Klacid Uno

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Klacid Uno

500 mg, modified-release tablets

Clarithromycin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Klacid Uno and what is it 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 packaging and other information

1. What is Klacid Uno and what is it used for

Klacid Uno contains the active substance clarithromycin. It is a macrolide antibiotic that inhibits the growth of bacteria that cause infections. The medicine is in the form of modified-release tablets. The tablet has been prepared in a special way and contains excipients that allow for modification of the release rate and time 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 susceptible 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., infectious eczema, folliculitis, cellulitis, erysipelas, abscesses).

2. Important information before taking Klacid Uno

When not to take 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), as there is no possibility of reducing the dose (the tablets cannot be divided). In these patients, it is recommended to use a medicine containing clarithromycin with immediate release of the active substance.
• If the patient is taking ergot alkaloids, such as ergotamine or dihydroergotamine (used, among other things, in migraine) or oral midazolam (used in anxiety and insomnia).
• If the patient is taking medicines that may cause severe heart rhythm disturbances.
• If the patient is taking astemizole or terfenadine (used in allergies), cisapride or domperidone (used in gastrointestinal disorders), pimozide (used in psychiatric disorders), as concurrent use with Klacid Uno may cause severe heart rhythm disturbances.
• If the patient is taking ticagrelor or ranolazine (used in heart and circulation diseases).
• If the patient is taking colchicine (used in gout).
• If the patient is taking statins - lovastatin, simvastatin (used to lower cholesterol levels in the blood).
• If the patient is taking oral midazolam (used in anxiety and insomnia).

Warnings and precautions

If the patient has any of the following conditions, they should discuss this with their doctor before starting treatment with Klacid Uno.

• The patient is pregnant or thinks they may be pregnant.
• The patient has kidney or liver function disorders.
• The patient has coronary artery disease, severe heart failure, or bradycardia.
• The patient is taking any of the medicines listed in the "Klacid Uno and other medicines" section.

If any of the following situations occur during treatment with Klacid Uno, the patient should tell their doctor.

• Severe hypersensitivity reactions, such as rash, urticaria, angioedema, bronchospasm. The patient should immediately consult a doctor, who will provide appropriate treatment.
• Diarrhea, especially acute or prolonged. The patient should tell their doctor as soon as possible. If necessary, the doctor will prescribe appropriate treatment. The patient should not take anti-diarrheal medicines.
• Symptoms of liver function disorders, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. The patient should stop treatment and consult a doctor.
• New infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially during prolonged use of the antibiotic. The doctor will prescribe appropriate treatment.

In addition, during treatment with Klacid Uno, the following may occur:

• Cross-resistance of bacteria (bacteria resistant to clarithromycin may also be resistant to other macrolide antibiotics and lincosamides and clindamycin).

Klacid Uno and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The patient must inform their doctor if they are taking any of the following medicines, as their use with Klacid Uno is contraindicated:

• Ergot alkaloids, such as ergotamine or dihydroergotamine (used, among other things, in migraine)
• Astemizole or terfenadine (used in allergies)
• Cisapride or domperidone (used in gastrointestinal disorders)
• Pimozide (used in psychiatric disorders)
• Ticagrelor or ranolazine (used in heart and circulation diseases)
• Colchicine (used in gout)
• Statins - lovastatin, simvastatin (used to lower cholesterol levels in the blood)
• Oral midazolam (used in anxiety and insomnia)

The patient should inform their doctor if they are taking any of the following medicines, as special caution is required when using them with Klacid Uno:

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 treatment)
• Digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (medicines used in heart rhythm disorders or hypertension)
• Alprazolam, triazolam, intravenous or oral midazolam (medicines used in anxiety and insomnia)
• Warfarin or other oral anticoagulants, such as dabigatran, rivaroxaban, apixaban (medicines used to thin the blood)
• Quetiapine or other atypical antipsychotics
• Carbamazepine, valproate, phenytoin (antiepileptic medicines)
• Methylprednisolone (anti-inflammatory medicine)
• Omeprazole (medicine that reduces stomach acid production)
• Cilostazol (medicine used in intermittent claudication, which is characterized by leg pain during exercise and relieved by rest)
• Cyclosporine, tacrolimus, sirolimus (medicines used, among other things, after transplants)
• Sildenafil, tadalafil, vardenafil (medicines used in erectile dysfunction)
• Ibrutinib or vinblastine (medicines used in cancer chemotherapy)
• Theophylline (medicine used in asthma)
• Tolterodine (medicine used in urinary incontinence)
• Phenobarbital (antiepileptic medicine)
• St. John's wort (herbal medicine used in mild depression)
• Sulfonylurea, nateglinide, repaglinide, insulin (medicines used in diabetes)

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

The safety of clarithromycin during pregnancy and breastfeeding has not been established.

Klacid Uno may be used during pregnancy only if the doctor believes that the benefits to the mother outweigh the potential risks to the fetus.

As clarithromycin passes into breast milk, breastfeeding women should exercise caution when taking Klacid Uno.

Driving and using machines

The medicine may cause dizziness, confusion, and disorientation, which may affect the ability to drive and use machines.

Klacid Uno contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Klacid Uno contains sodium

The medicine contains 15.3 mg of sodium (the main component of common salt) per tablet.

If the patient takes 2 tablets of Klacid Uno per day, the total amount of sodium ingested is 30.6 mg.

This corresponds to 1.5% of the maximum recommended daily intake of sodium in the diet for adults.

Klacid Uno contains quinoline yellow

Quinoline yellow (dye) may cause allergic reactions in sensitive individuals.

3. How to take Klacid Uno

This medicine should always be taken as directed by the doctor.

In case of doubts, the patient should consult their doctor or pharmacist.

The medicine is for oral use.

The tablet should be swallowed whole, with water. It should not be chewed, divided, or sucked.

Adults

Recommended dose: one 500 mg tablet, once a day, during a meal.

In severe infections, the dose may be increased to 1 gram once a day (two 500 mg tablets).

Treatment usually lasts 5 to 14 days.

Only in the case of pneumonia or sinusitis should the medicine be taken for 6 to 14 days.

Children over 12 years of age

Dosing is the same as for adults.

Children under 12 years of age

It is recommended to use Klacid in the form of an oral suspension.

Patients with renal impairment

In patients with moderate renal impairment (creatinine clearance 30 to 60 ml/min), the dose of Klacid Uno should be reduced by half, i.e., to a maximum of 1 tablet of Klacid Uno per day.

In patients with severe renal impairment (creatinine clearance less than 30 ml/min), Klacid Uno is contraindicated, as there is no possibility of reducing the dose (the tablets cannot be divided).

In these patients, it is recommended to use a medicine containing clarithromycin with immediate release of the active substance.

Taking a higher dose of Klacid Uno than recommended

In case of taking a higher dose of Klacid Uno than recommended, the patient should immediately consult their doctor or pharmacist.

Taking a higher dose of Klacid Uno than recommended by the doctor may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missing a dose of Klacid Uno

In case of missing a dose of Klacid Uno, the patient should take it as soon as possible, and then take the next dose at the scheduled time.

The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Klacid Uno

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

The patient should not stop treatment, even if they feel better and the symptoms of the disease have disappeared after a few days of taking the medicine.

4. Possible side effects

Like all medicines, Klacid Uno can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects at any stage of treatment with Klacid Uno, they should stop taking the medicine and consult their doctor immediately:

• Anaphylactic shock - a life-threatening allergic reaction, characterized by confusion, pallor, low blood pressure, sweating, oliguria, tachypnea, weakness, and fainting
• Allergic reactions: rash (frequent), itching, urticaria (uncommon), angioedema of the face, tongue, lips, eyes, and throat, difficulty breathing
• Severe skin reactions:
• Acute generalized exanthematous pustulosis - a red, scaly rash with papules and blisters under the skin
• Stevens-Johnson syndrome - a severe disease characterized by sudden onset of fever and blisters, which heal quickly and spontaneously after discontinuation of the medicine
• Toxic epidermal necrolysis - a severe, rapidly progressing disease characterized by large, blistering skin lesions, extensive skin necrosis, and fever
• DRESS syndrome - a severe (life-threatening) drug rash, which occurs with an increase in the number of eosinophils and involvement of internal organs
• Severe or prolonged diarrhea, which may be bloody or contain mucus. Diarrhea may occur even after two months after completion of clarithromycin treatment. In such cases, the patient should also consult their doctor
• Jaundice, skin irritation, dark urine, itching, or abdominal pain. These may be symptoms of liver function disorders
• Muscle swelling, cramps, and pain, which may be symptoms of rhabdomyolysis (a syndrome of disease symptoms caused by muscle tissue breakdown). In some cases of rhabdomyolysis, clarithromycin was administered concurrently with other medicines known to cause rhabdomyolysis, such as lipid-lowering agents (e.g., statins, fibrates) or gout medicines (e.g., colchicine or allopurinol). These reactions occur with unknown frequency, unless otherwise specified.

Other side effects

In clinical trials and after the medicine was marketed, clarithromycin oftencaused the following side effects (occurring in 1 to 10 out of 100 patients):

• Insomnia
• Taste disorders, headache
• Diarrhea, vomiting, nausea, abdominal pain
• Abnormal liver function test results
• Excessive sweating

Side effects reported uncommonly(occurring in 1 to 10 out of 1,000 patients):

• Candidiasis (fungal infection), gastritis, vaginal infection
• Decreased white blood cell count
• Hypersensitivity
• Anorexia, decreased appetite
• Restlessness
• Dizziness, drowsiness, tremors
• Balance disorders, hearing loss, tinnitus
• Palpitations, changes in ECG (QT interval prolongation)
• Nosebleeds
• Gastroesophageal reflux disease, gastritis, proctitis, stomatitis, glossitis, constipation, dry mouth, belching, flatulence
• Increased activity of liver enzymes: aspartate aminotransferase (AST), alanine aminotransferase (ALT)
• Muscle pain
• Asthenia (weakness, lack of strength)

The following side effects have been reported with unknown frequency(frequency cannot be estimated from available data) after marketing of Klacid tablets and suspension:

• Rosacea
• Agranulocytosis (decreased granulocyte count), thrombocytopenia (decreased platelet count)
• Acne
• Psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania
• Seizures, ageusia, dysgeusia, anosmia, paresthesia (numbness, tingling)
• Deafness
• Heart rhythm disorders, such as torsades de pointes, ventricular tachycardia, atrial fibrillation
• Bleeding
• Acute pancreatitis, tongue discoloration, tooth discoloration
• Myopathy (muscle disease with muscle weakness), muscle pain
• Kidney failure, interstitial nephritis
• Changes in laboratory test results (increased international normalized ratio (INR), prolonged prothrombin time, abnormal urine color)

Patients with impaired immune function

In addition to symptoms related to the course of the disease, the following side effects have been observed in adult patients with impaired immune function:

• Nausea, vomiting, changes in taste, constipation, abdominal pain, diarrhea, flatulence, dry mouth
• Headache, hearing disorders
• Rash
• Dyspnea, insomnia
• Abnormal laboratory test results: increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT), increased blood urea nitrogen, decreased platelet and white blood cell count

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 side effects will help gather more information on the safety of the medicine.

5. How to store Klacid Uno

The medicine should be stored 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 month stated.

Do not store above 30°C.

Store in the outer packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the packaging and other information

What Klacid Uno contains

• The active substance of the medicine is clarithromycin. One modified-release tablet contains 500 mg of clarithromycin.
• The other ingredients are: citric acid, sodium alginate, calcium sodium alginate, lactose monohydrate, povidone K 30, talc, stearic acid, magnesium stearate; coating ingredients: hypromellose, macrogol 400, macrogol 8000, titanium dioxide (E 171), quinoline yellow (E 104) (aluminum lake), sorbic acid.

What Klacid Uno looks like and what the packaging contains

Klacid Uno is available in the form of modified-release tablets.

The tablet is yellow, oval in shape.

The packaging contains: 7 tablets, 14 tablets.

PVC/PVdC/Aluminum blisters in a cardboard box.

For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

Mylan Österreich GmbH

Guglgasse 15

1110 Vienna

Austria

Manufacturer:

AbbVie S.r.L.

04011 Campoverde di Aprilia

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

Austrian marketing authorization number:1-22085

Parallel import authorization number: 54/22 Date of leaflet approval: 19.01.2022

[Information about the trademark]