Clarithromycin Alter

Italy
Brand name Clarithromycin Alter
Form tablets, film-coated
Active substance / Dosage
CLARITHROMYCIN
Prescription type Prescription only
ATC code
J01FA09
Registration number 037670
Manufacturer LABORATORI ALTER S.R.L.

Table of Contents

Package leaflet: Information for the patient

CLARITROMYCIN ALTER 250 mg film-coated tablets, 500 mg film-coated tablets

Clarithromycin
Generic medicine
Read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CLARITROMICINA ALTER is and what it is used for

CLARITROMICINA ALTER contains clarithromycin, an active substance belonging to a group of
medicines called macrolide antibiotics. Antibiotics are medicines that block the growth of bacteria
causing infections.
CLARITROMICINA ALTER is used to treat:

  • respiratory tract infections, such as bronchitis and pneumonia;
  • throat infections (tonsillitis, pharyngitis) and sinus infections;
  • skin and soft tissue infections, for example impetigo, folliculitis, erysipelas, furunculosis and infected wounds.

CLARITROMICINA ALTER 500 mg is also used in the following cases:

  • infections due to certain bacteria called Mycobacterium;
  • infections caused by Helicobacter pylori (a bacterium associated with stomach and duodenal ulcers).

In addition, CLARITROMICINA ALTER 250 mg is also used to treat infections of the mouth and teeth.

2. What you should know before taking CLARITROMICIN ALTER

Do not take CLARITROMICIN ALTER if:

  • you are allergic to clarithromycin, to other types of macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients of this medicine (listed in section 6);
  • you are taking ergotamine or dihydroergotamine, medicines used for migraine headaches. Combining these medicines with CLARITROMICIN ALTER may cause serious adverse effects. Consult your doctor, who will advise you on alternative treatments;
  • you are taking terfenadine or astemizole (medicines widely used for hay fever or allergies), cisapride or domperidone (medicines used for stomach disorders), or pimozide (a medicine used for mental health conditions). Combining these medicines with CLARITROMICIN ALTER may cause serious disturbances in heart rhythm. Consult your doctor, who will advise you on alternative treatments;
  • you are taking ticagrelor (a medicine used to thin the blood) or ranolazine (a medicine used for heart disease). Consult your doctor, who will advise you on alternative treatments;
  • you are taking midazolam (a medicine used as an anaesthetic) or colchicine (a medicine used in gout). Combining these medicines with CLARITROMICIN ALTER may cause serious adverse effects. Consult your doctor, who will advise you on alternative treatments;
  • you are taking lovastatin or simvastatin (a type of statin), medicines used to reduce cholesterol levels in the blood. Combining these medicines with CLARITROMICIN ALTER may cause serious muscle problems. Consult your doctor, who will advise you on alternative treatments;
  • you have or have had the following heart problems: QT interval prolongation or ventricular cardiac arrhythmia;
  • you have abnormally low levels of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia);
  • you have severe liver problems associated with kidney problems;
  • you are taking a medicine containing lomitapide.

CLARITROMICIN ALTER tablets are not suitable for children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking CLARITROMICIN ALTER if:

  • you are elderly (over 65 years of age);
  • you have liver or kidney problems;
  • you have a fungal infection (e.g., oral thrush) or know you are at risk of this condition;
  • you have heart disease, for example, severe heart failure or problems with the blood vessels of the heart (coronary artery disease);
  • you have heart rhythm problems or a slow heart rate (bradycardia);
  • you are taking other medicines that may cause ear damage (ototoxic). In such cases, your doctor may prescribe tests to monitor vestibular and hearing function;
  • you are pregnant or breastfeeding.

Children
CLARITROMICIN ALTER tablets are not suitable for children under 12 years of age.
Other medicines and CLARITROMICIN ALTER
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Do not take CLARITROMICIN ALTER if you are already taking any of the following medicines:

  • ergotamine or dihydroergotamine (for migraine);
  • cisapride (for stomach disorders);
  • pimozide (for psychiatric conditions);
  • terfenadine or astemizole (for hay fever or allergies);
  • domperidone;
  • colchicine (used for gout);
  • ticagrelor or ranolazine (for heart or circulatory problems);
  • medicines used to treat high blood cholesterol (statins such as simvastatin, lovastatin); if co-administration cannot be avoided, the lowest dose of these medicines is recommended;
  • medicines known to cause serious disturbances in heart rhythm (see section “Do not take CLARITROMICIN ALTER if”).

Do not take CLARITROMICIN ALTER if you are also taking midazolam, a medicine used as an anaesthetic.
It is particularly important that you inform your doctor if you are taking:

  • medicines for heart problems, such as digoxin;
  • medicines used for heart rhythm (antiarrhythmics), such as quinidine, disopyramide;
  • calcium channel blockers, such as verapamil, amlodipine, diltiazem, used for high blood pressure;
  • blood-thinning medicines (anticoagulants) taken by mouth, such as warfarin, or any other anticoagulant, e.g., dabigatran, rivaroxaban, apixaban, cilostazol;
  • medicines for epilepsy (phenytoin, carbamazepine, phenobarbital, valproate);
  • St. John’s wort, used for depression or anxiety;
  • medicines used for HIV infection, such as efavirenz, etravirine, nevirapine, ritonavir, zidovudine;
  • rifampicin, rifabutin, rifapentine, medicines used for bacterial infections;
  • itraconazole and fluconazole, medicines used for fungal infections;
  • zidovudine and saquinavir, antiviral medicines;
  • triazole-benzodiazepines, e.g., alprazolam, triazolam, medicines used for anxiety;
  • atypical antipsychotics, e.g., quetiapine, medicines used for schizophrenia or other mental disorders;
  • sirolimus, tacrolimus and ciclosporin, medicines used to suppress the immune system;
  • medicines used to lower blood sugar levels (oral hypoglycaemics/insulin), e.g., nateglinide and repaglinide;
  • other types of statins (other than lovastatin or simvastatin), medicines used to reduce blood cholesterol levels;
  • omeprazole, a medicine used for certain stomach disorders, e.g., ulcers;
  • theophylline, a medicine that helps breathing;
  • methylprednisolone, a corticosteroid;
  • ibrutinib or vinblastine, medicines used for cancer treatment;
  • tolterodine, a medicine used for urinary incontinence;
  • medicines that cause a change in the electrocardiogram called long QT syndrome or torsades de pointes;
  • ergot alkaloids, used, for example, for headaches;
  • medicines used for erectile dysfunction, such as sildenafil, tadalafil and vardenafil.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine, as the safety of CLARITROMICIN ALTER during pregnancy and breastfeeding is not known.
Driving and using machines
CLARITROMICIN ALTER may cause dizziness, vertigo, confusion and disorientation. Make sure you do not experience these side effects before driving or operating machinery.
CLARITROMICIN ALTER contains wheat starch
The wheat starch in this medicine contains only a very small amount of gluten; it is very unlikely to cause problems if you have coeliac disease.
One 250 mg tablet of CLARITROMICIN ALTER contains no more than 94.5 micrograms of gluten.
One 500 mg tablet of CLARITROMICIN ALTER contains no more than 189 micrograms of gluten.
If you are allergic to wheat (a condition different from coeliac disease), do not take this medicine.

3. How to take CLARITROMYCIN ALTER

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
For respiratory infections, throat or sinus infections, skin or soft tissue infections
The usual dose of CLARITROMYCIN ALTER for adults and children over 12 years of age is 1 tablet of 250 mg twice daily (every 12 hours) for 5–14 days. In case of severe infections, your doctor may increase the dose up to 2 tablets of 250 mg twice daily or 1 tablet of 500 mg twice daily (every 12 hours).
For infections of the mouth and teeth
The usual dose of CLARITROMYCIN ALTER for adults and children over 12 years of age is 1 tablet of 250 mg twice daily for 5 days.
For infections caused by Mycobacterium
The usual dose of CLARITROMYCIN ALTER for adults is 1 tablet of 500 mg twice daily.
In special cases (e.g. patients with AIDS), your doctor may recommend taking other medicines in combination with CLARITROMYCIN ALTER.
For infections caused by Helicobacter pylori
Your doctor may prescribe one of the following treatment regimens:

  • 1 tablet of CLARITROMYCIN ALTER twice daily, taken together with omeprazole (20 mg once daily) and amoxicillin (1000 mg twice daily), for 7–10 days;
  • 1 tablet of CLARITROMYCIN ALTER twice daily, taken together with lansoprazole (30 mg twice daily) and amoxicillin (1000 mg twice daily), for 10 days;
  • 1 tablet of CLARITROMYCIN ALTER three times daily, taken together with omeprazole (40 mg once daily), for 14 days. This is followed by 1 tablet of KLACID three times daily, taken together with omeprazole (20–40 mg once daily), for another 14 days;
  • 1 tablet of CLARITROMYCIN ALTER three times daily, taken together with lansoprazole (60 mg once daily), for 14 days. Your doctor may use other medicines different from those listed above.

Method of administration
CLARITROMYCIN ALTER is for oral use (by mouth).
Patients with severe kidney problems
If you have severe kidney problems (creatinine clearance value less than 30 ml/min), your doctor will prescribe a lower dose than those indicated above.
Use in children
CLARITROMYCIN ALTER tablets are not suitable for children under 12 years of age.
If you take more CLARITROMYCIN ALTER than you should
You may experience stomach or intestinal problems. If you take an overdose of CLARITROMYCIN ALTER, or if a child accidentally swallows any tablets, contact your doctor immediately or go to the nearest hospital.
If you forget to take CLARITROMYCIN ALTER
If you forget to take a dose at the scheduled time, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed tablet.
If you stop taking CLARITROMYCIN ALTER
It is important that you continue taking this medicine for the full duration prescribed by your doctor. Do not stop treatment just because you feel better, as your symptoms may return or worsen.
If you have any doubts about how to use 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.
Stop taking CLARITHROMYCIN ALTER immediately and contact your doctor if you experience any of the following:

  • severe allergic reactions: swelling (angioedema) of the face, eyes, lips, tongue, or throat, breathing difficulties, increased heart rate with possible sudden drop in blood pressure (anaphylactic reactions);
  • severe skin rashes with redness, blistering, and skin peeling, mouth and lip ulcers, and skin lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis);
  • skin rash with fever and abnormalities in blood, lungs, heart, or liver (DRESS syndrome);
  • weight loss, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching, or abdominal pain (possible signs of liver problems such as hepatitis, cholestasis, or liver failure);
  • severe or prolonged diarrhoea, presence of blood in diarrhoeal stools, even up to 2 months after the last dose (possible signs of pseudomembranous colitis caused by a bacterium called Clostridium difficile).

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 unknown (cannot be estimated from available data).
Contact your doctor if, during treatment with CLARITHROMYCIN ALTER, you notice any of the following:

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

  • difficulty falling asleep (insomnia);
  • changes in taste sensation, headache;
  • diarrhoea, vomiting, nausea, indigestion, abdominal pain;
  • abnormal liver function tests;
  • excessive sweating;
  • development of skin rash.

Uncommon side effects (may affect up to 1 in 100 people):

  • infections due to Candida, vaginal infections;
  • reduced number of white blood cells in the blood (or reduced number of certain types of white blood cells called neutrophils) (which may increase the risk of infections);
  • increased number of certain types of white blood cells called eosinophils (eosinophilia);
  • anorexia, decreased appetite;
  • anxiety, dizziness, vertigo, somnolence, tremor;
  • ringing in the ears (tinnitus), hearing disturbances;
  • changes in electrocardiogram (prolongation of QT interval), sensation of "racing heart";
  • inflammation of the mouth or tongue, dry mouth, inflammation of the stomach (gastritis), abdominal distension, difficulty passing stools (constipation), belching, presence of gas in the intestine (flatulence);
  • itching, urticaria;
  • malaise, feeling of weakness (asthenia), fatigue, chest pain, chills;
  • abnormal blood test results: increased serum alkaline phosphatase, increased serum lactate dehydrogenase, increased transaminases (alanine aminotransferase and aspartate aminotransferase), increased gamma-glutamyl transferase.

Other side effects

  • skin infection (erysipelas);
  • reduced platelet levels in the blood (increasing the risk of bruising or bleeding);
  • decreased number of certain types of white blood cells called granulocytes (agranulocytosis);
  • severe allergic reaction (anaphylaxis), including swelling of the face, throat, or lips (angioedema) which may cause breathing difficulties;
  • changes in perception of reality (psychotic disorder) or of oneself (depersonalization), confusion, depression, disorientation, hallucinations (seeing unreal things), abnormal dreams, mania, seizures, disturbances in smell (ageusia, parosmia, anosmia), numbness or a "tingling" sensation (paraesthesia);
  • hearing loss;
  • changes in heart rhythm (torsades de pointes, ventricular tachycardia, ventricular fibrillation);
  • bleeding;
  • inflammation of the pancreas;
  • changes in the colour of the tongue and teeth;
  • acne;
  • muscle disorders (myopathy) such as loss of muscle tissue (rhabdomyolysis);
  • abnormal urine colour, kidney problems such as inflammation or kidney failure;
  • abnormalities in certain laboratory tests such as: increased international normalized ratio (INR), prolonged prothrombin time.

Reporting of side effects
If you experience any side effect, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store CLARITROMYCIN ALTER

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 that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CLARITROMICINA ALTER contains
CLARITROMICINA ALTER 250 mg film-coated tablets

  • The active substance is clarithromycin. Each tablet contains 250 mg of clarithromycin.
  • The other components are: polysorbate 80, polyvinylpyrrolidone, sodium croscarmellose, wheat starch, microcrystalline cellulose, anhydrous colloidal silica, stearic acid, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), glycerol triacetate.

CLARITROMICINA ALTER 500 mg film-coated tablets

  • The active substance is clarithromycin. Each tablet contains 500 mg of clarithromycin.
  • The other components are: polysorbate 80, polyvinylpyrrolidone, sodium croscarmellose, wheat starch, microcrystalline cellulose, anhydrous colloidal silica, stearic acid, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), glycerol triacetate.

Description of the appearance of CLARITROMICINA ALTER and contents of the pack
Film-coated tablets for oral use. Blister packs of 12 tablets of 250 mg.
Film-coated tablets for oral use. Blister packs of 14 or 21 tablets of 500 mg.
Marketing Authorization Holder
Laboratori Alter S.r.l. – Via Egadi, 7 - 20144 Milano.
Manufacturer
Laboratorios Alter S.A. – C/ Mateo Inurria, 30 – 28036 Madrid– Spain.