Clarithromycin Almus

Package leaflet: Information for the user

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

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Each Claritromicina Almus 250 mg film-coated tablet contains 250 mg of
clarithromycin.
Each Claritromicina Almus 500 mg film-coated tablet contains 500 mg of
clarithromycin.
Claritromicina Almus is an antibiotic belonging to the macrolide group. This
antibiotic inhibits the growth of bacteria responsible for infections.
Claritromicina Almus is used to treat the following acute and chronic infections caused
by bacteria sensitive to clarithromycin:
Infections of the throat (tonsillitis, pharyngitis, tracheitis), of the nasal sinuses (sinusitis), and
of the middle ear (otitis);
Bronchitis, bacterial pneumonia, and atypical pneumonia;
Infections of the skin and soft tissues: 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 (the bacterium responsible for duodenal ulcers).
Clarithromycin is indicated in adults and children aged 12 years and older.

2. What you need to know before taking Claritromycin Almus

Do not take Claritromycin Almus:
if you are allergic to clarithromycin, to other macrolide antibiotic medicines, or to any of the other ingredients of this medicine (listed in section 6);
if you are taking:
ergot alkaloids (e.g. ergotamine or dihydroergotamine) (medicines used to treat migraine);
terfenadine or astemizole (medicines used 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 risk of heart attack or stroke);
midazolam (used to regulate sleep and/or anxiety);
colchicine (for gout).
If you are taking other medicines known to cause disturbances in heart rhythm;
if you have low blood potassium levels (hypokalaemia);
if you have a history of QT interval prolongation or ventricular cardiac arrhythmia, including torsade de pointes;
if you are taking medicines for high cholesterol (e.g. 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 an abnormal electrocardiogram (ECG, electrical recording of the heart) called "long QT syndrome".
Inform your doctor if any of the conditions listed above apply to you.

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

• if you are or think you may be pregnant. Claritromycin Almus is not recommended during pregnancy unless your doctor has carefully evaluated the benefits against the risks;
• if you have moderate to severe renal impairment;
• if you have hepatic insufficiency or disorders and/or symptoms such as anorexia, jaundice, dark urine, pruritus, or abdominal discomfort;
• if you are taking colchicine, as this medicine may cause serious adverse reactions;
• if you develop severe or prolonged diarrhoea during or after taking Claritromycin Almus, contact your doctor immediately;
• if you experience worsening of symptoms of myasthenia gravis;
• 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 blood magnesium levels (hypomagnesaemia), consult your doctor before taking these tablets. In these situations, do not take Claritromycin Almus without first consulting your doctor or pharmacist.

Other medicines and Claritromycin Almus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as they may cause serious adverse reactions:
digoxin, quinidine, or disopyramide (used to regulate heart rhythm);
warfarin or other anticoagulants (used as blood thinners);
ergotamine/dihydroergotamine (medicines used to treat migraine);
carbamazepine, valproic acid, or phenytoin (used to control epilepsy or bipolar disorders (manic-depressive type));
phenobarbital (for epilepsy and seizures);
theophylline (used for respiratory disorders);
terfenadine or astemizole (medicines used 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 (medicines 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 shown to be effective in treating certain 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 (certain types of penicillins and cephalosporins);
aminoglycosides and other ototoxic medicines;
nateglinide or repaglinide (for diabetes);
insulin and/or oral hypoglycaemic agents;
other macrolide medicines, 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).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Claritromycin Almus with food and drink
Claritromycin Almus 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 pregnancy, or breastfeeding, consult 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 careful evaluation of benefits and risks.
Claritromycin is excreted in breast milk.

Driving and using machines
Dizziness, vertigo, confusion, and disorientation may occur with the use of Claritromycin Almus. Therefore, Claritromycin Almus may impair your ability to drive or operate machinery.

3. How to use Claritromicina Almus

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult 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 clarithromycin suspension (oral suspension granules) should be used.
Claritromicina Almus is 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 full duration prescribed by your doctor to achieve complete recovery. Even if you feel better, do not stop treatment.

Recommended dose of clarithromycin for adults and children over 12 years of age:

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 daily. In severe infections, the usual dose is one 500 mg tablet twice daily.
The average duration of treatment is 6–14 days.

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

Mycobacterial infections
Treatment: The initial dose in adults should be 500 mg twice daily.
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, treatment of disseminated Mycobacterium avium complex (MAC) infection should continue as long as clinical and microbiological benefits are observed. Clarithromycin should be used in combination with other antibiotics.
Treatment of other infections caused by non-tuberculous mycobacteria should be continued according to your doctor's instructions.
Prophylaxis: The recommended dose in adults is 500 mg twice daily.

Eradication of Helicobacter pylori (bacterium responsible for duodenal ulcers)
Triple therapy:

• Claritromicina Almus 500 mg twice daily + amoxicillin 1000 mg twice daily + omeprazole 20 mg once daily for 7–10 days;
• Claritromicina Almus 500 mg twice daily + amoxicillin 1000 mg twice daily + lansoprazole 30 mg twice daily for 10 days.

Dual therapy:
Claritromicina Almus 500 mg three times daily for 14 days + omeprazole 40 mg once daily, followed by omeprazole 20 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.

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

Elderly patients
Clarithromycin may be used in elderly patients with normal renal function at the recommended adult dose and with appropriate medical guidance.

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

• Creatinine clearance between 30 and 60 ml/min – reduce clarithromycin dose by half;
• Creatinine clearance below 30 ml/min – reduce clarithromycin dose by 75%;
• Clarithromycin doses must not exceed 1 g per day when taken concomitantly with ritonavir.

Hepatic impairment
No dose adjustment is necessary for patients with mild to moderate hepatic impairment who have normal renal function.

Duration of treatment
The duration of treatment will vary depending on your individual characteristics and medical condition.

If you take more Claritromicina Almus than you should
If you accidentally take more Claritromicina Almus 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.
Cases of overdose should be managed by prompt elimination of unabsorbed drug and other supportive measures.
Taking excessive amounts of Claritromicina Almus may cause vomiting and gastrointestinal symptoms. Mental status changes, paranoid behavior, low potassium levels, and inadequate blood oxygenation may also occur.
As with other macrolides, plasma levels of clarithromycin do not appear to be significantly 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, resume treatment at your next scheduled 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 must always follow your doctor's instructions regarding dosage and duration of treatment.
If you have any doubts about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. You must contact your doctor immediately if you experience any of these symptoms or any other symptoms. Consult your doctor if symptoms persist or worsen.
Contact your doctor immediately if you experience a severe skin reaction: a red, scaly rash with pustule and blister formation (exanthematous pustulosis). The frequency of this reaction is unknown (cannot be estimated from the available data).

Common side effects (may affect from 1 to 10 people in 100):

• Abdominal pain (stomach), indigestion, nausea, vomiting, and diarrhoea
• Dysgeusia, taste perversion
• Insomnia
• Abnormal liver function tests
• Rash, hyperhidrosis
• Headache

Uncommon side effects (may affect from 1 to 10 people in 1,000):

• Candidiasis, vaginal infections
• Leucopenia (reduced white blood cell count), neutropenia (reduced neutrophil count), eosinophilia
• Anorexia, reduced appetite
• Anxiety, nervousness
• Loss of consciousness, dyskinesia, dizziness, somnolence, tremor
• Vertigo, impaired hearing, tinnitus
• QT interval prolongation on electrocardiogram, palpitations
• Gastritis, stomatitis, glossitis, abdominal distension, constipation, dry mouth, eructation, flatulence
• Cholestasis, hepatitis, increased alanine aminotransferase, increased aspartate aminotransferase, increased gamma-glutamyl transferase
• 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 estimated from the available data):

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

If any of these side effects occur, contact your doctor or pharmacist.
If you have diarrhoea while taking Claritromycin Almus, you must contact your doctor immediately. Although diarrhoea may occur as a side effect of this medicine, it could also be a sign of a more serious condition. Your doctor will be able to distinguish between these two situations.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website: 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 Claritromycin Almus

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp."
The expiry date refers to the last day of the month indicated.
Important information on disposal of medicines
Do not dispose of any medicine via wastewater 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 Claritromycin Almus contains:
The active substance is clarithromycin. Each tablet of Claritromycin Almus contains 250 mg
or 500 mg of the active substance clarithromycin.
The other ingredients are: pregelatinized starch, sodium croscarmellose, povidone, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, talc, and propylene glycol.
What Claritromycin Almus looks like and contents of the pack:
Claritromycin Almus 250 mg film-coated tablets
Pack sizes 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 an instruction leaflet.

Clarithromycin Almus 500 mg film-coated tablets

Pack sizes of 14 and 16 film-coated tablets, white or almost white, oblong and
biconvex, contained in PVC/PVDC-Aluminium blisters, inside a cardboard carton
with a leaflet.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa
Italy
Manufacturer
Bluepharma Industria Farmaceutica, SA
São Martinho do Bispo
3045-016 Coimbra
Portugal
This medicinal product is authorized in EEA Member States under the following names:
Italy
Clarithromycin Almus 250 mg, film-coated tablets
Clarithromycin Almus 500 mg film-coated tablets
Portugal
Clarithromycin APceuticals
This leaflet was last reviewed on: