Mac Allevo DR

( Naproxen + Esomeprazole )

Composition :

Each film coated tablet contains
Naproxen 500 mg
Esomeprazole 20 mg
(eq . to esomeprazolemangesiumtrihydrate) 22.3 mg
Excipients q.s

Pharmaceutical Form : Tablets

Read this carefully before you start taking Mac Mac Mac Allevo DR and each time you get a refill. This leaflet is a
summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical
condition and treatment and ask if there is any new information about Mac Mac Allevo DR.

• Serious Warnings and Precautions If you have, or previously had, any of the following medical conditions, see
  your health care provider to discuss treatment options other than Mac Allevo DR.

  Heart Attack or Angina | Stroke or Mini-stroke | Loss of Vision | Current Pregnancy (less than 28 weeks) |
  Congestive Heart Failure

• What is Mac Allevo DR used for?Mac Allevo DR treats the signs and symptoms of:
  Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis.

  Mac Allevo DR helps to reduce pain, swelling, redness and heat (inflammation).
  It is used for people who:

  • need to take an anti-inflammatory medicine.

  • and are at risk of getting a stomach ulcer (sore) or an ulcer in the small intestine (gut).

• How does Mac Allevo DR work?Mac Allevo DR contains 2 drugs which work together.

  • • Naproxen belongs to a group of medicines called“nonsteroidal anti-inflammatory drugs”(NSAIDs). It
      reduces the substances in your body which cause pain and swelling.

    • Esomeprazole belongs to a group of medicines called“proton pump inhibitors”(PPIs). It reduces the
      amount of acid produced by your stomach.

    • Naproxen can damage the stomach but esomeprazole helps reduce this damage.

    • Mac Allevo DR only treats the symptoms of pain and inflammation of the illness as long as you use it.
      Mac Allevo DR does not cure the illness.

  Mac Allevo DR is supplied in bottles of 60 tablets.

• Do not use Mac Allevo DR if:

  • you have heart bypass surgery (planning to have or recently had)

  • you have severe, uncontrolled heart failure.

  • you have bleeding in the brain or other bleeding disorders.

  • you are pregnant (after 28 weeks of pregnancy).

  • you are currently breastfeeding (or planning to breastfeed).

  • you are allergic to ASA (Acetylsalicylic Acid), other NSAIDs, naproxen, esomeprazole, substituted
    benzimidazoles or other ingredients of Mac Allevo DR (see “What are the ingredients in Mac Allevo DR” )

  • you have an active ulcer.

  • you have active bleeding from the stomach or gut.

  • you have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis).

  • you have liver disease (active or severe).

  • you have kidney disease (severe or worsening).

  • you have high potassium in the blood.

  • you are taking rilpivirine

• Patients who took a drug in the same class as Mac Allevo DR after a type of heart surgery (coronary artery
  bypass grafting (CABG)) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s),
  and infections or other complications than those who did NOT take that drug. Mac Allevo DR must not be used
  after recent CABG.Mac Allevo DR should NOT be used in patients under 18 years of age.

• To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Mac
  Allevo DR. Talk about any health conditions or problems you may have, including if you:have high blood pressure, have high cholesterol, have diabetes mellitus or are on a low sugar diet, have
  atherosclerosis, have poor blood flow to your extremities, for example, your hands and feet, are a smoker or
  ex-smoker, have kidney disease or urine problems, had a previous ulcer (sore) or bleeding from the stomach
  or gut (small or large intestine), previously had bleeding in the brain, have bleeding problems, have a
  family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal,
  etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, Ketorolac, mefenamic acid,
  meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, sulindac, tenoxicam, tiaprofenic acid or tolmetin
  (NOT a complete list), have a family history of asthma, nasal polyps, long-term swelling of the sinus
  (chronic sinusitis) or hives, are planning to get pregnant, are due to have a specific blood test
  (Chromogranin A).

• Other warnings you should know about:This medicine should be used at the lowest dose and for the shortest time suitable for your condition. Talk
  to your doctor if you have any concerns about your treatment.

  Medicines such as Mac Allevo DR may be associated with an increased risk of heart attack (myocardial
  infarction) or stroke. This risk may happen early In treatment.

  If you take antibiotics while taking Mac Allevo DR: If you experience symptoms such as severe (bloody or
  repeated watery) diarrhea, with or without fever, abdominal pain or tenderness, you may have bowel
  inflammation caused by a bacterial infection (Clostridium difficile). If this happens, stop taking the drug
  combination and call your healthcare professional immediately.

  Tell any doctor, dentist, pharmacist or health care professional that you see, that you are taking this
  medicine. This is especially important if you are planning to have heart surgery.

  Do NOT drink alcohol while taking this medication. You would be more likely to get stomach problems.

  Fertility may be decreased. The use of Mac Allevo DR is not recommended in women trying to get pregnant.

• The following may interact with Mac Allevo DR (NOT a complete list) :

  • Acetylsalicylic Acid (ASA) or other NSAIDs (e.g. celecoxib, diclofenac, ibuprofen, indomethacin,
    ketorolac, meloxicam, naproxen).

  • Antacids

  • Antidepressants (Selective Serotonin Reuptake Inhibitors (SSRIs), e.g. citalopram, fluoxetine,
    paroxetine, sertraline).

  • Blood pressure medications (ACE (angiotensin converting enzyme) inhibitors, e.g. enalapril, lisinopril,
    perindopril, ramipril) or ARBs (angiotensin Il receptor blockers, e.g. candesartan, irbesartan,
    losartan, valsartan).

  • Blood thinners (e.g. warfarin, AŞA, clopidogrel).

  • Corticosteroids (including glucocorticoids e.g. prednisone).

  • Cyclosporin

  • Digoxin

  • Diuretics (e.g. furosemide, hydrochlorothiazide).

  • Erlotinib (or any other anticancer drug from the same class).

  • Lithium

  • Methotrexate

  • Oral contraceptives.

  • Oral hypoglycemics (diabetes medications).

  • Tacrolimus

  Drugs used to prevent blood clotting (warfarin or coumarin derivatives, clopidogrel) have been reported to
  interact with esomeprazole. Speak to your doctor or pharmacist if you are taking any of these drugs as
  monitoring may be required when you start or stop taking Mac Allevo DR. Use of Mac Allevo DR with dopidogrel
  should be avoided.

  Esomeprazole may decrease the effectiveness of some drugs used for HIV treatment. Atazanavir, nelfinavir, and
  saquinavir should not be used with Mac Allevo DR.

• Overdose :if you think you have taken too much Mac Allevo DR, contact your healthcare professional, hospital emergency
  department or regional Poison Control Centre immediately, even if there are no symptoms.

• What are possible side effects from using Mac Allevo DR?Mac Allevo DR may cause some side effects, especially if you use it for a long time or take large doses.
  When these side effects occur, you may need to see a health care provider. These are not all the possible
  side effects you may feel when taking Mac Allevo DR. If you experience any side effects not listed here,
  contact your healthcare professional. Please also see Warnings and Precautions.

  Mac Allevo DR may cause you to become drowsy or tired. Be careful about driving or doing activities that
  require you to be alert. If you become drowsy, dizzy or light-headed after taking Mac Allevo DR, do NOT
  drive or use machines.

  Mac Allevo DR may cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn,
  skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from
  the sun, check with your health care provider

• Common:

  • Nausea

  • Stomach upset

  • Diarrhea

  • Headache

• Uncommon:

  • Dry mouth

  • Dizziness

  • Insomnia

  • Feeling of burning/prickliness/numbing.

  • Swelling of extremities.

  • Feeling sleepy.

  • Feeling like you or your surroundings are moving (vertigo).

• Rare:

  • Taste disorders.

  • Nervousness

  • Hair loss

  • Increased sweating

Storage:

Mac Allevo DR tablets should be kept in their original container. Keep bottles tightly closed to protect from
moisture.

Store at room temperature (15-30°C). Do not keep Mac Allevo DR in the bathroom medicine cabinet or other warm, moist
places.

Do NOT keep expired medicine or medicine no longer needed. Return to your pharmacist.

Keep out of sight and reach of children.