Skip to Content

UK Edition. Click here for US version.

OLMETEC PLUS 40 MG/12.5 MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / OLMESARTAN MEDOXOMIL

View full screen / Print PDF » Download PDF ⇩
Transcript
504406/PL1c

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 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 only. Do not
pass it on 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.
What is in this leaflet:
1. What Olmetec Plus is and what it is used for
2. What you need to know before you take Olmetec Plus
3. How to take Olmetec Plus
4. Possible side effects
5. How to store Olmetec Plus
6. Contents of the pack and other 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):

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).
Children and adolescents
Olmetec Plus is not recommended
adolescents under the age of 18.

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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
OLMETEC PLUS
Do not take Olmetec Plus:
• if you are allergic to olmesartan medoxomil or
hydrochlorothiazide, or any of the other ingredients of this
medicine (listed in section 6) or substances similar to
hydrochlorothiazide (sulfonamides)
• if you are more than 3 months pregnant (it is also better to
avoid Olmetec Plus in early pregnancy – see pregnancy
section)
• if you have kidney problems
• if you have diabetes or impaired kidney function and you
are treated with a blood pressure lowering medicine
containing aliskiren
• if you 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
• if you 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.
Warnings and precautions
Talk to your doctor before using Olmetec Plus.
Before you take the tablets, tell your doctor if you are taking
any of the following medicines used to treat high blood
pressure:
• an ACE-inhibitor (for example enalapril, lisinopril, ramipril),
in particular if you have diabetes-related kidney problems.
• aliskiren
Your doctor may check your kidney function, blood pressure,
and the amount of electrolytes (e.g. potassium) in your blood at
regular intervals. See also information under the heading “Do
not take 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.
Contact your doctor if you experience diarrhoea that is severe,
persistent and causes substantial weight loss. Your doctor may
evaluate your symptoms and decide on how to continue your
blood pressure medication.
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.

children

and

Other medicines and Olmetec Plus
Tell your doctor or pharmacist if you are using, have recently
used or might use any other medicines.
In particular, tell your doctor or pharmacist about any of the
following:




• 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.

for

































Other
blood
pressure
lowering
medicines
(antihypertensives), as the effect of Olmetec Plus can be
increased.
Your doctor may need to change your dose and/or to take
other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also
information under the headings “Do not take Olmetec
Plus” and “Warnings and precautions”).
Medicines which may alter 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.
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.
Colesevelam hydrochloride, a drug that lowers the level
of cholesterol in your blood, as the effect of Olmetec Plus
may be decreased. Your doctor may advise you to take
Olmetec Plus at least 4 hours before colesevelam
hydrochloride.
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.
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.

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.
Black patients
As with other similar drugs the blood pressure lowering effect of
Olmetec Plus 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 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start
breast-feeding. Olmetec Plus is not recommended for mothers
who are breastfeeding, and your doctor may choose another
treatment for you if you wish to breast-feed.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this 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.
Olmetec Plus 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 medicine.
3. HOW TO TAKE OLMETEC PLUS
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended 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 a double dose to make up
for a forgotten 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 medicine,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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.
These are the other
so far with Olmetec Plus:

side

effects

known

about

If these side effects occur, they are often mild and
you do not need to stop your treatment.
Common side effects
(may affect up to 1 in 10 people):
Dizziness, weakness, headache, tiredness, chest pain,
swelling of ankles, feet, legs, hands or arms.
Uncommon side effects
(may affect up to 1 in 100 people):
Fluttering of the heartbeat (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
(may affect up to 1 in 1,000 people):
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
(may affect up to 1 in 10 people):
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.

Hydrochlorothiazide:
Very common side effects
(may affect more than 1 in 10 people):
Changes in blood results including: Increase in blood fat and
uric acid levels.
Common side effects
(may affect up to 1 in 10 people):
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
(may affect up to 1 in 100 people):
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
(may affect up to 1 in 1,000 people):
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 heartbeat,
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
(may affect up to 1 in 10,000 people):
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 or pharmacist.
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 this medicine 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.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
• If your medicine shows any signs of discolouration or
deterioration, please tell your pharmacist immediately.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Olmetec Plus contains
Each film-coated tablet contains 40 mg olmesartan medoxomil
and 12.5 mg hydrochlorothiazide.
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.
What Olmetec Plus looks like and contents of the pack:
Olmetec Plus 40 mg/12.5 mg film-coated tablets are
reddish-yellow, 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.
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.
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.
This leaflet was last revised on 22nd September 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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
(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), 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
(may affect up to 1 in 1,000 people):
Impaired kidney function, lack of energy.
Some changes in blood test results have also been seen rarely
and include: Increase in blood potassium.

504406/PL1c

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