Package Leaflet: Information for the User

Claritromicina Krka 500mg Film-Coated Tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before taking Claritromicina Krka

3.How to take Claritromicina Krka

4.Possible side effects

5.Storage of Claritromicina Krka

6.Contents of the pack and additional information

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

Claritromicina is used in the treatment of the following infections:

• Respiratory tract infections, such as bronchitis and pneumonia.
• Throat infections and sinusitis.
• Skin and tissue infections.
• Infections caused byHelicobacter pyloriassociated with duodenal ulcers.

Do not take Claritromicina Krka

• If you are allergic to clarithromycin or to other macrolide antibiotics (such as erythromycin or azithromycin) or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called ergot alkaloids, for example, ergotamine or dihydroergotamine tablets or are using inhalers with ergotamine for migraine. Consult your doctor about other treatment options.
• If you are taking medicines called statins, such as simvastatin or lovastatin (used to reduce blood lipids such as cholesterol or triglycerides).
• If you are taking a medicine called lomitapida.
• If you are taking medicines called terfenadine or astemizol (commonly used to treat hay fever or allergies) or cisaprida or domperidone (to treat stomach disorders) or pimozide (to treat mental disorders) as the combination of these medicines may cause severe heart rhythm disturbances. Consult your doctor about other treatment options.
• If you are taking other medicines known to cause severe 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 has a history of heart rhythm disorders (ventricular arrhythmia, including torsades de pointes) or an abnormality in the electrocardiogram (ECG, heart electrical recording) called "long QT syndrome".

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

Warnings and precautions

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

• If you have heart problems;
• If you are pregnant or breastfeeding;
• If you need midazolam intravenously;

Inform your doctor immediately if you experience intense or persistent diarrhea during or after taking clarithromycin Krka, as this may 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 immediately if 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 palpitations.

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

The prolonged use of Claritromicina Krka may lead to bacterial and fungal resistance.

Children and adolescents

Claritromicina Krka is not suitable for children under 12 years.

Other medicines and Claritromicina Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

This is especially important if you are taking medicines called:

• Digoxin, disopyramide or quinidine (medicines for the treatment of various heart problems). Your heart may need to be monitored (ECG) or blood tests may need to be done if you have taken clarithromycin with some medicines used to treat heart problems.
• Warfarin, or any other anticoagulant such as dabigatran, rivaroxaban, apixaban (used to make the blood more fluid). You may need to have blood tests to check that your blood clots efficiently.
• Omeprazole (medicine for the treatment of indigestion and stomach ulcers), except if your doctor prescribes it for the treatment of Helicobacter pylori infection associated with duodenal ulcers.
• Ergot alkaloids derived from ergot, such as ergotamine or dihydroergotamine (medicines for the treatment of migraine).
• Colchicine (medicine for the treatment of gout). Your doctor may want to monitor you.
• Theophylline (medicine for the treatment of respiratory problems such as asthma).
• Terfenadine or astemizol (medicines for the treatment of hay fever or allergies).
• Triazolam, alprazolam or midazolam intravenously or oromucously (sedatives).
• Cilostazol (medicine for the treatment of poor blood circulation).
• Cisaprida, domperidone or cimetidine (medicines for the treatment of digestive problems).
• Carbamazepine, valproate, phenytoin or phenobarbital (medicines for the treatment of epilepsy).
• Methylprednisolone (corticosteroid).
• Vinblastine (medicine for the treatment of cancer).
• Ciclosporin, tacrolimus or sirolimus (immunosuppressants used for organ transplantation and severe eczema).
• Pimozide or St. John's Wort (medicine for the treatment of mental health problems).
• Rifabutin, rifampicin, rifapentine, fluconazole or itraconazole (medicines used for the treatment of certain infectious diseases).
• Verapamil, amlodipine or diltiazem (medicine for the treatment of high blood pressure).
• Tolterodine (medicine for the treatment of overactive bladder).
• Simvastatin or lovastatin (medicines known as HMG-CoA reductase inhibitors, used for the treatment of high cholesterol).
• Ritonavir, efavirenz, nevirapine, atazanavir, saquinavir, etravirine and zidovudine (antiviral or anti-HIV medicines).
• Sildenafil, vardenafil and tadalafil (for the treatment of erectile dysfunction in adult men or to treat pulmonary hypertension - high blood pressure in the blood vessels of the lungs).
• Insulin, repaglinide, rosiglitazone, pioglitazone or nateglinide (medicines for the treatment of diabetes).
• Aminoglycosides (a type of antibiotic) such as gentamicin, streptomycin, tobramycin, amikacin or netilmicin.

Inform 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, or think you may be pregnant, consult your doctor before taking this medicine.There is no established safety of clarithromycin during pregnancy and breastfeeding. Therefore, its use is not recommended during pregnancy and breastfeeding without carefully considering the benefits against the risks. Clarithromycin is excreted in breast milk.

Driving and use of 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".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

For respiratory, skin, and soft tissue infections:

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

Your doctor will increase the dose in 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 infections caused byHelicobacter pyloriassociated with duodenal ulcers:

There are several effective treatment combinations for the treatment ofHelicobacter pyloriin which Claritromicina Krka tablets are taken together with one or two medications.

These combinations include:

1. one Claritromicina Krka 500 mg tablet, twice a day, with 1000 mg of amoxicilina, twice a day, and 30 mg of lansoprazol, twice a day.
2. one Claritromicina Krka 500 mg tablet, twice a day, with lansoprazol 30 mg twice a day, plus metronidazol 400 mg, twice a day.
3. one Claritromicina Krka 500 mg tablet, twice a day, with 1000 mg of amoxicilina, twice a day, or metronidazol 400 mg, twice a day, plus omeprazol 40 mg once a day.
4. one Claritromicina Krka 500 mg tablet, twice a day, with 1000 mg of amoxicilina, twice a day, plus omeprazol 20 mg once a day.
5. one Claritromicina Krka 500 mg tablet, three times a day, with omeprazol 40 mg, once a day.

In accordance with the dosing, there are other more suitable medications available on the market. Your doctor will indicate the most suitable medication 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 the tablets you should take, or for how long you should take them, please 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 the treatment to a maximum of 14 days.

Use in children and adolescents

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

If you take more Claritromicina Krka than you should

If you accidentally took more tablets in a day than your doctor 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Claritromicina Krka

If you forgot to take a Claritromicina tablet, take the tablet as soon as you remember. Do not take more tablets in a day than your doctor indicated. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Claritromicina Krka

Do not stop taking your medication because you feel better. If you stop taking Claritromicina too soon, the bacteria causing the infection may not have been completely eliminated and the infection could reappear.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, clarithromycin can cause side effects, although not everyone will experience them.

If any of the following 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-colored 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 the formation of blisters on the skin, mouth, lips, eyes, and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis). A red, scaly rash with bumps under the skin and blisters (pustular exanthem); the frequency of this side effect is considered unknown (cannot be estimated from available data). Rare skin allergies that cause severe diseases with mouth ulcers, lip ulcers, and skin ulcers that cause severe diseases with skin rash, fever, and inflammation of internal organs (DRESS).
• muscle pain or weakness known as rhabdomyolysis (a condition that causes muscle tissue breakdown that may result in kidney damage).

Frequent side 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 results in liver function blood tests;
• skin rash, excessive sweating, redness.

Rare side effects (may affect up to 1 in 100 people):

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

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

• colon infection;
• skin infection;
• psychotic disorder, confusion, changes in perception of reality, depression, 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);
• hearing loss;
• bleeding;
• type of heart rhythm disorder (Torsade de pointes, ventricular tachycardia);
• pancreatitis;
• decoloration of the tongue, decoloration of the teeth;
• liver insufficiency, jaundice (yellowing of the skin);
• rare skin allergies, such as the syndrome of nl DRESS (which causes a severe disease with skin rash, fever, and inflammation of internal organs);
• acne;
• muscle disease (myopathy);
• kidney inflammation (which may cause inflammation of the ankles or high blood pressure) or renal failure.

Reporting of side effects:

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

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

Do not use this medication 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 disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Claritromicina Krka

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

Appearance of the product and contents of the package

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

Claritromicina Krka 500 mg is available in packages with blisters containing 7, 10, 14, 16, 20, or 21 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

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

Responsiblefor manufacturing

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 medication by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L.,

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

28108 Alcobendas, Madrid, Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: May 2021

More detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/