Klacid

Leaflet attached to the packaging: patient information

Klacid, 125 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.
• 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. Package contents 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 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), as concomitant use with Klacid 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 heart attack 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 blood cholesterol levels).
• If the patient has severe liver failure with concomitant kidney failure.
• If the patient or their family members have a history of heart rhythm disorders (ventricular arrhythmias, including torsades de pointes) or electrocardiogram (ECG) abnormalities known as "prolonged QT interval".
• 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 allergic reactions, such as rash, urticaria, angioedema, anaphylaxis. 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 pain. The patient should stop treatment and consult a doctor.
• New infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially during long-term 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).

If symptoms of hearing or balance organ damage occur (see section 4), it is recommended to perform relevant 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:

Medications that should not be taken with Klacid:

• 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 or to reduce the risk of heart attack or stroke)
• Colchicine (used in gout)
• Statins - lovastatin, simvastatin (used to lower blood cholesterol levels)
• 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 taking 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 (given 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 antipsychotic medications
• Carbamazepine, valproate, phenytoin (used in epilepsy)
• Methylprednisolone (used as an anti-inflammatory medication)
• Omeprazole (used to reduce stomach acid production)
• Cilostazol (used in intermittent claudication, which is characterized by leg pain during exercise and relieved by 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 (used as an antiepileptic medication)
• St. John's Wort (a herbal remedy used in mild depression)
• Sulfonylureas, 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 conditions).

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 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 operating machinery

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 2.75 g of sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should inform their doctor before starting treatment with Klacid oral suspension. If the medication is prescribed for 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 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) with food or between meals. The medication can be given with milk.
Dosing in children
The table below shows the amount of suspension to be given based on the child's body weight.
5 ml of the suspension measured with the dosing device provided with the medication contains 125 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 (10 ml suspension) twice a day.
In severe infections, the dose of clarithromycin can be increased to 500 mg (20 ml suspension) twice a day.

How to prepare the Klacid suspension

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

Before each 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.
Treatment should not be stopped, even if the patient's condition improves and symptoms disappear 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, they should stop takingKlacid and immediately consult their doctor:

• 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 condition 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 genitals, fever, and joint pain
• Toxic epidermal necrolysis - a severe, rapidly progressing condition characterized by large, bursting subepidermal blisters, 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, possibly with 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
• 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 the medication was released onto the market, the following side effects were frequentlyreported (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 1,000 patients):

• Infection, candidiasis (fungal infection), vaginal infection
• Decreased white blood cell count, increased platelet count
• Anorexia, decreased appetite
• Anxiety, nervousness
• Dizziness, drowsiness, tremors
• Balance disorders, hearing loss, tinnitus
• Palpitations, changes in ECG (QT interval prolongation)
• Gastritis, stomatitis, glossitis, constipation, dry mouth, belching, flatulence
• Increased liver enzyme activity (aspartate aminotransferase, alanine aminotransferase)
• Rash
• Muscle cramps
• Fever, asthenia (weakness, lack of energy)

The following side effects have been reported with unknown frequency(frequency cannot be determined based on available data) after the release of Klacid oral suspension onto the market:

• Rash
• 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
• Tongue discoloration, tooth discoloration
• Myopathy (muscle disease with muscle weakness)
• Kidney failure, interstitial nephritis
• Changes in diagnostic test results (increased INR, prolonged prothrombin time, abnormal urine color)

Patients with impaired immune systems
In addition to symptoms related to the underlying 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 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
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 will help gather 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. Package contents and other information

What Klacid contains

• The active substance of the medication is clarithromycin. 5 ml of the suspension contains 125 mg of clarithromycin.
• Other ingredients are: carbomers (Carbopol 974P), povidone K90, hypromellose phthalate (HP-55), castor oil, colloidal silicon dioxide, maltodextrin, sucrose, xanthan gum, flavoring agent "Fruit Punch", potassium sorbate, anhydrous citric acid, titanium dioxide (E 171).

What Klacid looks like and what the package 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 60 ml or 100 ml HDPE bottle and a dosing device in the form of a syringe, in a cardboard box.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
ul. 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.
ul. Postępu 21B
02-676 Warsaw
Phone: 22 546 64 00

Date of last revision of the leaflet: