Klacid uno

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet, information on the immediate packaging 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 taking 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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. The medicine is formulated as prolonged-release tablets. The tablet has been specially prepared and contains excipients that enable 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 such patients, Klacid with non-extended 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), or pimozide (a medicine used for psychiatric disorders), because concomitant use with Klacid may lead to 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 or simvastatin (medicines belonging to the statin group, used to reduce blood cholesterol levels).
• If the patient has severe hepatic impairment associated with renal impairment.
• If the patient has a history of cardiac arrhythmias (ventricular arrhythmias, including torsade de pointes) or ECG abnormalities known as "long QT syndrome", either personally or in the family.
• If the patient is taking colchicine (a medicine used for 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 the 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 must 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
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)
• 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 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 oral mucosal midazolam (medicines used for anxiety 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 that reduces gastric acid secretion)
• cilostazol (a medicine used for intermittent claudication, characterised by leg muscle pain during exercise that resolves with short 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 for 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 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 fetus.
Since clarithromycin passes into human milk, women who are breastfeeding 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 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
Quinoline yellow (a colouring agent) may cause allergic reactions in sensitive individuals.

3. How to use Klacid Uno

This medicine should always be taken 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 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
Klacid Uno in the form of an 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 dose reduction is not possible (the tablet cannot be divided).
In these patients, a medicine containing clarithromycin with immediate release is recommended.

Taking more Klacid Uno than recommended
If you have taken more Klacid Uno than recommended, seek immediate advice 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 Klacid Uno treatment
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Do not stop treatment, even if you feel better and symptoms improve 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, pale skin, 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, peeling rash with subcutaneous nodules and blisters
  • bullous erythema multiforme (Stevens-Johnson syndrome) characterized by sudden onset of fever and blisters, which resolve quickly 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 erosions on the skin, shedding of large sheets of epidermis, and fever
  • DRESS syndrome – a severe (life-threatening) drug eruption occurring with an increase in 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 completion of clarithromycin treatment. In such cases, medical advice should also be sought
• 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 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 reactions occur with unknown frequency unless otherwise stated.

Other adverse reactions
The following adverse reactions were frequently reported in clinical studies and after marketing of clarithromycin (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
• anorexia, decreased appetite
• anxiety
• dizziness, drowsiness, tremor
• imbalance, hearing loss, tinnitus
• palpitations, changes in ECG recording (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 strength)

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

• rosacea
• agranulocytosis (reduced granulocyte count 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
• torsade de pointes arrhythmia, ventricular tachycardia, ventricular fibrillation
• hemorrhage
• acute pancreatitis, tongue discoloration, tooth discoloration
• myopathy (muscle disease with reduced muscle strength)
• 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, flatulence, 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 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.: 22 49 21 301, fax: 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 the 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, 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 prolonged-release tablets.
The tablet is yellow and oval-shaped.
The pack contains 5, 7, 10, 14 or 20 prolonged-release tablets, packed in
PVC/PVDC/Al blisters, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
MYLAN HEALTHCARE GmbH
Lütticher Straße 5
53842 Troisdorf
Germany
Manufacturer:
ABBVIE S.R.L.
S.R. 148 Pontina Km 52 snc
04011 Campoverde di Aprilia (LT)
Italy
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorisation number in Romania, country of export: 8384/2015/01
8384/2015/02
8384/2015/03
Parallel import authorisation number: 230/22