250 mg and 500 mg film-coated tablets 
clarithromycin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Clarithromycin Krka is and what it is used for 
2. What you need to know before you use Clarithromycin Krka 
3. How to use Clarithromycin Krka 
4. Possible side effects 
5. How to store Clarithromycin Krka 6. Contents of the pack 
and other information 

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

Clarithromycin Krka belongs to a group of medicines called macrolide antibiotics. Antibiotics prevent bacteria that cause infection from multiplying.

Clarithromycin Krka is used to treat adults and children from 12 years of age for the following bacterial infections:

  • respiratory tract infections such as bronchitis and pneumonia
  • the infection you in the throat and sinuses
  • the infection you in the skin and soft tissues
  • infection is caused by

Clarithromycin contained in Clarithromycin Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you use Clarithromycin Krka

Do not use Clarithromycin Krka

  • if you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of this medicine.
  • if you are taking medicines called ergot alkaloids, such as ergotamine or dihydroergotamine tablets, or use an ergotamine inhaler to treat migraines. Talk to your doctor for advice on treatment options.
  • if you are taking medicines containing simvastatin or lovastatin (also called statins, these are used to treat high blood fats, such as cholesterol and triglycerides )
  • If you are taking medicines containing terfenadine or astemizole (medicines for hay fever and allergies ) or cisapride or domperidone (for stomach problems) or pimozide tablets (for the treatment of certain mental illnesses), this combination of these medicines can sometimes cause serious disturbances in the heart rhythm. Talk to your doctor for advice on treatment options.
  • if you are taking other medicines that are known to cause severe heart rhythm disorders
  • if you are taking medicines containing tikagrelor or ranolazine (to treat angina or to reduce the risk of heart attack or stroke )
  • if you are taking a medicine called colchicine (for gout )
  • if you have abnormally low levels of potassium in your blood ( hypokalaemia )
  • if you are taking the medicine midazolam by mouth (a sedative)
  • if you have any problems with your liver or kidneys
  • if you or someone in your family has a history of cardiac arrhythmias (ventricular arrhythmias, including torsades de pointes ) or electrocardiogram changes ( ECG, electrocardiography) called prolonged QT syndrome

Clarithromycin Krka 250 mg, 500 mg film-coated tablets are not suitable for use in children under 12 years of age.

Warnings and cautions

Talk to your doctor or pharmacist before taking Clarithromycin Krka.

  • if you have heart problems
  • if you are pregnant or breastfeeding
  • if you need intravenous
  • if you have an abnormally low level of magnesium in your blood (hypomagnesemia)

If you get severe or prolonged diarrhea while using or after using Clarithromycin Krka, you should consult your doctor immediately as this may be a symptom of a serious condition, such as pseudomembranous colitis or diarrhea associated with Clostridium difficile .

If you develop any symptoms of hepatic impairment such as decreased appetite, yellow skin, and whites of the eyes, dark urine, itching, or soreness in the stomach, stop using Clarithromycin Krka immediately and talk to your doctor immediately.

Talk to your doctor before taking Clarithromycin Krka if you have kidney problems.

Long-term treatment with Clarithromycin Krka can lead to infection with resistant bacteria and fungal infection.

Children and young people

Clarithromycin Krka is not suitable for use in children under 12 years of age.

Other medicines and Clarithromycin Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important when taking the following medicines:

  • digoxin, quinidine, or disopyramide (used to treat heart problems). Your heart function may need to be monitored ( ECG ), or you may need to take blood samples if you are taking clarithromycin with certain medicines used to treat heart problems.
  • warfarin or any other blood thinner ( anticoagulant ). It may be necessary to take blood samples to check that your blood is coagulating properly.
  • omeprazole (against indigestion and stomach ulcers ), unless your doctor has förskrivigt it to you to treat Helicobacter pylori – infection associated with ulcers in the duodenum one.
  • ergot alkaloids, eg ergotamine or dihydroergotamine (for the treatment of migraine )
  • colchicine (for the treatment of gout ). Your doctor may want to monitor you.
  • theophylline (used by patients with respiratory problems such as asthma )
  • terfenadine or astemizole (for hay fever or allergy )
  • triazolam, alprazolam, or midazolam, taken intravenously or orally (for insomnia)
  • cilostazol (for poor blood circulation)
  • cisapride, domperidone, or cimetidine (for stomach upset)
  • carbamazepine, valproate, phenytoin, or phenobarbital (for the treatment of epilepsy )
  • methylprednisolone (a corticosteroid )
  • vinblastine (for the treatment of cancer)
  • ciclosporin, tacrolimus, or sirolimus (medicines that lower the immune system in connection with organ transplants or severe eczema )
  • pimozide or St. John’s wort (used to treat mental health problems)
  • rifabutin, rifampicin, fluconazole, and itraconazole (used to treat infections )
  • verapamil, amlodipine, or diltiazem (for the treatment of high blood pressure )
  • tolterodine (for overactive bladder )
  • simvastatin and lovastatin (also called HMG-CoA reductase inhibitors for the treatment of high cholesterol )
  • ritonavir, efavirenz, nevirapine, atazanavir, saquinavir, zidovudine, and etravirine (antiviral drug or drugs against HIV – infection )
  • sildenafil, vardenafil, and tadalafil (for impotence in adult men or for use against pulmonary arterial hypertension – high blood pressure in the blood vessels of the lungs)
  • insulin, repaglinide, rosiglitazone, pioglitazone, or nateglinide (medicines used to treat diabetes )
  • aminoglycosides (a type of antibiotic ), such as gentamycin, streptomycin, tobramycin, amikacin, and netilmicin

Talk to your doctor if you are taking oral contraceptives and get diarrhea or vomiting as you may need to use additional contraceptives such as condoms.

Clarithromycin Krka with food, drink, and alcohol

Clarithromycin Krka can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, 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 during use during pregnancy and lactation has not been established. It is therefore not recommended to use the drug during pregnancy without carefully weighing the benefits against the risks.

Clarithromycin is excreted in breast milk.

Driving and using machines

Clarithromycin Krka may cause dizziness, dizziness, confusion, and disorientation. If you are affected, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Clarithromycin Krka contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.

3. How to use Clarithromycin Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

For the treatment of respiratory infections, throat or sinus infections, and skin and soft tissue infections:

The usual dose of Clarithromycin Krka film-coated tablets for adults and children over 12 years of age is 250 mg twice daily for 6-14 days, ie a Clarithromycin Krka 250 mg film-coated tablet in the morning and early in the evening. Your doctor may increase the dose one to one Clarithromycin Krka 500 mg twice daily in case of severe infection.

Clarithromycin Krka should be swallowed with at least half a glass of water.

For the treatment of Helicobacter pylori infection associated with duodenal ulcers:

There are a number of effective treatment combinations for the treatment of Helicobacter pylori where Clarithromycin Krka tablets are taken with one or two other medicines.

These combinations include the following:

  1. One Clarithromycin Krka 500 mg tablet twice daily together with 1000 mg amoxicillin twice daily and 30 mg lansoprazole twice daily.
  2. One Clarithromycin Krka 500 mg tablet twice daily together with 30 mg lansoprazole twice daily and 400 mg metronidazole twice daily.
  3. One Clarithromycin Krka 500 mg tablet twice daily together with 1000 mg amoxicillin twice daily or 400 mg metronidazole twice daily, and 40 mg omeprazole once daily.
  4. One Clarithromycin Krka 500 mg tablet twice daily together with 1000 mg amoxicillin twice daily and 20 mg omeprazole once daily.
  5. One Clarithromycin Krka 500 mg tablet three times daily with 40 mg omeprazole once daily.

The treatment combination you use may differ from that described above. Your doctor will prescribe the treatment recommendation that is most suitable for you. If you are not sure which medicines to take or how long to take them, talk to your doctor.

Use for children and adolescents

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

If you forget to use Clarithromycin Krka

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

If you stop using Clarithromycin Krka

Do not stop taking your tablets, even if you feel better. It is important that you take your tablets as long as your doctor tells you to, otherwise, there is a risk that the symptoms will return.

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

4. Possible side effects

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

If you get any of the following side effects at any time during treatment, STOP TAKING the tablets and contact your doctor immediately:

  • severe or prolonged diarrhea, which may include blood or mucus. Diarrhea can occur over two months after treatment with clarithromycin, also in this case you should contact your doctor.
  • rash, difficulty breathing, fainting, or swelling of the face and throat. This may be a sign that you have developed an allergic reaction.
  • yellowing of the skin (jaundice), skin irritation, pale stools, dark-colored urine, sore stomach, or loss of appetite. This may be a sign that your liver is not working properly.
  • severe skin reactions such as blisters on the skin, mouth, lips, eyes, and genitals (symptoms of an allergic reaction called Stevens-Johnson syndrome / toxic epidermal necrolysis ): red, scaly rash with lumps under the skin and blisters (exanthematous pustulosis ). This side effect occurs in an unknown number of users (has been reported). Rare allergic skin reactions with blisters in the mouth, on the lips, and skin that cause serious illness with rash, fever, and inflammation of internal organs (DRESS).
  • muscle pain or weakness called rhabdomyolysis (a condition that causes the breakdown of muscle tissue which can lead to kidney damage).

Common: may affect up to 1 in 10 users

  • difficulty sleeping
  • altered sense of taste
  • headache
  • stomach upset such as nausea, vomiting, abdominal pain, indigestion, diarrhea
  • abnormal liver values ​​during blood tests
  • rash, excessive sweating, flushing ( flushing )

Uncommon: may affect up to 1 in 100 people

  • infection is in skin or vagina, fungal infections (cod)
  • altered white blood cell count (which may increase the risk of infection )
  • altered platelet count (increased risk of bruising, bleeding, or blood clots)
  • allergic reaction
  • decreased appetite
  • anxiety, nervousness, screaming
  • fainting, dizziness, drowsiness, tremors, involuntary movements of the tongue, face, lips or arms, and legs
  • a feeling of dizziness ( vertigo ), ringing in the ears, hearing loss
  • palpitations ( palpitation s), heart rhythm disturbances, or cardiac arrest
  • difficulty breathing ( asthma ), nosebleeds
  • blood clots in the lungs
  • stomach upset such as bloating, constipation, gas, belching, acid regurgitation, or pain in the rectum
  • inflammation of the gastric mucosa or esophagus
  • soreness in the mouth, dry mouth, inflammation of the tongue
  • liver problems such as hepatitis or cholestasis (biliary obstruction or impaired bile flow) which can cause yellow skin (jaundice), pale stools, and dark urine
  • increased levels of liver enzymes
  • itching, hives, inflammation of the skin
  • stiffness, aches, or spasms in the muscles
  • kidney problems, such as elevated levels of protein normally excreted by the kidneys or elevated levels of kidney enzymes
  • fever, chills, weakness, fatigue, chest pain or general discomfort
  • abnormal results on blood tests

Has been reported: occurs in an unknown number of users

  • infection of the colon
  • skin infection
  • psychotic disorder, confusion, altered perception of reality, depression, lost perception of space (disorientation), hallucinations (see things that do not exist), abnormal dreams (nightmares), manic episodes
  • convulsions (convulsions)
  • changes or loss of taste and/or sense of smell
  • stinging and burning sensation in the skin, numbness, and crawling
  • deafness
  • bleeding
  • heart rhythm disturbance ( torsade de pointes, fast heart rhythm ( ventricular tachycardia ))
  • inflammation of the pancreas
  • discoloration of the tongue and teeth
  • liver failure, jaundice (yellow skin)
  • unusual allergic reactions such as DRESS (causing a serious illness with rash, fever, and inflammation of internal organs)
  • acne
  • muscle disease ( myopathy )
  • inflammation of the kidneys (which can cause swollen ankles or high blood pressure ) or kidney failure

Talk to your doctor immediately if you develop any of these symptoms or have any other unexpected or unusual symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Clarithromycin Krka

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is clarithromycin.250 mg: Each film-coated tablet contains 250 mg of clarithromycin.500 mg: Each film-coated tablet contains 500 mg of clarithromycin.
  • The other ingredients are microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, magnesium stearate, talc, and stearic acid in the tablet core. Titanium dioxide E171, hypromellose, hydroxypropyl cellulose, yellow iron oxide E172 and propylene glycol in the film coating. See section 2 “Clarithromycin Krka contains sodium”.

What the medicine looks like and the contents of the pack

250 mg: oval, biconvex, slightly brownish-yellow film-coated tablets, length 15-15.2 mm and width 8 mm.

500 mg: oval, biconvex, slightly brownish-yellow film-coated tablets, length 19.5-19.8 mm and width 10 mm.

Clarithromycin Krka 250 mg is available in blister cards of 10, 12, 14, 16, or 20 film-coated tablets.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative

KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm,

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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