Klacid

Package leaflet: Information for the patient

Klacid, 250 mg/5 ml, granules for oral suspension
Clarithromycinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Klacid is and what it is used for

Klacid contains the active substance clarithromycin. It is a macrolide antibiotic that inhibits the growth of bacteria causing infections.
Klacid in the form of oral suspension is indicated for use in children aged 6 months to 12 years 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. impetigo, folliculitis, cellulitis, abscesses)
• Disseminated or localized infections caused by mycobacteria

2. Important information before using Klacid

When not to use Klacid

• If the patient is allergic to clarithromycin or other macrolide antibiotics (such as azithromycin, erythromycin) or to any of the other ingredients of this medicine (listed in section 6)
• If the patient is taking ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, for migraine) or oral midazolam (a medicine used for anxiety and insomnia)
• If the patient is taking medicines that may cause severe heart rhythm disturbances
• If the patient is taking astemizole or terfenadine (medicines used for allergies), cisapride or domperidone (a medicine used for gastrointestinal motility disorders), pimozide (a medicine used for psychiatric disorders), because concomitant use with Klacid may cause severe heart rhythm disturbances
• If the patient is taking ticagrelor, ivabradine or ranolazine (used in the treatment of angina or to reduce the risk of heart attack or stroke)
• If the patient has low blood potassium or magnesium levels (hypokalaemia or hypomagnesaemia)
• If the patient is taking lovastatin, simvastatin (statin medicines used to lower blood cholesterol levels)
• If the patient has severe hepatic impairment with concomitant renal impairment
• If the patient has previously experienced, or there is a family history of, cardiac arrhythmias (ventricular arrhythmias, including torsade de pointes) or electrocardiogram (ECG) abnormalities known as "long QT syndrome"
• If the patient is taking colchicine (a medicine used for gout)
• If the patient is taking a medicine containing lomitapide

Warnings and precautions
If any of the following situations apply to the patient, discuss them with the doctor before starting treatment with Klacid.

• The patient is pregnant or suspects she may be pregnant.
• The patient has impaired kidney or liver function.
• The patient has coronary artery disease, severe heart failure, or bradycardia (slow heart rate).
• The patient is taking any of the medicines listed in the section "Klacid with other medicines".

If any of the following situations occur during treatment with Klacid, inform the doctor immediately.

• Severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, laryngeal oedema, bronchospasm. Immediate medical attention is required, and appropriate treatment must be initiated.
• Diarrhoea, especially if acute or prolonged. Inform the doctor as soon as possible. If necessary, the doctor will recommend appropriate treatment. Do not use anti-diarrhoeal medicines.
• Symptoms suggesting liver dysfunction such as loss of appetite, jaundice, dark urine, itching or abdominal pain. Discontinue treatment and consult the doctor.
• New infection (superinfection) with bacteria resistant to clarithromycin or fungi, particularly during prolonged antibiotic use. The doctor will recommend appropriate treatment.

Additionally, during treatment with Klacid, the following may occur:

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

If symptoms indicating damage to the hearing organ or vestibular system occur (see section 4), appropriate follow-up examinations are recommended after completion of treatment.

Klacid with other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

It is essential to inform the doctor if the patient is taking any of the following medicines,
as their concomitant use with Klacid is contraindicated:

• Ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, for migraine)
• Astemizole or terfenadine (medicines used for allergies)
• Cisapride or domperidone (a medicine used for gastrointestinal motility disorders)
• Pimozide (a medicine used for psychiatric disorders)
• Ticagrelor, ranolazine (medicines used for heart and circulatory diseases)
• Colchicine (a medicine used for gout)
• Statins – lovastatin, simvastatin (medicines lowering blood cholesterol levels)
• Oral midazolam (a medicine used for anxiety or insomnia)

Inform the doctor if the patient is taking any of the following medicines,
as special caution is required when using them with Klacid:

• Rifampicin, rifapentine, rifabutin (antibiotics used in the treatment of tuberculosis)
• Fluconazole, itraconazole (antifungal medicines)
• Atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used in the treatment of HIV infection)
• Digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used in the treatment of cardiac arrhythmias or hypertension)
• Alprazolam, triazolam, intravenous or oral mucosal midazolam (medicines used for anxiety or insomnia)
• Warfarin or any other anticoagulant, e.g. dabigatran, rivaroxaban, apixaban, edoxaban (medicines used to thin the blood)
• Quetiapine or other atypical antipsychotics
• Carbamazepine, valproate, phenytoin (antiepileptic medicines)
• Methylprednisolone (an anti-inflammatory medicine)
• Omeprazole (a medicine reducing gastric acid secretion)
• Cilostazol (a medicine used for intermittent claudication, which causes leg muscle pain during exertion, relieved by short rest)
• Cyclosporine, tacrolimus, sirolimus (medicines used, among others, after organ transplantation)
• Sildenafil, tadalafil, vardenafil (medicines used for erectile dysfunction)
• Ibrutinib or vinblastine (medicines used in cancer chemotherapy)
• Theophylline (a medicine used in bronchial asthma)
• Tolterodine (a medicine used for urinary incontinence)
• Phenobarbital (an anticonvulsant medicine)
• St. John’s wort (a herbal medicine used for mild depression)
• Sulfonylureas, nateglinide, repaglinide, insulin (medicines used in diabetes)

This is also important when using the following medicines:

• Hydroxychloroquine or chloroquine (used, among others, for rheumatoid arthritis, and for treatment or prevention of malaria). Taking these medicines together with clarithromycin may increase the risk of cardiac arrhythmias and other serious adverse effects on the heart
• Corticosteroids administered orally, by injection or by inhalation (used to suppress immune system activity, useful in treating many different conditions)

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
The safety of clarithromycin during pregnancy and breastfeeding has not been established.
Klacid may be used during pregnancy only if, in the doctor’s opinion, the benefit to the mother outweighs the potential risk to the foetus.
Since clarithromycin passes into human milk, a breastfeeding woman should exercise particular caution when using Klacid.

Driving and operating machinery
The medicine may cause dizziness, confusion and disorientation, which may affect the ability to drive or operate machinery.

Klacid contains sucrose
5 ml of the oral suspension contains 2.28 g of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, they should inform the doctor before starting treatment with Klacid oral suspension. If the medicine is prescribed to patients with diabetes, the sucrose content should be taken into account.

3. How to use Klacid

This medicine should always be used exactly as your doctor has instructed. If in doubt, consult your
doctor or pharmacist.
This is an oral medicine.
Children
The usual dose of Klacid oral suspension is 7.5 mg/kg body weight twice daily.
The maximum dose is 500 mg twice daily.
The duration of treatment is usually between 5 and 10 days, depending on the type of bacteria and the course of the disease. The medicine should be taken twice daily (preferably in the morning and evening), during or between meals.
Klacid may be taken with milk.
Dosing in children
The table below shows the volume of suspension to be administered according to the child's body weight.

5 ml of the suspension measured with the dosing device supplied with the medicinal product package contains 250 mg
of clarithromycin.
Dosing in children with renal impairment
Depending on the degree of renal impairment, the physician may recommend reducing the dose by half,
i.e. to 250 mg once daily. In severe infections – 250 mg twice daily.
The administration of the medicinal product should not last longer than 14 days.
Dosing in children with infections caused by mycobacteria
The recommended dose of the medicinal product is 7.5 to 15 mg/kg body weight twice daily. The maximum dose should not exceed 500 mg twice daily.

Treatment should be continued for as long as advised by the physician.
Adults
If this medicine is used in adults, the recommended dose of clarithromycin is 250 mg
(5 ml of suspension) twice daily.
In severe infections, the dose of clarithromycin may be increased to 500 mg (10 ml of suspension) twice
daily.
Preparation of Klacid suspension

• Boil water and cool it to room temperature.
• Add the boiled and cooled water to the bottle containing the medicine, up to the line indicated on the label.
• Shake vigorously. If necessary, add water up to the line indicated on the label.

The suspension should be shaken well before each use to ensure uniform dispersion of particles.
The properly prepared suspension may contain small, undissolved particles resembling
sugar crystals. This is due to the properties of the medicine and should not cause concern.
Note: Do not store the suspension in the refrigerator.
Accidental ingestion of a higher than recommended dose of Klacid
If a higher than recommended dose of Klacid has been taken, consult a physician or pharmacist immediately.
Taking a higher than recommended dose of Klacid may cause gastrointestinal symptoms (vomiting, abdominal pain).
Missed dose of Klacid
If a dose of Klacid is missed, take it as soon as possible, then continue with the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.
Stopping treatment with Klacid
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.
Do not discontinue treatment, even if you feel better and symptoms of the illness have subsided
after a few days of taking the medicine.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur in a patient at any time during treatment,
stop taking Klacid and consult a doctor immediately:

• anaphylactic shock – an acute, life-threatening allergic reaction, manifested among others by confusion, pale skin, drop in blood pressure, sweating, low urine output, rapid breathing, weakness and fainting
• allergic reactions: rash (frequent), itching, urticaria (not common), angioedema of the face, tongue, lips, eyes and throat, breathing difficulties
• severe skin reactions:
  • acute generalized exanthematous pustulosis – red, peeling rash with subcutaneous nodules and blisters
  • erythema multiforme with bullae (Stevens-Johnson syndrome), characterized by sudden onset of fever and blisters, which resolve rapidly and spontaneously after discontinuation of the drug; a severe condition characterized by blisters and erosions on the skin, in the oral cavity, eyes and genital organs, accompanied by fever and joint pain
  • toxic epidermal necrolysis (Lyell's syndrome) – a severe, rapidly progressing disease characterized by rupturing giant subepidermal blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever
  • DRESS syndrome – a severe (life-threatening) drug-induced rash associated with increased eosinophil count and internal organ involvement
• severe or prolonged diarrhoea, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhoea may occur even up to two months after completion of clarithromycin treatment. In such cases, contact a doctor immediately
• yellowing of the skin (jaundice), skin irritation, pale stool, dark urine, abdominal tenderness or loss of appetite. These may be symptoms of liver failure
• severe upper abdominal pain, nausea, vomiting, diarrhoea and fever. These may be symptoms of acute pancreatitis

These reactions occur at an unknown frequency, unless otherwise stated.
Other adverse reactions
In clinical studies and post-marketing surveillance of clarithromycin, the following adverse reactions were reported frequently (occurring in 1 to 10 of 100 patients):

• insomnia
• taste disturbances, headache
• diarrhoea, vomiting, dyspepsia, nausea, abdominal pain
• abnormal liver function test results
• excessive sweating

Adverse reactions reported uncommonly (occurring in 1 to 10 of 1000 patients):

• infection, candidiasis (fungal infection), vaginal infection
• decreased white blood cell count, increased platelet count
• anorexia, decreased appetite
• anxiety, nervousness
• dizziness, somnolence, tremor
• loss of balance, hearing loss, tinnitus
• palpitations, changes in ECG (prolongation of QT interval)
• gastritis, oral inflammation, glossitis, constipation, dry mouth, belching, bloating with flatulence
• increased activity of alanine aminotransferase (ALT), increased activity of aspartate aminotransferase (AST)
• maculopapular rash
• muscle cramps
• fever, asthenia (weakness, lack of energy)

The following adverse reactions have been reported after marketing authorization of Klacid oral suspension, with unknown frequency (frequency cannot be estimated from available data):

• rosacea
• agranulocytosis (decreased granulocyte count in blood), thrombocytopenia (decreased platelet count)
• acne
• psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania
• seizures, loss of taste, parosmia, anosmia, paresthesia (numbness, tingling)
• deafness
• cardiac arrhythmias of the torsade de pointes type, ventricular tachycardia, ventricular fibrillation
• bleeding
• tongue discoloration, tooth discoloration
• myopathy (muscle disease with muscle weakness)
• renal failure, interstitial nephritis
• changes in diagnostic test results (increased international normalized ratio (INR), prolonged prothrombin time, abnormal urine color)

Patients with impaired immunity
In addition to symptoms related to the underlying disease, the following adverse reactions have been observed in adult patients with impaired immunity:

• nausea, vomiting, taste disturbances, constipation, abdominal pain, diarrhoea, bloating with flatulence, dry mouth
• headache, hearing disturbances
• rash
• dyspnoea, insomnia
• abnormal laboratory test results: increased aspartate aminotransferase (AspAT) and alanine aminotransferase (AlAT) activity, increased blood urea nitrogen, decreased platelet and white blood cell counts

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Klacid

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the stated month. The batch number is indicated on the packaging after "Lot".
No special precautions for storage of the medicine are required.
The suspension should be used within 14 days. Do not store the suspension in the refrigerator.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Klacid contains

• The active substance is clarithromycin. 5 ml of suspension contains 250 mg of clarithromycin.
• The other ingredients are: polyacrylic acid (Carbopol 974P), povidone K90, hypromellose phthalate (HP-55), castor oil, silicon dioxide, maltodextrin, sucrose, titanium dioxide (E171), xanthan gum, flavouring agent "Fruit Punch", potassium sorbate, anhydrous citric acid.

What Klacid looks like and contents of the pack
Klacid is supplied as a granulate which, when mixed with water, forms a suspension.
The properly prepared suspension may contain small, undissolved particles resembling sugar crystals. This is due to the nature of the medicine and should not be a cause for concern.
The pack consists of an HDPE plastic bottle with a capacity of 50 ml, 60 ml or 100 ml, and an oral syringe dosing device, all contained in a cardboard box.

Marketing Authorisation Holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Poland

Manufacturer
AbbVie S.r.l.
S.R. 148 Pontina km 52 Snc
04011 Campoverde di Aprilia (LT)
Italy

For further information regarding this medicinal product, please contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Poland
Tel: 22 546 64 00