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SEVIKAR 40MG/10MG FILM-COATED TABLETS

Active substance(s): AMLODIPINE BESILATE / OLMESARTAN MEDOXOMIL

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Korrekturabzug

Package Leaflet: Information for the User

Sevikar® 20 mg / 5 mg
Sevikar® 40 mg / 5 mg
Sevikar® 40 mg / 10 mg
Film-Coated Tablets
olmesartan medoxomil/amlodipine
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 is and what it is used for
2. What you need to know before you take
Sevikar
3. How to take Sevikar
4. Possible side effects
5. How to store Sevikar
6. Contents of the pack and other information

1. What Sevikar is and what it is used for
Sevikar contains two substances called
­olmesartan medoxomil and amlodipine (as
amlodipine besilate). Both of these substances
help to control high blood pressure.
• Olmesartan medoxomil belongs to a group of
medicines called “angiotensin-II receptor
antagonists” which lower blood pressure by
relaxing the blood vessels.
• Amlodipine belongs to a group of substances
called “calcium channel blockers”.
Amlodipine stops calcium from moving into
the blood vessel wall which stops the blood
vessels from tightening thereby also reducing
blood pressure.
The actions of both these substances contribute
to stopping the tightening of blood vessels, so
that blood vessels relax and blood pressure
decreases.
Sevikar is used for the treatment of high blood
pressure in patients whose blood pressure is
not controlled enough with either olmesartan
medoxomil or amlodipine alone.

2. What you need to know before you
take Sevikar
Do not take Sevikar
• if you are allergic to olmesartan medoxomil
or to amlodipine or a special group of calcium­
channel blockers, the dihydropyridines, or to
any of the other ingredients of this medicine
(listed in section 6).
If you think you may be allergic, talk to your
doctor before taking Sevikar.
• if you are more than 3 months pregnant. ­
(It is also better to avoid Sevikar in early
pregnancy – see section “Pregnancy and
breastfeeding”).
• if you have diabetes or impaired kidney
f­unction and you are treated with a blood
pressure lowering medicine containing
aliskiren.
• if you have severe liver problems, if bile
secretion is impaired or drainage of bile ­
from the gallbladder is blocked (e.g. by
­gallstones), or if you are experiencing any
jaundice (yellowing of the skin and eyes).
• if you have very low blood pressure.
• if you are suffering from insufficient blood
supply to your tissues with symptoms like
e.g. low blood pressure, low pulse, fast
heartbeat (shock, including cardiogenic
shock). Cardiogenic shock means shock due
to severe heart troubles.
• if the blood flow from your heart is obstructed­
(e.g. because of the narrowing of the aorta
(aortic stenosis)).
• if you suffer from low heart output (resulting
in shortness of breath or peripheral swellings)
after a heart attack (acute myocardial
­infarction).
Warnings and precautions
Talk to your doctor or pharmacist before using
Sevikar.
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”.
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 levels of potassium in your blood.
• Problems with your adrenal glands (hormoneproducing glands on top of the kidneys).
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 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.

You must tell your doctor if you think that you
are (or might become) pregnant. Sevikar 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 breast-feeding”).
Children and adolescents (under 18)
Sevikar is not recommended for children and
adolescents under the age of 18.
Other medicines and Sevikar
Tell your doctor or pharmacist if you are taking
or have recently taken any of the following
medicines:­
• Other blood pressure lowering medicines,
as the effect of Sevikar 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” and “Warnings and precautions”).
• Potassium supplements, salt substitutes
containing potassium, “water tablets”
­(diuretics) or heparin (for thinning the blood
and prevention of blood clots). Using these
medicines at the same time as Sevikar may
raise the levels of potassium in your blood.
• Lithium (a medicine used to treat mood
swings and some types of depression) used
at the same time as Sevikar may increase the
toxicity of lithium. If you have to take lithium,
your doctor will measure your lithium blood
levels.
• 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 may increase the risk of kidney
failure.­The effect of Sevikar can be
decreased by NSAIDs.
• Colesevelam hydrochloride, a drug that
lowers the level of cholesterol in your blood,
as the effect of Sevikar may be decreased.
Your doctor may advise you to take Sevikar at
least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion or heartburn
remedies), as the effect of Sevikar can be
slightly decreased.
• Medicines used for HIV/AIDS (e.g. ritonavir,
indinavir, nelfinavir) or for the treatment ­
of fungal infections (e.g. ketoconazole,
­itraconazole).
• Diltiazem, verapamil, (agents used for heart
rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin
(agents used for tuberculosis or other
infections.­
• St. John’s wort (Hypericum perforatum), a
herbal remedy.
• Dantrolene (infusion for severe body
temperature­ abnormalities).
• Simvastatine, an agent used to lower levels
of cholesterol and fats (triglycerides) in the
blood.
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Sevikar with food and drink
Sevikar can be taken with or without food.
Swallow the tablet with some fluid (such as one
glass of water). If possible, take your daily dose
at the same time each day, for example at
breakfast time.
Grapefruit juice and grapefruit should not be
consumed by people who are taking Sevikar.
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.
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.
Black patients
As with other similar drugs the blood pressure
lowering effect of Sevikar can be somewhat less
in black patients.
Pregnancy and breastfeeding
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
before you become pregnant or as soon as you
know you are pregnant and will advise you to
take another medicine instead of Sevikar.
Sevikar 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, 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 is not
­recommended for mothers who are breast-­
Please turn the page.
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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 is one
tablet per day.
• The tablets 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 them 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 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
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 Sevikar
It is important to continue to take Sevikar unless
your doctor tells you to stop.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Uncommon (affecting less than 1 in
100 patients):
Trouble sleeping; sleep disturbances; mood
changes including feeling anxious; depression;
irritability; shiver; taste changes; fainting; visual
disturbances including double vision; ringing in
the ears (tinnitus); worsening of angina pectoris
(pain or uncomfortable feeling in the chest);
runny or stuffy nose; loss of hair; purplish spots
or patches on the skin due to small haemorrhages (purpura); discoloration of the skin;
excessive sweating; eruption of the skin; itching;
pain of joints or muscles; problems to pass
urine; urge to pass urine at night; increased
need to urinate (pass urine); breast enlargement
in men; chest pain; pain, feeling unwell; increase
or decrease in weight.
Rare (affecting less than 1 in 1,000 patients):
Confusion
Very rare (affecting less than 1 in
10,000 patients):
Reduction in the number of white cells in the
blood, which could increase the risk of infections;
a reduction in the number of a type of blood
cells known as platelets, which can result in
easily bruising or prolonged bleeding time;
increase in blood glucose; increased tightness
of muscles or increased resistance to passive
movement (hypertonia); tingling or numbness of
hands or feet; heart attack and irregular heartbeat; inflammation of blood vessels; inflammation­
of the liver or the pancreas; inflammation of
stomach lining; thickening of gums; elevated
liver enzymes; yellowing of the skin and eyes;
increased sensitivity of the skin to light; allergic
reactions (itching, rash, swelling of the face,
mouth and/or larynx (voice box) together with
itching and rash , other allergic conditions with
inflammation and peeling of the skin, sometimes
life-threatening).
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.

4. Possible side effects

5. How to store Sevikar

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. If this happens, do not drive or
use machines until the symptoms wear off. Ask
your doctor for advice.

3. How to take Sevikar

Like all medicines, this medicine can cause side
effects, although not everybody gets them. If
they 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, that may affect the whole
body, with swelling of the face, mouth and/or
larynx (voice box) together with itching and rash
may occur during treatment with Sevikar. If this
happens stop taking Sevikar and talk to your
doctor immediately.
Sevikar can cause the blood pressure to fall too
low in susceptible individuals or as the result of
an allergic reaction. This could cause severe
light-headedness or fainting. If this happens
stop taking Sevikar, talk to your doctor
immediately and lie down flat.
Other possible side effects with Sevikar:
Common (affecting less than 1 in 10 patients):
Dizziness; headache; swelling of ankles, feet,
legs, hands, or arms; tiredness.
Uncommon (affecting less than 1 in
100 patients):
Dizziness on standing up; lack of energy;
­tingling or numbness of hands or feet; vertigo;
strong heart beat; fast heart beat; low blood
pressure with symptoms such as dizziness,
light-headedness; laboured breathing; cough;
nausea; vomiting; indigestion; diarrhoea;
­constipation; dry mouth, upper abdominal pain;
skin rash; muscle spasms; pain in arms and
legs; back pain; feeling more of an urge to pass
urine; sexual inactivity; inability to get or
­maintain an erection; weakness.
Some changes in blood test results have also
been seen and include the following:
increased as well as decreased blood potassium­
levels, increased blood creatinine levels, increased
uric acid levels, increases in a test of liver
­function (gamma glutamyl transferase levels).
Rare (affecting less than 1 in 1,000 patients):
Drug hypersensitivity; fainting; redness and
warm feeling of the face; rash with hives;
­swelling of face.
Side effects reported with use of olmesartan
medoxomil or amlodipine alone, but not with
Sevikar or in a higher frequency:
Olmesartan medoxomil
Common (affecting less than 1 in 10 patients):
Bronchitis; sore throat; runny or stuffy nose;
cough; abdominal pain; stomach flu; diarrhoea;
indigestion; nausea; pain in the joints or bones;
back pain; blood in the urine; infection of the
urinary tract; chest pain; flu-like symptoms;
pain. Changes in blood test results as increased
fat levels (hypertriglyceridaemia), blood urea or
uric acid increased and increase in tests of liver
and muscle function.
Uncommon (affecting less than 1 in
100 patients):
Reduced number of a type of blood cells,
known as platelets, which can result in easily
bruising or prolonged bleeding time; 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); angina (pain
or uncomfortable feeling in the chest, known as
angina pectoris); itching; eruption of the skin;
allergic skin rash; rash with hives; swelling of
the face; muscular pain; feeling unwell.
Rare (affecting less than 1 in 1,000 patients):
Swelling of the face, mouth and/or larynx (voice
box); acute kidney failure and kidney insufficiency;­
lethargy.
Amlodipine
Common (affecting less than 1 in 10 patients):
Abdominal pain; nausea; ankle swelling; feeling
sleepy; redness and warm feeling of the face.

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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 condition.
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 contains
The active substances are olmesartan medoxomil
and amlodipine (as besilate).
Each tablet contains 20 mg of olmesartan
medoxomil and 5 mg amlodipine (as besilate).
Each tablet contains 40 mg of olmesartan
medoxomil and 5 mg amlodipine (as besilate).
Each tablet contains 40 mg of olmesartan
medoxomil and 10 mg amlodipine (as besilate).
Other ingredients are
Tablet core: Pregelatinised maize starch, silicified
microcrystalline cellulose, croscarmellose sodium,
magnesium stearate,
Tablet coat: polyvinyl alcohol, macrogol 3350,
talc, titanium dioxide (E171) and iron (III) oxide
(E172, Sevikar 40 mg/5 mg and 40 mg/10 mg
film coated tablets only).
What Sevikar looks like and contents of the
pack
Sevikar 20 mg/5 mg film-coated tablets are
white, round with C73 on one side.
Sevikar 40 mg/5 mg film-coated tablets are
cream, round with C75 on one side.
Sevikar 40 mg/10 mg film-coated tablets are
brownish-red, round with C77 on one side.
Sevikar film-coated tablets are available in
packs of 14, 28, 30, 56, 90, 98 and 10 x 28, ­
10 x 30 film-coated tablets and in packs with
perforated unit dose blisters of 10, 50 and ­
500 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
81366 München
Germany
This leaflet was last revised in December 2014.
UK: Sevikar 20 mg/5 mg, 40 mg/5 mg,
40 mg/10 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 20 mg/5 mg
­Film-Coated Tablets
Reference number: PL 08265/0026
This is a service provided by the Royal
National Institute of Blind People.

17.06.15 11:59

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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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