Klabion Uno

Package Leaflet: Information for the Patient

Klabion UNO, 500 mg, Prolonged-Release Coated Tablets

Clarithromycin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Klabion UNO and what is it used for
• 2. Important information before taking Klabion UNO
• 3. How to take Klabion UNO
• 4. Possible side effects
• 5. How to store Klabion UNO
• 6. Contents of the pack and other information

1. What is Klabion UNO and what is it used for

Klabion UNO is an antibiotic belonging to a group of medicines called macrolides. Antibiotics inhibit the growth of certain microorganisms that cause infections. Its use is described below.
The tablets of Klabion UNO are prolonged-release tablets, which means that the active substance is released from the tablet slowly, so it is sufficient to take the medicine once a day.

What is Klabion UNO used for?

Klabion UNO is used to treat infections such as:

• 1. Chest infections, such as bronchitis or pneumonia,
• 2. Throat and sinus infections,
• 3. Skin and soft tissue infections, which can also be referred to as connective tissue inflammation, folliculitis or rosacea.

Klabion UNO is indicated for use in adults and adolescents over 12 years of age.

2. Important information before taking Klabion UNO

When not to take Klabion UNO

• If the patient is allergic to clarithromycin or other antibiotics from the same group (macrolide antibiotics), such as erythromycin or azithromycin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking ergot alkaloids (e.g., ergotamine or dihydroergotamine in tablets or ergotamine in inhalation form for the treatment of migraine, or midazolam in oral form (a medicine used for anxiety and insomnia).
• If the patient is taking other medicines that may cause severe heart rhythm disturbances.
• If the patient is taking medicines such as astemizole or terfenadine (medicines used to treat hay fever or allergies), cisapride or domperidone (medicines used to treat stomach disorders) or pimozide (a medicine used to treat certain mental disorders) - taking these medicines with Klabion UNO may sometimes cause severe heart rhythm disturbances.
• If the patient is taking ticagrelor, ivabradine or ranolazine (medicines used to treat angina pectoris or to reduce the risk of heart attack or stroke).
• If the patient has abnormally low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia).
• If the patient is taking medicines that lower cholesterol levels (such as lovastatin or simvastatin).
• If the patient is taking a medicine containing lomitapide.
• If the patient has severe liver or kidney function disorders.
• If the patient has or has had heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or an electrocardiogram abnormality known as "prolonged QT interval".
• If the patient is taking colchicine (a medicine used to treat gout).

Before taking clarithromycin, consult a doctor if any of these conditions apply to the patient.

Warnings and precautions

Before starting treatment with Klabion UNO, discuss it with your doctor or pharmacist:

• if the patient is pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if the patient experiences severe or prolonged diarrhea during or after treatment with Klabion UNO - in such cases, contact a doctor immediately;
• if the patient has heart problems (coronary artery disease, severe heart failure, heart rhythm disturbances or very slow heart rate);
• if the patient has liver or kidney function disorders, as the dose may need to be reduced.

Before taking clarithromycin, consult a doctor if any of these conditions apply to the patient.

Klabion UNO and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, as a dose change or regular tests may be necessary.
Klabion UNO should not be taken with the following medicines: ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain cholesterol-lowering medicines, and medicines that may cause severe heart rhythm disturbances (see "When not to take Klabion UNO").
In particular, tell your doctor if you are taking any of the following medicines:

• Digoxin, quinidine or disopyramide (heart medicines).
• Warfarin or any other anticoagulant, such as dabigatran, rivaroxaban, apixaban, edoxaban (blood thinners).
• Eletriptan (a medicine used to treat migraines).
• Carbamazepine, valproic acid, phenobarbital or phenytoin (medicines used to treat epilepsy or bipolar disorder).
• St. John's Wort (herbal products used to treat depression).
• Theophylline (a medicine used to treat asthma or chronic obstructive pulmonary disease).
• Triazolam, alprazolam or midazolam given intravenously or orally (sedatives and sleeping pills).
• Omeprazole (a medicine used to treat stomach disorders).
• Quetiapine or ziprasidone (medicines used to treat schizophrenia or other mental disorders).
• Zidovudine, ritonavir, atazanavir, saquinavir, nevirapine, efavirenz or etravirine (medicines used to treat HIV infections).
• Rifabutin, rifapentine or rifampicin (antibiotics used to treat certain infections, such as tuberculosis).
• Itraconazole or fluconazole (medicines used to treat fungal infections).
• Sildenafil, tadalafil or vardenafil (medicines used to treat erectile dysfunction).
• Tolterodine (a medicine used to treat bladder disorders).
• Methylprednisolone (a steroid used to treat inflammatory conditions).
• Ibrutinib or vinblastine (medicines used to treat cancer).
• Aprepitant (a medicine used to prevent nausea and vomiting during chemotherapy).
• Cilostazol (a medicine used to improve blood circulation in the legs).
• Any beta-lactam antibiotic (penicillins and cephalosporins).
• Tacrolimus, sirolimus or cyclosporin (medicines used in organ transplants).
• Nateglinide, repaglinide, sulfonylurea derivatives or insulin (medicines used to treat diabetes).
• Aminoglycosides (a group of antibiotics used to treat bacterial infections).
• Calcium channel blockers (medicines used to treat high blood pressure).

This is also important when taking the following medicines:

• Hydroxychloroquine or chloroquine (used to treat, among other things, rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines at the same time as 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 she may be pregnant or is planning to have a baby, she should consult a doctor or pharmacist before taking this medicine. The safety of Klabion UNO during pregnancy or breastfeeding has not been established.

Driving and using machines

Klabion UNO may cause dizziness, which may affect the ability to drive and use machines.

Klabion UNO contains lactose

This medicine contains lactose, a type of sugar.
If the patient has been diagnosed with intolerance to some sugars, the patient should contact a doctor before taking the medicine.

3. How to take Klabion UNO

This medicine should always be taken as directed by the doctor. In case of doubt, consult a doctor or pharmacist.
Usually, the recommended dose of Klabion UNO for adults and adolescents over 12 years of age is 500 mg once a day for 6 to 14 days.
In severe infections, the doctor may increase the dose to two 500 mg tablets. Both tablets should be taken at the same time.

Route and method of administration

Klabion UNO should be taken with food; the tablets should be swallowed whole, not chewed.
Each dose should be taken at the same time every day throughout the treatment period.
Do not stop taking Klabion UNO if the patient feels better. It is important to take the tablets for as long as the doctor has prescribed, otherwise the infection may not be completely cured and the problem may return.

Children

These tablets are not suitable for children under 12 years of age, as they may have difficulty swallowing tablets. In children, it is usually better to use liquid medicines. The doctor will prescribe another medicine suitable for the child.

Missing a dose of Klabion UNO

If a dose of Klabion UNO is missed, it should be taken as soon as the patient remembers. Do not take a double dose to make up for the missed dose.

Taking more than the recommended dose of Klabion UNO

If more than two tablets of Klabion UNO are taken accidentally in one day, or if a child accidentally swallows several tablets, contact a doctor immediately, even if no symptoms occur. Overdose of Klabion UNO may cause vomiting and stomach pain, and allergic reactions may also occur.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the tablets and contact a doctor immediately if any of the following symptoms occur:

• Severe or prolonged diarrhea with blood or mucus in the stool, abdominal pain and fever. Diarrhea may occur even two months after treatment with clarithromycin.
• Rash, difficulty breathing, fainting or swelling of the face and throat. Contact a doctor immediately, as these may be symptoms of an allergic reaction and may require emergency treatment.
• Lack of appetite, yellowing of the skin (jaundice), dark urine, pale stools, itching or sore abdomen. Contact a doctor immediately, as these may be symptoms of liver function disorders.
• Severe skin reactions, potentially life-threatening, such as blisters on the skin, mouth, lips, eyes and genitals (symptoms of a rare allergic reaction known as Stevens-Johnson syndrome and (or) toxic epidermal necrolysis) or red, scaly rash with lumps under the skin and blisters (symptoms of pustular psoriasis). The frequency of this side effect is unknown (cannot be estimated from the available data).
• Muscle pain or weakness known as rhabdomyolysis (a condition that causes muscle tissue to break down, which can lead to kidney damage).

Other side effects

Common (occurring in less than 1 in 10 patients):

• Insomnia
• Headache
• Changes in taste
• Diarrhea
• Vomiting
• Nausea
• Queasiness
• Indigestion, abdominal pain
• Abnormal blood test results (elevated liver enzyme levels)
• Rash
• Excessive sweating.

Uncommon (occurring in less than 1 in 100 patients):

• Infections, such as gastritis, skin inflammation, oral thrush or vaginal thrush
• Low white blood cell count and other white blood cell disorders
• Allergic reactions, such as rash, swelling, itching, hives
• Lack of appetite
• Anxiety
• Nervousness
• Fainting, dizziness, tremors, drowsiness
• Ringing in the ears, dizziness (feeling of spinning) and ear disorders
• Lack of energy, chest pain, facial swelling, feeling of general discomfort, pain and thirst
• Changes in heart rhythm, prolonged QT interval in the electrocardiogram (abnormal ECG)
• Asthma and shortness of breath
• Nosebleeds
• Constipation, anal pain, dry mouth, gas in the stomach, belching and bloating (gas)
• Heartburn, gastritis (inflammation of the stomach lining), oral inflammation, tongue inflammation
• Muscle pain, muscle cramps
• Chills, fatigue, fever.

Frequency not known (cannot be estimated from the available data):

• Bacterial infection of the outer skin layers
• Psychiatric disorders, such as unusual dreams, confusion, depersonalization, disorientation, hallucinations (seeing things that do not exist), psychotic disorders, depression, mania
• Seizures or convulsions, loss of taste, inability to smell or loss of sense of smell, tingling
• Deafness
• Ventricular fibrillation (uncoordinated contraction of the heart muscle)
• Bleeding
• Kidney disorders, including kidney inflammation and blood in the urine
• Acute pancreatitis (pain in the upper abdomen that radiates to the back, which may be associated with loss of appetite, nausea or vomiting)
• Discoloration of the tongue, discoloration of the teeth
• Acne
• Low blood cell count (symptoms may include pale skin and fatigue) and low levels of certain blood elements that help fight infections (symptoms may include sore throat, fever, feeling of extreme weakness, easy bruising, bleeding)
• Muscle weakness.

Blood tests performed while taking clarithromycin may show decreased clotting factor levels and increased levels of other enzymes, as well as detect protein in the urine.
If diarrhea occurs during or after treatment with clarithromycin, consult a doctor immediately. Diarrhea may occur as a reaction to the medicine, or it may be a sign of a more serious condition. The doctor will determine the cause of the diarrhea.
In the unlikely event that the infection is caused by a microorganism against which Klabion UNO is not effective, the symptoms may worsen. In such cases, consult a doctor.
If side effects worsen or any side effects not listed in this leaflet occur, inform a doctor or pharmacist.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. 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
Phone: +48 22 49 21 301
Fax: +48 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 Klabion 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 carton.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
After the expiry date, return the medicine to the pharmacy and, if necessary, consult a doctor for a new prescription.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Klabion UNO contains

• The active substance of the medicine is clarithromycin citrate. Each prolonged-release coated tablet contains 500 mg of clarithromycin.
• The other ingredients are: Tablet core: Lactose monohydrate, Hypromellose, Hypromellose phthalate, Magnesium stearate, Talc

Tablet coating:
Hypromellose 15cP
Lactose monohydrate
Titanium dioxide (E171)
Macrogol 4000
Talc
Macrogol 400
Quinoline yellow, lake (E104)

What Klabion UNO looks like and what the pack contains

Yellow, oblong, biconvex, prolonged-release coated tablets.
Klabion UNO is available in blisters in packs containing:
5, 7, 10, 14 prolonged-release coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański

Importer

Farmaprojects S.A.U.
Parc Cientific de Barcelona
C/Baldiri Reixac, 4/12 i 15
08028 Barcelona
Spain
Date of leaflet approval:March 2024