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

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Olmesartán/Amlodipino Stada is and what it is used for

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

• Olmesartán medoxomilo belongs to a group of medicines known as “angiotensin II receptor antagonists”, which lower 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, thereby preventing blood vessels from narrowing, which also reduces blood pressure.

The combined action of both substances helps prevent the narrowing of blood vessels, allowing them to relax and reducing blood pressure.

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

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

DO NOT take Olmesartan/Amlodipine Stada

• if you are allergic to olmesartan medoxomil, or to amlodipine, or to 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 best to avoid olmesartan/amlodipine in early pregnancy (see section “Pregnancy and breastfeeding”).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• if you have severe liver problems, if bile secretion is impaired, or its release from the gallbladder is blocked (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• if you have very low blood pressure.
• if you have inadequate blood supply to tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems.
• if blood flow from your heart is blocked (e.g., due to narrowing of the aorta (aortic stenosis)).
• if you have low cardiac output (causing shortness of breath or peripheral swelling) after a heart attack (acute myocardial infarction).

Warnings and precautions

Talk to 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 monitor your kidney function, blood pressure, and blood levels of electrolytes (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 conditions:

• 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 medicines that increase urine output (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 causing significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Consult your doctor if you develop 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, excessive lowering of 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.

Inform your doctor if you are pregnant or think you might be pregnant. Use of olmesartan/amlodipine is not recommended during early 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 at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents

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

Other medicines and Olmesartan/Amlodipine Stada

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

• other blood pressure-lowering medicines, as they may enhance the effect of olmesartan/amlodipine.

Your doctor may need to adjust your dose and/or take additional precautions:

If you are taking an angiotensin-converting enzyme inhibitor (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 containing potassium, medicines that increase urine output (diuretics), or heparin (used to thin the blood and prevent blood clots). Using these medicines together with olmesartan/amlodipine may increase potassium levels in the blood.
• lithium (a medicine used to treat mood disorders and certain types of depression) used together with olmesartan/amlodipine may increase its toxicity. If you need to take lithium, your doctor will monitor 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 together with olmesartan/amlodipine may increase the risk of kidney failure. 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 acid reflux), as they may slightly reduce the effect of olmesartan/amlodipine.
• medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or for treating fungal infections (e.g., ketoconazole, itraconazole).
• diltiazem, verapamil (medicines used for 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 (administered by infusion for severe body temperature abnormalities).
• simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• tacrolimus, cyclosporine (used to control the body’s immune response, making it possible for the 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 some 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 olmesartan/amlodipine must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may lead to increased blood levels of the active ingredient amlodipine, which could 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 monitor your blood pressure each time your dose is increased, to ensure it does not drop too much.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might be 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 recommend an alternative medicine. Use of olmesartan/amlodipine is not recommended during early pregnancy, and it must not be taken after the first 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

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

Breastfeeding

It has been shown that amlodipine, one of the active ingredients of Olmesartan/Amlodipine Stada, passes into breast milk in small amounts. Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan/amlodipine is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

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

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, unwell, dizzy, or have a headache. If this happens, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartan/Amlodipine Stada contains lactose

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

3. How to take Olmesartan/Amlodipine Stada

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of olmesartan/amlodipine is one tablet daily.

Method of administration

• The tablets can be taken with or without food. Take the tablets with some 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 are likely to experience a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

If you take more tablets than prescribed or if a child accidentally ingests some tablets, contact your doctor immediately or go to the nearest emergency department and bring the medicine packaging or this leaflet with you.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

In case of overdose or accidental ingestion, contact 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 the missed doses.

If you stop taking Olmesartan/Amlodipine Stada

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

If you have any further questions about 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 everyone will experience them. If they do occur, they are often mild and do not require discontinuation of treatment.

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

During treatment with olmesartan/amlodipine, allergic reactions (itching, rash, swelling of the face, mouth and/or larynx (vocal cords), together with itching and rash), severe skin reactions, including severe skin rash, urticaria, redness of the skin, severe itching, blisters, skin peeling and skin inflammation, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening, may occur.

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

Olmesartan/amlodipine may cause a marked drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This may 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, or skin itching, even if you started treatment with olmesartan/amlodipine some time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to continue your 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 upon standing
• lack of energy
• tingling or numbness in the hands or feet
• vertigo
• awareness of heartbeats
• rapid heartbeat
• low blood pressure with symptoms such as dizziness, lightheadedness
• difficulty breathing
• cough
• nausea
• vomiting
• indigestion
• diarrhea
• constipation
• dry mouth
• upper abdominal pain
• skin rash
• cramps
• pain in arms and legs
• back pain
• feeling of urgency to urinate
• sexual inactivity
• inability to achieve or maintain an erection
• weakness.

Some changes in the results of certain blood tests have also been observed:

Increase or decrease in blood potassium levels, increase in blood creatinine levels, increase in blood uric acid levels, increase in liver function test values (levels of gamma-glutamyl transferase).

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

• hypersensitivity to the medicine
• fainting
• redness and feeling of warmth in the face
• red, itchy rash (urticaria)
• facial swelling.

Adverse effects reported with olmesartan medoxomil or amlodipine used alone, but not with olmesartan/amlodipine, or with higher frequency:

Olmesartan medoxomil

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

• bronchitis
• sore throat
• nasal congestion and discharge
• 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 blood uric acid and urea levels; and increased values in 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 may lead to easy bruising or prolonged bleeding time
• rapid allergic reactions, which may affect the whole body and may cause breathing difficulties as well as a rapid drop in blood pressure, possibly leading to fainting (anaphylactic reactions)
• angina (chest pain or discomfort, known as angina pectoris)
• itching
• skin rash
• allergic skin rash
• urticarial rash
• facial swelling
• muscle pain
• malaise

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

• swelling of the face, mouth and/or larynx (vocal cords)
• acute kidney failure and renal failure
• lethargy
• intestinal angioedema: swelling in the intestine causing 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
• ankle swelling
• drowsiness
• redness and feeling of warmth in the face
• visual disturbances (including double vision and blurred vision)
• awareness of 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
• tremor
• taste disturbances
• fainting
• ringing in the ears (tinnitus)
• worsening of angina pectoris (chest pain or discomfort)
• irregular heartbeat
• nasal discharge or congestion
• hair loss
• purple spots or spots on the skin due to small hemorrhages (purpura)
• skin discoloration
• excessive sweating
• skin rash
• itching
• red, itchy rash (urticaria)
• joint or muscle pain
• problems urinating
• need to urinate at night
• increased need to urinate
• breast enlargement in men
• chest pain
• pain
• feeling of malaise
• weight gain or weight 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 known as platelets, which could lead to bruising and prolonged bleeding time
• increased blood glucose
• increased muscle tension or increased resistance to passive movement (hypertonia)
• tingling or numbness in the hands or feet
• heart attack
• inflammation of blood vessels
• inflammation of the liver or pancreas
• inflammation of the stomach wall
• gum overgrowth
• elevated liver enzymes
• yellowing of the skin and eyes
• increased skin sensitivity to light

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

• tremor, rigid posture, mask-like facial expression, slow movements, and shuffling gait with imbalance

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Amlodipine Stada

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to properly discard medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán/Amlodipino Stada

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

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

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

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

The other components are:

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

Tablet coating:

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

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

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

Appearance of the product and contents of the pack

Olmesartán/Amlodipino Stada 20 mg/5 mg are film-coated tablets, white in colour, round and biconvex, packed in oPA-Aluminium-PVC/Aluminium blisters.

Olmesartán/Amlodipino Stada 40 mg/5 mg are film-coated tablets, white-yellowish in colour, round and biconvex, packed in oPA-Aluminium-PVC/Aluminium blisters.

Olmesartán/Amlodipino Stada 40 mg/10 mg are film-coated tablets, red-brownish in colour, round and biconvex, packed in oPA-Aluminium-PVC/Aluminium blisters.

Olmesartán/Amlodipino Stada film-coated tablets EFG are available in pack sizes of 10, 14, 28, 30, 56, 60, 90, 98, 100 and 112 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area member states under 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

Date of the latest review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es