Tuesday, October 25, 2016

Metronidazole Tablets 500mg






Metronidazole tablets 500mg




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 to others. It may harm them, even if their symptoms are the same as yours.



Index



  • 1 What Metronidazole tablets are and what they are used for


  • 2 Before you take


  • 3 How to take


  • 4 Possible side effects


  • 5 How to store


  • 6 Further information




What Metronidazole tablets are and what they are used for


Metronidazole tablets belong to a group of medicines called anti-infective agents. They may be used to treat:


  • infections, caused by bacteria of the blood, brain, bone, lung, stomach lining and pelvic area, following childbirth or in a wound following an operation

  • urinary or genital infections caused by a parasite, Trichomonas

  • genital infection in women caused by bacteria

  • the parasitic diseases amoebiasis

  • the disease giardiasis

  • gum and teeth infections

  • infected leg ulcers or pressure sores

  • stomach ulcers caused by Helicobacter pylori.

  • or prevent infections occurring after operations.



Before you take



Do not take Metronidazole tablets and tell your doctor if you:


  • are allergic (hypersensitive) to Metronidazole tablets or any of the other ingredients (see section 6)

  • are in the first 3 months of pregnancy or are breastfeeding.


Check with your doctor or pharmacist before taking Metronidazole tablets if you:


  • have kidney disease, particularly if you require dialysis treatments

  • have ever suffered from any liver disease

  • are in the 4th-9th month of pregnancy

  • have epilepsy or have ever had fits

  • have porphyria (a genetic disease that can cause skin blisters, abdominal pain and brain/nervous system disorders)

  • have any disorder of the blood and/or blood cells

  • have any nervous system disorders

  • have been exposed to any sexually transmitted disease.


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.


Especially:


  • medicines to stop the blood clotting such as warfarin

  • lithium (used to treat depression)

  • medicines to treat epilepsy such as phenobarbital, phenytoin, primidone

  • disulfiram (to treat alcohol addiction)

  • ciclosporin (used following organ transplants)

  • fluorouracil (used to treat some forms of cancer)

  • cimetidine (used to treat stomach ulcers)

  • oestrogen contraceptives (‘the pill’).



Pregnancy and breastfeeding


Metronidazole tablets must not be taken during the first 3 months of pregnancy and should not be taken during the rest of the pregnancy.


If you breastfeed you should stop whilst taking Metronidazole tablets and for 12-24 hours after the course of tablets has finished before breastfeeding again.


Ask your doctor or pharmacist for advice before taking this medicine.




Driving and using machines


Metronidazole tablets may make you feel drowsy, dizzy, confused or affect your vision, cause fits or hallucinations. Make sure you are not affected before you drive, operate machinery or take part in any activities where these may put you or others at risk.




Sugar intolerance


If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a sugar called lactose.




Tests


If you are taking this medicine for more than 10 days, your doctor may wish to carry out further tests.


If you need any blood or urine tests, tell your doctor you are taking Metronidazole tablets before the test.





How to take


Always take Metronidazole tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.


You are advised not to drink alcohol whilst taking this medicine and for 48 hours after finishing the course of tablets, as this might cause unpleasant side-effects, such as feeling or being sick, stomach pain, hot flushes, palpitations and headache.


Swallow the tablets whole, during or after meals, with a glass of water. Do not chew them.



Doses:



  • Treatment of bacterial infections


    Adults and children over 10 years: 500mg eight hourly. Treatment is usually for 7 days but will depend upon your condition.


  • Treatment of infection caused by Trichomonas


    Adults and children over 10 years: 2g as a single dose for 1 day or 250mg twice a day for 6 days. In severe cases 500mg twice a day for 6 days. Your partner should also be treated.


  • Treatment of non-specific genital infection in women



    Women and girls over 10 years: 500mg twice a day for 7 days, or 2g as a single dose for 1 day only.


  • Treatment of amoebiasis

    Affecting the gut


    Adults and children over 10 years: 750mg three times a day for 5 days.

    Children 7-10 years: 500mg three times a day for 5 days.
    Affecting the gut, liver (treat for 5-10 days) or other part of the body (for 5 days)

    Adults and children over 10 years: 500mg three times a day.

    Children 7-10 years: 250mg three times a day.
    Asymptomatic carriers (cyst passers) treat for 5-10 days


    Adults and children over 10 years: 500-750mg three times a day.

    Children 7-10 years: 250-500mg three times a day.


  • Treatment of giardiasis


    Adults and children over 10 years: 2g once a day for 3 days or 500mg twice a day for 7 to 10 days Children 7-10 years: 1g once a day for 3 days or 250mg once a day for 10 days


  • Treatment of infections of the gums (for 3 days) or teeth (for 3-7 days)


    Adults and children over 10 years: 250mg three times a day.


  • Treatment of infected leg ulcers or pressure sores (for 7 days)


    Adults and children over 10 years: 500mg three times a day


  • Treatment of stomach ulcers caused by Helicobacter pylori


    To be taken as directed by your doctor as part of a course with two other medicines.


  • Prevention of infections after surgery


    Adults and children over 10 years: 1g as a single dose 24 hours before surgery then, 500mg at 8 hourly intervals during the 24 hours before the operation.

If you are elderly or have liver disease, it is particularly important to take this medicine exactly as directed by the doctor.




If you take more than you should


If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include feeling or being sick, loss of appetite, diarrhoea, metallic taste, headache, dizziness, insomnia or drowsiness.




If you forget to take the tablets


Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.




If you stop taking the tablets


If you stop taking the tablets your infection may come back. Talk to your doctor before you stop taking the tablets and follow their advice.





Possible side effects


Like all medicines, Metronidazole tablets can cause side effects, particularly when you first start taking it, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.



Contact your doctor at once if you notice any of the following side effects:



  • Allergic reactions: skin rash, which may be itchy, swelling of the face, lips, tongue or throat, fever or difficulty in breathing.


Tell your doctor if you notice any of the following side effects or notice any other effects not listed:



  • Blood: your medicine may alter the numbers and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats or infections, you should tell your doctor who might want you to have a blood test.


  • Nervous system: drowsiness, dizziness, headache, poor co-ordination or muscle control, hallucinations, double vision, short sightedness, confusion, depression, ‘pins and needles’, fits, numbness, tingling, pain or a feeling of weakness in the arms or legs.


  • Stomach and intestines: unpleasant taste in the mouth, furred tongue, taste disorders, mouth ulcers, feeling or being sick, loss of appetite, diarrhoea, stomach pain and upset stomach.


  • Liver and bile ducts: jaundice (yellowing of the skin or whites of the eyes), inflammation of the pancreas (pancreatitis causing very severe abdominal pains), changes in liver function tests.


  • Skin: skin rashes, itching, small pus-containing blisters, erythema multiforme (circular, irregular red
    patches).


  • Muscles and bones: muscle and joint pain.


  • Kidneys and urinary system: darkening of the urine.

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.




How to store


Keep out of the reach and sight of children.


Store below 25°C protect from light.


Do not use Metronidazole tablets after the expiry date stated on the label/carton/bottle. 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.




Further information



What Metronidazole tablets contain


  • The active substance (the ingredient that makes the tablets work) is metronidazole.

  • The other ingredients are carmellose sodium, lactose, povidone, magnesium stearate, maize starch, microcrystalline cellulose, methylhydroxypropylcellulose (E464), macrogol 400 and titanium dioxide (E171).



What Metronidazole tablets look like and contents of the pack


Metronidazole are white, film-coated tablets.


Pack sizes are 21 tablets




Marketing Authorisation Holder



Actavis Group PTC ehf

Reykjavikurvegi 76-78

Hafnarfjordur

Iceland




Manufacturer



Balkanpharma-Dupnitsa AD

3, Samokovsko shosse Str.

2600 Dupnitsa

Bulgaria




Distibutor



Actavis

Barnstaple

EX32 8NS

UK




Date of last revision: March 2010




Actavis

Barnstaple

EX32 8NS

UK


L18778JAK-30






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