as modified-release tablets. The tablet has been specially prepared 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 in an immediate-release formulation 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 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 heart attack 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 reduce blood cholesterol levels).
• If the patient has severe hepatic impairment with concomitant renal impairment.
• If the patient has, or has 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 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, 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 oedema, 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, itching 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:

• 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 examinations 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 (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 (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 oromucosal 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),
• 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, among others, for rheumatoid arthritis, or for treatment or prevention of malaria). Concomitant use 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, 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 foetus.
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 lactose monohydrate
If the patient has been previously diagnosed with an 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 colouring agent) 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 oral suspension 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), because the dose cannot be reduced (the tablet cannot be divided).
In these patients, a medicine containing clarithromycin with immediate release is recommended.

Taking more Klacid Uno than prescribed
If more Klacid Uno has been taken than prescribed, consult 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 a dose of Klacid Uno is missed, 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 resolve 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 any of the following adverse reactions occur in the patient at any stage of taking the medicine,
stop taking Klacid 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, low 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, scaling rash with subcutaneous nodules and blisters
  • bullous erythema multiforme (Stevens-Johnson syndrome) characterized by sudden onset of fever and blisters, resolving rapidly and spontaneously after discontinuation of the drug; a severe disease 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 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 number of eosinophils 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, medical advice should also be sought
• 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 concurrently with other drugs known to cause rhabdomyolysis, such as: drugs used in lipid disorder treatment, e.g. statins, fibrates; drugs used in gout treatment, e.g. colchicine or allopurinol. These reactions occur with unknown frequency, unless otherwise stated.

Other adverse reactions
In clinical trials and post-marketing surveillance of clarithromycin, the following adverse reactions were reported commonly (occurring in 1 to 10 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 of 1,000 patients):

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

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

• erythema,
• agranulocytosis (reduced granulocyte count in blood), thrombocytopenia (reduced platelet count),
• acne,
• psychotic disorders, confusion, depersonalization, depression, disorientation, hallucinations, abnormal dreams, mania,
• seizures, loss of taste, parosmia, anosmia, 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 decreased immunity
In addition to symptoms related to the underlying disease, the following adverse reactions have been observed in adult patients with decreased immunity:

• nausea, vomiting, taste disturbances, constipation, abdominal pain, diarrhoea, bloating with gas release, 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 levels, and decreased platelet and white blood cell counts.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your 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, 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 the 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.
Store below 30°C. Keep in the original 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, sodium alginate, sodium calcium alginate, lactose monohydrate, povidone 40, talc, stearic acid 95%, magnesium stearate; coating ingredients: hypromellose, polyethylene glycol 400, polyethylene glycol 8000, titanium dioxide (E 171), quinoline yellow (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 in 1 blister.
PVC/PVDC/Al blisters in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin, Ireland
Manufacturer:
AbbVie S.r.l., Via Pontina, km 52, 04011 Campoverde di Aprilia (LT), 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 the Czech Republic, country of export: 15/062/98-C
Parallel import authorisation number: 402/14