Linezolid Hetero Europe 600 mg filmomhulde tabletten

Linezolid Hetero Europe is an antibiotic of the oxazolidinones group that works by stopping the growth of certain bacteria (germs) that cause infections. It is used to treat pneumonia and some infections in the skin or under the skin. Your doctor will have decided if Linezolid Hetero Europe is suitable to treat your infection.

Do not take Linezolid Hetero Europe:

• if you are allergic to linezolid or any of the other ingredients of this medicine (listed in section 6)
• if you are taking or have taken within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs for example phenelzine, isocarboxazid, selegiline, moclobemide). These may be used to treat depression or Parkinson’s disease.
• if you are breastfeeding. This is because it passes into breast milk and could affect the baby.

Linezolid Hetero Europe may not be suitable for you if you answer yes to any of the following questions. In this case tell your doctor as he/she will need to check your general health and your blood pressure before and during your treatment, or may decide that another treatment is better for you.

Ask your doctor if you are not sure whether these categories apply to you.

• Do you have high blood pressure?
• Have you been diagnosed with an overactive thyroid?
• Do you have a tumour of the adrenal glands (phaeochromocytoma) or carcinoid syndrome (caused by tumours of the hormone system with symptoms of diarrhoea, flushing of the skin, wheezing )?
• Do you suffer from manic depression, schizoaffective disorder, mental confusion or other mental problems?
• Are you taking any of the following medicines?

-decongestant cold or flu remedies containing pseudoephedrine or phenylpropanolamine -medicines used to treat asthma such as salbutamol, terbutaline, fenoterol

-antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors) for example amitriptyline, cipramil, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine; sertraline

-medicines used to treat migraine such as sumatriptan and zolmitriptan

-medicines used to treat sudden, severe allergic reactions such as adrenaline (epinephrine)

-medicines which increase your blood pressure, such as noradrenaline (norepinephrine),dopamine and dobutamine

• medicines used to treat moderate to severe pain, such as pethidine
• medicines used to treat anxiety disorders, such as buspirone
• an antibiotic called rifampicin

Warnings and precautions

Talk to you doctor, pharmacist or nurse before taking Linezolid Hetero Europe if you

• bruise and bleed easily
• are anaemic
• are prone to getting infections
• have a history of seizures
• have liver problems or kidney problems particularly if you have dialysis
• have diarrhoea

Tell your doctor immediately if during treatment you suffer from

• problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
• You may develop diarrhoea while taking or after taking antibiotics, including Linezolid Hetero Europe. If this becomes severe or persistent or you notice that your stools contains blood or mucus, you should stop taking Linezolid Hetero Europe immediately and consult your doctor. In this situation, you should not take medicines that stop or slow bowel movement.
• recurrent nausea or vomiting, abdominal pain or over breathing

Other medicines and Linezolid Hetero Europe

There is a risk that Linezolid Hetero Europe may sometimes interact with certain other medicines to cause side effects such as changes in blood pressure, temperature or heart rate

Tell your doctor if you are taking or have taken within the last 2 weeks the following medicines as Linezolid Hetero Europe must not be taken if you are already taking these medicines or have taken them recently. (See also Section 2 above ‘What you need to know before you take Linezolid Hetero Europe’.

• monoamine oxidase inhibitors ( MAOIs for example phenelzine, isocarboxazid, selegiline, moclobemide). These may be used to treat depression or Parkinson’s disease

Also tell your doctor if you are taking the following medicines. Your doctor may still decide to give you Linezolid Hetero Europe, but will need to check your general health and your blood pressure before and during your treatment. In other cases, your doctor may decide that another treatment is better for you.

• Decongestant cold or flu remedies containing pseudoephedrine or phenylpropanolamine.
• Some medicines used to treat asthma such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many of these, including amitriptyline, cipramil, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline.
• Medicines used to treat migraine such as sumatriptan and zolmitriptan.
• Medicines used to treat sudden, severe allergic reactions such as adrenaline (epinephrine).

• Medicines which increase your blood pressure, such as noradrenaline (norepinephrine) dopamine and dobutamine.
• Medicines used to treat moderate to severe pain, such as pethidine.
• Medicines used to treat anxiety disorders, such as buspirone.
• Medicines that stop blood clotting, such as warfarin.

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

Linezolid Hetero Europe with food and drink

• You can take Linezolid Hetero Europe either before, during or after a meal.
• Avoid eating large amounts of mature cheese, yeast extracts, or soya bean extracts e.g. soy sauce and drinking alcohol, especially draught beers and wine. This is because this medicine may react with a substance called tyramine which is naturally present in some foods to cause an increase in your blood pressure.
• If you develop a throbbing headache after eating or drinking, tell your doctor or pharmacist immediately.

Pregnancy and breast-feeding

The effect of Linezolid Hetero Europe in pregnant women is not known. Therefore it should not be taken in pregnancy unless advised by your doctor. Tell your doctor if you are pregnant, think you may be pregnant or are trying to become pregnant.

You should not breastfeed when taking Linezolid Hetero Europe because it passes into breast milk and could affect the baby.

Driving and using machines

Linezolid Hetero Europe may make you feel dizzy or experience problems with your vision. If this happens, do not drive or operate any machinery. Remember that if you are unwell your ability to drive or operate machinery may be affected.

Linezolid Hetero Europe contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Use in adults

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. The usual dose is one tablet (600mg linezolid) twice daily (every twelve hours). Swallow the tablet whole with some water.

If you are on kidney dialysis, you should take Linezolid Hetero Europe after dialysis.

A course of treatment usually lasts 10 to 14 days but can last up to 28 days. The safety and effectiveness of this medicine have not been established for treatment periods longer than 28 days. Your doctor will decide how long you should be treated.

While you are taking Linezolid Hetero Europe, your doctor should perform regular blood tests to monitor your blood count.

Your doctor should monitor your eyesight if you take Linezolid Hetero Europe for more than 28 days.

Use in children

Linezolid Hetero Europe is not normally used to treat children and adolescents (under 18 years old).

If you take more Linezolid Hetero Europe than you should

Tell your doctor or pharmacist immediately.

If you forget to take Linezolid Hetero Europe

Take the forgotten tablet as soon as you remember. Take the next tablet 12 hours after this and continue taking your tablets every 12 hours. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Linezolid Hetero Europe

Unless your doctor instructs you to stop treatment, it is important to continue taking Linezolid Hetero Europe. If you stop and your original symptoms come back tell your doctor or pharmacist immediately.

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

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

Tell your doctor, nurse or pharmacist immediately if you notice any of these side effects during your treatment with Linezolid Hetero Europe:

• skin reactions such as red sore skin and flaking (dermatitis), rash, itching, or swelling, particularly around the face and neck. This may be the sign of an allergic reaction and it may be necessary for you to stop taking Linezolid Hetero Europe.
• problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
• severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including pseudomembranous colitis), which in very rare circumstances may develop into complications that are life-threatening.
• recurrent nausea or vomiting, abdominal pain or over breathing.
• fits or seizures have been reported with Linezolid Hetero Europe. You should let your doctor know if you experience agitation, confusion, delirium, rigidity, tremor, incoordination and seizure while also taking antidepressants known as SSRI’s (see section 2).

Numbness, tingling or blurred vision have been reported by patients who have been given Linezolid Hetero Europe for more than 28 days. If you experience difficulties with your vision you should consult your doctor as soon as possible.

Other side effects include:

Common side-effects (likely to occur in less than 1 in 10 people) :

• Fungal infections especially vaginal or oral “thrush”
• Headache

• Metallic taste in the mouth
• Diarrhoea, nausea or vomiting
• Changes in some blood test results including those measuring your kidney or liver function or blood sugar levels
• Unexplained bleeding or bruising, which may be due to changes in the numbers of certain cells in the blood which may affect blood clotting or lead to anaemia

Uncommon side-effects (likely to occur in less than 1 in 100 people) :

• Inflammation of the vagina or genital area in women
• Changes in numbers of certain cells in the blood which may affect your ability to fight infection
• Difficulty in sleeping
• Dizziness, sensations such as tingling or feeling numb
• Blurred vision
• “Ringing” in the ears (tinnitus)
• Increased blood pressure, inflammation of the veins
• Indigestion, stomach pain, constipation
• Dry or sore mouth , swollen, sore, or discoloured tongue
• Skin rash
• A need to urinate more often
• Fever or chills, aches and pains
• Feeling tired or thirsty
• Inflammation of the pancreas
• Increased sweating
• Changes in proteins, salts or enzymes in the blood which measure kidney or liver function.
• Reduction in the numbers of cells in the blood which fight against infection.

Rare side-effects (likely to occur in less than 1 in 1000 people) :

• Changes in heart rate (eg, increase rate)
• Transient ischaemic attacks (temporary disturbance of blood flow to the brain causing short term symptoms such as loss of vision, leg and arm weakness, slurring of speech and loss of consciousness),
• Kidney failure

The following side effects have also been reported frequency not known):

• Serotonin syndrome (symptoms include fast heart rate, confusion, abnormal sweating, hallucinations, involuntary movements chills and shivering)
• Lactic acidosis (symptoms include recurrent nausea and vomiting, abdominal pain, overbreathing)
• Severe skin disorders
• Convulsions
• Superficial tooth discolouration, removable with professional dental cleaning (manual descaling)
• Alopecia (hair loss)
• Hyponatraemia (low blood sodium levels)
• Changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted

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

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

Store below 30ºC.

Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. The measures will help protect the environment.

What Linezolid Hetero Europe contains

-The active substance in this medicine is called linezolid. Each tablet contains 600 mg linezolid

-The other ingredients are lactose monohydrate, hypromellose (E464), polacrilin potassium, magnesium stearate (E572) and silica colloidal anhydrous. The film coating contains hypromellose (E464), titanium dioxide (E171), macrogol and carnauba wax (E903).

What Linezolid Hetero Europe filmomhulde tabletten looks like and contents of the pack

Linezolid Hetero Europe 600 mg Film-coated Tablets are white to off white, oval shaped tablets debossed with

“I” on one side and “22” on the other side.

Linezolid Hetero Europe tablets are available in pack sizes of 10 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Hetero Europe S.L.

Viladecans Business Park – Edificio Brasil

Catalunya 83-85

08840 Viladecans (Barcelona)

Spanje

Manufacturer

Pharmadox Healthcare Ltd.

KW 20A Corradino lndustrial Estate

Paola PLA 3000

Malta

In het Register ingeschreven onder:

RVG 112420

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

Deze bijsluiter is voor het laatst goedgekeurd in september 2013