OLSART 40 mg/5 mg Film-Coated Tablets

Зміст інструкції

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

Olsart 20 mg/5 mg, 40 mg/5 mg, 40 mg/10 mg

Generic medicine

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

1. What is Olsart and what is it used for

Olsart contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate).
Both of these substances are used to control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists” which lowers blood pressure by relaxing the blood vessels.
• Amlodipine belongs to a group of substances called “calcium antagonists”. Amlodipine prevents calcium from entering the vessel wall, thus preventing the vessels from constricting and reducing blood pressure.

The action of both of these substances helps to stop the narrowing of the vessels, so that the vessels
relax and blood pressure decreases.
Olsart is used for the treatment of high blood pressure in patients whose blood pressure
is not sufficiently controlled by olmesartan medoxomil or amlodipine alone.

2. What you need to know before taking Olsart

Do not useOlsart

• 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 think you may be allergic, talk to your doctor before taking Olsart.
• if you are pregnant for more than three months(it is best to avoid taking Olsart even in the early stages of pregnancy - see section “Pregnancy and breastfeeding”)
• if you have diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren
• if you have severeliver problems, if the secretion of bile is impaired or the flow of bile from the gallbladder is blocked (for example by gallstones) or if you are developing jaundice (yellowing of the skin and eyes)
• if you have very low blood pressure
• 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 the heart is obstructed (for example 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 Olsart.

Tell 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 Olsart”.

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)

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 treatment for high blood pressure.
As with any medicine that lowers blood pressure, an excessive decrease in blood pressure in patients with
disorders of blood flow to the heart or brain can lead to a heart attack or stroke. The doctor will therefore
carefully monitor your blood pressure.
You should tell your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Olsart 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 (under 18 years)
Olsart is not recommended in children and adolescents under 18 years of age.

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

• Other medicines that lower blood pressurebecause the effect of Olsart may be increased. 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 Olsart” and “Warnings and precautions”).
• Potassium supplements, salt substitutes containing potassium, diureticsor heparin(to thin the blood and prevent thrombosis). Taking these medicines together with Olsart may increase potassium levels in the blood.
• Lithium(a medicine used to treat mood swings and some types of depression) used together with Olsart may increase lithium toxicity. If you need to take lithium, your doctor will measure 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 Olsart may increase the risk of kidney failure. The effect of Olsart may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, because the effect of Olsart may be decreased. Your doctor may advise you to take Olsart at least 4 hours before colesevelam hydrochloride.
• Some antacids(used for indigestion or heartburn) because the effect of Olsart may be slightly reduced.
• Medicines used for HIV/AIDS(for example ritonavir, indinavir, nelfinavir) or for thetreatment of fungal infections(for example 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 alterations of body temperature).
• Simvastatin, a substance used to reduce cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, cyclosporine, used to control the body's immune response and thus allow the body to accept transplanted organs.

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Olsart with food and drink
Olsart can be taken with or without food. Swallow the tablet with some liquid (such as a
glass of water). If possible, take the daily dose every day at the same time, for example with
breakfast.
Grapefruit and grapefruit juice should not be consumed by people taking Olsart.
This is because grapefruit and grapefruit juice can lead to an increase in the levels of the
active ingredient amlodipine in the blood, which may lead to an unpredictable increase in the blood
pressure-lowering effect of Olsart.

Elderly
If you are over 65 years of age, your doctor will regularly check your blood pressure with each
increase in dose, to avoid the blood pressure becoming too low.

Patients of black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Olsart may be, in
some ways, reduced in patients of black ethnicity.

Pregnancy and breastfeeding
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 Olsart before
starting pregnancy or as soon as you find out you are pregnant and will advise you to take another
medicine instead of Olsart. Olsart 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 Olsart, inform and see your doctor
immediately.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Amlodipine has been
shown to pass into breast milk in small amounts. Olsart is not recommended for women who
are breastfeeding and your doctor may choose another treatment if you wish to breastfeed, especially if
the baby is newborn or premature.
If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
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.

Olsart contains lactose
If your doctor has diagnosed you with intolerance to some sugars (e.g. lactose), contact him before
taking this medicine.

3. How to take Olsart

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 Olsart is one tablet a day.
• The tablets can be taken with or without food. Swallow the tablet with a little liquid (such as a glass of water). The tablet must not be chewed. Do not take it with grapefruit juice.
• If possible, take the dose every day at the same time, for example with breakfast.

Olsart 20 mg/5 mg and 40 mg/5 mg film-coated tablets: The score line is only to
help you divide the tablet if you have difficulty swallowing it whole.
Olsart 40 mg/10 mg film-coated tablets: The tablet can be divided into two equal doses.
Therefore, you can obtain the 20 mg/5 mg dose by breaking the 40 mg/10 mg tablet into two doses
and taking half a tablet a day.

If you take more Olsart than you should
If you take more tablets than you should, you may have a reduction in blood pressure with
symptoms such as dizziness, fast or slow heartbeat.
If you take more tablets than you should or if a child accidentally ingests any, go
immediately to your doctor or the nearest emergency room bringing with you the package of the

If you forget to take Olsart
If you forget to take a dose, take the normal dose the next day. Do nottake a double
dose to make up for a missed dose.

If you stop taking Olsart
It is important to continue taking Olsart 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 gets them.
manifest them.

Even if they do not appear in all people, the following two side effects can
be serious. Go to your doctor immediately if you experience any of the following side
effects after taking this medicine.

• During treatment with Olsart, 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 rash.
• Severe skin reactions including rash, urticaria, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Olsart may cause an excessive drop in blood pressure in sensitive individuals or as a result of an allergic reaction. This can cause severe dizziness or fainting . If thishappens, stop taking Olsart, see your doctor immediately and remain ina lying position.

Other possible side effects with Olsart:
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 when getting 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;
arm and leg pain; back pain; feeling of urgency to urinate; 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 potassium levels in the blood, increased creatinine levels in the blood,
increased uric acid levels, increased liver function tests (gamma glutamyl
transferase levels).

Rare (may affect up to 1 in 1000 people):
Hypersensitivity to the medicine; fainting; redness and warmth to the face; itchy, raised wheals
(urticaria); swelling of the face.

Side effects reported with the use of olmesartan medoxomil or amlodipine alone, but not
with Olsart 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 urine;
urinary tract infection; chest pain; flu-like symptoms; pain. Changes in laboratory tests such as increased fats (hypertriglyceridemia); increased urea or uric acid
plasma levels and increased liver and muscle function test values.

Uncommon (may affect up to 1 in 100 people):
Reduced number of a type of blood cell 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 as well as a rapid drop in
blood pressure which can also cause weakness (anaphylactic reactions); angina (chest pain or
discomfort, known as angina pectoris); itching; rash; allergic skin rash; rash with urticaria, swelling of the face; muscle pain; feeling of
illness.

Rare (may affect up to 1 in 1000 people):
Swelling of the face, mouth and/or larynx (the seat of the vocal cords); acute renal failure and
kidney failure; 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 to 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 or purple spots on the skin due to minor bleeding (purpura); skin discoloration; excessive sweating; rash; itching; itchy, raised wheals (urticaria); muscle or joint pain; problems with urination; 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 1000 people):
Confusion.

Very rare (may affect up to 1 in 10,000 people):
Reduced number of white blood cells, which may increase the risk of infections;
reduced number of a type of blood cell 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 lining; thickening of the gums; high
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 (the seat
of the vocal cords) together with itching and rash, severe skin reactions including intense
rash, urticaria, redness of the skin over the entire surface of the body, severe itching,
blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-
Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening.

Not known (frequency cannot be estimated from available data):
Tremor, rigid posture, mask-like face, slowness of movements, shuffling and unsteady gait.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Olsart

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.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Olsart contains

• The active ingredients are olmesartan medoxomil and amlodipine (as besilate). Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate). Each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate). Each tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besilate).
• The other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, crospovidone, povidone, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate

Tablet coating:partially hydrolyzed polyvinyl alcohol (E1203), macrogol
(E1521, polyethylene glycol), talc (E553b), red iron oxide (E172) (only for Olsart
40mg/10mg film-coated tablets), titanium dioxide (E171) (only for Olsart 20mg/5mg,
40mg/5mg film-coated tablets), yellow iron oxide (E172) (only for Olsart
40mg/5mg film-coated tablets).

Description of Olsart and package contents
Olsart 20 mg/5 mg film-coated tablets are white, round, convex film-coated tablets,
with a diameter of approximately 6.8 mm, with “5” imprinted on one side, with a score line on the other side
with “2” imprinted on the left side of the score line and “0” on the right side.
Olsart 40 mg/5 mg film-coated tablets are yellow, round, convex film-coated tablets,
with a diameter of approximately 8.6 mm, with “5” imprinted on one side, with a score line
on the other side with “4” imprinted on the left side of the score line and “0” on the right side.
Olsart 40 mg/10 mg film-coated tablets are brownish-red, round, convex film-coated tablets,
with a diameter of approximately 8.6 mm, with “10” imprinted on one side, with
a score line on the other side with “4” imprinted on the left side of the score line and “0” on the
right side.
Olsart film-coated tablets are available in blister packs of 28 film-coated
tablets.

Marketing Authorisation Holder
S.F. GROUP S.r.l.
Via Tiburtina 1143

• 00156 – Rome Italy

Manufacturers
Merckle GmbH
Ludwig-Merckle-Strasse 3
Blaubeuren
Baden-Wuerttemberg
89143 Germany
Balkanpharma- Dupnitsa AD
3 Samokovsko Shosse Str. 2600
Dupnitsa
Bulgaria