Olmesartan medoxomil Mylan

Patient Information Leaflet

Olmesartan medoxomil Mylan 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

olmesartan medoxomil
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 give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Olmesartan medoxomil Mylan is and what it is used for

Olmesartan medoxomil Mylan belongs to a group of medicines called angiotensin II receptor antagonists. These medicines lower blood pressure by dilating blood vessels.
This medicine is used to treat high blood pressure (also known as “hypertension”) in adults, 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.
High blood pressure usually does not cause symptoms. It is important to monitor your blood pressure regularly to help prevent damage.
High blood pressure can be controlled with medicines such as Olmesartan medoxomil Mylan tablets. 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 salt in your diet). 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 Mylan

Do not take Olmesartan medoxomil Mylan

• if you are allergic 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 this medicine even in the early stages of pregnancy – see section “Pregnancy”).
• if you have yellowing of the skin and eyes (jaundice) or disorders affecting 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 or pharmacist before taking Olmesartan medoxomil Mylan

• If you have kidney problems
• If you have liver disease
• If you suffer from heart failure or have heart valve or heart muscle problems
• If you are diabetic, have severe vomiting or diarrhoea, are being treated with high doses of diuretics, or are on a low-salt diet
• If you have high levels of potassium in your blood
• If you have adrenal gland problems
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
• aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information in the section “Do not take Olmesartan medoxomil Mylan”.
During treatment
Contact your doctor if you experience persistent and severe diarrhoea with significant weight loss. Your doctor will assess your symptoms and decide how to continue antihypertensive therapy.
As with any medicine that lowers blood pressure, excessive reduction 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 may be pregnant (or if there is a possibility of becoming pregnant). This medicine 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 Mylan has been studied in children and adolescents. For further information, consult your doctor. This medicine is not recommended for children from 1 year to less than 6 years of age and must not be used in children under 1 year of age, as no data are available.
Elderly
If you are over 65 years old 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 avoid excessive lowering.
Black patients
As with other similar medicines, the blood pressure-lowering effect of this medicine is somewhat reduced in black patients.
Other medicines and Olmesartan medoxomil Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (used to thin the blood). Taking these medicines together with Olmesartan medoxomil Mylan 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 Mylan may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis, e.g. ibuprofen, aceclofenac) taken together with Olmesartan medoxomil Mylan may increase the risk of kidney failure, and the effectiveness of Olmesartan medoxomil Mylan may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of Olmesartan medoxomil Mylan. Your doctor may advise you to take Olmesartan medoxomil Mylan at least 4 hours before colesevelam hydrochloride.
• Other medicines that lower blood pressure may enhance the effect of Olmesartan medoxomil Mylan.
• Some antacids (used for indigestion) may slightly reduce the effectiveness of Olmesartan medoxomil Mylan.

Your doctor may need to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also information in the sections “Do not take Olmesartan medoxomil Mylan” and “Warnings and precautions”).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative treatment.
This medicine 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 after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. This medicine is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.
Driving and using machines
You may experience drowsiness or dizziness during antihypertensive treatment. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.
Olmesartan medoxomil Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Olmesartan medoxomil Mylan

Take this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
Adults
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 or 40 mg
once daily, or may prescribe other 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 whole with a
sufficient amount of water (for example, a glass of water). The tablets must not be
chewed. If possible, take your daily dose at the same time each day, for example with
your first meal of the day.
Children and adolescents from 6 years up to but 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 adjust the dose up to 20 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 Mylan 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, and bring the
medicine pack with you.
If you forget to take Olmesartan medoxomil Mylan
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 dose.
If you stop taking Olmesartan medoxomil Mylan
It is important to continue taking this medicine unless your doctor tells you otherwise.
If you have any questions about how to use 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 mostly mild and do not require discontinuation of treatment.

Although they do not occur in everyone, the following side effects can be serious. If you experience any of the following, contact your doctor or go immediately to the Emergency Department of the nearest hospital:

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

• Rapid allergic reactions affecting the whole body, which may cause breathing difficulties or a sudden drop in blood pressure that may even lead to fainting (anaphylactic reactions).
• Pain and sensation of tightness or heaviness in the chest, especially during physical exertion. These may be signs of heart problems (angina).

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

• Swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash, may occur during treatment with this medicine. If this happens, stop taking this medicine and contact your doctor immediately.
• Rarely (but slightly more frequently in elderly people), this medicine may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This could cause severe dizziness or fainting. If this occurs, stop taking this medicine, contact your doctor immediately and remain lying down.
• Difficulty or pain when urinating, with changes in the colour and amount of urine. Back pain, nausea or vomiting, general feeling of being unwell. These may be signs of serious kidney problems.

Frequency not known:

• If you develop yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking Olmesartan medoxomil Mylan for a long time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with treatment for high blood pressure.

The following are other side effects known so far with Olmesartan medoxomil Mylan:

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

• Dizziness, headache
• Feeling unwell, indigestion, diarrhoea, stomach pain, gastroenteritis
• Feeling of fatigue
• Sore throat, nasal hypersecretion or nasal congestion, bronchitis, flu-like symptoms, cough
• Pain, particularly in the back, bones or joints
• Urinary tract infection
• Blood in the urine
• Swelling of ankles, feet, legs, hands or arms

The following laboratory test abnormalities have also been observed:

• Increase in blood fats (hypertriglyceridemia)
• Increase in uric acid in the blood (hyperuricemia)
• Increase in blood urea
• Increase in liver and muscle function test values

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

• Dizziness
• Vomiting, weakness, feeling unwell
• Muscle pain
• Skin rash, allergic skin rash, itching, rash (exanthema), skin blisters (wheals)

The following changes in blood test results have also been observed:

• Decrease in the number of a type of blood cell called platelets (thrombocytopenia)

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

• Lack of energy
• Muscle cramps
• Reduced kidney function, which may cause increased need to urinate, especially at night, and which is detected through blood tests
• Hypotension, which may cause dizziness or fatigue

The following blood test abnormalities have also been observed:

• Increase in potassium levels (hyperkalaemia)
• Increase in substances related to kidney function

Very rare (may affect up to 1 in 10,000 people):

• Persistent and severe diarrhoea with significant weight loss

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 commonly reported side effect occurring only in children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following 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 Mylan

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton and on the blister/pottle after "Exp.". The expiry date refers to the last day of that month.
For plastic containers:
Tablets 20 mg: use within 100 days of first opening
Tablets 10 mg: use within 180 days of first opening
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Olmesartan medoxomil Mylan contains

• The active substance is olmesartan medoxomil.
• Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomil.
• The other components of the tablet core are croscarmellose sodium, mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate.
• The film coating contains hypromellose, titanium dioxide (E171), macrogol, talc.

Description of the appearance of Olmesartan medoxomil Mylan and package contents
Olmesartan medoxomil Mylan 10 mg: white, round, biconvex film-coated tablets with bevelled edges, marked with “M” on one side and “O1” on the other.
Olmesartan medoxomil Mylan 20 mg: white, round, biconvex film-coated tablets with bevelled edges, marked with “M” on one side and “O2” on the other.
Olmesartan medoxomil Mylan 40 mg: white, oval, biconvex film-coated tablets with bevelled edges, marked with “M” on one side and “O4” on the other.
Olmesartan medoxomil Mylan film-coated tablets are available in packs containing 14, 28, 30, 50x1, 56, 90 and 98 film-coated tablets. The 10 mg tablets are also available in plastic bottles containing 500 film-coated tablets, and the 20 mg tablets are also available in plastic bottles containing 98 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
McDermott Laboratories Ltd t/a Gerard Laboratories, 35/36 Grange Road, Baldoyle Industrial Estate, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komárom, Mylan útca 1, Hungary

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Greece: Olmesartan / Mylan 10 mg, 20 mg & 40 mg
Ireland: Olmesartan medoxomil 10 mg, 20 mg & 40 mg Film-coated tablets
Italy: Olmesartan medoxomil Mylan 10, 20, 40 mg
Portugal: Olmesartan medoxomilo Mylan
United Kingdom (Northern Ireland): Olmesartan medoxomil 10 mg, 20 mg & 40 mg Film-coated tablets
Spain: Olmesartan Viatris 10 mg - 20 mg - 40 mg comprimidos recubiertos EFG