Olmesartan/amlodipine Sandoz 40 mg/10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Olmesartan/Amlodipine Sandoz 20 mg/5 mg film-coated tablets EFG

Olmesartan/Amlodipine Sandoz 40 mg/5 mg film-coated tablets EFG

Olmesartan/Amlodipine Sandoz 40 mg/10 mg film-coated tablets EFG

olmesartan medoxomil/amlodipine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Olmesartán/Amlodipino Sandoz is and what it is used for

Olmesartán/Amlodipino Sandoz contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines known as “angiotensin II receptor antagonists”, which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, thereby preventing blood vessels from narrowing, which also reduces blood pressure.

The combined action of both substances helps prevent the narrowing of blood vessels, allowing them to relax and thereby lowering blood pressure.

Olmesartan/amlodipine is used to treat high blood pressure in adult patients whose blood pressure is not adequately controlled with olmesartan medoxomil or amlodipine alone.

2. What you need to know before taking Olmesartan/Amlodipine Sandoz

Do not take Olmesartan/Amlodipine Sandoz

• if you are allergic to olmesartan medoxomil, or to amlodipine, or to a special group of calcium channel blockers called dihydropyridines, or to any of the other components of this medicine (listed in section 6).

If you think you may be allergic, inform your doctor before taking Olmesartan/Amlodipine Sandoz.

• if you are more than 3 months pregnant. It is best to avoid olmesartan/amlodipine during early pregnancy (see section “Pregnancy and breastfeeding”),
• if you have diabetes or kidney problems 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 release from the gallbladder is blocked (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes),
• if you have very low blood pressure,
• if you have inadequate blood supply to tissues, with symptoms such as low blood pressure, weak pulse, or rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems,
• if blood flow from your heart is blocked (e.g., due to narrowing of the aorta (aortic stenosis)),
• if you have low 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/Amlodipine Sandoz.

Tell your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (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 electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartan/Amlodipine Sandoz”.

Tell your doctor if you have any of the following health conditions:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands (hormone-producing glands located above the kidneys).

Contact your doctor if you experience severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

As with any other medicine that lowers blood pressure, excessive reduction in blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You must inform your doctor if you are (or might become) pregnant. The use of olmesartan/amlodipine is not recommended during early pregnancy, and it must not be taken after the 3rd month of pregnancy, as it may cause serious harm to your baby if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents

Olmesartan/amlodipine is not recommended for children and adolescents under 18 years of age.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartan/amlodipine. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan/amlodipine on your own.

Taking Olmesartan/Amlodipine Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:

• Other blood pressure-lowering medicines, as they may enhance the effect of olmesartan/amlodipine. Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Olmesartan/Amlodipine Sandoz” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine elimination (diuretics), or heparin (used to thin the blood and prevent blood clots). Taking these medicines together with olmesartan/amlodipine may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression) taken together with olmesartan/amlodipine may increase its 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 relieve pain, swelling, and other symptoms of inflammation, including arthritis) taken together with olmesartan/amlodipine may increase the risk of kidney failure. The effect of olmesartan/amlodipine may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of olmesartan/amlodipine. Your doctor may advise you to take olmesartan/amlodipine at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and heartburn), as they may slightly reduce the effect of olmesartan/amlodipine.
• Medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or for treating fungal infections (e.g., ketoconazole, itraconazole).
• Diltiazem, verapamil (medicines used for heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin (antibiotics).
• Erythromycin, clarithromycin (for bacterial infections).
• St. John’s wort (Hypericum perforatum), a herbal remedy.
• Dantrolene (administered by infusion for serious body temperature abnormalities).
• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine (used to control the body’s immune response, making it possible for your body to accept a transplanted organ).

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

Taking Olmesartan/Amlodipine Sandoz with food and drink

Olmesartan/Amlodipine Sandoz can be taken with or without food. Take the tablets 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.

People taking olmesartan/amlodipine must not consume grapefruit or grapefruit juice. 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 olmesartan/amlodipine.

Elderly

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure it does not drop too low.

Black patients

As with other similar medicines, the blood pressure-lowering effect of olmesartan/amlodipine is somewhat reduced in black patients.

Pregnancy and breastfeeding

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

Pregnancy

You must inform your doctor if you are (or might become) pregnant.

Your doctor will advise you to stop taking olmesartan/amlodipine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of olmesartan/amlodipine is not recommended during early pregnancy, and it must not be taken after the 3rd month of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

If you become pregnant while taking olmesartan/amlodipine, inform and see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts.

Olmesartan/amlodipine is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, unwell, dizzy, or have headaches. If this happens, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartan/Amlodipine Sandoz contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Olmesartán/Amlodipino Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

If you take more Olmesartán/Amlodipino Sandoz than you should

If you take more tablets than you should, you are likely to experience a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop 24–48 hours after ingestion.

If you take more tablets than prescribed or if a child accidentally ingests any tablets, contact your doctor immediately or go to the nearest emergency department, and bring the medicine pack or this leaflet with you.

If you have taken more Olmesartán/Amlodipino Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olmesartán/Amlodipino Sandoz

If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartán/Amlodipino Sandoz

It is important to continue taking olmesartan/amlodipine unless your doctor tells you to stop.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If they do occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious, although they affect only a small number of people:

During treatment with olmesartan/amlodipine, severe skin reactions may occur, including rash, blisters, skin redness, and swelling of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions. If this happens to you, stop taking olmesartan/amlodipine and consult your doctor immediately.

Olmesartan/amlodipine may cause a marked drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens to you, stop taking olmesartan/amlodipine, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching—even if you started treatment with olmesartan/amlodipine some time ago—contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

Other possible adverse effects with olmesartan/amlodipine:

Common (may affect up to 1 in 10 people):

• dizziness,
• headache,
• swelling of the 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 the hands or feet,
• vertigo,
• awareness of heartbeat,
• rapid heartbeat,
• low blood pressure with symptoms such as dizziness, lightheadedness,
• difficulty breathing,
• cough,
• nausea,
• vomiting,
• indigestion,
• diarrhea,
• constipation,
• dry mouth,
• upper abdominal pain,
• skin rash,
• cramps,
• pain in arms and legs,
• back pain,
• feeling of urgency to urinate,
• sexual inactivity,
• inability to achieve or maintain an erection,
• weakness.

Also observed have been some changes in the results of certain blood tests: increase or decrease in blood potassium levels, increase in blood creatinine levels, increase in blood uric acid levels, and increased values in liver function tests (gamma-glutamyl transferase levels).

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

• hypersensitivity to the medicine,
• fainting,
• redness and sensation of warmth in the face,
• itchy red welts (urticaria),
• facial swelling.

Adverse effects reported with olmesartan medoxomil or amlodipine used alone, but not with olmesartan/amlodipine, or reported more frequently:

Olmesartan medoxomil

Common (may affect up to 1 in 10 people):

Bronchitis; sore throat; nasal congestion and discharge; cough; abdominal pain; viral gastroenteritis; diarrhea; indigestion; nausea; joint and bone pain; back pain; blood in urine; urinary tract infection; chest pain; flu-like symptoms; pain. Changes in blood test results, such as increased levels of a type of fat (hypertriglyceridemia); increased blood uric acid and urea levels; and increased values in liver and muscle function tests.

Uncommon (may affect up to 1 in 100 people):

Reduction in the number of a type of blood cell called platelets, which may cause easy bruising or prolonged bleeding time; rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure, possibly leading to fainting (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; urticarial rash; facial swelling; muscle pain; malaise.

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

Swelling of the face, mouth, and/or larynx (vocal cords); acute kidney failure and renal insufficiency; lethargy.

Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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; ankle swelling; drowsiness; redness and sensation of 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):

Difficulty sleeping; sleep disorders; mood changes including anxiety; depression; irritability; tremor; taste disturbances; fainting; ringing in the ears (tinnitus); worsening of angina (chest pain or discomfort); irregular heartbeat; nasal discharge or congestion; hair loss; purple spots or skin lesions due to minor bleeding (purpura); skin discoloration; excessive sweating; skin rash; itching; itchy red welts (urticaria); joint or muscle pain; urinary problems; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain; feeling of 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 could increase the risk of infections; reduction in the number of a type of blood cells known as platelets, which could lead to bruising and prolonged bleeding time; increased blood glucose levels; increased muscle tone or resistance to passive movement (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; gum enlargement; elevated 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 (vocal cords), along with itching and rash); severe skin reactions, including intense skin rash, urticaria, redness of the entire skin, severe itching, blisters, peeling and swelling of the skin, and inflammation of mucous membranes, sometimes very severe.

Not known (cannot be estimated from available data):

Tremors, rigid posture, mask-like face, slow movements, and shuffling gait with loss of balance.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Olmesartán/Amlodipino Sandoz Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, bottle, and carton after CAD/EXP. The expiry date refers to the last day of the indicated month.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect it from moisture.

Validity period after first opening:

Bottles: use within 100 days following first opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Amlodipine Sandoz

• The active substances are olmesartan medoxomil and amlodipine (as besilate).

Olmesartan/Amlodipine Sandoz 20 mg/5 mg: each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).

Olmesartan/Amlodipine Sandoz 40 mg/5 mg: each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).

Olmesartan/Amlodipine Sandoz 40 mg/10 mg: each tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besilate).

• The other components are:

Core: lactose monohydrate, croscarmellose sodium, pregelatinized maize starch, magnesium stearate, silicified microcrystalline cellulose.

Film coating:

Olmesartan/Amlodipine Sandoz 20 mg/5 mg: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG 3350, talc.

Olmesartan/Amlodipine Sandoz 40 mg/5 mg: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG 3350, talc, yellow iron oxide (E 172).

Olmesartan/Amlodipine Sandoz 40 mg/10 mg: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of the product and contents of the pack

Olmesartan/Amlodipine Sandoz 20 mg/5 mg:

Round, film-coated tablet, white to off-white, marked with “20 5” on one side, with an approximate diameter of 7.1 mm.

Olmesartan/Amlodipine Sandoz 40 mg/5 mg:

Round, film-coated tablet, yellow, marked with “40 5” on one side, with an approximate diameter of 9.1 mm.

Olmesartan/Amlodipine Sandoz 40 mg/10 mg:

Round, film-coated tablet, pink, marked with “40 10” on one side, with an approximate diameter of 9.1 mm.

The film-coated tablets are packed in OPA/Alu/PVC-Alu blisters inserted into a cardboard outer carton.

The film-coated tablets are also packed in HDPE bottles with child-resistant screw caps sealed with induction heat or an internal transparent sealing layer, containing a desiccant which must not be swallowed, and included in a cardboard carton.

Pack sizes:

Blister: 10, 14, 28, 30, 56, 90, 98 film-coated tablets.

Olmesartan/Amlodipine Sandoz 20 mg/5 mg and Olmesartan/Amlodipine Sandoz 40 mg/5 mg:

Bottle: 28, 100, 250 film-coated tablets with a container containing 1 g of desiccant.

Olmesartan/Amlodipine Sandoz 40 mg/10 mg:

Bottle: 28 and 100 film-coated tablets with a container containing 1 g of desiccant per bottle.

250 film-coated tablets with a container containing 2 g of desiccant per bottle (2 x 1 g or 1 x 2 g).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d

Verovškova 57,

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d

Trimlini 2D

9220 Lendava,

Slovenia

Date of latest revision of the package leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/