CLARITHROMYCIN KRKA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Claritromicina Krka 500 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Claritromicina Krka and what is it used for
2. What you need to know before you take Claritromicina Krka
3. How to take Claritromicina Krka
4. Possible side effects
5. Storage of Claritromicina Krka
6. Contents of the pack and other information

1. What is Claritromicina Krka and what is it used for

Claritromicina belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of the bacteria that cause infections.

Claritromicina is used to treat the following infections:

• Respiratory tract infections, such as bronchitis and pneumonia.
• Infections of the throat and sinusitis.
• Skin and soft tissue infections.
• Infections caused by Helicobacter pyloriassociated with duodenal ulcers.

2. What you need to know before you take Claritromicina Krka

Do not take Claritromicina Krka

• If you are allergic to clarithromycin or other macrolide antibiotics (such as erythromycin or azithromycin) or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called ergot alkaloids, such as ergotamine or dihydroergotamine tablets, or are using inhalers containing ergotamine for migraine. Consult your doctor about other treatment options.
• If you are taking medicines called simvastatin or lovastatin (known as statins, used to lower blood lipids such as cholesterol or triglycerides).
• If you are taking a medicine called lomitapide.
• If you are taking medicines called terfenadine or astemizol (commonly used to treat hay fever or allergies) or cisapride or domperidone (for stomach disorders) or pimozide (for mental health disorders), as the combination of these medicines can sometimes cause serious heart rhythm disturbances. Consult your doctor about other treatment options.
• If you are taking other medicines known to cause serious heart rhythm disturbances.
• If you are taking medicines called ticagrelor or ranolazine (for angina or to prevent stroke or heart attack).
• If you are taking a medicine called colchicine (for gout).
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• If you are taking midazolam orally (a sedative).
• If you have any liver or kidney problems.
• If you or a family member have a history of heart rhythm disorders (ventricular arrhythmia, including torsades de pointes) or an abnormality in the electrocardiogram (ECG, electrical recording of the heart) called "long QT syndrome".

Claritromicina Krka 250 mg film-coated tablets EFG are not suitable for children under 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Claritromicina Krka:

Tell your doctor immediatelyif you experience severe or persistent diarrhea during or after taking clarithromycin Krka, as this can be a symptom of a more serious condition such as pseudomembranous colitis or Clostridium difficile-associated diarrhea.

Stop taking Claritromicina Krka and inform your doctor immediatelyif you develop any symptoms of liver dysfunction such as loss of appetite, yellowing of the skin or whites of the eyes, dark urine, itching, or abdominal pain.

If you have kidney problems, consult your doctor before taking Claritromicina Krka.

Prolonged use of Claritromicina Krka may lead to resistant bacterial and fungal infections.

Children and adolescents

Claritromicina Krka is not suitable for children under 12 years of age.

Other medicines and Claritromicina Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is especially important if you are taking medicines called:

• digoxin, disopyramide, or quinidine (medicines for various heart problems). Your heart may need to be monitored (ECG) or blood tests may be necessary if you have taken clarithromycin with any medicine used for heart problems.
• warfarin or any other anticoagulant such as dabigatran, rivaroxaban, apixaban (used to make blood more fluid). Blood tests may be necessary to check that your blood is clotting properly.
• omeprazole (medicine for the treatment of indigestion and stomach ulcers), unless your doctor prescribes it for the treatment of Helicobacter pyloriinfection associated with duodenal ulcers.
• ergot alkaloids such as ergotamine or dihydroergotamine (medicines for migraine).
• colchicine (medicine for gout). Your doctor may want to monitor you.
• theophylline (medicine for respiratory problems such as asthma).
• terfenadine or astemizol (medicines for hay fever or allergies).
• triazolam, alprazolam, or intravenous midazolam (sedatives).
• cilostazol (medicine for poor blood circulation).
• cisapride, domperidone, or cimetidine (medicines for stomach disorders).
• carbamazepine, valproate, phenytoin, or phenobarbital (medicines for epilepsy).
• methylprednisolone (corticosteroid).
• vinblastine (medicine for cancer).
• cyclosporin, tacrolimus, or sirolimus (immunosuppressants used for organ transplants and severe eczema).
• pimozide or St. John's Wort (medicine for mental health disorders).
• rifabutin, rifampicin, rifapentine, fluconazole, or itraconazole (medicines used to treat certain infectious diseases).
• verapamil, amlodipine, or diltiazem (medicine for high blood pressure).
• tolterodine (medicine for overactive bladder).
• simvastatin or lovastatin (medicines known as HMG-CoA reductase inhibitors, used to treat high cholesterol).
• ritonavir, efavirenz, nevirapine, atazanavir, saquinavir, etravirine, or zidovudine (antiviral or anti-HIV medicines).
• sildenafil, vardenafil, or tadalafil (for impotence in adult men or to treat pulmonary arterial hypertension — high blood pressure in the blood vessels of the lungs).
• insulin, repaglinide, rosiglitazone, pioglitazone, or nateglinide (medicines for diabetes).
• aminoglycosides (a type of antibiotic) such as gentamicin, streptomycin, tobramycin, amikacin, or netilmicin.

Tell your doctor if you are taking oral contraceptives and experience diarrhea or vomiting, as you may need to take additional contraceptive precautions, such as using a condom.

Taking Claritromicina Krka with food and drinks

Claritromicina Krka can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. The safety of clarithromycin during pregnancy and breastfeeding has not been established. Therefore, its use is not recommended during pregnancy and breastfeeding unless the benefits outweigh the risks. Clarithromycin is excreted in breast milk.

Driving and using machines

Claritromicina Krka may cause dizziness, vertigo, confusion, and disorientation. Do not drive or use machines if you experience these symptoms.

Sodium: This medicine contains less than 23 mg (1 mmol) of sodium per dose; this is essentially "sodium-free".

3. How to take Claritromicina Krka

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

For respiratory tract infections, skin and soft tissue infections:

The usual dose for Claritromicina Krka film-coated tablets for adults and adolescents over 12 years is 250 mg twice a day for 6-14 days, e.g., one Claritromicina Krka 250 mg tablet in the morning and one in the evening.

Your doctor may increase the dose for more severe infections to Claritromicina Krka 500 mg tablets, 2 times a day.

Claritromicina Krka tablets should be taken with at least half a glass of water.

For the treatment of Helicobacter pyloriinfections associated with duodenal ulcers:

There are several effective treatment combinations for Helicobacter pyloriin which Claritromicina Krka tablets are taken with one or two other medicines.

These combinations include:

1. one Claritromicina Krka 500 mg tablet, twice a day, with 1000 mg of amoxicillin, twice a day, and 30 mg of lansoprazole, twice a day.
2. one Claritromicina Krka 500 mg tablet, twice a day, with lansoprazole 30 mg twice a day, plus metronidazole 400 mg, twice a day.
3. one Claritromicina Krka 500 mg tablet, twice a day, with 1000 mg of amoxicillin, twice a day, or metronidazole 400 mg, twice a day, plus omeprazole 40 mg once a day.
4. one Claritromicina Krka 500 mg tablet, twice a day, with 1000 mg of amoxicillin, twice a day, plus omeprazole 20 mg once a day.
5. one Claritromicina Krka 500 mg tablet, three times a day, with omeprazole 40 mg, once a day.

Depending on the dosage, there may be other medicines on the market that are more suitable. Your doctor will indicate the most suitable medicine for your treatment.

The treatment combination you receive may be slightly different from the above. Your doctor will decide which treatment combination is most suitable for you. If you are unsure about which tablets to take or for how long, consult your doctor.

Patients with kidney problems:

If you have severe kidney problems, your doctor may need to reduce the dose to half, i.e., once a day, and limit treatment to a maximum of 14 days.

Use in children and adolescents

Do not give these tablets to children under 12 years of age. Your doctor will prescribe another medicine that is suitable for these children.

If you take more Claritromicina Krka than you should

If you accidentally take more tablets in a day than your doctor has indicated, or if a child accidentally swallows several tablets, contact your doctor or the nearest emergency service immediately.

Overdose may cause stomach pain and vomiting.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Claritromicina Krka

If you forget to take a clarithromycin tablet, take it as soon as you remember. Do not take more tablets in a day than your doctor has indicated. Do not take a double dose to make up for forgotten doses.

If you stop taking Claritromicina Krka

Do not stop taking your medicine just because you feel better. If you stop taking clarithromycin too soon, you may not have eliminated all the bacteria that cause the infection, and the infection may recur.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, clarithromycin can cause adverse effects, although not all people will suffer from them.

If any of the following cases occur during treatment, stop taking these tablets immediately and inform your doctor:

• severe or prolonged diarrhea, which may present with blood or mucus. Diarrhea may occur two months after treatment with clarithromycin, in which case you should continue to consult with your doctor.
• skin rash, difficulty breathing, fainting, or inflammation of the face and throat. This is a sign that you have developed an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, abdominal pain on palpation, or loss of appetite. These may be signs that your liver is not functioning properly.
• severe skin reactions such as blistering of the skin, mouth, lips, eyes, and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome / toxic epidermal necrolysis). A red and scaly rash with bumps under the skin and blisters (pustular exanthema); the frequency of this adverse effect is considered unknown (cannot be estimated from the available data). Rare allergic skin reactions that cause serious diseases with ulcers of the mouth, lips, and skin that cause serious diseases with rash, fever, and inflammation of the internal organs (DRESS).
• muscle pain or weakness known as rhabdomyolysis (a condition that causes muscle tissue to break down, which can result in kidney damage).

Common Adverse Effects (may affect up to 1 in 10 people):

• difficulty sleeping (insomnia);
• changes in taste;
• headache;
• stomach problems such as nausea, vomiting, stomach pain, indigestion, or diarrhea;
• abnormal liver function test results;
• skin rash, excessive sweating, redness.

Uncommon Adverse Effects (may affect up to 1 in 100 people):

• fungal infections of the skin or vagina (candidiasis);
• change in white blood cell concentration in the blood (which can make infections more frequent);
• change in platelet levels in the blood (increased risk of bruising, bleeding, or blood clots);
• allergic reactions;
• loss of appetite;
• anxiety, nervousness, screaming;
• fainting, dizziness, drowsiness, tremors, involuntary movements of the tongue, face, lips, or limbs;
• feeling of spinning (vertigo), ringing in the ears, hearing loss;
• strong and rapid heartbeats (palpitations), changes in heart rhythm or cardiac arrest;
• respiratory problems (asthma), nosebleeds;
• blood clots in the lungs;
• stomach problems, such as abdominal distension, constipation, gas (flatulence), belching, heartburn, or anal pain;
• inflammation of the stomach wall or esophagus (the tube that connects the mouth to the stomach);
• mouth pain, dry mouth, tongue inflammation;
• liver problems, such as hepatitis or cholestasis, which can cause yellowing of the skin (jaundice), pale stools, or dark urine;
• increased liver enzymes;
• itching, hives, skin inflammation;
• stiffness, pain, or spasms in the muscles;
• kidney problems, such as elevated protein levels that are normally excreted by the kidneys or elevated kidney enzyme levels;
• fever, chills, weakness, fatigue, chest pain, or general feeling of discomfort;
• abnormal blood test results.

Unknown Frequency(frequency cannot be estimated from the available data):

• colon infection;
• skin infection;
• psychotic disorder, confusion, changes in sense of reality, depression, loss of orientation (disorientation), hallucinations (seeing things), abnormal dreams (nightmares), manic episodes;
• seizures;
• change or loss of sense of taste and/or smell;
• paresthesia (tingling and burning sensation in the skin, numbness, tingling sensation);
• deafness;
• bleeding;
• type of heart rhythm disorder (Torsade de pointes, ventricular tachycardia);
• pancreatitis;
• discoloration of the tongue, discoloration of the teeth;
• liver failure, jaundice (yellowing of the skin);
• rare allergic skin reactions, such as DRESS syndrome (which causes a serious disease with rash, fever, and inflammation of the internal organs);
• acne;
• muscle disease (myopathy),;
• kidney inflammation (which can cause ankle inflammation or high blood pressure) or kidney failure.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Clarithromycin Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Clarithromycin Krka

• The active ingredient is clarithromycin. Each film-coated tablet contains 500 mg of clarithromycin.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, povidone K30, colloidal anhydrous silica, magnesium stearate, talc, and stearic acid in the core of the tablet and titanium dioxide (E171), hypromellose, hydroxypropylcellulose, yellow iron oxide (E172), and propylene glycol in the coating. See section 2 "Clarithromycin Krka contains sodium".

Appearance and Package Contents

Film-coated tablets are oval, biconvex, and slightly yellow-brown in color, 19.5 to 19.8 mm long and 10 mm wide.

Clarithromycin Krka 500 mg is available in blister packs containing 7, 10, 14, 16, 20, or 21 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

or

TAD Pharma GmbH,

Heinz-Lohmann-Straße 5,

27472 Cuxhaven, Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L.,

C/ Anabel Segura 10, Pta. Baja, Oficina 1

28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this prospectus: May 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/