Xetinin XL 500mg Prolonged 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 toothers. 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 Xetinin XL Tablets are and what they are used for

2.    Before you take Xetinin XL Tablets

3.    Howto take XetininXL Tablets

4.    Possible side effects

5.    Howtostore XetininXL Tablets

6.    Further information

1. WHAT XETININ XL TABLETS ARE AND WHAT THEY ARE USED FOR

Xetinin XL 500mg Prolonged Release Tablets (Called Xetinin XL Tablets in this leaflet) contain the active ingredient clarithromycin citrate. Clarithromycin belongs to a group of drugs called macrolide antibiotics which are used in the treatment of:

1.    chest infections such as bronchitis and pneumonia

2.    sinus infection

3.    skin and soft tissue infections (mild to moderate severity)

2. BEFORE YOU TAKE XETININ XL TABLETS

Do not take Xetinin XL Tablets if you

•    are allergic to clarithromycin or other macrolide antibiotics such as erythromycin or azithromycin.

•    are taking the following, you should consult your doctorfor advice on alternative medicines:

.    colchicine (for gout)

. ergotamine or dihydroergotamine tablets or use ergotamine inhalers for migraine . cisapride (for stomach disorders), pimozide (for some mental illnesses), terfenadine and astemizole (for hay fever or allergy) or other macrolide antibiotics, as combining these drugs with clarithromycin can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines.

•    have serious kidney or liver problems, consult your doctor immediately.

•    have or someone in your family is known to have an abnormality of electrocardiogram (ECG) called 'long QT syndrome¹.

Take special care with XETININ XL Tablets

•    if you have liver problems

•    if you have kidney problems

•    If you develop severe or prolonged diarrhoea during or after taking Xetinin XL Tablets

•    If your potassium levels are low (hypokalaemia).

If any of the above apply to you, please tell your doctor immediately.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

•    Digoxin, quinidineordisopyramide(heartdrugs)

•    Warfarin orother drugs to thin the blood

•    Ergotamine, dihydroergotamine or eletriptan (for migraine)

•    Carbamazepine, valproate or phenytoin (drugs for epilepsy)

•    Colchicine (for gout)

•    Theophylline (helps breathing)

•    Terfenadine or astemizole (for hay fever or allergy)

•    Triazolam, alprazolam or midazolam (sedatives)

•    Cilostazol (for poor circulation)

•    Simvastatin or lovastatin (for high cholesterol)

•    Cisapride or omeprazole (for stomach disorders)

•    Itraconazole orfluconazole (forfungal infections)

•    Tolterodine (for overactive bladder)

•    Aprepitant (for preventing vomiting during chemotherapy)

•    Methylprednisolone (a corticosteroid)

•    Vinblastine (for treatment of cancer)

•    Sildenafil, tadalafil or vardenafil (for impotence)

•    Cyclosporin (immune suppressant)

•    Pimozide orziprasidone (for psychiatric conditions)

•    Zidovudine, ritonavir, atazanavir, saquinavir, nevirapine or efavirenz (anti-viral [anti-HIV] drugs)

•    Rifabutin or rifampicin (for treatment of some infections such as tuberculosis)

•    Tacrolimus (fororgan transplants).

Xetinin XL Tablets do not interact with oral contraceptives.

Taking Xetinin XL Tablets with food and drink

The tablets should be taken with food and must be swallowed whole and not chewed.

Pregnancy and breast-feeding

Do not take Xetinin XL Tablets if you are pregnant or breast feeding without consulting your doctor or pharmacist.

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 Xetinin XL Tablets

Xetinin XL Tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact yourdoctor before taking this medicinal product.

3. HOW TO TAKE XETININ XL TABLETS

Always take Xetinin XL Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose in:

Adults and children over 12 years: One (1) 500mg tablet daily for seven (7) to fourteen (14) days. Your doctor may increase the dose to two (2) 500mg tablets daily in severe infections.

Children under 12years: Not recommended.

If you take more Xetinin XL Tablets than you should

Ifyou (or someone else) swallow a lot oftablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.

Ifyou forget to take Xetinin XL Tablets

Take the missed dose as soon as you remember, unless it's nearly time for the next dose. Do not take two doses at the same time to make up forforgotten individual doses.

Ifyou stop taking Xetinin XL Tablets

Do not stop taking Xetinin XL Tablets 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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, clarithromycin can cause side effects, although not everybody gets them.

Very common: Affects more than 1 people in 10.

Common: Affects 1 to 10 people in 100.

Uncommon: Affects 1 to 10 people in 1,000.

Rare: Affects 1 to 10 people in 10,000.

Very rare: Affects less than 1 people in 10,000.

Not known: Frequency cannot be estimated from the available data.

If any of the following happen, stop taking Xetinin XL and tell your doctor immediately or go to your nearest hospital emergency department:

•    Severe pain in the abdomen and back caused by inflammation of the pancreas.

•    Severe diarrhoea with blood in the stools during or after taking Xetinin XL Tablets. Diarrhoea may occur over two months after treatment with Xetinin XL Tablets.

•    Dark urine, pale stools, jaundice (yellowing of the skin and/or eyes), nausea, fever.

•    Allergic reactions including rashes have been reported with Xetinin XL Tablets. In very rare cases, difficulty in breathing, fainting and swelling of the face and throat can occur which may need emergency treatment. Allergic rashes may range in severity from mild itchy skin eruptions to a rarer, more serious condition called Stevens-Johnson syndrome (which may cause ulceration of the mouth, lips and skin) or toxic epidermal necrolysis (which causes severe illness and sloughing of the skin).

•    In the unlikely event that your infection has been caused by a bug which Xetinin XL Tablets cannot treat, your symptoms may get worse.

If this happens, you should consult yourdoctor.

Common side effects (Affects more than 1 people in 10) include;

•    feeling sick

. vomiting . stomach pain . indigestion . diarrhoea

•    headache

•    changes in sense of taste orsmell

Uncommon side effects (Affects 1 to 10 people in 1000) include;

•    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, increased appetite and other nutrition disorders

•    Psychiatric disorders such as depression, difficulty sleeping (insomnia), nervousness and feeling sleepy.

•    Dizziness, headache and tremor.

•    Conjunctivitis (inflammation of the eyes) and visual disturbances.

•    Ringing in the ears, vertigo and eardisorders.

•    Vasodilation (flushing).

•    Asthma, 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, jointormuscle pain.

•    Kidney disorders including the presence of protein and blood in urine, passing urine with pus (if you have a urine test).

•    Genital discharge.

•    Lack of energy, chest pain, swelling of face, a feeling of general discomfort, pain and thirst.

•    If you have a blood test while taking (product name), 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, prothrombin time prolongation (increased blood clotting time) and an increase in other enzymes may also be detected. Changes in laboratory test values such as chloride, uric acid and calcium.

Very rare side effects: (Affects less than 1 people in 10,000) include;

•    Tinglingornumbnessoflimbs

Not known frequency of occurrence (frequency cannot be estimated from the available data) include;

•    Decrease in platelets (blood cells that help you stop bleeding)

•    Low blood sugar levels

•    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

•    Abnormal electric activity tracing of the heart (ECG), changes in heart rhythm

•    Inflammation of the tongue and tooth discolouration

•    Liverfailure, abnormal liverfunction orhepatitis

•    Inflammation of the kidneys and

•    Liver enzymes increased.

Inflammation of the colon (Pseudomembranous colitis) has been reported with nearly all antibacterial medicines including clarithromycin. Its symptoms include diarrhoea after taking clarithromycin. Please inform your doctor immediately if you sufferfrom diarrhoea.

Clarithromycin may worsen the symptoms of myasthenia gravis (a condition in which the muscles become weak and tire easily) in patients who already sufferfrom this condition.

5. HOWTOSTOREXETININXLTABLETS

This medicinal product does not require any special storage conditions.

Keep out of the reach and sight of children.

Do not use Xetinin XL Tablets after the expiry date which is stated on the carton. 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

WhatXetininXLTablets contain

The active substance is clarithromycin citrate. Each prolonged-release tablet contains clarithromycin citrate equivalentto clarithromycin 500mg.

The other ingredients in the tablet core are Lactose Monohydrate, Hypromellose, Hypromellose Phthalate, Talc, Magnesium Stearate. The tablet coating contains Hypromellose, Macrogol, Quinoline Yellow Aluminium Lake (E104), Talc and Titanium Dioxide (E171)

What Xetinin XL Tablets looks like and contents of the pack

Xetinin XL Tablets are yellow coloured, film coated, oblong shaped, biconvex tablets, with both sides plain.

They are available in blister packs of 7,10,14, 20, 28, 30, 56, 60,84,90,100 and 112 film coated tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Morningside Healthcare Ltd 115 Narborough Road, Leicester LE3 0PA, United Kingdom

Manufacturer

Morningside Pharmaceuticals Ltd Pavilion Way, Loughborough,

LE11 5GW, United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

UK: Xetinin XL IE: CloromXL

This leafletwas last approved in 02/2011