Klacid

Package Leaflet: Information for the Patient

Klacid, 500 mg, Film-Coated Tablets

Clarithromycin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 is indicated for use in adults and children over 12 years of age for the treatment of infections caused by bacteria susceptible 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 dermatitis, folliculitis, cellulitis, abscesses)
• -disseminated or localized infections caused by mycobacteria

In patients with HIV infection (CD4 cell 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 confirmed diagnostic infection with Helicobacter pylori, clarithromycin is recommended in combination with acid suppressants and another antibiotic, in accordance with national and international guidelines for the eradication of Helicobacter pylori.

2. Important information before taking Klacid

When not to take Klacid

• If you are 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 you are taking ergot alkaloids (such as ergotamine or dihydroergotamine) used to treat migraine or midazolam oral (used to treat anxiety and insomnia).
• If you are taking medicines that may cause serious heart rhythm disturbances.
• If you are taking astemizole or terfenadine (used to treat allergies), cisapride or domperidone (used to treat gastrointestinal disorders), pimozide (used to treat psychiatric disorders), as concomitant use with Klacid may cause serious heart rhythm disturbances.
• If you are taking ticagrelor, ivabradine, or ranolazine (used to treat angina or to reduce the risk of heart attack or stroke).
• If you have low potassium or magnesium levels in your blood (hypokalemia or hypomagnesemia).
• If you are taking lovastatin or simvastatin (statins used to lower cholesterol levels).
• If you have severe liver failure with concomitant renal failure.
• If you or a family member have a history of heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or abnormalities in the electrocardiogram (ECG, a recording of the heart's electrical activity) known as "prolonged QT interval".
• If you are taking colchicine (used to treat gout).
• If you are taking lomitapide.

Warnings and precautions

If you have any of the following conditions, you should discuss them with your doctor before starting treatment with Klacid.

• You are pregnant or think you may be pregnant.
• You have kidney or liver problems.
• You have coronary artery disease, severe heart failure, or bradycardia.
• You are taking any of the medicines listed in the "Klacid and other medicines" section.

If you experience any of the following while taking Klacid, tell your doctor.

• Severe allergic reactions, such as hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing.
• Diarrhea, especially severe or prolonged. Tell your doctor as soon as possible. If necessary, your doctor will prescribe appropriate treatment. Do not take anti-diarrheal medicines.
• Signs of liver problems, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. Stop treatment and consult your doctor.
• New infection (superinfection) with bacteria or fungi, especially during prolonged use of the antibiotic. Your 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);
• Antibiotic resistance (e.g. treatment of Helicobacter pylori infection may lead to the development of resistant strains).

If you experience symptoms of hearing loss or balance disorders (see section 4), it is recommended to perform follow-up tests after completing treatment.

Klacid and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
You must inform your doctor if you are taking any of the following medicines, as their use with Klacid is contraindicated:

• ergot alkaloids, such as ergotamine or dihydroergotamine (used to treat migraine)
• astemizole or terfenadine (used to treat allergies)
• cisapride or domperidone (used to treat gastrointestinal disorders)
• pimozide (used to treat psychiatric disorders)
• ticagrelor, ranolazine (used to treat heart conditions)
• colchicine (used to treat gout)
• statins - lovastatin, simvastatin (used to lower cholesterol levels)
• midazolam oral (used to treat anxiety or insomnia)

You should inform your doctor if you are taking any of the following medicines, as special caution is required when taking them with Klacid:

Klacid:

• rifampicin, rifapentine, rifabutin (antibiotics used to treat tuberculosis)
• fluconazole, itraconazole (antifungal medicines)
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used to treat HIV infection)
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used to treat heart rhythm disorders or high blood pressure)
• alprazolam, triazolam, midazolam intravenous or oral (used to treat anxiety or insomnia)
• warfarin or other anticoagulants, such as dabigatran, rivaroxaban, apixaban, edoxaban (used to thin the blood)
• quetiapine or other atypical antipsychotics
• carbamazepine, valproate, phenytoin (used to treat epilepsy)
• methylprednisolone (used to treat inflammation)
• omeprazole (used to reduce stomach acid)
• cilostazol (used to treat intermittent claudication)
• cyclosporin, tacrolimus, sirolimus (used to prevent transplant rejection)
• sildenafil, tadalafil, vardenafil (used to treat erectile dysfunction)
• ibrutinib or vinblastine (used to treat cancer)
• theophylline (used to treat asthma)
• tolterodine (used to treat urinary incontinence)
• phenobarbital (used to treat epilepsy)
• St. John's Wort (a herbal medicine used to treat mild depression)
• sulfonylureas, nateglinide, repaglinide, insulin (used to treat diabetes)

It is also important if you are taking any of the following medicines:

• hydroxychloroquine or chloroquine (used to treat rheumatoid arthritis, or to prevent or treat malaria). Taking these medicines 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of clarithromycin during pregnancy and breastfeeding has not been established.
Klacid may be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.
As clarithromycin passes into breast milk, breastfeeding women should exercise caution when taking Klacid.

Driving and using machines

The medicine may cause dizziness, confusion, and disorientation, which may affect your ability to drive or operate machinery.

Klacid contains yellow iron oxide

Yellow iron oxide (a coloring agent) may cause allergic reactions in sensitive individuals.
The medicine contains 6.1 mg of sodium per tablet. The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to take Klacid

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is for oral use.
Swallow the tablet whole with water. Do not chew or suck the tablet.
The tablets can be taken with or without food.
Respiratory tract infections, skin and soft tissue infections, acute otitis media
Adults
In severe infections - one 500 mg tablet twice a day (every 12 hours). Treatment usually lasts 5 to 14 days, except for pneumonia and sinusitis, when treatment lasts 6 to 14 days.
Children over 12 years
Dosage as for adults.
Children under 12 years
Klacid oral suspension is recommended.
Patients with renal impairment
Your doctor may recommend reducing the dose of Klacid by half, which means taking one 250 mg tablet once a day.
In severe infections - one 250 mg tablet twice a day.
Klacid 250 mg tablets are recommended. Treatment should not last more than 14 days.
Infections caused by mycobacteria
Recommended dose for adults: one 500 mg tablet twice a day.
Treatment of disseminated Mycobacterium avium complex (MAC) infection in patients with AIDS should be continued for as long as recommended by your doctor. Klacid should be used in combination with other medicines that are effective against Mycobacterium.
Treatment of other non-tuberculous mycobacterial infections should be continued according to your doctor's recommendations.
Prevention of Mycobacterium avium complex (MAC) infections
Recommended dose for adults: one 500 mg tablet twice a day.
Helicobacter pylori infections
In patients with gastric or duodenal ulcer caused by Helicobacter pylori infection, clarithromycin can be given for 7 to 14 days at a dose of 500 mg twice a day, in combination with other appropriate antibacterial therapy and proton pump inhibitors, in accordance with national and international guidelines for the eradication of Helicobacter pylori.

Overdose of Klacid

If you have taken more Klacid than you should, contact your doctor or pharmacist immediately.
Taking more Klacid than prescribed by your doctor may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missed dose of Klacid

If you miss a dose of Klacid, take it as soon as possible, and then take the next dose at the scheduled 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 taking this medicine, ask your doctor or pharmacist.
Do not stop treatment, even if you feel better and your symptoms have improved after a few days of taking the medicine.

4. Possible side effects

Like all medicines, Klacid can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Klacid and consult your doctor immediately:

• anaphylactic shock - a severe, life-threatening allergic reaction, which may cause confusion, pale skin, low blood pressure, sweating, decreased urine production, rapid breathing, weakness, and fainting
• allergic reactions: rash (common), itching, urticaria (uncommon), angioedema of the face, lips, tongue, or 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 skin and mucous membrane disorder, which may cause a sudden onset of fever and blisters, which may be self-limiting after discontinuation of the medicine; a severe condition characterized by blisters and ulcers on the skin, in the mouth, eyes, and genitals, fever, and joint pain
• toxic epidermal necrolysis - a severe, life-threatening skin condition, which may cause large blisters under the skin, widespread skin ulcers, and shedding of the skin, as well as fever
• DRESS syndrome - a severe, life-threatening skin reaction, which may cause a rash, increased eosinophil count, and involvement of internal organs
• severe or prolonged diarrhea, which may be bloody or contain mucus. Diarrhea may occur even after two months after completing treatment with clarithromycin. In such cases, you should also contact your doctor
• jaundice, skin irritation, pale stools, dark urine, or abdominal tenderness. These may be signs of liver failure, cholestasis (elevated bile salts in the blood), or hepatitis (inflammation of the liver). These reactions are rare.

Other side effects

In clinical trials and after marketing, the following side effects have been reported commonly(in 1 to 10 out of 100 patients):

• insomnia
• taste disturbances, headache
• diarrhea, vomiting, nausea, abdominal pain
• abnormal liver function tests
• excessive sweating

The following side effects have been reported uncommonly(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
• loss of appetite, decreased appetite
• restlessness
• dizziness, drowsiness, tremors
• balance disorders, hearing loss, tinnitus
• palpitations, changes in ECG (prolonged QT interval)
• gastritis, oral thrush, tongue discoloration, abdominal distension, constipation, dry mouth, eructation, flatulence
• increased liver enzyme activity: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase
• malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue
• increased enzyme activity: alkaline phosphatase and lactate dehydrogenase

The following side effects have been reported with an unknown frequency(frequency cannot be estimated from the available data) after marketing of Klacid tablets and oral suspension:

• rosacea
• agranulocytosis (decreased neutrophil 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 (tingling, numbness)
• deafness
• heart rhythm disturbances, such as torsades de pointes, ventricular tachycardia, atrial fibrillation
• bleeding
• acute pancreatitis, tongue discoloration, tooth discoloration
• liver failure, jaundice
• 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 the symptoms of 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 disturbances
• rash
• shortness of breath, insomnia
• abnormal laboratory test results: increased aspartate aminotransferase and alanine aminotransferase, increased blood urea nitrogen, and decreased platelet and white blood cell count

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 to gather more information on the safety of this medicine.

5. How to store Klacid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of that month.
Batch number is stated on the packaging after "Lot".
Store in a temperature below 30°C, in a dry place, protected from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Klacid contains

• -The active substance is clarithromycin. One film-coated tablet contains 500 mg of clarithromycin.
• -The other ingredients are: croscarmellose sodium, microcrystalline cellulose, silicon dioxide, povidone (K29-32), stearic acid, magnesium stearate, talc; coating: hypromellose, sorbitan monooleate, propylene glycol, titanium dioxide, vanillin, yellow iron oxide (E 104) (aluminum 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.
The tablet is yellow, oval, and approximately 19 x 9 x 7 mm in size.
The pack contains 14, 20, or 42 tablets.
Blisters of PVC/PVDC in a cardboard box.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B

• 02- 676 Warsaw

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
To obtain more detailed information on this medicine, 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: