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OLMETEC PLUS 20MG/12.5MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE / OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE / OLMESARTAN MEDOXOMIL

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Package Leaflet: Information for the user
Olmetec® Plus 20 mg/12.5 mg film-coated tablets



(Olmesartan medoxomil / Hydrochlorothiazide)



The name of your medicine is Olmetec Plus 20mg / 12.5mg filmcoated tablets, but will be referred to as Olmetec Plus throughout
the remainder of the leaflet.
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.
Your medicine is also available in the following strength
20mg/25mg.
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.)

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).

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:

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 any of the following
symptoms:

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.

decrease in vision or eye pain. These could be symptoms of
an increase of pressure in your eye and can happen within
hours to weeks of taking Olmetec Plus. This can lead to
permanent vision impairment, if not treated.
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 breastfeeding. 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.
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).

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).

Blind or partially sighted?
Is this leaflet hard to see or read?
Contact Quadrant Pharmaceuticals
Ltd, Tel: 01204 473081

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).
Not known (frequency cannot be estimated from the available
data):
Decrease in vision or eye pain (possible signs of acute angleclosure glaucoma).
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 this medicine 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.
6. Contents of the pack and other information
Each film-coated tablet contains 20mg olmesartan medoxomil and
12.5mg hydrochlorothiazide .
Also contains: Microcrystalline cellulose, lactose monohydrate,
low substituted hydroxyproyl cellulose, hyprolose, magnesium
stearate, titanium dioxide (E 171), talc, hypromellose, iron (III)
oxide red (E 172) and yellow iron oxide (E172).
* See 'Olmetec Plus contains lactose' section above.
Olmetec Plus 20 mg/12.5 mg film-coated tablets of 8.5 mm are
reddish-yellow round film-coated tablets embossed with "C22" on
one side and plain on reverse
Olmetec Plus is available in blister pack of 28 and 56 tablets.
Manufactured by: Daiichi Sankyo Europe GmbH, Luitpoldstrasse
1, 85276 Pfaffenhofen, Germany. Procured from within the EU.
Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock
House, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by
Maxearn Ltd, Bolton, BL6 4SA.
PL 20774/1443
Olmetec Plus 20 mg/12.5 mg film-coated tablets

POM

Olmetec is a registered trademark of Daiichi Sankyo Company
Limited
Date of preparation 7th February 2017
PP2/1443/V1

Expand Transcript

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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