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BAKTROQUELL XL 500 MG MODIFIED-RELEASE TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

BAKTROQUELL XL 500 mg
MODIFIED-RELEASE TABLETS
®

(clarithromycin)

Read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Baktroquell XL is and what it is used for.
2. Before you take Baktroquell XL.
3. How to take Baktroquell XL.
4. Possible side effects.
5. How to store Baktroquell XL.
6. Further information.
1. WHAT BAKTROQUELL XL IS AND WHAT IT IS USED FOR
Baktroquell XL is an antibiotic belonging to a group of medicines
called the macrolides. Antibiotics stop the growth of bacteria
(bugs), which cause infections.
Baktroquell XL tablets are modified-release tablets, which means
that the active ingredient is released slowly from the tablet so that
you only have to take it once a day.
Baktroquell XL is used to treat infections such as:
• Chest infections such as bronchitis and pneumonia.
• Throat and sinus infections.
• Mild to moderate skin and tissue infections, such as folliculitis,
cellulitis or erysipelas.
2. BEFORE YOU TAKE BAKTROQUELL XL
Do not take Baktroquell XL if you:
• Know that you are allergic to clarithromycin, other macrolide
antibiotics such as erythromycin or azithromycin, or any of the
other ingredients in the tablets.
• Have a creatinine clearance of less than 30 ml/min.
• Have an irregular heart rhythm.
• Suffer from severe kidney and liver problems.
• Are taking medicines called ergotamine or dihydroergotamine
tablets or use ergotamine inhalers for migraine while taking
Baktroquell XL tablets. Consult your doctor for advice on
alternative medicines.
• Are taking medicines called terfenadine, or astemizole (widely
taken for hay fever or allergies) or cisapride (for stomach
problems) or pimozide (for mental problems) while taking
Baktroquell XL tablets, as combining these drugs can sometimes
cause serious disturbances in heart rhythm. Consult your doctor
for advice on alternative medicines.
• Are taking medicines called lovastatin or simvastatin (to lower
cholesterol levels), as combining these drugs can sometimes
increase the possibility of side effects. Consult your doctor for
advice on alternative medicines.
Baktroquell XL tablets are not suitable for use in children under 12
years of age.
Take special care with Baktroquell XL
You should tell your doctor before taking this medicine if:
• You have any heart, kidney or liver problems.
• You have, or are prone to, fungal infections (e.g. thrush).
• You are pregnant or breast feeding.
• You are taking medicines called colchicines, triazolam,
midazolam, lovastatin, simvastatin.
• You are diabetic, (your glucose levels will need to be monitored).
• You are taking a medicine called warfarin (to thin your blood).
• You have myasthenia gravis, a condition in which your muscles
become weak and tire easily.
• You develop severe or prolonged diarrhoea during or after
taking Baktroquell XL, consult your doctor immediately.
If any of these apply to you, consult your doctor before taking
Baktroquell XL tablets.

This medicine product contains 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.

Your doctor may increase the dose to two 500 mg tablets daily in
severe infections. Baktroquell XL tablets should be taken with
food and must be swallowed whole and not chewed.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including those obtained
without a prescription. This is especially important if you are
taking medicines for:
• Heart problems (e.g. digoxin, verapamil, quinidine or
disopyramide).
• Thinning your blood (e.g. warfarin).
• Migraines (e.g. ergotamine or dihydroergotamine).
• Epilepsy (carbamazepine, valproate or phenytoin).
• High cholesterol (e.g. simvastatin or lovastatin).

If you take more Baktroquell XL than you should
If you accidentally take more Baktroquell XL tablets in one day
than your doctor has told you to, or if a child accidentally swallows
some tablets, contact your doctor or nearest hospital emergency
department immediately. An overdose of Baktroquell XL tablets is
likely to cause vomiting and stomach pains.

or if you are taking any medicines called:
• Colchicine (usually taken for gout).
• Theophylline (used in patients with breathing difficulties such as
asthma).
• Terfenadine or astemizole (for hay fever or allergy).
• Triazolam, alprazolam or midazolam (sedatives).
• Cilostazol (for poor circulation).
• Cisapride (for stomach disorders).
• Methylprednisolone (a corticosteroid).
• Vinblastine (for treatment of cancer).
• Ciclosporin (immune suppressant).
• Pimozide (for mental problems).
• Rifabutin (for treatment of some infections).
• Tacrolimus (for organ transplants and severe eczema).
• Ritonavir (an anti-viral or anti-HIV drug).
• Sildenafil, tadalafil or vardenafil (for impotence in adult males or
for use in pulmonary arterial hypertension (high blood pressure
in the blood vessels of the lung).
• Zidovudine (to treat viruses).
• St John's Wort (herbal product to treat depression).
• Phenobarbital (drug for epilepsy).
• Nevirapine & Efavirenz may lower the levels of Baktroquell XL.
• Rifampicin (to treat tuberculosis).
• Omeprazole (to treat heart burn & stomach/intestinal ulcers).
• Ritonavir (anti-viral drug used in the treatment of HIV infection)
may increase the levels of Baktroquell XL Atazanavir & Saquinavir
(also anti-viral drugs used in the treatment of HIV infection):
Taking these drugs with Baktroquell XL may increase both the
levels of Atazanavir (or Saquinavir) and Baktroquell XL.
• Itraconazole (an anti-fungal drug) taken together with
Baktroquell XL may increase the levels of both medicines.
• Fluconazole, another anti-fungal drug, may increase the levels of
Baktroquell XL.
• Tolterodine (to treat symptoms of overactive bladder syndrome).
In certain patients, the levels of tolterodine may be increased
when taken with Baktroquell XL.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or if you are
breast-feeding, consult your doctor before taking Baktroquell XL
tablets, as the safety of Baktroquell XL tablets in pregnancy and
breast-feeding is not known.
Driving and using machines
Do not drive or operate machinery if you feel dizzy, drowsy or
confused while taking this medicine.
Important information about some of the ingredients of
Baktroquell XL
This medicinal product contains 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 BAKTROQUELL XL
Do not give these tablets to children under 12 years. Your doctor
will prescribe another suitable medicine for your child.
Always take Baktroquell XL exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
Patients with severe kidney and liver problems
Patients with severe kidney and liver problems should not take
Baktroquell XL.
The usual dose of Baktroquell XL tablets for adults and children
over 12 years is one 500 mg tablet once a day for 6 to 14 days.

If you forget to take Baktroquell XL
If you forget to take a dose of Baktroquell XL tablets, take it as
soon as you remember. Do not take more tablets in one day than
your doctor has told you to. Do not stop taking Baktroquell XL
tablets, even if 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.
4. POSSIBLE SIDE EFFECTS

Unknown frequency of occurrence (frequency cannot be
estimated from the available data):
• Decrease in platelets (blood cells that help you stop bleeding).
• Psychiatric disorders such as abnormal dreams, anxiety,
confusional state, depersonalisation, disorientation,
hallucination (seeing things) and other psychotic disorders.
• Convulsions and change in the sense of smell.
• Deafness.
• Inflammation of the tongue and tooth discolouration.
• Liver failure, abnormal liver function or hepatitis.
• Acne.
• Severe muscle pain.
• Inflammation of the kidneys and
• Abnormal urine colour.
Inflammation of the colon (Pseudomembranous colitis) has been
reported with nearly all antibacterial medicines including
clarithromycin. It's symptoms include diarrhoea after taking
clarithromycin. Please inform your doctor immediately if you
suffer from diarrhoea.

Like all medicines, this medicine can cause side effects, although
not everybody gets them. If you develop severe or prolonged
diarrhoea, which may have blood or mucus in it, during or after
taking Baktroquell XL tablets, consult your doctor immediately.

If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.

If you develop a rash, difficulty breathing, fainting or swelling of
the face and throat, contact your doctor immediately as these
may be signs of an allergic reaction.

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

Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

Affects more than 1 people in 10
Affects 1 to 10 people in 100
Affects 1 to 10 people in 1,000
Affects 1 to 10 people in 10,000
Affects less than 1 people in 10,000
Frequency cannot be estimated from the
available data.

Other side effects of Baktroquell XL tablets may include:
Common side effects (affecting 1 to 10 people in 100):
• Insomnia (difficulty falling asleep).
• Headache.
• Rash.
• Feeling sick (nausea) & vomiting.
• Indigestion (upset stomach).
• Abdominal (stomach) pain.
• Diarrhoea.
• Change in the sense of taste.
Uncommon side effects (affecting 1 to 10 people in 1,000):
• Inflammation of the stomach and intestine, oral thrush, rash,
inflammation of the nose causing it to run, vaginal thrush and
vaginal infections.
• Low levels of white blood cells, anaemia, other white blood cell
disorders and an excessive level of platelets in the blood (blood
cells that help you stop bleeding) leading to abnormal blood
clotting or bleeding.
• Anorexia, decreased appetite.
• Psychiatric disorders such as anxiety.
• Dizziness, and tremor.
• Ringing in the ears, vertigo and ear disorders.
• Palpitations (a fast heart beat).
• Shortness of breath and other lung disorders.
• Bloating (excess gas in the stomach), constipation, dry mouth,
burping, passing gas, bleeding from the stomach, inflammation
of the corners of the mouth, tongue discolouration, vomiting
and other stomach and intestine disorders.
• Yellowing of the skin and eyes (jaundice).
• Dry skin, eczema, itching of the skin, rash, hives, and excessive
perspiration.
• Back and muscle pain.
• Kidney disorders including the presence of protein and blood in
urine, passing urine with pus (if you have a urine test).
• Lack of energy, chest pain, swelling of face, a feeling of general
discomfort, pain and thirst.
• If you have a blood test while taking Baktroquell XL, it may show
raised liver enzymes and abnormal liver function test results. The
presence of protein in the urine and other abnormalities may
show the presence of kidney disorders. A decrease in clotting
factor and an increase in other enzymes may also be detected.

5. HOW TO STORE BAKTROQUELL XL

This medicinal product does not require any special storage
conditions.
Do not use Baktroquell XL after the expiry date which is stated on
the carton after 'EXP'. 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 Baktroquell XL contains
• Each tablet contains 500 mg of clarithromycin as clarithromycin
citrate.
• The active substance is clarithromycin.
• The other ingredients are lactose monohydrate, hypromellose,
hypromellose phthalate, talc, magnesium stearate (E 572). The
coating (Opadry II Yellow) contains hypromellose 15cP, lactose
monohydrate, titanium dioxide (E171), macrogol/PEG 4000, Talc
(E553b); quinoline yellow aluminium lake (E104); macrogol/PEG
400.
What Baktroquell XL looks like and contents of the pack
Your medicine comes as a yellow coloured, oblong shaped,
biconvex film-coated tablet of length 19.15 ± 0.2 mm, width 8.95
± 0.2 mm and thickness 7.55 ± 0.2 mm with both sides plain.
Baktroquell XL is available in blisters of 5, 6, 7, 8, 10, 14, 16, 20, 21,
28, 30 and 60 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland.
Baktroquell XL is a registered trademark.

This leaflet was last revised in: February 2012

100003530

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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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