OLMETRIVART 20 mg/5 mg /12.5 Mg Film-Coated Tablets

Зміст інструкції

1. Olmetrivart 20 mg/5 mg/12,5 mg film-coated tablets, 40 mg/5 mg/12,5 mg film-coated tablets, 40 mg/5 mg/25 mg film-coated tablets, 40 mg/10 mg/12,5 mg film-coated tablets, 40 mg/10 mg/25 mg film-coated tablets
   1. What Olmetrivart is and what it is used for
   2. What you need to know before taking Olmetrivart
   3. How to take Olmetrivart
   4. Possible side effects
   5. How to store Olmetrivart
   6. Package Contents and Other Information

Olmetrivart 20 mg/5 mg/12,5 mg film-coated tablets, 40 mg/5 mg/12,5 mg film-coated tablets, 40 mg/5 mg/25 mg film-coated tablets, 40 mg/10 mg/12,5 mg film-coated tablets, 40 mg/10 mg/25 mg film-coated tablets

olmesartan medoxomil/amlodipine/hydrochlorothiazide

Read this leaflet carefully before 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
signs and symptoms of the illness are the same as yours, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Olmetrivart is and what it is used for

Olmetrivart contains three substances called olmesartan medoxomil, amlodipine (as amlodipine
besilate) and hydrochlorothiazide. All of them are used 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 antagonists”. Amlodipine also lowers blood pressure by relaxing the blood
vessels.
Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics” (medicines
to stimulate diuresis). It lowers blood pressure by helping the body to eliminate
excess water by causing the kidneys to produce more urine.
The action of these substances helps to reduce blood pressure.
Olmetrivart is used to treat high blood pressure:
in adult patients whose blood pressure is not adequately controlled by the combination
of olmesartan medoxomil and amlodipine taken as a fixed-dose combination, or
in patients who are already taking a fixed-dose combination of olmesartan medoxomil and
hydrochlorothiazide plus amlodipine as a single tablet, or a fixed-dose combination of
olmesartan medoxomil and amlodipine plus hydrochlorothiazide as a single tablet.

2. What you need to know before taking Olmetrivart

Do not take Olmetrivart if:
you are allergic to olmesartan medoxomil, amlodipine or a particular group of calcium
antagonists (dihydropyridines), to hydrochlorothiazide or to substances similar to hydrochlorothiazide
(called sulfonamides), or to any of the excipients of this medicine listed in
paragraph 6. If you think you may be allergic, talk to your doctor before taking
Olmetrivart.
you have severe kidney problems.
you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine
that lowers blood pressure, containing aliskiren.
you have low levels of potassium or sodium, or if you have high levels of calcium or uric acid (with symptoms of
gout or kidney stones) in the blood that do not improve after treatment.
you are pregnant for more than three months (it is best to avoid taking Olmetrivart even in the
early stages of pregnancy - see the section “Pregnancy and breastfeeding”).
you suffer from severe liver problems, if bile secretion is impaired or the passage of bile is
blocked (for example, by gallstones), or if you have jaundice (yellowing of the skin and eyes).
you suffer from reduced blood flow to the tissues with symptoms such as low blood pressure, weak pulse,
rapid heartbeat or shock (including cardiogenic shock, which means shock due to
severe heart problems).
you have very low blood pressure.
the blood flow from your heart is slow or obstructed. This happens if the blood vessels or valves
that carry blood out of the heart narrow (aortic stenosis).
you suffer from reduced cardiac output due to a heart attack (acute myocardial
infarction). A reduction in cardiac output manifests with difficulty breathing or swelling
of the feet and ankles.
If you think you are in any of the above conditions, do not take Olmetrivart.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Warnings and precautions
Talk to your doctor or pharmacist before taking Olmetrivart if:
you have had breathing or lung problems (including inflammation or fluid in the
lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking
Olmetrivart, consult
your doctor immediately.

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.
Talk to your doctor if you experience abdominal pain, nausea, vomiting or
diarrhea after taking Olmetrivart. The doctor will decide on the continuation of the treatment. Do not stop taking
Olmetrivart on your own.
The 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 in the section “Do not take Olmetrivart if”:

Tell your 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 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). Diabetes. Lupus erythematosus (an autoimmune disease).

Allergies or asthma.
Skin reactions such as sunburn or rash after exposure to the sun or sunlamps.
If you have had skin cancer in the past or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and
of the lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and
UV rays while taking Olmetrivart.

Tell your doctorif any of the following symptoms occur:
severe and prolonged diarrhea with significant weight loss. Your doctor will assess the
symptoms and decide whether to continue this antihypertensive treatment;
decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in
your eye and can occur within hours or weeks of taking Olmetrivart. This
increase, if left untreated, can lead to permanent vision impairment.
As with any medicine that lowers blood pressure, an excessive reduction in 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.
Olmetrivart may cause an increase in fats and uric acid (causing gout - painful swelling
of the joints) in the blood. Your doctor will probably want to perform periodic blood tests to assess these conditions.
The levels of some substances, called electrolytes, in the blood may change. Your doctor will probably want to perform periodic blood tests to assess these conditions. Signs of
electrolyte disturbances are: thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), feeling weak, sluggish, tired,
sleepy or unrested, nausea, vomiting, reduced need to urinate, rapid heart rate. Tell your doctor if these symptoms occur.
If you are to undergo parathyroid function testing, discontinue taking
Olmetrivart before the tests are performed.
You must tell your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Olmetrivart 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 the section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years of age)
Olmetrivart is not recommended in children and adolescents under 18 years of age.

Other medicines and Olmetrivart
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any of the following medicines:

Other medicines that lower blood pressure,as they may increase the effect of
Olmetrivart. The doctor may need to adjust the dose and/or take other
precautions:
if you are taking an ACE inhibitor or aliskiren (see also the section “Do not
take Olmetrivart if” and “Warnings and precautions”).

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

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

Rifampicin, erythromycin, clarithromycin, tetracyclines or sparfloxacin,
antibiotics, used for tuberculosis and other infections.

St. John's Wort(Hypericum perforatum), a herbal remedy for the treatment of
depression.

Cisapride,used to speed up the passage of food through the stomach and intestines.

Difemanil,used to treat a slow heartbeat or reduce sweating.

Alofantrine,used for malaria.

Vincamine e.v.,used to improve circulation in the nervous system.

Amantadine,used for Parkinson's disease.

Potassium supplements, salt substitutes containing potassium, diuretics or heparin(for
thinning the blood and preventing thrombosis), ACE inhibitors (for lowering blood pressure),
laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a drug used for
treating mouth and stomach ulcers), sodium benzylpenicillin (also called
benzylpenicillin sodium, an antibiotic), certain painkillers such as acetylsalicylic acid (aspirin)
or salicylates. Taking these medicines together with Olmetrivart may alter the levels of
potassium in the blood.

Nonsteroidal anti-inflammatory drugs(NSAIDs, medicines used to reduce pain, the
swelling and other symptoms of inflammation, including arthritis) used together with Olmetrivart
may increase the risk of kidney failure. The effectiveness of Olmetrivart may be reduced
by NSAIDs. In case of taking high doses of salicylate, the toxic effects on the central nervous system may be increased.

Sleeping pills, sedatives and antidepressants,used together with Olmetrivart may cause a sudden drop
in blood pressure when you stand up.

Colesevelam hydrochloride,a medicine that reduces cholesterol levels in the blood, which may
decrease the effect of Olmetrivart. Your doctor may advise you to take Olmetrivart
at least 4 hours before colesevelam hydrochloride.

Some antacids(used for indigestion or heartburn) may slightly reduce
the effectiveness of Olmetrivart.

Some muscle relaxants,such as baclofen and tubocurarine.

Anticholinergic drugs,such as atropine and biperidene.

Calcium supplements.
Dantrolene(infusion for severe temperature alterations).

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

Medicines used to control your body's immune response(such as tacrolimus,
cyclosporine) that allow your body to accept transplanted organs.
Also, tell your doctor or pharmacist if you are taking, have recently taken or will take any other
medicine.

Olmetrivart with food and drink
Olmetrivart can be taken with or without food.
People taking Olmetrivart should not consume grapefruit and grapefruit juice as grapefruit and its juice can cause an increase in the levels of the active ingredient
amlodipine in the blood, and this may lead to an unpredictable increase in the hypotensive effect of
Olmetrivart.
Be careful to drink alcohol while taking Olmetrivart, as some people may
feel faint or confused. If this happens to you, do not drink alcohol.

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

Pregnancy and breastfeeding
Pregnancy
You must 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 Olmetrivart
before becoming pregnant or as soon as you find out you are pregnant and
will advise you to take another medicine instead of Olmetrivart. Olmetrivart is not recommended
during 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 while taking Olmetrivart, inform and see your doctor immediately.

Breast-feeding
Inform your doctor if you are breast-feeding or are about to start breast-feeding. It has been demonstrated that
amlodipine passes into breast milk in small amounts. Olmetrivart is not recommended for women
who are breast-feeding and your doctor may choose another treatment for you if you wish to breast-feed.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breast-feeding with
breast milk, ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
You may experience drowsiness, confusion, dizziness or headache during treatment for high blood pressure. If
this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor for
advice.

Olmetrivart contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact them before
taking this medicine.

3. How to take Olmetrivart

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 Olmetrivart is one tablet a day.
• The tablet can be taken with or without food. Swallow the tablet with some liquid (such as a glass of water). The tablets 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 Olmetrivart 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 any, go
immediately to your doctor or the nearest emergency room bringing with you the package of

If you forget to take Olmetrivart
If you forget to take a dose, take your normal dose the next day. Do not take a
double dose to make up for the missed dose.

If you stop taking Olmetrivart
It is important to continue taking Olmetrivart unless your doctor tells you to stop.
If you have any doubts 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 mostly mild and do not require discontinuation of treatment.

Although they do not appear in all people, the following side effects can be serious:
During treatment with this medicine, allergic reactions may occur with swelling of the
face, mouth and/or larynx (the site of the vocal cords), associated with itching and skin rash. If
this happens, stop taking Olmetrivart and contact your doctor immediately.
Olmetrivart may cause excessive reductions in blood pressure in sensitive individuals. This
could cause severe dizziness or fainting. If this happens, stop taking
Olmetrivart, contact your doctor immediately and remain lying down.
Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, skin itching,
even if you have been taking Olmetrivart for a long time, contact your doctor immediately who
will evaluate the symptoms and decide how to proceed with therapy for the treatment of high blood pressure.
Olmetrivart is a combination of three active substances. The following information first reports
other side effects reported so far with the Olmetrivart combination (in addition to those already mentioned above)
and, secondly, those side effects known for each of the three separate substances or when
two substances are administered together.
To give you an idea of how many patients have experienced these side effects, they have been
listed as common, uncommon, rare and very rare.

These are the other side effects with Olmetrivart known so far:
If they do occur, they are mostly mild and do not require discontinuation of treatment.
Common
(may affect up to 1 in 10 people)
Upper respiratory tract infection; sore throat and nose inflammation; urinary tract infection,
dizziness; headache; perception of heartbeats; low blood pressure; nausea; diarrhea;
constipation; cramps; joint swelling; feeling of urgency to urinate; weakness; ankle swelling;
fatigue; laboratory value abnormalities.

Uncommon
(may affect up to 1 in 100 people)
Dizziness when assuming an upright position; vertigo; fast heartbeat; feeling of weakness;
redness and warmth to the face; cough; dry mouth; muscle weakness; inability to
obtain or maintain an erection.

These are the side effects known for each of the components taken alone or for two
components taken together:
They may be side effects of Olmetrivart even if they have not been observed, so far, with
this medicine.

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

Common
(may affect up to 1 in 10 people)
Bronchitis; gastrointestinal infection; vomiting; increased blood sugar; glucose in urine;
confusion; drowsiness; vision disorders (including double and blurred vision); runny or
blocked nose; sore throat inflammation; difficulty breathing; cough; abdominal pain; heartburn;
stomach discomfort; flatulence; joint or bone pain; lower back pain; skeletal pain; blood in
urine; flu-like symptoms; chest pain; pain.

Uncommon
(may affect up to 1 in 100 people)
Reduction of a type of blood cells called platelets which can cause easy bruising or
prolonged bleeding time; anaphylactic reactions; abnormal reduction in appetite
(anorexia); difficulty falling asleep; irritability; mood changes including anxiety;
feeling of depression; chills; sleep disorders; taste alterations; loss of consciousness;
reduced tactile sensitivity; tingling; worsening of near vision; ringing in the ears
(tinnitus); angina (chest pain or discomfort, known as angina pectoris);
irregular heartbeat; rash; hair loss; allergic skin inflammation;
redness of the skin; small red spots on the skin due to minor hemorrhages (purpura);
skin discoloration; itchy red blisters (urticaria); excessive sweating; itching; skin rash; skin reactions to light such as sunburn or rash; muscle pain; difficulty
urinating; nocturnal urge to urinate; enlargement of the breasts in men;
decreased sexual desire; facial swelling; feeling unwell; weight gain or loss; exhaustion.

Rare
(may affect up to 1 in 1000)
Swelling and pain of the salivary glands; reduced number of white blood cells in the blood
which can increase the risk of infections; low number of red blood cells (anemia); bone marrow damage;
restlessness; lack of interest (apathy); convulsions; seeing yellow objects;
dry eyes; 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 gallbladder; symptoms of lupus
erythematosus such as rash, joint pain and cold fingers and hands; severe skin reactions including intense rash, hives, redness of the skin over the entire body surface,
severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes
(Stevens Johnson syndrome, toxic epidermal necrolysis); impaired movement;
acute kidney failure; non-infectious kidney inflammation; reduced kidney function; fever,
intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain,
nausea, vomiting and diarrhea.

Very rare
(may affect up to 1 in 10,000)
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and
confusion), muscle hypertonia; numbness of the hands or feet; heart attack;
inflammation of the stomach; thickening of the gums; intestinal blockage; inflammation of the
liver.

Not known
(frequency cannot be estimated from the available data)
Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). Tremor, rigid posture, mask-like face, slow movements and a shuffling, dragging gait.
Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please 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 Olmetrivart

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 package and on the blister after
“EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Olmetrivart Contains
The active ingredients are olmesartan medoxomil, amlodipine (as amlodipine besylate) and
hydrochlorothiazide.
Olmetrivart 20 mg/5 mg /12.5 mg: Each film-coated tablet contains 20 mg of olmesartan
medoxomil, 5 mg of amlodipine (as besylate) and 12.5 mg of hydrochlorothiazide.
Olmetrivart 40 mg/5 mg /12.5 mg: Each film-coated tablet contains 40 mg of olmesartan
medoxomil, 5 mg of amlodipine (as besylate) and 12.5 mg of hydrochlorothiazide.
Olmetrivart 40 mg/5 mg /25 mg: Each film-coated tablet contains 40 mg of olmesartan
medoxomil, 5 mg of amlodipine (as besylate) and 25 mg of hydrochlorothiazide.
Olmetrivart 40 mg/10 mg /12.5 mg: Each film-coated tablet contains 40 mg of olmesartan
medoxomil, 10 mg of amlodipine (as besylate) and 12.5 mg of hydrochlorothiazide.
Olmetrivart 40 mg/10 mg /25 mg: Each film-coated tablet contains 40 mg of olmesartan
medoxomil, 10 mg of amlodipine (as besylate) and 25 mg of hydrochlorothiazide.
The other ingredients are:
Tablet core: povidone; pregelatinized corn starch; microcrystalline cellulose;
anhydrous colloidal silica, lactose monohydrate; magnesium stearate.
Coating: polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol (E1521); talc
(E553b); yellow iron oxide (E172); black iron oxide (E172) (only film-coated
tablets of 20 mg/5 mg/12.5 mg); red iron oxide (E172) (only film-coated tablets of
20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mg).

Description of the appearance of Olmetrivart and contents of the pack
Olmetrivart 20 mg/5 mg/12.5 mg film-coated tablets are tablets approximately 8 mm in
diameter, film-coated, round in shape, with beveled edges, with
the abbreviation “OC1” imprinted on one side and smooth on the other side.
Olmetrivart 40 mg/5 mg/12.5 mg film-coated tablets are light yellow in color,
film-coated tablets, approximately 9.5 mm in diameter, round in shape, with beveled edges, with
the abbreviation “OC2” imprinted on one side and smooth on the other side.
Olmetrivart 40 mg/5 mg/25 mg film-coated tablets are light yellow in color,
film-coated tablets, approximately 15.00 mm in length, 7.00 mm in width, oval in shape, with
beveled edges, with the abbreviation “OC3” imprinted on one side and smooth on the other side.
Olmetrivart 40 mg/10 mg/12.5 mg film-coated tablets are brick red in color,
film-coated tablets, approximately 9.50 mm in diameter, with beveled edges, round in shape with
the abbreviation “OC4” imprinted on one side and smooth on the other side.
Olmetrivart 40 mg/10 mg/25 mg film-coated tablets are brick red in color,
film-coated tablets, approximately 15.00 mm in length, 7.00 mm in width, with beveled edges, oval in shape
with the abbreviation “OC5” imprinted on one side and smooth on the other side.
Pack containing aluminum-aluminum blister packs in packs of: 28 film-coated tablets
28 x 1 film-coated tablets
98 film-coated tablets
98 x 1 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturers
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,
08040 Barcelona, Spain
Synoptis Industrial Sp. z o. o.
ul. Rabowicka 15, 62-020
Swarzędz, Poland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany