Klacid

Package Leaflet: Information for the Patient

Klacid, 250 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 any not listed in this leaflet, please 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 eczema, folliculitis, cellulitis, abscesses)
• dental and oral infections (e.g. periapical abscess, periodontitis)
• disseminated or localized infections caused by mycobacteria. In HIV-infected patients (CD4 cell count ≤100/mm), 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, it is recommended to use Klacid in combination with drugs that inhibit gastric acid secretion and another antibiotic.

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 for migraine), or midazolam orally (used for anxiety and insomnia).
• If you are taking drugs that may cause severe heart rhythm disturbances.
• If you are taking astemizole or terfenadine (used for allergies), cisapride or domperidone (used for gastrointestinal disorders), pimozide (used for psychiatric disorders), as concomitant use with Klacid may cause severe heart rhythm disturbances.
• If you are taking ticagrelor, ivabradine, or ranolazine (used for angina pectoris or to reduce the risk of myocardial infarction or stroke).
• If you have low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia).
• If you are taking lovastatin or simvastatin (statins used to lower cholesterol levels in the blood).
• 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 electrocardiogram (ECG) abnormalities known as "prolonged QT interval".
• If you are taking colchicine (used for gout).
• If you are taking a medicine containing 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 rash, urticaria, angioedema, anaphylaxis. You should immediately consult a doctor, who will provide appropriate treatment.
• Diarrhea, especially severe or prolonged. You should tell your doctor as soon as possible. If necessary, your doctor will prescribe appropriate treatment. Do not take anti-diarrheal medicines.
• Symptoms of liver dysfunction, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. You should stop treatment and consult a doctor.
• New infections (superinfections) with bacteria resistant to clarithromycin 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 and clindamycin);
• Antibiotic resistance (e.g., treatment of Helicobacter pylori infection may lead to the selection of resistant strains).

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

Klacid and other medicines

Tell your doctor about all the medicines you are taking, have recently taken, or 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 for migraine)
• Astemizole or terfenadine (used for allergies)
• Cisapride or domperidone (used for gastrointestinal disorders)
• Pimozide (used for psychiatric disorders)
• Ticagrelor, ranolazine (used for heart disease and circulation)
• Colchicine (used for gout)
• Statins - lovastatin, simvastatin (used to lower cholesterol levels in the blood)
• Midazolam orally (used for anxiety or insomnia)

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

• Rifampicin, rifapentine, rifabutin (antibiotics used for tuberculosis)
• Fluconazole, itraconazole (antifungal medicines)
• Atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used for HIV infection)
• Digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used for heart rhythm disturbances or hypertension)
• Alprazolam, triazolam, midazolam intravenously or orally (used for anxiety or insomnia)
• Warfarin or other anticoagulants, e.g. dabigatran, rivaroxaban, apixaban, edoxaban (used to thin the blood)
• Quetiapine or other atypical antipsychotics
• Carbamazepine, valproate, phenytoin (antiepileptic medicines)
• Methylprednisolone (anti-inflammatory medicine)
• Omeprazole (used to reduce gastric acid secretion)
• Cilostazol (used for intermittent claudication)
• Cyclosporine, tacrolimus, sirolimus (used for organ transplantation)
• Sildenafil, tadalafil, vardenafil (used for erectile dysfunction)
• Ibrutinib or vinblastine (used for cancer chemotherapy)
• Theophylline (used for asthma)
• Tolterodine (used for urinary incontinence)
• Phenobarbital (antiepileptic medicine)
• St. John's Wort (herbal medicine used for mild depression)
• Sulfonylureas, nateglinide, repaglinide, insulin (used for diabetes)

This is also important for the following medicines:

• Hydroxychloroquine or chloroquine (used for rheumatoid arthritis, malaria treatment or prevention). Taking these medicines with clarithromycin may increase the risk of heart rhythm disturbances and other serious side effects affecting the heart.
• Corticosteroids taken orally, by injection, or inhaled (used to suppress the immune system, which is useful in treating many different diseases).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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 doctor considers that the benefits to the mother outweigh the potential risks 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 and use machines.

Klacid contains yellow iron oxide

Yellow iron oxide (colorant) may cause allergic reactions in sensitive individuals.
The medicine contains 3.4 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.
Tablets can be taken with or without food.
If a single dose of 500 mg is required, it is recommended to use Klacid containing 500 mg of clarithromycin per tablet.
Respiratory tract infections, skin and soft tissue infections, acute otitis media
Adults
One 250 mg tablet twice a day (every 12 hours).
In severe infections, your doctor may prescribe a dose of two 250 mg tablets (i.e., 500 mg) 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
Dosing is the same as for adults.
Children under 12 years
Klacid oral suspension is recommended.
Patients with renal impairment
Your doctor may prescribe a reduced dose of the medicine, which means taking one 250 mg tablet once a day.
In severe infections, one 250 mg tablet twice a day.
Treatment should not last more than 14 days.
Dental and oral infections
One 250 mg tablet twice a day (every 12 hours). Treatment usually lasts 5 days.
Mycobacterial infections
Recommended dose for adults: two 250 mg tablets (i.e., 500 mg) twice a day.
Treatment of disseminated Mycobacterium avium complex (MAC) infection in AIDS patients should be continued for as long as the doctor recommends. 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 the doctor's recommendations.
Prevention of Mycobacterium avium complex (MAC) infections
Recommended dose for adults: two 250 mg tablets (i.e., 500 mg) twice a day.
Helicobacter pylori infections
In patients with gastric or duodenal ulcer caused by Helicobacter pylori infection, clarithromycin can be administered for 7 to 14 days at a dose of 500 mg twice a day, in combination with other appropriate antibacterial treatment 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 than the prescribed dose of Klacid, contact your doctor or pharmacist immediately.
Taking a higher dose of 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 the use of this medicine, ask your doctor or pharmacist.
Do not stop treatment, even if you feel better and the symptoms of the disease have disappeared 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 life-threatening allergic reaction, which may include confusion, pallor, low blood pressure, sweating, decreased urine output, rapid breathing, weakness, and fainting
• Allergic reactions: rash (frequent), 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 skin and mucous membrane disorder, which may include a sudden onset of fever and blisters, and may be life-threatening
• Toxic epidermal necrolysis - a severe skin condition, which may include large blisters under the skin, widespread skin peeling, and fever
• DRESS syndrome - a severe (life-threatening) drug rash, which may include an increased number of eosinophils and involvement of internal organs
• Severe or prolonged diarrhea, which may include blood or mucus in the stool. 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, itching, or abdominal tenderness. These may be symptoms of liver failure, cholestasis (elevated bile components in the blood), or hepatitis (inflammation of the liver). These reactions are rare and their frequency is unknown.

Other side effects

In clinical trials and after marketing, the following side effects were commonly reported (occurring 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 were reported uncommonly (occurring 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
• Restlessness
• Dizziness, drowsiness, tremors
• Balance disturbances, hearing loss, tinnitus
• Palpitations, ECG changes (prolonged QT interval)
• Gastritis, oral inflammation, tongue discoloration, tooth discoloration, abdominal distension, constipation, dry mouth, belching, 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:

• 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 disturbances, such as torsades de pointes, ventricular tachycardia, atrial fibrillation
• Bleeding
• Acute pancreatitis, 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 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
• Dyspnea, insomnia
• Abnormal laboratory test results: increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT), increased blood urea nitrogen, and decreased platelet and white blood cell counts

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your 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.
By reporting side effects, you can help provide 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 stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
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 that are no longer needed. 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 250 mg of clarithromycin.
• The other ingredients are: croscarmellose sodium, microcrystalline cellulose, pregelatinized starch, colloidal anhydrous silica, povidone, stearic acid, magnesium stearate, talc, yellow iron oxide (E 104); coating: hypromellose, hydroxypropylcellulose, propylene glycol, sorbitan monooleate, titanium dioxide (E 171), vanillin, sorbic acid, yellow iron oxide (E 104).

What Klacid looks like and contents of the pack

Klacid is available as film-coated tablets.
The tablet is yellow, oval in shape.
The pack contains 10 tablets (1 blister) or 14 tablets (1 blister).
PVC/PVDC/Al blister 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 on this medicine, please 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: