Klacid uno

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Klacid Uno (Klacid SR), 500 mg, prolonged-release tablets
Clarithromycinum
Klacid Uno and Klacid SR are different brand names for the same medicine.
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. It 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 is a macrolide antibiotic that inhibits the growth of bacteria causing infections. Klacid Uno is formulated as prolonged-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 to 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, Klacid in a formulation 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 (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 (statins used to reduce 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 (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, or bronchospasm. Immediate medical attention is required, and appropriate treatment will 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 immediately.
• New infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially 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 be resistant to other macrolide antibiotics, as well as to lincomycin and clindamycin).

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
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 heart and circulatory diseases)
• Colchicine (a medicine used for gout)
• Statins – lovastatin, simvastatin (medicines that lower blood cholesterol levels)
• Midazolam administered orally (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 with Klacid Uno:

• Rifampicin, rifapentine, rifabutin (antibiotics used in tuberculosis treatment)
• Fluconazole, itraconazole (antifungal medicines)
• Atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (medicines used in HIV infection treatment)
• 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 other oral anticoagulants, 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 that reduces gastric acid secretion)
• Cilostazol (a medicine used in intermittent claudication, characterised by leg muscle pain during exertion that resolves 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 in 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 in diabetes).

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.
Klacid Uno 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, 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) per 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 (E 104)
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 directed 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 during a meal. 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. In cases of pneumonia or sinusitis, the medicine should 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 reduced by half, 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 medicine containing clarithromycin with immediate release is recommended.

Accidental overdose of Klacid Uno
If more Klacid Uno has been taken than recommended, consult your doctor or pharmacist immediately.
Taking more than the recommended dose of Klacid Uno may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missed 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 using this medicine, consult your doctor or pharmacist.
Do not stop treatment prematurely, even if you start feeling better and symptoms improve after a few days of treatment.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following adverse reactions occur in a patient at any stage during treatment, 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) – sudden onset of 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 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 eosinophilia 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 a case, contact a doctor immediately
• 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 drugs 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 adverse 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 commonly reported (occur 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 (occur in 1 to 10 out of 1,000 patients):

• candidiasis (fungal infection), gastritis and enteritis, vaginal infection
• decreased white blood cell count
• hypersensitivity
• anorexia, decreased appetite
• anxiety
• dizziness, somnolence, tremor
• balance disorders, hearing loss, tinnitus
• palpitations, ECG changes (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 authorization of Klacid tablets and oral suspension, with unknown frequency (frequency cannot be estimated from available data):

• erythema
• agranulocytosis (reduced number of granulocytes in blood), thrombocytopenia (reduced 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
• hemorrhage
• acute pancreatitis, tongue discoloration, tooth discoloration
• myopathy (muscle disease with muscle weakness), muscle pain
• 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, 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 levels, 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, 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, in the original packaging.
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 packaging and other information

What Klacid Uno contains

• The active substance is clarithromycin. One prolonged-release tablet contains 500 mg of clarithromycin.
• The other ingredients are: citric acid, sodium alginate, sodium calcium alginate, lactose monohydrate, povidone K 30, talc, stearic acid, magnesium stearate; coating ingredients: hypromellose 6 cps, macrogol 400, macrogol 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 prolonged-release tablets.
The tablet is yellow and oval-shaped.
Pack contents: 5 tablets, 7 tablets, 10 tablets, 14 tablets, or 20 tablets.
PVC/PVDC/Al blisters in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, the country of export:
VIATRIS HEALTHCARE LIMITED
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin, Ireland
Manufacturer:
ABBVIE S.R.L.
S.R. 148 Pontina KM 52 snc
04011 Campoverde di Aprilia (LT), Italy
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
Marketing authorisation numbers in Romania, the country of export: 8384/2015/01
8384/2015/02
8384/2015/03
Parallel import authorisation number: 181/19