OLMESARTAN/AMLODIPINE STADA 20 mg/5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

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

Olmesartan medoxomil/Amlodipine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

• Olmesartan medoxomilbelongs to a group of medicines called “angiotensin II receptor antagonists”, which lower blood pressure by relaxing blood vessels.
• Amlodipinebelongs to a group of medicines called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, which prevents the blood vessels from narrowing, and thus also lowers 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 patients whose blood pressure is not adequately controlled with olmesartan medoxomil or amlodipine alone.

2. What you need to know before you take Olmesartan/Amlodipine Stada

Do not take Olmesartan/Amlodipine Stada

• if you are allergic to olmesartan medoxomil, or amlodipine, or a special group of calcium channel blockers called dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6).
• if you think you may be allergic, inform your doctor before taking olmesartan/amlodipine.
• if you are more than 3 months pregnant. It is better to avoid olmesartan/amlodipine at the start of pregnancy (see section “Pregnancy and breast-feeding”).
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine 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 poor heart function (causing difficulty breathing, or swelling) after a heart attack (acute myocardial infarction).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Olmesartan/Amlodipine Stada.

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 need to check 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 Stada”.

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

• kidney problems or a kidney transplant.
• liver disease.
• heart failure or problems with the heart valves or heart muscle.
• severe vomiting, diarrhea, treatment with high doses of medicines that increase urine production (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.

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.

As with any other medicine that lowers blood pressure, an excessive decrease in blood pressure in patients with impaired blood flow to 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 are pregnant or think you may be pregnant.

Children and adolescents

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

Other medicines and Olmesartan/Amlodipine Stada

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

• other blood pressure-lowering medicines, 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 an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Olmesartan/Amlodipine Stada” and “Warnings and precautions”).

• potassium supplements, salt substitutes that contain potassium, medicines that increase urine production (diuretics), or heparin (to thin the blood and prevent blood clots). Taking these medicines at the same time as olmesartan/amlodipine may increase potassium levels in the blood.
• lithium (a medicine 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 drugs (NSAIDs, medicines 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 medicine 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.
• medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or to treat fungal infections (e.g., ketoconazole, itraconazole).
• diltiazem, verapamil (medicines used to treat heart rhythm problems and high blood pressure).
• rifampicin, erythromycin, clarithromycin (antibiotics – used to treat bacterial infections).
• St. John's Wort (Hypericum perforatum), a herbal remedy.
• dantrolene (in infusion for severe body temperature abnormalities).
• simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• tacrolimus, cyclosporin (used to control the body's immune response, making it possible for your body to accept a transplanted organ)

Taking Olmesartan/Amlodipine Stada with food and drink

Olmesartan/amlodipine 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 can cause an unpredictable increase in the blood pressure-lowering effect of olmesartan/amlodipine.

Elderly patients

If you are over 65 years old, your doctor will regularly check your blood pressure whenever your dose is increased, to make sure it does not decrease too much.

Black patients

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

Pregnancy and breast-feeding

Pregnancy

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

Your doctor will advise you to stop taking olmesartan/amlodipine before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of olmesartan/amlodipine. It is not recommended to take olmesartan/amlodipine at the start of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

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

Breast-feeding

It has been shown that amlodipine, one of the active substances in Olmesartan/Amlodipine Stada, passes into breast milk in small amounts. Inform your doctor if you are breast-feeding or about to start breast-feeding. Olmesartan/amlodipine is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed, especially if your baby is newborn or premature.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 gone away. Consult your doctor.

Olmesartan/Amlodipine Stada contains lactose

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

3. How to take Olmesartan/Amlodipine Stada

Follow exactly the instructions of your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

Dose

The recommended dose of olmesartan/amlodipine is one tablet per day.

Method of administration

• 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 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 Stada 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.

If you take more tablets than you should, or a child accidentally takes some tablets, contact your doctor or go to the nearest emergency department immediately and take the medicine pack or this leaflet with you.

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

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

If you forget to take Olmesartan/Amlodipine Stada

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 Olmesartan/Amlodipine Stada

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

If you have any further questions on 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 all people suffer from them. If they occur, they are often mild and do not require interrupting treatment.

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

During treatment with olmesartan/amlodipine, 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 of the body, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes with a risk to life) may occur.

If this happens to you, stop taking olmesartan/amlodipine and consult your doctor immediately.

Olmesartan/amlodipine may cause a marked 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.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, 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 heartbeats
• low blood pressure with symptoms such as dizziness, dizziness
• difficulty breathing
• cough
• nausea
• vomiting
• indigestion
• diarrhea
• constipation
• dry mouth
• pain in the upper abdomen
• skin rash
• cramps
• pain in the arms and legs
• back pain
• urge to urinate
• sexual inactivity
• inability to have or maintain an erection
• weakness

Some changes in the results of certain blood tests have also 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 medicine
• fainting
• redness and feeling of heat in the face
• red itchy rashes (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
• pain in the joints and bones
• 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

Uncommon (may affect up to 1 in 100 people)

• reduction in the number of a type of blood cells called platelets, which can cause easy bruising or prolonged bleeding
• 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
• skin rash with 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
• sleepiness
• redness and feeling of heat in the face
• visual disturbances (including double vision and blurred vision)
• noticing heartbeats
• 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
• 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 red spots on the skin due to small hemorrhages (purpura)
• skin discoloration
• excessive sweating
• skin rash
• itching
• red itchy rashes (urticaria)
• pain in the joints or muscles
• urination problems
• need to urinate at night
• increased need to urinate
• enlargement of the breasts 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 cause bruising and prolonged bleeding
• increased blood sugar
• increased muscle tension or increased resistance to 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
• thickening of the gums
• elevated liver enzymes
• yellowing of the skin and eyes
• increased sensitivity of the skin to light

Frequency not known (frequency cannot be estimated from available data)

• tremors, rigid posture, mask-like face, slow movements, and walking with feet dragging, unbalanced

Reporting of 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 prospectus. 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. Conservation of Olmesartan/Amlodipine Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 moisture.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipine Stada

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

20 mg/5 mg: Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).

40 mg/5 mg: Each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).

40 mg/10 mg: Each tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).

The other components are:

Core of the tablet:microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, magnesium stearate, lactose monohydrate

Coating of the tablet:

20 mg/5 mg: Opadry ® II 32F280008 white (hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide)

40 mg/5 mg: Opadry ® II 32F220004 yellow (hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, yellow iron oxide)

40 mg/10 mg: Opadry ® II 32F250011 red (hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, red iron oxide, black iron oxide)

Appearance of the product and package contents

Olmesartan/Amlodipine Stada 20 mg/5 mg are film-coated tablets, white, round, and biconvex, packaged in oPA-Aluminum-PVC/Aluminum blisters.

Olmesartan/Amlodipine Stada 40 mg/5 mg are film-coated tablets, white-yellowish, round, and biconvex, packaged in oPA-Aluminum-PVC/Aluminum blisters.

Olmesartan/Amlodipine Stada 40 mg/10 mg are film-coated tablets, reddish-brown, round, and biconvex, packaged in oPA-Aluminum-PVC/Aluminum blisters.

Olmesartan/Amlodipine Stada film-coated tablets EFG are available in packages of 10, 14, 28, 30, 56, 60, 90, 98, 100, and 112 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Olmesartan/ Amlodipine EG 20mg/5mg film-coated tablets

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

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

Belgium: Olmesartan/ Amlodipine EG 20mg/5mg film-coated tablets

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

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

Luxembourg: Olmesartan/ Amlodipine EG 20mg/5mg film-coated tablets

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

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

Germany: Olmesartan/Amlodipin AL 20 mg/5 mg film-coated tablets

Olmesartan/Amlodipin AL 40 mg/5 mg film-coated tablets

Olmesartan/Amlodipin AL 40 mg/10 mg film-coated tablets

Spain: Olmesartán/Amlodipino Stada 20 mg/5 mg film-coated tablets EFG

Olmesartán/Amlodipino Stada 40 mg/5 mg film-coated tablets EFG

Olmesartán/Amlodipino Stada 40 mg/10 mg film-coated tablets EFG

Ireland: Olmesartan/Amlodipine Clonmel 20 mg/5 mg film-coated tablets

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

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

Portugal: Amlodipine + Olmesartan medoxomil Ciclum

Italy: Olmesartan e Amlodipina EG

Date of the last revision of this prospectus:February 2025

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

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