Febzin XL 500mg Prolonged-release Tablets

Clarithromycin

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 or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    The full name of this medicine is Febzin XL 500mg Prolonged release Tablets but within the leaflet it will referred to as Febzin XL tablets.

What is in this leaflet:

j What Febzin XL tablets are and what they are used for

What you need to know before you take How to take 5 Possible side effects Jj How to store

~6 Contents of the pack and other information_

T| What Febzin XL tablets are and what they are used for

Febzin XL tablets contains the active substance clarithromycin. Clarithromycin is an antibiotic belonging to a group of medicines called the macrolides. Antibiotics stop the growth of bacteria which cause infections.

Febzin XL tablets are prolonged-release tablets which means that the active substance is released slowly from the tablet so that you only have to take them once a day.

Febzin XL tablets are used in adults and children older than 12 years to treat infections such as:

•    Chest infections such as bronchitis and pneumonia

•    Throat infections such as pharyngitis

•    Sinus infections (sinusitis)

•    Skin and soft tissue infections such as folliculitis, cellulitis and erysipelas.

What you need to know before you take Do not take Febzin XL tablets if you

•    are allergic to clarithromycin or other macrolide antibiotics such as erythromycin or azithromycin or any of the other ingredients of this medicine (listed in section 6).

•    are taking any of the following consult your doctor for advice on alternative medicines:

-    ergotamine or dihydroergotamine tablets (for migraines)

-    lovastatin or simvastatin (for high cholesterol)

-    ticagrelor (a blood thinning medicine)

-    ranolazine (to treat angina)

-    colchicine (for gout)

-    cisapride (for stomach disorders), pimozide (for some mental illnesses), terfenadine or astemizole (for hay fever or allergy), as combining these drugs with clarithromycin can sometimes cause serious disturbances in heart rhythm.

•    are taking other medicines which are known to cause serious disturbances in heart rhythm.

•    have kidney problems

•    have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia)

•    or someone in your family has a history of heart rhythm disorders (ventricular cardiac arrhythmia including torsade de pointes) or abnormality of electrocardiogram (ECG, electrical recording of the heart) called "long QT syndrome”

•    have severe liver problems in combination with kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Febzin XL tablets if you

•    are pregnant

•    have liver problems

•    develop severe or prolonged diarrhoea during or after taking Febzin XL tablets, consult your doctor immediately

•    are taking triazolam and midazolam (sedatives)

•    are taking other ototoxic medicinal products, especially aminoglycosides (group of medicine to treat some infections)

•    have coronary heart disease, severe cardiac insufficiency, slow heart beat (bradycardia)

•    have repeated infections with bacteria or fungi. Consult your doctor for advice

•    are taking atorvastatin or rosuvastatin (for high cholesterol)

•    are taking certain anti-diabetic drugs (e.g. nateglinide, pioglitazone, repaglinide and rosiglitazone) as Febzin XL tablets may lower your blood sugar levels

•    are taking anticoagulants (medicines to thin the blood).

In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, Febzin XL tablets therapy should be discontinued immediately and appropriate treatment should be urgently initiated.

Other medicines and Febzin XL tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You should not take Febzin XL tablets if you are taking any of the medicines listed in the section above "Do not take Febzin XL tablets".

Consult your doctor if you are taking any of the following medicines:

•    itraconazole or fluconazole (anti-fungal drugs)

•    zidovudine, ritonavir, atazanavir, saquinavir, etravirine, nevirapine or efavirenz (anti-viral [anti-HIV] drugs)

•    rifabutin (an antibiotic effective against some infections)

•    rifampicin and rifapentine (to treat tuberculosis)

•    aminoglycosides (medicines used as antibiotics to treat infections)

•    digoxin, quinidine, disopyramide, amlodipine, diltiazem (heart drugs)

•    carbamazepine, valproate, phenobarbital or phenytoin (drugs for epilepsy)

•    statins for high cholesterol (such as atorvastatin, rosuvastatin)

•    warfarin (blood thinner)

•    quetiapine (antipsychotic)

•    sildenafil, tadalafil or vardenafil (for treating erectile dysfunction)

•    theophylline (helps breathing)

•    tolterodine (to treat symptoms of overactive bladder syndrome)

•    triazolam, alprazolam or midazolam (sedatives)

•    omeprazole (for stomach disorders)

•    tacrolimus, sirolimus or cyclosporin (for organ transplants)

•    methylprednisolone (a corticosteroid to treat inflammation)

•    vinblastine (a chemotherapy agent used to treat cancer)

•    cilostazol (used to improve circulation in the legs)

•    St John's Wort (herbal remedy)

•    Verapamil

•    insulin or oral anti-diabetic medicines such as nateglinide or repaglinide (to reduce blood sugar levels).

Febzin XL tablets with food and drink

Febzin XL tablets should be taken with food and must be swallowed whole and not chewed.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or breast feeding do not take Febzin XL tablets without consulting your doctor first, as the safety of Febzin XL tablets in pregnancy and breast feeding is not known.

Driving and using machines

There is no data on the effect of clarithromycin on the ability to drive or use machines. As Febzin XL tablets may cause dizziness, confusion and disorientation it may affect your ability to drive or use machinery.

Febzin XL tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

^ How to take

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Febzin XL tablets should be taken with food and must be swallowed whole and not chewed. You should take each dose at the same time each day throughout your course of treatment.

Adults and children over 12 years

The recommended dose of Febzin XL tablet is one 500mg prolonged-release tablet once a day for 6 to 14 days.

Your doctor may increase the dose to two 500mg prolonged-release tablets in severe infections. You should take both of these tablets at the same time.

Children 12 years old and younger

These tablets are not suitable for children 12 years old and younger. Your doctor will prescribe another suitable medicine for your child.

Patients with kidney problems

These tablets are not suitable for patients with kidney problems. Your doctor will prescribe another suitable medicine.

If you take more Febzin XL tablets than you should

If you accidentally take more than you should of Febzin XL tablets or if a child accidentally swallows some tablets, seek medical advice urgently. An overdose of Febzin XL tablets is likely to cause vomiting and stomach pains and there is a possibility of allergic reactions.

If you forget to take Febzin XL tablets

If you forget to take a Febzin tablet, take one as soon as you remember.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Febzin XL tablets

Do not stop taking Febzin XL tablets because you feel better. It is important to take the tablets for as long as the doctor has told you to, otherwise the problem might come back.

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

^ Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Febzin XL tablets and contact a doctor immediately:

•    Severe pain in the abdomen and back caused by inflammation of the pancreas. This effect is of unknown frequency

•    Dark urine, pale stools, jaundice (yellowing of the skin and/ or eyes), nausea and fever which can be symptoms of liver problems. This effect is of unknown frequency

•    Sudden wheezing, swelling of your lips, face or body, rash, fainting or difficulties swallowing (severe allergic reaction). This effect is of unknown frequency

•    Severe and painful diarrhoea caused by inflammation of the intestines (preudomembranous colitis). This effect is of unknown frequency

•    Reddening of the skin with blisters or peeling and may be associated with a high fever and joint pain. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis. This effect is of unknown frequency.

Other possible side effects

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

•    Insomnia

•    Abdominal pain, diarrhoea, vomiting, digestive discomfort and feeling sick

•    Changes in sense of taste (dysgeusia), headache

•    Dilation of a blood vessel¹

•    Liver function test abnormal

•    Rash, excessive sweating.

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

•    Thrush and vaginal thrush (candidiasis), gastric flu², infections³, vaginal infections, inflammation of the skin caused by infections¹

•    Changes in the numbers of blood platelets (thrombocythemia), neutrophils (neutropenia)⁴, or white blood cells (leukopenia)

•    Increased number of white blood cells called eosinophils (eosinophilia)⁴

•    Anaphylactoid reaction¹, hypersensitivity

•    Anorexia, decreased appetite

•    Anxiety, nervousness³,

•    Loss of consciousness¹, difficulty controlling movement¹, dizziness, sleepiness and tremor

•    Ringing in the ears (tinnitus), sensation of spinning or whirling motion (vertigo) and hearing impairment

•    Heart stops beating (cardiac arrest)¹, irregular heart and pulse rate¹, abnormal electric activity tracing of the heart (ECG), aware of heart beat (palpitation), premature heart beat (extrasystoles)¹

•    Asthma¹, nosebleed², obstruction of pulmonary arteries¹

•    Inflammation of the oesophagus¹, heartburn², inflammation of the stomach, pain in the rectum (proctalgia)², inflammation of the inside of the mouth (stomatitis), inflammation of the tongue (glossitis), constipation, swollen stomach (abdominal distension)⁴, burping (eructation), dry mouth, flatulence

•    Failure in the flow of bile (cholestasis)⁴, inflammation of the liver (hepatitis)⁴, increases in some liver enzymes (alanine and aspartate aminotransferase and gamma-glutamyltransferase⁴)

•    Inflammation of the skin with blisters (dermatitis bullous)¹, itching of the skin, skin rash and hives (urticaria), rash characterized by a flat, red area on the skin that is covered with small confluent bumps (rash maculo-papular)³

•    Muscle spasms³, muscle pain², musculoskeletal stiffness¹

•    Lack of energy⁴, weakness or loss of strength, fever³, chest pain⁴, chills⁴, mental or physical tiredness⁴

•    Increase of creatinine and urea in the blood¹

•    Change in some blood tests (increase of alkaline phosphatase⁴ and lactate dehydrogenase⁴), albumin globulin ratio abnormal¹.

Side effects of unknown frequency (frequency cannot be

estimated from the available data):

•    Inflammation of the intestines causing severe and painful diarrhoea, bacterial skin infections (erysipelas).

•    Severe acute deficiency in neutrophils (type of blood cells), symptoms include high temperature and ulcers in the mouth and throat (agranulocytosis); reduction of platelets in the blood (thrombocytopenia)

•    Sudden allergic reactions (swelling of the face, lips, throat or tongue or difficulty breathing or swallowing), angioedema (swollen face lips throat or tongue)

•    Abnormal dreams, confusional state, depersonalization, depression, disorientation, hallucination (seeing things), psychotic disorder, feeling elated or over-excited, which causes unusual behavior (mania)

•    Convulsions, changes in or loss of sense of smell, loss of sense of taste, numbness tingling or pins and needles (paraesthesia).

•    Deafness

•    Life-threatening irregular heartbeat, increased heartbeat

•    Bleeding

•    Tongue discolouration, sudden inflammation of the pancreas, tooth discolouration

•    Liver failure, jaundice

•    Allergic reactions including rashes. In very rare cases, difficulty in breathing, fainting and swelling of the face and throat can occur which may need emergency treatment. Allergic rashes may range in severity from mild itchy skin eruptions to a rarer, more serious condition called Stevens-Johnson syndrome (which may cause ulceration of the mouth, lips and skin) or toxic epidermal necrolysis (which causes severe illness and sloughing of the skin) or drug rash with eosinophilia and systemic symptoms (DRESS).

•    Acne.

•    Muscle weakness, tenderness or pain (rhabdomyolysis)²

•    Kidney failure, inflammation of the kidneys (interstitial nephritis)

•    Abnormal colour of the urine

•    Blood clotting time increased (increased INR and prothrombin time)

¹    side effects reported only for the Powder for Solution for Injection formulation

²    side effects reported only for the Extended-Release Tablets formulation

³    side effects reported only for the Granules for Oral Suspension formulation

⁴    side effects reported only for the Immediate-Release Tablets formulation

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

How to store

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

« Contents of the pack and other information What Febzin XL tablets contains

•    The active substance is clarithromycin. Each prolonged-release tablet contains clarithromycin citrate equivalent to 500mg of clarithromycin.

•    The other ingredients are: tablet core: lactose monohydrate, hypromellose, hypromellose phthalate, talc, magnesium stearate; tablet coat: hypromellose, lactose monohydrate, quinoline yellow aluminium lake (E104), titanium dioxide (E171), talc, macrogol/ PEG 4000, macrogol/PEG 400.

What Febzin XL tablets look like and contents of the pack

Yellow, oblong shaped, biconvex film-coated tablets, 19.15 ± 0.2mm long, 8.95 ± 0.2mm width and 7.55 ± 0.2mm thick with no markings.

PVC/PVDC/Aluminium blister strip(s) in a cardboard carton.

Pack sizes:

7 and 14 prolonged-release tablets.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78 220 Hafnarfjorour Iceland

Manufacturer

Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str.,

2600 Dupnitsa Bulgaria

This leaflet was last revised August 2016