OLMETEC PLUS 40 MG/12.5 MG FILM-COATED TABLETS

Active substance: OLMESARTAN MEDOXOMIL

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500000/PL1a

®

Olmetec Plus 40 mg/12.5 mg film-coated tablets
(olmesartan medoxomil / hydrochlorothiazide)
Patient Information Leaflet
The name of your medicine is Olmetec Plus 40 mg/12.5 mg
film-coated tablets. Throughout this leaflet it will be referred to
as Olmetec Plus. Other strengths are 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 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
Before you take the tablets, tell your doctor if you have any
of the following health problems:

Kidney transplant

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:
- 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 (antihypertensives), 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-sugarincreasing effect
• Methyldopa, a medicine used to treat high blood
pressure
• Medicines such as noradrenaline, used to increase
blood pressure and slow heart rate
• Diphemanil, used to treat a slow heartbeat or reduce
sweating
• 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
adolescents under the age of 18.

for

children

and

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.
Continued overleaf

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.
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:
Very common
Common
Uncommon
Rare
Very rare

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
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.

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.
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 haemorrhages (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).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE OLMETEC PLUS
• Keep out of the sight and reach 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.
• If your medicine shows any signs of discolouration or
deterioration, please tell your pharmacist immediately.
6. FURTHER INFORMATION
What Olmetec Plus contains
Each film-coated tablet contains 40 mg
medoxomil and 12.5 mg hydrochlorothiazide.

olmesartan

The other ingredients are: microcrystalline cellulose, lactose
monohydrate*, low substituted hydroxypropylcellulose,
hydroxypropylcellulose, magnesium stearate, titanium dioxide
(E171), talc, hypromellose, yellow iron oxide (E172) & red iron
oxide (E172).
* See ‘Important information about some of the
ingredients of Olmetec Plus’ section above

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.

What Olmetec Plus looks like and contents of the pack:
Olmetec Plus 40 mg/12.5 mg film-coated tablets are reddishyellow, oval film-coated tablets with C23 debossed on one
side and plain on the other side.
They are available in packs of 30 or 90 film-coated tablets.

Further side effects reported with use of olmesartan
medoxomil or hydrochlorothiazide alone, but not with
Olmetec Plus or in a higher frequency:

Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.

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.

Manufacturer
DAIICHI SANKYO EUROPE GmbH, Luitpoldstrasse 1, 85276
Pfaffenhofen, Germany
®

Olmetec Plus 40 mg/12.5 mg film-coated tablets
PL No: 18067/0462

POM

®

Olmetec is a registered trademark of Daiichi Sankyo
Company, Limited.
th

This leaflet was last revised on 28 July 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.
500000/PL1a

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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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