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OLMETEC PLUS 20MG/12.5MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / OLMESARTAN MEDOXOMIL

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Package Leaflet: Information for the User
®

Olmetec Plus 20mg/12.5mg
Film-Coated Tablets



olmesartan medoxomil/hydrochlorothiazide

if you have severe 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 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).

The name of your medicine is Olmetec® Plus
20mg/12.5mg Film-Coated Tablets, it will be referred to
as Olmetec Plus throughout this leaflet. This product is
also available as 20mg/25mg strength.



Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.

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 diabetesrelated
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”.




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):
• 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. 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.)

Before you take the tablets, tell your doctor if you have
any of the following health problems:
• Mild to moderate kidney problems or if you have
had a recent 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.
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 for children and
adolescents under the age of 18.




Other medicines and Olmetec Plus
Tell your doctor or pharmacist (chemist) 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:
• 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 that 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 breast-feeding, 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.
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 20
mg/12.5 mg tablet a day. However, if your blood
pressure is not controlled, your doctor may decide to
change your dose to one Olmetec Plus 20 mg/25 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 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
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 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
(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.
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.

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, noninfectious 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
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 blood potassium.
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).

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date printed on
the carton and on the blister strip as EXP. The expiry
date refers to the last day of the 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 the tablets become discoloured or show any other
signs of deterioration, you should seek advice of your
pharmacist who will tell you what to do.
If your doctor tells you to stop taking your tablets, take
any tablets you have left back to your pharmacist.

6. Contents of the pack and other
information
What Olmetec Plus contains:
The active substance in Olmetec Plus is olmesartan
medoxomil and hydrochlorothiazide.
Olmetec Plus: Each film-coated tablet contains 20mg
olmesartan medoxomil and 12.5mg hydrochlorothiazide.
The other ingredients are: Microcrystalline cellulose,
lactose monohydrate, low substituted
hydroxypropylcellulose, hydroxypropylcellulose,
magnesium stearate, titanium dioxide (E 171), talc,
hypromellose, iron (III) oxides (E 172).
What Olmetec Plus looks like and contents of the
pack
Olmetec Plus comes in blister packs containing 14 and
28 film-coated tablets


Olmetec plus are peach round film-coated tablets
embossed with "C22" on one side and plain on the
reverse.

Manufacturer
Olmetec Plus are manufactured by Berlin-Chemie AG,
Glienicker Weg 125, 12489 Berlin, Germany or Daiichi
Sankyo Europe GmbH, 81366 Munchen, Germany.
Procured from within the EU and repackaged in the UK
by the Parallel Import Product Licence holder: CD
Pharma Limited, Unit 3, Manor Point, Manor Way,
Borehamwood Herts WD6 1EE.
Olmetec Plus 20mg/12.5mg Film-Coated Tablets
PL No.: 20492/0365
POM
Date of approval of this leaflet: 04th August 2015
Olmetec is a registered trademark of Daiichi Sankyo
Company, Limited

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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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