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SEVIKAR HCT 40 MG/5 MG/12.5 MG FILM-COATED TABLETS

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

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Transcript
Korrekturabzug

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.
• 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 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.
• Olmesartan belongs to a group of
medicines called “angiotensin-II
receptor antagonists” that lower
blood pressure by relaxing blood
vessels.
• Amlodipine belongs to a group of
substances called “calcium channel
blockers”. Amlodipine also lowers
blood pressure by relaxing 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.
The actions of these substances
contribute to decrease your blood
pressure.
Sevikar HCT is used to treat high
blood pressure in patients 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
­hydrochlorothiazide as a single tablet.

2 What you need to know
before you take Sevikar HCT
Do not take Sevikar HCT if:
• you are allergic to olmesartan, to
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.
• you have diabetes or impaired
kidney function and you are treated
with a blood pressure lowering
medicine containing aliskiren.
• you have low potassium, low
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.
• you are more than 3 months
pregnant. (It is also better to avoid
Sevikar HCT in early pregnancy –
see section “Pregnancy and breastfeeding”.)
• you have severe liver problems,
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).
• you have a poor blood supply to
your tissues with symptoms such
as low blood pressure, low pulse,
fast heartbeat or shock (including
cardiogenic shock, which means
shock due to severe heart troubles).
• you have very low blood pressure.
• the blood flow from your heart is
slow or blocked. This may happen ­
if the blood vessel or valve that
takes blood away from your heart
­becomes narrow (aortic stenosis).
• you have a low heart output after ­
a heart attack (acute myocardial
infarction). Low heart output may
make you feel short of breath or
have 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 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 Sevikar HCT if:”
Tell your doctor if you have any of the
following health problems:
• Kidney problems or a kidney
transplant.
• Liver disease.
• Heart failure or problems with your
heart valves or heart muscle.
• Severe vomiting, diarrhoea,
­treatment with high doses of “water
tablets” (diuretics) or if you are on a
low salt diet.
• Increased potassium in your blood.
• Problems with your adrenal glands
• Diabetes.
• Lupus erythematosus
(an autoimmune disease).
• Allergies or asthma.
• Skin reactions such as sunburn or
rash after being in the sun or using
a sunbed.
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.
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.
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 (hypo­
tension), 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:
• Other blood pressure lowering
medicines, as the effect of Sevikar
HCT 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
Sevikar HCT if:” and “Warnings and
precautions”).
• Lithium (a medicine used to treat
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
­measure your lithium blood levels.
• Diltiazem, verapamil, used for
heart rhythm problems and high
blood pressure.
• R
 ifampicin, erythromycin, clarithromycin, used for tuberculosis and
other infections.
• St. John’s wort (Hypericum
­perforatum), a herbal remedy for
treatment of depression.
• Cisapride, used to increase food
movement in the stomach and gut.
• Diphemanil, used to treat a slow
heartbeat or reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve
circulation to the nervous system.
• Amantadine, used for Parkinson’s
disease.
• Potassium supplements, salt
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.
• Non-Steroidal Anti-Inflammatory
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.
• Sleeping tablets, sedatives and
anti-depressant medicines as
using these medicines together with
Sevikar HCT may cause a sudden
drop in blood pressure when
standing up.
• Colesevelam hydrochloride, a drug
that lowers the level of cholesterol in
your blood, as the effect of Sevikar
HCT may be decreased. Your
doctor may advise you to take
Sevikar HCT at least 4 hours before
colesevelam hydrochloride.
• Certain antacids (indigestion or
heartburn remedies) as the effect of
Sevikar HCT can be slightly
­decreased.
• C
 ertain muscle relaxing medicines
such as baclofen and tubocurarine.
• Anticholinergic agents such as
atropine and biperiden.
• Calcium supplements.
• Dantrolene (infusion for severe
body temperature abnormalities)
• Simvastatin, used to lower levels of
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:
• Treat certain mental health
­problems such as thioridazine,
chlorpromazine, levomepromazine,
trifluoperazine, cyamemazine,
sulpiride, amisulpride, pimozide,
sultopride, tiapride, droperidol or
haloperidol.
• Treat low blood sugar (e.g.
­diazoxide) or high blood pressure
(e.g. beta-blockers, methyldopa) as
Sevikar HCT can affect how these
drugs work.
• Treat heart rhythm problems such
as mizolastine, pentamidine,
terfenadine, dofetilide, ibutilide or
erythromycin injections.
• Treat HIV/AIDS (e.g. ritonavir
indinavir, nelfinavir)
• Treat fungal infections (e.g.
ketoconazole, itraconazole,
­amphotericin).
• Treat heart problems such as
quinidine, hydroquinidine,
­disopyramide, amiodarone, sotalol,
bepridil or digitalis.
• Treat cancers such as amifostine,
cyclophosphamide or methotrexate.
• Increase blood pressure (such as
noradrenaline) and slow heart rate
• Treat infections such as the
anti­biotics called tetracyclines or
sparfloxacin.
• Treat gout such as probenecid,
sulfinpyrazone and allopurinol.
• Lower blood fat levels such as
colestyramine and colestipol.
• Stop rejection of organ transplants
such as ciclosporin.
• Lower blood sugar such as
­metformin or insulin
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
Taking 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.
Please turn the page.
GB 113201

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Older people
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)
­pregnant. 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
during 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.
Breast-feeding
Tell your doctor if you are breast-feeding
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.
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.
• The recommended dose of Sevikar
HCT is one tablet per day.
• The tablet can be taken with or
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.
• If possible, take your daily dose
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
­swallows 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. If side effects do
occur they are often mild and do not
require treatment to be stopped.
Although not many people may get
them, the following two side effects
can be serious:
Allergic reactions with swelling of the
face, mouth and/or larynx (voice box)
together with itching and rash may
occur during treatment with Sevikar
HCT. If this happens stop taking
Sevikar HCT and contact your
doctor immediately.
Severe light-headedness or fainting
because Sevikar HCT can cause the
blood pressure to fall too low in
susceptible individuals. If this happens
stop taking Sevikar HCT, contact
your doctor immediately and lay
down flat.
Sevikar HCT is a combination of three
active substances. The following
information firstly gives the other ­
side effects reported so far with the
combination Sevikar HCT (besides
those already mentioned above) and,
secondly, those side effects, which ­
are known for each of the separate
substances or when two substances
are given together.
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 are the other side effects
known about so far with Sevikar
HCT:
If these side effects occur they are
often mild and you do not need to
stop your treatment.
Common
(affects less than 1 in 10 people)
Upper respiratory tract infection; sore
throat and nose; urinary tract infection;
dizziness; headache; awareness of
heartbeat; low blood pressure; nausea;
diarrhoea; constipation; muscle spasm;
joint swelling; feeling more of an urge
to pass urine; weakness; swelling of
ankles, feet, legs, hands or arms;
tiredness; abnormal laboratory values.
Uncommon
(affects less than 1 in 100 people)
Dizziness on standing up; vertigo; fast
heartbeat; feeling faint; redness and
warm feeling of the face; cough; dry
mouth; muscular weakness; inability ­
to get or maintain an erection.
These are the side effects, which
are known for each of the separate
substances or when two substances
are given together:
They may be side effects for Sevikar
HCT, even if they have not been seen
so far with Sevikar HCT.
Common
(affects less than 1 in 10 people)
Bronchitis; stomach and gut infection;
vomiting; increased blood sugar; sugar
in urine; confusion; feeling sleepy;
runny or stuffy nose; sore throat;
abdominal pain; heartburn; stomach
discomfort; flatulence; pain in the
joints or bones; back pain; skeletal
pain; blood in the urine; flu-like
­symptoms; chest pain; pain.
Uncommon
(affects less than 1 in 100 people)
Reduced number of a type of blood
cells known as platelets, which can
result in bruising easily or a prolonged
bleeding time; anaphylactic reactions;
abnormally reduced appetite (anorexia);
problems sleeping; irritability; mood
changes including feeling anxious;
feeling “down” or depressed; shiver;
sleep disturbances; distorted sense of
taste; loss of consciousness; reduced
sense of touch; tingling sensations;
visual disturbance (including double
vision and blurred vision); worsening ­
of shortsightedness; ringing in the ears
(tinnitus); angina (pain or uncomfortable feeling in the chest, known as
angina pectoris); difficulty breathing;
rash; loss of hair; allergic inflammation
of the skin; redness of skin; purplish
spots or patches on the skin due to
small haemorrhages (purpura); discolouration of the skin; red itchy bumps
(hives); increased sweating; itching;
eruption of the skin; skin reactions to
light such as sunburn or rash; muscle
pain; problems to pass urine; feeling
urge to pass urine at night; breast
enlargement in men; decreased sexual
desire; swelling of the face; feeling
unwell; weight increase or decrease;
exhaustion.

32064724_Sevikar_HCT_GB_113201.indd 2

Rare
(affects less than 1 in 1,000 people)
Swollen and sore salivary glands;
reduced number of white cells in the
blood, which could increase the risk ­
of infections; low red blood cell count
(anaemia); bone marrow damage;
restlessness; feeling uninterested
(apathy); fits (convulsions); objects you
look at appearing yellow; dry eyes;
irregular heart beat; blood clots (thrombosis, embolism); fluid accumulation in
the lungs; pneumonia; inflammation of
blood vessels and small blood vessels
in the skin; inflammation of the
­pancreas; yellowing of the skin and
eyes; acute inflammation of the gall
bladder; symptoms of lupus erythematosus such as rash, joint pains and
cold hands and fingers; peeling and
blistering of the skin; impaired
movement; acute kidney failure;
non-infectious kidney inflammation;
poor kidney function; fever.
Very Rare
(affects less than 1 in 10,000 people)
High muscle tension; numbness of
hands or feet; heart attack; inflammation
of the stomach; thickening of the gums;
blockage in the gut; inflammation of
the liver; allergic skin rash.
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 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:
• in blister packs of 14, 28, 30, 56,
84, 90, 98 and 10 x 28, 10 x 30
film-coated tablets
• in packs with perforated unit dose
blisters of 10, 50 and 500 film-­
coated tablets.
• Sevikar HCT in HDPE-bottles in
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
March 2015.
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.

31.07.15 11:32

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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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