Leaflet: information for the user

Olmesartán/Amlodipino Stada 20 mg/5 mg film-coated tablets

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

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

Olmesartán medoxomilo/Amlodipino

Read this 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. Do not give it to others even if they have the same symptoms as 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 Olmesartán/Amlodipino Stada and what it is used for

2. What you need to know before starting to take Olmesartán/Amlodipino Stada

3. How to take Olmesartán/Amlodipino Stada

4. Possible side effects

5. Storage of Olmesartán/Amlodipino Stada

6. Contents of the pack and additional information

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

• olmesartán medoxomilobelongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• amlodipinobelongs 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 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 Stada

• 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 other components of this medication (listed in section 6).
• if you think you may be allergic, inform your doctor before taking olmesartán/amlodipino.
• 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 (e.g., by gallstones), or if you have jaundice (yellow skin and eyes).
• if you have very low blood pressure.
• if you have inadequate blood flow to 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 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 Stada.

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

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

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

See also the information under the heading “Do not take Olmesartán/Amlodipino 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 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.
• high levels of potassium in the 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.

Tell 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.

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 may 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 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.

Other medications and Olmesartán/Amlodipino Stada

Tell 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.

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 Stada” and “Warnings and precautions”).

• potassium supplements, salt substitutes containing potassium, diuretics, or heparin (to thin the blood and prevent blood clots). The use of these medications with olmesartán/amlodipino may increase potassium levels in the blood.
• litium (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 litium, your doctor will measure your litium levels in the 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 reduce the effect of olmesartán/amlodipino.
• medications used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or fungal infections (e.g., ketoconazol, itraconazol).
• diltiazem, verapamilo (medications used to treat heart rhythm problems and high blood pressure).
• rifampicina, eritromicina, claritromicina (antibiotics – used to treat infections caused by bacteria).
• St. John's Wort (Hypericum perforatum), herbal remedy.
• dantroleno (in infusion for severe body temperature abnormalities).
• simvastatina, a medication used to lower cholesterol and triglyceride levels in the blood.
• tacrólimus, ciclosporina (used to control the body's immune response, making it possible for the body to accept the transplanted organ).

Taking Olmesartán/Amlodipino Stada with food and drinks

Olmesartán/amlodipino 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 the blood levels of the active ingredient amlodipino, which may cause an unpredictable increase in the blood pressure-lowering effect of olmesartán/amlodipino.

Older patients

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

Pregnancy

You should inform your doctor if you are pregnant, or if you think you may be 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 used during this period.

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

Breastfeeding

It has been shown that amlodipino, one of the active ingredients of Olmesartán/Amlodipino Stada, passes into breast milk in small amounts. Inform your doctor if you are breastfeeding or about to start breastfeeding. 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.

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 machinery

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 machinery until the symptoms have disappeared. Consult your doctor.

Olmesartán/Amlodipino Stada contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Dose

The recommended dose of olmesartán/amlodipino is one tablet per day.

Administration Form

• 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 olmesartán/amlodipino 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 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 a rapid or slow heart rate.

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.

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

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

If You Forget to Take Olmesartán/Amlodipino Stada

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 Stada

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 medications, this medication may 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 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, body skin redness, severe itching, blisters, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes with life-threatening risk) may occur.

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

Olmesartan/amlodipine may cause a pronounced 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: If you experience yellowing of the whites 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.

Rare (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
• upper abdominal pain
• skin rash
• muscle cramps
• arm and leg pain
• back pain
• urinary urgency
• sexual dysfunction
• impotence
• weakness.

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

Increased, as well as decreased, potassium levels in the blood, increased creatinine levels in the blood, increased uric acid levels, 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 sensation of heat in the face
• hives with itching (urticaria)
• 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
• throat pain
• nasal congestion and secretion
• cough
• abdominal pain
• gastroenteritis caused by a virus
• 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 triglyceride levels; increased uric acid and urea levels in the blood, and increased values of liver and muscle function tests.

Poorly 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 that 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 (chest pain or discomfort, known as angina pectoris)
• itching
• skin rash
• allergic skin rash
• hives with itching (urticaria)
• swelling of the face
• muscle pain
• uncomfortable feeling

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

• inflammation of the face, mouth, and/or larynx (vocal cords)
• acute kidney failure and renal insufficiency
• lethargy
• intestinal angioedema: swelling in the intestine that presents 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
• drowsiness
• redness and sensation of heat in the face
• visual disturbances (including double vision and blurred vision)
• noticing heartbeats
• diarrhea
• constipation
• indigestion
• muscle cramps
• weakness
• difficulty breathing.

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

• difficulty sleeping
• sleep disorders
• changes in mood, including anxiety
• depression
• irritability
• tremor
• alterations in taste
• fainting
• tinnitus (ringing in the ears)
• worsening of angina pectoris (chest pain or discomfort)
• irregular heartbeat
• nasal secretion or congestion
• hair loss
• purple spots or patches on the skin due to small hemorrhages (purpura)
• skin discoloration
• excessive sweating
• skin rash
• itching
• hives with itching (urticaria)
• joint or muscle pain
• urinary problems
• nocturia (urination at night)
• increased need to urinate
• enlargement of the breasts in men
• chest pain
• pain
• uncomfortable feeling
• 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 cell, called platelets, which could cause easy bruising and prolong bleeding time
• increased glucose levels in the blood
• increased muscle tension or greater resistance to passive movement (hypertonia)
• tingling or numbness of the hands or feet
• heart attack
• inflammation of the blood vessels
• inflammation of the liver or pancreas
• inflammation of the stomach wall
• gum thickening
• increased liver enzymes
• yellow skin and eyes
• increased sensitivity of the skin to light

Unknown frequency (the frequency cannot be estimated from the available data):

• tremor, rigid posture, face with a mask-like appearance, slow movements, and dragging feet, unsteadily

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 prospectus. 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 medication.

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 moisture.

Medications should not be disposed of through drains or trash. Dispose of 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 Olmesartan/Amlodipine Stada

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

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

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

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

The other components are:

Tablet core:microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, magnesium stearate, lactose monohydrate

Tablet coating:

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 contents of the package

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

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

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

Olmesartan/Amlodipine Stada film-coated tablets 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

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Responsible for manufacturing

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 with the following names:

Netherlands:Olmesartan/ Amlodipine EG 20mg/5mg filmomhulde tabletten

Olmesartan/ Amlodipine EG 40mg/5mg filmomhulde tabletten

Olmesartan/ Amlodipine EG 40mg/10mg filmomhulde tabletten

Belgium:Olmesartan/ Amlodipine EG 20mg/5mg filmomhulde tabletten

Olmesartan/Amlodipine EG 40mg/5mg filmomhulde tabletten

Olmesartan/Amlodipine EG 40mg/10mg filmomhulde tabletten

Luxembourg:Olmesartan/ Amlodipine EG 20mg/5mg comprimé pelliculé

Olmesartan/Amlodipine EG 40mg/5mg comprimé pelliculé

Olmesartan/Amlodipine EG 40mg/10mg comprimé pelliculé

Germany:Olmesartan/Amlodipin AL 20 mg/5 mg Filmtabletten

Olmesartan/Amlodipin AL 40 mg/5 mg Filmtabletten

Olmesartan/Amlodipin AL 40 mg/10 mg Filmtabletten

Spain:Olmesartán/Amlodipino Stada 20 mg/5 mg comprimidos recubiertos con película EFG

Olmesartán/Amlodipino Stada 40 mg/5 mg comprimidos recubiertos con película EFG

Olmesartán/Amlodipino Stada 40 mg/10 mg comprimidos recubiertos con película 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:Amlodipina + Olmesartan medoxomilo Ciclum

Italy:Olmesartan e Amlodipina EG

Last review date of this leaflet:February 2025

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

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