PATIENT

INFORMATION

Clarithromycin

500mg/vial

Lyophilisate for Solution for Infusion¹

*For easier reading the product is called "Clarithromycin 500mg/vial" in the rest of this leaflet.

-    Keep this leaflet. You may need to read it again.

-    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

-    If you have any further questions, ask your doctor or nurse.

1.    What Clarithromycin 500mg/vial is and what it is used for

2.    Before you are given Clarithromycin 500mg/vial

3.    How Clarithromycin 500mg/vial is given

4.    Possible side effects

5.    How Clarithromycin 500mg/vial is stored

6.    Further information

Clarithromycin 500mg/vial contains clarithromycin. Clarithromycin belongs to a group of drugs called macrolides and is an antibiotic which stops the growth of many types of “bugs” that cause infections.

Clarithromycin 500mg/vial may be used to treat:

•    Chest infections such as bronchitis and pneumonia.

•    Throat and sinus infections.

•    Skin and soft tissue infections.

2. Before you are given Clarithromycin 500mg/vial

Do not take Clarithromycin 500mg/vial

if you are;

•    Allergic to clarithromycin or other macrolide antibiotics such as erythromycin or azithromycin,

or if you are allergic to any of the other ingredients listed in section 6, Further information.

•    Taking any medicines for headaches containing ergotamine or dihydroergotamine, since taking these medicines with Clarithromycin may cause your blood vessels to narrow.

•    Taking any medicines containing;

-    pimozide (a drug for psychiatric conditions).

-    cisapride (a drug for stomach disorders).

-    terfenadine or astemizole (drugs for hay fever or allergy).

Taking these medicines with

Clarithromycin 500mg/vial can

sometimes cause serious changes

in the rhythm of your heart.

•    Suffering from certain forms of irregular heartbeat, or abnormal levels of potassium in your blood.

•    Taking drugs to lower your cholesterol level ('Statins' or HMG-CoA reductase inhibitors) such as simvastatin, lovastatin or atorvastatin, as this can cause muscle breakdown leading to kidney problems.

•    Suffering from severe liver failure with kidney problems.

Take special care with Clarithromycin

500mg/vial and tell your doctor if;

•    You experience any symptoms of allergic reaction such as breathing difficulties, dizziness, swelling of the face or throat,

or blistering of the skin. Stop taking clarithromycin immediately and consult your doctor if you experience any of these symptoms.

•    You have any liver or kidney problems.

•    You have been given Clarithromycin 500mg/vial for a long period of time or on

a regular basis, as this may allow resistant “bugs” to grow.

•    You are taking colchicine, a drug used to treat gout.

•    You are sensitive to or have suffered a reaction to other macrolide antibiotics, clindamycin or lincomycin.

•    Suffer from diarrhoea while taking clarithromycin, as this may be a sign of bacterial infection.

•    Notice worsening muscle weakness/tiredness.

•    Suffer from heart or blood vessel disease, abnormally slow heartbeat, abnormal heart rhythm, abnormal levels of potassium or magnesium in your blood, or you are taking other medicines that affect your heart rhythm.

Taking other medicines:

You should tell your doctor or nurse if you are taking, or have recently taken, any of the following medicines as they may interact with Clarithromycin 500mg/vial:

•    Any other antimicrobial, antibiotic, lincomycin or clindamycin.

•    Any medicine from a group known as 'aminoglycosides' for example streptomycin or neomycin, or any drug known to cause hearing or balance problems. These functions should be monitored during and after treatment with clarithromycin.

•    Digoxin, quinidine, disopyramide or verapamil (drugs for the heart).

•    Warfarin or other drugs to thin the blood.

•    Carbamazepine, valproate or phenytoin (drugs for epilepsy).

•    Theophylline (a drug to help breathing).

•    Triazolam, alprazolam or midazolam (drugs to help you sleep).

•    Cilostazol (drugs for poor circulation).

•    Simvastatin, lovastatin, atorvastatin, rosuvastatin or cerivastatin (drugs for high cholesterol).

•    Methylprednisolone (a corticosteroid). ¹

•    Sildenafil, tadalafil or vardenafil (drugs for impotence).

•    Cyclosporin, tacrolimus or sirolimus (drugs that affect your immune system).

•    Zidovudine (an anti-viral drug).

•    Rifabutin (a drug for treatment of some infections).

•    Tacrolimus (a drug taken to prevent rejection of organ transplants).

•    Colchicine (a drug for gout).

•    Ritanovir, atazanavir or saquinavir (drugs for the treatment of HIV).

•    Insulin or other drugs for diabetes taken by mouth, such as nateglinide, pioglitazone, repaglinide or rosiglitazone.

•    Tolterodine (a drug for urinary incontinence).

•    Efavirenz, nevirapine, rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort. The way these drugs work may make clarithromycin less effective.

•    Omeprazole (for stomach problems) and Pimozide (for psychosis). Clarithromycin may affect the way these drugs work.

•    Itraconazole (for fungal infections) as this may affect or be affected by clarithromycin.

Clarithromycin 500mg/vial does not interfere with the effect of oral contraceptives.

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

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Your doctor or nurse may need to test you before starting treatment with Clarithromycin 500mg/vial, because certain infections are resistant to this type of antibiotic.

Pregnancy and breast-feeding:

If you think you are pregnant, likely to become pregnant or are breast feeding, you must tell your doctor or nurse before being given this medicine.

Driving and using machines:

Clarithromycin 500mg/vial may affect your ability to drive or operate machines if you experience any side-effects such as dizziness, vertigo, confusion or disorientation.

3. How Clarithromycin 500mg/vial is given

Clarithromycin 500mg/vial will be prepared by your doctor or nurse.

It will be given to you by infusion into one of your veins (like a blood transfusion) over a period of at least one hour.

Adults, the elderly, and children older than 12 years:

The usual dose of Clarithromycin 500mg/vial is 500 mg (1 vial) taken twice a day for a period of 2 to 5 days. Your doctor or nurse will work out the correct dose for you.

If you suffer from weak or damaged kidneys then your dose should be reduced to half of the normal adult recommended dose.

Children:

Not recommended for children younger than 12 years.

Like all medicines, Clarithromycin 500mg/vial can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after receiving Clarithromycin 500mg/vial, you should contact your doctor immediately;

•    Any sudden wheeziness, difficulty in breathing, swelling of the face, eyelids, lips or throat.

•    Peeling and blistering of the skin, mouth and lips.

The most common side effects with Clarithromycin 500mg/vial are:

•    Swelling of the vein, causing inflammation, pain or tenderness at the point of infusion (affects more than 1 in 10 patients).

Common side effects

(affects fewer than 1 in 10 patients):

•    ‘Thrush’ in mouth

•    Difficulty sleeping

•    Changes in taste

•    Fleadache

•    Changes in smell

•    Widening of blood vessels

•    Severe or prolonged diarrhoea

•    Being sick

•    Indigestion

•    Feeling sick

•    Abdominal pain

•    Abnormal liver function tests

•    Rash

•    Excessive sweating

•    Pain, swelling or tenderness at the site of the infusion.

Uncommon side effects

(affects fewer than 1 in 100 patients):

•    Swelling under the skin

•    Infections

•    Stomach irritation

•    Vaginal infections

•    Low levels of white cells that fight infection

•    Low levels of cells that help blood clot (which may result in bruising)

•    Other abnormal blood tests

•    Allergic reactions including breathing difficulties, swelling

of the face, skin rashes, possibly severe

•    Loss of appetite, possibly severe

•    Anxiety or nervousness

•    Screaming

•    Loss of consciousness

•    Uncontrolled muscle movements or shaking

•    Dizziness

•    Feeling sleepy

•    Abnormal feeling of movement (Vertigo)

•    Hearing problems

•    ‘Ringing’ sound in the ears

•    Heart attack

•    Changes in heart rhythm

•    Irregular heart beat

•    Asthma

•    Breathing difficulties

•    Nosebleeds

•    Blood clot signified by chest pain, breathing problems, fainting, changes to heart rate, lips or extremities turning blue

•    Irritation of the gullet

•    Heartburn and swallowing difficulties (Reflux)

•    Irritation of the stomach

•    Sudden sharp pain in the rectal area

•    Inflammation of the mouth or tongue

•    Tooth or tongue discolouration

•    Swollen belly

•    Constipation

•    Dry mouth

•    Increased belching or wind

•    Liver dysfunction or irritation

•    Abnormal levels of certain enzymes

•    Blistering of the skin

•    Hives

•    Itchy rashes including swellings on the skin

•    Muscle spasms

•    Joint pain

•    Muscle pain

•    Abnormal kidney tests

•    Loss of bearing

•    Fever

•    Muscle weakness

•    Chest pain

•    Chills

•    Tiredness

•    Abnormal blood tests

•    Abnormal liver function tests.

Rare side effects (affects fewer than 1 in 1,000 patients)

•    Inflammation of the eye, especially if also taking rifabutin (reversible).

Very rare side effects (affects fewer than 1 in 10,000 patients):

•    ‘Pins and needles’ (only if Clarithromycin is taken by mouth).

Frequency not known:

•    Irritation or swelling of the bowel

•    Swelling of the skin and nearby tissues (erysipelas)

•    Contagious skin condition affecting warm moist areas of the body (erythrasma)

•    Fever with swollen neck, sore throat and occasionally ulcers (agranulocytosis)

•    Blood changes (low platelet count)

•    Allergic skin rashes

•    Serious allergic reaction (anaphylaxis) including breathing difficulty, swelling of the face, eyelids, lips or throat

•    Low blood sugar level

•    Loss of contact with reality

•    Confusion

•    Loss of sense of identity

•    Depression

•    Disorientation

•    Seeing or hearing things

•    Abnormal dreams or nightmares

•    Fits (convulsions)

•    Abnormal sense of smell

•    Loss of the sense of taste or smell

•    Hearing loss, which usually gets better when treatment stops

•    Changes in heart rhythm

•    Faster than normal heartbeat

•    Abnormal bleeding

•    Inflammation of the pancreas

•    Tooth or tongue discolouration (reversible)

•    Liver failure resulting in death

•    Yellowing of the skin and/or white of the eyes

•    Severe lesions in the skin, including mouth, nose, gullet, genital area, and inside of eyelids (Stevens-Johnson syndrome)

•    Reddening of the skin followed by extensive peeling

•    Allergic skin disease with patches of swelling beneath the skin (Angioedema)

•    Drug reaction involving rashes, fever and irritation to certain internal organs (DRESS)

•    Spots (Acne)

•    Muscle weakness, pain or swelling which can lead to breakdown of the muscle

•    Kidney failure

•    Kidney problems

•    Abnormal urine colour

•    Abnormal blood or liver function tests.

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 nurse.

5. How Clarithromycin 500mg/vial is stored

The hospital will ensure that Clarithromycin 500mg/vial is stored correctly and that it is not used after the expiry date stated on the vial label and carton.

6. Further information

What Clarithromycin 500mg/vial contains:

Each vial of Clarithromycin 500mg/vial contains:

Active ingredient:

500mg of sterile clarithromycin as the active ingredient, which provides approximately 2mg/ml of clarithromycin when reconstituted as recommended.

Other ingredients:

Lactobionic acid and sodium hydroxide.

What Clarithromycin 500mg/vial looks like:

Clarithromycin 500mg/vial Lyophilisate for Solution for Infusion is a white/almost white sterile freeze-dried powder in a glass vial.

Marketing Authorisation Holder and Manufacturer:

Britannia Pharmaceuticals Ltd, ParkView House, 65 London Road, Newbury, Berkshire RG14 1JN, UK.

Marketing authorisation number:

PL 04483/0063

If you have any questions about your treatment with Clarithromycin 500mg/vial which are not answered by this leaflet, please ask your doctor or nurse.

This leaflet was last approved in:

August 2011.

^Britannia

U K002    Pharmaceuticals Limited

1

   Vinblastine (a drug for the treatment of cancer).