OLMETEC 40MG TABLETS

Active substance: OLMESARTAN MEDOXOMIL

View full screen / Print PDF » Download PDF ⇩

Transcript
OLMETEC® 10mg TABLETS/OLMESARTAN MEDOXOMIL 10mg
TABLETS
OLMETEC® 20mg TABLETS/OLMESARTAN MEDOXOMIL 20mg
TABLETS
OLMETEC® 40mg TABLETS/OLMESARTAN MEDOXOMIL 40mg
TABLETS
(olmesartan medoxomil)
Patient Information Leaflet
This product is known as any of the above names but will be referred to as Olmetec
throughout this leaflet.
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 four or more months pregnant



if you are breast feeding



if you suffer from gallstones or jaundice (yellowing of the skin).

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.
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
Tell your doctor before taking Olmetec if you are pregnant, think you may be pregnant or
are planning to become pregnant. It is best not to take Olmetec during the first 3 months
of pregnancy. If pregnancy is diagnosed, treatment should be stopped immediately. You
must definitely not take Olmetec if you are four or more months pregnant (see “Do not
take Olmetec” above).
You must not take Olmetec if you are breast feeding.
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.
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.
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).
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
Olmetec tablets/Olmesartan medoxomil tablets should not be stored above 25°C.
Do not use after the expiry date printed on the carton label or blister strip.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist
for safe disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, consult your
pharmacist who will tell you what to do.
6. Further information
Your medicine is called Olmetec tablets/Olmesartan medoxomil tablets.
Olmetec 10mg tablets/Olmesartan medoxomil 10mg tablets: each white, round, filmcoated tablet contains 10mg of the active ingredient, olmesartan medoxomil and is
marked '‘C13’ on one side and plain on the reverse.
Olmetec 20mg tablets/Olmesartan medoxomil 20mg tablets: each white, round, filmcoated tablet contains 20mg of the active ingredient, olmesartan medoxomil and is
marked '‘C14’ on one side and plain on the reverse.
Olmetec 40mg tablets/Olmesartan medoxomil 40mg tablets: each white, oval, filmcoated tablet contains 40mg of the active ingredient, olmesartan medoxomil and is
marked '‘C15’ on one side and plain on the reverse.
Olmetec tablets/Olmesartan medoxomil tablets also contain the following inactive
ingredients:
lactose monohydrate, microcrystalline cellulose, hydroxylpropyl cellulose, magnesium
stearate, hyprolose, titanium dioxide (E171), hypromellose and talc.
Olmetec tablets/Olmesartan medoxomil tablets are available as blister packs of 28
tablets.
POM

PL No: 6464/2041 Olmetec 10mg tablets/Olmesartan medoxomil 10mg tablets
PL No: 6464/2042 Olmetec 20mg tablets/Olmesartan medoxomil 20mg tablets
PL No: 6464/2043 Olmetec 40mg tablets/Olmesartan medoxomil 40mg tablets

These products are manufactured by Sankyo Pharma GmbH, Zeilstattstraβe 9, 81379
Munich, Germany and procured from within the EU and repackaged by the Product
Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 29.9.2008
OLMETEC is a registered trademark of Sankyo Company Limited

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)