Klacid

Package leaflet: Information for the patient

Klacid, 500 mg, film-coated tablets
Clarithromycinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those 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:

• Infections of the upper respiratory tract (e.g. streptococcal pharyngitis, sinusitis)
• Infections of the lower respiratory tract (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. In HIV-infected patients (CD4 lymphocyte count ≤100/mm³), Klacid is indicated for the prevention of disseminated infections caused by the 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 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 lead to 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 myocardial infarction or stroke).
• If the patient has low blood potassium or magnesium levels (hypokalaemia or hypomagnesaemia).
• If the patient is taking lovastatin, simvastatin (statin group medicines used to reduce blood cholesterol levels).
• If the patient has severe hepatic impairment with concomitant renal impairment.
• If the patient has a history of, or 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 in the treatment of gout).
• If the patient is taking a medicine containing lomitapide.

Warnings and precautions
If any of the situations described below apply to the patient, they should 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, the patient should inform their doctor immediately.

• Severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, laryngeal oedema, or bronchospasm. The patient should immediately consult a doctor who will initiate appropriate treatment.
• Diarrhoea, especially acute or prolonged. The patient should inform the doctor as soon as possible. If necessary, the doctor will recommend appropriate treatment. Antidiarrhoeal medicines should not be used.
• Symptoms indicating liver dysfunction such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. Treatment should be discontinued and the patient should 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 the emergence of drug-resistant microorganisms).

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

Klacid with other medicines
The patient should inform the doctor about all medicines currently or recently taken, as well as any medicines planned for future use.
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, in migraine)
• astemizole or terfenadine (medicines used in allergy)
• cisapride or domperidone (medicines used in gastrointestinal motility disorders)
• pimozide (a medicine used in psychiatric disorders)
• ticagrelor, ranolazine (medicines used in heart and circulatory diseases)
• colchicine (a medicine used in gout)
• statins – lovastatin, simvastatin (medicines lowering blood cholesterol levels)
• midazolam administered orally (a medicine used in anxiety or insomnia)

The patient should inform the doctor if they are taking any of the following medicines,
as 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 treatment of cardiac arrhythmias or hypertension)
• alprazolam, triazolam, intravenous or buccal 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 (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 exercise, subsiding after short 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 (a medicine used in bronchial asthma)
• tolterodine (a medicine used in urinary incontinence)
• phenobarbital (an anticonvulsant medicine)
• St. John's wort (a 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, among others, in the treatment of rheumatoid arthritis, or in the treatment and prevention of malaria). Concomitant use of these medicines with clarithromycin may increase the risk of cardiac rhythm disturbances and other serious adverse cardiac effects.
• 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 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 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, 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 Quinoline Yellow
Quinoline Yellow (a dye) may cause allergic reactions in sensitive individuals.
The medicine contains 6.1 mg of sodium per tablet. It 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 exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
For oral use.
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.

Respiratory tract, skin and soft tissue infections, acute otitis media
Adults
For severe infections – one 500 mg tablet 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 for adults.

Children 12 years of age and younger
Use of Klacid oral suspension is recommended.

Patients with renal impairment
Your doctor may recommend reducing the dose by half, meaning one 250 mg tablet once daily.
For severe infections – one 250 mg tablet twice daily.
In such cases, use of Klacid tablets containing 250 mg clarithromycin is recommended.
Treatment should not last longer than 14 days.

Mycobacterial infections
Recommended dose in adults: one 500 mg tablet 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 antimycobacterial agents active against Mycobacterium.
Treatment of other nontuberculous mycobacterial infections should be continued according to
the doctor's instructions.

Prophylaxis of MAC infections
Recommended dose in adults: one 500 mg tablet 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 agents and proton pump inhibitors, in accordance with
national and international guidelines for Helicobacter pylori eradication.

Taking more Klacid than recommended
If you take more Klacid than recommended, seek immediate advice from your doctor
or pharmacist.
Taking a higher than recommended dose of Klacid may cause gastrointestinal symptoms
(such as vomiting, abdominal pain).

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

Stopping Klacid treatment
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 will experience them.
If the patient experiences any of the following adverse reactions at any stage 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 (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
  • blistering erythema multiforme (Stevens-Johnson syndrome) characterized 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 sheets of epidermis, and fever
  • DRESS syndrome – a severe (life-threatening) drug-induced rash occurring 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, tenderness on abdominal palpation, or loss of appetite. These may be symptoms of liver failure, cholestasis (increased concentration of bile components in blood), or hepatitis (not common). 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
• diarrhoea, vomiting, dyspepsia, nausea, abdominal pain
• abnormal liver function tests
• 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, and increased eosinophil count
• anorexia, decreased appetite
• anxiety
• dizziness, somnolence, tremor
• loss of balance, hearing loss, tinnitus
• palpitations, changes in ECG (prolongation of QT interval)
• gastritis, oral inflammation, 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 of Klacid tablets and suspension, with unknown frequency (frequency cannot be estimated from available data):

• roseola
• agranulocytosis (reduced granulocyte count in blood), thrombocytopenia (reduced platelet count)
• acne
• psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania
• seizures, ageusia (loss of taste), parosmia (distorted sense of smell), anosmia (loss of smell), paresthesia (numbness, tingling)
• deafness
• torsade de pointes arrhythmia, ventricular tachycardia, ventricular fibrillation
• hemorrhage
• acute pancreatitis, tongue discoloration, tooth discoloration
• liver failure, parenchymal jaundice
• 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, 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 Reactions of Medicinal Products at 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 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".
Store below 30°C, in a dry place. Protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Klacid contains

• The active substance is clarithromycin. One coated tablet contains 500 mg of clarithromycin.
• Other ingredients are: sodium croscarmellose, microcrystalline cellulose, silicon dioxide, povidone (K29-32), stearic acid, magnesium stearate, talc; coating components: hypromellose, sorbitan monooleate, propylene glycol, titanium dioxide, vanillin, quinoline yellow (E 104) (aluminium lake), hydroxypropylcellulose, sorbic acid; glazing agents: hypromellose, propylene glycol, sorbic acid, vanillin.

What Klacid looks like and contents of the pack
Klacid is available as film-coated tablets.
Yellow, oval-shaped tablets, approximately 19 x 9 x 7 mm in size.
Pack contents: 14 tablets, 20 tablets or 42 tablets.
Blister packs made of PVC/PVDC foil in a cardboard box.

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

Manufacturer
Aesica Queenborough Limited
Queenborough
Kent ME11 5EL
United Kingdom
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy

For further information on this medicinal product, please contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Poland
Tel.: +48 22 546 64 00