Patient Information Leaflet

Olmesartan/Amlodipine Sandoz 20 mg/5 mg Film-Coated Tablets

Olmesartan/Amlodipine Sandoz 40 mg/5 mg Film-Coated Tablets

Olmesartan/Amlodipine Sandoz 40 mg/10 mg Film-Coated Tablets

olmesartan medoxomil/amlodipine

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start 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 additional information

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

• Olmesartan medoxomilbelongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease 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, which prevents blood vessel constriction, thereby also decreasing blood pressure.

The action of both substances contributes to preventing blood vessel constriction, so that they relax and blood pressure decreases.

Olmesartán/Amlodipino is used to treat high blood pressure in adult patientswhose blood pressure is not adequately controlled with olmesartan medoxomilor amlodipine alone.

Do not take Olmesartán/Amlodipino Sandoz

• if you are allergic to olmesartán medoxomilo, or to amlodipino, or to a special group of calcium channel blockers called dihidropiridinas, or to any of the othercomponents of this medication (listed in section 6).

Inform your doctor before taking Olmesartán/Amlodipino Sandoz if you think you may be allergic.

• if you are more than 3 months pregnant. It is best to avoid olmesartán/amlodipino at the beginning of pregnancy (see section “Pregnancy and breastfeeding”),
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén,
• if you have severe liver problems, if your bile secretion is altered, or if your bile release is blocked (for example, by gallstones), or if you have jaundice (yellow skin and eyes),
• if you have very low blood pressure,
• if you have inadequate blood supply to your 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 your heart's blood flow is blocked (for example, due to aortic stenosis),
• if you have poor heart function (producing difficulty breathing, or peripheral edema) after a heart attack (acute myocardial infarction).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán/Amlodipino Sandoz.

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

• a converting enzyme inhibitor (IECA) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
• aliskirén.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in your blood at regular intervals.

See also the information under the heading “Do not take Olmesartán/Amlodipino 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 production (diuretics), or if you are on a low-sodium diet.
• high levels of potassium in your blood.
• problems with the adrenal glands (glands that produce hormones located above the kidneys).

Contact your doctor if you experience severe, persistent diarrhea, and significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your treatment for high blood pressure.

As with any other medication that lowers blood pressure, an excessive decrease in blood pressure in patients with altered blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

Inform your doctor if you think you are (or may become) pregnant. Olmesartán/amlodipino is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents

Olmesartán/amlodipino is not recommended for children and adolescents under 18 years old.

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

Taking Olmesartán/Amlodipino Sandoz with other medications

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

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

If you are taking an IECA or aliskirén (see also the information under the headings “Do not take Olmesartán/Amlodipino Sandoz” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medications that increase urine production(diuretics), orheparin(to thin the blood and prevent blood clots). The use of these medications at the same time as olmesartán/amlodipino may elevate potassium levels in the blood.
• Lithium(a medication used to treat mood changes and some types of depression) used at the same time as olmesartán/amlodipino may increase its toxicity. If you need to take lithium, your doctor will measure lithium levels in your blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs, medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as olmesartán/amlodipino may increase the risk of kidney failure. The effect of olmesartán/amlodipino may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartán/amlodipino. Your doctor may advise you to take olmesartán/amlodipino at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reducethe effect of olmesartán/amlodipino.
• Medications used to treat HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir)or fungal infections(e.g. ketoconazole, itraconazole).

• Diltiazem,verapamil(medications used to treat heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin(antibiotics).
• Erythromycin, clarithromycin(for bacterial infections).
• St. John's Wort(Hypericum perforatum), herbal remedy.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, a medication used to lower cholesterol and triglyceride levels in the blood.
• Tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine(used to control the body's immune response, makingit possible for the body to accept the transplanted organ).

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

Taking Olmesartán/Amlodipino Sandoz with food and drinks

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

People taking olmesartán/amlodipino should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in blood levels of the active ingredient amlodipino, which may cause an unpredictable increase in the blood pressure-lowering effect of olmesartán/amlodipino.

Older adults

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

Black patients

As with other similar medications, the blood pressure-lowering effect of olmesartán/amlodipino is somewhat less in black patients.

Pregnancy and breastfeeding

Inform your doctor or pharmacist if you are pregnant, breastfeeding, or plan to become pregnant. Olmesartán/amlodipino is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see section “Pregnancy and breastfeeding”).

Pregnancy

Inform your doctor if you are (or may become) pregnant.

Your doctor will advise you to stop taking olmesartán/amlodipino before becoming pregnant or as soon as you know you are pregnant, and will recommend another medication in place of olmesartán/amlodipino. Olmesartán/amlodipino is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period.

If you become pregnant while taking olmesartán/amlodipino, inform and visit your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to startbreastfeeding.Amlodipino has been shown to pass into breast milk in small amounts.

Olmesartán/amlodipino is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machines

During treatment for high blood pressure, you may experience drowsiness, feel sick, or dizzy, or have a headache. If this occurs, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Olmesartán/Amlodipino 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; it is essentially “sodium-free”.

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

• The recommended dose of Olmesartán/Amlodipino Sandoz is one tablet per day.
• 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 Olmesartán/Amlodipino Sandoz with grapefruit juice.
• Try to 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 a rapid or slow heart rate.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may 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 immediately or go to the nearest emergency center and bring the medication packaging or this leaflet with you.

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

If you forget to take Olmesartán/Amlodipino Sandoz

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

If you interrupt treatment with Olmesartán/Amlodipino Sandoz

It is essential to continue taking olmesartán/amlodipino, 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

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

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

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

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

Other possible side 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.

Less frequent (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 heartbeats,
• low blood pressure with symptoms such as dizziness, fainting,
• difficulty breathing,
• cough,
• nausea,
• vomiting,
• indigestion,
• diarrhea,
• constipation,
• dry mouth,
• abdominal pain,
• skin rash,
• cramps,
• arm and leg pain,
• back pain,
• urgency to urinate,
• sexual dysfunction,
• inability to achieve or maintain an erection,
• weakness,
• also some changes in blood test results have been observed: increased, as well as decreased levels of potassium in the blood, increased levels of creatinine in the blood, increased levels of uric acid, increased values of liver function tests (gamma-glutamyl transferase levels).

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

• hypersensitivity to the medication,
• fainting,
• redness and warmth of the face,
• hives with itching,
• inflammation of the face.

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

Olmesartan medoxomilo

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

bronchitis; sore throat; congestion and nasal 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 in the blood, and increased values of liver and muscle function tests.

Less frequent (may affect up to 1 in 100 people):

reduction in the number of a type of blood cell, called platelets, which can cause easy bruising or prolong bleeding time; rapid allergic reactions, which can affect the whole body and cause respiratory problems, as well as rapid drop in blood pressure, which can even cause fainting (anaphylactic reactions);angina (painorsensations ofuncomfortablefeelingin thechest,knownasangina pectoris); itching;skineruption;allergicskineruption;urticaria;swelling of the face;muscle pain;discomfort.

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

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

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

Amlodipino

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 sleepy; redness and warmth of the face, visual disturbances (including double vision and blurred vision), noticing heartbeats, diarrhea, constipation, indigestion, cramps, weakness, difficulty breathing.

Less frequent (may affect up to 1 in 100 people):

difficulty sleeping; sleep disorders; mood changes, including anxiety;depression;irritability;shakiness;alterations in taste; fainting;ringing in the ears(tinnitus);emergenceofangina pectoris(painorsensations ofuncomfortablefeelingin thechest); irregular heartbeat;nasal secretion or congestion; hair loss;purple spotsorspotson theskin duetosmall hemorrhages(purpura);skindecoloration;excessive sweating;skineruption; itching; hives with itching;muscle pain;problemsurinating;urgency to urinate;increased need to urinate,enlargement of the breastsinmen,chest pain;pain;feeling ofuncomfortable;increaseordecreaseinweight.

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 cell, called platelets, which could cause the appearance of bruises and prolong bleeding time; increased blood glucose; increased muscle tensionorincreased resistancetopassive movement(hypertonia);tingling or numbness of the hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; gum thickening; elevated liver enzymes; yellow skin and eyes; increased sensitivity of the skin 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, skin redness, severe itching, blisters, peeling, and inflammation of the skin, inflammation of mucous membranes sometimes very severe).

Unknown (cannot be estimated from available data):

tremors, rigid posture, mask-like face, slow movements, and walking with feet dragging and without balance.

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister pack, bottle, and carton packagingafter CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from moisture.

Shelf life after the first opening:

Bottles: use within the next 100 days.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Olmesartán/Amlodipino Sandoz

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

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

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

Olmesartán/Amlodipino 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, sodium croscarmellose, pregelatinized cornstarch, magnesium stearate, microcrystalline cellulose.

Coating:

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

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

Olmesartán/Amlodipino 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 contents of the package

Olmesartán/Amlodipino Sandoz 20 mg/5 mg:

film-coated tablet, white to off-white, marked with “20 5” on one face with a diameter of approximately 7.1 mm.

Olmesartán/Amlodipino Sandoz 40 mg/5 mg:

film-coated tablet, yellow, marked with “40 5” on one face with a diameter of approximately 9.1 mm.

Olmesartán/Amlodipino Sandoz 40 mg/10 mg:

film-coated tablet, pink, marked with “40 10” on one face with a diameter of approximately 9.1 mm.

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

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

Package sizes:

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

Olmesartán/Amlodipino Sandoz 20 mg/5 mg and Olmesartán/Amlodipino Sandoz 40 mg/5 mg:

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

Olmesartán/Amlodipino 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 some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d

Verovškova 57,

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d

Trimlini 2D

9220 Lendava,

Slovenia

Last review date of thisleaflet:February 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/