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Clarithromycin
Clarithromycin

P1513465
P1513465
Package leaflet: Information for the user Clarithromycin may increase the effect of the following
medicines:
Clarithromycin 250 mg film-coated tablets • astemizole, terfenadine (antiallergic), pimozide (antipsychotic),
Clarithromycin 500 mg film-coated tablets cisapride (gastric medicine), ergotamine, dihydroergotamine
(migraine medicines), lovastatin, simvastatin (medicines to
Clarithromycin lower cholesterol) (see “Do not take Clarithromycin”)
Read all of this leaflet carefully before you start taking this • alprazolam, triazolam, midazolam (hypnotics)
medicine because it contains important information for you. • atorvastatin, rosuvastatin (cholesterol lowering agents)
- Keep this leaflet. You may need to read it again. • warfarin, phenprocoumon (blood thinners): concomitant use
- If you have any further questions, ask your doctor or may increase the risk of bleeding. Checking of the blood
pharmacist. clotting should be more frequent if Clarithromycin used
- This medicine has been prescribed for you only. Do not pass it concomitantly.
on to others. It may harm them, even if their signs of illness are • Nateglinide, repaglinide or insulin (antidiabetics)
the same as yours. • carbamazepin, phenytoin, valproate (medicines to treat
- If you get any side effects, talk to your doctor or pharmacist. epilepsy)
This includes any possible side effects not listed in this leaflet. • cilostazol (used to improve circulation in the legs)
See section 4. • colchicine (to treat gout)
• cyclosporine, sirolimus, tacrolimus (immunosuppressants)
What is in this leaflet: • digoxin, verapamil, quinidine, disopyramide (heart medicines),
1. What Clarithromycin is and what it is used for concomitant use of clarithromycin and these agents may cause
2. What you need to know before you take Clarithromycin cardiac arrhythmias.
3. How to take Clarithromycin • methylprednisolone (a cortisone to treat inflammation)
4. Possible side effects • omeprazole (gastric medicine)
5. How to store Clarithromycin • rifabutin (antibiotic)
6. Contents of the pack and other information. • sildenafil, tadalafil, vardenafil (medicines to treat erectile
dysfunction)
1. What Clarithromycin is and what it is used for • theophylline (antiasthmatic)
Clarithromycin belongs to a group of medicine called macrolide • tolterodine (to treat overactive bladder syndrome)
antibiotics. Antibiotics stop the growth of bacteria which cause • vinblastine (medicine for cancer therapy)
infections. • medicines with the risk to affect hearing, especially
aminoglycosides (group of antibiotics that are given to vein)
Clarithromycin is used to treat following infections:
• Chest infections such as bronchitis and pneumonia, • atypical antipsychotics (e.g. quetiapine)
• Throat and sinus infections, Both, the effect of Clarithromycin and the effect of the
• Skin and soft tissue infections, following medicines may be increased when taken together:
• Helicobacter pylori infections associated with duodenal ulcers.
• atazanavir, saquinavir (medicines to treat HIV)
2. What you need to know before you take Clarithromycin • itraconazole (medicine to treat fungal infections)
Do not take Clarithromycin if: If your doctor has specifically recommended to take Clarithromycin
• you are allergic to clarithromycin, other macrolide antibiotics or and any of the above mentioned medicines at the same time, your
any of the other ingredients of this medicine (listed in section 6). doctor may need to monitor you more closely.
• you have a history of certain abnormal heart rhythms Clarithromycin may weaken the effect of following medicines:
(ventricular arrhythmia, including torsades de pointes) or
• zidovudine ((used to treat HIV infection). In order to avoid this
changes in the heart activity as measured in the electro-
you should leave a 4 hour interval between taking these
cardiogram called “QT prolongation”,
medicines.
• you suffer from severe liver failure and kidney problems at the
same time, The following medicines may weaken the effect of
• You are taking medicines called terfenadine or astemizole (for Clarithromycin:
hay fever or allergies) or cisapride or pimozide tablets as • rifampicin, rifabutin, rifapentine (antibiotics)
combining these drugs can sometimes cause serious • efavirenz, nevirapine, etravirine (medicines to treat HIV)
disturbances in heart rhythm. Consult your doctor for advice on • phenytoin, carbamazepine, phenobarbitone (antiepileptic)
alternative medicines. • St John’s Wort (a herbal product used to treat depression)
• You are taking other medicines which are known to cause The following medicines may strengthen the effect of
serious disturbances in heart rhythm. Clarithromycin:
• You have abnormally low levels of potassium in your blood • ritonavir (antiviral)
(hypokalaemia) • fluconazole (medicine to treat fungal infections)
• You or someone in your family has a history of heart rhythm
disorders (ventricular cardiac arrhythmia, including torsade de The use of clarithromycin at the same time as digoxin, quinidine,
pointes) or abnormality of electrocardiogram (ECG, electrical disopyramide or verapamil (heart medicines), or other macrolide
recording of the heart) called “long QT syndrome”. antibiotics may cause cardiac arrhythmia.
• you are taking any of the following medicines Tell your doctor or pharmacist if you are taking, have recently taken
• ergotamine, dihydroergotamine (medicines to treat or might take any other medicines.
migraine)
• lovastatin, simvastatin (medicines to lower cholesterol), Pregnancy,breast-feeding and fertility
• colchicines (medicine to treat gout), If you are pregnant or breast-feeding, think you may be pregnant or
• ticagrelor or ranolazine (medicines to prevent stroke or are planning to have a baby, ask your doctor or pharmacist for
heart attack). advice before taking this medicine.
Consult your doctor and take this medicine if any of the above If you are pregnant or breast-feeding do not take Clarithromycin
cases apply to you, or that in the past. before consulting your doctor.
Warnings and precautions Driving and using machines
Talk to your doctor or pharmacist before taking Clarithromycin, Clarithromycin has generally no effect on the ability to drive or use
• if you are allergic to lincomycin or clindamycin machines. However, if side effects, such as dizziness, confusion
• if you have reduced liver or kidney function, and disorientation, your reaction may be adversely affected. Use
• if you have, or have had, heart problems caution when driving or operating machinery until you know how
• if you are pregnant (see section “Pregnancy, breast-feeding and you react to this medicine.
fertility”)
• if you have abnormally low levels of magnesium in your blood 3. How to take Clarithromycin
(hypomagnesaemia) consult your doctor before taking these Always take this medicine exactly as your doctor has told you. You
tablets should check with your doctor or pharmacist if you are not sure.
• if you develop severe or prolonged diarrhoea
(pseudomembranous colitis) during or after taking Clarithromycin may be taken with or without food
Clarithromycin, consult your doctor immediately. Inflammation Clarithromycin 500 mg film-coated tablet is not suitable for doses
of the colon (Pseudomembranous colitis) has been reported below 500 mg. There are other options for this strength available
with nearly all antibacterial medicines including clarithromycin. on the market.
• if you have used clarithromycin before on several occasions or
The recommendations for the usual doses are given below:
for a long time.
• Patients should be advised to stop treatment and contact their Adults including the elderly and adolescents (children over
doctor if signs and symptoms of hepatic disease develop, such 12 years)
as anorexia, jaundice, dark urine, pruritus, or tender abdomen. The usual dose is 250 mg twice a day. The usual dose is 250 mg
• if you take combination a combination of clarithromycin and twice daily. In severe infections, your doctor may increase the dose
benzodiazepines, such as alprazolam, triazolam and to 500 mg twice daily. The treatment takes 7-14 days and should
midazolam (see section “Other medicines and Clarithromycin”) last at least two days after the disappearance of the symptoms.
• if you take other drugs which affect your auditory function. Loss
of hearing will be checked during and after treatment. Use in infections with H. pylori:
• In the event of severe acute hypersensitivity reactions, such as In adult patients with ulcers of stomach and duodenum by infection
anaphylaxis, Stevens-Johnson Syndrome, and toxic epidermal with H. Pylori, as a part of triple combination therapy administered
necrolysis, clarithromycin therapy should be discontinued usual dose is 500 mg twice a day.
immediately and appropriate treatment should be urgently Patients with kidney problems
initiated. If you have severe kidney problems your doctor may need to
• Concomitant use of clarithromycin with lovastatin or simvastatin reduce your dose by half, i.e. once daily and restrict treatment to
is contraindicated (see section “Do not take Clarithromycin if”). 14 days at the most.
Caution should be exercised when using clarithromycin with
other statins.If you also use oral anticoagulants besides Children under 12 years
clarithromycin. There is a risk of serious bleeding. Use of Clarithromycin tablets for children under the age of 12 years
If any of these apply to you, consult your doctor before taking (under 30 kg bodyweight) is not recommended. Your doctor will
Clarithromycin tablets. prescribe another medication that is appropriate for your chlid.

Other medicines and Clarithromycin For children with a body weight of more than 30 kg, the same dose
Certain other medicines may affect the effectiveness of as for adults is used.
Clarithromycin or vice-versa.
If you feel that the effect of this medicine is too strong or too weak?
Please contact your doctor or pharmacist.

Black Size: 210 x 480 mm

Product Name Component Item Code Date & Time

Clarithromycin Leaflet P1513465 15.10.2016 & 10:00 am

Customer / Country Version No. Reason Of Issue Reviewed / Approved by

Milpharm_UK_Unit-3 00 Revision
Team Leader Arjun Pradhan Dimensions Colours :

Initiator Arief 210 x 480 mm

Artist: Pharmacode No. of Colours : 01

13465

Additional Information : Supersede Item code: P1511876 Sign / Date

If you take more Clarithromycin than you should Malta The United Kingdom
If you have taken too much of Clarithromycin, contact your doctor ADR Reporting Yellow Card Scheme
or nearest hospital emergency department as soon as possible. Website: Website:
Overdose can cause gastrointestinal discomfort and possibly other www.medicinesauthority.gov.mt www.mhra.gov.uk/yellowcard
complaints. e-mail:
postlicensing.medicinesauthority@gov.mt
If you forget to take Clarithromycin
If you forget to take a dose of Clarithromycin, take it as soon as you 5. How to store Clarithromycin
remember. If it is almost time for your next dose, do not take the
Keep this medicine out of the sight and reach of children.
missed dose and just carry on as before. Do not take a double
dose to make up for a forgotten dose. Do not use this medicine after the expiry date which is stated on
If you stop taking Clarithromycin the blister and carton after EXP. The expiry date refers to the last
It is important that you take your medicine in accordance with the day of that month.
doctor’s instructions. Do not suddenly stop using Clarithromycin This medicinal product does not require any special storage
without discussing it first with your doctor. Otherwise symptoms
conditions.
may return.
Do not throw away any medicines via wastewater or household
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist. waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
4. Possible side effects
6. Contents of the pack and other information
Like all medicines, this medicine can cause side effects, although
not everybody gets them. What Clarithromycin contains
- The active substance is clarithromycin.
Serious side effects:
Each film-coated tablet contains 250 mg of clarithromycin
If any of the following happens, stop taking this medicine and tell Each film-coated tablet contains 500 mg of clarithromycin
your doctor immediately or go to the casualty department at your
nearest hospital: - The other ingredients are: Microcrystalline cellulose,
• allergic reactions such as sudden difficulty in breathing, croscarmellose sodium, silica, colloidal anhydrous, magnesium
speaking and swallowing stearate, povidone, hypromellose, propylene glycol, titanium
• extreme dizziness or fainting dioxide (E 171), hydroxypropyl cellulose, vanillin, sorbic acid
• severe or itchy skin rash, especially if this shows blistering and and iron oxide yellow (E 172).
there is soreness of the eyes, mouth or genital organs
What Clarithromycin looks like and contents of the pack
Take as soon as possible, contact your doctor if the following Film-coated tablet
symptoms develop:
• diarrhoea that is serious, lasts a long time or has blood in it, Clarithromycin 250 mg film-coated tablets:
with stomach pain or fever. This can be a sign of a serious Light yellow coloured, oval shaped, biconvex film-coated tablets,
bowel inflammation. Your doctor may discontinue treatment. Do with ‘D’ debossed on one side and ‘62’ on the other side. The size
not take medicines that reduce bowel movements. is 15.1 mm x 7.1 mm
• Liver function with following possible symptoms
• loss of appetite Clarithromycin 500 mg film-coated tablets:
• yellowing of the skin or whites of the eyes (jaundice), Light yellow coloured, oval shaped, biconvex film-coated tablets,
• pale stools, dark urine with ‘D’ debossed on one side and ‘63’ on the other side. The size
• Itchy rash is 18.5 mm x 8.1 mm
• Abdominal pain
• Palpitations or irregular heartbeat Clarithromycin 250 mg & 500 mg tablets are available in clear
• severe pain in the abdomen and back, caused by pancreas PVC/PVDC/Aluminium blister packs of 7, 12, 14 and 21 film-coated
inflammation tablets.

Other possible side effects: Not all pack sizes may be marketed.
Common (may affect up to 1 in 10 people): Marketing Authorisation Holder
• difficulty sleeping UK_ Milpharm Limited
• headache
Ares Block, Odyssey Business Park
• changes in sense of taste
• abdominal pain, nausea, vomiting, diarrhoea, indigestion West End Road
• abnormal liver function test results Ruislip HA4 6QD
• skin rash United Kingdom
• excessive sweating.
MT_ Aurobindo Pharma (Malta) Limited
Uncommon (may affect up to 1 in 100 people): Vault 14, Level 2, Valletta Waterfront
• yeast infections (candidiasis) (Eg: in the mouth) Floriana FRN 1913
• infections of the vagina Malta
• reduction in the level of certain white blood cells, which can
make infections more likely ( leucopenia and neutropenia) Manufacturer
• increased number of certain white blood cells (eosinophilia) APL Swift Services (Malta) Limited
• loss of appetite HF26, Hal Far Industrial Estate, Hal Far
• anxiety, dizziness, difficulty sleeping, chills Birzebbugia, BBG 3000
• spinning sensation Malta
• impaired hearing, ringing in the ears (tinnitus)
• palpitations or
• inflammation of the stomach, mouth and tongue
• Flatulence, constipation and indigestion Milpharm Limited
• dry mouth Ares Block, Odyssey Business Park
• chlolestasis West End Road
• increase of liver enzymes in the blood Ruislip HA4 6QD
• itching, hives United Kingdom
• muscle pain
• generally feeling unwell This medicinal product is authorised in the Member States of
• weakness the EEA under the following names:
• chest pain Cyprus Clarithromycin Aurobindo 500 mg επικαλυμμένο
• chills με λεπτό υμένιο δισκία
• fatigue Czech Republic Clarithromycin Aurobindo 250 mg/ 500 mg
Not known [frequency cannot be estimated from the available potahované tablety
data]: Denmark Clarithromycin “Aurobindo”
• Inflammation of the gut with severe diarrhea called Estonia Clarithromycin Aurobindo
Pseudomembranous collitus, France CLARITHROMYCINE ARROW LAB 250 mg/
• Saint Anthony’s fire (erysipelas), acne 500 mg, comprimé pelliculé
• severe reduction of white blood cells associated with sudden Ireland Clarithromycin Aurobindo 250 mg/500 mg film-
high fever, severe sore throat and mouth ulcers coated tablets
(agranulocytosis) Latvia CLARITHROMYCIN AUROBINDO 500 mg
• unusual bruising or bleeding caused by low blood platelets apvalkotās tabletes
• Serious allergic reaction which causes swelling of the face or
Lithuania Clarithromycin Aurobindo 500 mg plėvele dengtos
throat (angioedema)
• psychosis, a feeling of loss of identity tabletės
• confusion, change in sense of reality or panicking, Malta Clarithromycin 250 mg/500 mg film-coated tablets
• depression, nightmares, disorientation, hallucinations, mania Netherlands Claritromycine Aurobindo 250 mg/500 mg,
• convulsions filmomhulde tabletten
• disturbed sense of smell, loss of sense of smell or taste Romania Claritromicină Aurobindo 250 mg/500 mg
• deafness comprimate filmate
• tingling or numbness in the hands or feet Spain CLARITROMICINA AUROBINDO 250 mg/500 mg
• difficulty with your blood clotting comprimidos recubiertos con película EFG
• discoloration of the teeth and tongue Sweden Clarithromycin Aurobindo 250 mg/500 mg
• acne
filmdragerade tabletter
• pain or weakness in muscles
• Inflammation of the kidneys, renal failure United Kingdom Clarithromycin 250 mg/500 mg film-coated tablets
• abnormal urine colour. This leaflet was last revised in 09/2016.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly (see details below). By
P1513465

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