Olmesartan Medoxomil 40mg Tablets
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OLMETEC® 40mg Tablets / OLMESARTAN MEDOXOMIL 40mg Tablets
(olmesartan medoxomil)
Patient Information Leaflet
This product is available using either of the above names but will be referred to as Olmetec throughout the leaflet.
Other strengths of this product are also available.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is Olmetec and what it is used for
2. Before you take Olmetec
3. How to take Olmetec
4. Possible side effects
5. How to store Olmetec
6. Further information
1. What is Olmetec and what it is used for
Olmetec belongs to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels.
Olmetec 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 Olmetec 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. Before you take Olmetec Do not take Olmetec
• if you are allergic (hypersensitive) to olmesartan medoxomil or to any other of the ingredients of Olmetec
• if you are more than 3 months pregnant. (It is also better to avoid Olmetec 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).
Take special care with Olmetec
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, 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.
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. Olmetec 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).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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 Olmetec 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 Olmetec 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 Olmetec may increase the risk of kidney failure and the effect of Olmetec can be decreased by NSAIDs.
• Other blood pressure lowering medicines, as the effect of Olmetec can be increased.
• Certain antacids (indigestion remedies), as the effect of Olmetec can be slightly decreased.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Olmetec with food and drink
Olmetec 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.
Children and adolescents (under 18)
Olmetec is 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 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 Olmetec is somewhat less in black patients.
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 Olmetec before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Olmetec. Olmetec 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. Olmetec 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
It is unlikely that Olmetec 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.
Important information about some of the ingredients in Olmetec
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.
POM
3. How to take Olmetec
Always take Olmetec exactly as your doctor has told you. You should 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 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.
If you take more Olmetec 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 Olmetec
If you forget a dose, take your normal dose on the following day as usual. Do not take any extra tablets to make up for the missed dose.
If you stop taking Olmetec
It is important to continue to take Olmetec 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, Olmetec 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 Olmetec. If this happens stop taking Olmetec and contact your doctor immediately.
Rarely (but slightly more often in elderly patients) Olmetec can cause the blood pressure to fall too low in susceptible individuals. This could cause severe light-headedness or fainting. If this occurs stop taking Olmetec, contact your doctor immediately and lie down flat.
To give you an idea of how many patients might get side effects, they have been listed as common, uncommon, rare and very rare. These mean the following:
|
Common |
less than 1 in 10 people. |
|
Uncommon |
less than 1 in 100 people. |
|
Rare |
less than 1 in 1,000 people. |
|
Very rare |
less than 1 in 10,000 people. |
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).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Olmetec
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Olmetec after the expiry date (“EXP”) which is stated on the box and on the blister strip.
If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Olmetec contains
The active substance is olmesartan medoxomil
Each film-coated tablet contains 40 mg olmesartan medoxomil.
Other ingredients are
Microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose,
magnesium stearate, titanium dioxide (E171), talc and hypromellose.
What Olmetec looks like and contents of the pack
Olmetec 40mg Tablets are white, oval, film-coated tablets marked C15 embossed on one side and plain on the reverse.
Olmetec tablets are supplied in blister packs of 30 film-coated tablets.
Manufacturer and Product Licence holder
This medicine is manufactured by Daiichi Sankyo Europe GmbH, Luitpoldstrasse 1, 85276 Pfaffenhofen, Germany. It is procured from within the EU by the Product Licence Holder: Swinghope Ltd, Marlowe Way, Croydon CR0 4XS and repackaged by Interport Ltd, Marlowe Way, Croydon CR0 4XS.
PL No: 10380/1082
Leaflet revision date: 14/08/12
Olmetec® is a registered trademark of Sankyo Company Limited, Japan.
Common side effects:
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 side effects:
Vertigo, skin rash, angina (pain or uncomfortable feeling in the chest).
Rare side effects:
Rarely, blood test results have shown increased potassium levels (hyperkalaemia).
Very rare side effects:
Headache, muscle cramps and muscular pain, impaired kidney function, kidney failure, weakness, lack of energy, feeling unwell, vomiting, itching, exanthema (skin eruption).
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