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Clarithromycin 500 Mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 00289-0458 change

Package leaflet: Information for the user

Clarithromycin 250 mg Film-Coated Tablets Clarithromycin 500 mg Film-Coated Tablets Clarithromycin

Read all of this leaflet carefully before you start using this medicine becuase 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 Clarithromycin is and what it is used for

2.    What you need to know before you use Clarithromycin

3.    How to use Clarithromycin

4.    Possible side effects

5.    How to store Clarithromycin

6.    Contents of the pack and other information

1.    What Clarithromycin is and what it is used for

•    Clarithromycin belongs to a group of drugs called macrolide antibiotics.

•    Clarithromycin is used to treat a range of infections such as:

•    chest infections e.g. bronchitis and pneumonia

•    throat and sinus infections e.g. sinusitis and pharyngitis

•    skin and soft tissue infections

•    Helicobacter pylori infection associated with duodenal ulcer.

2.    What you need to know before you use Clarithromycin film coated tablets Do not take Clarithromycin

•    if you are allergic to Clarithromycin, other macrolide antibiotic (e.g. erythromycin, azithromycin) or any of the other ingredients of this medicine (listed in section 6)

•    if you are taking medicines called terfenadine or astemizole (for hay fever or allergies) or cisapride or pimozide tablets as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines.

•    if you have been told by your doctor that you have abnormally low levels of potassium in your blood (hypokalaemia)

•    if you 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”

•    if you are taking ergotamine-like drugs (usually used for migraine)

•    if you are taking cholesterol-lowering drugs (lovastatin or simvastatin)

•    if you have heart problems such as abnormal heart rhythm

•    if you have severe liver problems in combination with kidney problems

•    if you are taking ticagrelor (a blood-thinning drug) uk-pil-clean-00289-0457-0458

if you are taking ranolazine (used to treat angina) if you are taking colchicine (used to treat gout)

Warnings and precautions

Talk to your doctor or pharmacist before taking Clarithromycin if you

•    are allergic to the antibiotics lincomycin or clindamycin

•    have liver problems

•    have kidney problems

•    have heart problems

•    have, or are prone to, fungal infections (e.g. thrush)

•    have muscle problems known as myasthenia gravis

•    taking drugs that lower your blood sugar (oral hypoglycaemic agents) or insulin

•    have abnormally low levels of magnesium in your blood (hypomagnesaemia)

•    have an imbalance in other salts in your blood (electrolytes)

•    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 Clarithromycin’)

Other medicines and Clarithromycin

Tell your doctor or pharmacist if you are taking,have recenty taken or might take any other medicines.

Do not take Clarithromycin if you are taking

•    ergotamine or dihydroergotamine (to treat migraines)

•    terfenadine or astemizole (used to treat hay fever and other allergies)

•    pimozide (used to treat mental disorders)

•    cisapride (used to treat stomach problems)

•    simvastatin or lovastatin (used to lower cholesterol)

•    other macrolides e.g. erythromycin or azithromycin

•    ticagrelor (a blood-thinning drug)

•    ranolazine (used to treat angina)

•    colchicine (used to treat gout)

Talk to your doctor if you are taking any of the following

•    coumarin anticoagulants used to thin your blood, e.g. warfarin

•    medicines used to treat an abnormal heart beat, e.g. disopyramide or quinidine

•    medicines used to treat heart failure, e.g. digoxin

•    medicines used to treat epilepsy, e.g. phenytoin, valproate or carbamazepine

•    medicines to treat certain mental illness e.g. quetiapine

•    theophylline, used to treat asthma

•    benzodiazepines used as medicines that make you sleepy, e.g. alprazolam, midazolam or triazolam

•    phenobarbital, used as a sedative and anti-convulsant

•    rifabutin, rifampicin, rifapentine or aminoglycosides (e.g. gentamicin), used to treat some infections

•    ciclosporin, tacrolimus or sirolimus, used following organ transplant

•    medicines used to lower cholesterol, e.g. atorvastatin or rosuvastatin

•    ritonavir, atazanavir, etravirine, saquinavir, efavirenz, nevirapine or zidovudine, used to treat HIV infected patients

•    St John’s Wort, used to treat depression

•    sildenafil, tadalafil, vardenafil, used to treat erection problems

•    cilostazol (a treatment for leg cramps)

•    methylprednisolone (used to treat inflammation)

•    vinblastine (a cancer treatment)

•    omeprazole, used to treat indigestion

•    tolterodine, used for urinary frequency

•    itraconazole or fluconazole, used in fungal infections

•    Calcium channel blockers e.g verapamil, amlodipine, diltiazem (used to treat high blood pressure or heartbeat disorders)

•    drugs that lower your blood sugar (oral hypoglycaemic agents e.g. nateglinide, repaglinide) or insulin

Clarithromycin with food and drink

• You can take Clarithromycin either with or without food, whichever you prefer 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.

Clarithromycin should not be given to pregnant or breast-feeding mothers unless the benefits to the mother outweigh the risks to the baby.

Small amounts of clarithromycin can pass into breast milk..

Driving and using machines

•    Your tablets may make you feel sleepy, dizzy or confused. Do not drive or operate machinery if you are affected.

Clarithromycin film coated tablets contain Tartrazine lake and Allura red lake Tartrazine lake (E102) and Allura red lake (E129) may cause allergic reactions.

3. How to use Clarithromycin film coated tablets

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed preferably with a glass of water.

The recommended dosage instructions are given below:

Adults including the elderly:

•    For chest infections, throat or sinus infections and skin and soft tissue infections:

The recommended dose is 250 mg twice a day. Your doctor may increase the dose to 500 mg twice a day in severe infections. The usual duration of treatment is 6 to 14 days. Treatment should be continued for at least 2 days after you have stopped having symptoms.

Adults

•    For the treatment of Helicobacter pylori infection associated with duodenal ulcers:

Clarithromycin should be taken in a dose of 500 mg twice daily in combination with other medicines to treat Helicobacter pylori.

Your doctor will decide on the best treatment combination for you. If you are at all unsure as to which medicine to take and when to take the medicine you must speak to your doctor.

Patients with liver or kidney problems

If you have liver or severe kidney problems your doctor may need to reduce your dose. Clarithromycin should not be taken for more than 14 days if you have these problems.

Use in children and adolescents

Children under 12 years old

Clarithromycin is not recommended for use in children under 12 years of age, but there are other formulations e.g oral suspensions which your doctor will prescribe for children under 12 years of age.

Children over 12 years old

• For chest infections, throat or sinus infections and skin and soft tissue infections:

The recommended dose is 250 mg twice a day. Your doctor may increase the dose to 500 mg twice a day in severe infections. The usual duration of treatment is 6 to 14 days. Treatment should be continued for at least 2 days after you have stopped having symptoms.

If you take more Clarithromycin than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose is likely to cause vomiting and stomach pains.

Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Clarithromycin

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

If you stop taking Clarithromycin

Do not stop taking your medicine because you are feeling better. It is important that you complete your prescribed course of treatment, otherwise the problem may come back and this medicine may be less effective next time.

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.

Serious side effects:

Stop taking Clarithromycin and tell your doctor immediately or go to the casualty department at your nearest hospital, if the following happens:

Uncommon: may affect up to 1 in 100 people

•    an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, or severe skin rash or hives1

•    gall bladder problems (cholestasis)4

•    yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tender abdomen or loss of appetite. These may be signs of hepatitis (an inflammation of the liver)4

•    changes in heart beat/rhythm (an abnormally fast, slow, or irregular pulse)

Not known: frequency cannot be estimated from the available data

•    Torsades de pointes, a life threatening irregular heart beat

•    blistering of the skin, mouth eyes and genitals; this could be caused by Steven-Johnson syndrome or toxic epidermal necrosis, which are serious illnesses

•    pseudomembranous colitis (infection of the bowel with severe or prolonged diarrhoea, which,may have blood or mucus in it)

•    agranulocytosis (severe reduction in white blood cells with an increased risk of infection); symptoms include high temperature, ulcers in the mouth and throat, and unexplained bruising or bleeding

•    pancreatitis - nausea, vomiting, abdominal pain and back pain

•    fits

•    changes in the heart rythm (ventricular tachycardia, ventricular fibrillation)

• liver failure and jaundice - yellowing of the skin and the whites of the eyes, with increased liver enzymes in the blood

Other side effects:

The following side effects have been reported at the approximate frequencies shown:

Common: may affect up to 1 in 10 people

•    stomach problems such as nausea, vomiting, indigestion, stomach pains, or diarrhoea

•    change in sense of taste

•    headache

•    difficulty sleeping

•    altered liver function tests

•    rash, increased sweating

•    widening of blood vessels (vasodilation)1

Uncommon: may affect up to 1 in 100 people

•    fungal infection, vaginal infection

•    blood disorders, such as a change in the number of white blood cells making infections more likely. These may be characterised by fever chills, sore throat, ulcers in your mouth

•    joint pain and muscle pain, muscle stiffness1, muscle cramps3

•    increased blood clotting time3, nose bleeding2

•    altered liver or kidney function tests or blood tests

•    nettle rash, itching, flat, red areas on the skin covered with small confluent bumps (maculopapular rash)1 , blisters on the skin which are filled with fluid (dermatitis bullous)2

•    loss of appetite, decreased appetite

•    anxiety, nervousness1

•    dizziness, sleepiness, tremor (shaking), movement disorders (dyskinesia)2

•    vertigo (spinning sensation), ringing in the ears, hearing impaired

•    inflammation of the stomach lining and small intestine, heartburn3, bloating, constipation, dry mouth, belching, flatulence (wind)4, rectal pain3

•    inflammation of the gullet (oesophagitis)

•    inflammation or ulceration of the mouth or tongue, feeling of weakness or discomfort, loss of consciousness2, general feeling of being unwell4, chest pain, ECG abnormalities

•    chills, tiredness, fever1

•    hypersensitivity reactions (allergic reactions)

•    changes in the levels of several enzymes in the blood, shown by a blood test2

•    asthma2

•    cough and coughing up blood (signs of pulmonary embolism)2

•    cellulitis1 (a skin infection caused by bacteria)

•    infections1

•    cardiac arrest1 (a sudden stop in effective blood circulation due to the failure of the heart to contract effectively)

Very rare: may affect up to 1 in 10,000 people

•    numbness or pins-and-needles (paresthesia)

Not known: frequency cannot be estimated from the available data

•    erysipelas or erythrasma (infections of the skin)

•    decreased platelets count in the blood

•    confusion, change in the sense of reality and feeling panicky, disorientation, hallucinations

•    teeth discolouration (this can usually be corrected by professional cleaning)

•    tongue discolouration

•    kidney failure, kidney inflammation

•    psychotic disorder (mental illness), depression, abnormal dreams, feeling elated or overexcited, which causes unusual behaviour (mania)

•    loss of taste, smell alteration, loss of ability to smell

•    hearing loss

•    unusual bleeding or unexplained bruising

•    low blood sugar levels in diabetic patients

•    drug rash with eosinophilia (type of white blood cells increase) and systemic symptoms (DRESS), acne

•    myopathy (muscular weakness), rhabdomyolosis (muscle pain, breakdown of muscle fibres)

•    international normalised ratio increased (increased blood clotting time), urine colour abnormal

•    prothrombin time prolonged

You may get side effects which you are not aware of, such as changes in the number of certain blood cells, other blood components or liver enzymes. Your doctor may choose to do blood tests to check this.

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 Clarithromycin film coated tablets:

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

Do not store above 25°C. Keep the container in the outer carton. Do not transfer to another container.

Do not use this medicine after the expiry date which is stated on the blister and carton 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 protect the environment.

6.    Contents of the pack and other information What Clarithromycin film coated Tablets contain

•    The active substance is clarithromycin. Each tablet contains either 250 mg or 500 mg of Clarithromycin.

•    The other ingredients are sodium starch glycolate, microcrystalline cellulose, povidone (PVP K-30), magnesium hydroxide, croscarmellose sodium, anhydrous colloidal silica, stearic acid, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol 400, tartrazine lake (E102), allura red AC lake (E129), indigo carmine lake (E132) and vanillin.

What Clarithromycin film coated tablets looks like and contents of the pack

•    The 250 mg tablet is a yellow, oval shaped film-coated tablet marked with “93” on one side and “7157” on the other.

•    The 500 mg tablet is a light yellow, oval shaped film-coated tablet marked with “93” on one side and “7158” on the other.

•    The 250 mg product is available in pack sizes of 7, 8, 10, 12, 14, 14 calendar pack, 16, 20, 30, 100 and 120 tablets.

•    The 500 mg product is available in pack sizes of 7, 8, 10, 14, 14 calendar pack, 16, 20, 21, 30, 42 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

TEVA UK Limited, Eastbourne, BN22 9AG.

Manufacturer:

TEVA UK Limited, Eastbourne, BN22 9AG.

OR*

Teva Pharmaceutical Works Private Limited Company, Debrecen, H-4042, Hungary

OR*

Merckle GmbH,

Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany

Distributed by: TEVA UK Limited, Leeds, LS27 0JG. This leaflet was last revised in August 2016

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

1

   Side effects reported only for the Granules for Oral Suspension formulation

2

   Side effects reported only for the Powder for Solution for Injection formulation

3

   Side effects reported only for the Extended-Release Tablets formulation

4

   Side effects reported only for the Immediate-Release Tablets formulation