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ZACHTE XL 500MG PROLONGED RELEASE TABLETS

Active substance(s): CLARITHROMYCIN

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Package leaflet: Information for the user
Zachte XL 500 mg 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.
What is in this leaflet
1.
2.
3.

What Zachte XL is and what it is used for
What you need to know before you take Zachte XL
How to take Zachte XL

4.
5.
6.

Possible side effects
How to store Zachte XL
Contents of the pack and other information

1. 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.

2.

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 migraine)
are taking simvastatin or lovastatin (to reduce cholesterol)
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
immediately
you have, or are prone to, bacterial infections or fungal infections (e.g. thrush)
you are allergic to lincomycin or clindamycin (antibiotics)
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
increased:
 Digoxin, quinidine or disopyramide (heart drugs)
 Warfarin (blood thinner)
 Carbamazepine, valproate or phenytoin (drugs for epilepsy)
 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 zidovudine.
 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 inflammation)
 Vinblastine (a chemotherapy agent used to treat cancer)
 Ziprasidone (an antipsychotic drug)
 Quetiapine (an atypical antipsychotic)
 Eletriptan (used for migraine)
 Halofantrine (used to treat malaria)
 Aprepitant (used to prevent vomiting during chemotherapy)
 Cilostazol (used to improve circulation in the legs)
 Rifampicin, rifapentine (to treat tuberculosis)
 Tacrolimus, sirolimus or cyclosporin (for organ transplants)
 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.

3.

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 back.





The tablets should be swallowed whole with some liquid
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 treatment
The tablets should be taken with food.

Dosage
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 reactions.

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.

4.

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 beat.
Contact a doctor immediately if you experience a serious skin reaction: a red, scaly rash with bumps
under the skin and blisters (exanthematous pustulosis). The frequency of this side effect is not known
(cannot be estimated from the available data).

Common side effects (may affect up to 1 in 10 people) include;
• 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 (proctalgia)
dry mouth
muscle pain
chest pain or changes in heart rhythm such as palpitations
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 (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)
• swelling of the lips and face (angioedema)
• drug rash with eosinophilia and systemic symptoms (DRESS)
• 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: 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 Zachte XL

Keep this medicine out of the sight and reach of children.
[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 conditions.
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.
6.

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 and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG, UK
OR*
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany
OR*

TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
OR*
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem,

The Netherlands

OR*
PLIVA Krakow Zakłady Farmaceutyczne S.A., ul. Mogilska 80. 31-546, Krakow, Poland
OR*
TEVA PHARMA S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain

This leaflet was last revised in 12/2017
PL 00289/1377

*Only the actual site of batch release will appear on the printed version of the leaflet

+ 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.

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