KLARMIN 250 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Klarmin, 250 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Klarmin and what is it used for
4. Important information before taking Klarmin
   1. When not to take Klarmin
   2. Warnings and precautions
   3. Klarmin and other medicines
   4. The patient must inform their doctor if they are taking any of the following medicines, as their use with Klarmin is contraindicated:
   5. The patient should inform their doctor if they 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. Taking a higher dose of Klarmin than recommended
   3. Missing a dose of Klarmin
   4. Stopping treatment with Klarmin
6. Possible side effects
   1. The patient should immediately contact their doctor and go to the nearest hospital emergency department
   2. Other side effects:
   3. Reporting side effects
7. How to store Klarmin
8. Contents of the packaging and other information
   1. What Klarmin contains
   2. What Klarmin looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of the last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Klarmin, 250 mg, film-coated tablets

Clarithromycin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Klarmin and what is it 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 packaging and other information

1. What is Klarmin and what is it 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 microorganisms susceptible to clarithromycin. 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, cellulitis, abscesses,
• dental and oral infections, such as periapical abscess, periodontitis,
• disseminated or localized infections caused by mycobacteria.

In patients with HIV infection (CD4 lymphocyte 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 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 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 the patient has too low a level of potassium or magnesium in the blood (hypokalemia or hypomagnesemia).
• If the patient or someone in their family has a history of changes in the ECG recording (prolonged QT interval) and heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes).
• If the patient has severe liver failure with concomitant kidney failure.
• If the patient is taking a medicine containing lomitapide.

Warnings and precautions

Before starting treatment with Klarmin, the patient should discuss it with their doctor if:

• the patient is pregnant or thinks they may be pregnant,
• the patient has kidney or liver function disorders,
• the patient has coronary artery disease, severe heart failure, bradycardia,
• the patient is taking any of the medicines listed in the "Klarmin and other medicines" section.

If any of the following situations occur during treatment with Klarmin, the patient should tell their doctor (see also section 4):

• severe hypersensitivity reactions, such as rash, urticaria, angioedema, bronchospasm - the patient should immediatelyconsult a doctor, who will provide appropriate treatment;
• diarrhea, especially acute or prolonged - the patient should as soon as possibletell their doctor; if necessary, the doctor will prescribe appropriate treatment; the patient should not take anti-diarrheal medicines;
• symptoms of liver function disorders, such as loss of appetite, jaundice, dark urine, itching or abdominal pain - the patient should stop treatment and immediatelyconsult a doctor;
• new infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially during long-term use of the antibiotic - the doctor will prescribe appropriate treatment.

In addition, during treatment with Klarmin, the following may occur:

• cross-resistance of bacteria (bacteria resistant to clarithromycin may also be resistant to other macrolide antibiotics and lincosamides and clindamycin),
• bacterial resistance (e.g., treatment of Helicobacter pylori infection may lead to the selection of resistant microorganisms).

Klarmin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The patient must inform their doctor if they 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 that lower blood cholesterol levels),
• midazolam given orally (a medicine used to treat anxiety or insomnia),
• colchicine (a medicine used to treat gout).

The patient should inform their doctor if they 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 hypertension),
• 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 that lower blood cholesterol levels),
• methylprednisolone (a very potent anti-inflammatory medicine),
• omeprazole (a medicine that reduces gastric 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),
• sulfonylurea, nateglinide, repaglinide, insulin (medicines used to treat diabetes),
• aminoglycosides (a group of antibiotics),

This is also important if the patient is taking any of 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,
• oral, injectable, or inhaled corticosteroids (used to suppress the body's immune response, which is useful in treating many different diseases).

Klarmin with food, drink, and alcohol

The tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a child, they should consult their doctor or pharmacist before taking this medicine.
The safety of clarithromycin during pregnancy and breastfeeding has not been established.
Klarmin may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Because 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 the ability to drive and use machines.

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, i.e., the medicine is considered "sodium-free".

3. How to take Klarmin

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The medicine is for oral use.
The tablet should be swallowed whole, with a glass of water. Do not chew or suck the tablet.
If a dose of 500 mg is required, it is recommended to use Klarmin containing 500 mg of clarithromycin per tablet.
Respiratory tract infections, skin and soft tissue infections, acute otitis media
Adults:one tablet (250 mg) twice a day (every 12 hours).
In severe infections, the doctor may recommend increasing the dose to two tablets of 250 mg (500 mg) twice a day (every 12 hours). Treatment usually lasts from 5 to 14 days, except for pneumonia and sinusitis, when treatment lasts 6 to 14 days.

Use in children and adolescents

Children over 12 years old:the same dosage as for adults.
Children under 12 years old:the use of clarithromycin in the form of film-coated tablets has not been studied in children under 12 years old. In these children, it is recommended to use clarithromycin in the form of an oral suspension.
Patients 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. Treatment should not last longer than 14 days.
Dental and oral infections
One tablet (250 mg) twice a day (every 12 hours). Treatment usually lasts 5 days.
Infections caused by mycobacteria
Recommended dose for adults: two tablets of 250 mg (500 mg) 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 act 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: two tablets of 250 mg (500 mg) 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 two 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.

Taking a higher dose of Klarmin than recommended

If the patient has taken a higher dose of Klarmin than recommended, they should immediately consult their doctor or pharmacist.
Taking a higher dose of Klarmin than recommended by the doctor may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missing a dose of Klarmin

If the patient misses a dose of Klarmin, they should take it as soon as possible, and then take the next dose at the scheduled time.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Klarmin

The patient should not stop treatment, even if they feel better and the symptoms of the disease disappear after a few days of taking the medicine.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately contact their doctor and go to the nearest hospital emergency department

if they experience any of the following symptoms:
If the patient experiences a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular psoriasis), they should immediately contact their 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 with redness, fever, blisters, or ulcers (Stevens-Johnson syndrome), severe rash with redness, peeling, and itching of the skin, resembling severe burns (toxic epidermal necrolysis [Lyell's syndrome]),
• rash, fever, abnormal blood test results, and inflammation of internal organs. These may be symptoms of a 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 the patient feels unwell or has 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 disorders, tinnitus,
• gastritis, oral infections, tongue inflammation, abdominal distension, constipation, dry mouth, belching, flatulence,
• cholestasis (increased bile components in the blood), hepatitis, increased liver enzyme activity,
• pruritus, urticaria,
• fatigue, asthenia (weakness, lack of strength), chest pain, chills, fatigue,
• increased blood levels of enzymes: 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 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 the patient is taking oral anticoagulants at the same time),
• discoloration of the tongue, discoloration of the teeth,
• liver failure, jaundice,
• acne.

Patients with impaired immunity
In addition to symptoms related to the course of the disease, the following side effects have been observed in adult patients with impaired immunity:

• nausea, vomiting, changes in taste, constipation, abdominal pain, diarrhea, flatulence,
• headache, hearing disorders,
• 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 counts.

If any of the side effects worsen or if any side effects not listed in this leaflet occur, the patient should tell their doctor or pharmacist.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Klarmin

The medicine should be stored out of 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Klarmin contains

The active substance of Klarmin is clarithromycin: one film-coated tablet contains 250 mg of clarithromycin.
The other ingredients of the medicine are: microcrystalline cellulose, pregelatinized starch, 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), yellow iron oxide (E 172), soya lecithin (E 322), xanthan gum (E 415).

What Klarmin looks like and what the pack contains

Klarmin, 250 mg, is a yellow, film-coated, oval, biconvex tablet.
The packaging 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 the last revision of the leaflet: