Medication Guide App

OLMETEC 40MG TABLETS

Active substance: OLMESARTAN MEDOXOMIL

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is known as any of the above names but will be referred to as Olmetec throughout this leaflet.

1. What Olmetec is 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.

DATE:
16/10/13

Children and adolescents
Olmetec is not recommended for children and adolescents under the age of 18.
Other medicines and Olmetec:
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 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.
UK PIL APRIL 2013

TVT CHECKED
6464/2041 2042 2043 D
CODE:

DT

DATE OF PROOF:

DATE:

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).

Olmetec 10mg 20mg 40mgtabs

ARTWORKER:

WARNING!

Warnings and precautions
Talk to your doctor before taking Olmetec. 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.

PRODUCT:

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

2. What you need to know before you take Olmetec:
Do not take Olmetec
• 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 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).

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 Olmetec is somewhat less in black patients.
Olmetec with food and drink
Olmetec can be taken with or without food.
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
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.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

What is in this leaflet:
1. What Olmetec is and what it is used for
2. What you need to know before you take Olmetec
3. How to take Olmetec
4. Possible side effects
5. How to store Olmetec
6. Contents of the pack and other information

PROOF HISTORY:
v.1 - waymade - 16/10/13

Leaflet Flat Size = 148 x 400

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. 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).

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Olmetec 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 medicinal product.
3. How to take Olmetec
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 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.

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, 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 Olmetec. If this happens stop taking Olmetec and contact your doctor immediately.
Rarely (but slightly more often in older people) Olmetec 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 Olmetec, contact your doctor immediately and lie down flat.

WARNING!

These are the other side effects known about so far with Olmetec

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 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 side effects (may affect up to 1 in 1000 people):
Lack of energy, muscle cramps, impaired kidney function, kidney failure.

DATE:
16/10/13






TVT CHECKED




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 sight and reach 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines that are no longer required. These measures will help to protect the
environment.

6. Contents of the pack and other information
Your medicine is called Olmetec tablets/Olmesartan medoxomil tablets.
Olmetec 10mg tablets/Olmesartan medoxomil 10mg tablets: each white, round, film-coated tablet contains
10mg of the active ingredient, olmesartan medoxomil and is marked ‘C13’ on one side and plain on the
reverse.
UK PIL APRIL 2013

6464/2041 2042 2043 D

DATE OF PROOF:

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 (see details below). By reporting side effects you can
help provide more information on the safety of this medicine.

CODE:

DT
ARTWORKER:
PRODUCT:

Olmetec 10mg 20mg 40mgtabs

Q.A.
APPROVED:
05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

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.

Olmetec 20mg tablets/Olmesartan medoxomil 20mg tablets: each white, round, film-coated 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, film-coated 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, hydroxypropyl cellulose, magnesium stearate, hyprolose,
titanium dioxide (E171), hypromellose and talc.
Olmetec tablets/Olmesartan medoxomil tablets are available as blister packs of 28 tablets.
POM

Colour
Swatch

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.) 15.10.2013
OLMETEC is a registered trademark of Sankyo Company Limited
Reporting of side effects:
United Kingdom
Yellow Card Scheme
Tel: Free phone 0808 100 3352
Website: www.mhra.gov.uk/yellowcard

000-0000D

Black

WARNING!

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.
DATE:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

If you forget to take Olmetec
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.

PROOF HISTORY:
v.1 - waymade - 16/10/13

Leaflet Flat Size = 148 x 400

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.

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.

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