CLARITROMICINA 250 mg Tabletki Powlekane

Treść ulotki

1. Claritromicina HCS 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What is Claritromicina HCS and what is it used for
   2. What you need to know before taking Claritromicina HCS
   3. How to take Claritromicina HCS
2. Claritromicina HCS tablets must be swallowed whole with at least half a glass of
   1. Possible side effects
   2. How to store Claritromicina HCS
   3. Contents of the pack and other information

Package Leaflet: Information for the Patient

Claritromicina HCS 250 mg film-coated tablets, 500 mg film-coated tablets

Claritromicina

Generic medicine

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

• Keep this leaflet. 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 their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Claritromicina belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria that cause infections.
Claritromicina HCS is used in adults and children 12 years and older to treat the
following infections:

• Lung infections such as bronchitis and pneumonia,
• Throat and nose infections,
• Skin and soft tissue infections,
• Infections associated with Helicobacter pyloriwith duodenal ulcers.

2. What you need to know before taking Claritromicina HCS

Do not take Claritromicina HCS if:

• you know you are allergicto clarithromycin, to other macrolide antibiotics such as erythromycin or azithromycin, or to any of the excipients of this medicine.
• you are taking medicines called ergot alkaloids, for example ergotamine or dihydroergotamine tablets, or use ergotamine inhalers for migraine. Ask your doctor for advice about alternative medicines.
• you are taking medicines called simvastatin or lovastatin (commonly known as statins, used to lower increased lipids in the blood such as cholesterol and triglycerides)
• you are taking medicines called terfenadine or astemizole (for hay fever or allergies) or cisapride (for stomach diseases) or pimozide tablets (for mental health problems) as the combination of these medicines can sometimes cause serious heart rhythm disturbances. Ask your doctor for advice about alternative medicines
• you are taking other medicines that are known to cause serious heart rhythm disturbances
• you are taking medicines called ticagrelor or ranolazine (for angina or to reduce the likelihood of heart attack or stroke)
• you are taking a medicine called colchicine (for gout)
• you have abnormally low levels of potassium in the blood (hypokalaemia)
• you are taking midazolam orally (for epilepsy)
• you have problems with your kidneys and/or liver
• you or someone in your family has a history of heart rhythm disturbances (ventricular arrhythmia, including torsades de pointes) or abnormalities in the electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome”.

Claritromicina HCS 250 mg, 500 mg film-coated tablets are not suitable for
use in children under 12 years of age.
Warnings and precautions
Tell your doctor or pharmacist before taking Claritromicina HCS.

• If you have heart problems
• If you are pregnant or breastfeeding
• If you need to take midazolam intravenously
• If you have an abnormally low level of magnesium in the blood (hypomagnesaemia).

If you develop severe or prolonged diarrhoea during or after taking Claritromicina HCS,
tell your doctor immediately, as it may be a symptom of a more serious condition
such as pseudomembranous colitis or Clostridium difficile-associated diarrhoea.
If you develop any symptoms of liver dysfunction such as anorexia (loss of
appetite), yellowing of the skin or whites of the eyes, dark urine, itching or soft abdomen, stop taking Claritromicina HCS and tell your doctor immediately.
Tell your doctor before taking Claritromicina HCS if you have kidney problems.
Prolonged use of Claritromicina HCS can lead to an infection with resistance to bacteria and
fungi.

Children and adolescents
Claritromicina HCS is not suitable for use in children under 12 years of age.

Other medicines and Claritromicina HCS
Tell your doctor or pharmacist if you are taking or have recently taken or might
take any other medicines. This is particularly important if you are taking
medicines called:

• digoxin, quinidine or disopyramide (used to treat heart problems). Your heart should be monitored (ECG test) or you may need to have blood tests if you are taking clarithromycin with any medicine used to treat heart problems
• warfarin, or any anticoagulant (used to thin the blood). You may need to have blood tests to check that the blood clots efficiently
• omeprazole (used for the treatment of indigestion or stomach ulcers) unless your doctor has prescribed it for the treatment of Helicobacter pyloriinfection associated with duodenal ulcer
• ergot alkaloids such as ergotamine or dihydroergotamine (for the treatment of migraine)
• colchicine (for the treatment of gout). Your doctor may monitor you
• theophylline (used in patients with breathing difficulties such as asthma)
• terfenadine or astemizole (for hay fever or allergy)
• triazolam, alprazolam or midazolam (sedatives)
• cilostazol (for poor circulation)
• cisapride or cimetidine (for stomach problems)
• carbamazepine, valproate, phenytoin or phenobarbital (for the treatment of epilepsy)
• methylprednisolone (a corticosteroid)
• vinblastine (for the treatment of cancer)
• cyclosporine, tacrolimus or sirolimus (immunosuppressants used for organ transplantation and severe eczema)
• pimozide or St John's Wort (for mental health problems)
• rifabutin, rifampicin, rifapentine, fluconazole and itraconazole (treatment for infectious diseases)
• verapamil, amlodipine or diltiazem (for high blood pressure)
• tolterodine (for overactive bladder)
• simvastatin and lovastatin (known as HMG-CoA reductase inhibitors for the treatment of high cholesterol)
• ritonavir, efavirenz, nevirapine, atazanavir, saquinavir, etravirine and zidovudine (anti-viral or anti-HIV medicines)
• sildenafil, vardenafil and tadalafil (for impotence in adult males or used for pulmonary arterial 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, netilmicin

Claritromicina HCS with food and drink
Claritromicina TAD can be taken with or without food.

Pregnancy and breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning
a pregnancy ask your doctor or pharmacist for advice before taking this medicine.
Safety on the use of clarithromycin during pregnancy and breastfeeding has not been
established. Therefore, use during pregnancy is not recommended without careful evaluation
of the benefits against the risks. Clarithromycin is excreted in breast milk.

Driving and using machines
Claritromicina TAD can cause dizziness, vertigo, confusion and disorientation. If you experience
these symptoms do not drive or use machines.

Claritromicina HCS contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially
"sodium-free".

3. How to take Claritromicina HCS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

For lung infections, throat infections or nasal sinus infections and skin and soft tissue infections:
The usual dose of Claritromicina HCS film-coated tablets for adults and children over 12 years of age is 250 mg twice a day for 6-14 days, e.g. one Claritromicina HCS 250 mg film-coated tablet in the morning and one in the evening.
Your doctor may increase the dose to one Claritromicina HCS 500 mg film-coated tablet twice a day in severe infections.

Claritromicina HCS tablets must be swallowed whole with at least half a glass of

water.

For the treatment of infections fromHelicobacter pyloriassociated with duodenal ulcer:
There is a number of available combination treatments effective for the treatment of

Helicobacter pyloriin which Claritromicina HCS tablets are taken with one or two of the other
medicines.
The combinations include the following:
a) one Claritromicina HCS 500 mg tablet taken twice a day with amoxicillin
1000 mg twice a day and lansoprazole 30 mg twice a day.
b) one Claritromicina HCS 500 mg tablet taken twice a day with lansoprazole 30
mg twice a day and metronidazole 400 mg twice a day.
c) one Claritromicina HCS 500 mg tablet taken twice a day with amoxicillin
1000 mg twice a day or metronidazole 400 mg twice a day plus omeprazole 40
mg once a day.
d) one Claritromicina HCS 500 mg tablet taken twice a day with amoxicillin
1000 mg twice a day plus omeprazole 20 mg once a day.
e) one Claritromicina HCS 500 mg tablet taken three times a day together with omeprazole
40 mg once a day.
The combination treatment you receive may differ slightly from those above
indicated. Your doctor will decide which combination is most suitable for you. If you are not sure of
which tablets you should take or for how long, ask your doctor for advice.

Use in children and adolescents
Do not give these tablets to children under 12 years of age. Your doctor will prescribe a
medicine suitable for your child.

If you take more Claritromicina HCS than you should
If you accidentally take more tablets in a day than prescribed by your
doctor, or if a child accidentally swallows some tablets, contact your doctor or the nearest
hospital emergency room. An overdose of Claritromicina HCS tablets is
likely to cause vomiting and stomach pain.

If you forget to take Claritromicina HCS
If you forget to take a tablet, take it as soon as you remember. Do not take more
tablets in a day than prescribed by your doctor. Do not take a double dose
to make up for the forgotten tablet.

If you stop taking Claritromicina HCS
Do not stop the treatment even if you feel better. It is important to take the tablets
for the time prescribed by your doctor, otherwise the problem may recur.
If you have any doubts 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 everyone will experience them.
If you suffer from any of the following conditions at any time during treatment STOP taking the tablets and contact your doctor immediately:

• severe or prolonged diarrhea, which may contain blood or mucus. Diarrhea may persist for more than two months after treatment with clarithromycin; in this case, you should still contact your doctor.
• skin rash, difficulty breathing, fainting or swelling of the face and throat. This is a sign of the development of an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, soft abdomen or loss of appetite. These may be signs that the liver is not functioning properly.
• severe skin reactions such as blisters on 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 the formation of pustules and blisters (pustulosis exanthematica). The frequency of this reaction is unknown (cannot be defined based on available data).
• muscle pain or weakness known as rhabdomyolysis (a condition that causes muscle tissue breakdown that can cause kidney damage).

Common: may affect up to 1 in 10 people

• sleep disturbances (insomnia)
• changes in taste
• headache
• stomach problems such as feeling unwell, vomiting, stomach pain, indigestion, diarrhea
• abnormal liver function in blood tests
• skin rash, excessive sweating, hot flashes

Uncommon: may affect up to 1 in 100 people

• skin or vaginal infections, yeast infections (thrush)
• changes in white blood cell levels in the blood (which may make infections more likely)
• changes in platelet levels in the blood (increased risk of bruising, bleeding blood clots)
• allergic reaction
• decreased appetite
• anxiety, nervousness, screaming
• fainting, dizziness, drowsiness, tremor, involuntary movements of the tongue, face, lips or limbs
• sensation of spinning (vertigo), ringing in the ears, hearing loss
• fast and pounding heart (palpitations), changes in heart rate or cardiac arrest
• breathing problems (asthma), nosebleeds
• blood clots in the lungs
• problems with stomach swelling, constipation, gas (flatulence), belching, heartburn or anal pain
• inflammation of the lining of the stomach or esophagus (the tube connecting the mouth to the stomach)
• mouth pain, dry mouth, inflammation of the tongue
• 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 levels of protein normally excreted by the kidneys or increased levels of kidney enzymes
• fever, chills, weakness, fatigue, chest pain or a general feeling of being unwell
• abnormal blood test results

Not known: frequency cannot be defined on the basis of available data

• colon infection
• skin infection
• psychiatric disorders, confusion, altered sense of reality, depression, loss of position (disorientation), hallucinations (seeing things), abnormal dreams (nightmares), manic episodes.
• seizures
• change or loss of sense of touch and/or taste
• paresthesia (tingling and burning sensation of the skin, numbness, tingling sensation)
• deafness
• bleeding
• inflammation of the pancreas
• discoloration of the tongue, alteration of the color of the teeth
• liver failure, jaundice (yellowing of the skin)
• rare skin reactions such as DRESS (which can cause serious disorders such as rash, fever and inflammation of internal organs)
• acne
• muscle disorders (myopathy),
• inflammation of the kidneys (which can cause swelling of the ankles and high blood pressure) or kidney failure.

Consult your doctor immediately if you develop any of these symptoms or experience other unexpected or unusual symptoms.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenzia
farmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Claritromicina HCS

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 pack after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Claritromicina HCS contains

• The active ingredient is clarithromycin. 250mg: Each tablet contains 250 mg of clarithromycin. 500 mg: Each tablet contains 500 mg of clarithromycin.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, povidone K30, anhydrous colloidal silica, magnesium stearate, talc, stearic acid in the tablet core and titanium dioxide E171, hypromellose, hydroxypropylcellulose, yellow iron oxide E172 and propylene glycol in the tablet coating.

Description of the appearance of Claritromicina HCS and contents of the pack
250 mg: film-coated oval, biconvex tablets, slightly yellowish brown in color, measuring 15-15.2
mm in length and 8 mm in width.
500 mg: film-coated oval, biconvex tablets, slightly yellowish brown in color, measuring 19.5-
19.8 mm in length and 10 mm in width.
Claritromicina HCS 250 mg is available in blisters containing 10, 12, 14, 16, 20 film-coated tablets.
Claritromicina HCS 500 mg is available in blisters containing 7, 10, 14, 16, 20, 21 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
HCS BVBA

• H. KENNISSTRAAT 53, B 2650 EDEGEM, BELGIUM

Local Representative for Italy
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations: