Edarbi Tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• are allergic to azilsartan medoxomil or any of the other ingredients of this medicine (listed in section 6).
• are more than 3 months pregnant. (It is also better to avoid this medicine in early pregnancy - see pregnancy section).
• have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Talk to your doctor before taking Edarbi, especially if you

• have kidney problems.
• are on dialysis or had a recent kidney transplant.
• have severe liver disease.
• have heart problems (including heart failure, recent heart attack).
• have ever had a stroke.
• have low blood pressure or feel dizzy or lightheaded.
• are vomiting, have recently had severe vomiting, or have diarrhoea.
• have raised levels of potassium in your blood (as shown in blood tests).
• have a disease of the adrenal gland called primary hyperaldosteronism.
• have been told that you have a narrowing of the valves in your heart (called “aortic or mitral valve stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”).
• are taking any of the following medicines used to treat high blood pressure:
  • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
  • aliskiren.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Edarbi. Your doctor will decide on further treatment. Do not stop taking Edarbi on your own.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Edarbi”.

You must tell your doctor if you think you are (or might become) pregnant. Edarbi is not recommended in early pregnancy, and must NOT be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section "Pregnancy section and breast-feeding"). Edarbi may be less effective in lowering the blood pressure in black patients.

There is limited data on the use of Edarbi in children or adolescents under 18 years of age. Therefore, this medicine should not be given to children or adolescents.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Edarbi can affect the way some other medicines work and some medicines can have an effect on Edarbi.

In particular, tell your doctor if you are taking any of the following medicines:

• Lithium (a medicine for mental health problems)
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac or celecoxib (medicines to relieve pain and inflammation)
• Acetylsalicylic acid if taking more than 3 g per day (medicine to relieve pain and inflammation)
• Medicines that increase the amount of potassium in your blood; these include potassium supplements, potassium-sparing medicines (certain ‘water tablets’) or salt substitutes containing potassium
• Heparin (a medicine for thinning the blood)
• Diuretics (water tablets)
• Aliskiren or other medicines to lower your blood pressure (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker, such as enalapril, lisinopril, ramipril or valsartan, telmisartan, irbesartan).

Your doctor may need to change your dose and/or to take other precautions if you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Edarbi” and “Warnings and precautions”).

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Edarbi.

Edarbi is not recommended in early pregnancy, and must NOT be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding. Edarbi is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Edarbi is unlikely to have an effect on driving or using machines. However, some people may feel tired or dizzy when taking this medicine and if this happens to you, do not drive or use any tools or machines.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

If you take too many tablets, or if someone else takes your medicine, contact your doctor immediately. You may feel faint or dizzy if you have taken more than you should.

Do not take a double dose to make up for a forgotten dose. Just take the next dose at the usual time.

If you stop taking Edarbi, your blood pressure may increase again. Therefore, do not stop taking Edarbi without first talking to your doctor about alternative treatment options.

• Difficulties in breathing, or swallowing, or swelling of the face, lips, tongue and/or throat (angioedema)
• Itching of the skin with raised lumps.

Other possible side effects include:

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

• Dizziness
• Diarrhoea
• Increased blood creatine phosphokinase (an indicator of muscle damage).

Uncommon side effects (may affect up to 1 in 100 people):

• Low blood pressure, which may make you feel faint or dizzy
• Feeling tired
• Swelling of the hands, ankles or feet (peripheral oedema)
• Skin rash and itching
• Nausea
• Muscle spasms
• Increased serum creatinine in the blood (an indicator of kidney function)
• Increased uric acid in the blood.

Rare side effects (may affect up to 1 in 1 000 people):

• Changes in blood test results including decreased levels of a protein in the red blood cells (haemoglobin).

Not known (frequency cannot be estimated from the available data):

• Joint pain
• Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting, and diarrhoea has been reported after the use of similar products.

When Edarbi is taken with chlortalidone (a water tablet), higher levels of certain chemicals in the blood (such as creatinine), which are indicators of kidney function, have been seen commonly (in less than 1 in 10 users), and low blood pressure is also common.

Swelling of the hands, ankles or feet is more common (in less than 1 in 10 users) when Edarbi is taken with amlodipine (a calcium channel blocker for treating hypertension) than when Edarbi is taken alone (less than 1 in 100 users). The frequency of this effect is highest when amlodipine is taken alone.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is azilsartan medoxomil (as potassium).

Edarbi 20 mg: Each tablet contains 20 mg azilsartan medoxomil (as potassium).

Edarbi 40 mg: Each tablet contains 40 mg azilsartan medoxomil (as potassium).

Edarbi 80 mg: Each tablet contains 80 mg azilsartan medoxomil (as potassium).

• The other ingredients are mannitol, fumaric acid, sodium hydroxide, hydroxypropylcellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.

The tablets are white round debossed with “ASL” on one side and either “20”, “40” or “80” on the other.

Edarbi is provided in blisters with either 14 tablets or 15 tablets in cartons containing 14, 28, 56 or 98 tablets and blisters integrated with desiccant with either 14 tablets or 15 tablets in cartons containing 14, 28, 30, 56, 90 or 98 tablets.

Not all pack sizes may be marketed.