OLMESARTAN 20 mg/5 mg Фильм-Coated Таблетки

Содержание инструкции

1. Olmesartan medoxomil and Amlodipine Sandoz 20 mg/5 mg film-coated tablets, 40 mg/5 mg film-coated tablets, 40 mg/10 mg film-coated tablets
   1. What is Olmesartan medoxomil and Amlodipina Sandoz and what is it used for
   2. What you need to know before taking Olmesartan medoxomil and Amlodipina Sandoz
   3. How to take Olmesartan medoxomil and Amlodipina Sandoz
   4. Possible side effects
   5. How to store Olmesartan medoxomil and Amlodipina Sandoz
   6. Package contents and other information

Olmesartan medoxomil and Amlodipine Sandoz 20 mg/5 mg film-coated tablets, 40 mg/5 mg film-coated tablets, 40 mg/10 mg film-coated tablets

Generic medicine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Olmesartan medoxomil and Amlodipine Sandoz is and what it is used for
• 2. What you need to know before you take Olmesartan medoxomil and Amlodipine Sandoz
• 3. How to take Olmesartan medoxomil and Amlodipine Sandoz
• 4. Possible side effects
• 5. How to store Olmesartan medoxomil and Amlodipine Sandoz
• 6. Contents of the pack and other information

1. What is Olmesartan medoxomil and Amlodipina Sandoz and what is it used for

Olmesartan medoxomil and Amlodipina Sandoz contains two substances called olmesartan
medoxomil and amlodipine (as amlodipine besilate). Both are used to control
high blood pressure.
Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor
antagonists”. They lower blood pressure by relaxing the blood
vessels.
Amlodipine belongs to a group of substances called “calcium antagonists”.
Amlodipine prevents calcium from entering the wall of blood vessels
counteracting their tension and reducing blood pressure.
The action of both substances helps to counteract vascular tension, so that the
vessels relax and blood pressure is reduced.
Olmesartan medoxomil and Amlodipina Sandoz is used to treat high blood
pressure in adult patients whose blood pressure is not sufficiently controlled by
olmesartan medoxomil or amlodipine alone.

2. What you need to know before taking Olmesartan medoxomil and Amlodipina Sandoz

Do not take Olmesartan medoxomil and Amlodipina Sandoz
if you are allergic to olmesartan medoxomil or amlodipine or to a particular group of
calcium antagonists, 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 Olmesartan
medoxomil and Amlodipina Sandoz.
if you are pregnant for more than three months (it is best to avoid taking Olmesartan
medoxomil and Amlodipina Sandoz even in the early stages of pregnancy - see
section “Pregnancy and breastfeeding”).
if you suffer from diabetes or your kidney function is impaired and you are being treated with
a medicine that lowers blood pressure containing aliskiren.
if you suffer from severe liver problems, if bile secretion is impaired or its outflow from the
gallbladder is blocked (for example by gallstones) or if you develop
jaundice (yellowing of the skin and eyes).
if your blood pressure is very low.
if you suffer from insufficient blood supply to the tissues with symptoms such as low
blood pressure, weak pulse, rapid heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems.
if the blood flow from your heart is obstructed (for example due to a
narrowing of the aorta (aortic stenosis)).
if you suffer from reduced cardiac output (causing shortness of breath or peripheral swelling
) after a heart attack (acute myocardial infarction).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olmesartan medoxomil and
Amlodipina Sandoz.
Consult your doctorif you are taking any of the following medicines used to treat
high blood pressure:
an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you suffer from
kidney problems related to diabetes.
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 what is stated under “Do not take Olmesartan medoxomil and Amlodipina
Sandoz”.

Consultyour doctorif you also have any of the following health problems:
Kidney problems or kidney transplant.
Liver disease.
Heart failure or problems with the heart valves or heart muscle.
Severe vomiting, diarrhea, treatment with high doses of “water tablets” (diuretics)
or if you are on a low-salt diet.
Increased levels of potassium in the blood.
Problems with the adrenal glands (glands that produce hormones, located above the kidneys).
Tell your doctor if you experience severe and prolonged diarrhea with significant weight loss.
Your doctor will assess your symptoms and decide whether to continue this
antihypertensive treatment.
As with any medicine that lowers blood pressure, an excessive reduction
of blood pressure in patients with circulatory disorders of the heart or brain could lead
to a heart attack or stroke. Your doctor will therefore carefully monitor your
blood pressure.
You should inform your doctor if you think you are pregnant (or if there is a possibility of
becoming pregnant). Olmesartan medoxomil and Amlodipina Sandoz is not
recommended in early pregnancy and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this
period (see section “Pregnancy and breastfeeding”).

Children and adolescents
Olmesartan medoxomil and Amlodipina Sandoz is not recommended in children and adolescents
under the age of 18 years.

Other medicines and Olmesartan medoxomil and Amlodipina Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other of the following medicines:

Other medicines that lower blood pressure, as they may increase
the effect of Olmesartan medoxomil and Amlodipina Sandoz. Your doctor may need
to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated under
“Do not take Olmesartan medoxomil and Amlodipina Sandoz” and “Warnings and
precautions”).

Potassium supplements, salt substitutes containing potassium, “water tablets”(diuretics) or heparin(to thin the blood and prevent thrombosis). The use
of these medicines taken together with Olmesartan medoxomil and Amlodipina Sandoz may
increase potassium levels in the blood.

Lithium(a medicine used to treat mood swings and some types of depression)
used together with Olmesartan medoxomil and Amlodipina Sandoz may increase
lithium toxicity. If you have to take lithium, your doctor will measure your lithium levels in
your blood.

Non-steroidal anti-inflammatory drugs(NSAIDs, medicines used to reduce pain,
swelling and other symptoms of inflammation, including arthritis) used together with
Olmesartan medoxomil and Amlodipina Sandoz may increase the risk of
kidney failure. The effect of Olmesartan medoxomil and Amlodipina Sandoz may
be reduced by NSAIDs.

Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which
may reduce the effect of Olmesartan medoxomil and Amlodipina Sandoz. Your
doctor may advise you to take Olmesartan medoxomil and Amlodipina Sandoz
at least 4 hours before colesevelam hydrochloride.

Some antacids(used for indigestion or heartburn) may slightly reduce
the effect of Olmesartan medoxomil and Amlodipina Sandoz.

Medicines for HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir) or for the
treatment of fungal infections(e.g. ketoconazole, itraconazole).

Diltiazem, verapamil(medicines used for heart rhythm problems and high blood
pressure).

Rifampicin, erythromycin, clarithromycin(antibiotics).

St John's Wort(Hypericum perforatum), a herbal remedy.

Dantrolene(infusion for severe alterations in body temperature).

Simvastatin, a substance used to reduce cholesterol and fat (triglyceride) levels
in the blood.

Tacrolimus, sirolimus, temsirolimus, everolimus and cyclosporine(used to control
your body's immune response and thus allow your body to accept
transplanted organs).
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Olmesartan medoxomil and Amlodipina Sandoz with food and drink
Olmesartan medoxomil and Amlodipina Sandoz can be taken with or without food.
The tablet should be swallowed with some liquid (such as a glass of water). If possible,
take your daily dose every day at the same time, for example with breakfast.
People taking this medicine should not consume grapefruit and grapefruit juice as grapefruit and its juice can induce an increase in the levels
of the active substance amlodipine in the blood, and this may lead to an unpredictable increase
in the hypotensive effect of this medicine.

Elderly
If you are over 65 years of age, your doctor will regularly check your blood
pressure with each dose increase, to avoid it dropping too much.

Black patients
As with other similar medicines, the blood pressure-lowering effect of this
medicine may be somewhat reduced in black patients.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking
this medicine.

Pregnancy
You should tell your doctor if you think you are pregnant (or if there is a possibility of
becoming pregnant). As a rule, your doctor will advise you to stop taking Olmesartan medoxomil and Amlodipina Sandoz before becoming pregnant or as soon as you find out you are pregnant and will advise you to
take another medicine instead of Olmesartan medoxomil and Amlodipina Sandoz.
This medicine is not recommended in early pregnancy and should not be taken
if you are pregnant for more than three months as it can cause serious harm to the baby if
taken after the third month of pregnancy.
If you should become pregnant during treatment with this medicine, inform and
see your doctor immediately.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to breastfeed. Amlodipine
has been shown to pass into breast milk in small amounts. Olmesartan
medoxomil and Amlodipina Sandoz is not recommended for women who are breastfeeding
and your doctor may choose another treatment for you if you wish to breastfeed,
especially if the baby is newborn or premature.

Driving and using machines
You may feel drowsy, unwell or dizzy or have a headache during treatment
for high blood pressure. If this happens, do not drive or use machines until the
symptoms have disappeared. Ask your doctor for advice.

Olmesartan medoxomil and Amlodipina Sandoz contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before
taking this medicine.
This medicine contains less than 23 mg (1 mmol) of sodium per film-coated tablet,
which is essentially ‘sodium-free’.

3. How to take Olmesartan medoxomil and Amlodipina Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Olmesartan medoxomil and Amlodipina Sandoz is one
tablet a day.
The tablets can be taken on a full or empty stomach. Swallow the tablets
with some liquid (such as a glass of water). The tablet must not be
chewed. Do not take it with grapefruit juice.
If possible, take your daily dose every day at the same time, for example
with breakfast.

If you take more Olmesartan medoxomil and Amlodipina Sandoz than you should
If you take more tablets than you should, you may have a reduction in blood pressure
with symptoms such as dizziness, acceleration or slowing of the heartbeat.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of
breath which can develop up to 24-48 hours after taking it.
If you take more tablets than you should or if a child accidentally swallows some
go immediately to your doctor or the nearest emergency room

If you forget to take Olmesartan medoxomil and Amlodipina Sandoz
If you forget to take a dose, take your normal dose the next day. Do not
take a double dose to make up for a missed dose.

If you stop taking Olmesartan medoxomil and Amlodipina Sandoz
It is important to continue taking this medicine unless your doctor tells you
to stop.
If you have any questions about 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 everyone will experience them.
If they do occur, they are usually mild and do not require stopping treatment.

Although they do not occur in all people, the following side effects may be
serious:.
Severe skin reactions including intense rash, hives, redness of the skin
all over the body, strong feeling of itching, rash with blisters, peeling
and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic
epidermal necrolysis) or other allergic reactions may occur during treatment with
Olmesartan medoxomil and Amlodipina Sandoz.

If this happens, stop taking Olmesartan medoxomil and Amlodipina Sandoz
and contact your doctor immediately.
Olmesartan medoxomil and Amlodipina Sandoz may cause excessive reductions in blood
pressure in sensitive individuals or as a result of an allergic reaction. This could
cause severe dizziness or fainting. If this happens, stop taking
Olmesartan medoxomil and Amlodipina Sandoz, contact your doctor immediately and
remain lying down.
Frequency not known: If you experience yellowing of the whites of your eyes, dark urine, itching
of the skin, even if you have started therapy with Olmesartan medoxomil and Amlodipina
Sandoz a long time ago, contact your doctor immediatelywho will assess the symptoms and
decide how to continue the medicine for blood pressure.

Other possible side effects of Olmesartan medoxomil and Amlodipina Sandoz:
Common (may affect up to 1 in 10 people):
dizziness
headache
swelling of ankles, feet, legs, hands or arms
fatigue

Uncommon (may affect up to 1 in 100 people):
dizziness on standing up
lack of energy
tingling or numbness in the hands or feet
vertigo
awareness of heartbeat
fast heartbeat
low blood pressure with symptoms such as dizziness, lightheadedness
difficulty breathing
cough
nausea
vomiting
indigestion
diarrhea
constipation
dry mouth
pain in the upper abdomen
rash
cramps
pain in arms and legs
back pain
feeling of needing to urinate urgently
sexual inactivity
inability to get or maintain an erection
weakness.
Some changes in blood tests have also been observed, including the
following: increased or decreased levels of potassium in the blood, increased levels
of creatinine in the blood, increased levels of uric acid in the blood, increases in
a liver function test (gamma glutamyl transferase levels).

Rare (may affect up to 1 in 1,000):
hypersensitivity to the drug
fainting
redness and feeling of warmth in the face
red and itchy welts (urticaria)
swelling of the face.

Side effects reported with the use of olmesartan medoxomil or amlodipine alone, but
not with Olmesartan medoxomil and Amlodipina Sandoz or with a higher frequency:
Olmesartan medoxomil
Common (may affect up to 1 in 10 people):
Bronchitis; sore throat; stuffy or runny nose; cough; abdominal pain; flu-like
gastrointestinal; diarrhea; indigestion; nausea; bone or joint pain; back pain; blood in urine; urinary tract infection; chest pain; flu-like
symptoms; pain. Changes in laboratory tests such as increased fats
(hypertriglyceridemia); increased urea or uric acid in the blood and increased values of
liver and muscle function tests.

Uncommon (may affect up to 1 in 100 people):
Reduction in the number of a type of blood cells called platelets, which may
cause easier bruising or prolonged bleeding time;
immediate allergic reactions that can affect the whole body and can cause
breathing problems and a rapid drop in blood pressure which can also cause
weakness (anaphylactic reactions); angina (chest pain or discomfort,
known as angina pectoris); feeling of itching; rash; allergic rash; rash with hives, swelling of the face; muscle pain; feeling of
being unwell.

Rare (may affect up to 1 in 1,000):
Swelling of the face, mouth and/or larynx (the seat of the vocal cords); acute renal
failure and renal insufficiency; lethargy.

Amlodipine
Very common (may affect more than 1 in 10 people):
Edema (fluid retention).

Common (may affect up to 1 in 10 people):
Abdominal pain; nausea; swelling of the ankle; drowsiness; redness and feeling of
warmth in the face, visual disturbance (including double vision and blurred vision), awareness of the
heartbeat, diarrhea, constipation, indigestion, cramps, weakness, difficulty breathing.

Uncommon (may affect up to 1 in 100 people):
Restless sleep; sleep disturbances; mood disturbances including feeling anxious;
depression; irritability; tremors; altered taste; fainting; ringing in the ears
(tinnitus); worsening of angina pectoris (chest pain or discomfort);
irregular heartbeat; stuffy or runny nose; hair loss; small red or purple spots on the skin due to minor bleeding (purpura); skin discoloration; excessive sweating; rash; feeling of
itching; red and itchy welts (urticaria);
muscle or joint pain; problems with urination; need to urinate at night;
enlargement of the breasts in men; chest pain; pain, feeling unwell; weight gain or loss.

Rare (may affect up to 1 in 1,000):
Confusion.

Very rare (may affect up to 1 in 10,000):
Reduction in the number of white blood cells in the blood, which may increase the risk of
infections; reduction in the number of a type of blood cells called platelets, which may
cause easier bruising or prolonged bleeding time;
increased glucose in the blood;
increased muscle stiffness or increased resistance to passive movements (hypertonia);
tingling or numbness in the hands or feet; heart attack; inflammation of the blood
vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; thickening
of the gums; elevated levels of 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 (seat of the vocal cords) together with
itching and rash, severe skin reactions including intense rash, hives,
redness of the skin over the entire body surface, severe feeling of itching,
rash with blisters, peeling and swelling of the skin, inflammation
of the mucous membranes, sometimes life-threatening).

Not known(frequency cannot be estimated from the available data) :
tremor, rigid posture, face that looks like a mask, slow movements and shuffling gait,
unbalanced.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Olmesartan medoxomil and Amlodipina Sandoz

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 blister and on the package
after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olmesartan medoxomil and Amlodipine Sandoz contains

• The active ingredients are olmesartan medoxomil and amlodipine (as besylate).

20 mg/5 mg film-coated tablets:
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of
amlodipine (as besylate).

40 mg/5 mg film-coated tablets:
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of
amlodipine (as besylate).

40 mg/10 mg film-coated tablets:
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg
of amlodipine (as besylate).

• The other ingredients are: Tablet core: lactose monohydrate, sodium croscarmellose, pregelatinized starch (corn), magnesium stearate, microcrystalline cellulose silicified

Tablet coating:

20 mg/5 mg film-coated tablets:
partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG
3350, talc

40 mg/5 mg film-coated tablets:
partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG
3350, talc, yellow iron oxide (E 172)

40 mg/10 mg film-coated tablets:
partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG
3350, talc, yellow iron oxide (E 172), red iron oxide (E 172)

Description of the appearance of Olmesartan medoxomil and Amlodipine Sandoz and package contents

20 mg/5 mg film-coated tablets:
Film-coated tablet of color from white to off-white, round, with imprinted “20
5” on one side, with a diameter of approximately 7.1 mm.

40 mg/5 mg film-coated tablets:
Yellow film-coated tablet, round, with imprinted “40 5” on one side, with a
diameter of approximately 9.1 mm.

40 mg/10 mg film-coated tablets:
Pink film-coated tablet, round, with imprinted “40 10” on one side, with a
diameter of approximately 9.1 mm.
The film-coated tablets are packaged in blister packs with push-through opening
OPA/Alu/PVC/Alu and inserted into a carton.

Package sizes:
Blister: 10, 14, 28, 30, 56, 90 and 98 film-coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
AustriaOlmesartan/Amlodipin 1A Pharma 20 mg/5 mg – Filmtabletten
Olmesartan/Amlodipin 1A Pharma 40 mg/5 mg – Filmtabletten
Olmesartan/Amlodipin 1A Pharma 40 mg/10 mg - Filmtabletten

GermanyOlmesartan/Amlodipin HEXAL 20 mg/5 mg Filmtabletten
Olmesartan/Amlodipin HEXAL 40 mg/5 mg Filmtabletten
Olmesartan/Amlodipin HEXAL 40 mg/10 mg Filmtabletten

ItalyOlmesartan medoxomil and Amlodipine Sandoz