Klacid

Package leaflet: Information for the patient

Klacid, 250 mg, film-coated tablets
Clarithromycinum
Please read the entire leaflet carefully before taking 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, 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.
• 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 is indicated for use in adults and children over 12 years of age 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)
• dental and oral infections (e.g. periapical abscess, periodontitis)
• disseminated or localized infections caused by mycobacteria. In HIV-infected patients (CD4 lymphocyte count ≤100/mm³), Klacid is indicated for the prevention of disseminated infections caused by Mycobacterium avium complex (MAC).

In patients with duodenal ulcer and diagnosed Helicobacter pylori infection, treatment with Klacid is recommended in combination with agents that inhibit gastric acid secretion and another antibiotic.

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, in migraine) or oral midazolam (a medicine used in anxiety states 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 in allergy), cisapride or domperidone (medicines used in gastrointestinal motility disorders), pimozide (a medicine used in 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 too low blood potassium or magnesium levels (hypokalaemia or hypomagnesaemia).
• If the patient is taking lovastatin, simvastatin (statin group medicines used to lower blood cholesterol levels).
• If the patient has severe hepatic impairment with concomitant renal impairment.
• If the patient has previously experienced cardiac arrhythmias (ventricular arrhythmias, including torsade de pointes) or electrocardiogram (ECG) abnormalities known as "long QT syndrome", either personally or in their family.
• 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, 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 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. Immediately consult a doctor who will initiate appropriate treatment.
• Diarrhoea, especially acute or prolonged. Inform the doctor as soon as possible. If necessary, the doctor will recommend appropriate treatment. Do not use antidiarrhoeal medicines.
• Symptoms indicating liver dysfunction such as loss of appetite, jaundice, dark urine, itching or abdominal pain. Discontinue treatment and consult a doctor.
• New infection (superinfection) with bacteria resistant to clarithromycin or 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);
• Bacterial resistance (e.g. treatment of Helicobacter pylori infection may lead to emergence of drug-resistant microorganisms).

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

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,
because their concomitant use with Klacid is contraindicated:

• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, in migraine)
• astemizole or terfenadine (medicines used in allergy)
• cisapride or domperidone (medicine used in gastrointestinal motility disorders)
• pimozide (medicine used in psychiatric disorders)
• ticagrelor, ranolazine (medicines used in heart and circulatory diseases)
• colchicine (medicine used in gout)
• statins – lovastatin, simvastatin (medicines lowering blood cholesterol levels)
• midazolam administered orally (medicine used in anxiety or insomnia)

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

• rifampicin, rifapentine, rifabutin (antibiotics used in tuberculosis treatment)
• fluconazole, itraconazole (antifungal medicines)
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used in HIV infection treatment)
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used in heart rhythm disorders or hypertension)
• alprazolam, triazolam, intravenous or oral mucosal midazolam (medicines used in 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 (anti-inflammatory medicine)
• omeprazole (medicine reducing gastric acid secretion)
• cilostazol (medicine used in intermittent claudication, characterised by muscle pain in the lower limbs occurring during exertion and resolving after brief rest)
• cyclosporine, tacrolimus, sirolimus (medicines used, among others, after organ transplantation)
• sildenafil, tadalafil, vardenafil (medicines used in erectile dysfunction)
• ibrutinib or vinblastine (medicines used in cancer chemotherapy)
• theophylline (medicine used in bronchial asthma)
• tolterodine (medicine used in urinary incontinence)
• phenobarbital (anticonvulsant medicine)
• St. John's wort (herbal medicine used in mild depression)
• sulfonylureas, nateglinide, repaglinide, insulin (medicines used in diabetes)

This is also important when using the following medicines:

• hydroxychloroquine or chloroquine (used in the treatment, among others, of rheumatoid arthritis, and in the treatment or prevention of malaria). Taking these medicines together with clarithromycin may increase the risk of heart rhythm disturbances and other serious adverse effects affecting the heart.
• corticosteroids administered orally, by injection or by inhalation (used to suppress the immune system, 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 have a
child, 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 opinion of the doctor, the benefit to the mother
outweighs the potential risk to the foetus.
Since clarithromycin passes into human milk, women who are breastfeeding 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 and operate machinery.

Klacid contains quinoline yellow
Quinoline yellow (a colourant) may cause allergic reactions in susceptible individuals.
The medicine contains 3.4 mg of sodium in one tablet. The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Klacid

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
This is an oral medicine.
The tablet should be swallowed whole with water. Do not chew or suck the tablet.
Klacid tablets may be taken with food or on an empty stomach.
If a single dose of 500 mg is required, it is recommended to use Klacid tablets containing
500 mg of clarithromycin.

Respiratory tract, skin and soft tissue infections, acute otitis media
Adults
One 250 mg tablet twice daily (every 12 hours).
In severe infections, your doctor may recommend increasing the dose to two 250 mg tablets
(i.e. 500 mg) twice daily (every 12 hours).
Treatment usually lasts 5 to 14 days, except for pneumonia and sinusitis, for which treatment lasts 6 to 14 days.

Children over 12 years of age
Dosage as in adults.

Children aged 12 years and younger
It is recommended to use Klacid oral suspension.

Patients with renal impairment
Your doctor may recommend reducing the dose by half, which means taking one 250 mg tablet once daily.
In severe infections – one 250 mg tablet twice daily.
Treatment should not last longer than 14 days.

Dental and oral infections
One 250 mg tablet twice daily (every 12 hours). Treatment usually lasts 5 days.

Infections caused by mycobacteria
Recommended dose in adults: two 250 mg tablets (i.e. 500 mg) twice daily.
Treatment of disseminated infection caused by Mycobacterium avium complex (MAC)
in patients with AIDS should be continued as long as directed by the doctor. Klacid should be used
concurrently with other anti-Mycobacterium agents.
Treatment of other non-tuberculous Mycobacterium infections should be continued according to the doctor’s instructions.

Prevention of MAC infections
Recommended dose in adults: two 250 mg tablets (i.e. 500 mg) twice daily.

Helicobacter pylori infections
In patients with gastric or duodenal ulcer disease associated with Helicobacter pylori infection,
clarithromycin may be administered for 7 to 14 days at a dose of 500 mg twice daily, in combination
with other appropriate antibacterial therapy and proton pump inhibitors, in accordance with
national and international guidelines for Helicobacter pylori eradication.

Taking more Klacid than prescribed
If you take more Klacid than prescribed, seek immediate medical advice from your doctor
or pharmacist.
Taking more Klacid than prescribed may cause gastrointestinal symptoms (e.g. vomiting, abdominal pain).

Missing a dose of Klacid
If you miss a dose of Klacid, take it as soon as possible, then continue with the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Klacid
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Do not stop treatment prematurely, even if you feel better and symptoms improve
after a few days of taking the medicine.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following adverse reactions at any time during treatment,
discontinue taking Klacid and consult a doctor immediately:

• Anaphylactic shock – 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 (uncommon), angioedema of the face, tongue, lips, eyes, and throat, difficulty breathing
• Severe skin reactions:
  • Acute generalized exanthematous pustulosis – red, peeling rash with subcutaneous nodules and blisters
  • Bullous erythema multiforme (Stevens-Johnson syndrome) characterized by sudden onset of fever and blisters, which resolve spontaneously and rapidly 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 of 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 diarrhea, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even up to two months after completing 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, cholestasis (increased concentration of bile components in the blood), or hepatitis (uncommon). 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 were reported commonly (occur in 1 to 10 out of 100 patients):

• Insomnia
• Taste disturbances, headache
• Diarrhea, vomiting, dyspepsia, nausea, abdominal pain
• Abnormal liver function test results
• Excessive sweating

Adverse reactions reported uncommonly (occur in 1 to 10 out of 1,000 patients):

• Candidiasis (fungal infection), vaginal infection
• Decreased white blood cell count, decreased neutrophil count, increased eosinophil count
• Anorexia, decreased appetite
• Restlessness
• Dizziness, somnolence, tremor
• Loss of balance, hearing loss, tinnitus
• Palpitations, ECG changes (prolongation of QT interval)
• Gastritis, stomatitis, glossitis, abdominal distension, constipation, dry mouth, belching, flatulence
• Increased liver enzyme activity: alanine aminotransferase, increased aspartate aminotransferase activity, increased gamma-glutamyltransferase activity
• Malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue
• Increased blood levels of alkaline phosphatase and lactate dehydrogenase enzymes

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

• Erythema
• 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 (distorted sense of smell), anosmia (loss of smell), paresthesia (numbness, tingling)
• Deafness
• Cardiac arrhythmias of the torsade de pointes type, ventricular tachycardia, ventricular fibrillation
• Bleeding
• Acute pancreatitis, 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 decreased immunity
In addition to symptoms related to the underlying disease, the following adverse reactions have been observed in adult patients with decreased immunity:

• Nausea, vomiting, taste disturbances, constipation, abdominal pain, diarrhea, flatulence, dry mouth
• Headache, hearing disturbances
• Rash
• Dyspnea, 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, 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 specified month. The batch number is indicated on the packaging after "Lot".
Store below 30°C, in a dry place. Protect from light.
Medicines must not be disposed of via the sewage system 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. Each film-coated tablet contains 250 mg of clarithromycin.
• Other ingredients are: sodium croscarmellose, microcrystalline cellulose, pregelatinized starch, colloidal anhydrous silica, povidone, stearic acid, magnesium stearate, talc, quinoline yellow (E 104); coating ingredients: hypromellose, hydroxypropylcellulose, propylene glycol, sorbitan monooleate, titanium dioxide (E 171), vanillin, sorbic acid, quinoline yellow (E 104).

What Klacid looks like and contents of the pack
Klacid is available as film-coated tablets.
Yellow, oval-shaped tablet.
The pack contains 10 tablets (1 blister) or 14 tablets (1 blister).
PVC/PVDC/Al blister 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 about 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