CLARITROMICINA 250 mg Фильм-Coated Таблетки

Содержание инструкции

1. Claritromicina Almus 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What is Claritromicina Almus and what is it used for
   2. What you need to know before using Claritromicina Almus
   3. How to use Claritromicina Almus
2. Claritromicina Almus tablets is not recommended in children under 12 years of age.
3. Claritromicina Almus must be taken orally. The tablets must be swallowed
   1. Possible side effects
   2. How to store Claritromicina Almus
   3. Contents of the pack and other information

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

Generic medicine
Read this leaflet carefully before using this medicine as 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, pharmacist or nurse.
• 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 be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Each film-coated tablet of Claritromicina Almus 250 mg contains 250 mg of
clarithromycin.
Each film-coated tablet of Claritromicina Almus 500 mg contains 500 mg of
clarithromycin.
Claritromicina Almus is an antibiotic that belongs to the macrolide group. This
antibiotic blocks the growth of bacteria responsible for infections.
Claritromicina Almus is used for the treatment of the following acute and chronic infections caused
by bacteria sensitive to clarithromycin:
Infections of the throat (tonsillitis, pharyngitis, tracheitis), nasal sinuses (sinusitis) and
middle ear (otitis);
Bronchitis, bacterial pneumonia and atypical pneumonia;
Skin and soft tissue infections: impetigo, erysipelas, folliculitis, furunculosis and infected
wounds;
Infections of the oral cavity, such as gingivitis, periodontitis, acute dental infections and
dental abscess;
Prophylaxis and treatment of mycobacterial infections;
Eradication of Helicobacter pylori(bacteria responsible for duodenal ulcers).
Claritromicina is indicated in adults and children from 12 years of age.

2. What you need to know before using Claritromicina Almus

Do not use Claritromicina Almus:
if you are allergic to clarithromycin, to other macrolide antibiotic medicines or to any
of the other components of this medicine (listed in section 6);
if you are taking:
ergot alkaloids (for example ergotamine or dihydroergotamine) (medicines to treat
migraine);
terfenadine or astemizole (medicines to treat hay fever or allergies);
cisapride (for stomach disorders);
pimozide (used to treat mental health problems);
ticagrelor or ranolazine (medicines used to treat angina, to reduce the possibility of a
heart attack or stroke);
midazolam (used to regulate sleep and/or anxiety);
colchicine (for gout).
If you are taking other medicines known to cause heart rhythm disorders;
if you have low levels of potassium in your blood (hypokalaemia);
if you have a history of prolonged QT interval or ventricular cardiac arrhythmia including
torsade de pointes;
if you are taking medicines for high cholesterol (for example lovastatin or simvastatin);
if you have liver and/or kidney problems;
If you or someone in your family has a history of heart rhythm disorders (ventricular
cardiac arrhythmia, including torsade de pointes) or abnormalities in the
electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome”.
Tell your doctor if any of the above conditions apply to you.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Claritromicina Almus:

• if you are or think you might be pregnant. Claritromicina Almus is not recommended during pregnancy unless your doctor has carefully assessed the benefits against the risks;
• if you suffer from moderate to severe renal impairment;
• if you suffer from hepatic insufficiency or disorders and/or symptoms such as anorexia, jaundice, dark urine, itching or abdominal tension;
• if you are taking colchicine, as this medicine can cause serious adverse reactions;
• if you experience severe or prolonged diarrhea during or after taking Claritromicina Almus, contact your doctor immediately;
• if a worsening of your myasthenia gravis symptoms occurs;
• if you are taking triazolam or midazolam (used to regulate sleep and/or anxiety);
• if you are taking other macrolide antibiotics, such as lincomycin and clindamycin;
• if you have a hypersensitivity reaction;
• if you have abnormally low levels of magnesium in your blood (hypomagnesaemia) consult your doctor before taking these tablets. In these situations do not take Claritromicina Almus without first consulting your doctor or pharmacist.

Other medicines and Claritromicina Almus
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, as it may cause serious adverse reactions:
digoxin, quinidine or disopyramide (used to regulate the heartbeat);
warfarin or other anticoagulants (used as blood thinners);
ergotamine/dihydroergotamine (medicines used to treat migraine);
carbamazepine, valproic acid or phenytoin (used for the control of epilepsy or
bipolar disorder (manic-depressive type));
phenobarbital (for epilepsy and convulsions);
theophylline (used for respiratory disorders);
terfenadine or astemizole (medicines to treat hay fever or allergies);
triazolam, alprazolam or midazolam (used to regulate sleep and/or anxiety);
cisapride or omeprazole (for stomach disorders);
pimozide or ziprasidone (for schizophrenia or other psychiatric conditions);
cilostazol (used for blood circulation problems);
simvastatin or lovastatin (drugs to lower cholesterol);
methylprednisolone (a corticosteroid used for inflammation);
sildenafil, tadalafil or vardenafil (used for erectile dysfunction);
cyclosporine, or tacrolimus (used in patients who have received an organ transplant);
zidovudine, ritonavir, atazanavir, saquinavir, nevirapine, efavirenz or etravirine (used
for the treatment of HIV/AIDS infections);
rifabutin (an antibiotic that has been shown to be effective in the treatment of some infections);
itraconazole or fluconazole (for fungal infections);
colchicine (used for the treatment of gout);
tolterodine (for bladder problems);
aprepitant (for vomiting);
rifampicin (for tuberculosis);
any beta-lactam antibiotic (some types of penicillin and cephalosporin);
aminoglycosides and other ototoxic medicines;
nateglinide or repaglinide (for diabetes);
insulin and/or oral hypoglycemic agents;
other macrolide drugs, such as lincomycin and clindamycin;
calcium channel blockers (medicines used to treat high blood pressure);
St John's Wort (for depression and as a natural sedative).
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Claritromicina Almus with food and drink
Claritromicina Almus can be taken independently of meals, because its action is not
affected by food or drink.

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

Driving and using machines
With the use of Claritromicina Almus, dizziness, vertigo, confusion and
disorientation may occur. Therefore Claritromicina Almus may interfere with the ability to drive or
operate machinery.

3. How to use Claritromicina Almus

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, ask your doctor or pharmacist.
Claritromicina Almus should only be used in adults and children over 12 years of age. The use of

Claritromicina Almus tablets is not recommended in children under 12 years of age.

Therefore, for children under 12 years of age, a pediatric suspension of
clarithromycin (oral suspension granules) should be used.

Claritromicina Almus must be taken orally. The tablets must be swallowed

whole and must not be broken or chewed.
It is important that you take this medicine for the entire time that your doctor has told you for
achieving complete recovery. Even if you feel better, do not stop the treatment.
For adults and children over 12 years of age, the recommended dose of clarithromycin is:

Throat, sinus and middle ear infections
Respiratory tract infections, such as bronchitis and pneumonia
Skin and soft tissue infections
The recommended dose is one 250 mg tablet twice a day. In severe infections,
the usual dose is one 500 mg tablet twice a day.
The average duration of treatment is 6-14 days.

Oral cavity infections, such as a dental abscess
The recommended dose is one 250 mg tablet twice a day.
The average duration of treatment is 5 days.

Mycobacterial infections

Treatment:the initial dose in adults should be 500 mg twice a day.
For localized or disseminated infections ( M. avium, M. intracellulare, M. chelonae, M. fortuitum,

• M. kansassi) in adults, the recommended dose is 1000 mg per day, divided into two separate doses.

In patients with AIDS, the treatment of disseminated infections by Mycobacterium avium

complex(MAC) must be continued until clinical and
microbiological benefits are evident. Clarithromycin should be used in combination with other antibiotics.
The treatment of other infections caused by non-tuberculosis mycobacteria must be continued in
accordance with your doctor's instructions.

Prophylaxis:the recommended dose in adults is 500 mg, twice a day.

Eradication ofHelicobacter pylori (bacterium responsible for duodenal ulcers)

Triple therapy:

• Claritromicina Almus 500 mg, twice a day + amoxicillin 1000 mg, twice a day + omeprazole 20 mg, once a day, for 7-10 days;
• Claritromicina Almus 500 mg, twice a day + amoxicillin 1000 mg, twice a day + lansoprazole 30 mg, twice a day, for 10 days.

Dual therapy:
Claritromicina Almus 500 mg, three times a day, for 14 days + omeprazole 40 mg,
once a day, followed by omeprazole 20 or 40 mg once a day, for more than 14
days.
The treatment chosen by your doctor may be different from those listed above. Your doctor
will decide the best treatment for you.

Use in children
The use of clarithromycin (250 mg and 500 mg tablets) is not recommended for children under
12 years of age.

Elderly
Clarithromycin can be used by the elderly, with normal kidney function, with the dose
recommended for adults and with appropriate medical recommendations.

Renal insufficiency
In patients with renal insufficiency, with creatinine clearance less than 30 ml/min, the
dose of clarithromycin must be halved, i.e. 250 mg once or twice a day for
severe infections. Treatment with clarithromycin should not exceed 14 days.
In patients with renal insufficiency treated with ritonavir, the following
dose adjustments must be made:

• Creatinine clearance between 30 and 60 ml/min - reduce the dose of clarithromycin by half;
• Creatinine clearance below 30 ml/min - reduce the dose of clarithromycin by 75%;
• The doses of clarithromycin should not exceed 1 g per day when taken simultaneously with ritonavir.

Hepatic insufficiency
No adjustment is necessary for patients with mild to
moderate hepatic insufficiency, but with normal renal function.

Duration of treatment
The duration of treatment will vary depending on your characteristics and conditions.

If you take more Claritromicina Almus than you should
If you accidentally took more Claritromicina Almus than the recommended
dosage in one day, or if someone accidentally ingests some tablets, seek urgent
medical attention.
Cases of overdose should be treated with prompt elimination of the unabsorbed medicine and other supportive measures.
Taking high amounts of Claritromicina Almus is likely to cause vomiting and gastrointestinal
symptoms. Changes in mental status, paranoid behavior, reduced potassium levels and insufficient oxygenation of
the blood may occur.
As with other macrolides, plasma levels of clarithromycin do not appear to be
appreciably altered by hemodialysis or peritoneal dialysis.

If you forget to take Claritromicina Almus
If you forget to take one or more doses of Claritromicina Almus, you should resume the
treatment at the usual time, as prescribed by your doctor.
Do not take a double dose to make up for the missed dose.

If you stop taking Claritromicina Almus
You should always follow your doctor's instructions regarding the dose and duration of
treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist, or
the nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You should contact your doctor immediately if you experience these symptoms or any other symptom.
Consult your doctor if the symptoms persist or worsen.
Contact your doctor immediately if you experience a severe skin reaction: red and scaly rash with the formation of pustules and blisters (pustular exanthematous rash). The frequency
of this reaction is unknown (cannot be assessed based on available data).
Common side effects (may affect up to 1 in 10 people):
Abdominal pain, indigestion, nausea, vomiting and diarrhea
Dysgeusia, taste perversion
Insomnia
Abnormal liver function tests
Rash, hyperhidrosis
Headache
Uncommon side effects (may affect up to 1 in 1,000 people):
Candidiasis, vaginal infections
Leukopenia (decreased number of white blood cells), neutropenia (decreased number of
neutrophils), eosinophilia
Anorexia, decreased appetite
Anxiety, nervousness
Loss of consciousness, dyskinesia, dizziness, drowsiness, tremor
Vertigo, impaired hearing, tinnitus
Prolongation of the QT interval on the electrocardiogram, palpitations
Gastritis, stomatitis, glossitis, abdominal distension, constipation, dry mouth,
eructation, flatulence
Cholestasis, hepatitis, increased alanine aminotransferase, increased aspartate aminotransferase,
increased gamma-glutamyltransferase
Pruritus, urticaria
Muscle spasms, musculoskeletal rigidity, myalgia
Increased blood creatinine, increased blood urea
Malaise, asthenia, chest pain, chills, fatigue
Abnormal albumin/globulin ratio, increased blood alkaline phosphatase,
increased blood lactate dehydrogenase
Side effects with frequency “not known” (frequency cannot be established based on
available data):

• Pseudomembranous colitis, erysipelas
• Agranulocytosis, thrombocytopenia
• Anaphylactic reaction, angioedema
• Psychotic disorders, confused state, depersonalization, depression, mania, disorientation, hallucination, abnormal dreams
• Convulsion, loss of taste or smell or inability to smell, paresthesia (more commonly known as “pins and needles”)
• Deafness
• Torsade de pointes, ventricular tachycardia
• Bleeding
• Acute pancreatitis, discoloration of the tongue, discoloration of the teeth
• Liver failure, hepatocellular jaundice
• Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acne
• Rhabdomyolysis, myopathy
• Renal failure, interstitial nephritis
• Increased international normalized ratio, prolonged prothrombin time, abnormal urine color

If any of these side effects occur, contact your doctor or pharmacist.
If you have diarrhea while taking Claritromicina Almus, you should contact your
doctor immediately. Although diarrhea may occur as a side effect of this
medicine, it may also be a sign of a more serious condition. Your doctor will recognize
the difference between the two situations.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
http://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 Claritromicina Almus

Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after “Scad.”
The expiry date refers to the last day of the month indicated.

Important information regarding the disposal of medicines
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Claritromicina Almus contains:
The active ingredient is clarithromycin. Each Claritromicina Almus tablet contains 250 mg
or 500 mg of the active ingredient clarithromycin.
The excipients are: pregelatinized starch, sodium croscarmellose, povidone, microcrystalline
cellulose, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide, talc and
propylene glycol.

What Claritromicina Almus looks like and contents of the pack:
Claritromicina Almus 250 mg film-coated tablets
Packs of 12 and 16 film-coated tablets, white or almost white, round and biconvex,
contained in PVC/PVDC-Aluminum blisters, inside a cardboard box with a
package leaflet.
Claritromicina Almus 500 mg film-coated tablets
Packs of 14 and 16 film-coated tablets, white or almost white, oblong and
biconvex, contained in PVC/PVDC-Aluminum blisters, inside a cardboard box
with a package leaflet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genova
Italy

Manufacturer
Bluepharma Industria Farmaceutica, SA
São Martinho do Bispo
3045-016 Coimbra
Portugal
This medicinal product is authorised in the Member States of the EEA with the following denominations:
Italy
Claritromicina Almus 250 mg, film-coated tablets
Claritromicina Almus 500 mg film-coated tablets
Portugal
Claritromicina APceuticals

This leaflet was last approved: