Klacid Uno

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.

Klacid Uno (Klacid SR)

500 mg, tablets with modified release

Clarithromycin
Klacid Uno Klacid SRare different trade names for the same drug.

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you 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 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 tablets with modified release. The tablet has been prepared in a special way and contains auxiliary substances 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 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. 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 a medicine containing clarithromycin with immediate release of the active substance.
• If the patient is taking ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, in migraine), or midazolam oral (a medicine used in anxiety and insomnia).

and other conditions.

• If the patient is taking medicines that may cause severe heart rhythm disturbances.
• If the patient is taking astemizole or terfenadine (medicines used in allergies), cisapride or domperidone (a medicine used in gastrointestinal disorders), pimozide (a medicine used in psychiatric disorders), as concomitant use with Klacid Uno may cause severe heart rhythm disturbances. If the patient is taking ticagrelor or ranolazine (medicines used in heart and circulation diseases). If the patient has too low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia). If the patient is taking lovastatin or simvastatin (statin medicines used to lower cholesterol levels in the blood). If the patient has severe liver impairment with concurrent 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 "long QT syndrome".
• If the patient is taking colchicine (a medicine 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 treatment with Klacid Uno.

• The patient is pregnant or suspects they are 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 immediatelyconsult 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 infections (superinfections) with bacteria or fungi, especially during long-term use of antibiotics. 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).

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 (medicines used, among others, in migraine),
• Astemizole or terfenadine (medicines used in allergies),
• Cisapride or domperidone (a medicine used in gastrointestinal disorders),
• Pimozide (a medicine used in psychiatric disorders), ticagrelor, ranolazine (medicines used in heart and circulation diseases) - colchicine (a medicine used in gout)
• Statins - lovastatin, simvastatin (medicines used to lower cholesterol levels in the blood),
• Midazolam oral (a medicine 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 the treatment of tuberculosis),
• Fluconazole, itraconazole (antifungal medicines),
• Atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (medicines used in the treatment of HIV infection),
• Digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (medicines used in the treatment of heart rhythm disorders or hypertension),
• Alprazolam, triazolam, midazolam intravenous or oral (medicines used in anxiety and insomnia), warfarin or other anticoagulant medicines, e.g. dabigatran, rivaroxaban, apixaban (medicines used to thin the blood),
• Quetiapine or other atypical antipsychotic medicines,
• Carbamazepine, valproate, phenytoin (antiepileptic medicines),
• Methylprednisolone (an anti-inflammatory medicine),
• Omeprazole (a medicine that reduces stomach acid production),
• Cilostazol (a medicine used in intermittent claudication, which is characterized by leg pain during exercise and relieved by rest),
• Cyclosporine, tacrolimus, sirolimus (medicines used, among others, after transplants),
• Sildenafil, tadalafil, vardenafil (medicines used in erectile dysfunction),
• Ibrutinib or vinblastine (medicines used in cancer chemotherapy),
• Theophylline (a medicine used in asthma),
• Tolterodine (a medicine used in urinary incontinence),
• Phenobarbital (an antiepileptic medicine),
• St. John's wort (a herbal medicine used in mild depression),
• Sulfonylurea, nateglinide, repaglinide, insulin (medicines used in diabetes).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects 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, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
As clarithromycin passes into breast milk, breastfeeding women should exercise special caution when taking Klacid Uno.

Driving and operating machines

The medicine may cause dizziness, confusion, and disorientation, which may affect the ability to drive and operate 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 (a dye) may cause allergic reactions in sensitive individuals.

3. How to take Klacid Uno

This medicine should always be taken according to the doctor's instructions. 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 g, 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 (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 takingthe medicine and immediately consult their doctor:

• Anaphylactic shock - a life-threatening allergic reaction, characterized by, among others, confusion, pallor, low blood pressure, sweating, oliguria, tachypnea, weakness, and fainting
• Allergic reactions: rash (frequent), itching, urticaria (infrequent), 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; a 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, bursting blisters under the skin, extensive erosions on the skin, and fever
• DRESS syndrome - a severe (life-threatening) drug rash, which progresses with an increased number of eosinophils and involvement of internal organs
• Severe or prolonged diarrhea, which may be accompanied by blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even two months after completion of clarithromycin treatment. In such cases, the patient should also consult their doctor
• Jaundice, skin irritation, pale stools, dark urine, itching, or abdominal tenderness. These may be symptoms of liver dysfunction
• Muscle swelling, cramps, and muscle 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 an unknown frequency, unless otherwise specified.

Other side effects

In clinical trials and after the introduction of clarithromycin to the market, the following side effects were frequentlyreported (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 infrequently(occurring in 1 to 10 out of 1000 patients):

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

The following side effects have been reported with an unknown frequency(frequency cannot be estimated from the available data) after the introduction of Klacid tablets and oral suspension to the market:

• Rosacea,
• Agranulocytosis (decreased granulocyte count in the blood), 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, including torsades de pointes, ventricular tachycardia, atrial fibrillation,
• Bleeding
• Acute pancreatitis, tongue discoloration, tooth discoloration,
• Myopathy (muscle disease with muscle weakness),
• Kidney failure, interstitial nephritis,
• Changes in laboratory test results (increased INR, prolonged prothrombin time, abnormal urine color).

Patients with impaired immune function
In addition to symptoms resulting from 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 impairment,
• Rash,
• Dyspnea, insomnia,
• Abnormal laboratory test results: increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT), increased blood urea nitrogen, and 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301,
Fax: 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
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.
Store at a temperature below 30°C. Store in the original 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 Klacid Uno 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, macrogol 400, macrogol 8000, titanium dioxide, quinoline yellow (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 in 1 blister pack,
14 tablets in 2 blister packs of 7 tablets each,
14 tablets in 1 "double bubble" blister pack.
Blister packs made of PVC/PVDC/Al foil in a cardboard box.
"Double bubble" blister packs (2 tablets per compartment) made of PVC/PVDC/Al foil in a cardboard box.
For more detailed information about the medicine, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the 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 by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Pharmaceutical-Chemical Company 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 JOINT-STOCK COMPANY, ul. Beskidzka 190, 91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export:15/062/98-C
Parallel import authorization number:20/17
Date of leaflet approval: 19.01.2022
[Information about the trademark]