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SEVIKAR 20 MG / 5 MG FILM-COATED TABLETS

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

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Package Leaflet: Information for the User

Sevikar® 20 mg / 5 mg Film-Coated Tablets
Sevikar® 40 mg / 10 mg Film-Coated Tablets
(olmesartan medoxomil / amlodipine besilate)
This product is available as any of the above names but will be referred to as
Sevikar throughout this leaflet. Please note this leaflet also contains information
about other strength (Sevikar 40 mg / 5 mg Film-Coated Tablets).
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.
2.
3.
4.
5.
6.

What Sevikar is and what it is used for
What you need to know before you take Sevikar
How to take Sevikar
Possible side effects
How to store Sevikar
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.

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, have recently taken or might take
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.
Tacrolimus, cyclosporine, used to control your body’s immune response,
enabling your body to accept the transplanted organ.

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 (hormone-producing 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.

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.
Elderly
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 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 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- 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
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.
4. Possible side effects
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 (may affect less than 1 in 10 people):
Dizziness; headache; swelling of ankles, feet, legs, hands, or arms; tiredness.
Uncommon (may affect less than 1 in 100 people):
Dizziness on standing up; lack of energy; tingling or numbness of hands or feet;
vertigo; awareness of heart beat; fast heart beat; low blood pressure with
symptoms such as dizziness, light-headedness; difficult breathing; cough; nausea;
vomiting; indigestion; diarrhoea; constipation; dry mouth, upper abdominal pain;
skin rash; cramps; 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 (may affect less than 1 in 1,000 people):
Drug hypersensitivity; fainting; redness and warm feeling of the face; red itchy
bumps (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 (may affect less than 1 in 10 people):
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 (may affect less than 1 in 100 people):
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.

Common (may affect less than 1 in 10 people):
Abdominal pain; nausea; ankle swelling; feeling sleepy; redness and warm feeling
of the face; visual disturbance (including double vision and blurred vision);
awareness of heartbeat; diarrhoea; constipation; indigestion; cramps; weakness;
difficult breathing.
Uncommon (may affect less than 1 in 100 people):
Trouble sleeping; sleep disturbances; mood changes including feeling anxious;
depression; irritability; shiver; taste changes; fainting; ringing in the ears (tinnitus);
worsening of angina pectoris (pain or uncomfortable feeling in the chest); irregular
heartbeat; 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; red itchy bumps (hives); 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 (may affect less than 1 in 1,000 people):
Confusion
Very rare (may affect less than 1 in 10,000 people):
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;
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; severe skin reactions including intense skin rash,
hives, reddening of the skin over your whole body, severe itching, blistering,
peeling and swelling of the skin, inflammation of mucous membranes, 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.
5. How to store Sevikar
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton
after EXP. 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.
If your medicine become discoloured or show signs of any deterioration, consult
your doctor or pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Sevikar contains
The active substances are olmesartan medoxomil and amlodipine (as besilate).
Sevikar 20 mg / 5 mg Film-Coated Tablets:
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of
amlodipine (as amlodipine besilate).
Other ingredients are
Tablet core: Pregelatinised maize starch, silicified microcrystalline cellulose,
croscarmellose sodium, magnesium stearate,
Tablet coat: polyvinyl alcohol, macrogol 3350, talc and titanium dioxide (E171).
Sevikar 40 mg / 10 mg Film-Coated Tablets:
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of
amlodipine (as amlodipine 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), red
iron oxide (E172) and yellow iron oxide (E172).
What Sevikar looks like and contents of the pack
Sevikar 20 mg / 5 mg Film-Coated Tablets are white, round tablets with C73
debossed on one side and plain on the other side.
Sevikar 40 mg / 10 mg Film-Coated Tablets are brownish-red, round tablets with
C77 debossed on one side and plain on the other side.
Sevikar is available in packs of 30 film-coated tablets.
PL: 15814/1288
PL: 15814/1289

Sevikar® 20 mg / 5 mg Film-Coated Tablets
Sevikar® 40 mg / 10 mg Film-Coated Tablets

POM

Rare (may affect less than 1 in 1,000 people):
Swelling of the face, mouth and/or larynx (voice box); acute kidney failure and
kidney insufficiency; lethargy.

Manufactured by DAIICHI SANKYO EUROPE GmbH, Luitpoldstrasse 1, 85276
Pfaffenhofen, Germany. Procured from within the EU and repackaged by the
Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford,
Herts WD24 4PR.

Amlodipine

Leaflet revision and issue date (Ref): 03.02.2017.
Sevikar is a registered trademark of DAIICHI SANKYO COMPANY, LIMITED.

Very common (may affect more than 1 in 10 people):
Oedema (fluid retention)

To request a copy of this leaflet in Braille, large
print or audio please call 01923 332 796.

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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