Informations for option: Targaxan 550 Mg Film-Coated Tablets, show other option

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What is in this leaflet:

1.    What Targaxan is and what it is used for

2.    What you need to know before you take Targaxan

3.    How to take Targaxan

4.    Possible side effects

5.    How to store Targaxan

6.    Contents of the pack and other information

Targaxan contains the active substance - rifaximin. Targaxan is an antibiotic that destroys bacteria, which can cause a disease called hepatic encephalopathy (symptoms include agitation, confusion, muscle problems, difficulty in speaking and in some cases coma).

Targaxan is used in adults with liver disease to reduce the recurrence of episodes of overt hepatic encephalopathy.

Targaxan can either be used alone or more commonly together with medicines containing lactulose (a laxative).

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

The recommended dose is 1 tablet twice a day taken with a glass of water. Your doctor will assess the need for you to continue treatment after 6 months.

If you take more Targaxan than you should

If you take more than the recommended number of tablets, even if you do not notice any problems, please contact your doctor.

If you forget to take Targaxan

Take the next dose at its normal time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Targaxan

Do not stop taking Targaxan without talking to your doctor first because your symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Stop taking Targaxan and tell your doctor IMMEDIATELY if you have any of the following side effects:

•    If you get an allergic reaction, hypersensitivity or angioedema. Frequency is not known (cannot be estimated from the available data). Symptoms include:

-    swelling of the face, tongue or throat

-    swallowing difficulties ^w

-    hives and breathing difficulties.

•    If you have bleeding from swollen blood vessels in your throat (oesophageal varices). This is uncommon (may affect up to 1 in 100 people).

•    If you have severe diarrhoea during or after using this medicine. This may be due to an infection of the intestine. This is uncommon (may affect up to 1 in 100 people).

•    If you have any unexpected or unusual bleeding or bruising. This may be due to a decrease in the platelets in your blood which increases the risk of bleeding. Frequency is not known (cannot be estimated from the available data).

Other side effects that may occur Common (may affect up to 1 in 10 people):

•    Stomach ache or bloating/swelling

•    Dizziness

•    Depressed mood

•    Headache

•    Feeling or being sick

•    Diarrhoea

•    Accumulation of fluid in the abdominal cavity

•    Shortness of breath

•    Muscle cramps

•    Joint pain

•    Swelling of ankles, feet or fingers

•    Rash or itching

Uncommon (may affect up to 1 in

100 people):

•    Feeling unsteady

•    Loss of or poor memory

•    Loss of concentration

•    Confusion

•    Anxiety

•    Feeling sleepy

•    Difficulty sleeping

•    Dry mouth

•    Hot flushes

•    Yeast infections (such as thrush)

•    Urinary infection (such as cystitis)

•    Anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)

•    Loss of appetite

•    Hyperkalaemia (high level of potassium in the blood)

•    Needing to pass urine more often than usual

•    Difficulty or pain passing urine

•    Convulsions (fits)

•    Fever

•    Reduced sense of touch

•    Falls

•    Fluid around the lungs

•    Oedema (swelling due to too much fluid in the body)

•    Muscle pain

Rare (may affect up to 1 in 1,000 people):

•    Bruising

•    Protein in the urine

•    Chest infections including pneumonia

•    Cellulitis (inflammation of tissue under skin)

•    Upper respiratory tract infections (nose, mouth, throat)

•    Rhinitis (inflammation inside the nose)

•    Dehydration (body water loss)

•    Changes in blood pressure

•    Constant breathing problems (such as chronic bronchitis)

•    Feeling weak

•    Pain following surgery

•    Constipation

•    Back pain

Not known (frequency cannot be estimated from the available data):

•    Fainting or feeling faint

•    Skin irritation, eczema (itchy, red, dry skin)

•    Changes in the way the liver is working (seen in blood test)

•    Changes jn blood coagulation (International Normalised Ratio seen in blood test)

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month. Targaxan does not require any special storage conditions.

Do not throw away any medicine 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.

What Targaxan contains

The active substance is rifaximin. Each tablet contains 550 mg rifaximin.

The other ingredients are:

-    Tablet core: sodium starch glycolate (Type A), glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose.

-    Tablet coat (opadry oy-s-34907): hypromellose, titanium dioxide (E171), disodium edetate, propylene glycol, red iron oxide (E172).

What Targaxan looks like and contents of the pack

Pink oval curved film-coated tablets marked with “RX” on one side. Targaxan is available in cartons of 14, 28, 42, 56 and 98 tablets.

Not all pack-sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder (UK):

Norgine Pharmaceuticals Ltd.

Norgine House - Widewater Place -Moorhall Road - Harefield - Middlesex UB9 6NS - United Kingdom

Marketing Authorisation Holder (IE):

Norgine Limited

Norgine House - Widewater Place -Moorhall Road - Harefield - Middlesex UB9 6NS - United Kingdom

Manufacturer:

Alfa Wassermann S.p.A.

Via E. Fermi, 1 - 65020 Alanno (PE), ITALY This leaflet was last revised in 10/2012.

Targaxan is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies. Product under licence from Alfa Wassermann S.p.A.

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

TARGAXAN®: Belgium, Finland, Ireland, Luxembourg, United Kingdom

XIFAXAN®: Denmark, Germany, Netherlands, Norway, Sweden.

NORGINE    o