Klacid Uno

Leaflet attached to the packaging: patient information

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 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 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 (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 medications 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 "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 them 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 medications listed in the "Klacid Uno and other medications" section.

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

• Severe allergic reactions, such as rash, urticaria, angioedema, or anaphylaxis. The patient should immediately consult 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 medications.
• 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 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).

If symptoms of hearing or balance organ damage occur (see section 4), it is recommended to perform appropriate follow-up tests after completing treatment.

Klacid Uno and other medications

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

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

Klacid Uno:

• Rifampicin, rifapentine, rifabutin (antibiotics used in tuberculosis treatment)
• Fluconazole, itraconazole (antifungal medications)
• 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 intravenously or orally (used in anxiety or insomnia)
• Warfarin or other anticoagulant medications, such as dabigatran, rivaroxaban, apixaban, edoxaban (used to thin the blood)
• Quetiapine or other atypical antipsychotics
• Carbamazepine, valproate, phenytoin (antiepileptic medications)
• Methylprednisolone (anti-inflammatory medication)
• Omeprazole (medication that reduces stomach acid production)
• Cilostazol (medication used in intermittent claudication)
• Cyclosporine, tacrolimus, sirolimus (medications used in organ transplantation)
• Sildenafil, tadalafil, vardenafil (medications used in erectile dysfunction)
• Ibrutinib or vinblastine (medications used in cancer chemotherapy)
• Theophylline (medication used in asthma)
• Tolterodine (medication used in urinary incontinence)
• Phenobarbital (antiepileptic medication)
• St. John's Wort (herbal medication used in mild depression)
• Sulfonylureas, nateglinide, repaglinide, insulin (medications used in diabetes)

This is also important for the following medications:

• Hydroxychloroquine or chloroquine (used in rheumatoid arthritis, malaria treatment, or prevention)
• Corticosteroids administered orally, by injection, or inhalation (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 medication.

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

Klacid Uno may be used during pregnancy only if the doctor believes 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 operating machinery

The medication may cause dizziness, confusion, and disorientation, which can affect the ability to drive and operate machinery.

Klacid Uno contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medication.

Klacid Uno contains sodium

The medication contains 15.3 mg of sodium (the main component of table 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 sodium intake 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 medication should always be taken as directed by the doctor.

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

The medication 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 per day, taken during a meal.

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

Treatment usually lasts 5 to 14 days.

Only in the case of pneumonia or sinusitis should the medication 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, to a maximum of one tablet 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 medication 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 medication, 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 medication.

4. Possible side effects

Like all medications, Klacid Uno can cause side effects, although not everyone will experience 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, pale skin, low blood pressure, sweating, decreased urine production, rapid breathing, weakness, and fainting
• Allergic reactions: rash (frequent), itching, urticaria (less frequent), 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 disease characterized by sudden onset of fever and blisters, which resolve spontaneously after discontinuation of the medication; 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, extensive skin ulcers, and fever
• DRESS syndrome - a severe (life-threatening) drug rash that occurs with 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 completing treatment with clarithromycin. In such cases, the patient should also consult their doctor
• Jaundice, skin irritation, light-colored 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 medications known to cause rhabdomyolysis, such as lipid-lowering medications (e.g., statins, fibrates) or medications used in gout (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 frequently 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

The following side effects were reported less frequently (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, bloating with gas
• 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 an 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, loss of taste, abnormal smell, loss of smell, 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 diagnostic 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 disease, the following side effects have been observed in adult patients with impaired immune function:

• Nausea, vomiting, changes in taste, constipation, abdominal pain, diarrhea, bloating with gas, 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 those 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.: 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 medication.

5. How to store Klacid Uno

The medication should be stored out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after "EXP".

The expiration date refers to the last day of the specified month.

The batch number is listed on the packaging after "Lot".

Do not store above 30°C.

Medications should not be disposed of in wastewater or household waste.

The patient should ask their pharmacist how to dispose of unused medications.

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: anhydrous citric acid, sodium alginate, sodium-calcium alginate, lactose, povidone K30, talc, stearic acid, magnesium stearate; coating ingredients: hypromellose 6 cps, macrogol 400, macrogol 8000, titanium dioxide, quinoline yellow E 104 (aluminum lake), potassium sorbate

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 and oval in shape.

The packaging contains: 4 tablets in 1 blister pack, 5 tablets in 1 blister pack, 7 tablets in 1 blister pack, 10 tablets in 2 blister packs of 5 tablets each, 10 tablets in 1 "double bubble" blister pack, 14 tablets in 2 blister packs of 7 tablets each, 14 tablets in 1 "double bubble" blister pack, 20 tablets in 2 blister packs of 10 tablets each, 20 tablets in 2 "double bubble" blister packs.

Blisters are made of PVC film coated with PVDC, connected to aluminum foil, in a cardboard box.

"Double bubble" blisters (2 tablets per compartment) are made of PVC film coated with PVDC, connected to aluminum foil, in a cardboard box.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.

ul. Postępu 21B

02-676 Warsaw

Manufacturer

Aesica Queenborough Limited

Queenborough

Kent ME11 5EL

United Kingdom

AbbVie S.r.l.

S.R. 148 Pontina km 52 snc

04011 Campoverde di Aprilia (LT)

Italy

To obtain more detailed information about this medication, the patient should contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

ul. Postępu 21B

02-676 Warsaw

Tel.: 22 546 64 00

Date of last update of the leaflet: