Klacid uno

Package leaflet: Information for the patient

NOTE: 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 trade names for the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, 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 others, 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. The medicine is formulated as modified-release tablets. The tablet has been specially designed and contains excipients that modify the rate and timing 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 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 serious heart rhythm disorders.

• If the patient is taking astemizole or terfenadine (medicines used for allergy), cisapride or domperidone (medicines used for gastrointestinal motility disorders), pimozide (a medicine used for psychiatric disorders), because concomitant use with Klacid may cause serious heart rhythm disturbances. 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, 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 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 with 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 the doctor will initiate appropriate treatment.
• Diarrhoea, especially if acute or prolonged. Inform the doctor as soon as possible. If necessary, the doctor will recommend appropriate treatment. Do not use antidiarrhoeal 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 organisms resistant to clarithromycin or with 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 with other medicines
Tell your doctor about all medicines the patient is currently taking or has 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 allergy),
• 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),
• 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 together with Klacid Uno:

• Rifampicin, rifapentine, rifabutin (antibiotics used to treat tuberculosis),
• Fluconazole, itraconazole (antifungal medicines),
• Atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (medicines used to treat HIV infection),
• Digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (medicines used to treat 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 (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, which causes pain in the lower limb muscles during exercise and 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 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).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, 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 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, a breastfeeding woman should exercise particular caution when using Klacid Uno.

Driving and operating machinery
This 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 sodium intake in the diet 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 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.
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, a medicine containing clarithromycin with immediate release is recommended.
Taking more Klacid Uno than recommended
If more Klacid Uno has been taken 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 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 have improved 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 of taking the medicine,
discontinue taking Klacid and consult a doctor immediately:

• Anaphylactic shock – acute, life-threatening allergic reaction, manifested, among others, by confusion, pallor, 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, breathing difficulties
• 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, rapidly and spontaneously resolving after discontinuation of the drug; a severe condition 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 occurring with increased numbers 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, 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 of disorders 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 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 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 (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,
• Restlessness,
• 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, flatulence, increased activity of liver enzymes: 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 suspension, with unknown frequency (frequency cannot be estimated from available data):

• Erythema,
• 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, paraesthesia (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, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Klacid Uno contains

• The active substance is clarithromycin. One modified-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 95%, magnesium stearate; coating ingredients: hypromellose, polyethylene glycol 400, polyethylene glycol 8000, titanium dioxide, 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,
14 tablets in 2 blisters of 7 tablets each,
14 tablets in 1 "double bubble" blister.
Blister packs made of PVC/PVDC/Al foil in a cardboard box.
"Double bubble" blister packs (2 tablets per cavity) made of PVC/PVDC/Al foil in a cardboard box.
For more detailed information about the medicine, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Manufacturer:
AbbVie S.r.l., S.R. Via Pontina, km 52, 04011 Campoverde di Aprilia, Italy

Parallel Importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
CEFEA Sp. z o.o. sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warsaw
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź

Marketing Authorisation Number in the Czech Republic, country of export: 15/062/98-C
Parallel Import Authorisation Number: 20/17