AMLODIPINE/RAMIPRIL ARISTO 10 mg/5 mg HARD CAPSULES

Introduction

Prospect: patient information

Amlodipine/Ramipril Aristo 10mg/5mg hard capsules

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus

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

1. Package contents and additional 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 medications called ACE inhibitors (Angiotensin-Converting Enzyme Inhibitors). Amlodipine belongs to a group of medications called calcium channel blockers.

Ramipril acts:

• By decreasing the production of substances that can increase blood pressure
• By making your blood vessels relax and widen
• By making your heart pump blood more easily

Amlodipine acts:

• By relaxing and widening your blood vessels, allowing blood to pass through them more easily.

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

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

Do not take Amlodipine/Ramipril Aristo

• If you are allergic to ramipril, amlodipine (active substances), other ACE inhibitors or calcium channel blockers, or to any of the other components of this medication (listed in section 6). The symptoms of an allergic reaction can include a skin rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue. If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high (see section "Other medications and Amlodipine/Ramipril Aristo")
• If you have ever had a severe allergic reaction known as "angioedema". Symptoms include itching, hives, 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 lactation")
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication that contains aliskiren
• If your blood pressure is abnormally low (hypotension) or unstable. Your doctor should evaluate 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 suffer from heart failure after a heart attack

Do not take Amlodipine/Ramipril Aristo if you have any of the above circumstances. 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.

Inform your doctor if any of the following situations apply to you:

• If you have heart, liver, or kidney problems
• If you have lost a large amount of salts or 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 undergo allergy treatment, for example, for bee or wasp stings (desensitization)
• If you are going to be given an anesthetic, for example, in a dental operation. You may need to stop taking Amlodipine/Ramipril Aristo a day in advance; consult your doctor or pharmacist
• If you have high levels of potassium in your blood (shown in blood test results)
• If you are taking medications or have a condition that may decrease sodium levels in your blood. Your doctor should perform regular blood tests, especially to check sodium levels in your blood, particularly in elderly patients
• If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus
• Inform your doctor if you are pregnant (or think you may be). Amlodipine/Ramipril Aristo is not recommended during the first 3 months of pregnancy, and it may cause serious harm to your baby after 3 months of pregnancy (see section "Pregnancy and lactation")
• If you are taking any of the following medications used to treat high blood pressure (hypertension):

• Angiotensin II Receptor Antagonists (ARAII) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), particularly 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 an elderly person 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, hives, or hoarseness (angioedema), it may be a symptom of an allergic reaction. This can occur at any time during treatment. Black patients may be more likely to experience these symptoms. Inform your doctor immediately if you experience any of these symptoms.

Children and adolescents

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

Other medications and Amlodipine/Ramipril Aristo

Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or may need to take/use any other medication. This is because Amlodipine/Ramipril Aristo may affect how some other medications work. Similarly, some medications may affect how Amlodipine/Ramipril Aristo works.

Inform your doctor if you are taking any of the following medications. They may decrease the effect of Amlodipine/Ramipril Aristo:

• Medications used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, and acetylsalicylic acid)
• Medications 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)

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

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure (see section 2 "Do not take Amlodipine/Ramipril Aristo")

• If you are taking any of the following medications, it may increase the risk of angioedema:

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

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

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

• Medications 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 should closely monitor lithium levels in your blood.
• Simvastatin (a cholesterol-lowering medication). Amlodipine/Ramipril may increase simvastatin levels in your blood.

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

If any of the above circumstances apply 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

Consuming alcohol with Amlodipine/Ramipril Aristo may make you feel dizzy or drowsy. If you are concerned about how much you can drink while taking Amlodipine/Ramipril Aristo, talk to your doctor or pharmacist. Discuss with your doctor how blood pressure medications 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 amlodipine levels in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine/Ramipril Aristo.

Pregnancy, lactation, and fertility

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

Pregnancy

You should not take Amlodipine/Ramipril Aristo during pregnancy.

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

Breastfeeding

You should not take Amlodipine/Ramipril Aristo during breastfeeding.

Consult your doctor or pharmacist before taking any medication.

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 the formulation is changed, or when you start taking a higher dose.

Amlodipine/Ramipril Aristo contains sodium

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

3. How to take Amlodipine/Ramipril Aristo

Follow the administration instructions for this medication exactly as indicated by 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 medication 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 a day.

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 use in 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 medication packaging 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, phone 91 562 04 20, indicating the medication and the amount ingested.

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 how long you should take this medication. Your condition may recur if you stop taking this medication before your doctor indicates.

If you have any other questions about the use of this medication, 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 swallowing or breathing difficult, 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, skin redness 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 normal, any sign of bleeding (e.g., gum bleeding), purpura, rashes, or spots on the skin, or getting infections more easily than normal, 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, fatigue, 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 of discomfort (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 of discomfort
• Ringing in the ears
• Sneezing/nasal secretion 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, expelling more water (urine) than usual during the day
• Impotence, sexual dysfunction in men, reduced sexual desire in men or women
• Discomfort or breast enlargement 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, known as "intestinal angioedema," which presents 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 normal
• 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 functioning

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
• Light sensitivity
• Disorders combining stiffness, tremors, and/or movement disorders

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

• Concentrated urine (dark color), feeling of discomfort or nausea, 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 Medicines Monitoring System: 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 from light.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the 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 of Amlodipine/Ramipril Aristo

• The active ingredients are:

10 mg/5 mg, hard capsules:

Each capsule contains 5 mg of 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), and gelatin.

Appearance of Amlodipine/Ramipril Aristo and Package Contents

Amlodipine/Ramipril Aristo 10 mg/5 mg hard capsules are hard gelatin capsules, size No. 1, approximately 19.1-19.7 mm long, with the opaque cap brown-red in color and the opaque body white in color.

The contents of the capsules are a white to 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, 5 mg/10mg hard capsules

Germany: Ramipril Aristo plus Amlodipin 10 mg/5mg hard capsules

Italy: Bisar 5 mg/10 mg hard capsules

Spain: Amlodipine/Ramipril Aristo 10 mg/5 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/