Olmesartan medoxomil Accord

PATIENT LEAFLET: INFORMATION FOR THE USER

Olmesartan Medoxomil Accord 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse (see section 4). Contents of this leaflet:
  1. What Olmesartan Medoxomil Accord is and what it is used for.
  2. What you need to know before taking Olmesartan Medoxomil Accord.
  3. How to take Olmesartan Medoxomil Accord.
  4. Possible side effects.
  5. How to store Olmesartan Medoxomil Accord.
  6. Contents of the pack and other information.

1. What Olmesartan Medoxomil Accord is and what it is used for

Olmesartan Medoxomil Accord belongs to a group of medicines called angiotensin II receptor antagonists. These medicines lower blood pressure by relaxing blood vessels.
Olmesartan Medoxomil Accord is used to treat high blood pressure (also known as "hypertension") in adults, and in children and adolescents aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain and eyes. In some cases, this may lead to heart attacks, heart or kidney failure, stroke or blindness. Usually, high blood pressure does not cause symptoms. It is important to monitor your blood pressure to help prevent damage from occurring.
High blood pressure can be controlled with medicines such as Olmesartan Medoxomil Accord. Your doctor has likely also recommended that you make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake and reducing dietary salt). Your doctor may also have advised you to exercise regularly, such as walking or swimming. It is important that you follow your doctor's advice.

2. What you need to know before taking Olmesartan Medoxomil Accord

Do not take Olmesartan Medoxomil Accord

• if you are allergic (hypersensitive) to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than three months pregnant (it is better to avoid Olmesartan Medoxomil Accord even in early pregnancy – see section “Pregnancy”).
• if you have yellowing of the skin and eyes (jaundice) or impaired bile flow from the gallbladder (biliary obstruction, for example gallstones).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before using Olmesartan Medoxomil Accord.

Consult your doctor if you are taking any of the following medicines used to treat high blood pressure:

• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (for example potassium) in your blood at regular intervals.
See also the information under the heading "Do not take Olmesartan Medoxomil Accord".

Consult your doctor if you also have any of the following health problems:

• kidney problems.
• Liver diseases.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhoea, treatment with high doses of diuretics, or if you are on a low-salt diet.
• Increased levels of potassium in the blood.
• Problems with the adrenal glands.

Inform your doctor if you develop severe and prolonged diarrhoea with significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this antihypertensive treatment.
Contact your doctor if, after taking Olmesartan Medoxomil Accord, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan Medoxomil Accord on your own.
As with any medicine that lowers blood pressure, excessive lowering of blood pressure in patients with circulatory disorders of the heart or brain may lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Olmesartan Medoxomil Accord is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section “Pregnancy”).

Children and adolescents
Olmesartan Medoxomil Accord has been studied in children and adolescents. For further information, consult your doctor. Olmesartan Medoxomil Accord is not recommended for children aged 1 year to less than 6 years, and must not be used in children under 1 year of age due to lack of evidence.

Other medicines and Olmesartan Medoxomil Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist about the use of any of the following medicines:

• Other medicines that lower blood pressure, as they may increase the effect of Olmesartan Medoxomil Accord tablets. Your doctor may consider it necessary to adjust the dose and/or take other precautions: if you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Olmesartan Medoxomil Accord" and "Warnings and precautions").
• Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (used to thin the blood). Taking these medicines together with Olmesartan Medoxomil Accord may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Olmesartan Medoxomil Accord may increase lithium toxicity. If you are to take lithium, your doctor will monitor your lithium blood levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other inflammation symptoms, including arthritis) taken together with Olmesartan Medoxomil Accord may increase the risk of kidney failure, and the effectiveness of Olmesartan Medoxomil Accord may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of Olmesartan Medoxomil Accord tablets. Your doctor may advise you to take Olmesartan Medoxomil Accord tablets at least 4 hours before colesevelam hydrochloride.
• Some antacids (used for indigestion) may slightly reduce the effectiveness of Olmesartan Medoxomil Accord.

Elderly patients
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, your blood pressure must be regularly monitored by your doctor to prevent it from dropping too low.

Black patients
As with other similar medicines, the blood pressure-lowering effect of Olmesartan Medoxomil Accord tablets is somewhat reduced in black patients.

Olmesartan Medoxomil Accord with food and drink
Olmesartan Medoxomil Accord can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Normally, your doctor will advise you to stop taking Olmesartan Medoxomil Accord tablets before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Olmesartan Medoxomil Accord tablets.
Olmesartan Medoxomil Accord tablets are not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as they may cause serious harm to the unborn baby if taken after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to start breast-feeding. Olmesartan Medoxomil Accord tablets are not recommended for women who are breast-feeding; your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn or premature.

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

Driving and using machines
You may experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.

Olmesartan Medoxomil Accord contains lactose
This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Olmesartan Medoxomil Accord

Take this medicine exactly as directed by your doctor, pharmacist, or
nurse. If you are unsure, consult your doctor, pharmacist, or nurse.
The recommended starting dose is one 10 mg tablet once daily. However, if your blood
pressure is not controlled, your doctor may decide to increase the dose to 20 mg or 40 mg once daily,
or may prescribe additional medicines.
In patients with mild to moderate renal impairment, the dose must not exceed 20 mg once daily.
The tablets can be taken with or without food. Swallow the tablets with a sufficient
amount of water (for example, a glass of water). If possible, take your daily dose at the
same time each day, for example with breakfast.
Children and adolescents aged 6 to less than 18 years:
The recommended starting dose is 10 mg once daily. If the patient's blood pressure is not
adequately controlled, the doctor may decide to increase the dose up to 20 mg or 40 mg once daily.
In children weighing less than 35 kg, the dose must not exceed 20 mg once daily.
If you take more Olmesartan Medoxomil Accord than you should
If you take more tablets than you should, or if a child accidentally swallows any tablets, go
immediately to your doctor or nearest emergency department, taking the medicine pack with you.
If you forget to take Olmesartan Medoxomil Accord
If you forget to take a dose, take your usual dose the next day. Do not take a double
dose to make up for the forgotten tablet.
If you stop taking Olmesartan Medoxomil Accord
It is important to continue taking Olmesartan Medoxomil Accord unless your doctor tells you
to stop.
If you have any doubts about how to use Olmesartan Medoxomil Accord, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If they do occur, they are mostly mild and do not require discontinuation of treatment.
Although they do not occur in all people, the following side effects can be serious:
Rarely (affecting up to 1 in 1,000 people), the following allergic reactions affecting the whole body have been reported:
During treatment with Olmesartan Medoxomil Accord, swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash, may occur. If this happens, stop taking Olmesartan Medoxomil Accord and contact your doctor immediately.
Rarely (but slightly more frequently in elderly patients), Olmesartan Medoxomil Accord may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This could lead to severe dizziness or fainting. If this happens, stop taking Olmesartan Medoxomil Accord, contact your doctor immediately and lie down.

The following are the other side effects known so far with Olmesartan Medoxomil Accord:

Common side effects (may affect up to 1 in 10 people):
Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, throat irritation, nasal discharge, bronchitis, influenza-like symptoms, cough, pain, chest, back, bone or joint pain, urinary tract infection, swelling of ankles, feet, legs, hands or arms, blood in urine.

Some laboratory test abnormalities have also been observed, including the following: increased blood fats (hypertriglyceridaemia), increased uric acid in blood (hyperuricaemia), increased blood urea, increased liver and muscle function tests.

Uncommon side effects (may affect up to 1 in 100 people):
Rapid allergic reactions affecting the whole body, which may cause breathing difficulties or a rapid drop in blood pressure that may also lead to fainting (anaphylactic reactions), facial swelling, dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, rash, skin blisters (wheals), angina (pain or discomfort in the chest).

A reduction in the number of a type of blood particles normally present, called platelets (thrombocytopenia), has been observed in blood tests.

Rare side effects (may affect up to 1 in 1,000 people):
Lack of energy, muscle cramps, reduced kidney function, kidney failure.

Some laboratory test abnormalities have also been observed. These include increased potassium levels (hyperkalaemia) and increased levels of substances related to kidney function.

Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Not known: frequency cannot be estimated from the available data:
If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking Olmesartan Medoxomil Accord for a long time, contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with treatment for high blood pressure.

Additional side effects in children and adolescents:
Side effects in children are similar to those reported in adults. However, dizziness and headache occur more frequently in children, and nosebleeds are a common side effect observed only in children.

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the website: 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 Olmesartan Medoxomil Accord

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of medicines via wastewater 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 Olmesartan Medoxomil Accord contains
The active substance is olmesartan medoxomil.
Each film-coated tablet contains 10 mg.
Each film-coated tablet contains 20 mg.
Each film-coated tablet contains 40 mg.
The other components are:
microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc, and hypromellose.

Description of the appearance of Olmesartan Medoxomil Accord and package contents
Olmesartan Medoxomil Accord 10 mg are white, round, biconvex film-coated tablets, marked with "IO2" on one side and smooth on the other;
Olmesartan Medoxomil Accord 20 mg are white, round, biconvex film-coated tablets, marked with "IO3" on one side and smooth on the other;
Olmesartan Medoxomil Accord 40 mg are white, oval, biconvex film-coated tablets, marked with "IO4" on one side and smooth on the other;
Olmesartan Medoxomil Accord is available in packages containing 14, 28, 30, 56, 84, 90, 98 and 280 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland

This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: