Klacid Uno

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Klacid Uno

500 mg, tablets with modified release

Clarithromycin

The patient should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 tablets with modified release. The tablet has been prepared in a special way and contains excipients that allow for modification of the rate and time of release of the active substance.
Klacid Uno is indicated for use in adults and children over 12 years of age in 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., 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 (tablets cannot be divided). In these patients, it is recommended to use Klacid in the form of immediate-release tablets.
• If the patient is taking ergot alkaloids, such as ergotamine or dihydroergotamine (used in migraine), or midazolam orally (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 concomitant use with Klacid Uno may cause severe heart rhythm disturbances.
• If the patient is taking ticagrelor, ivabradine, or ranolazine (used in coronary artery disease or to reduce the risk of myocardial infarction or stroke).
• If the patient has low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia).
• If the patient is taking lovastatin or simvastatin (statins used to lower cholesterol levels in the blood).
• If the patient has severe liver impairment with concomitant renal impairment.
• If the patient or their family members have a history of heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or electrocardiogram (ECG) abnormalities known as "prolonged QT interval".
• If the patient is taking colchicine (used in gout).
• If the patient is taking a medicine containing lomitapide.

Warnings and precautions

If the patient has any of the following conditions, they should discuss this with their doctor before starting to take 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 while taking Klacid Uno, the patient should tell their doctor.

• Severe allergic reactions, such as rash, urticaria, angioedema, anaphylaxis. The patient should immediatelyconsult a doctor, who will provide appropriate treatment.
• Diarrhea, especially severe 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 infections (superinfections) with bacteria resistant to clarithromycin or fungi, especially during long-term use of antibiotics. The doctor will prescribe appropriate treatment.

In addition, while taking Klacid Uno, the patient may experience:

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

If the patient experiences symptoms of hearing or balance organ damage (see section 4), it is recommended to perform appropriate control tests after completing treatment.

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 in migraine)
• Astemizole or terfenadine (used in allergies)
• Cisapride or domperidone (used in gastrointestinal disorders)
• Pimozide (used in psychiatric disorders)
• Ticagrelor, ranolazine (used in coronary artery disease)
• Colchicine (used in gout)
• Statins - lovastatin, simvastatin (used to lower cholesterol levels in the blood)
• Midazolam orally (used in anxiety or 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 (used in HIV treatment)
• Digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used in arrhythmias or hypertension)
• Alprazolam, triazolam, midazolam intravenously or orally (used in anxiety or insomnia)
• Warfarin or other anticoagulant medicines, such as dabigatran, rivaroxaban, apixaban, edoxaban (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 (used in intermittent claudication, which is characterized by leg pain during exercise and relieved by rest)
• Cyclosporine, tacrolimus, sirolimus (used in organ transplantation)
• Sildenafil, tadalafil, vardenafil (used in erectile dysfunction)
• Ibrutinib or vinblastine (used in cancer chemotherapy)
• Theophylline (used in asthma)
• Tolterodine (used in urinary incontinence)
• Phenobarbital (antiepileptic medicine)
• St. John's Wort (herbal medicine used in mild depression)
• Sulfonylureas, nateglinide, repaglinide, insulin (used in diabetes) This is also important when taking the following medicines:
• Hydroxychloroquine or chloroquine (used in rheumatoid arthritis, malaria treatment or prevention) Taking these medicines with clarithromycin may increase the risk of heart rhythm disturbances and other serious side effects affecting the heart
• Corticosteroids taken orally, by injection, or inhaled (used to suppress the immune system, which is useful in treating many different diseases)

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.
Since 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
The recommended dose is 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
Klacid suspension is recommended.
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 (tablets cannot be divided).
In these patients, it is recommended to use a medicine containing clarithromycin with immediate release.

Taking a higher dose of Klacid Uno than recommended

If the patient takes a higher dose of Klacid Uno than recommended, they 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

If the patient misses a dose of Klacid Uno, they 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

If the patient has any further doubts about taking this medicine, they 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, they should stop taking Klacid Uno and immediately consult their doctor:

• 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 resolve spontaneously after discontinuation of the medicine; severe disease characterized by blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain
• Toxic epidermal necrolysis - a severe, rapidly progressing disease characterized by large, rupturing blisters under the skin, extensive erosions on the skin, exfoliation of large skin plates, and fever
• DRESS syndrome - a severe (life-threatening) drug rash characterized by an increased number of eosinophils and involvement of internal organs
• Severe or prolonged diarrhea, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even two months after completing treatment with clarithromycin. In such cases, the patient should also consult their doctor
• Jaundice, skin irritation, pale stools, dark urine, abdominal tenderness, or loss of appetite. These may be symptoms of liver failure
• 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 concomitantly with other medicines known to cause rhabdomyolysis, such as lipid-lowering agents (e.g., statins, fibrates); gout medicines (e.g., colchicine or allopurinol) These reactions occur with unknown frequency, unless otherwise specified.

Other side effects

In clinical trials and after marketing, clarithromycin commonlycaused 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 1000 patients):
• Candidiasis (fungal infection), gastritis, vaginal infection
• Decreased white blood cell count
• Hypersensitivity
• Anorexia, decreased appetite
• Anxiety
• Dizziness, drowsiness, tremors
• Balance disorders, hearing loss, tinnitus
• Palpitations, ECG changes (QT interval prolongation)
• Nosebleeds
• Gastroesophageal reflux disease, gastritis, proctitis, stomatitis, glossitis, constipation, dry mouth, belching, flatulence
• Increased liver enzyme activity: alanine aminotransferase (ALT), aspartate aminotransferase (AST)
• Muscle pain
• Asthenia (weakness, lack of energy)

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
• Arrhythmias, such as torsades de pointes, ventricular tachycardia, atrial fibrillation
• Bleeding
• Acute pancreatitis, tongue discoloration, tooth discoloration
• Myopathy (muscle disease with muscle weakness)
• Renal 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) activity, increased blood urea nitrogen levels, and decreased platelet and white blood cell counts.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 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.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
The medicine should not be stored at temperatures above 30°C. It should be stored in the outer packaging to protect it 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 Klacid Uno is clarithromycin. One modified-release tablet contains 500 mg of clarithromycin.
• The other ingredients are: citric acid (E 330), sodium alginate (E 401), sodium-calcium alginate, lactose monohydrate, povidone K 30, talc (E 553b), stearic acid, magnesium stearate; coating ingredients: hypromellose, macrogol 400, macrogol 8000, titanium dioxide (E 171), quinoline yellow, lake (E 104), 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 in 1 blister pack,
14 tablets in 2 blister packs of 7 tablets each.
Blisters made of PVC/PVDC/Al, 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:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin
Ireland

Manufacturer:

AbbVie S.r.L.
04011 Campoverde di Aprilia
Italy

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Austrian marketing authorization number: 1-22085

Parallel import authorization number: 246/16

Leaflet approval date: 09.04.2025

[Information about the trademark]