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SEVIKAR HCT 20 MG/5 MG/12.5 MG FILM-COATED TABLETS

Active substance: OLMESARTAN MEDOXOMIL

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Korrekturabzug

PACKAGE LEAFLET: INFORMATION FOR THE USER

SEVIKAR
SEVIKAR
SEVIKAR
SEVIKAR
SEVIKAR

HCT
HCT
HCT
HCT
HCT

20
40
40
40
40

mg/5 mg/12.5 mg
mg/5 mg/12.5 mg
mg/10 mg/12.5 mg
mg/5 mg/25 mg
mg/10 mg/25 mg

Film-Coated Tablets
olmesartan medoxomil/amlodipine/hydrochlorothiazide
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.
•  his medicine has been prescribed for you only. Do not pass it on to others.
T
It may harm them, even if their signs of illness are the same as yours.
• f you get any side effects, talk to your doctor or pharmacist. This includes
I
any possible side effects not listed in this leaflet.
What is in this leaflet
1 What Sevikar HCT is and what it is used for
2 What you need to know before you take Sevikar HCT
3 How to take Sevikar HCT
4 Possible side effects
5 How to store Sevikar HCT
6 Contents of the pack and other information

1 
What Sevikar HCT is and
what it is used for
Sevikar HCT contains three active substances: (i) olmesartan, (ii) amlodipine
and (iii) hydrochlorothiazide. All three
substances help to control high blood
pressure.
•  lmesartan belongs to a group of
O
medicines called “angiotensin-II
receptor antagonists” that lower
blood pressure by relaxing blood
vessels.
•  mlodipine belongs to a group of
A
substances called “calcium channel
blockers”. Amlodipine also lowers
blood pressure by relaxing blood
vessels.
•  ydrochlorothiazide is one of a
H
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.
Sevikar HCT is used to treat high
blood pressure in subjects who are
already taking either (a) a fixed-dose
combination of olmesartan medoxomil
and amlodipine (b) a fixed-dose
combination of olmesartan medoxomil
and hydrochlorothiazide plus the
amlodipine as a single tablet or (c) a
fixed-dose combination of olmesartan
medoxomil and amlodipine plus
h
­ ydrochlorothiazide as a single tablet.

2 
What you need to know
before you take Sevikar HCT
Do not take Sevikar HCT if:
•  ou are allergic to olmesartan, to
y
amlodipine, to hydrochlorothiazide,
to substances related to any of the
3 components or to any of the other
ingredients of this medicine listed in
section 6 of this leaflet. If you think
you may be allergic to the components of Sevikar HCT talk to your
doctor before taking Sevikar HCT.
• you have severe kidney problems.
•  ou have low potassium, low
y
sodium, high calcium or high uric
acid (with symptoms of gout or
kidney stones) levels in your blood
that have not got better when
treated.
•  ou are more than 3 months
y
pregnant. (It is also better to avoid
Sevikar HCT in early pregnancy –
see section “Pregnancy and breastfeeding”.)
•  ou have severe liver problems,
y
if bile secretion is impaired or
drainage of bile from the gall
bladder is blocked (e.g. by gallstones), or if you are jaundiced
(yellowing of the skin and eyes).
•  ou have very low blood pressure.
y
•  he blood flow from your heart is
t
impaired. This may happen if the
blood vessel or valve that takes
blood away from your heart
b
­ ecomes narrow (aortic stenosis).
•  ou have heart failure. Heart failure
y
may make you feel short of breath
or cause swelling in your feet and
ankles.
Do not take Sevikar HCT if any of the
above applies to you.
Warnings and precautions
Talk to your doctor or pharmacist
before using Sevikar HCT. Tell your
doctor if you have any of the following
health problems:
•  idney problems or a kidney
K
transplant.
•  iver disease.
L
•  eart failure or problems with your
H
heart valves or heart muscle.
•  evere vomiting, diarrhoea,
S
t
­ reatment with high doses of “water
tablets” (diuretics) or if you are on a
low salt diet.
• ncreased potassium in your blood.
I
•  roblems with your adrenal glands
P
•  iabetes.
D
•  upus erythematosus
L
(an autoimmune disease).
•  llergies or asthma.
A
•  kin reactions such as sunburn or
S
rash after being in the sun or using
a sunbed.
As with any medicine that reduces
blood pressure, an excessive drop in
blood pressure may lead to a heart
attack or stroke. Your doctor will
therefore check your blood pressure
carefully.
Sevikar HCT may cause a rise in blood
cholesterol and uric acid (the cause of
gout – painful swelling of the joints).
Your doctor may request blood tests
to check.
Sevikar HCT may also affect your
body’s salt balance. Your doctor may
request blood tests to check. Possible
symptoms include thirst, dryness of
the mouth, muscle pain or cramps,
tired muscles, low blood pressure,
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.
If you are due to have tests for parathyroid function you should stop taking
Sevikar HCT before these tests are
carried out.
You must tell your doctor if you think
that you are (or might become) pregnant. Sevikar HCT 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 section “Pregnancy and breastfeeding”).
Children and adolescents (under 18)
Sevikar HCT is not recommended for
children and adolescents under the
age of 18.
Other medicines and Sevikar HCT
Tell your doctor or pharmacist if you
are taking or have recently taken any
of the following:
•  ithium (a medicine used to treat
L
mood swings and some types of
depression), used at the same time
as Sevikar HCT may increase the
toxicity of lithium. If you have to
take lithium your doctor will
m
­ easure your lithium blood levels.

•  iltiazem, verapamil, used for heart
D
rhythm problems and high blood
pressure.
•  ifampicin, erythromycin, clarithroR
mycin, used for tuberculosis and
other infections.
•  t. John’s wort (Hypericum
S
p
­ erforatum), a herbal remedy for
treatment of depression.
•  isapride, used to increase food
C
movement in the stomach and gut.
•  iphemanil, used to treat a slow
D
heartbeat or reduce sweating.
•  alofantrine, used for malaria.
H
•  incamine IV, used to improve
V
circulation to the nervous system.
•  mantadine, used for Parkinson’s
A
disease.
•  otassium supplements, salt
P
substitutes containing potassium,
“water tablets” (diuretics), heparin
(for thinning the blood and prevention
of blood clots), ACE inhibitors (for
blood pressure lowering), laxatives,
steroids, adrenocorticotrophic
hormone (ACTH), carbenoxolone
(a medicine used to treat mouth
and stomach ulcers), penicillin, an
antibiotic), certain pain killers such
as aspirin or salicylates. Using these
medicines at the same time as
Sevikar HCT may alter the concentration of potassium in your blood.
•  on-Steroidal Anti-Inflammatory
N
Drugs (NSAIDs, medicines used to
relieve pain, swelling and other
symptoms of inflammation, including
arthritis), used at the same time as
Sevikar HCT may increase the risk
of kidney failure. The effect of
Sevikar HCT can be decreased by
NSAIDs. In case of high dosages of
salicylate the toxic effect on central
nervous system may be increased.
•  leeping tablets, sedatives and
S
anti-depressant medicines as using
these medicines together with
Sevikar HCT may cause a sudden
drop in blood pressure when
standing up.
•  ertain antacids (indigestion or
C
heartburn remedies) as the effect of
Sevikar HCT can be slightly
­decreased.
•  ther blood pressure lowering
O
medicines as the effect of Sevikar
HCT in lowering blood pressure can
be increased.
•  ertain muscle relaxing medicines
C
such as baclofen and tubocurarine.
•  nticholinergic agents such as
A
atropine and biperiden.
•  alcium supplements.
C
•  antrolene (infusion for severe body
D
temperature abnormalities)
•  imvastatin, used to lower levels of
S
cholesterol and fats (triglycerides) in
the blood.
Also, tell your doctor or pharmacist if
you are taking or have recently taken
any of the following medicines to:
•  reat certain mental health
T
p
­ roblems such as thioridazine,
chlorpromazine, levomepromazine,
trifluoperazine, cyamemazine,
sulpiride, amisulpride, pimozide,
sultopride, tiapride, droperidol or
haloperidol.
•  reat low blood sugar (e.g.
T
d
­ iazoxide) or high blood pressure
(e.g. beta-blockers, methyldopa) as
Sevikar HCT can affect how these
drugs work.
•  reat heart rhythm problems such
T
as mizolastine, pentamidine,
terfenadine, dofetilide, ibutilide or
erythromycin injections.
•  reat HIV/AIDS (e.g. ritonavir
T
indinavir, nelfinavir)
•  reat fungal infections (e.g. ketoconaT
zole, itraconazole, amphotericin).
•  reat heart problems such as
T
quinidine, hydroquinidine,
d
­ isopyramide, amiodarone, sotalol,
bepridil or digitalis.
•  reat cancers such as amifostine,
T
cyclophosphamide or methotrexate.
• ncrease blood pressure (such as
I
noradrenaline) and slow heart rate
•  reat infections such as the anti­
T
biotics called tetracyclines or
sparfloxacin.
•  reat gout such as probenecid,
T
sulfinpyrazone and allopurinol.
•  ower blood fat levels such as
L
colestyramine and colestipol.
•  top rejection of organ transplants
S
such as ciclosporin.
•  ower blood sugar such as
L
m
­ etformin or insulin
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
Sevikar HCT with food and drink.
Sevikar HCT can be taken with or
without food.
Grapefruit juice and grapefruit should
not be consumed by people who are
taking Sevikar HCT. This is because
grapefruit and grapefruit juice can lead
to an increase in the blood levels of
the active ingredient amlodipine, which
can cause an unpredictable increase in
the blood pressure lowering effect of
Sevikar HCT.
Take care when drinking alcohol
while you are taking Sevikar HCT as
some people feel faint or dizzy. If this
happens to you, do not drink any
alcohol.
Elderly patients
If you are over 65 years of age your
doctor will regularly check your blood
pressure at any dose increase, to
make sure that your blood pressure
does not become too low.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think
that you are (or might become)
p
­ regnant. Your doctor will normally
advise you to stop taking Sevikar HCT
before you become pregnant or as
soon as you know you are pregnant
and will advise you to take another
medicine instead of Sevikar HCT.
Sevikar HCT is not recommended in
early pregnancy, and must not be
taken when more than 3 months
pregnant as it may cause serious harm
to your baby if used after the third
month of pregnancy.
If you become pregnant during therapy
with Sevikar HCT please inform and
see your physician without delay.
Please turn the page.
GB 110666

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If you become pregnant during therapy
with Sevikar HCT please inform and
see your physician without delay.
Breast-feeding
Tell your doctor if you are breast-­eeding
f
or about to start breast-feeding. Sevikar
HCT is not recommended for mothers,
who are breast-feeding, and your doctor
may choose another treatment for you if
you wish to breast-feed, especially if
your baby is newborn, or was born
prematurely.
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, sick or dizzy or
get a headache while being treated for
your high blood pressure. Do not drive
or use machines whilst you have
symptoms. Ask your doctor for advice.

3 
How to take Sevikar HCT
Always take this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist
if you are not sure.
•  he recommended dose of Sevikar
T
HCT is one tablet per day.
•  he tablet can be taken with or
T
without food. Swallow the tablet
with some fluid (such as a glass of
water). The tablet should not be
chewed. Do not take the tablet with
grapefruit juice.
• f possible, take your daily dose
I
at the same time each day, for
example at breakfast time.
If you take more Sevikar HCT than
you should
If you take more tablets than you
should you may experience low blood
pressure with symptoms such as
dizziness, fast or slow heart beat.
If you take more tablets than you
should or if a child accidentally
s
­ wallows some go to your doctor or
nearest emergency department
immediately and take your medicine
pack or this leaflet with you.
If you forget to take Sevikar HCT
If you forget to take a dose take your
normal dose the following day as
usual. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Sevikar HCT
It is important to continue to take
Sevikar HCT 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
The following side effects are important and will require immediate action
if you experience them. You should
stop taking Sevikar HCT and see your
doctor immediately if the following
symptoms occur:
Common, affecting less than 1 in
10 people:
•  ngina (heart pain)
a
Rare, affecting less than 1 in
1000 people:
•  naemia causing shortness of
a
breath or looking pale
•  lood clots
b
•  evere, extensive, blistering skin
s
rash
•  sudden allergic reaction with
a
shortness of breath, rash, wheezing
and drop of blood pressure
• nflamed pancreas, causing abdomi
inal pain and vomiting
Very rare, affecting less than 1 in
10,000 patients
•  eart attack
h
•  welling of the face, tongue and
s
windpipe which can cause great
d
­ ifficulty in breathing
•  accid gut, causing vomiting and
fl
abdominal distension
• ncreased susceptibility to infection
i
causing, for example, fever, sore
throat or mouth ulcers
The following side-effects have also
been reported:
Common, affecting less than 1 in
10 people:
•  pper airways infection, bronchitis /
U
urinary infection / gastroenteritis
• Awareness of heartbeat
•  izziness, headache, tiredness,
D
flu-like symptoms, sleepiness,
confusion, weakness
•  ausea, vomiting, diarrhoea,
N
constipation, abdominal discomfort
or pain
•  ccumulation of gas in intestines,
A
heartburn
•  wollen joints, joint pains, muscle
S
spasms, aches and pains
•  ow blood pressure
L
•  requent need to pass urine, blood
F
in urine
•  luid retention causing swollen
F
limbs or face
•  hanges in blood test results that
C
report on how the kidneys, liver and
muscles are working
•  hanges in blood test results of salt
C
balance
•  aised blood sugar (may affect
R
diabetes status)
•  xcess glucose in urine
E
Uncommon, affecting less than 1 in
100 people:
•  izziness on standing, fainting,
D
spinning sensation (vertigo)
•  educed number of a type of blood
R
cells known as platelets, which
can result in bruising easily or a
prolonged bleeding time
•  naphylactic reactions, skin rash,
A
allergic inflammation of the skin,
redness of skin, skin discolouration
or flushing, red itchy bumps (hives),
sweating, itch, increased sensitivity
of skin to light causing sunburn, rash
and discomfort swelling of the face
•  ast heartbeat
F
• Difficulty sleeping sleep disturbances,

mood change, irritability
•  ough, dry mouth, breathlessness
C
•  bnormally reduced appetite,
A
weight decrease (or increase)
•  remor
T
•  isual disturbance (including
V
blurred vision), worsening of
shortsightedness
•  inging in ears (tinnitus)
R
•  ltered sense of taste
A
•  alpitations
P
•  ltered or decreased sensation of
A
touch
•  reast enlargement
B
•  ecreased sex drive, inability to
D
gain erection in males
•  xhaustion
E

Very rare, affecting less than 1 in
10,000 people:
• Inflamed blood vessels
• High muscle tension
• Allergy
If you get any side effects talk to your
doctor or pharmacist. This includes
any side effects not listed in this
leaflet.

5 
How to store Sevikar HCT
Keep this medicine out of the sight
and reach of children.
Do not use this medicine after the
expiry date, which is stated on the
carton. The expiry date refers to the
last day of that month.
This medicinal product does not
require any special storage conditions.
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
What Sevikar HCT contains
The active substances are olmesartan
medoxomil, amlodipine (as amlodipine
besilate) and hydrochlorothiazide.
Each film-coated tablet contains
20 mg olmesartan medoxomil, 5 mg
amlodipine (as amlodipine besilate)
and 12.5 mg hydrochlorothiazide.
Each film-coated tablet contains
40 mg olmesartan medoxomil, 5 mg
amlodipine (as amlodipine besilate)
and 12.5 mg hydrochlorothiazide.
Each film-coated tablet contains
40 mg olmesartan medoxomil, 10 mg
amlodipine (as amlodipine besilate)
and 12.5 mg hydrochlorothiazide.
Each film-coated tablet contains
40 mg olmesartan medoxomil, 5 mg
amlodipine (as amlodipine besilate)
and 25 mg hydrochlorothiazide.
Each film-coated tablet contains
40 mg olmesartan medoxomil, 10 mg
amlodipine (as amlodipine besilate)
and 25 mg hydrochlorothiazide.
Other ingredients are:
Tablet core: pregelatinized maize
starch, silicified microcrystalline
cellulose (microcrystalline cellulose
and silica colloidal anhydrous), croscarmellose sodium, magnesium
stearate
Film coat: polyvinyl alcohol, macrogol
3350, talc, titanium dioxide (E 171),
iron (III) oxide yellow (E 172), iron (III)
oxide red (E 172) (20 mg/5 mg/12.5mg,
40 mg/10 mg/12.5 mg, 40 mg/10 mg/
25mg film coated tablets only), iron
(II, III) oxide black (E°172) (20 mg/
5 mg/12.5 mg film coated tablets only)
What Sevikar HCT looks like and
contents of the pack
Sevikar HCT 20 mg/5 mg/12.5 mg
film-coated tablets of 8 mm are light
orange, round with C51 debossed on
one side.
Sevikar HCT 40 mg/5 mg/12.5 mg
film-coated tablets of 9.5 mm are light
yellow, round with C53 debossed on
one side.
Sevikar HCT 40 mg/10 mg/12.5 mg
film-coated tablets of 9.5 mm are
greyish red, round with C55 debossed
on one side.
Sevikar HCT 40 mg/5 mg/25 mg
film-coated tablets of 15 x 7 mm are
light yellow, oval with C54 debossed
on one side.
Sevikar HCT 40 mg/10 mg/25 mg
film-coated tablets of 15 x 7 mm are
greyish red, oval with C57 debossed
on one side.
Sevikar HCT film-coated tablets are
available:
• n blister packs of 14, 28, 30, 56,
i
84, 90, 98 and 10 x 28, 10 x 30
film-coated tablets
• n packs with perforated unit dose
i
blisters of 10, 50 and 500 film-­
coated tablets.
•  evikar HCT in HDPE-bottles in
S
packs of 7, 30 and 90 film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Daiichi Sankyo UK Limited
Chiltern Place
Chalfont Park
Gerrards Cross
Buckinghamshire
SL9 0BG
UK
Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen
Germany
This leaflet was last revised in
12/2012
UK:
Sevikar HCT 20 mg/5 mg/12.5 mg
Sevikar HCT 40 mg/5 mg/12.5 mg
Sevikar HCT 40 mg/10 mg/12.5 mg
Sevikar HCT 40 mg/5 mg/25 mg
Sevikar HCT 40 mg/10 mg/25 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: Sevikar HCT
20 mg/5 mg/12.5 mg
Film-Coated Tablets
Reference Number:
PL 08265/0031
This is a service provided by
the Royal National Institute of
Blind People.

Rare, affecting less than 1 in
1000 people:
•  estlessness
R
• Convulsions (fits)
•  ecreased tear production
D
(
­important if using contact lenses)
•  ever
F
•  luid accumulation in the lungs,
F
pneumonia
•  aundice, inflamed gall bladder
J
• nflamed salivary glands
I
•  idney problems that may become
K
severe, acute kidney failure

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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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