Clarithromycin Zentiva

CLARITHROMYCIN ZENTIVA
500 mg film-coated tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

CLARITHROMYCIN ZENTIVA

500 mg film-coated tablets
Generic medicine
Please read this leaflet carefully before taking this medicine

• 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What CLARITHROMYCIN ZENTIVA is and what it is used for
2. What you need to know before taking CLARITHROMYCIN ZENTIVA
3. How to take CLARITHROMYCIN ZENTIVA
4. Possible side effects
5. How to store CLARITHROMYCIN ZENTIVA
6. Package contents and other information

1. What CLARITROMYCIN ZENTIVA is and what it is used for

Each film-coated tablet of CLARITROMYCIN ZENTIVA 500 mg contains 500 mg of
clarithromycin.
CLARITROMYCIN ZENTIVA is an antibiotic belonging to the macrolide group. This antibiotic
inhibits the growth of bacteria responsible for infections.
CLARITROMYCIN ZENTIVA is used to treat the following acute and chronic infections caused by
bacteria sensitive to clarithromycin:

• Infections of the throat, sinuses and middle ear;
• Respiratory tract infections, such as bronchitis and pneumonia;
• Skin and soft tissue infections;
• Oral cavity infections, such as dental abscesses;
  • Treatment of infections caused by mycobacteria;
• Eradication of Helicobacter pylori (the bacterium responsible for duodenal ulcers).

Clarithromycin is indicated in adults and children aged 12 years and older.
Official guidelines on the appropriate use of antibacterial agents should be taken into consideration.

2. What you should know before taking CLARITROMICINA ZENTIVA

Do not take CLARITROMICINA ZENTIVA if:

• You are allergic (hypersensitive) to clarithromycin or other macrolides (for example, azithromycin and erythromycin), or to any of the other ingredients of this medicine (listed in section 6).

CLARITROMICINA ZENTIVA
500 mg film-coated tablets

• You are taking any of the following medicines:
• astemizole or terfenadine (used for hay fever or other allergies), cisapride (for stomach disorders), pimozide (used for mental health problems), because combining these medicines may sometimes cause serious changes in heart rhythm;
• other medicines known to cause serious disturbances in heart rhythm;
• ergotamine or dihydroergotamine (used for migraine);
• ticagrelor (to prevent serious heart and blood vessel problems in people who have had heart attacks or severe chest pain) or ranolazine (used to treat ongoing angina pectoris (chest pain));
• lovastatin or simvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to lower cholesterol levels in the blood);
• colchicine (usually taken for gout);
• midazolam (used to help sleep regularly and/or for anxiety).
• You have abnormally low levels of potassium in the blood (a condition known as hypokalaemia);
• You have severe liver disease with kidney disease;
• You have an irregular heartbeat.

If you think any of the conditions listed above apply to you, contact your doctor before taking clarithromycin.

Warnings and precautions

Talk to your doctor or pharmacist before taking CLARITROMICINA ZENTIVA. You need to be cautious if:

• you have problems with your liver or kidneys;
• you have heart problems or low levels of magnesium in the blood;
• you have, or are particularly prone to, fungal infections (such as oral thrush);
• you are pregnant or breastfeeding.

Other medicines and CLARITROMICINA ZENTIVA

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

In particular, inform your doctor if you are taking any of the following medicines, as your dose may need to be adjusted or you may need periodic monitoring:

• digoxin, quinidine, or disopyramide (used for heart problems);
• warfarin or other anticoagulants (used as blood thinners);
• ergotamine, dihydroergotamine (used for migraine);
• carbamazepine, valproate, phenobarbital, or phenytoin (used to control epilepsy);
• colchicine (used for gout);
• atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to lower cholesterol levels in the blood);
• nateglinide, repaglinide, or insulin (used to lower blood glucose levels);

CLARITROMICINA ZENTIVA
500 mg film-coated tablets

• theophylline (used for respiratory disorders);
• terfenadine and astemizole (used for hay fever or other allergies);
• triazolam, alprazolam, or midazolam (used to regulate sleep and/or anxiety);
• cilostazol (used for blood circulation problems);
• cisapride, omeprazole (for treating indigestion and gastric ulcers), unless prescribed by your doctor for the treatment of Helicobacter pylori infection associated with duodenal ulcer;
• pimozide (used to treat psychiatric disorders);
• methylprednisolone (a corticosteroid used, for example, in allergic reactions);
• vinblastine (for cancer treatment);
• sildenafil, vardenafil, and tadalafil (used for erectile dysfunction in adult men or for pulmonary arterial hypertension (high blood pressure in the lung vessels));
• cyclosporine, sirolimus, or tacrolimus (immunosuppressants used in organ transplant patients);
• etravirine, efavirenz, nevirapine, zidovudine, ritonavir, atazanavir, or saquinavir (antiviral medicines used to treat HIV/AIDS infections);
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used to treat certain bacterial or fungal infections);
• tolterodine (for overactive bladder);
• verapamil, amlodipine, diltiazem (for high blood pressure);
• St. John’s wort (a herbal medicine used to treat depression);
• aminoglycosides, such as amikacin (used to treat bacterial infections).

CLARITROMICINA ZENTIVA does not interfere with oral contraceptives.

CLARITROMICINA ZENTIVA with food and drink:

CLARITROMICINA ZENTIVA can be taken regardless of meals, as its action is not influenced by food or drink.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine, as the safety of CLARITROMICINA ZENTIVA during pregnancy and breastfeeding is not known.

Driving and using machines

CLARITROMICINA ZENTIVA may cause dizziness or drowsiness. If you experience these effects, do not drive, operate machinery, or perform any activity requiring alertness.

CLARITROMICINA ZENTIVA
500 mg film-coated tablets

3. How to take CLARITROMYCIN ZENTIVA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
CLARITROMYCIN ZENTIVA is taken orally. The tablets must be swallowed
whole and must not be broken or chewed.
For children under 12 years of age or weighing less than 30 kg, the use of clarithromycin tablets
is not recommended. Another pharmaceutical form more suitable for children should be used (clarithromycin
pediatric suspension). For children over 12 years of age or weighing more than 30 kg and for elderly
patients, the same dosage as for adults may be used.
It is important that you take this medicine for the entire duration prescribed by your doctor to achieve
complete recovery. Even if you feel better, do not stop the treatment prematurely.
Throat, sinus, and middle ear infections;
Respiratory tract infections, such as bronchitis and pneumonia;
Skin and soft tissue infections;
The usual dose is one 250 mg tablet twice daily. In severe infections, the usual dose is
one 500 mg tablet twice daily.
The average duration of treatment is 6–14 days.
Infections caused by mycobacteria
The usual dose is one 500 mg tablet twice daily.
The duration of treatment depends on your doctor’s decision.
Oral cavity infections, such as dental abscesses
The usual dose is one 250 mg tablet twice daily.
The average duration of treatment is 5 days.
Eradication of Helicobacter pylori (the bacterium responsible for duodenal ulcers)
There are several treatment regimens for Helicobacter pylori eradication, in which
CLARITROMYCIN ZENTIVA is taken together with other medicines, such as:

• CLARITROMYCIN ZENTIVA 500 mg twice daily + Amoxicillin 1000 mg twice daily + Omeprazole 20 mg once daily, for 7–10 days.
• CLARITROMYCIN ZENTIVA 500 mg three times daily for 14 days + Omeprazole 40 mg once daily, followed by Omeprazole 20 mg or 40 mg once daily for more than 14 days.

The treatment chosen by your doctor may differ from those listed above. Your doctor
will decide the most appropriate treatment for you.
Patients with kidney problems
If you have severe kidney impairment, your doctor may consider it necessary to reduce the dose by half.
The treatment should not last longer than 14 days.
If you are taking ritonavir concomitantly, your doctor may consider it necessary to reduce the dose by more than half, based on the results of kidney function tests.
If you take more CLARITROMYCIN ZENTIVA than you should
If you accidentally take more CLARITROMYCIN ZENTIVA than the recommended dose in one day, or
if someone accidentally ingests tablets, seek urgent medical attention.
Bring the package leaflet, container, and any remaining tablets with you.
CLARITROMYCIN ZENTIVA
500 mg film-coated tablets
Taking excessive amounts of CLARITROMYCIN ZENTIVA is likely to cause vomiting and
gastrointestinal symptoms.
If you forget to take CLARITROMYCIN ZENTIVA
If you forget to take a dose of CLARITROMYCIN ZENTIVA, take it as soon as you remember.
However, if it is almost time for your next dose, do not take the missed dose; instead, take only the
next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking CLARITROMYCIN ZENTIVA
Continue the treatment for the full duration prescribed by your doctor. Only in this way can you achieve
complete recovery. If you stop the treatment before the time specified by your doctor,
the infection may return, as the bacteria causing the infection may not have been completely eliminated.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If you develop any of the following conditions during treatment, STOP taking the tablets and contact your doctor immediately:

• Severe or prolonged diarrhoea, which may contain blood or mucus (frequency not known). Diarrhoea may occur more than two months after treatment with clarithromycin; in such cases, you must always contact your doctor.
• Severe allergic reaction causing skin rash, difficulty breathing, fainting, or swelling of the face and throat (frequency not known).
• Yellowing of the skin (jaundice), facial flushing, pale stools, dark urine, tender abdomen, or loss of appetite (frequency not known). 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 (frequency not known).
• Rapid or irregular heartbeat (frequency not known). Contact your doctor immediately if you experience a severe skin reaction: red, scaly rash with pustule and blister formation (exanthematous pustulosis). The frequency of this reaction is not known (cannot be estimated based on available data).

When taking CLARITROMYCIN ZENTIVA, the following adverse reactions may occur, classified according to their frequency:

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

• Difficulty sleeping
• Altered taste
• Headache
• Stomach problems such as stomach discomfort, indigestion, feeling unwell, vomiting, and diarrhoea
• Changes in liver function
• Skin rash, increased sweating

Uncommon (may affect up to 1 in 100 people):
CLARITROMYCIN ZENTIVA
500 mg film-coated tablets

• Oral or vaginal candidiasis (a fungal infection)
• Decreased levels of certain types of blood cells (which may increase susceptibility to infections), increased eosinophil count (a type of white blood cell)
• Immune system hypersensitivity
• Loss of appetite
• Anxiety, dizziness, drowsiness, tremors
• Vertigo, hearing disturbances, tinnitus (ringing in the ears)
• Prolonged QT interval on ECG – related to changes in heart rate, palpitations
• Inflammation of the stomach, tongue, or inside of the mouth, bloating, constipation, dry mouth, eructation, flatulence
• Liver disorders including hepatitis
• Itching, urticaria (hives)
• General malaise and weakness, chest pain, chills, fatigue
• Changes in levels of certain substances in the blood

Frequency not known (cannot be estimated based on available data):

• Erysipelas (a type of skin infection)
• Low levels of certain types of white blood cells (agranulocytosis) and low platelet count
• Disturbances in perception of reality, panic, confusion, depersonalization, depression, mania (abnormally elevated mood), disorientation, hallucinations (seeing things), abnormal dreams
• Seizures, loss of touch sensation, altered or loss of smell, paresthesia (sensory disturbances – tingling, prickling, itching)
• Deafness
• Bleeding from blood vessels (haemorrhage)
• Pancreatitis (inflammation of the pancreas), discolouration of the tongue or teeth
• Acne
• Muscle pain or loss of muscle tissue
• Kidney inflammation or impaired kidney function
• Changes in results of certain blood tests, unusual urine colour

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.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 CLARITROMICIN ZENTIVA

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use CLARITROMICIN ZENTIVA after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Important information on disposal of medicines
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
CLARITROMICIN ZENTIVA
500 mg film-coated tablets

6. Pack contents and other information

What CLARITROMICINA ZENTIVA contains
The active substance is clarithromycin.
The excipients are: pregelatinized starch, sodium croscarmellose, povidone, microcrystalline cellulose,
anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, talc and propylene glycol.
Description of the appearance of CLARITROMICINA ZENTIVA and pack contents
CLARITROMICINA ZENTIVA 500 mg
Pack sizes of 14 and 16 film-coated tablets, white or almost white, elongated and biconvex,
contained in blisters, packed in a cardboard box with a leaflet.
Marketing Authorisation Holder and Manufacturer
Zentiva Italia S.r.l.
Viale L. Bodio 37/B
20158 Milan
Italy
Manufacturer
Bluepharma Indústria Farmacêutica, SA
São Martinho do Bispo
3045-016 Coimbra
PORTUGAL
This medicinal product is authorised in the European Economic Area countries under the following
names:
Italy
CLARITROMICINA ZENTIVA 500 mg
Portugal
Claritromicina Zentiva