KLARMIN 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Klarmin, 500 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Contents of the leaflet
3. What Klarmin is and what it is used for
4. Important information before taking Klarmin
   1. When not to take Klarmin
   2. Warnings and precautions
   3. Klarmin and other medicines
   4. You must inform your doctor if you are taking any of the following medicines, as their use with Klarmin is contraindicated:
   5. You should inform your doctor if you are taking any of the following medicines, as special caution is required when using them with Klarmin:
   6. Klarmin:
   7. Klarmin with food, drink, and alcohol
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Klarmin contains yellow iron oxide
   11. Klarmin contains sodium
5. How to take Klarmin
   1. Use in children and adolescents
   2. Overdose of Klarmin
   3. Missed dose of Klarmin
   4. Stopping treatment with Klarmin
6. Possible side effects
   1. You should immediately contact a doctor and go to the nearest hospital emergency department if you experience any of the following symptoms:
   2. Other side effects:
   3. Reporting side effects
7. How to store Klarmin
8. Contents of the pack and other information
   1. What Klarmin contains
   2. What Klarmin looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Klarmin, 500 mg, film-coated tablets

Clarithromycin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• 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.

Contents of the leaflet

• 1. What Klarmin is and what it is used for
• 2. Important information before taking Klarmin
• 3. How to take Klarmin
• 4. Possible side effects
• 5. How to store Klarmin
• 6. Contents of the pack and other information

1. What Klarmin is and what it is used for

Klarmin contains the active substance – clarithromycin. It is a macrolide antibiotic that inhibits the growth of bacteria that cause infections.
Klarmin is indicated for the treatment of infections caused by susceptible organisms. These infections include:

• upper respiratory tract infections, such as streptococcal pharyngitis, sinusitis,
• lower respiratory tract infections, such as bronchitis, pneumonia,
• acute otitis media,
• skin and soft tissue infections, such as infectious eczema, folliculitis,
• connective tissue inflammation,
• widespread or localized infections caused by mycobacteria.

In patients with HIV infection (CD4 cell count ≤ 100/mm) Klarmin 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, it is recommended to use Klarmin in combination with drugs that inhibit gastric acid secretion and another antibiotic.

2. Important information before taking Klarmin

When not to take Klarmin

• If you are 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 you are taking any of the following medicines:
• astemizole or terfenadine (medicines used to treat allergies), cisapride (a medicine used to treat gastrointestinal disorders), pimozide (a medicine used to treat psychiatric disorders) - as this may lead to serious heart rhythm disturbances,
• any other medicines known to cause heart rhythm disturbances,
• tikagrelor, ivabradine or ranolazine (medicines used to treat angina or to reduce the risk of heart attack or stroke),
• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among other things, to treat migraines),
• lovastatin, simvastatin (statins, used to lower blood cholesterol levels),
• midazolam given orally (a medicine used to treat anxiety or insomnia),
• colchicine (a medicine used to treat gout).
• If you have low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• If you or a family member have a history of changes in the ECG recording (prolonged QT interval) and heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes).
• If you have severe liver failure with concurrent kidney failure.
• If you are taking a medicine containing lomitapide.

Warnings and precautions

Before starting treatment with Klarmin, you should discuss it with your doctor if:

• you are pregnant or think you may be pregnant,
• you have kidney or liver problems,
• you have coronary artery disease, severe heart failure, or slow heart rate,
• you are taking any of the medicines mentioned in the section "Klarmin and other medicines".

If any of the following situations occur while taking Klarmin, you should tell your doctor (see also section 4):

• severe allergic reactions such as rash, urticaria, purpura, angioedema, bronchospasm - you should immediately consult a doctor who will provide appropriate treatment;
• diarrhea, especially acute or prolonged - you should tell your doctor as soon as possible; if necessary, the doctor will prescribe appropriate treatment; you should not take anti-diarrheal medicines;
• symptoms of liver function disorders such as loss of appetite, jaundice, dark urine, itching or abdominal pain - you should stop treatment and immediately consult a doctor;
• new infection (superinfection) with bacteria insensitive to clarithromycin or fungi, especially during long-term use of antibiotics - the doctor will prescribe appropriate treatment.

In addition, while taking Klarmin, the following may occur:

• cross-resistance of bacteria (bacteria insensitive 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 microorganisms).

Klarmin and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

You must inform your doctor if you are taking any of the following medicines, as their use with Klarmin is contraindicated:

• astemizole or terfenadine (medicines used to treat allergies),
• cisapride (a medicine used to treat gastrointestinal disorders),
• pimozide (a medicine used to treat psychiatric disorders),
• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among other things, to treat migraines),
• statins - lovastatin, simvastatin (medicines used to lower blood cholesterol levels),
• midazolam given orally (a medicine used to treat anxiety or insomnia),
• colchicine (a medicine used to treat gout).

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

Klarmin:

• rifampicin, rifapentine, rifabutin (antibiotics used to treat tuberculosis),
• fluconazole, itraconazole (medicines used to treat fungal infections),
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (medicines used to treat HIV infection),
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (medicines used to treat heart rhythm disturbances or high blood pressure),
• alprazolam, triazolam (medicines used to treat anxiety or insomnia),
• warfarin or any other anticoagulant, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (medicines used to thin the blood),
• carbamazepine, valproate, phenytoin (antiepileptic medicines),
• atorvastatin, rosuvastatin (statins, medicines used to lower blood cholesterol levels),
• methylprednisolone (a very potent anti-inflammatory medicine),
• omeprazole (a medicine that reduces stomach acid secretion),
• cilostazol (a medicine used to treat intermittent claudication - a disease characterized by leg pain when walking and relieved by rest),
• cyclosporin, tacrolimus, sirolimus (medicines used, among other things, after organ transplantation),
• sildenafil, tadalafil, vardenafil (medicines used to treat erectile dysfunction),
• vinblastine (a medicine used in cancer chemotherapy),
• theophylline (a medicine used to treat asthma),
• tolterodine (a medicine used to treat urinary incontinence),
• phenobarbital (an antiepileptic medicine),
• St. John's Wort (a herbal medicine used to treat mild depression),
• sulfonylureas, nateglinide, repaglinide, insulin (medicines used to treat diabetes),
• aminoglycosides (a group of antibiotics),

This is also important if you are taking the following medicines:

• hydroxychloroquine or chloroquine (used to treat, among other things, rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines with clarithromycin may increase the risk of heart rhythm disturbances and other serious side effects affecting the heart,

Concomitant use of oral corticosteroids, injections, or inhalations (used to suppress the body's immune system, which is useful in treating many different diseases) may increase the risk of tendon disorders, including tendon rupture.

Klarmin with food, drink, and alcohol

The tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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 in pregnancy and breastfeeding has not been established.
Klarmin should only be used during pregnancy 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 Klarmin.

Driving and using machines

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

Klarmin contains yellow iron oxide

Yellow iron oxide (a coloring agent) may cause allergic reactions in sensitive individuals.

Klarmin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Klarmin

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
The medicine is for oral use.
Swallow the tablet whole with water. Do not chew or suck the tablet.
Respiratory tract infections, skin and soft tissue infections, acute otitis media
Adults:in severe infections, one tablet (500 mg) twice a day (every 12 hours).
Treatment usually lasts from 5 to 14 days, except for pneumonia and sinusitis, when treatment lasts from 6 to 14 days.

Use in children and adolescents

Children over 12 years:the same dosage as for adults.
Children under 12 years: the use of clarithromycin in the form of film-coated tablets has not been studied in children under 12 years of age. In these children, it is recommended to use clarithromycin in the form of an oral suspension.
Patient with renal impairment: the doctor may recommend reducing the dose of the medicine by half, which means taking one tablet (250 mg) once a day. In severe infections - one tablet (250 mg) twice a day.
It is recommended to use Klarmin containing 250 mg of clarithromycin in a tablet. Treatment should not last longer 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 the doctor recommends. Klarmin 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 MAC infections
Recommended dose for adults: one 500 mg tablet twice a day.
Helicobacter pylori infections
In patients with Helicobacter pylori infection, one of the following treatment regimens is recommended.

• clarithromycin 500 mg twice a day (every 12 hours) with amoxicillin 1 g twice a day and lansoprazole 30 mg twice a day for 10 days; or
• clarithromycin 500 mg twice a day with amoxicillin 1 g twice a day and omeprazole 20 mg once a day for 7 to 10 days.

Treatment with 2 medicines:

• clarithromycin 500 mg three times a day and omeprazole 40 mg once a day for 14 days. Omeprazole 20 mg or 40 mg once a day should be continued for the next 14 days; or
• clarithromycin 500 mg three times a day and lansoprazole 60 mg once a day for 14 days. To achieve complete healing of the ulcer, further use of gastric acid secretion inhibitors may be necessary.

Overdose of Klarmin

If you have taken more than the recommended dose of Klarmin, you should immediately consult a doctor or pharmacist.
Taking a higher dose of Klarmin than recommended by your doctor may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missed dose of Klarmin

If you miss a dose of Klarmin, you should take it as soon as possible, and then take the next dose at the scheduled time.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Klarmin

You should not stop treatment, even if you feel better and the symptoms of the disease have disappeared after a few days of taking the medicine.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

You should immediately contact a doctor and go to the nearest hospital emergency department if you experience any of the following symptoms:

If you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular psoriasis), you should immediately contact a doctor. The frequency of these side effects is unknown (cannot be estimated from the available data).
Side effects reported with an unknown frequency (frequency cannot be estimated from the available data):

• sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching,
• severe rash, including Stevens-Johnson syndrome, severe rash with redness, peeling, and swelling of the skin, resembling severe burns (toxic epidermal necrolysis),
• rash, fever, abnormal blood test results, and inflammation of internal organs. These may be symptoms of drug reaction with eosinophilia and systemic symptoms (DRESS),
• severe or prolonged diarrhea, which may be bloody or mucous (pseudomembranous colitis). Diarrhea may also occur after stopping clarithromycin (see also "Warnings and precautions"),
• jaundice (yellowing of the skin or whites of the eyes), skin irritation, pale stools, dark urine, itching, or abdominal pain. These symptoms may indicate liver function disorders,
• dangerously fast heartbeat, irregular heartbeat, extra heartbeats,
• pancreatitis (severe pain in the upper abdomen radiating to the back with nausea and vomiting),
• kidney inflammation (blood in the urine, fever, and back pain),
• muscle weakness, tenderness, or pain, especially if you feel unwell or have a high temperature - this may be a sign of muscle breakdown, which can lead to kidney problems (rhabdomyolysis).

Side effects reported not very often (occurring in 1 to 10 in 1,000 patients):

• changes in the ECG recording, palpitations (prolonged QT interval),
• abnormal liver function test results.

Other side effects:

In clinical trials and after the introduction of clarithromycin to the market, the following side effects were oftenreported (occurring in 1 to 10 in 100 patients):

• insomnia,
• taste disorders, headache, change in taste,
• diarrhea, vomiting, nausea, abdominal pain,
• abnormal liver function test results,
• rash, excessive sweating.

Side effects reported not very often(occurring in 1 to 10 in 1,000 patients):

• candidiasis (fungal infection), vaginal infection,
• decreased white blood cell count, decreased neutrophil count, and increased eosinophil count,
• hypersensitivity,
• anorexia, decreased appetite,
• anxiety,
• dizziness, drowsiness, tremors,
• balance disorders, hearing impairment, tinnitus,
• gastritis, oral thrush, glossitis, abdominal distension, constipation, dry mouth, belching, flatulence,
• cholestasis (increased bile components in the blood), hepatitis, increased liver enzyme activity,
• pruritus, urticaria,
• malaise, asthenia (weakness, lack of strength), chest pain, chills, fatigue,
• increased blood levels of 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 the introduction of clarithromycin to the market in the form of tablets and oral suspension:

• psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania,
• erythema,
• agranulocytosis (decreased granulocyte count in the blood),
• thrombocytopenia (decreased platelet count),
• seizures, ageusia, parosmia, anosmia, paresthesia (numbness, tingling),
• deafness,
• bleeding and changes in blood clotting parameters (especially if you are taking oral anticoagulants at the same time),
• discoloration of the tongue, discoloration of the teeth,
• liver failure, jaundice,
• acne.

Patients with impaired immune systems
In addition to symptoms related to the course of the 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 impairment,
• rash,
• dyspnea, insomnia,
• abnormal laboratory test results: increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity, increased blood urea nitrogen levels, and decreased platelet and white blood cell count.

If any of the side effects get worse or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 Klarmin

The medicine should be stored out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
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.
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 Klarmin contains

The active substance of the medicine is clarithromycin: one film-coated tablet contains 500 mg of clarithromycin.
The other ingredients of the medicine are: microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide, povidone (E 1201), talc (E 553b), stearic acid (E 570), magnesium stearate (E 470b);
coating ingredients:polyvinyl alcohol, titanium dioxide (E 171), quinoline yellow lake (E 104),
soy lecithin (E 322), xanthan gum (E 415).

What Klarmin looks like and contents of the pack

Klarmin, 500 mg, is a yellow, film-coated, oval, biconvex tablet.
The pack contains 14 or 28 film-coated tablets in PVC/PE/PVDC/Aluminum blisters, placed in a cardboard box with a patient information leaflet.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +48 17 865 51 00

Manufacturer

Bausch Health Poland sp. z o.o.
Przemysłowa 2
35-959 Rzeszów
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów

Date of last revision of the leaflet: