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Zachte XL 500 mg
Prolonged-release Tablets
Package leaflet: Information for the user
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.
What is in this leaflet
1. What Zachte XL is and what it is used for
2. What you need to know before you take Zachte XL
3. How to take Zachte XL
4. Possible side effects
5. How to store Zachte XL
6. Contents of the pack and other information


What Zachte XL is and what it is used for

Zachte XL contains the active substance clarithromycin.
Clarithromycin is an antibiotic belonging to a group of
medicines called the macrolides. Antibiotics stop the
growth of bacteria (bugs), which cause infections.
Zachte 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 it once a day.
Zachte XL is used to treat the following infections:
• Bronchitis and pneumonia
• Throat and sinus infections
• Mild to moderate skin and soft tissue infections
Zachte XL is not suitable for children younger than
12 years of age. Your doctor may prescribe another
form of clarithromycin.


What you need to know before you take
Zachte XL

Do not take Zachte XL if you
• are allergic to Clarithromycin, any other macrolide
antibiotics (e.g. erythromycin, azithromycin) or any
of the other ingredients of this medicine (listed in
section 6)
• are taking medicines called terfenadine or astemizole
(for hay fever or allergies) or cisapride (for stomach
disorders) or pimozide (for mental illness) tablets as
combining these drugs can sometimes cause
serious disturbances in heart rhythm. Consult your
doctor for advice on alternative medicines
• 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 kidney problems. Your doctor may
prescribe another form of clarithromycin
• are taking ticagrelor (a blood-thinning drug)
• are taking ranolazine (used to treat angina)
• are taking ergotamine-like drugs (usually used for
• are taking simvastatin or lovastatin (to reduce
• have been told by your doctor that you have low
levels of potassium in your blood (hypokalaemia)
• have severe liver disease with kidney disease
• are taking colchicine (used to treat gout).
Warnings and precautions
Talk to your doctor or pharmacist before taking Zachte
XL if:
• you have any kidney or liver problems
• 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 Zachte XL, consult your doctor
• you have, or are prone to, bacterial infections or
fungal infections (e.g. thrush)
• you are allergic to lincomycin or clindamycin
• you have abnormally low levels of magnesium in
your blood (hypomagnesaemia)
• you are taking other medicines which are known to
cause serious disturbances in heart rhythm (for the
medicines terfenadine, astemizole, cisapride, and
pimozide: see ‘Do not take Zachte XL’).
Other medicines and Zachte XL
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
You should not take Zachte XL if you are taking any of
the medicines listed in the section above “Do not take
Zachte XL”

If taken with Zachte XL, the levels and therefore the
effects of the following listed medicines may be
• Digoxin, quinidine or disopyramide (heart drugs)
• Warfarin (blood thinner)
• Carbamazepine, valproate or phenytoin (drugs for
• Theophylline (for asthma)
• Triazolam, alprazolam or midazolam (sedatives)
• Omeprazole (for stomach disorders)
Zachte XL may interact with the Anti-viral [HIV] drugs
in the following manner:
• Zidovudine, Zachte XL may lower the levels of
• Ritonavir may increase the levels of Zachte XL.
• Atazanavir & Saquinavir: Taking these drugs with
Zachte XL may increase both the levels of
Atazanavir (or Saquinavir) and Zachte XL.
• Nevirapine & Efavirenz may lower the levels of
Zachte XL.
• Etravirine may lower the levels of Zachte XL.
Other interactions include:
• Rifabutin (an antibiotic effective against some
infections) may lower the levels of Zachte XL
• Itraconazole (an anti-fungal drug) taken together with
Zachte XL may increase the levels of both medicines
• Fluconazole, another anti-fungal drug, may increase
the levels of Zachte XL
• Sildenafil, tadalafil or vardenafil (for treating
erectile dysfunction). Taking these drugs with
Zachte XL may increase both their levels
• Tolterodine (to treat symptoms of overactive
bladder syndrome). In certain patients, the levels of
tolterodine may be increased when taken with
Zachte XL
• Methylprednisolone (a corticosteroid to treat
• Vinblastine (a chemotherapy agent used to treat
• Ziprasidone (an antipsychotic drug)
• Quetiapine (an atypical antipsychotic)
• Eletriptan (used for migraine)
• Halofantrine (used to treat malaria)
• Aprepitant (used to prevent vomiting during
• Cilostazol (used to improve circulation in the legs)
• Rifampicin, rifapentine (to treat tuberculosis)
• Tacrolimus, sirolimus or cyclosporin (for organ
• St John’s Wort (herbal product to treat depression)
• Phenobarbital (drug for epilepsy)
• Medicines used to treat diabetes, e.g. insulin,
nateglinide, repaglinide
• Atorvastatin, rosuvastatin (HMG-CoA reductase
inhibitors, commonly known as statins and used to
lower levels of cholesterol (a type of fat) in the blood)
• Aminoglycosides (antibiotics) e.g. gentamicin
• Calcium channel blockers e.g. verapamil, amlodipine,
diltiazem (used to treat high blood pressure).
Zachte XL with food and drink
This medicine should be taken with food.
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.
Use of clarithromycin is not advised to pregnant or
breast-feeding mothers unless the benefits to the
mother outweigh the risks to the baby.
Clarithromycin is excreted into human breast milk.
Driving and using machines
There are no data available on the effect of
clarithromycin on the ability to drive or use
machines.Your tablets may cause dizziness, confusion
and disorientation..DO NOT drive or operate
machinery if you are affected.
Zachte XL contains lactose
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.


How to take Zachte XL

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure. Your doctor will tell you how to take
Zachte XL and how long for. Do not stop taking Zachte
XL early even if your symptoms improve. It is
important to take the tablets for as long as the doctor
has told you to, otherwise the infection might come
• The tablets should be swallowed whole with some
• The tablets should not be chewed or halved
• The tablets should be taken once daily preferably at
the same time each day for your course of
• The tablets should be taken with food.

The recommended dose is:
Adults including the elderly and children
12 years and older: The recommended dose is 500 mg
once daily for 6 days to 14 days. However your doctor
will decide the length of your treatment. Your doctor
may increase the dose to two 500 mg tablets in severe
infections. You should take both of these tablets at the
same time.
Children under 12 years: Do not give this medicine to
children under 12 years of age. Your doctor will
prescribe another suitable medicine for your child.
Patients with severe kidney and liver problems:
Patients with severe kidney and liver problems should
not take Zachte XL.
If you take more Zachte XL than you should
Contact your doctor or nearest hospital emergency
department immediately. Take the container and any
remaining tablets with you. Symptoms of overdose
include feeling or being sick, diarrhoea, indigestion or
stomach pains and there is the possibility of allergic
If you forget to take Zachte XL
Take the next dose as soon as you remember unless it
is almost time for your next dose. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Zachte XL
Do not stop taking Zachte XL 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 suffer from any of the following at any time
during your treatment STOP TAKING your tablets and
contact your doctor immediately. These side effects
are of unknown frequency:
• severe or prolonged diarrhoea, which may have
blood or mucus in it. Diarrhoea may occur over two
months after treatment with clarithromycin, in
which case you should still contact your doctor.
• a rash, difficulty breathing, fainting or swelling of
the face and throat. This is a sign that you may have
developed an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale
stools, dark urine, tender abdomen or loss of
appetite. These may be signs that your liver may not
be working properly.
• severe skin reactions such as blistering of the skin,
mouth, lips, eyes and genitals (symptoms of a rare
allergic reaction called Stevens-Johnson
syndrome/toxic epidermal necrolysis).
• torsade de pointes, a life threatening irregular heart
Common side effects (may affect up to 1 in 10 people)
• headache
• difficulty sleeping
• changes in sense of taste
• stomach problems such as feeling sick, vomiting,
stomach pain, indigestion, diarrhoea
• abnormal liver function (seen in blood results)
• skin rash
• increased sweating.
Uncommon side effects (may affect up to 1 in 100
people) include:
• oral or vaginal ‘thrush’ (a fungal infection)
• reduction in the level of certain blood cells (which
can make infections more likely)
• loss of appetite, heartburn, constipation, wind,
burping (eructation)
• anxiety, nervousness,, drowsiness, tiredness,
weakness, dizziness, tremor or shaking, or a
general feeling of being unwell
• ringing in the ears or hearing loss
• vertigo
• inflammation of the mouth or tongue
• inflammation of the stomach, pain in the rectum
• dry mouth
• muscle pain
• chest pain or changes in heart rhythm such as
• nosebleed
• failure in the flow of bile (cholestasis), a change in
the levels of products made by the liver,
inflammation of the liver, an inability of the liver to
function properly or liver failure (you may notice
yellowing of the skin, dark urine, pale stools or
itchiness of the skin)
• itching of the skin, hives.

Not known (frequency cannot be estimated from
available data):
• swelling, redness or itchiness of the skin
• 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
• swelling of the lips and face (angioedema)
• drug rash with eosinophilia and systemic symptoms
• acne
• inflammation of the pancreas
• confusion, loss of bearings, hallucinations (seeing
things), change in sense of reality or panicking,
depression, abnormal dreams or nightmares, mania
• convulsion (fits)
• bleeding
• discolouration of the tongue or teeth
• loss of taste or smell or inability to smell properly
• pins and needles
• deafness
• muscle pain or loss of muscle tissue. If you suffer
from myasthenia gravis (a condition in which the
muscles become weak and tire easily)
clarithromycin may worsen these symptoms
• low blood sugar levels
• inflammation of the kidney or an inability of the
kidney to function properly (you may notice
tiredness, swelling or puffiness in the face,
abdomen, thighs or ankles or problems with
urination), or kidney failure
• abnormal colour of the urine
• blood clotting time increased.
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:
By reporting side effects you can help provide more
information on the safety of this medicine.


How to store Zachte XL

Keep this medicine out of the sight and reach of
[PVC/PVdC aluminium blister pack]
Do not store above 30°C. Store in the original package
in order to protect from moisture.
[OPA/AL/PVC/AL blister pack]
This product does not require any special storage
Do not use this medicine after the expiry date which is
stated on the label after Exp. The expiry date refers to
the last day of that month.
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 to protect the environment.


Contents of the pack and other information

What Zachte XL contains
The active substance is clarithromycin. Each tablet
contains 500 mg clarithromycin.
The other ingredients are: citric acid anhydrous,
sodium calcium alginate, sodium alginate manucol,
lactose monohydrate, povidone, talc, stearic acid,
magnesium stearate, vanillin, opadry II 31F32870
Yellow (containing lactose monohydrate,
hypromellose (E464), titanium dioxide (E171),
polyethylene glycol, iron oxide yellow (E172), iron
oxide red (E172), iron oxide black (E172)).
What Zachte XL looks like and contents of the pack
Zachte XL Prolonged-release Tablets are light yellow
to yellow, film-coated, oval shaped tablets debossed
with “C” on one side and “500” on the other side.
Your tablets come in blister packs in pack sizes of 5, 6,
7, 10, 14, 20 & 1 tablet unit dose pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
TEVA Pharmaceutical Works Private Limited Company,
Pallagi út 13, 4042 Debrecen, Hungary
This leaflet was last revised in 03/2016
PL 00289/1377


Expand Transcript

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.