Klacid

Package leaflet: Information for the patient

Klacid, 125 mg/5 ml, granules for oral suspension
Clarithromycinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet 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 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 disorders.
• 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 pectoris 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 reduce blood cholesterol levels).
• If the patient has severe hepatic insufficiency associated with renal insufficiency.
• If the patient or a family member has previously experienced heart rhythm disorders (ventricular arrhythmias, including torsade de pointes) or electrocardiogram (ECG) abnormalities known as "long QT syndrome".
• If the patient is taking colchicine (a medicine used in the treatment of gout).
• If the patient is taking a medicine containing lomitapide.

Warnings and precautions
If any of the following situations apply to the patient, please discuss them with a 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, or bronchospasm. Immediate medical attention is required, and appropriate treatment should 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 antidiarrhoeal medicines.
• Symptoms suggesting liver dysfunction, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. Discontinue treatment and consult a doctor immediately.
• New infection (superinfection) caused by bacteria resistant to clarithromycin or by fungi, especially 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 show resistance 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 tests are recommended after completion of treatment.

Klacid with other medicines
Inform the doctor about all medicines currently 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 cardiovascular 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 together 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 heart rhythm disorders 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 in intermittent claudication, characterised by pain in the lower limb muscles during exertion, subsiding after brief 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, in the treatment of rheumatoid arthritis, or for treatment and prevention of malaria). Concomitant use with clarithromycin may increase the risk of heart rhythm disturbances and other serious cardiac adverse effects.
• corticosteroids administered orally, by injection, or by inhalation (used to suppress immune system activity, which is useful in treating many different conditions).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The safety of clarithromycin use 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 oral suspension contains 2.75 g of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, he or she 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 as directed by your doctor. If in doubt, consult your doctor or pharmacist.
This is an oral medicine.
Children
The usual dose of Klacid 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. The medicine 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 using the dosing device supplied with the medicine package contains 125 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 medicine should not last longer than 14 days.
Dosing in children with infections caused by mycobacteria
The recommended dose is 7.5 to 15 mg/kg body weight twice daily. The maximum dose of 500 mg twice daily must not be exceeded.
Treatment should be continued as long as advised by the physician.
Adults
If this medicine is used in adults, the recommended dose of clarithromycin is 250 mg
(10 ml of suspension) twice daily.
In severe infections, the dose of clarithromycin may be increased to 500 mg (20 ml of suspension) twice daily.
Instructions for preparing the Klacid suspension

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

Each time before use, the suspension must be shaken thoroughly to achieve a 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 overdose of Klacid
If an overdose of Klacid is taken, seek immediate advice from a doctor or pharmacist.
Taking a higher dose of Klacid than recommended 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 take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.
Discontinuation of Klacid treatment
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Do not discontinue treatment even if you feel better and symptoms of the disease disappear after a few days of taking the medicine.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur in a patient, at any stage of 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, reduced urine output, rapid breathing, weakness, and fainting
• Allergic reactions: rash (common), itching, urticaria (not common), angioedema of the face, tongue, lips, eyes, and throat, difficulty breathing
• Severe skin reactions:
  • Acute generalized exanthematous pustulosis – red, scaly rash with subcutaneous nodules and blisters
  • Stevens-Johnson syndrome (bullous erythema multiforme) manifested by sudden onset of fever and blisters, which resolve rapidly and spontaneously after discontinuation of the drug; a severe disease 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 epidermal sheets, 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-coloured stools, dark-coloured 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 with unknown frequency, unless otherwise stated.

Other adverse reactions
In clinical studies and post-marketing surveillance of clarithromycin, the following adverse reactions have been reported commonly (occurring in 1 to 10 out 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 out of 1,000 patients):

• Infection, candidiasis (fungal infection), vaginal infection
• Decreased white blood cell count, increased platelet count
• Anorexia, decreased appetite
• Restlessness, nervousness
• Dizziness, drowsiness, tremor
• Balance disorders, hearing loss, tinnitus
• Palpitations, changes in ECG (QT interval prolongation)
• Gastritis, oral inflammation, glossitis, constipation, dry mouth, belching, bloating with gas release
• Increased activity of liver enzymes alanine aminotransferase, increased aspartate aminotransferase activity
• Maculopapular rash
• Muscle cramps
• Fever, asthenia (weakness, lack of energy)

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

• Roseola
• 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 such as torsade de pointes, 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 reduced immunity
In addition to symptoms related to the underlying disease, the following adverse reactions have been observed in adult patients with reduced immunity:

• Nausea, vomiting, taste disturbances, constipation, abdominal pain, diarrhoea, bloating with gas release, 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 Adverse Drug Reactions of the 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 to provide more information on the safety of the medicine.

5. How to store Klacid

Keep the medicine out of the 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 should 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 125 mg of clarithromycin.
• The other ingredients are: carbomers (Carbopol 974P), povidone K90, hypromellose phthalate (HP-55), castor oil, colloidal anhydrous silica, maltodextrin, sucrose, xanthan gum, flavouring substance "Fruit Punch", potassium sorbate, anhydrous citric acid, titanium dioxide (E 171).

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 product and should not be a cause for concern.
HDPE plastic bottle with a capacity of 60 ml or 100 ml, with an oral dosing syringe, in a cardboard carton.

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 about this medicine, please contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Poland
Tel: 22 546 64 00