Olmesartan and amlodipine HCS

PACKAGE LEAFLET

Package leaflet: Information for the patient

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
Please 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Olmesartan and Amlodipine HCS is and what it is used for

Olmesartan and Amlodipine HCS contains two active substances called olmesartan medoxomil and amlodipine (as amlodipine besilate).
Both are used to control hypertension.
Olmesartan medoxomil belongs to a group of medicines called "angiotensin II receptor antagonists". These lower blood pressure by relaxing blood vessels.
Amlodipine belongs to a group of substances called "calcium antagonists". Amlodipine prevents calcium from entering the walls of blood vessels, thereby reducing vessel tension and lowering blood pressure.
The combined action of both substances helps counteract vascular tension, allowing blood vessels to relax and blood pressure to decrease.
Olmesartan and Amlodipine HCS is used to treat high blood pressure (also known as "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 specific group of calcium antagonists called dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than three months pregnant (it is better to avoid taking Olmesartan and Amlodipine HCS 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 its outflow from the gallbladder is blocked (e.g. by gallstones), or if you have jaundice (yellowing of the skin and eyes).
• if your blood pressure is very low.
• if you have severely reduced blood flow 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 your 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 Olmesartan and Amlodipine HCS.
Consult 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), particularly if you have kidney problems related to diabetes.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take Olmesartan and Amlodipine HCS”.

Consult your doctor if you also have any of the following health conditions:
Kidney problems or kidney transplant.
Liver disease.
Heart failure or problems with heart valves or heart muscle.
Severe vomiting, diarrhoea, treatment with high doses of diuretics ("water tablets"), or if you are on a low-salt diet.
Elevated potassium levels 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 accompanied by significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this antihypertensive treatment.
As with any medicine that lowers blood pressure, excessive reduction of blood pressure in patients with circulatory disorders of 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). Olmesartan and Amlodipine HCS 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 child if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents
Olmesartan and Amlodipine HCS is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan and Amlodipine HCS
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 may enhance the effect of Olmesartan and Amlodipine HCS. Your doctor may need to adjust your dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also “Do not take Olmesartan and Amlodipine HCS” and “Warnings and precautions”).
Potassium supplements, potassium-containing salt substitutes, diuretics ("water tablets") or heparin (used to thin the blood and prevent thrombosis). Taking these medicines together with Olmesartan and Amlodipine HCS may increase potassium levels in the blood.
Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Olmesartan and Amlodipine HCS may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) taken together with Olmesartan and Amlodipine HCS may increase the risk of kidney failure. The effect of Olmesartan and Amlodipine HCS may be reduced by NSAIDs.
Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce 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 stomach acidity) may slightly reduce the effect of Olmesartan and Amlodipine HCS.
Medicines 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 (infusion for severe disturbances in body temperature).
Simvastatin (a substance used to reduce cholesterol and fat (triglyceride) levels in the blood).
Tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to alter the function of the immune system).
Ciclosporin (an immunosuppressant).

Olmesartan and Amlodipine HCS with food and drink
Olmesartan and Amlodipine HCS can be taken with or without food. Swallow the tablet with some liquid (such as a glass of water). If possible, take your daily dose at the same time each day, for example with breakfast.
People taking Olmesartan and Amlodipine HCS must not consume grapefruit or grapefruit juice, as grapefruit and its juice may increase blood levels of the active substance amlodipine, which could unpredictably enhance the hypotensive effect of Olmesartan and Amlodipine HCS.

Elderly people
If you are over 65 years of age, your doctor will regularly monitor your blood pressure with each dose increase to avoid excessive lowering.

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

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

Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will normally advise you to stop taking Olmesartan and Amlodipine HCS before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan and Amlodipine HCS 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 child if taken after the third month of pregnancy.
If you become pregnant while taking Olmesartan and Amlodipine HCS, inform and see your doctor immediately.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Olmesartan and Amlodipine HCS 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 a newborn or was born prematurely.
It has been shown that amlodipine passes into breast milk in small amounts.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy.

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

Olmesartan and Amlodipine HCS contains lactose monohydrate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 Amlodipine HCS

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

If you take more Olmesartan and Amlodipine HCS than you should
If you take more tablets than prescribed, you may experience a drop in blood pressure with symptoms such as dizziness, increased or decreased heart rate.
If you take more tablets than you should, or if a child accidentally swallows any, go immediately to your doctor or the nearest emergency department, taking the medicine pack or this leaflet with you.

If you forget to take Olmesartan and Amlodipine HCS
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 missed dose.

If you stop taking Olmesartan and Amlodipine HCS
It is important to continue taking Olmesartan and Amlodipine HCS unless your doctor tells you to stop.
If you have any questions about how to use 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.

Although they do not occur in all people, the following two side effects can be serious:

During treatment with Olmesartan and Amlodipine HCS, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis). If this occurs, stop taking Olmesartan and Amlodipine HCS and contact your doctor immediately.

Olmesartan and Amlodipine HCS may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This could cause severe dizziness or fainting. If this occurs, stop taking Olmesartan and Amlodipine HCS, contact your doctor immediately, and remain lying down.

Other possible side effects of Olmesartan and Amlodipine 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; lack of energy; tingling or numbness in hands or feet; vertigo; more noticeable or faster heartbeat; low blood pressure with symptoms such as dizziness, empty-headed feeling, shortness of breath; cough; nausea; vomiting; indigestion; diarrhoea; constipation; dry mouth; upper abdominal pain; skin rash; muscle spasms; pain in arms and legs; back pain; feeling of urgency to urinate; loss of sexual interest; 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 creatinine in blood, increased uric acid in blood, increased liver function tests (levels of gamma-glutamyl transferase).

Rare (may affect up to 1 in 1,000 people):
Hypersensitivity to the medicine; flushing and sensation of warmth in the face; skin rash with hives; facial swelling.

Side effects reported with use of olmesartan medoxomil or amlodipine alone, but not with Olmesartan and Amlodipine HCS or at higher 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 (hypertriglyceridaemia); increased blood 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 cells called platelets, which may lead to easier bruising or prolonged bleeding time; immediate allergic reactions which may affect the whole body and may cause breathing difficulties or rapid drop in blood pressure, which may also lead to weakness (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; skin rash with hives, facial swelling; muscle pain; feeling of malaise.

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; flushing and sensation of warmth in the face; visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhoea; constipation; indigestion; cramps; weakness; difficulty breathing.

Uncommon (may affect up to 1 in 100 people):
Restless sleep; sleep disturbances; mood disorders 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; red spots or patches on the skin due to small bleedings (purpura); skin discoloration; excessive sweating; skin rash; itching; itchy red bumps (wheals); muscle or joint pain; problems urinating; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain, discomfort; weight gain or weight 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 lead to easier bruising or prolonged bleeding time; increased blood glucose; increased muscle stiffness or increased resistance to passive movement (hypertonia); tingling or numbness in hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; gum enlargement; elevated liver enzyme levels; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions: itching, skin rash, swelling of the face, mouth and/or larynx (site of the vocal cords) together with itching and skin rash, severe skin reactions including severe skin rash, hives, redness all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes, sometimes life-threatening.

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

Reporting of side effects

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

5. How to store Olmesartan and Amlodipine 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 packaging after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
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. Package contents and other information

What Olmesartan and Amlodipine HCS contains

• The active substances are olmesartan medoxomil and amlodipine.
• Olmesartan and Amlodipine HCS 20 mg/5 mg film-coated tablets: Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).
  Olmesartan and Amlodipine HCS 40 mg/5 mg film-coated tablets: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).
  Olmesartan and Amlodipine HCS 40 mg/10 mg film-coated tablets: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besilate).
  The other ingredients are silicified microcrystalline cellulose, pregelatinized maize 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 40 mg/5 mg film-coated tablets and red iron oxide (E172) – only for 40 mg/10 mg film-coated tablets in the coating. See section 2 “Olmesartan and Amlodipine HCS contains lactose monohydrate and sodium”.

Description of the appearance of Olmesartan and Amlodipine HCS and contents of the pack
Olmesartan and Amlodipine HCS 20 mg/5 mg film-coated tablets: white or almost white, round, biconvex film-coated tablets with bevelled edges. Tablet size: diameter 7 mm, thickness: 2.5 – 4.2 mm.
Olmesartan and Amlodipine HCS 40 mg/5 mg film-coated tablets: light brownish-yellow, round, biconvex film-coated tablets with bevelled edges, marked with the number 5 on one side of the tablet. Tablet size: diameter 9 mm, thickness: 3.6 – 5.3 mm.
Olmesartan and Amlodipine HCS 40 mg/10 mg film-coated tablets: reddish-brown, round, biconvex film-coated tablets with rounded 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 Amlodipine HCS is available in packs 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 blister calendar packs. Not all pack sizes may be marketed.

Marketing Authorization 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-Straße 5, 27472 Cuxhaven, Germany
This medicinal product is authorized in the European Economic Area countries under the following names: