Package Insert: Information for the Patient

Amlodipino/ramipril Aristo 5mg/10mg Hard Capsules

Read this package insert carefully before you start taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Table of Contents

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

6. Contents of the pack and additional information

Amlodipino/ramipril Aristo contains two active ingredients: ramipril and amlodipino. Ramipril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Amlodipino belongs to a group of medicines called calcium antagonists.

Ramipril acts:

• Decreasing the production of substances that can increase blood pressure.
• Making its blood vessels relax and widen.
• Making it easier for the heart to pump blood.

Amlodipino acts:

• Relaxing and widening the blood vessels, so that blood can pass through them more easily.

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

Do not take Amlodipino/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 may include a skin rash, difficulty swallowing or breathing, 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 Amlodipino/ramipril Aristo”).
• If you have ever had a severe allergic reaction known as "angioedema". The symptoms include itching, urticaria, red marks on your hands, feet, and throat, inflammation of your throat and tongue, swelling around your eyes and lips, difficulty breathing and swallowing.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Amlodipino/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 breastfeeding”).
• If you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskiren.
• If your blood pressure is abnormally low (hypotension) or unstable. Your doctor must evaluate you.
• If you have a narrowing of the aortic heart valve (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 Amlodipino/ramipril Aristo if you have any of the above circumstances. If you are unsure, consult your doctor or pharmacist before taking Amlodipino/ramipril Aristo.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipino/ramipril Aristo.

Inform your doctor if any of the following situations affect you:

• If you have heart, liver, or kidney problems
• If you have lost a large amount of salt or fluids (due to vomiting, diarrhea, excessive sweating, low-sodium diets, long-term diuretic use, or dialysis)
• If you are undergoing a treatment to reduce allergy to stings, such as bee or wasp stings (desensitization)
• If you are to receive an anesthetic, such as in a dental operation. You may need to stop taking Amlodipino/ramipril Aristo a day before; 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 blood levels. Your doctor should perform regular blood tests, especially to check sodium blood levels, especially 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 suspect you may be). Amlodipino/ramipril Aristo is not recommended during the first 3 months of pregnancy, and may cause severe harm to your baby after 3 months of pregnancy (see section “Pregnancy and breastfeeding”)
• If you are taking any of the following medications used to treat high blood pressure:

• Angiotensin II receptor antagonists (also known as sartans - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
• Aliskiren.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (such as potassium) at regular intervals. See also the information under the heading “Do not take Amlodipino/ramipril Aristo”

• 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, urticaria, or hoarseness (angioedema). This may be a symptom of an allergic reaction. This can occur at any time during treatment. People of black race may have a higher risk of experiencing these symptoms. Inform your doctor immediately if you experience any of these symptoms.

Children and adolescents

Amlodipino/ramipril Aristo is not recommended for children and adolescents under 18 years of age because there is no available information for this age group.

Other medications and Amlodipino/ramipril Aristo

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

Inform your doctor if you are taking any of the following medications. These may reduce the effect of Amlodipino/ramipril Aristo:

• Medications used to relieve pain and inflammation (such as nonsteroidal 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 (antibiotic for treating tuberculosis)
• Hypericum perforatum (St. John's Wort for treating depression).

Inform your doctor if you are taking any of the following medications. They may increase the risk of experiencing adverse effects if taken in combination with Amlodipino/ramipril Aristo:

• Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure. (see section 2 “Do not take Amlodipino/ramipril Aristo”)

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

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

• Medications used to relieve pain and inflammation (such as nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, and acetylsalicylic acid)
• Chemotherapy medications
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, and amiloride), and other medications that may increase potassium levels in the blood (such as trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to thin the blood to prevent clots)
• Diuretics (urine tablets) such as furosemide
• Glucocorticoids for inflammation, such as prednisolone
• Alopurinol (used to lower uric acid 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 (intravenous for severe body temperature abnormalities)

Your doctor may need to modify 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 Amlodipino/ramipril Aristo” and “Warnings and precautions”)

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

• Diabetes medications such as oral hypoglycemic agents or insulin. Amlodipino/ramipril Aristo may reduce your blood sugar levels. Monitor your blood sugar levels while taking Amlodipino/ramipril Aristo.
• Lithium (for mental health problems). Amlodipino/ramipril Aristo may increase lithium levels in the blood. Your doctor should closely monitor lithium blood levels.
• Simvastatin (a cholesterol-lowering medication). Amlodipino/ramipril may increase simvastatin levels in the blood.

Amlodipino/ramipril Aristo may further lower blood pressure if you are already taking other medications for high blood pressure.

If any of the above circumstances affect you (or you are unsure), speak with your doctor or pharmacist before taking Amlodipino/ramipril Aristo.

Taking Amlodipino/ramipril Aristo with food, drinks, and alcohol

Consuming alcohol with Amlodipino/ramipril Aristo may make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking Amlodipino/ramipril Aristo, speak with your doctor or pharmacist. Speak with your doctor about how medications used to lower blood pressure and alcohol may have additive effects.

Oranges and orange juice should not be consumed by people taking Amlodipino/ramipril Aristo. This is because oranges and orange juice may lead to an increase in amlodipine levels in the blood, which may cause an unpredictable increase in the blood pressure-lowering effect of Amlodipino/ramipril Aristo.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not take Amlodipino/ramipril Aristo during pregnancy.

If you become pregnant while taking Amlodipino/ramipril Aristo, inform your doctor immediately. A change to an alternative suitable treatment should be made before a planned pregnancy.

Breastfeeding

You should not take Amlodipino/ramipril Aristo during breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Fertility

There is insufficient data on the effect on fertility.

Driving and operating machinery

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

Amlodipino/ramipril Aristo contains sodium

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

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

If you feel that the effect of Amlodipino/ramipril Aristo is too strong or too weak, consult your doctor or pharmacist.

Take this medication orally at the same time of day. Amlodipino/ramipril Aristo can be taken with or without food.

Swallow the entire capsule with some liquid.

Do not take Amlodipino/ramipril Aristo with grapefruit juice.

Amlodipino/ramipril Aristoshould be administered once a day.

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

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

Older patients

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

Use in children and adolescents

No recommended use of Amlodipino/ramipril Aristo in children and adolescents under 18 years old since there are no available data for this population group.

If you take more Amlodipino/ramipril Aristo than you should

Taking too many capsules can cause your blood pressure to be 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 moist, and you may lose consciousness.

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

Inform your doctor or go to the nearest hospital emergency service. Do not drive to the hospital, have someone take you or call an ambulance. Bring the medication packaging with you to indicate to the doctor what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeAmlodipino/ramipril Aristo

If you forget to take a capsule, leave that capsule and take the next dose at the correct time.Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withAmlodipino/ramipril Aristo

Your doctor will indicate for how long you should take this medication.Your condition may reappear if you interrupt the treatment with this medication before the doctor indicates.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Amlodipino/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 Amlodipino/ramipril Aristo.
• Severe skin reactions, including intense skin rash, mouth ulcers, hives, skin redness all over the body, intense itching, peeling, and skin swelling, mucous membrane inflammation, worsening of an existing skin disease, blisters, or skin detachment (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) or other allergic reactions.

Consult your doctor immediately if you experience:

• Fast or irregular heartbeat, strong heart palpitations, chest pain, chest tightness, or more severe problems such as heart attack and stroke.
• Difficulty breathing or coughing. These may be symptoms of lung problems.
• Bleeding, prolonged bleeding, any sign of bleeding (e.g., gum bleeding), purpura, rashes, or spots on the skin, or catching infections more easily than usual, sore throat, and fever, feeling tired, weakness, dizziness, or pale skin. These may be signs of blood or bone marrow problems. Severe stomach pain that can reach 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
• Sensation of dizziness. This is more likely to occur when starting to take Amlodipino/ramipril Aristo or starting a higher dose
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or getting up quickly
• Dry cough, sinusitis (inflammation of the sinuses), or bronchitis, difficulty breathing
• Abdominal pain, stomach pain, or intestinal pain, changes in bowel habits, diarrhea, constipation, indigestion, nausea (feeling queasy)
• Visual disturbances, double vision
• Skin rash, with or without inflammation
• Chest pain
• Muscle cramps or pain
• Blood tests showing higher-than-normal potassium levels

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

• Mood changes, anxiety, depression, feeling depressed, insomnia
• Tremor, fainting, pain, feeling unwell
• Tinnitus (ringing in the ears)
• Nasal congestion and secretion caused by inflammation of the nasal mucosa (rhinitis)
• Stomach burning and dry mouth
• Hair loss, increased sweating, itching skin, red spots on the skin, skin discoloration
• Urinary problems: increased need to urinate at night and increased frequency of urination, excessive water loss (urine) during the day
• Impotence, male sexual dysfunction, reduced sexual desire in men or women
• Mastalgia (breast pain) or breast enlargement in men
• Joint pain, back pain
• Weight gain or loss
• Balance problems (dizziness)
• Unusual sensations in the skin such as numbness, tingling, pinching, burning, loss of pain sensation (paresthesia)
• Numbness or tingling in the extremities, loss of pain sensation
• Loss or change in taste
• Sleep problems
• Sensation of nervousness or restlessness
• Nasal congestion, difficulty breathing, or worsening of asthma
• Intestinal inflammation called "intestinal angioedema" that 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 show 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, and rash
• Problems with the nails (e.g., weakness or separation of the nail from its bed)
• Skin rash or hematomas
• Spots on the skin and cold extremities
• Eye redness, itching, and swelling
• Auditory problems
• Blood tests show a decrease in the number of red cells, white cells, platelets, or hemoglobin

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

• Decreased platelet count in the blood that can cause easy bleeding or unusual bruises
• Increased sensitivity to the sun
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, tingling, or numbness
• Gingivitis, gum bleeding
• Abdominal distension (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Sensitivity to light
• Movement disorders combining rigidity, tremor, and/or movement disorders

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

• Concentrated urine (dark color), feeling unwell or nauseous, muscle cramps, confusion, and seizures 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 with dragging feet.

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 lower-than-normal sodium levels
• Change in color in the fingers of the hands and feet with cold and tingling or painful sensation with heat (Raynaud's phenomenon)
• Lateness or difficulty reacting
• Change in the perception of odors

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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 below30°C.

Store in the original packaging to protect it from light.

Medications should not be thrown into the drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofAmlodipino/ramipril Aristo

• The active ingredients are:

5 mg/10 mg, hard capsules:

Each capsule contains 10 mg of ramipril and amlodipine besilate equivalent to 5 mg of amlodipine.

• The other components are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized cornstarch, sodium starch glycolate (type A), sodium stearate fumarate, red iron oxide (E172), titanium dioxide (E171), and gelatin.

Appearance ofAmlodipino/ramipril Aristoand contents of the package

Amlodipino/ramipril Aristo 5 mg/10 mg hard capsules are hard gelatin capsules of size No. 1, approximately 19.1-19.7 mm in length, with an opaque dark pink cap and an opaque white body. The contents of the capsules are a white or almost white powder.

Amlodipino/ramipril Aristo is presented in a blister pack, in containers that contain 28, 30, 32, 50, 56, 60, 90, 91, 96, 98, or 100 capsules.

Not all package sizes may be marketed.

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Responsible manufacturer

Laboratorios Medicamentos Internacionales, S. A. (Medinsa)

Calle Solana, 26

28850 Torrejón de Ardoz (Madrid).

Spain

Or

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

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

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850Torrejón de Ardoz

Madrid. Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Sweden:Ramipril/Amlodipin Aristo, 10 mg/5mg hard capsules

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

Italy:Bisar 10 mg/5 mg rigid capsule

Spain:Amlodipino/Ramipril Aristo 5 mg/10 mg hard capsules

Last review date of this leaflet: February 2023

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