OLMETEC PLUS 40MG/12.5MG FILM-COATED TABLETS

Active substance: OLMESARTAN MEDOXOMIL

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Package Leaflet: Information for the User

Olmetec® Plus 40 mg/12.5 mg
Film-Coated Tablets
Olmesartan medoxomil/Hydrochlorothiazide

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 on 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 Olmetec Plus is and what it is used for
2. Before you take Olmetec Plus
3. How to take Olmetec Plus
4. Possible side effects
5. How to store Olmetec Plus
6. Further information

1. What Olmetec Plus is and what it is used for
Olmetec Plus contains two active substances,
olmesartan medoxomil and hydrochlorothiazide,
that are used to treat high blood pressure
(hypertension):
• Olmesartan medoxomil is one of a group of
medicines called angiotensin II-receptor
antagonists. It lowers blood pressure by
relaxing the blood vessels.
• Hydrochlorothiazide is one of a group of
medicines called thiazide diuretics (“water
tablets”). It lowers blood pressure by helping
the body to get rid of extra fluid by making your
kidneys produce more urine.
You will only be given Olmetec Plus if Olmetec
(olmesartan medoxomil) alone has not adequately
controlled your blood pressure. When given
together, the two active substances in Olmetec
Plus help to lower blood pressure more than if
either of them were given alone.
You may already be taking medicines to treat your
high blood pressure, but your doctor may want
you to take Olmetec Plus to lower it more.
High blood pressure can be controlled with
medicines such as Olmetec Plus 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 Plus
Do not take Olmetec Plus if you:
• are allergic (hypersensitive) to olmesartan
medoxomil or to hydrochlorothiazide, or to any
of the other ingredients in the tablets (Section 6
contains a complete list) or to substances similar
to hydrochlorothiazide (sulfonamides)
• are more than 3 months pregnant (It is also
better to avoid Olmetec Plus in early pregnancy –
see pregnancy section)
• have kidney problems
• suffer from low potassium, low sodium, high
calcium or high uric acid levels in the blood
(with symptoms of gout or kidney stones) that
do not get better when treated
• suffer from moderate or severe liver problems
or yellowing of the skin and eyes (jaundice) or
problems with drainage of the bile from the
gallbladder (biliary obstruction, e.g. gallstones)
If you think any of these apply to you, or you are
unsure, do not take the tablets. Talk to your
doctor first and follow the advice given.
Take special care with Olmetec Plus

– potassium supplements (as well as salt
substitutes containing potassium)
– water tablets (diuretics)
– heparin (for thinning the blood)
– laxatives
– steroids
– adrenocorticotrophic hormone (ACTH)
– carbenoxolone (a medicine used to treat
mouth and stomach ulcers)
– penicillin G sodium (also called benzylpenicillin
sodium, an antibiotic)
– certain pain killers such as aspirin or
salicylates
• Lithium (a medicine used to treat mood swings
and some types of depression) used at the
same time as Olmetec Plus 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 Plus may increase the risk of kidney
failure and the effect of Olmetec Plus can be
decreased by NSAIDs
• Other blood pressure lowering medicines
(anti-hypertensives), as the effect of Olmetec
Plus can be increased
• Sleeping tablets, sedatives and anti-depressant
medicines, as using these medicines together
with Olmetec Plus may cause a sudden drop in
blood pressure when standing up
• Certain medicines such as baclofen and
tubocurarine, used to relax muscles
• Amifostine and some other drugs used to
treat cancers, such as cyclophosphamide or
methotrexate
• Colestyramine and colestipol, medicines for
lowering blood fat levels
• Anticholinergic agents, such as atropine and
biperiden
• Drugs such as thioridazine, chlorpromazine,
levomepromazine, trifluoperazine, cyamemazine,
sulpiride, amisulpride, pimozide, sultopride,
tiapride, droperidol or haloperidol, used to treat
certain psychiatric disorders
• Certain medicines such as quinidine,
hydroquinidine, disopyramide, amiodarone,
sotalol or digitalis, used to treat heart problems
• Medicines such as mizolastine, pentamidine,
terfenadine, dofetilide, ibutilide or erythromycin
injections, which may change the heart rhythm
• Oral anti-diabetic medicines, such as metformin
or insulin, used to lower blood sugar
• Beta-blockers and diazoxide, medicines used
to treat high blood pressure or low blood sugar,
respectively, as Olmetec Plus can enhance
their blood-sugar-increasing effect
• Methyldopa, a medicine used to treat high
blood pressure

Before you take the tablets, tell your doctor if
you have any of the following health problems:

• Medicines such as noradrenaline, used to
increase blood pressure and slow heart rate

• Kidney transplant

• Diphemanil, used to treat a slow heartbeat or
reduce sweating

• Liver diseases
• Heart failure or problems with your heart valves
or heart muscles
• Vomiting (being sick) or diarrhoea which is
severe or it goes on for several days
• Treatment with high doses of water tablets
(diuretics) or if you are on a low salt diet
• Problems with your adrenal glands (e.g. primary
aldosteronism)
• Diabetes
• Lupus erythematosus (an autoimmune disease)
• Allergies or asthma.
Your doctor may want to see you more often
and do some tests if you have any of these
conditions.
Olmetec Plus may cause a rise in blood fat levels
and uric acid levels (the cause of gout – painful
swelling of the joints). Your doctor will probably
want to do a blood test from time to time to check
these.
It may change the levels of certain chemicals in
your blood called electrolytes. Your doctor will
probably want to do a blood test from time to
time to check these. Signs of electrolyte changes
are: thirst, dryness of the mouth, muscle pain or
cramps, tired muscles, low blood pressure
(hypotension), feeling weak, sluggish, tired,
sleepy or restless, nausea, vomiting, less need to
pass urine, a rapid heart rate. Tell your doctor if
you notice these symptoms.
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.
If you are due to have tests for parathyroid
function, you should stop taking Olmetec Plus
before these tests are carried out.
If you are a sports person, this medicine could
change the results of an anti-dope test to make it
positive.
You must tell your doctor if you think that you are
(or might become) pregnant. Olmetec Plus 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 other medicines
including medicines obtained without a
prescription.
In particular, tell your doctor or pharmacist about
any of the following:
• Medicines which may raise the levels of
potassium in your blood if used at the same
time as Olmetec Plus. These include:

• Medicines such as probenecid, sulfinpyrazone
and allopurinol, used to treat gout
• Calcium supplements
• Amantadine, an anti-viral drug
• Ciclosporin, a medicine used to stop rejection
of organ transplants
• Certain antibiotics called tetracyclines or
sparfloxacin
• Amphotericin, a medicine used to treat fungal
infections
• Certain antacids, used to treat too much
stomach acid, such as aluminium magnesium
hydroxide, as the effect of Olmetec Plus can be
slightly decreased.
• Cisapride, used to increase food movement in
the stomach and gut
• Halofantrine, used for malaria
Taking Olmetec Plus with food and drink
Olmetec Plus can be taken with or without food.
Take care when drinking alcohol while you are
taking Olmetec Plus, as some people feel faint or
dizzy. If this happens to you, do not drink any
alcohol, including wine, beer or alcopops.
Children and adolescents (under 18)
Olmetec Plus is not recommended for children
and adolescents under the age of 18.
Black patients
As with other similar drugs the blood pressure
lowering effect of Olmetec Plus is somewhat less
in black patients.
Pregnancy and breastfeeding
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 Plus before
you become pregnant or as soon as you know
you are pregnant and will advise you to take
another medicine instead of Olmetec Plus.
Olmetec Plus is not recommended during
pregnancy, and must not be taken when more
than 3 months pregnant, as it may cause serious
harm to your baby if it is used after the third
month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or about
to start breastfeeding. Olmetec Plus is
not recommended for mothers who are
breastfeeding, and your doctor may choose
another treatment for you if you wish to breastfeed.
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.
GB 109572

Important information about some of the
ingredients of Olmetec Plus
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 medicine.

3. How to take Olmetec Plus
Always take Olmetec Plus exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
The usual dose is one Olmetec Plus 40 mg/12.5 mg
tablet a day.
Swallow the tablet with water. If possible, you
should take your dose at the same time each
day, for example at breakfast time. It is important
to continue to take Olmetec Plus until your
doctor tells you to stop.
If you take more Olmetec Plus than you should
If you take more tablets than you should, or if a
child accidentally swallows one or more, go to
your doctor or nearest accident and emergency
(A&E) department immediately and take your
medicine pack with you.
If you forget to take Olmetec Plus
If you forget to take 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 Plus
It is important to continue to take Olmetec Plus
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 Plus can cause side
effects, although not everybody gets them.
However, the following two side effects can be
serious:
• Allergic reactions that may affect the whole
body, with swelling of the face, mouth and/or
voice box (larynx) together with itching and rash
may occur very rarely. If this happens, stop
taking Olmetec Plus and contact your doctor
immediately.
• Olmetec Plus can cause the blood pressure to
fall too low in susceptible individuals or as the
result of an allergic reaction. Light-headedness
or fainting may occur uncommonly. If this
happens, stop taking Olmetec Plus, contact
your doctor immediately and lie down flat.
Olmetec Plus is a combination of two active
substances and the following information firstly
gives the other side effects reported so far with
the combination Olmetec Plus (besides those
already mentioned above) and, secondly, those
which are known about for the separate active
substances.
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:

Hydrochlorothiazide:
Very common side effects:
Changes in blood results including: Increase in
blood fat and uric acid levels.
Common side effects:
Feeling confused, abdominal pain, stomach upset,
bloated feeling, diarrhoea, nausea, vomiting,
constipation, excretion of glucose into the urine.
Some changes in blood results have also been
seen and include:
Increase in blood creatinine, urea, calcium and
sugar levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase of
serum amylase (hyperamylasaemia).
Uncommon side effects:
Decreased or loss of appetite, severe difficulty
breathing, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing
myopia erythema, skin reactions to light, itching,
purplish spots or patches on the skin due to
small hemorrhages (purpura), skin lumps
(wheals).
Rare side effects:
Swollen and sore salivary glands, decreased
number of white blood cells, decreased number
of blood platelets, anaemia, bone marrow
damage, restlessness, feeling ‘down’ or
depressed, problems sleeping, feeling uninterested
(apathy), tingling and numbness, fits (convulsions),
objects you look at appearing yellow, blurred
vision, dry eyes, irregular heart beat, inflammation
of the blood vessels, blood clots (thrombosis or
embolism), inflammation of the lung, fluid accumulation in the lungs, inflammation of the
pancreas, jaundice, infection in the gall bladder,
symptoms of lupus erythematosus (such as rash,
joint pains and cold hands and fingers), allergic
skin reactions, peeling and blistering of the skin,
non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (sometimes causing impaired movement).
Very rare side effects:
Electrolyte disturbance leading to an abnormally
depleted level of chloride in the blood (hypochloraemic alkalosis), blockage in the gut
(paralytic ileus).
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 Plus
Keep out of the reach and sight of children.
This medicinal product does not require any
special storage conditions.
Do not use Olmetec Plus after the expiry date
which is stated on the carton and on the blister
strip as EXP. The expiry date refers to the last day
of that month.
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.

Very common

affects more than 1 user in 10

6. Further information

Common

affects 1 to 10 users in 100

What Olmetec Plus contains

Uncommon

affects 1 to 10 users in 1,000

Rare

affects 1 to 10 users in 10,000

Very rare

affects less than 1 user
in 10,000

These are the other side effects known about
so far with Olmetec Plus:
If these side effects occur, they are often mild and
you do not need to stop your treatment.
Common side effects:
Dizziness, weakness, headache, tiredness, chest
pain, swelling of ankles, feet, legs, hands or arms.
Uncommon side effects:
Fluttering of the heart beat (palpitations), rash,
eczema, vertigo, cough, indigestion, abdominal
pain, nausea, vomiting, diarrhoea, muscle
cramps and muscular pain, pain in joints, arms
and legs, back pain, erection difficulties in men,
blood in urine.
Some changes in blood test results have also
been seen uncommonly and include:
Rise in blood fat levels, rise in blood urea or uric
acid, rise in creatinine, rise or decrease in blood
potassium levels, rise in blood calcium levels, rise
in blood sugar, increase in levels of liver function.
Your doctor will know about these from a blood
test and will tell you if you need to do anything.
Rare side effects:
Feeling unwell, disturbances in consciousness,
skin lumps (wheals), acute kidney failure.
Some changes in blood test results have also
been seen in rare cases and include:
Rise in blood urea nitrogen, decrease in haemoglobin and haematocrit values. Your doctor will
know about these from a blood test and will tell
you if you need to do anything.
Further side effects reported with use of
olmesartan medoxomil or hydrochlorothiazide
alone but not with Olmetec Plus or in a higher
frequency:
Olmesartan medoxomil:
Common side effects:
Bronchitis, cough, runny or stuffy nose, sore
throat, abdominal pain, indigestion, diarrhoea,
nausea, gastroenteritis, pain in the joints or
bones, back pain, blood in urine, urinary tract
infection, flu-like symptoms, pain.
Some changes in blood test results have also
been seen commonly and include:
Rise in blood fat levels, rise in blood urea or
uric acid, increase in levels of liver and muscle
function.
Uncommon side effects:
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), swelling
of the face, angina (pain or uncomfortable feeling
in the chest; known as angina pectoris), feeling
unwell, allergic skin rash, itching, exanthema (skin
eruption), skin lumps (wheals).
Some changes in blood test results have also
been seen uncommonly and include:
Reduced numbers of a type of blood cell, known
as platelets (thrombocytopenia).
Rare side effects:
Impaired kidney function, lack of energy.
Some changes in blood test results have also
been seen rarely and include:
Increase in blood potassium.

The active substances are:
Olmetec Plus 40 mg/12.5 mg: Each film-coated
tablet contains 40 mg olmesartan medoxomil and
12.5 mg hydrochlorothiazide.
The other ingredients are:
Microcrystalline cellulose, lactose monohydrate*,
low substituted hyprolose, hyprolose, magnesium
stearate, titanium dioxide (E 171), talc,
hypromellose, iron (III) oxides (E 172).
* See ‘Important information about some of
the ingredients of Olmetec Plus’ section
above
What Olmetec Plus looks like and contents of
the pack:
Olmetec Plus 40 mg/12.5 mg film-coated tablets
are reddish-yellow, oval with "C23" on one side.
They are available in packs of 14, 28, 30, 56, 84,
90, 98, 10 x 28 and 10 x 30 film-coated tablets
and in packs with perforated unit dose blisters of
10, 50 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
DAIICHI SANKYO UK LTD
Chiltern Place, Chalfont Park, Gerrards Cross
Buckinghamshire SL9 0BG
UK
Manufacturer
DAIICHI SANKYO EUROPE GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen, Germany
Date of approval of this leaflet: April 2012
UK:
Olmetec 40 mg/12.5 mg Film-Coated Tablets:
The following pack sizes are currently marketed:
28 film-coated tablets.

Problems reading this leaflet?
To listen to or request a copy
of this leaflet in Braille, large
print or audio, please call,
free of charge 0800 198 5000
(UK only)
Please be ready to give the
following information:
Product name: Olmetec Plus
40 mg/12.5 mg Film-Coated
Tablets
Reference number:
PL 08265/0029
This is a service provided by
the Royal National Institute of
Blind People.

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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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