AMLODIPINE/RAMIPRIL ARISTO 10 mg/10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Amlodipine/Ramipril Aristo 10mg/10mg hard capsules

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 Amlodipine/Ramipril Aristo is and what it is used for
2. What you need to know before you take Amlodipine/Ramipril Aristo
3. How to take Amlodipine/Ramipril Aristo
4. Possible side effects
5. Storage of Amlodipine/Ramipril Aristo

1. Contents of the pack and other information

1. What Amlodipine/Ramipril Aristo is and what it is used for

Amlodipine/Ramipril Aristo contains two active substances: ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (Angiotensin-Converting Enzyme Inhibitors). Amlodipine belongs to a group of medicines called calcium antagonists.

Ramipril works by:

• Reducing the production of substances that may increase blood pressure
• Making your blood vessels relax and widen
• Making your heart beat more easily and pump blood more efficiently

Amlodipine works by:

• Relaxing and widening your blood vessels, making it easier for your blood to pass through them.

Amlodipine/Ramipril Aristo is used to treat high blood pressure (hypertension) in adult patients whose blood pressure is adequately controlled with amlodipine and ramipril given separately at the same doses as in the combination Amlodipine/Ramipril Aristo.

2. What you need to know before you take Amlodipine/Ramipril Aristo

Do not take Amlodipine/Ramipril Aristo

• If you are allergic to ramipril, amlodipine (the active substances), other ACE inhibitors or calcium antagonists, or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction can include a rash, difficulty swallowing or breathing, swelling of your face, lips, throat or tongue. If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased (see section “Other medicines and Amlodipine/Ramipril Aristo”)
• If you have ever had a severe allergic reaction known as “angioedema”. Symptoms include itching, rash, red marks on the hands, feet, and throat, inflammation of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Amlodipine/Ramipril Aristo may not be suitable for you
• If you have kidney problems that reduce blood supply (renal artery stenosis)

• During the last 6 months of pregnancy (see section “Pregnancy and breast-feeding”)
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren
• If your blood pressure is abnormally low (hypotension) or unstable. Your doctor will assess you
• If you have a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a situation where the heart is unable to supply enough blood to the body)
• If you have heart failure after a heart attack

Do not take Amlodipine/Ramipril Aristo if you have any of the above conditions. If you are unsure, consult your doctor or pharmacist before taking Amlodipine/Ramipril Aristo.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipine/Ramipril Aristo.

Tell your doctor if any of the following apply to you:

• If you have heart, liver, or kidney problems
• If you have lost a lot of salt and fluids (due to vomiting, diarrhea, excessive sweating, low-salt diets, or long-term use of diuretics or if you are undergoing dialysis)
• If you are going to have an allergy treatment (e.g., bee or wasp sting desensitization)
• If you are going to have an anesthetic, e.g., for dental surgery. You may need to stop taking Amlodipine/Ramipril Aristo a day before; consult your doctor or pharmacist
• If you have high levels of potassium in your blood (as shown in blood test results)
• If you are taking medicines or have a condition that may lower your blood sodium levels. Your doctor will need to perform regular blood tests, especially to check your sodium levels, particularly in elderly patients
• If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus
• Tell your doctor if you are pregnant (or think you might be). Amlodipine/Ramipril Aristo is not recommended during the first 3 months of pregnancy, and may cause serious harm to your baby after 3 months of pregnancy (see section “Pregnancy and breast-feeding”)
• If you are taking any of the following medicines used to treat high blood pressure:

• Angiotensin II Receptor Antagonists (ARAII) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
• Aliskiren

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the information under the headings “Do not take Amlodipine/Ramipril Aristo” and “Warnings and precautions”

• If you have severe increases in blood pressure (hypertensive crises)
• If you are elderly and need a dose increase

If you experience sudden swelling of your lips, face, tongue, throat, and neck, possibly hands and feet, difficulty swallowing or breathing, rash, or hoarseness (angioedema), this may be a symptom of an allergic reaction. This can occur at any time during treatment. Black patients may be at higher risk of experiencing these symptoms. Inform your doctor immediately if you experience any of these symptoms.

Children and adolescents

Amlodipine/Ramipril Aristo is not recommended for children and adolescents under 18 years of age because there is no information available for this population.

Other medicines and Amlodipine/Ramipril Aristo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Amlodipine/Ramipril Aristo may affect the way some other medicines work. Also, some medicines may affect the way Amlodipine/Ramipril Aristo works.

Tell your doctor if you are taking any of the following medicines. They may reduce the effect of Amlodipine/Ramipril Aristo:

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, and acetylsalicylic acid)
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to check your blood pressure
• Rifampicin (an antibiotic used to treat tuberculosis)
• Hypericum perforatum (St. John's Wort used to treat depression)

Tell your doctor if you are taking any of the following medicines. They may increase the risk of side effects if taken with Amlodipine/Ramipril Aristo:

• Sacubitril/valsartan - used to treat a certain type of long-term (chronic) heart failure (see section 2 “Do not take Amlodipine/Ramipril Aristo”)
• If you are taking any of the following medicines, you may be at increased risk of angioedema:

• Racecadotril, a medicine used to treat diarrhea
• Medicines used to prevent organ transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus)
• Vildagliptin, a medicine used to treat diabetes

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, and acetylsalicylic acid)
• Cancer medicines (chemotherapy)
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, and amiloride), and other medicines that may increase potassium levels in your blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots)
• Diuretics (water pills) such as furosemide
• Steroid medicines for inflammation, such as prednisolone
• Allopurinol (used to lower uric acid levels in the blood)
• Procainamide (for heart rhythm problems)
• Ketoconazole, itraconazole (antifungal medicines)
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV)
• Erythromycin, clarithromycin (antibiotics)
• Verapamil, diltiazem (heart medicines)
• Dantrolene (in infusion for severe body temperature abnormalities)

Your doctor may need to adjust your dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Amlodipine/Ramipril Aristo” and “Warnings and precautions”)

Tell your doctor if you are taking any of the following medicines, as they may be affected by Amlodipine/Ramipril Aristo:

• Medicines for diabetes, such as oral hypoglycemic agents or insulin. Amlodipine/Ramipril Aristo may lower your blood sugar levels. Check your blood sugar levels while taking Amlodipine/Ramipril Aristo.
• Lithium (for mental health problems). Amlodipine/Ramipril Aristo may increase lithium levels in your blood. Your doctor will need to closely monitor your lithium levels.
• Simvastatin (a cholesterol-lowering medicine). Amlodipine/Ramipril may increase simvastatin levels in your blood.

Amlodipine/Ramipril Aristo may further lower your blood pressure if you are already taking other medicines for high blood pressure.

If any of the above applies to you (or you are unsure), talk to your doctor or pharmacist before taking Amlodipine/Ramipril Aristo.

Taking Amlodipine/Ramipril Aristo with food, drinks, and alcohol

Drinking alcohol with Amlodipine/Ramipril Aristo may make you feel dizzy or faint. If you are concerned about how much you can drink while taking Amlodipine/Ramipril Aristo, talk to your doctor or pharmacist. Talk to your doctor about how blood pressure medicines and alcohol can have additive effects.

Grapefruit and grapefruit juice should not be consumed by people taking Amlodipine/Ramipril Aristo. This is because grapefruit and grapefruit juice can lead to an increase in the levels of amlodipine in your blood, which can cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine/Ramipril Aristo.

Pregnancy, breast-feeding, and fertility

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.

Pregnancy

Do not take Amlodipine/Ramipril Aristo during pregnancy.

If you become pregnant while taking Amlodipine/Ramipril Aristo, inform your doctor immediately. A switch to an alternative treatment should be made before a planned pregnancy.

Breast-feeding

Do not take Amlodipine/Ramipril Aristo during breast-feeding.

Consult your doctor or pharmacist before taking any medicine.

Fertility

There is not enough data on the effect on fertility.

Driving and using machines

Amlodipine/Ramipril Aristo may affect your ability to drive or use machines. If you feel unwell, dizzy, tired, or have a headache while taking Amlodipine/Ramipril Aristo, do not drive or use machines and contact your doctor immediately. This can occur especially at the start of treatment with amlodipine/ramipril, when changing formulation, or when starting to take a higher dose.

Amlodipine/Ramipril Aristo contains sodium

This medicine contains less than 1mmol of sodium (23 mg) per capsule; this is essentially “sodium-free”.

3. How to take Amlodipine/Ramipril Aristo

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

If you think the effect of Amlodipine/Ramipril Aristo is too strong or too weak, consult your doctor or pharmacist.

Take this medicine orally, at the same time each day. Amlodipine/Ramipril Aristo can be taken with or without food.

Swallow the capsule whole with some liquid.

Do not take Amlodipine/Ramipril Aristo with grapefruit juice.

Amlodipine/Ramipril Aristo should be taken once daily.

Your doctor may adjust the dose depending on the effect it has on you.

The maximum daily dose is one 10 mg/10 mg capsule.

Elderly patients

Your doctor will reduce the initial dose and adjust the treatment slowly.

Use in children and adolescents

Amlodipine/Ramipril Aristo is not recommended for children and adolescents under 18 years of age, as there is no data available for this population.

If you take more Amlodipine/Ramipril Aristo than you should

Taking too many capsules can cause your blood pressure to become too low or dangerously low. You may feel dizzy or weak, and if the drop in blood pressure is severe enough, you may experience shock. Your skin may feel cold and clammy, and you may lose consciousness.

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

Inform your doctor or go to the emergency department of the nearest hospital. Do not drive to the hospital, have someone drive you or call an ambulance. Bring the medicine pack with you to show the doctor what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amlodipine/Ramipril Aristo

If you forget to take a capsule, leave that capsule and take the next dose at the right time. Do not take a double dose to make up for forgotten doses.

If you stop taking Amlodipine/Ramipril Aristo

Your doctor will tell you for how long you should take this medicine. Your condition may come back if you stop taking this medicine before your doctor tells you to.

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.

Stop taking Amlodipine/Ramipril Aristo and consult a doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:

• Swelling of the face, eyelids, lips, tongue, or throat that makes it difficult to swallow or breathe, as well as itching and skin rash. This could be a sign of a severe allergic reaction to Amlodipine/Ramipril Aristo.
• Severe skin reactions, including intense skin rash, ulcers in the mouth, hives, redness of the skin all over the body, intense itching, peeling, and swelling of the skin, inflammation of mucous membranes, worsening of a pre-existing skin disease, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) or other allergic reactions.

Consult your doctor immediately if you experience:

• Faster heart rate, irregular or strong heartbeats (palpitations), chest pain, chest tightness, or more serious problems such as heart attack and stroke.
• Difficulty breathing or coughing. These may be symptoms of lung problems.
• Bruises, bleeding for longer than usual, any sign of bleeding (e.g., gum bleeding), purpura, rashes, or spots on the skin, or getting infections more easily than usual, sore throat, and fever, feeling tired, weak, dizzy, or having pale skin. These may be signs of blood or bone marrow problems.
• Severe stomach pain that can radiate to the back. This could be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These may be signs of liver problems, such as hepatitis (inflammation of the liver) or liver damage.

Other side effects:

Inform your doctor if any of the following symptoms worsen or last more than a few days.

Very common (may affect more than 1 in 10 people)

• Fluid retention (edema)

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

• Drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeats), flushing
• Swelling of the ankles
• Headache or feeling weak or tired
• Feeling dizzy. This is more likely to occur when you start taking Amlodipine/Ramipril Aristo or start taking a higher dose
• Fainting, low blood pressure (abnormally low blood pressure), especially when standing up or getting up quickly
• Dry cough, sinus inflammation (sinusitis), or bronchitis, difficulty breathing
• Abdominal pain, stomach pain, or intestinal discomfort, alteration of bowel habits, diarrhea, constipation, indigestion, feeling queasy (nausea)
• Visual disturbances, double vision
• Skin rash, with or without inflammation
• Chest pain
• Muscle cramps or muscle pain
• Blood tests showing high potassium levels

Uncommon (may affect up to 1 in 100 people):

• Mood changes, anxiety, depression, feeling depressed, insomnia
• Tremors, fainting, pain, feeling unwell
• Ringing in the ears
• Sneezing/nasal discharge caused by inflammation of the nasal lining (rhinitis)
• Heartburn and dry mouth
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration
• Urinary disorders: increased need to urinate at night and increased number of times urinating, passing more water (urine) than usual during the day
• Impotence, sexual dysfunction in men, reduced sexual desire in men or women
• Discomfort or enlargement of the breasts in men
• Joint pain, back pain
• Weight gain or loss
• Balance problems (vertigo)
• Itching and unusual sensations in the skin such as numbness, tingling, pinching, burning, or loss of pain sensation (paresthesia)
• Numbness or tingling in the limbs, loss of pain sensation
• Loss or change in the taste of things
• Sleep disorders
• Feeling nervous or restless
• Nasal congestion, difficulty breathing, or worsening of asthma
• Inflammation of the intestine called "intestinal angioedema" with symptoms such as abdominal pain, vomiting, and diarrhea
• Loss or decrease in appetite (anorexia)
• Increased or irregular heartbeats
• Swollen arms and legs. This may be a sign that your body is retaining more water than usual
• Blurred vision
• Cough
• Low blood pressure
• Fever
• Increased number of certain white blood cells (eosinophilia) found during a blood test
• Blood tests showing changes in how your liver, pancreas, or kidneys are working

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

• Feeling weak or confused
• Red and swollen tongue
• Severe skin peeling, itching, rash
• Nail problems (e.g., weakness or separation of the nail from its bed)
• Skin rash or bruising
• Spots on the skin and cold extremities
• Redness of the eyes, itching, swelling
• Hearing problems
• Blood tests showing a decrease in the number of red blood cells, white blood cells, platelets, or the amount of hemoglobin

Very rare (may affect up to 1 in 10,000 people):

• Decrease in the number of blood platelets that can cause easy bleeding or unusual bruising
• Increased sensitivity to the sun
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, tingling, or numbness
• Inflammation of the gums, gum bleeding
• Abdominal distension (gastritis)

• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests
• Increased muscle tension

• Inflammation of blood vessels, often with skin rash
• Sensitivity to light
• Disorders combining stiffness, tremors, and/or movement disorders

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

• Concentrated urine (dark color), feeling unwell or nauseous, muscle cramps, confusion, and convulsions that may be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible
• Tremors, rigid posture, "mask-like" face, slow movements, and unsteady gait

Other side effects:

Inform your doctor if any of the following symptoms worsen or last more than a few days.

• Difficulty concentrating
• Swelling of the mouth
• Blood tests showing low sodium levels
• Change in color of the fingers and toes with cold and tingling or painful sensation with heat (Raynaud's phenomenon)
• Slowness or difficulty reacting
• Burning sensation
• Change in the perception of smells

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 is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Amlodipine/Ramipril Aristo

Keep this medicine out of the 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 below 30°C.

Keep in the original packaging to protect it from light.

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

6. Package Contents and Additional Information

Composition ofAmlodipine/Ramipril Aristo

• The active ingredients are:

10 mg/10 mg, hard capsules:

Each capsule contains 10 mg ramipril and amlodipine besylate equivalent to 10 mg of amlodipine.

• The other ingredients are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized corn starch, sodium starch glycolate (type A), sodium stearyl fumarate, red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), and gelatin.

Appearance ofAmlodipine/Ramipril Aristoand Package Contents

Amlodipine/Ramipril Aristo 10 mg/10 mg hard capsules are hard gelatin capsules, size No. 1, approximately 19.1-19.7 mm long, with an opaque brown cap and an opaque white body. The contents of the capsules are a white or almost white powder.

Amlodipine/Ramipril Aristo is available in blister packs, in packages containing 28, 30, 32, 50, 56, 60, 90, 91, 96, 98, or 100 capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

Calle Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

Manufacturer

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Or

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

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

Sweden: Ramipril/Amlodipin Aristo, 10 mg/10mg hard capsules

Germany: Ramipril Aristo plus Amlodipin 10 mg/10mg hard capsules

Italy: Bisar 10 mg/10 mg hard capsules

Spain: Amlodipine/Ramipril Aristo 10 mg/10 mg hard capsules

Date of the last revision of this leaflet: February 2023

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/