OLMESARTAN 20 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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.

What is in this leaflet

• 1. What olmesartan is and what it is used for

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

• 3. How to take olmesartan

• 4. Possible side effects

• 5. How to store olmesartan

• 6. Contents of the pack and other information

1. what olmesartan is and what it is used for

The name of your medicine is called Olmesartan10mg, 20mg or 40mg Film-coated tablets (referred to as olmesartan throughout this leaflet).

Olmesartan belongs to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels.

Olmesartan is used for the treatment of 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 a heart attack, heart or kidney failure, stroke or blindness. Usually high blood pressure has no symptoms. It is important to have your blood pressure checked to prevent damage occurring.

High blood pressure can be controlled with medicines such as olmesartan tablets. Your doctor has probably also recommended that you make some changes in your lifestyle to help lower your blood pressure (for example losing weight, giving up smoking, reducing the amount of alcohol you drink and reducing the amount of salt in your diet). Your doctor may also have urged you to take regular exercise, such as walking or swimming. It is important to follow this advice from your doctor.

2. what you need to know before you take olmesartan

Do not take olmesartan

• if you are allergic to olmesartan medoxomil or any of the other ingredients ofthis medicine (listed in section 6).
• if you are more than 3 months pregnant. (It is also better to avoid olmesartan tablets in early pregnancy – see pregnancy section).
• if you suffer from yellowing of the skin and eyes (jaundice) or problems with drainage of the bile from the gallbladder (biliary obstruction e.g. gallstones).
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking olmesartan.

Before you take the tablets, tell your doctor if you have any of the following health problems:

• kidney problems
• liver disease
• heart failure or problems with your heart valves or heart muscle
• severe vomiting or diarrhoea
• treatment with high doses of water tablets (diuretics) or if you are on a low salt diet
• increased levels of potassium in your blood
• problems with your adrenal glands (e.g. primary aldosteronism).
• if you 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.

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 olmesartan”.

Contact your doctor if you experience diarrhoea that is severe, persistent and causes substantial weight loss. Your doctor may evaluate your symptoms and decide on how to continue your blood pressure medication.

As with any medicine which reduces blood pressure, an excessive drop in blood pressure in patients with blood flow disturbances of the heart or brain could lead to a heart attack or stroke. Your doctor will therefore check your blood pressure carefully.

You must tell your doctor if you think you are (or might become) pregnant. Olmesartan 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 pregnancy section).

Children and adolescents

Olmesartan medoxomil has been studied in children and adolescents. For more information, talk to your doctor. Olmesartan is not recommended for children from 1 year to less than 6 years and should not be used in children under the age of 1 year as no experience is available.

Other medicines and olmesartan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular:-

• Other blood pressure lowering medicines, as the effect of olmesartan can be increased. 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 olmesartan” and “Warnings and precautions”).
• Potassium supplements, a salt substitute which contains potassium, water tablets (diuretics) or heparin (for thinning the blood). Using these medicines at the same time as olmesartan may raise the levels of potassium in your blood.
• Lithium (a medicine used to treat mood swings and some types of depression) used at the same time as olmesartan may increase the toxicity of lithium. If you have to take lithium, your doctor will measure your lithium blood levels.
• Non-steroidal anti-inflammatory (NSAIDs) medicines (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) used at the same time as olmesartan may increase the risk of kidney failure and the effect of olmesartan can be decreased by NSAIDs.
• Colesevelam hydrochloride, a drug that lowers the level of cholesterol in your blood, as the effect of olmesartan may be decreased. Your doctor may advise you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion remedies), as the effect of olmesartan can be slightly decreased.

Elderly

If you are over 65 years of age and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, then you need to have your blood pressure regularly checked by your doctor to make sure that your blood pressure does not become too low.

Black patients

As with other similar drugs the blood pressure lowering effect of Olmesartan is somewhat less in black patients.

Olmesartan with food and drink

Olmesartan can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking olmesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of olmesartan. Olmesartan 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 or about to start breast-feeding. Olmesartan is not recommended for mothers who are breast-feeding, 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.

If you are breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel sleepy or dizzy while being treated for your high blood pressure. If this happens, do not drive or use machines until the symptoms wear off. Ask your doctor for advice.

Olmesartan contains lactose

This medicine contains lactose (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.

3. how to take olmesartan

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose is one 10 mg tablet once a day. However, if your blood pressure is not controlled, your doctor may decide to change your dose up to 20 or 40 mg once a day, or prescribe additional medicines.

In patients with mild to moderate kidney disease, your dose will not be higher than 20 mg once a day.

Use in children and adolescents from 6 to less than 18 years of age.

The recommended starting dose is 10 mg once daily. If the patient’s blood pressure is not adequately controlled, the doctor may decide to change the dose up to 20 or 40 mg once a day.

In children who weigh less than 35 kg, the dose will not be higher than 20 mg once a day.

The tablets can be taken with or without food. Swallow the tablets with a sufficient amount of water (e.g. one glass). If possible, take your daily dose at the same time each day , for example at breakfast time.

If you take more olmesartan than you should

If you take more tablets than you should or if a child accidentally swallows some, go to your doctor or nearest accident and emergency department immediately and take your medicine pack with you.

If you forget to take olmesartan

If you forget a dose, take your normal dose on the following day as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking olmesartan

It is important to continue to take olmesartan unless your doctor tells you to stop.

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.

If they do occur, they are often mild and do not require treatment to be stopped.

Although not many people may get them, the following side effects can be serious:

• On uncommon occasions (may affect up to 1 in 100 people) quick allergic reactions that may affect the whole body and may cause breathing problems as well as a rapid fall of blood pressure that may even lead to fainting (anaphylactic reactions) may occur.
• Rarely (may affect up to 1 in 1,000 people) swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during treatment with olmesartan.
• Rarely (but slightly more often in older people) olmesartan can cause the blood pressure to fall too low in susceptible individuals or as the result of an allergic reaction. This could cause severe light-headedness or fainting.

If any of above mentioned occurs, stop taking olmesartan, contact your doctor immediately and lie down flat.

These are the other side effects known about so far with olmesartan medoxomil:

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

• Dizziness, headache
• Bronchitis, sore throat, cough, runny or stuffy nose
• Gastroenteritis (inflammation of the stomach or intestines), diarrhoea, stomach ache, nausea, indigestion,
• Pain in joints, back or bones
• Blood in the urine, infection of the urinary tract
• Pain, pain in the chest, swelling of the ankles, feet, legs, hands or arms, flu-like symptoms, tiredness
• Changes in blood test results:

• – Increased fat levels (hypertriglyce­ridaemia)

• – Increased uric acid levels (hyperuricaemia)

• – Rise in blood urea

• – Increases in tests of liver and muscle function.

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

• A feeling of dizziness or spinning (vertigo)
• Angina (pain or uncomfortable feeling in the chest)
• Vomiting
• Skin rash, allergic skin rash, hives, itching, exanthema (skin eruption), skin lumps (wheals)
• Muscle pain
• Swelling of the face, feeling of weakness or feeling unwell
• In blood tests a reduction of the numbers of a type of blood cell, known as platelets has been seen (thrombocytopenia)

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

• Acute kidney failure, impaired kidney function
• Muscle cramps
• Lack of energy
• Changes in blood test results:

• – Increased potassium levels (hyperkalaemia)

• – Increased levels of compounds related to kidney function

Additional side effects in children and adolescents

In children, side effects are similar to those reported in adults. However, dizziness and headache are seen more often in children, and nose bleeding is a common side effect seen in children only.

Reporting of side effects

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 at: 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.

5. how to store olmesartan

Keep this medicine out of the sight and reach of children.

Do not store above 25 °C.

Do not use this medicine after the expiry date which is stated on the box and on the blister after (“EXP”). The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other nformation

What olmesartan contains

The active substance is olmesartan medoxomil.

Each film-coated tablet contains 10 mg, 20 mg or 40 mg olmesartan medoxomil.

The other ingredients are:

Microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, low-hydroxypropyl cellulose-11, magnesium stearate, colloidal anhydrous silica, hypromellose, talc, titanium dioxide (E171).

What olmesartan looks like and contents of the pack

Olmesartan 10 and 20 mg are white-coloured, round film-coated tablets.

Olmesartan 40 mg are white, oval, film-coated tablets.

Olmesartan film-coated tablets are packed in Al/Al (OPA/AL/PVC and AL foils) blister. Olmesartan film-coated tablets are available in blister packs of 14, 28, 30, 50, 56, 84, 90, 98, 100 and 500 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP United Kingdom

Manufacturer

S.C. Zentiva, S.A., B-dul Theodor Pallady nr.50, sector 3, 032266 Bukuresti, Romania

This leaflet was last revised in May 2020