Olmesartan 20 Mg Film-Coated Tablets
Package leaflet: Information for the user
Olmesartan 10mg, 20mg and 40mg 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 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.
• The full name of this medicine is Olmesartan 10mg, 20mg and 40mg Film-coated Tablets but within the leaflet it will be referred to as Olmesartan Tablets.
What is in this leaflet
J What Olmesartan Tablets are and what they are used for
^ What you need to know before you take Olmesartan Tablets ^ How to take Olmesartan Tablets ^ Possible side effects ^ How to store Olmesartan Tablets 3 Contents of the pack and other information
j What Olmesartan Tablets are and what they are used for
Olmesartan Tablets belong to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels.
Olmesartan 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 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 Tablets
Do not take Olmesartan 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 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 before taking Olmesartan Tablets 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.
And 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 Tablets'!
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 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 Tablets are not recommended for children and adolescents under the age of 18.
Elderly patients
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan medoxomil to 40mg 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 Tablets is somewhat less in black patients.
Other medicines and Olmesartan Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following 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 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 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 Tablets may increase the risk of kidney failure and the effect of Olmesartan Tablets can be decreased by NSAIDs.
• Other blood pressure lowering medicines, as the effect of Olmesartan Tablets can be increased.
• Certain antacids (indigestion remedies), as the effect of Olmesartan Tablets can be slightly decreased.
Tell your doctor or pharmacist if you 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:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings "Do not take Olmesartan Tablets" and "Warnings and precautions").
Pregnancy and breast-feeding
You must tell your doctor if you think you are (might become) pregnant. Your doctor will normally advise you to stop taking Olmesartan 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 Tablets. Olmesartan 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.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Olmesartan 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 if your baby is newborn, or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Olmesartan Tablets will affect your ability to drive or operate machinery. However, dizziness or fatigue can occasionally occur during the treatment of high blood pressure. If you notice such effects, do not drive or use machines until the symptoms wear off. Ask your doctor for advice.
Olmesartan Tablets contain lactose
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 Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The tablets can be taken with or without food. Swallow the tablets with a little water. If possible, take your daily dose at the same time each day, for example at breakfast time.
The usual starting dose is one 10mg tablet once a day.
However, if your blood pressure is not controlled, your doctor may decide to change your dose up to 20 or 40mg once a day, or prescribe additional medicines.
In patients with mild to moderate kidney disease, your dose will not be higher than 20mg once a day.
If you take more Olmesartan 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 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 dose.
If you stop taking Olmesartan Tablets
It is important to continue to take Olmesartan Tablets 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 very rare occasions the following allergic reactions have been reported:
Swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during treatment with Olmesartan Tablets. If this happens stop taking Olmesartan Tablets and contact your doctor immediately.
Rarely (but slightly more often in elderly patients) Olmesartan Tablets can cause the blood pressure to fall too low in susceptible individuals. This could cause severe lightheadedness or fainting. If this occurs stop taking Olmesartan Tablets, contact your doctor immediately and lie down flat.
Other side effects include:
Common (may affect up to 1 in 10 people):
Dizziness, nausea, indigestion, diarrhoea, stomach ache, gastroenteritis, tiredness, sore throat, runny or stuffy nose, bronchitis, flu-like symptoms, cough, 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), increases in tests of liver and muscle function.
Uncommon (may affect up to 1 in 100 people):
Vertigo, skin rash, angina (pain or uncomfortable feeling in the chest).
Rare (may affect up to 1 in 1,000 people):
Rarely, blood test results have shown increased potassium levels (hyperkalaemia).
Very rare (may affect up to 1 in 10,000 people):
Headache, muscle cramps and muscular pain, impaired kidney function, kidney failure, weakness, lack of energy, feeling unwell, vomiting, itching, exanthema (skin eruption).
Some changes in blood test results have also been seen. These include increased levels of compounds related to kidney function and reduced numbers of a type of blood cell, known as platelets (thrombocytopenia).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 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.
^1 How to store Olmesartan Tablets
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 carton or 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.
3 Contents of the pack and other information
What Olmesartan Tablets contain
• The active substance is: olmesartan medoxomil
• The other ingredients are:
Tablet core: Microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low substituted hydroxyl propylcellulose and magnesium stearate.
Tablet coat: Titanium dioxide (E171), hypromellose 6cP, lactose monohydrate, macrogol 3350 and triacetin.
What Olmesartan Tablets look like and contents of the pack
Olmesartan 10mg Film-coated Tablets are white, round, biconvex and 6.5mm in diameter, with OL 10 debossed on one side.
Olmesartan 20mg Film-coated Tablets are white, round, biconvex and 8.5mm in diameter, with OL 20 debossed on one side.
Olmesartan 40mg Film-coated Tablets are white, oval, biconvex and 15x7mm in diameter, with OL 40 debossed on one side.
Olmesartan 10mg, 20mg, 40mg Film-coated Tablets are available in packs of 28 film-coated tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland
Manufacturer
Actavis Ltd
BLB016 Bulebel Industrial Estate
ZTN 3000
Malta
This leaflet was last revised in July 2016.
If you would like a leaflet with larger text, please contact 01271 385257.
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Cactavis
Actavis, Barnstaple, EX32 8NS, UK