Klacid

Leaflet attached to the packaging: patient information

Klacid, 250 mg/5 ml, granules for oral suspension

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 your 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 as yours.
• 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 and what is it 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 is Klacid and what is it used for

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

2. Important information before taking Klacid

When not to take Klacid

• 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 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 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), because concomitant use with Klacid may cause severe heart rhythm disturbances

If the patient is taking ticagrelor, ivabradine, or ranolazine (for angina pectoris 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, simvastatin (statins used to lower cholesterol levels in the blood)
• If the patient has severe liver failure with concomitant kidney failure
• 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 it with their doctor before starting Klacid.

• 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 and other medications" section.

If any of the following situations occur while taking Klacid, the patient should tell their doctor.

• Severe hypersensitivity reactions, such as maculopapular rash, urticaria, petechiae, laryngeal edema, 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 medications.
• Symptoms of liver function disorders, such as loss of appetite, jaundice, dark urine, itching, or abdominal tenderness. The patient should stop treatment and consult a doctor.
• New infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially during prolonged antibiotic use. The doctor will prescribe appropriate treatment.

In addition, while taking Klacid, the following may occur:

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

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

Klacid 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 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 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:

• 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 (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 (used to reduce stomach acid production)
• Cilostazol (used in intermittent claudication, which is characterized by leg pain during exercise that subsides 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 medication)
• St. John's Wort (herbal remedy used in mild depression)
• Sulfonylurea, nateglinide, repaglinide, insulin (used in diabetes)

This is also important for the following medications:

• Hydroxychloroquine or chloroquine (used in rheumatoid arthritis, malaria treatment or prevention). Taking these medications with clarithromycin may increase the risk of heart rhythm disturbances and other serious side effects affecting the heart.
• Oral, injectable, or inhaled corticosteroids (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 use during pregnancy and breastfeeding has not been established.
Klacid may be used during pregnancy only if the doctor believes the benefits to the mother outweigh the potential risks to the fetus.
Since clarithromycin passes into breast milk, breastfeeding women should exercise caution when taking Klacid.

Driving and using machines

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

Klacid contains sucrose

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

3. How to take Klacid

This medication should always be taken as directed by the doctor. If there are any doubts, the patient should consult their doctor or pharmacist.
The medication is for oral use.
Children
The usual dose of Klacid in the form of oral suspension is 7.5 mg/kg body weight twice a day.
The maximum dose of the medication is 500 mg twice a day.
Treatment usually lasts from 5 to 10 days, depending on the type of bacteria and the course of the disease. The medication should be taken twice a day (preferably in the morning and evening) during or between meals.
The medication can be taken with milk.
Dosing in children
The following table shows the amount of suspension to be given based on the child's body weight.

5 ml of the measured suspension contains 250 mg of clarithromycin.
Dosing in children with kidney failure
Depending on the degree of kidney failure, the doctor may recommend reducing the dose by half, i.e., to 250 mg once a day. In severe infections, 250 mg twice a day.
Treatment should not last longer than 14 days.
Dosing in children with mycobacterial infections
The recommended dose is 7.5 to 15 mg/kg body weight twice a day. The maximum dose should not exceed 500 mg twice a day.

Treatment should be continued for as long as the doctor recommends.
Adults
If this medication is used in adults, the recommended dose of clarithromycin is 250 mg (5 ml of suspension) twice a day.
In severe infections, the dose of clarithromycin can be increased to 500 mg (10 ml of suspension) twice a day.

How to prepare the Klacid suspension

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

Each time before use, the suspension should be shaken until a uniform dispersion of particles is obtained.
A properly prepared suspension may contain small, undissolved "lumps" that resemble sugar crystals. This is due to the properties of the medication and should not cause concern.

Note. Suspensions should not be stored in the refrigerator.

Taking more than the recommended dose of Klacid

If more than the recommended dose of Klacid is taken, the patient should immediately consult their doctor or pharmacist.
Taking more than the recommended dose of Klacid may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missing a dose of Klacid

If a dose of Klacid is missed, 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 treatment

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 subsided after a few days of taking the medication.

4. Possible side effects

Like all medications, Klacid can cause side effects, although not everyone will experience them.
If the patient experiences any of the following side effects at any stage of taking the medication, they should stop takingKlacid and immediately consult their doctor:

• Anaphylactic shock - a life-threatening allergic reaction, characterized by confusion, pallor, low blood pressure, sweating, oliguria, tachypnea, weakness, and fainting
• Hypersensitivity reactions: rash (frequent), itching, urticaria (not very frequent), angioedema of the face, tongue, lips, eyes, and throat, difficulty breathing
• Severe skin reactions:
• Acute generalized exanthematous pustulosis - a red, scaling rash with papules and blisters
• Stevens-Johnson syndrome - a severe disease characterized by sudden onset of fever and blisters, which resolve spontaneously after discontinuation of the medication; a severe disease characterized by blisters and erosions 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, rupturing blisters, extensive skin necrosis, and fever
• DRESS syndrome - a severe (life-threatening) drug rash, which progresses with an increased number of eosinophils and involvement of internal organs
• Severe or prolonged diarrhea, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even two months after completing treatment with clarithromycin. In this case, the patient should also consult their doctor
• Jaundice, skin irritation, light-colored stools, dark urine, itching, or abdominal tenderness. These may be symptoms of liver failure
• Severe abdominal pain, nausea, vomiting, diarrhea, and fever. These may be symptoms of acute pancreatitis

These reactions occur with unknown frequency, unless otherwise specified.

Other side effects

In clinical trials and after marketing, clarithromycin oftencaused the following side effects (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 not very often(occurring in 1 to 10 out of 1000 patients):

• Infection, candidiasis (thrush), vaginal infection
• Decreased white blood cell count, increased platelet count
• Anorexia, decreased appetite
• Anxiety, nervousness
• Dizziness, drowsiness, tremors
• Balance disorders, hearing loss, tinnitus
• Palpitations, ECG changes (QT interval prolongation)
• Gastritis, oral thrush, glossitis, constipation, dry mouth, belching, flatulence
• Increased liver enzyme activity (aspartate aminotransferase, alanine aminotransferase)
• Maculopapular rash
• Muscle spasms
• Fever, 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 in the form of oral suspension:

• Rash
• 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 disturbances, such as torsades de pointes, ventricular tachycardia, atrial fibrillation
• Bleeding
• Tongue discoloration, tooth discoloration
• Myopathy (muscle disease with muscle weakness)
• Kidney failure, interstitial nephritis
• Changes in laboratory test results (increased INR, prolonged prothrombin time, abnormal urine color)

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

• 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 and alanine aminotransferase activity, increased blood urea nitrogen levels, and decreased platelet and white blood cell counts

Reporting side effects
If any side effects occur, including those not listed in this leaflet, the patient 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
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: 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 helps collect more information on the safety of the medication.

5. How to store Klacid

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".
There are no special precautions for storing the medication.
The suspension should be used within 14 days. Do not store the suspension in the refrigerator.
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 pack and other information

What Klacid contains

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

What Klacid looks like and what the pack contains

Klacid is available in the form of granules, which, when mixed with water, form a suspension.
A properly prepared suspension may contain small, undissolved "lumps" that resemble sugar crystals. This is due to the properties of the medication and should not cause concern.
The medication is available in a 50 ml, 60 ml, or 100 ml HDPE bottle, along with a dosing syringe, in a cardboard box.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
Postępu 21B
02-676 Warsaw

Manufacturer

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.
Postępu 21B
02-676 Warsaw
Phone: 22 546 64 00

Date of last revision of the leaflet: