Prospect: information for the user

Olmesartan/Amlodipine TAD 20 mg/5 mg film-coated tablets

Olmesartan/Amlodipine TAD 40 mg/5 mg film-coated tablets

Olmesartan/Amlodipine TAD 40 mg/10 mg film-coated tablets

olmesartan medoxomil/amlodipine

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

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

Olmesartán/Amlodipino TAD contains two substances called olmesartán medoxomilo and amlodipino (as amlodipino besilato). The two substances help control high blood pressure.

• Olmesartán medoxomilo belongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipino belongs to a group of medicines called “calcium channel blockers”. Amlodipino prevents calcium from entering the blood vessel wall, preventing blood vessel constriction, which also decreases blood pressure.

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

Olmesartán/Amlodipino TAD is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartán medoxomilo or amlodipino alone.

Do not take Olmesartán/Amlodipino TAD:

• if you are allergic to olmesartán medoxomilo, or to amlodipino, or to a group of special calcium channel blockers called dihidropiridinas, or to any of the other components of this medication (listed in section 6).
• if you are more than 3 months pregnant. It is better to avoid Olmesartán/Amlodipino TAD at the beginning of pregnancy (see section “Pregnancy and breastfeeding”).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication that contains aliskireno.
• 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 the blood flow to your heart 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 use Olmesartán/Amlodipino TAD.

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

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

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (for example, potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartán/Amlodipino TAD”.

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.
• intense vomiting, diarrhea, treatment with high doses of medications that increase urine elimination (diuretics), or if you are on a low-sodium diet.
• elevated potassium levels 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, excessive lowering of blood pressure in patients with alterations in blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You should inform your doctor if you are pregnant or think you may be pregnant. Olmesartán/Amlodipino TAD 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 used from the third month of pregnancy (see section “Pregnancy and breastfeeding”).

Children and adolescents

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

Other medications and Olmesartán/Amlodipino TAD

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

• Other blood pressure-lowering medications,as they may increase the effect of Olmesartán/Amlodipino TAD. Your doctor may need to adjust your dose and/or take other precautions:
• if you are taking an ACE inhibitor or aliskireno (see also the information under the headings “Do not take Olmesartán/Amlodipino TAD” and “Warnings and precautions”).
• Potassium supplements, salt substitutes containing potassium, medications that increase urine elimination(diuretics), orheparin(to thin the blood and prevent blood clots). The use of these medications at the same time as Olmesartán/Amlodipino TAD may elevate potassium levels in your blood.
• Thelithium(medication used to treat mood changes and some types of depression) used at the same time as Olmesartán/Amlodipino TAD may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Thenonsteroidal 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 TAD may increase the risk of kidney failure. The effect of Olmesartán/Amlodipino TAD may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in your blood, as it may reduce the effect of Olmesartán/Amlodipino TAD. Your doctor may advise you to take Olmesartán/Amlodipino TAD at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of Olmesartán/Amlodipino TAD.
• Medications used to treat HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir)or to treat fungal infections(e.g. ketoconazole, itraconazole).
• Diltiazem,verapamil(medications used to treat heart rhythm problems and high blood pressure).
• Rifampicin,erythromycin, clarithromycin(used to treat bacterial infections).
• St. John's Wort(Hypericum perforatum), herbal remedy.
• Dantrolene(in perfusion for severe body temperature abnormalities).
• Simvastatin, a medication used to lower cholesterol and triglyceride levels in your blood.
• Tacrolimus,sirolimus, temsirolimus, and everolimus(medications used to alter the function of your immune system).
• Ciclosporin(immunosuppressant).

Taking Olmesartán/Amlodipino TAD with food and drinks

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

Older patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time you increase your 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 TAD is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant or think you may be pregnant.

Your doctor will advise you to stop taking Olmesartán/Amlodipino TAD before becoming pregnant or as soon as you know you are pregnant, and will recommend another medication in place of Olmesartán/Amlodipino TAD. Olmesartán/Amlodipino TAD 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 used from the third month of pregnancy.

If you become pregnant while taking Olmesartán/Amlodipino TAD, inform and visit your doctor immediately.

Breastfeeding

You should inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartán/Amlodipino TAD is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Amlodipino has been shown to pass into breast milk in small amounts.

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

Driving and operating machines

During high blood pressure treatment, 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 TAD contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, 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 TAD is one tablet per day.
• Tablets can be taken with or without food. Take the tablets with a small amount of liquid (such as a glass of water). Do not chew the tablet. Do not take Olmesartán/Amlodipino TAD 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 TAD than you should

If you take more tablets than you should, you will likely 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.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Olmesartán/Amlodipino TAD

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 TAD

It is essential to continue taking Olmesartán/Amlodipino TAD, 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.

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

During treatment with Olmesartán/Amlodipino TAD, allergic reactions can occur, which can affect the whole body, with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash (Stevens-Johnson syndrome and toxic epidermal necrolysis).If this happens, stop taking Olmesartán/Amlodipino TAD and consult your doctor immediately.

Olmesartán/Amlodipino TAD can cause a pronounced drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This can cause dizziness or severe drowsiness.If this happens, stop taking Olmesartán/Amlodipino TAD, 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, itching of the skin, even if you started treatment with Olmesartán/Amlodipino TAD some time ago,contact your doctor immediately, who will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Other possible side effects with Olmesartán/Amlodipino TAD:

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

Dizziness; headache; swelling of the ankles, feet, legs, hands, or arms; fatigue.

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

Dizziness when standing up; lack of energy; tingling or numbness of the hands or feet; vertigo; feeling the heartbeat; rapid heartbeat; low blood pressure with symptoms such as dizziness, drowsiness; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; abdominal pain; skin rash; muscle cramps; pain in the arms and legs; back pain; sensation of urgency to urinate; sexual inactivity; inability to achieve or maintain an erection; weakness.

Also, some changes in the results of certain blood tests have been observed:

increase, as well as decrease in potassium levels in the blood, increase in creatinine levels in the blood, increase in uric acid levels, increase in liver function test values (gamma-glutamyl transferase levels).

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

Medication hypersensitivity; fainting; flushing and feeling of heat in the face; red itchy rash (urticaria); facial inflammation.

Side effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with Olmesartán/Amlodipino TAD, or with a higher frequency:

Olmesartan medoxomil

Frequent (can 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 the results of blood tests, 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.

Less frequent (can 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 (painorsensation ofdiscomfortin thechest,knownasangina pectoris); itching;skin rash;allergic skin rash;urticaria;facial swelling;muscle pain;uncomfortable feeling.

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

Facial, mouth, and/or laryngeal inflammation (vocal cords); acute renal failure and renal insufficiency; lethargy.

Amlodipine

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

Edema (fluid retention).

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

Abdominal pain; nausea; swelling of the ankles; feeling sleepy; flushing and feeling of heat in the face, visual disturbances (including double vision and blurred vision), feeling the heartbeat, indigestion, weakness, difficulty breathing.

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

Difficulty sleeping; sleep disorders; mood changes, including anxiety;depression;irritability;shakiness;alterations in taste;alteration of bowel habits (including diarrhea and constipation);syncope;ringing in the ears(tinnitus);exacerbationofangina pectoris(painorsensation ofdiscomfortin thechest); irregular heartbeat;nasal secretion or congestion; hair loss;purple spotsor spotson the skin due to small hemorrhages(purpura);skin discoloration;excessive sweating;skin rash;itching;red itchy rash (urticaria);joint or muscle pain;urinary problems;urgency to urinate at night;increased need to urinate,enlargement of the breastsinmen,chest pain;pain;uncomfortable feeling;weight gain or loss.

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

Confusion.

Very rare (can 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 bruising and prolong bleeding time; increased glucose levels in the blood; increased muscle tensionorincreased resistanceto passive 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 skin sensitivity to light; severe allergic reactions, itching, rash, facial, mouth, and/or laryngeal inflammation (vocal cords), along with itching and rash, severe skin reactions, including intense skin rash, urticaria, facial flushing, severe itching, blisters, peeling, and inflammation of the skin, severe inflammation of the mucous membranes sometimes very severe.

Unknown frequency (cannot be estimated from available data):

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

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 Vigilance 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.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

This medication does not require special storage temperature.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Olmesartán/Amlodipino TAD

• The active principles are olmesartán medoxomilo and amlodipino.

Olmesartán/Amlodipino TAD 20 mg /5 mg film-coated tablets:Each film-coated tablet contains 20 mg of olmesartán medoxomilo and 5 mg of amlodipino (as amlodipino besilato).

Olmesartán/Amlodipino TAD 40 mg /5 mg film-coated tablets:Each film-coated tablet contains 40 mg of olmesartán medoxomilo and 5 mg of amlodipino (as amlodipino besilato).

Olmesartán/Amlodipino TAD 40 mg /10 mg film-coated tablets:Each film-coated tablet contains 40 mg of olmesartán medoxomilo and 10 mg of amlodipino (as amlodipino besilato).

• The other components (excipients) are siliconized microcrystalline cellulose, pregelatinized cornstarch, lactose monohydrate, sodium croscarmellose and magnesium stearate (E470b) in the core of the tablet and polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172) - only for 40 mg/5 mg film-coated tablets and 40 mg/10 mg film-coated tablets - and red iron oxide (E172) - only for 40 mg/10 mg film-coated tablets - in the film-coating. See section 2 “Olmesartán/Amlodipino TAD contains lactose and sodium”.

Appearance of the product and contents of the package

Olmesartán/Amlodipino TAD 20 mg /5 mg film-coated tablets: film-coated tablet, white or almost white, round, biconvex and with beveled edges. Dimensions of the tablet: diameter: 7 mm, thickness: 2.5- 4.2 mm.

Olmesartán/Amlodipino TAD 40 mg /5 mg film-coated tablets: film-coated tablet, pale yellowish-brown, round, biconvex, with beveled edges and marked with a 5 on one face of the tablet. Dimensions of the tablet: diameter: 9 mm, thickness: 3.6- 5.3 mm.

Olmesartán/Amlodipino TAD 40 mg /10 mg film-coated tablets: film-coated tablet, reddish-brown, round, biconvex with beveled edges and scored on one face of the tablet. Dimensions of the tablet: diameter: 9 mm, thickness: 3.6- 5.3 mm.The tablet can be divided into equal doses.

Olmesartán/Amlodipino TAD is available in packages with blisters of 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets.

Olmesartán/Amlodipino TAD is supplied in packages with blisters in calendar format: 14, 28, 56 or 98 film-coated tablets.

Some package sizes may be marketed in the future.

Marketing authorization holder

TAD Pharma GmbH,Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto,Slovenia

TAD Pharma GmbH,Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last revision date of this leaflet:January 2024

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).