Mac Eradera

Bismuth Subcitrate Potassium 140 mg,
Metronidazole 125 mg, Tetracycline HCI 125 mg

Composition

Each capsule contains :
Bismuth subcitrate potassium ….. 140mg
Metronidazole ….. 125mg
Tetracycline hydrochloride 125mg

Pharmaceutical Form : Capsules

Read all of this leaflet carefully before you start taking Mac Eradera.

– Keep this leaflet. You may need to read It again.
– If you have any further questions, please ask your doctor or pharmacist.
– This medicine has been prescribed for you. Do not pass iton to others. It may harm them, even If thelr 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 Mac Eradera is and what it is used for
2. Before you take Mac Eradera
3. How to take Mac Eradera
4. Possible side effects
5. How ta store Mac Eradera
6. Further information

  • 1. WHAT MAC ERADERA IS AND WHAT IT IS USED FOR

    Mac Eradera contains a group of medicines used to treat adult patients infected with Helicobacter pylori (H.
    pylori) who have or have had an ulcer. H. pylori is a bacteria found in the stomach lining.
    Mac Eradera contains 3 different active ingredients: bismuth subcitrate potassium, metronidazole and
    tetracycline hydrochloride. Tetracycline and metronidazole belong to a group of medicines called antibiotics.
    Bismuth subcitrate potassium helps the antibiotics treat the infection.
    Mac Eradera should be taken together with a medicine called omeprazole. Omeprazole is a medicine that
    works by reducing the amount of acid that your stomach produces. Mac Eradera, taken with omeprazole works
    together to treat the infection and reduce the inflammation of the stomach lining.

  • 2. BEFORE YOU TAKE MAC ERAOERA

    Do not take Mac Eradera

    • if youare allergic (hypersensitive) to bismuth subcitrate potassium, metronidazole or other
      nitroimidazole derivatives, tetracycline or any of the other ingredients in Mac Eradera (listed in
      Section 6: Further information)

    • if you are pregnant or breast-feeding

    • if you are less than 12yearsof age

    • if yousuffer from kidney problems

    • if yousuffer from liver problems

      • Take special care with MacEradera

    • if you have to go for an x-ray as Mac Eradera may affect the results ofx-rays

    • if you go for blood tests, as Mac Eradera may affect the results of your blood tests

    • if you have been told by your doctor that you have an intolerance to some sugars

      • Avoid the sun and using sun beds during treatment with Mac Eradera as it can exaggerate the effects of the
      sun. Tell your doctor if you get sun burnt.

    • Children

      MacEradera capsules must not be given to children below the age of 12 and are not recommended in
      children 12 to 18 years of age.

    • Taking other medicines

      Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines .
      This includes medicines that you buy without a prescription.
      In particular tell your doctor if you are taking or have recently taken any of the following medicines:

    • lithium used to treat some mental illness

    • medicines used to thin the blood or which prevent blood clotting (e.g. warfarin)

    • phenytoin and phenobarbital for epilepsy

    • methoxyflurane(an anaesthetic)

    • other antibiotics, particularly penicillin

    • supplements containing iron, zinc, sodium bicarbonate

    • the combination of Mac Eradera with other drugs that contain bismuth, used long term, may affect the
      nervous system

    • busulfan and fluorouracil used for chemotherapy

    • cyclosporin used to lower your body’s immune reaction after transplants

    • disulfiram used to treat people with drinking problems

    • ranitidine used for indigestion and heartburn

    • retinoids for skin disorders

    • atovaquone to treat an infection of the lungs

      • Do not take antacids containing aluminium, calcium or magnesium at the same time as Mac Eradera.

    • Taking Mac Eradera with food anddrink

      Take Mac Eradera with a full glass of water after meals and at bedtime (preferably with a snack).
      Do not eat or drink any dairy products (such as milk or yoghurt) or drinks with added calcium, at the
      same time as Mac Eradera capsules and throughout your treatment with Mac Eradera, as they may affect the
      way Mac Eradera works.
      Do not drink any alcohol while taking Mac Eradera and for at least 24 hours after finishing your
      treatment. Drinking alcohol when taking Mac Eradera may cause unpleasant side effects, such as feeling
      sick (nausea), being sick (vomiting), stomach pain (abdominal cramps), hot flushes and headaches.
      Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines ,
      including medicines obtained without a prescription.

    • Pregnancy and breast-feeding

      Do not take Mac Eradera if you are pregnant, might become pregnant during treatment or think you may be
      pregnant. Speak to your doctor if you become pregnant while taking Mac Eradera.
      Do not breast-feed while you are taking Mac Eradera. This is because small amounts of the components of
      Mac Eradera may pass into the breast milk.
      Ask your doctor or pharmacist for advice before taking any medicine.

    • Driving and using machines

      Do not drive or use any tools or machines if you feel dizzy, sleepy, have fits (convulsions) or
      experience temporary blurred or double vision.

    • Important information about some of the ingredients in MacEradera

      Mac Eradera contains lactose, which is a type of sugar. If you have been told by your doctor that you
      have an intolerance to some sugars, contact your doctor before taking this medicinal product.
      Mac Eradera contains approximately 96 mg of potassium per dose. To be taken into consideration by
      patients with reduced kidney function or patients on a controlled potassium diet.

  • 3. HOW TO TAKE MAC ERAOERA

    Always take Mac Eradera exactly as your doctor has told you. Mac Eradera should be taken together with a
    medicine called omeprazole. Check with your doctor or pharmacist if you are not sure.

    • Adults and the elderly

      Take 3 Mac Eradera capsules after breakfast, 3 capsules after lunch, 3 capsules after your evening meal
      and 3 capsules at bedtime (preferably with a snack), a total of 12 capsules per day. Swallow the
      capsules whole with a full glass of water to avoid any irritation to the throat. It is important to
      finish the complete course of treatment (10 days) and to take all 120 capsules.
      Take one omeprazole 20 mg capsule/tablet with the breakfast and evening doses of Mac Eradera.

    • Daily dosing schedule for MacEradera
      Time of dose Number of capsules of Mac Eradera
      After breakfast 3
      After lunch 3
      @After evening meal 3
      At bedtime
      (preferably with a snack)       		3
    • If you take more MacEradera than you should

      If you take more than the recommended dose of Mac Eradera per day, then you should tell your doctor or
      go to your nearest hospital emergency department. Take the remaining capsules with you. This is so that
      the doctor knows what you have taken.

    • If you forget to take MacEradera

      If you forget to take Mac Eradera, take it as soon as you remember. However, if it is almost time for
      your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
      If you miss more than 4 consecutive doses of Mac Eradera (1 day), contact your doctor.

    • If you forget to take MacEradera

      If you forget to take Mac Eradera, take it as soon as you remember. However, if it is almost time for
      your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
      If you miss more than 4 consecutive doses of Mac Eradera (1 day), contact your doctor.

    • If you stoptaking MacEradera before the end of treatment

      It is important that you finish the full course of treatment even if you begin to feel better after a
      few days. If you stop taking Mac Eradera too soon, your infection may not be completely cured and the
      symptoms of the infection may return or get worse. You might also develop resistance to tetracycline
      and/or metronidazole (antibiotics).
      If you have any further questions on the use of this product, ask your doctor or pharmacist.

  • 4. POSSIBLE SIDE EFFECTS

    Like all medicines, Mac Eradera can cause sideeffects, although not everybody gets them.

    Stop taking MacEradera and contact a doctor orgo toahospital immediately if you develop or notice anyof the
    following:

    • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing.

    • an itchy, lumpy rash (hives) or nettle rash (urticaria).These could be signs of an allergic reaction.

      • Other possible side effects

    • Very common side effects (affect more than 1 in 10patients):

      Changes in consistency orcolourof your faeces including dark coloured faeces (black stools), diarrhoea,
      nausea, bad or metallic-taste

    • Common side effects (affect more than 1 in 100patients):

      Abdominal pain, constipation, dry mouth, vomiting, passing wind /abdominal gas, headache, feeling weak,
      feeling low in energy or tired, feeling generally unwell, vaginal infection – symptoms include itching
      and irritation in the genital area, burning sensation or yellowish / white vaginal discharge, blood
      tests may show increased levels of liver enzymes (transaminases), dark-coloured urine, loss or decreased
      appetite, feeling dizzy / light-headed feeling, feeling sleepy, skin problems such as redness (rash)

    • Less common side effects (affect more than 1 in 1000 patients):

      Allergic reaction to the drug (symptoms include swelling of the face, lips, tongue or throat which may
      cause difficulty in swallowing or breathing, or an itchy, lumpy rash (hives) or nettle rash
      (urticaria)., feeling bloated / swollen abdomen, burping or belching, open sore inside the mouth / mouth
      ulcers, changes in the colour of your tongue (dark tongue), swollen tongue, chest pain, chest
      discomfort, yeast (candida) infections, which can occur in the mouth (symptoms include white spots in
      the mouth) or in the genitals (symptoms including severe itching, burning sensation, soreness),
      numbness, tingling / pins and needles, trembling, feeling anxious, depressed or difficulty sleeping,
      memory disturbance, skin problems such as itching or hives (urticaria), blurred (hazy) vision, vertigo
      (head spinning)
      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 pharmacist.

  • 5. HOW TO STORE MAC ERAOERA

    • Keep out of the reach and sight of children.

    • This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.

    • Do not use Mac Eradera after the expiry date which is stated on the carton and bottle after EXP. 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 protect the environment.

  • 6. FURTHER INFORMATION
    • What Mac Eradera capsules contain

      MacEradera capsules contains: Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride

Presentation :

12 Capsules in a blister of one mono carton.