LECOCLAR XL 5 tablets 500 mg

SANDOZ
LECOCLAR XL 5 tablets 500 mg
€ 8.00
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WHAT LECOCLAR XL AND WHAT IT IS USED
The active substance in Lecoclar XL is clarithromycin. It is an antibiotic of the macrolide group and is used to suppress the growth of bacteria that cause infections.
Lecoclar XL tablets are modified-release, which means that the active substance is released slowly from the tablet, allowing you to take it only once a day.
Lecoclar XL is used for the treatment of acute and chronic infections caused by bacteria sensitive to clarithromycin as:
infections of the lower respiratory tract (bronchitis, pneumonia);
infections of the upper respiratory tract (throat infections - pharyngitis) and inflammation of the cavities in the bones around the nose (sinusitis);
Infections of skin and skin structure;
Mycobacterial infections Mycohacrerium avium complex (MAC), M.kansassi, M.marinum and M.leprae;
Removal of Helicobacter pylori in patients with gastric ulcer and duodenal (always in combination with other drugs).
2. BEFORE YOU TAKE LECOCLAR XL
Do not take Lecoclar XL
if you are allergic to clarithromycin, other macrolide antibiotics or any of the other ingredients of Lecoclar XL;
if you take ergotamine or dihydroergotamine tablets or using ergotamine inhalers for migraine;
if you have severe impairment of kidney function;
if you are taking at the same time as medicines astemizole or terfenadine (for hay fever or allergies), cisapride (a medicine for the gastrointestinal tract), pimozide (antipsychotic), because the combination of these medicinal products and Lecoclar XL can sometimes cause serious disturbances in heart rhythm;
if your doctor has told you that the level of potassium in your plasma is too low;
if you have had heart problems such as the extension of QT- interval on the electrocardiogram or ventricular arrhythmias, including torsades depointes;
if you are currently taking medicines to lower cholesterol (statins), lovastatin or simvastatin because of the risk of rhabdomyolysis, a rare condition representing the decomposition of muscle cells;
if your liver function is severely impaired in combination with damaged kidneys.
Take special care with Lecoclar XL
Tell your doctor before taking this medicine,
if you are pregnant. Your doctor will carefully consider the benefits and risks, particularly in the first three months of pregnancy;
if you suffer from myasthenia gravis;
if you have or have had kidney damage or impaired hepatic function;
if a severe diarrhea during or after treatment;
if you notice symptoms of liver disease, such as lack of appetite, jaundice, dark urine, itching or tender abdomen, stop taking and consult your doctor;
if you are hypersensitive to lincomycin or clindamycin;
if you have or have had problems with your heart (coronary heart disease, severe heart failure), bradycardia (heart rate below 50 beats / min);
if your potassium and magnesium levels in the blood were low before treatment;
if you are taking other drugs that may prolong the QT-interval in your electrocardiogram;
if you have a congenital or acquired prolongation of the interval QT- in your electrocardiogram;
if you have or have previously had a ventricular arrhythmia;
if you are taking other medicines that can interact with Lecoclar (see "Taking other medicines");
If superinfection occurs with other bacteria or fungi;
if severe hypersensitivity (allergic). In these cases, treatment should be discontinued immediately and urgently begin appropriate therapy.
Tell your doctor about these conditions.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If different drugs are used at the same time, their efficacy and / or side effects can be mutually influenced.

Strictly contraindicated due to the likelihood of serious drug interactions are the following medicines:
cisapride (for gastro-intestinal tract);
pimozide (an antipsychotic drug);
astemizole and terfenadine (antihistamines, allergy medications);
ergotamine / dihydroergotamine (medicines for migraine).
Some other drugs may interfere with the effect of the clarithromycin, and vice versa.
Please tell your doctor or pharmacist if you are taking any of the following medicines:
digoxin, verapamil (for the treatment of heart disease);
fluconazole, itraconazole (prescribed for fungal infections);
oral anticoagulants such as warfarin (to prevent blood clotting);
ergotamine or dihydroergotamine (for migraine);
carbamazepine, valproate, phenytoin or phenobarbital (for epilepsy);
theophylline (helps breathing);
tolterodine (prescribed for urinary incontinence);
midazolam, triazolam or alprazolam (soothing);
quinidine or disopyramide (used to treat heart disease);
lovastatin, simvastatin, atorvastatin or cerivastatin (to treat high cholesterol);
rifampicin, rifabutin, rifapentine, zidovudine, ritonavir, nevirapine, atazanavir, efavirenz or saquinavir (for treatment of some infections);
tsiklosiorin, tacrolimus or sirolimus (for organ transplants);
methylprednisolone (sometimes prescribed as an anti-inflammatory);
colchicine (gout);
antidiabetic drugs;
antacids, ranitidine or omeprazole (for the treatment of ulcers of the stomach or intestines);
beta lactam antibiotics, lincomycin or clindamycin (other antibiotics);
sildenafil, tadalafil or vardenafil (prescribed for erectile dysfunction);
cilostazol (with peripheral vascular diseases);
vinblastine (prescribed in some forms of cancer);
products containing St. John's wort (Hypericum perforatum).
Clarithromycin does not affect the effectiveness of oral contraceptives.
Taking Lecoclar XL with food and drink
Always take the tablets with food.

Pregnancy and lactation
pregnancy
Ask your doctor or pharmacist before taking any medicine. If you are pregnant, please consult your doctor before you start taking this medicine, because safety Lecoclar XL during pregnancy has not been established. If you become pregnant during treatment, consult your doctor.

breastfeeding
Ask your doctor or pharmacist before taking any medicine.
If you are breastfeeding, tell your doctor before you start taking this medicine, as the safety of Lecoclar XL during lactation has not been established.

Driving and using machines
Less likely Lecoclar XL influence on the ability to drive and use machines. In performing these activities must be considered possible adverse reactions such as dizziness, vertigo, confusion and disorientation. If you experience any of these effects, do not drive or operate machinery.

3. HOW TO TAKE LECOCLAR XL
Take the tablets exactly as your doctor tells you. If you are unsure, ask your doctor or pharmacist.
Follow these instructions unless your doctor has told you otherwise.
For adults and children over 12 years, the recommended dose is one 500 mg tablet taken with a meal. The tablets should be taken with sufficient water.
In the case of serious infections the daily dosage may be increased to two tablets of 500 mg.
Usually the treatment takes from 7 to 14 days.
Lecoclar XL is not recommended for children under 12 years.
If you feel that the effect of Lecoclar XL is too strong or too weak, talk to your doctor or pharmacist.

Dosage adjustment in hepatic and / or renal impairment
This product can be used without reducing the dosage in patients with mild to moderate hepatic impairment, if there is normal renal function.
In patients with severe renal insufficiency dose adjustment required of Lecoclar.

Dose adjustment in elderly patients
In the elderly is not necessary to reduce the dosage, except those with severe renal impairment.

If you take more dose Lecoclar XL
If you take more than two tablets in a day, immediately contact your doctor or nearest hospital for advice. An overdose of this medicine usually causes gastrointestinal disorders, headaches and confusion.
Adverse reactions accompanying overdosage should be treated by gastric lavage and supportive measures.

If you forget to take Lecoclar XL
If you missed to take a dose, take it as soon as you remember and carry on as you have begun. Do not take a double dose to make up.

If you stop taking Lecoclar XL
Do not stop taking Lecoclar XL in its sole discretion, even if you feel better. It is important to take the tablets for a period determined by your doctor, otherwise the infection may return.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Lecoclar XL can cause side effects, although not everybody gets them. Lecoclar XL is generally well tolerated. The majority of adverse reactions were mild and transient. The most frequently reported were nausea, vomiting, diarrhea, dyspepsia, taste perversion, abdominal pain and headache.

Very common side effects: affect more than 1 user in 10;
Common: affects 1 to 10 users in 100;
Uncommon: affects 1 to 10 users in 1000;
Rare: affects 1 to 10 users in 10,000;
Very rare: affects less than 1 user in 10,000;
Not known: from the available data can not be estimated.

Serious side effects:
If you notice any of these side effects, contact your doctor:
Rare: allergic reactions, including rashes. Allergic reactions can vary in severity from mild itchy skin rash to more serious (but very rarely) a condition called syndrome of Stevens-Johnson (which causes severe illness with ulceration of the mouth, lips and skin).
In very rare cases may arise difficulty breathing, fainting, swelling of the face and throat, which require emergency treatment.
Immediately contact your doctor if you experience severe diarrhea during or after treatment.

Other side effects:
Common side effects:
insomnia;
headache;
nausea;
stomach discomfort after meals;
diarrhea;
heartburn;
vomiting;
stomach pain;
altered sense of taste and smell (eg. metal or bitter taste);
swollen and dark language;
inflammation of the mouth and tongue (stomatitis, glossitis);
staining of the teeth;
fungi in the mouth;
elevated levels of blood urea;
abnormal liver function tests.
These are transient effects that do not require discontinuation of the drug.
Uncommon side effects:
fungal infection in the vagina or in the skin folds, vaginal infection;
elevated levels of liver enzymes. These levels usually return to normal and it is unlikely to occur with symptoms. However clarithromycin may rarely cause liver problems (with or without jaundice) that may be severe and even fatal in very rare cases. If you feel unwell or become yellowing of the skin and / or eyes, consult your doctor immediately;
Transient changes in laboratory parameters including hematology tests (leukopenia - low number of leukocytes, eosinophilia - increased number of eosinophils, increased prothrombin time) and tests of renal function, including some instances of increased serum creatinine (a standard test of kidney function);
joint pain or muscle pain;
Allergic reactions ranging from urticaria and mild rash to severe hypersensitivity reactions;
decreased appetite, loss of appetite;
anxiety;
dizziness, drowsiness, tremors;
dizziness, impaired hearing, noise or ringing in the ears;
irregular heart rhythm (QT prolongation in the electrocardiogram), palpitations.
stomach pain and nausea, sores in the mouth, sore tongue, bloating, constipation, dry mouth, hiccups and belching, flatulence;
itchy, itchy rash;
pain in joints and muscles;
general feeling of malaise, weakness, chest pain, chills, fatigue;
Increased levels of the enzyme alkaline phosphatase;
Increased levels of the enzyme lactate dehydrogenase.
Very rare side effects:
reduced number of platelets;
numbness or tingling sensation;
decrease in white blood cell count (thrombocytopenia, neutropenia);
dizziness;
loss of balance;
anxiety;
sleep disturbances, nightmares;
confusion;
disorientation;
hallucinations;
impaired sense of reality and depersonalization;
inflammation of the pancreas;
seizures (such as epilepsy);
continuous pain in muscles and joints;
temporary loss of hearing;
altered heart rate;
rare kidney problems including kidney failure;
severe hepatic impairment;
fainting due to low blood sugar may occur occasionally in patients receiving at the same time antidiabetic agents or insulin;
pseudomembranous colitis caused by toxins of Clostridium difficile (bacteria that causes this condition), to whose overgrowth in the intestines can cause most of antibacterial drugs, including macrolides. Depending on the severity of symptoms, colitis may be from mild to life threatening.

Side effects with unknown frequency (from the available data could not be estimated, as occurred in very small number of patients):
inflammation of the colon, causing watery diarrhea usually mixed with blood and mucus, abdominal pain and / or fever. Painful, red, swollen patches on the skin, infection of the superficial layers of the skin;
significant reduction in number of white blood cells (agranulocytosis), low number of cells involved in blood clotting (thrombocytopenia);
severe allergic reaction;
a reduced level of blood sugar;
psychotic disorder, confusional state, feelings of depersonalization, depression, disorientation, hallucinations, abnormal dreams;
seizures, loss of taste sensation, changing the perception of smell, loss of sense of smell;
deafness;
irregular heartbeat (torsades depointes), fast heartbeat (ventricular tachycardia);
bleeding;
acute inflammation of the pancreas, tongue discoloration, discoloration of the teeth;
liver failure, severe damage to the liver cells;
drug rash with an increased number of certain white blood cells and systemic symptoms (DRESS), acne;
discolored urine.

If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE LECOCLAR XL
Keep out of the reach and sight of children.
Do not store above 25 ° C.
Store in the original package in order to protect from moisture.
Do not use Lecoclar XL after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Lecoclar XL
The active substance is clarithromycin. Each modified-release tablet contains 500 mg of clarithromycin.
Other ingredients are: tablet core - hypromellose, glntseroldibehenat, povidone, microcrystalline cellulose, stearic acid, colloidal anhydrous silica dnoksid, calcium stearate, talc, polysorbate 80: Tablet - hypromellose, hydroxypropylcellulose, macrogol 400, iron oxide yellow (E 172 ), titanium dioxide (E 171), talc, vanilla essence.
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