OLMESARTAN/AMLODIPINE SANDOZ 40 mg/5 mg FILM-COATED TABLETS

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 package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Olmesartan/Amlodipine Sandoz and what is it 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. Storage of Olmesartan/Amlodipine Sandoz
6. Contents of the pack and further information

1. What is Olmesartan/Amlodipine Sandoz and what is it used for

Olmesartan/Amlodipine Sandoz contains two active substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). Both substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medications called "angiotensin II receptor antagonists", which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medications called "calcium channel blockers". Amlodipine prevents calcium from entering the blood vessel wall, preventing the narrowing of blood vessels, thus also lowering blood pressure.

The action of both substances contributes to preventing the narrowing of blood vessels, so they relax and blood pressure decreases.

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 amlodipine, or a special group of calcium channel blockers called dihydropyridines, or any of the other ingredients of this medication (listed in section 6).

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

• if you are pregnant for more than 3 months. It is recommended to avoid olmesartan/amlodipine at the start of pregnancy (see section "Pregnancy and lactation"),
• if you have diabetes or kidney problems and are being treated with a blood pressure medication that contains aliskiren,
• if you have severe liver problems, if bile secretion is altered, or its release by the gallbladder is blocked (e.g., by gallstones), or if you have jaundice (yellowing of the skin and eyes),
• if you have very low blood pressure,
• if you have insufficient blood supply to the tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart problems,
• if the blood flow to your heart is blocked (e.g., due to narrowing of the aorta, aortic stenosis),
• if you have low cardiac output (causing difficulty breathing or peripheral swelling) after a heart attack (acute myocardial infarction).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartan/Amlodipine Sandoz.

Tell your doctorif you are taking any of the following medications used to treat high blood pressure (hypertension):

• a converting enzyme 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 doctorif you have any of the following health problems:

• 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 medications that increase urine elimination (diuretics), or if you are on a low-salt diet.
• High potassium levels 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 medication that lowers blood pressure, an excessive decrease in blood pressure in patients with altered blood flow in the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You must inform your doctor if you think you are (or might become) pregnant. Olmesartan/amlodipine is not recommended at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage (see section "Pregnancy and lactation").

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 medications

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

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

If you are taking a converting enzyme inhibitor or aliskiren (see also the information under the headings "Do not take Olmesartan/Amlodipine Sandoz" and "Warnings and precautions").

• Potassium supplements, salt substitutes that contain potassium, medications that increase urine elimination(diuretics), or heparin(to thin the blood and prevent blood clots). The use of these medications at the same time as olmesartan/amlodipine may increase potassium levels in the blood.
• Lithium(a medication used to treat mood changes and some types of depression) used at the same time as olmesartan/amlodipine may increase its toxicity. If you need to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory medications(NSAIDs, medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as olmesartan/amlodipine may increase the risk of kidney problems. The effect of olmesartan/amlodipine may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, 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.
• Medications used for HIV/AIDS(e.g., ritonavir, indinavir, nelfinavir) or for the treatment of fungal infections(e.g., ketoconazole, itraconazole).

• Diltiazem, verapamil(medications 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(in infusion for severe body temperature abnormalities).
• Simvastatin, a medication 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).

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

Taking Olmesartan/Amlodipine Sandoz with food and drinks

Olmesartan/Amlodipine Sandoz can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). If possible, take your daily dose at the same time each day, for example, at breakfast time.

People taking olmesartan/amlodipine should not consume grapefruit or grapefruit juice. 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 cause an unpredictable increase in the blood pressure-lowering effect of olmesartan/amlodipine.

Older adults

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

Black patients

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

Pregnancy and lactation

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

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 advise you to take another medication instead of olmesartan/amlodipine. Olmesartan/amlodipine is not recommended at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken from the third month of pregnancy onwards.

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

Breastfeeding

Tell 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 in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, feel sick, or dizzy, or have a headache. If this happens, do not drive or use machines until the symptoms have disappeared. 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 with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Olmesartan/Amlodipine Sandoz

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose of Olmesartan/Amlodipine Sandoz is one tablet per day.
• The tablets can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). Do not chew the tablet. Do not take Olmesartan/Amlodipine 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 Olmesartan/Amlodipine Sandoz than you should

If you take more tablets than you should, you will probably experience a drop in blood pressure, accompanied by symptoms such as dizziness, and rapid or slow heart rate.

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

If you take more tablets than you should, or a child accidentally ingests some tablets, contact your doctor or go to the nearest emergency center immediately and take the medication package or this package leaflet with you.

If you have taken more Olmesartan/Amlodipine Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Olmesartan/Amlodipine Sandoz

If you forget to take a dose, take your usual dose the next day. Do nottake a double dose to make up for forgotten doses.

If you stop taking Olmesartan/Amlodipine Sandoz

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If they occur, they are often mild and do not require interruption of treatment.

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

During treatment with olmesartan/amlodipine, severe skin reactions can occur, including skin rash, blisters, redness of the skin, inflammation 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 pronounced decrease in blood pressure, in susceptible patients, or as a result of an allergic reaction. This can cause 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.

Unknown frequency: if you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with olmesartan/amlodipine a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with blood pressure treatment.

Other possible adverse effects with olmesartan/amlodipine:

Frequent (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 when standing up,
• lack of energy,
• tingling or numbness of the hands or feet,
• vertigo,
• noticing heartbeats,
• rapid heartbeat,
• low blood pressure with symptoms such as dizziness, dizziness,
• breathing difficulties,
• cough,
• nausea,
• vomiting,
• indigestion,
• diarrhea,
• constipation,
• dry mouth,
• upper abdominal pain,
• skin rash,
• cramps,
• arm and leg pain,
• back pain,
• urinary urgency,
• sexual inactivity,
• inability to have or maintain an erection,
• weakness,
• also, some changes in the results of certain blood tests have been observed: increase, as well as decrease in blood potassium levels, increase in blood creatinine levels, increase in blood uric acid levels, increase in liver function test values (gamma glutamyl transferase levels).

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

• hypersensitivity to the medicine,
• fainting,
• redness and feeling of heat in the face,
• red itchy hives (urticaria),
• facial inflammation.

Adverse effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with olmesartan/amlodipine, or with a higher frequency:

Olmesartan medoxomil

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

bronchitis; sore throat; nasal congestion and secretion; cough; abdominal pain; viral gastroenteritis; diarrhea; indigestion; nausea; joint and bone pain; back pain; blood in the 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 uric acid and urea levels in the blood and 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 can easily cause bruising or prolong bleeding time; rapid allergic reactions, which can affect the whole body and cause respiratory problems, as well as a rapid drop in blood pressure, which can even cause fainting (anaphylactic reactions); angina (chest pain or discomfort known as angina pectoris); itching; skin rash; allergic skin rash; urticaria; facial swelling; muscle pain; discomfort.

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

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

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

Amlodipine

Very frequent (may affect more than 1 in 10 people):

edema (fluid retention).

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

abdominal pain; nausea; swelling of the ankles; feeling of sleep; redness and feeling of heat in the face, visual disturbances (including double vision and blurred vision), noticing heartbeats, diarrhea, constipation, indigestion, cramps, weakness, breathing difficulties.

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

difficulty sleeping; sleep disorders; mood changes including anxiety; depression; irritability; tremors; taste disturbances; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; nasal secretion or congestion; hair loss; purple or colored spots on the skin due to small hemorrhages (purpura); skin discoloration; excessive sweating; skin rash; itching; red itchy hives (urticaria); joint or muscle pain; urination problems; need to urinate at night; increased need to urinate, increased breast size 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 called platelets, which could lead to bruising and prolonged bleeding time; increased blood glucose; increased muscle tension or greater resistance to passive movement (hypertonia); tingling or numbness of the hands or feet; heart attack; blood vessel inflammation; liver or pancreas inflammation; stomach wall inflammation; gum thickening; elevated liver enzymes; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions (itching, rash, inflammation 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 skin all over the body, severe itching, blisters, peeling, and skin inflammation, mucous membrane inflammation sometimes very severe).

Unknown frequency (cannot be estimated from available data):

tremors, rigid posture, mask-like face, slow movements, and unsteady gait.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Olmesartan/Amlodipine Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the blister, bottle, and carton after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Validity period after first opening:

Bottles: use within the next 100 days.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipine Sandoz

• The active ingredients are olmesartan medoxomil and amlodipine (as besylate).

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

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

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

• The other ingredients are:

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

Coating:

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

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

Olmesartan/Amlodipine Sandoz 40 mg/10 mg: partially hydrolyzed 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 package contents

Olmesartan/Amlodipine Sandoz 20 mg/5 mg:

film-coated tablet, round, 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:

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

Olmesartan/Amlodipine Sandoz 40 mg/10 mg:

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

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

The film-coated tablets are packaged in HDPE bottles with a child-resistant polypropylene screw cap sealed by heat induction or a transparent internal coating containing a desiccant that should not be swallowed and included in a carton.

Package 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 package 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).

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 the last revision of thisleaflet:February 2025

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