Olmesartan Medoxomil 40 Mg Film-Coated Tablets
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Package leaflet: Information for the patient
Olmesartan medoxomil 10 mg film-coated tablets Olmesartan medoxomil 20 mg film-coated tablets Olmesartan medoxomil 40 mg film-coated tablets
Olmesartan medoxomil
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 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 film-coated tablets are and what they are used for
2. What you need to know before you take Olmesartan medoxomil film-coated tablets
3. How to take Olmesartan medoxomil film-coated tablets
4. Possible side effects
5. How to store Olmesartan medoxomil film-coated tablets
6. Contents of the pack and other information
1. What Olmesartan medoxomil film-coated tablets are is and what they are used for
Olmesartan medoxomil film-coated tablets belong to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels.
Olmesartan medoxomil film-coated tablets are 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 film-coated 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 medoxomil film-coated tablets
Do not take Olmesartan medoxomil film-coated tablets
- if you are allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6).
- if you are more than 3 months pregnant. (It is also better to avoid Olmesartan medoxomil film-coated tablets in early pregnancy - see pregnancy section.)
- ifyou 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 before taking Olmesartan medoxomil film-coated tablets 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 ifyou 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 film-coated tablets”.
Tell your doctor ifyou 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 film-coated tablets are 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 film-coated tablets are not recommended for children and adolescents under the age of 18.
Other medicines and Olmesartan medoxomil film-coated tablets
Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines. Your doctor may need to change your dose and/or to take other 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 medoxomil film-coated tablets 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 film-coated tablets 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 medoxomil film-coated tablets may increase the risk of kidney failure and the effect of Olmesartan medoxomil film-coated tablets can be decreased by NSAIDs.
- If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Olmesartan medoxomil film-coated tablets” and “Warnings and precautions”).
- Other blood pressure lowering medicines, as the effect of Olmesartan medoxomil film-coated tablets can be increased.
- Certain antacids (indigestion remedies), as the effect of Olmesartan medoxomil film-coated tablets 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 drugs the blood pressure lowering effect of Olmesartan medoxomil film-coated tablets is somewhat less in black patients.
Olmesartan medoxomil film-coated tablets with food and drink
Olmesartan medoxomil film-coated tablets can be taken with or without food.
Pregnancy and breast-feeding
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will normally advise you to stop taking Olmesartan medoxomil film-coated tablets 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 film-coated tablets. Olmesartan medoxomil film-coated tablets are 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.
Manufacturer
PSI supply nv Axxes Business Park Guldensporenpark 22 -Block C 9820 Merelbeke Belgium
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Olmesartan medoxomil film-coated tablets are not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially ifyour 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. Ifthis happens, do not drive or use machines until the symptoms wear off.Askyour doctor for advice.
Olmesartan medoxomil film-coated tablets contain 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 medoxomil film-coated tablets
Always take this medicine exactly as your doctor 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 mg or a maximum of 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). The tablets should not be chewed. If possible, take your daily dose at the same time each day, for example at breakfast time.
If you take more Olmesartan medoxomil film-coated tablets 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 film-coated tablets
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 film-coated tablets
It is important to continue to take Olmesartan medoxomil film-coated tablets unless your doctor tells you to stop.
If you have any further questions on the use of this product, 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 two side effects can be serious:
On rare occasions (may affect up to 1 in 1000 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 medoxomil film-coated tablets. If this happens stop taking Olmesartan medoxomil film-coated tablets and contact your doctor immediately.
Rarely (but slightly more often in older people) Olmesartan medoxomil film-coated tablets 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 film-coated tablets, contact your doctor immediately and lie down flat.
These are the other side effects known about so far with Olmesartan medoxomil film-coated tablets:
Common side effects (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 side effects (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 inthe chest).
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 1000 people):
Lack of energy, muscle cramps, impaired kidney function, kidney failure, low blood pressure (hypotension), swelling of the skin and mucosa (angioedema), severe and persistent diarrhoea causing substantial weight loss (sprue-like enterophathy).
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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). By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Olmesartan medoxomil film-coated tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and on the blister strip (“EXP”). The expiry date refers to the last day of that month.
Store below25°C.
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 to protect the environment.
6. Contents of the pack and other information
What Olmesartan medoxomil film-coated tablets contain
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, hydroxypropylcellulose, low substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc and hypromellose.
What Olmesartan medoxomilfilm-coated tablets looklike and contents ofthe pack Olmesartan medoxomil 10 mg film-coated tablets are white, circular with “C9” debossed on one side.
Olmesartan medoxomil 20 mg film-coated tablets are white, circular with “D1” debossed on one side.
Olmesartan medoxomil 40 mg film-coated tablets are white, oval with “466” debossed on one side.
Olmesartan medoxomil film-coated tablets are available in packs of 14,28,30, 56, 84,90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed. MarketingAuthorisation Holder and Manufacturer
MarketingAuthorisation Holder
JubilantPharmaceuticals nv Axxes Business Park Guldensporenpark 22 -Block C 9820 Merelbeke Belgium
This medicinal product is authorised in the Member States of the EEA under the following names:
Cyprus: Olmesartan medoxomil Jubilant
Denmark: Olmesartan Jubilant
Sweden: Olmesartan Jubilant
The Netherlands: Olmesartan medoxomil Jubilant
UK: Olmesartan medoxomil film-coated tablets
This leaflet was last revised in June 2015.