Olsart

Package leaflet: Information for the user

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

Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to 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 taking 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 Olsart is and what it is 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 lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of substances called "calcium antagonists". Amlodipine prevents calcium from entering the vessel wall, thereby preventing blood vessels from constricting and thus reducing blood pressure.

The action of both these substances helps prevent blood vessel constriction, allowing the vessels to relax and blood pressure to decrease.
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 should know before taking Olsart

Do not use Olsart

• if you are allergic to olmesartan medoxomil or amlodipine, or to a specific group of calcium channel blockers called dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, speak with your doctor before taking Olsart.
• if you are more than three months pregnant (it is best to avoid taking Olsart even in the early stages of pregnancy – see section “Pregnancy and breastfeeding”)
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you have severe liver problems, if bile secretion is impaired, or if bile flow from the gallbladder is blocked (e.g. due to gallstones), or if you are experiencing jaundice (yellowing of the skin and eyes)
• if you have very low blood pressure
• if you suffer from inadequate blood supply to tissues, with symptoms such as low blood pressure, weak pulse, or rapid heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems
• if blood flow from the heart is obstructed (e.g. due to narrowing of the aorta (aortic stenosis))
• if you have reduced cardiac output (causing shortness of breath or peripheral swelling) following a heart attack (acute myocardial infarction).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olsart.
Inform your doctor if 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 have kidney problems related to diabetes,
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.
See also information under the section “Do not take Olsart”.
Inform your doctor if you also have any of the following health conditions:

• Kidney problems or kidney transplant
• Liver disease
• Heart failure or heart valve or heart muscle problems
• Severe vomiting, diarrhoea, 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 (hormone-producing glands located above the kidneys)

Inform your doctor if you develop severe and prolonged diarrhoea with significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this treatment for high blood pressure.
As with any medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Olsart is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section “Pregnancy and breastfeeding”).

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

Other medicines and Olsart Inform 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 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 information under “Do not take Olsart” and “Warnings and precautions”).
• Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (used 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 certain types of depression) taken together with Olsart may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) taken 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, as the effect of Olsart may be reduced. Your doctor may advise you to take Olsart at least 4 hours before colesevelam hydrochloride.
• Some antacids (used for indigestion or stomach acidity), as the effect of Olsart may be slightly reduced.
• Medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir) or for 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 (intravenous infusion for severe disturbances in 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 acceptance of transplanted organs.

Inform 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 at the same time each day, for example with breakfast.
Grapefruit and grapefruit juice must not be consumed by people taking Olsart.
This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of Olsart.

Elderly
If you are over 65 years old, your doctor will regularly monitor your blood pressure with each dose increase, to prevent your blood pressure from becoming too low.

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

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Olsart before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olsart. Olsart is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
If you become pregnant while taking Olsart, inform your doctor and seek medical advice immediately.

Breastfeeding
Inform your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. Olsart is not recommended for breastfeeding women, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is newborn or was born prematurely.

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
You may experience drowsiness, discomfort, dizziness, or headache during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.

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

3. How to take Olsart

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.

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

Olsart 20 mg/5 mg and 40 mg/5 mg film-coated tablets: The score line is only intended 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, the 20 mg/5 mg dose can be obtained by splitting the 40 mg/10 mg tablet into two equal parts and taking half a tablet daily.
If you take more Olsart than you should
If you take more tablets than prescribed, you may experience a drop in blood pressure with symptoms such as dizziness, or a faster or slower heartbeat.
If you take more tablets than you should, or if a child accidentally swallows any, go immediately to a doctor or the nearest emergency room, taking the medicine pack or this leaflet with you.
If you forget to take Olsart
If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for the forgotten dose.
If you stop taking Olsart
It is important to continue taking Olsart unless your doctor tells you otherwise.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following two side effects can be serious, even if they do not occur in all people. If you experience any of the following side effects after taking this medicine, seek immediate medical attention.

• During treatment with Olsart, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth and/or larynx (the site of the vocal cords), associated with itching and skin rash.
• Severe skin reactions including rash, urticaria, redness of the skin over the entire body, severe itching, blisters, peeling and swelling of the skin, inflammation of 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 consequence of an allergic reaction. This may lead to severe dizziness or fainting. If this occurs, stop taking Olsart, seek immediate medical advice and remain lying down.

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 upon standing; lack of energy; tingling or numbness in hands or feet; vertigo; awareness of heartbeat; rapid heartbeat; low blood pressure with symptoms such as dizziness, lightheadedness, shortness of breath; cough; nausea; vomiting; indigestion; diarrhoea; constipation; dry mouth; upper abdominal pain; rash; cramps; pain in arms and legs; back pain; urgency to urinate; reduced sexual activity; inability to achieve or maintain an erection; weakness.
Some blood test abnormalities have also been observed, including the following: increase or decrease in blood potassium levels, increased blood creatinine levels, increased levels of uric acid, increased liver function tests (gamma-glutamyl transferase levels).
Rare (may affect up to 1 in 1,000 people):
Hypersensitivity to the medicine; fainting; facial flushing and sensation of warmth; red, itchy raised areas (urticaria); facial swelling.

Side effects reported with olmesartan medoxomil or amlodipine used alone, but not with Olsart or with different frequency:

Olmesartan medoxomil
Common (may affect up to 1 in 10 people):
Bronchitis; sore throat; stuffy or runny nose; cough; abdominal pain; gastroenteritis; diarrhoea; indigestion; nausea; bone or joint pain; back pain; blood in urine; urinary tract infection; chest pain; flu-like symptoms; pain. Laboratory test abnormalities such as increased fats (hypertriglyceridemia); increased plasma urea or uric acid; increased liver and muscle function test values.
Uncommon (may affect up to 1 in 100 people):
Reduction in the number of a type of blood cell called platelets, which may lead to easier bruising or prolonged bleeding time; immediate allergic reactions that may affect the whole body and may cause breathing difficulties as well as a rapid drop in blood pressure, possibly leading to weakness (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; skin rash with urticaria, facial swelling; muscle pain; feeling unwell.
Rare (may affect up to 1 in 1,000 people):
Swelling of the face, mouth and/or larynx (site of the vocal cords); acute renal failure and renal failure; lethargy.

Amlodipine
Very common (may affect more than 1 in 10 people):
Oedema (fluid retention).
Common (may affect up to 1 in 10 people):
Abdominal pain; nausea; swollen ankles; drowsiness; facial flushing and sensation of warmth; visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhoea; constipation; indigestion; cramps; weakness; shortness of breath.
Uncommon (may affect up to 1 in 100 people):
Restless sleep; sleep disorders; 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 or patches on the skin due to minor bleeding (purpura); skin discolouration; excessive sweating; rash; itching; red, itchy raised areas (urticaria); muscle or joint pain; difficulty urinating; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain, discomfort; 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, which may increase the risk of infections; reduction in the number of a type of blood cell called platelets, which may lead to easier bruising or prolonged bleeding time; increased blood glucose levels; increased muscle stiffness or increased resistance to passive movements (hypertonia); tingling or numbness in hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach lining; gum hyperplasia; high levels of liver enzymes; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions: itching, rash, swelling of the face, mouth and/or larynx (site of the vocal cords) together with itching and rash, severe skin reactions including intense rash, urticaria, redness of the skin over the entire body, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening.
Not known (frequency cannot be estimated from the available data):
Tremor, rigid posture, mask-like facial expression, slowed movements, shuffling and unsteady gait.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting side effects 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 stated on the carton 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Olsart contains

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

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

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

Marketing Authorization 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