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FEBZIN XL 500MG PROLONGED-RELEASE TABLETS

Active substance(s): CLARITHROMYCIN CITRATE

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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:
1 What Febzin XL tablets are and what they are used
for
2 What you need to know before you take
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other information
1 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.

2 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)
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AAAI6009

• 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.

3 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 prolongedrelease tablets in severe infections. You should take both of these
tablets at the same time.

Continued over page

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.

4 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.

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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

s ide 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.

5 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.

6 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.
Reykjavíkurvegi 76-78
220 Hafnarfjörõur
Iceland
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
2600 Dupnitsa
Bulgaria
This leaflet was last revised August 2016

Actavis, Barnstaple, EX32 8NS, UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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