VIMOVO 500 mg/20 mg Модифицированные Таблетки С Замедленным Высвобождением

Содержание инструкции

1. What is VIMOVO and what is it used for
2. How to take VIMOVO
3. Possible side effects
4. Package Contents and Other Information

VIMOVO 500 mg/20 mg modified-release tablets
naproxen and esomeprazole

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful. If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What VIMOVO is and what it is used for
• 2. What you need to know before you take VIMOVO
• 3. How to take VIMOVO
• 4. Possible side effects
• 5. How to store VIMOVO
• 6. Contents of the pack and other information

1. What is VIMOVO and what is it used for

What is VIMOVO
VIMOVO contains two different medicines called naproxen and esomeprazole. Each of these
medicines works in a different way.

• Naproxen belongs to a group of medicines called “Non-Steroidal Anti-Inflammatory Drugs” (NSAIDs). It reduces pain and inflammation.
• Esomeprazole belongs to a group of medicines called “proton pump inhibitors”. It reduces the amount of acid in the stomach. Esomeprazole helps to reduce the risk of developing ulcers and stomach problems in patients who need to take NSAIDs.

What is VIMOVO used for
VIMOVO is used in adults to relieve the symptoms of:

• Osteoarthritis.
• Rheumatoid arthritis.
• Ankylosing spondylitis.

VIMOVO helps to relieve pain, swelling, redness and heat (inflammation).
This medicine will be given to you if it is considered likely that a lower dose of NSAIDs
will not be effective in relieving the pain and if you are at risk of developing a stomach ulcer or in the
first part (duodenum) of the small intestine when taking NSAIDs.

• 2. What you need to know before you take VIMOVO

Do not take VIMOVO if:

• You are allergic (hypersensitive) to naproxen.
• You are allergic to esomeprazole or other medicines that are proton pump inhibitors.
• You are allergic to any of the other ingredients of this medicine (listed in section 6).
• You are taking a medicine called “atazanavir” or “nelfinavir” (used in the treatment of HIV).
• Acetylsalicylic acid (e.g. aspirin), naproxen or other NSAIDs such as ibuprofen, diclofenac or COX-2 inhibitors (e.g. celecoxib, etoricoxib) have caused you asthma (difficulty breathing) or an allergic reaction such as itching or skin rash (urticaria).
• You are in the last 3 months of pregnancy.
• You have severeproblems with your liver, kidneys or heart.
• You have an ulcer in your stomach or intestine.
• You have a bleeding disorder or severe and sudden bleeding.

Do not take VIMOVO if you have any of the conditions listed above. If you are unsure
consult your doctor or pharmacist before taking VIMOVO.

Warnings and precautions
Talk to your doctor before taking VIMOVO.
Do not take VIMOVO and consult your doctor immediately if one of the following events occurs before or
during taking VIMOVO, as this medicine may mask the symptoms of other diseases:

• You lose a lot of weight for no reason and have difficulty swallowing.
• You start vomiting food or blood.
• Presence of black stools (presence of digested blood in the stool).

If one of the events listed above occurs (or if you have doubts), consult your doctor or pharmacist before
taking this medicine.
Consult your doctor or pharmacist before taking this medicine if:

• You have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• You have any other problems with your liver or kidneys or if you are elderly.
• You are taking medicines such as corticosteroids, warfarin, clopidogrel, Selective Serotonin Reuptake Inhibitors (SSRIs), acetylsalicylic acid (aspirin) or NSAIDs including COX-2 inhibitors (see Other medicines and VIMOVO).
• You have ever had a skin reaction after treatment with a medicine similar to esomeprazole (which is a component of VIMOVO) that reduces stomach acidity.
• You need to undergo a specific blood test (Chromogranin A).

If one of the events listed above occurs (or if you have doubts), consult your doctor or pharmacist before
taking this medicine.
If you have had an ulcer or bleeding in the stomach in the past, tell your doctor. You will be asked to
report any unusual stomach symptoms (e.g. pain) to your doctor.
Medicines like VIMOVO may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. The risk is more likely with high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment.
VIMOVO contains the NSAID naproxen. As with all NSAIDs, naproxen should be used at the
lowest effective dose for the shortest possible time to reduce the risk of side effects. Your doctor will therefore assess at regular intervals whether VIMOVO is still appropriate for you.
VIMOVO is not suitable for obtaining rapid relief from acute pain, as it takes several hours
before naproxen, the pain-relieving substance, is present in the blood.
Also, consult your doctor before taking this medicine if you have heart problems, have had a stroke
or if you think you may be at risk of one of these problems. You may be at risk of one of these
problems if:

• You have high blood pressure.
• You have problems with blood circulation or blood clotting.
• You have diabetes.
• You have high cholesterol.
• You are a smoker.

If you are taking a proton pump inhibitor (which is a component of VIMOVO), especially for
more than a year, there may be a slight increase in the risk of fractures of the hip,
wrist or spine. If you suffer from osteoporosis or are taking corticosteroids (which
may increase the risk of osteoporosis) consult your doctor.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as it may be necessary to stop treatment with VIMOVO. Remember to report any other side effects such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (see also
section 4). The rash may involve ulcers of the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes). These severe rashes often occur after flu-like symptoms such as fever, headache, muscle aches. The rash may cover large areas of the
body with blistering and peeling skin.
If at any time during treatment (even after several weeks) you develop a rash
or any of these skin symptoms, stop taking this medicine and contact
your doctor immediately.

Children and adolescents
The use of VIMOVO is not recommended in children or adolescents of 18 years or younger.

Other medicines and VIMOVO
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines, including herbal products. This
is because VIMOVO can affect how other medicines work. Also, other medicines
can affect how VIMOVO works.
Do not take this medicine and tell your doctor or pharmacist if you are taking:

• a medicine called “atazanavir” or “nelfinavir” (used in the treatment of HIV). Tell your doctor or pharmacist if you are taking one of the following medicines:
• Acetylsalicylic acid (aspirin) (used as a pain reliever or to prevent blood clots). If you take low-dose acetylsalicylic acid (aspirin) you may still be able to take VIMOVO.
• Other NSAID medicines (including COX-2 inhibitors).
• Some medicines such as ketoconazole, itraconazole, posaconazole or voriconazole (used in the treatment of fungal infections).
• Erlotinib (or other drugs of the same class against cancer).
• Cholestyramine (used to lower cholesterol).
• Clarithromycin (used in the treatment of infections).
• Quinolone antibiotics (for infections) such as ciprofloxacin or moxifloxacin.
• Diazepam (used in the treatment of anxiety, to relax muscles or used in the treatment of epilepsy).
• Hydantoins as well as phenytoin (used in the treatment of epilepsy).
• Lithium (used in the treatment of some types of depression).
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis and cancers).
• Probenecid (for gout).
• “Selective Serotonin Reuptake Inhibitors” (SSRIs) (used in the treatment of severe depression and anxiety disorders).
• Cyclosporine or tacrolimus (medicines used to reduce the body's immune reactions).
• Digoxin (used in the treatment of heart disorders).
• Sulfonylureas such as glimepiride (oral medicines used in diabetic patients to control blood sugar levels).
• Medicines used to treat high blood pressure called diuretics (such as furosemide or hydrochlorothiazide), ACE inhibitors (such as enalapril), angiotensin II receptor antagonists (such as losartan) and beta-blockers (such as propranolol).
• Corticosteroid medicines such as hydrocortisone or prednisolone (used as anti-inflammatory medicines).
• Medicines used to block blood clotting, such as warfarin, dicoumarol, heparin or clopidogrel.
• Rifampicin (used to treat tuberculosis).
• St John's Wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used for leg pain due to poor blood flow).

If one of the events listed above occurs (or if you have doubts), consult your doctor or pharmacist before
taking VIMOVO.

VIMOVO with food and drink
Do not take VIMOVO with food as this may reduce and/or delay the effect of VIMOVO. Take the
tablets at least 30 minutes before meals.

Pregnancy, breastfeeding and fertility

• Do not take VIMOVO if you are in the last 3 months of pregnancy.
• Consult your doctor before taking this medicine if you are in the first or second trimester of pregnancy. The doctor will decide if you can take VIMOVO.
• Do not breastfeed if you are taking VIMOVO. This is because small amounts of medicine can pass into breast milk. If you intend to breastfeed, you should not take VIMOVO. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, may become pregnant or are breastfeeding. VIMOVO may make it more difficult to conceive. Tell your doctor if you are planning a pregnancy or have trouble conceiving.

Driving and using machines
You may feel dizzy or have blurred vision while taking VIMOVO. If this happens, do not
drive or use tools or machinery.

VIMOVO contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
These ingredients may cause allergic reactions. These reactions may not occur
immediately.
VIMOVO contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take VIMOVO

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

Taking this medicine

• Swallow the tablets whole with water. Do not chew, divide or crush the tablets. It is important to take the tablets whole for the medicine to work properly.
• Take the tablets at least 30 minutes before meals. Food may reduce the protective effect of VIMOVO on your stomach and intestines. Food may also cause a significant delay in pain and inflammation relief.
• If you take this medicine for a long period, your doctor will want to monitor you (especially if you take it for more than one year).

How much to take

• Take one tablet twice a day for the period of time that your doctor has told you.
• VIMOVO is only available in the 500 mg/20 mg dosage. If your doctor considers this dose is not suitable for you, they may prescribe another therapy.

If you take more VIMOVO than you should
If you take more VIMOVO than you should, tell your doctor or pharmacist immediately. Symptoms of
overdose may include lethargy, dizziness, drowsiness, upper abdominal pain and/or
discomfort, heartburn, indigestion, nausea, liver problems (visible from blood tests),
kidney problems which may be severe, higher than normal acid levels in the blood, confusion, vomiting, bleeding in the stomach or intestines, high blood pressure, difficulty in
breathing, coma, sudden allergic reactions (which may include shortness of breath, skin rashes,
swelling of the face and/or throat, and/or collapse) and involuntary body movements.

If you forget to take VIMOVO

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take the next dose, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine.

Stop taking VIMOVO and consult your doctor immediately if you notice any of the
following serious side effects, as you may need urgent medical attention:

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Sudden onset of a severe skin rash or reddening of the skin with blisters or peeling. Severe blisters and bleeding may also occur on the lips, eyes, mouth, nose and genitals. The rashes may develop into widespread severe skin damage (peeling of the epidermis and mucous membranes) with potentially life-threatening consequences. This could be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms”. These effects are very rare and can affect up to 1 in 10,000 people.
• Yellowing of the skin or the white of the eyes, dark urine and fatigue, which may be symptoms of liver problems.
• Medicines like VIMOVO may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. Signals include chest pain that spreads

to the neck and shoulders and spreads to the left arm, feeling confused or muscle weakness
or numbness that may be on one side of the body.

• Presence of black and sticky stools or diarrhea with blood.
• Vomiting blood or dark particles that look like coffee grounds.

Inform your doctor as soon as possible if you experience any of the following symptoms:
VIMOVO can, in rare cases, affect the number or function of white blood cells in the blood,
resulting in an impaired immune system.
If you have an infection with symptoms such as fever with a worsening of your general condition or fever
with symptoms of a local infection such as sore throat, sore throat or in the mouth, or difficulty urinating, you should
consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out
with a blood test. It is important for you at this time to provide information
about your medicine.

Other possible side effects include:
Common (may affect up to 1 in 10 people)

• Headache.
• Fatigue.
• Thirst.
• Depression.
• Shortness of breath.
• Increased sweating.
• Itchy skin and skin rashes.
• Dizziness.
• Red or purple marks, bruises or spots on the skin.
• Nausea or vomiting.
• Fast and light heartbeat (palpitations).
• Disturbed sleep or difficulty sleeping (insomnia).
• Hearing problems or ringing in the ears.
• Dizziness, drowsiness or lightheadedness.
• Swelling of the hands, feet and ankles (edema).
• Inflammation inside the mouth.
• Vision problems.
• Diarrhea, stomach pain, heartburn, indigestion, constipation, belching or flatulence.
• Gastric ulcer or ulcer in the first part (duodenum) of the small intestine
• Inflammation of the lining of the stomach (gastritis)
• Benign polyps in the stomach

Uncommon, rare or very rare (may affect up to 1 in 100 people or less)

• Pain in the mouth or mouth ulcers
• Vision problems such as blurred vision, conjunctivitis or eye pain
• Strange dreams
• Feeling sleepy
• Increased amount of sugar (glucose) in the blood. Symptoms may include feeling thirsty and increased amount of urine.
• Low levels of sugar (glucose) in the blood. Symptoms may include feeling hungry or weak, sweating and a fast heartbeat.
• Coma
• Inflammation of blood vessels
• Perforation (hole) of the stomach or intestine
• Systemic lupus erythematosus (SLE), a disease in which the immune system attacks the body, causing joint pain, skin rashes and fever.
• Swollen lymph nodes
• Hip, wrist or spine fracture (if Vimovo is used in high doses and for a long duration)
• Fever.
• Fainting.
• Dry mouth.
• Aggression.
• Hearing loss.
• Asthma attack.
• Convulsions or epileptic seizures.
• Menstrual cycle problems.
• Weight changes.
• Hair loss (alopecia).
• Raised skin rash (urticaria).
• Joint pain (arthralgia).
• Breast enlargement in men.
• Painful or swollen tongue.
• Involuntary movements or muscle tremors.
• Appetite problems or changes in taste.
• Muscle weakness or pain (myalgia).
• Blood clotting may take longer than normal.
• Problems with conception in women.
• Fever, redness or other signs of infection.
• Irregular, slow or very fast heartbeat.
• Tingling.
• Difficulty with memory or concentration.
• Agitation, confusion, anxiety or restlessness.
• General feeling of being unwell, weakness and lack of energy.
• Parts of the body swollen or painful due to increased fluid retention.
• High or low blood pressure. You may feel like you are going to faint or feel dizzy.
• Skin rashes or blisters, or the skin becomes more sensitive to sunlight.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Changes in blood test results, such as those to check liver function. Your doctor will be able to explain these in detail.
• Infection called “candidiasis” that can affect the digestive system and is caused by a fungus.
• Blood in the urine or other kidney problems. You may experience back pain.
• Difficulty breathing, which may gradually worsen. This may be a symptom of pneumonia or fluid buildup in the lungs.
• Low levels of salt (sodium) in the blood. This can cause weakness, vomiting and cramps.
• Symptoms of meningitis such as fever, nausea or vomiting, stiff neck, headache, sensitivity to bright light and confusion.
• Pancreas problems. Symptoms include severe stomach pain that spreads to the back.
• Pale stools, which are a symptom of severe liver problems (hepatitis). Severe liver problems can lead to liver failure and brain disorders.
• Colitis or worsening of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis. Symptoms include stomach pain, diarrhea, vomiting and weight loss.
• Blood problems, such as a lower number of red blood cells (anemia), white blood cells or platelets. This can cause weakness, bruising, fever, severe chills, sore throat or can make you more vulnerable to infections.
• Increased number of a certain type of white blood cells (eosinophilia);
• Deficiency of all types of blood cells (pancytopenia).
• Problems with the way the heart pumps blood around the body or damage to blood vessels. Symptoms may include fatigue, shortness of breath, feeling faint, chest pain or general pain.

Frequency not known (frequency cannot be estimated from available data)

• If you take VIMOVO for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium or calcium levels. The doctor should decide whether to check blood magnesium levels periodically.
• Erythema, possible joint pain.

Do not be worried by this list of possible side effects.It is possible that none of them will
occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

• 5. How to store VIMOVO

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 pack, bottle or blister
after EXP. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Bottle: Store in the original package and keep the bottle tightly closed to protect the
medicine from moisture.
Blister: Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine via water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What VIMOVO contains

• The active ingredients are naproxen 500 mg and esomeprazole 20 mg.
• The other ingredients (excipients) in the tablet core are sodium croscarmellose, magnesium stearate, povidone K90, colloidal silicon dioxide, and in the film coating are carnauba wax, glycerol monostearate 40-55, hypromellose type 2910 (3 mPas, 6 mPas and 50 mPas, iron oxide (E172, yellow, black), macrogol 8000, acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, methyl parahydroxybenzoate (E218), polydextrose, polysorbate 80, propylene glycol, propyl parahydroxybenzoate (E216), sodium lauryl sulfate, titanium dioxide (E171), triethyl citrate.

Description of VIMOVO and package contents
They are oval, yellow 18x9.5 mm tablets, marked with the inscription 500/20 in black ink.
Bottle:
Pack sizes - 6, 10, 20, 30, 60, 100, 180 or 500 modified-release tablets.
The bottles contain silica gel desiccants (to keep the tablets dry). Do not ingest the
sachet containing the desiccant.
The bottles contain silica gel desiccants in the screw cap (to keep the tablets
dry).
Aluminum blister pack:
Pack sizes - 10, 20, 30, 60 or 100 modified-release tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
GRÜNENTHAL ITALIA S.r.l.
Via Carlo Bo, 11
20143 Milan
Manufacturer
AstraZeneca AB, Gärtunavägen, SE-151 85 Södertälje (Sweden)
Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen (Germany)

This medicinal product is authorised in the Member States of the European Economic Area with the
following names: