OLMESARTAN 20 mg/5 mg Film-Coated Tablets

Зміст інструкції

1. Olmesartan and Amlodipine HCS 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 and Amlodipine HCS and what is it used for
   2. What you need to know before taking Olmesartan and Amlodipine HCS
   3. How to take Olmesartan and Amlodipina HCS
   4. Possible side effects
   5. How to store Olmesartan e Amlodipina HCS
   6. Package contents and other information

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

Olmesartan medoxomil/Amlodipine

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 and Amlodipine HCS is and what it is used for
• 2. What you need to know before you take Olmesartan and Amlodipine HCS
• 3. How to take Olmesartan and Amlodipine HCS
• 4. Possible side effects
• 5. How to store Olmesartan and Amlodipine HCS
• 6. Contents of the pack and other information

1. What is Olmesartan and Amlodipine HCS and what is it used for

Olmesartan and Amlodipine HCS contains two substances called olmesartan medoxomil and amlodipine
(as amlodipine besylate).
Both are used to control high blood pressure.
Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor blockers”. 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 the 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 and Amlodipine HCS is used to treat high blood pressure (also called “arterial hypertension”) in patients whose blood pressure is not sufficiently controlled by olmesartan
medoxomil or amlodipine alone.

2. What you need to know before taking Olmesartan and Amlodipine HCS

Do not take Olmesartan and Amlodipine HCS:

• if you are allergic to olmesartan medoxomil or amlodipine or to a particular group of calcium channel blockers, the dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than three months (it is best to avoid taking Olmesartan and Amlodipine HCS even in the early stages of pregnancy - see the 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 (e.g. by gallstones) or if you experience 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 severe heart problems.
• if the blood flow from your heart is obstructed (e.g. due to a narrowing of the aorta (aortic stenosis)).
• if you suffer from reduced cardiac output (which causes 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 and Amlodipine HCS.

Consult your doctorif you are taking any of the following medicines used to treat high blood
pressure:

• an “ACE inhibitor” (e.g. 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 and Amlodipine HCS”.

Consult 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 “water tablets” (diuretics) or if you are
following 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 the symptoms and decide whether to continue this antihypertensive treatment.
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.
You should tell your doctor if you think you might be pregnant (or if there is a possibility of becoming
pregnant). Olmesartan and Amlodipine HCS 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
Olmesartan and Amlodipine HCS is not recommended in children and adolescents under 18 years of age.

Other medicines and Olmesartan and Amlodipine HCS
Tell your doctor or pharmacist if you are taking or have recently taken any of the following
medicines:

Other medicines that lower blood pressurecan increase the effect of
Olmesartan and Amlodipine HCS. 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 and Amlodipine HCS" and "Warnings and
precautions”).

Potassium supplements, salt substitutes containing potassium, “water tablets”
(diuretics) or heparin(to thin the blood and prevent thrombosis). Using these
medicines together with Olmesartan and Amlodipine HCS can increase potassium
levels in the blood.

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

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

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

Some antacids(used for indigestion or heartburn) may slightly reduce
the effect of Olmesartan and Amlodipine HCS.

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(medicines used for tuberculosis or other infections.)

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

Dantrolene(infusion for severe temperature alterations).

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

Tacrolimus,sirolimus, temsirolimus and everolimus (medicines used to alter the
functioning of the immune system)

Cyclosporine(immunosuppressant).

Olmesartan and Amlodipine HCS with food and drink
Olmesartan and Amlodipine HCS 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 Olmesartan and Amlodipine HCS should not consume grapefruit and grapefruit juice
as grapefruit and its juice can increase the levels of the active substance amlodipine in the blood, and this
may lead to an unpredictable increase in the hypotensive effect of Olmesartan and Amlodipine HCS.

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

Black patients
As with other similar medicines, the blood pressure lowering effect of Olmesartan and
Amlodipine HCS may be, to some extent, reduced in black patients.

Pregnancy and breastfeeding
If you are pregnant, suspect you are 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 might be pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking Olmesartan and
Amlodipine HCS before starting pregnancy or as soon as you find out you are
pregnant and will advise you to take another medicine instead of Olmesartan and
Amlodipine HCS. Olmesartan and Amlodipine HCS 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 were to become pregnant during therapy with Olmesartan and Amlodipine HCS, inform and see
your doctor immediately.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Olmesartan and
Amlodipine HCS 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 was born prematurely.
Amlodipine has been shown to pass into breast milk in small amounts.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or are
breastfeeding or think you may be pregnant or are planning to become pregnant.

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.

Olmesartan and Amlodipine HCS contains lactose monohydrate and sodium
If your doctor has told you that you have an intolerance to some sugars, contact him/her before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Olmesartan and Amlodipina HCS

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 and Amlodipina HCS is one tablet a day.
The tablets can be taken with or without food. Swallow the tablets with some
liquid (such as a glass of water). The tablets must not be chewed. Do not take them with grapefruit juice.
If possible, take your daily dose every day at the same time, for example with
breakfast.

If you take more Olmesartan and Amlodipina HCS 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.
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 Olmesartan and Amlodipina HCS
If you forget to take a dose, take your normal dose the next day. Do nottake a
double dose to make up for a missed dose.

If you stop taking Olmesartan and Amlodipina HCS
It is important to continue taking Olmesartan and Amlodipina HCS 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.

Although they do not occur in all people, the following two side effects can be serious:
During treatment with Olmesartan and Amlodipina HCS, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth and/or larynx (the seat of the vocal cords), associated with itching and skin rash (Stevens Johnson syndrome, toxic epidermal necrolysis). If this happens, stop taking Olmesartan and Amlodipina HCS and contact your doctor immediately.
Olmesartan and Amlodipina HCS may cause excessive reductions in blood pressure in sensitive individuals or as a result of an allergic reaction. This may cause severe dizziness or fainting. If this happens, stop taking Olmesartan and Amlodipina HCS, contact your doctor immediately and lie down.
Other possible side effects of Olmesartan and Amlodipina HCS:
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 upon standing up; lack of energy; tingling or numbness in the hands or feet; vertigo; faster or more pronounced heartbeat; low blood pressure with symptoms such as dizziness, lightheadedness, shortness of breath; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; pain in the upper abdomen; skin rash; muscle spasms; pain in arms and legs; back pain; feeling of urgency to urinate; sexual inactivity; inability to obtain or maintain an erection; weakness.
Some changes in blood tests have also been observed, including the following:
increase or decrease in potassium in the blood, increased creatinine in the blood, increased uric acid in the blood, increased liver function tests (gamma glutamyl transferase levels).

Rare (may affect up to 1 in 1,000 people):
Hypersensitivity to the drug; fainting; redness and warmth in the face; skin rash with hives; swelling of the face.

Side effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with Olmesartan and Amlodipina HCS 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; gastrointestinal flu; diarrhea; indigestion; nausea; bone or joint pain; back pain; blood in the urine; urinary tract infection; chest pain; flu-like symptoms; pain. Changes in laboratory tests such as increased fats (hypertriglyceridemia); increased urea or plasma uric acid 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 result in easier bruising or prolonged bleeding time; immediate allergic reactions that can affect the whole body and can cause breathing problems or a rapid drop in blood pressure which can also determine weakness (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; skin rash with hives, swelling of the face; muscle pain; feeling unwell.

Rare (may affect up to 1 in 1,000 people):
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; swollen ankles; drowsiness; redness and warmth in the face, visual disturbances (including double vision and blurred vision), awareness of heartbeat, diarrhea, constipation, indigestion, cramps, weakness, difficulty breathing.

Uncommon (may affect up to 1 in 100 people):
Restless sleep; sleep disturbances; mood disturbances including anxiety; 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 spots on the skin due to minor hemorrhages (purpura); skin discoloration; excessive sweating; skin rash; itching; itchy red bumps (hives); muscle or joint pain; problems urinating; need to urinate at night; increased need to urinate; enlargement of the breasts in men; chest pain; pain, malaise; weight gain or loss.

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

Very rare (may affect up to 1 in 10,000 people):
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 result in 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 blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; thickening of the gums; high levels of liver enzymes; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions: itching, skin rash, swelling of the face, mouth and/or larynx (the seat of the vocal cords) together with itching and skin rash, severe skin reactions including intense rash, hives, redness all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes, sometimes with a life-threatening risk).

Not known (frequency cannot be estimated based on available data):
Tremors, rigid posture, mask-like face, slowed movements and unbalanced gait.

Reporting of side effects
If you experience any side effects, including 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 e Amlodipina HCS

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 pack after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture.
This medicine does not require any particular 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 Olmesartan and Amlodipina HCS contains

• The active ingredients are olmesartan medoxomil and amlodipine.
• Olmesartan and Amlodipina HCS 20mg/5 mg film-coated tablets: Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besylate). Olmesartan and Amlodipina HCS 40mg/5 mg film-coated tablets: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besylate). Olmesartan and Amlodipina HCS 40mg/10 mg film-coated tablets: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besylate). The other ingredients are microcrystalline cellulose, pregelatinized corn starch, lactose monohydrate, sodium croscarmellose and magnesium stearate (E470b) in the tablet core and poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172) - only for the 40 mg/5 mg and 40 mg/10 mg film-coated tablets and red iron oxide (E172) - only for the 40 mg/10 mg film-coated tablets. See section 2 “Olmesartan and Amlodipina HCS contains lactose monohydrate and sodium”.

Description of the appearance of Olmesartan and Amlodipina HCS and package contents
Olmesartan and Amlodipina HCS 20mg/5 mg film-coated tablets (tablets): film-coated
tablets white or almost white, round, biconvex with beveled edges. Tablet size:
diameter 7 mm, thickness: 2.5 - 4.2 mm.
Olmesartan and Amlodipina HCS 40mg/5 mg film-coated tablets (tablets): film-coated
tablets with beveled edges, light yellow-brown, round, biconvex, with the number 5 engraved on one
side of the tablet. Tablet size: diameter 9 mm, thickness: 3.6 - 5.3 mm.
Olmesartan and Amlodipina HCS 40mg/10 mg film-coated tablets (tablets): film-coated
tablets reddish-brown, round, biconvex with chamfered corners, marked on one side of the
tablet. Tablet size: diameter 9 mm, thickness: 3.6 - 5.3 mm. The tablet can
be divided into equal doses.
Olmesartan and Amlodipina HCS is available in boxes containing:

• 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in blisters.
• 14, 28, 56 and 98 film-coated tablets in blisters, calendar packaging. Not all packs may be marketed.

Marketing Authorisation Holder
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH,Heinz-Lohmann-Straβe 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following names: