Klacid Uno

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Klacid Uno (Klacid SR)

500 mg, prolonged-release tablets

Clarithromycin
Klacid Uno and Klacid SR are different trade names for the same medicine.

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 you need to.
• In case of any doubts, you should consult a 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 pack 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 prolonged-release tablets. 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 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 (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 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 concomitant 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 has too low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia).
• If the patient is taking lovastatin, 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 "long QT syndrome".
• 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 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, purpura, 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 infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially during long-term use of the antibiotic. The doctor will prescribe appropriate treatment.

In addition, while taking 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 in migraine)
• Astemizole or terfenadine (used in allergies)
• Cisapride or domperidone (used in gastrointestinal disorders)
• Pimozide (used in psychiatric disorders)
• Ticagrelor, 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 taking 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 heart rhythm disorders or hypertension)
• Alprazolam, triazolam, midazolam (used in anxiety and insomnia)
• Warfarin or other anticoagulant medicines, such as dabigatran, rivaroxaban, apixaban (used to thin the blood)
• Quetiapine or other atypical antipsychotic medicines
• 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 that disappears after a short 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)
• Sulfonylurea, nateglinide, repaglinide, insulin (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 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 (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. If in doubt, 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
It is recommended to use Klacid Uno in the form of an oral suspension.
Patient 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 Klacid Uno

In case of any further doubts about taking 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 disappear 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 consult their doctor immediately:

• Anaphylactic shock - a life-threatening allergic reaction, characterized by confusion, pallor, low blood pressure, sweating, decreased urine production, rapid breathing, weakness, and fainting
• Allergic reactions: rash (common), 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 bumps under the skin and blisters
• Stevens-Johnson syndrome - a severe skin and mucous membrane disorder, characterized by a sudden onset of fever and blisters, which resolve on their own after stopping the medicine; a severe disease characterized by blisters and ulcers on the skin, in the mouth, eyes, and genital areas, fever, and joint pain
• Toxic epidermal necrolysis - a severe, rapidly progressing disease, characterized by large, bursting blisters under the skin, widespread ulcers on the skin, shedding of large skin flakes, 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, which may contain blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even two months after stopping clarithromycin treatment. In such cases, the patient should also consult their doctor
• Jaundice, skin irritation, light-colored stools, dark urine, itching, or abdominal pain. These may be symptoms of liver failure
• Muscle swelling, cramps, and pain, which may be symptoms of rhabdomyolysis (a syndrome of 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, the following side effects were commonly reported (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
• Restlessness
• 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
• 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)
• Kidney failure, interstitial nephritis
• Changes in laboratory test results (increased international normalized ratio (INR), prolonged prothrombin time, abnormal urine color)

Patient with impaired immune system
In addition to symptoms related to the underlying disease, the following side effects have been observed in adult patients with impaired immune system:

• 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 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 Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected 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 expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 30°C, in the original packaging.
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 pack and other information

What Klacid Uno contains

• The active substance of the medicine is clarithromycin. One prolonged-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, 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 pack contains

Klacid Uno is available in the form of prolonged-release tablets.
The tablet is yellow, oval in shape.
The pack contains 5, 7, 10, 14, or 20 prolonged-release tablets, packaged in a PVC/PVDC/Al blister pack, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

MYLAN HEALTHCARE GmbH
Lütticher Straße 5
53842 Troisdorf
Germany

Manufacturer:

ABBVIE S.R.L.
S.R. 148 Pontina Km 52 snc
04011 Campoverde di Aprilia (LT)
Italy

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Romanian marketing authorization number: 8384/2015/01
8384/2015/02
8384/2015/03
Parallel import authorization number: 230/22
Date of leaflet approval: 26.05.2022
[Information about the trademark]