Olmesartan Medoxomil 40 Mg Film-Coated Tablets
OLMESARTAN MEDOXOMIL 10 mg, 20 mg, 40 mg FILM-COATED TABLETS
Package leaflet: Information for the user
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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.
What is in this leaflet:
1. What Olmesartan Medoxomil is and what it is used for
2. What you need to know before you take Olmesartan Medoxomil
3. How to take Olmesartan Medoxomil
4. Possible side effects
5. How to store Olmesartan Medoxomil
6. Contents of the pack and other information
OH What Olmesartan Medoxomil is and what it is used for
Olmesartan Medoxomil belongs to a group of medicines called angiotensin-II antagonists. They lower blood pressure by relaxing the blood vessels.
Olmesartan Medoxomil is used for the treatment of high blood pressure (also known as 'hypertension'). 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 Medoxomil 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.
What you need to know before you take Olmesartan Medoxomil
Do not take Olmesartan Medoxomil if you:
• are allergic to olmesartan 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 Olmesartan Medoxomil in early pregnancy - see section 2: Pregnancy, breast-feeding and fertility)
• suffer from yellowing of the skin and eyes (jaundice) or problems with drainage of the bile from the gallbladder (biliary obstruction e.g. gallstones)
• 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 Medoxomil.
• 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 Medoxomil'.
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, 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.
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 Medoxomil is not recommended in early pregnancy. This medicine 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 2: Pregnancy, breast-feeding and fertility).
Children and adolescents
Olmesartan Medoxomil is not recommended for children and adolescents under the age of 18.
Other medicines and Olmesartan Medoxomil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• 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 Medoxomil 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 Medoxomil may increase the toxicity of lithium. If you have to take lithium, your doctor will measure your lithium blood levels.
• Non-Steroidal Anti-Inflammatory Drugs, also known as NSAIDs (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) used at the same time as Olmesartan Medoxomil may increase the risk of kidney failure and the effect of Olmesartan Medoxomil can be decreased by NSAIDs.
• Other blood pressure lowering medicines,
as the effect of Olmesartan Medoxomil 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 Medoxomil' and 'Warnings and precautions').
• Certain antacids (indigestion remedies), as the effect of Olmesartan Medoxomil can be slightly decreased.
Older people
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 medicines, the blood pressure lowering effect of olmesartan medoxomil is somewhat less in black patients.
Olmesartan Medoxomil with food and drink
Olmesartan Medoxomil can be taken with or without food (see section 3).
Pregnancy, breast-feeding and fertility
If you are pregnant or 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.
Pregnancy
You must tell your doctor if you are or might become pregnant. Your doctor will normally advise you to stop taking Olmesartan Medoxomil before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Olmesartan Medoxomil.
Olmesartan Medoxomil 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 Medoxomil 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.
Ask your doctor or pharmacist for advice before taking any 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 Medoxomil 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 medicine.
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How to take Olmesartan Medoxomil
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 for adults is 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 mg 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.
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.
Olmesartan Medoxomil 20 mg and 40 mg film-coated tablets: The tablet can be divided into equal doses.
If you take more Olmesartan Medoxomil than you should
If you take more tablets than you should or if a child accidentally swallows some, go to your doctor or nearest emergency department immediately and take your medicine pack with you.
If you forget to take Olmesartan Medoxomil
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 Medoxomil
It is important to continue to take Olmesartan Medoxomil unless your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 two side effects can be serious: On rare occasions (may affect up to 1 in 1,000 people) the following allergic reactions, that may affect the whole body have been reported:
• swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during treatment with olmesartan. If this happens stop taking Olmesartan Medoxomil and contact your doctor immediately
• rarely (but 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 this occurs stop taking Olmesartan Medoxomil, contact your doctor immediately and lie down flat.
These are the other side effects known about so far with olmesartan:
Common: may affect up to 1 in 10 people
dizziness headache nausea indigestion diarrhoea stomach ache gastroenteritis tiredness sore throat runny or stuffy nose bronchitis flu-like symptoms cough pain
pain in the chest, back, bones or joints infection of the urinary tract swelling of ankles, feet, legs, hands, or arms
• blood in the urine.
Some changes in blood test results have also been seen and include the following:
• increased fat levels (hypertriglyceridaemia)
• increased uric acid levels (hyperuricaemia)
• rise in blood urea
• increases in tests of liver and muscle function.
Uncommon: 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)
• vertigo
• vomiting
• weakness
• feeling unwell
• muscular pain
• skin rash
• allergic skin rash
• itching
• exanthema (skin eruption)
• skin lumps (wheals)
• angina (pain or uncomfortable feeling in the chest).
In blood tests a reduction of the numbers of a type of blood cell, known as platelets has been seen (thrombocytopenia).
Rare: may affect up to 1 in 1,000 people
• lack of energy
• muscle cramps
• impaired kidney function
• kidney failure.
Some changes in blood test results have also been seen. These include increased potassium levels (hyperkalaemia) and 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: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
©■ How to store Olmesartan Medoxomil
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and carton 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.
©H Contents of the pack and other information
What Olmesartan Medoxomil contains
The active substance is olmesartan medoxomil. Each Olmesartan Medoxomil film-coated tablet contains 10 mg, 20 mg or 40 mg olmesartan medoxomil.
The other ingredients are:
Tablet core: lactose monohydrate cellulose, microcrystalline low-substituted hydroxypropyl cellulose magnesium stearate.
Film coating: Opadry II 85F18378 white [poly(vinyl alcohol) - partly hydrolyzed, titanium dioxide (E171), macrogol 3350 (polyethylene glycol), talc].
What Olmesartan Medoxomil looks like and contents of the pack
Olmesartan Medoxomil 10 mg film-coated tablets: White, round standard convex, film-coated tablets of 6.1 mm, debossed with "O" on one side and "10" on the other side.
Olmesartan Medoxomil 20 mg film-coated tablets: White, round standard convex, film-coated tablets of 8.2 mm, debossed with "O" on one side, the other side of the tablet is scored and debossed with "2" on the left side of the score and "0" on the right side.
Olmesartan Medoxomil 40 mg film-coated tablets: White, oval shaped, film-coated tablets of 15.2 mm in length and 7.1 mm width, debossed with "O" on one side, the other side of the tablet is scored and debossed with "4" on the left side of the score and "0" on the right side.
Olmesartan Medoxomil comes in blister packs of: 14, 28, 30, 56, 90 and 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Teva Operations Poland Sp. z.o.o, ul.
Mogilska 80. , Krakow, 31-546, Poland
This leaflet was last revised in 06/2016
PL 00289/1887 PL 00289/1888 PL 00289/1889
50073-C
395x160 12345678 (|23)
SAP (material code) Pharma code number number