Amlodipine/ramipril Aristo 5 mg/10 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amlodipine/Ramipril Aristo 5 mg/10 mg hard capsules

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Package leaflet contents

1. What Amlodipino/ramipril Aristo is and what it is used for

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 container 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 can increase blood pressure.
• Causing your blood vessels to relax and widen.
• Helping the heart to pump blood more easily.

Amlodipine works by:

• Relaxing and widening blood vessels, allowing blood to pass through them more easily.

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

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

Do not take Amlodipino/ramipril Aristo

• If you are allergic to ramipril, amlodipine (active substances), other ACE inhibitors or calcium antagonists, or to any of the other components of this medicine (listed in section 6). Symptoms of an allergic reaction may include 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 medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin, such as in the throat) is high (see section “Other medicines and Amlodipino/ramipril Aristo”).

• If you have ever had a serious allergic reaction known as "angioedema". Symptoms include itching, hives, red patches on the hands, feet, and throat, swelling 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, 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 renal 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 must assess you.

• If you have narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply sufficient blood to the body).

• If you suffer from heart failure following a heart attack.

Do not take Amlodipino/ramipril Aristo if any of the above conditions apply to you. 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 Amlodipine/Ramipril Aristo.

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

• If you have heart, liver, or kidney problems

• If you have lost large amounts of salts or fluids (due to vomiting, diarrhoea, excessive sweating, low-salt diets, long-term use of diuretics (water tablets), or if you are undergoing dialysis)

• If you are about to undergo treatment to reduce allergy to insect stings, for example, bee or wasp (desensitisation)

• If you are due to receive an anaesthetic, for example, for a dental procedure. You may need to stop taking Amlodipine/Ramipril Aristo one 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 medicines or have a medical condition that could lower your blood sodium levels. Your doctor should carry out periodic blood tests, especially to monitor sodium levels, 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 suspect you might be). Amlodipine/Ramipril Aristo is not recommended during the first 3 months of pregnancy and can cause serious harm to your baby after 3 months of pregnancy (see section “Pregnancy and breastfeeding”)

• If you are taking any of the following medicines used to treat high blood pressure:

• Angiotensin II Receptor Antagonists (ARAII) (also known as sartans – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes

• Aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (for example, potassium) at regular intervals. See also the information under the heading “Do not take Amlodipine/Ramipril Aristo”

• If you have severe increases in blood pressure (hypertensive crises)
• If you are elderly and require 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), these may be symptoms 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 develop any of these symptoms.

Children and adolescents

Amlodipine/ramipril Aristo is not recommended in children and adolescents under 18 years of age, as there is no available information for this population group.

Other medicines and Amlodipine/ramipril Aristo

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Amlodipine/ramipril Aristo may affect how some other medicines work. Likewise, some medicines may affect how Amlodipine/ramipril Aristo works.

Inform your doctor if you are taking any of the following medicines. These 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 monitor 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 medicines. These may increase the likelihood of experiencing adverse effects when taken in combination with Amlodipine/ramipril Aristo:

• Sacubitril/valsartan – used to treat a type of chronic heart failure. (See section 2 “Do not take Amlodipine/ramipril Aristo”)

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

• Racecadotril, a medicine used to treat diarrhoea;

• Medicines used to prevent rejection of organ transplants and for 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, indometacina, and acetylsalicylic acid)

• Medicines for cancer (chemotherapy)

• Potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, triamterene, and amiloride), and other medicines 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 medicine used to thin the blood to prevent clots)

• Diuretics (water tablets), such as furosemide

• Steroid medicines for inflammation, such as prednisolone

• Allopurinol (used to lower uric acid 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 (medicines for the heart)

• Dantrolene (by infusion for serious 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 (ARB) or aliskiren (see also 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 medicines, as they may be affected by Amlodipine/ramipril Aristo:

• Medicines for diabetes, such as oral hypoglycaemics or insulin. Amlodipine/ramipril Aristo may reduce your blood sugar levels. Monitor your blood sugar levels while taking Amlodipine/ramipril Aristo.
• Lithium (for mental health conditions). Amlodipine/ramipril Aristo may increase lithium levels in the blood. Your doctor should closely monitor your blood lithium levels.
• Simvastatin (a cholesterol-lowering medicine). Amlodipine/ramipril may increase simvastatin levels in the blood.

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

If any of the above situations apply to you (or you are unsure), speak with 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 lightheaded. If you are concerned about how much alcohol you can drink while taking Amlodipine/ramipril Aristo, speak with your doctor or pharmacist. Discuss with your doctor how blood pressure-lowering medicines and alcohol may have additive effects.

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

Pregnancy, breastfeeding, 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 medicine.

Pregnancy

You must not take Amlodipine/ramipril Aristo during pregnancy.

If you become pregnant while being treated with Amlodipine/ramipril Aristo, inform your doctor immediately. A switch to an appropriate alternative treatment should be made before a planned pregnancy.

Breastfeeding

You must not take Amlodipine/ramipril Aristo while breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Fertility

There are insufficient data on the effect on fertility.

Driving and use of machines

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

Amlodipine/ramipril Aristo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially "sodium-free".

3. How to take Amlodipine/Ramipril Aristo

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

If you feel that 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 how it affects you.

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

Elderly patients

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

Use in children and adolescents

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

If you take more Amlodipine/Ramipril Aristo than you should

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

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

Contact your doctor or go to the nearest hospital emergency department. Do not drive to the hospital; have someone take you or call an ambulance. Take the medicine packaging with you so the doctor knows what you have taken.

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

If you forget to take Amlodipine/Ramipril Aristo

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

If you stop taking Amlodipine/Ramipril Aristo

Your doctor will advise you on how long you should take this medicine. Your condition may return if you stop treatment with this medicine before your doctor recommends doing so.

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.

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, causing difficulty swallowing or breathing, together with itching and skin rash. This could be a sign of a severe allergic reaction to Amlodipine/Ramipril Aristo.
• Severe skin reactions, including severe rash, mouth ulcers, hives, redness of the skin all over the body, intense itching, skin peeling and swelling, mucous membrane inflammation, worsening of a pre-existing skin condition, blisters or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme), or other allergic reactions.

Contact 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 or stroke.
• Difficulty breathing or cough. These may be symptoms of lung problems.
• Bruising, bleeding that lasts longer than normal, any sign of bleeding (e.g., bleeding gums), purpura, rashes or spots on the skin, or increased susceptibility to infections, 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 may 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 (liver inflammation) 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 heartbeat), flushing
• Swelling of the ankles
• Headache or feeling weak or tired
• Dizziness. This is more likely when starting Amlodipine/Ramipril Aristo or increasing the dose
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or getting up quickly
• Dry cough, sinus inflammation (sinusitis), or bronchitis, difficulty breathing
• Abdominal pain, stomach or intestinal pain, changes in bowel habits, diarrhea, constipation, indigestion, feeling unwell (nausea)
• Visual disturbances, double vision
• Skin rash, with or without inflammation
• Chest pain
• Muscle cramps or muscle 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
• Ringing in the ears (tinnitus)
• Sneezing/nasal discharge due to inflammation of the nasal lining (rhinitis)
• Heartburn and dry mouth
• Hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration
• Urinary disorders: increased need to urinate at night and increased frequency of urination, passing more 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 weight loss
• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning, loss of pain sensation (paresthesia)
• Numbness or tingling in the limbs, loss of pain sensation
• Loss or change in taste
• Sleep problems
• Feeling nervous or restless
• Nasal congestion, difficulty breathing, or worsening of asthma
• Intestinal swelling called "intestinal angioedema" presenting symptoms such as abdominal pain, vomiting, and diarrhea
• Loss or decrease in appetite (anorexia)
• Increased or irregular heartbeat
• Swollen arms and legs. This may be a sign that your body is retaining more fluid than normal
• Blurred vision
• Cough
• Low blood pressure
• Fever
• Increased number of certain white blood cells (eosinophilia) found during blood tests
• 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, 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, itching, swelling of the eyes
• Hearing problems
• Blood tests show a decrease in red blood cells, white blood cells, platelets, or hemoglobin levels

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

• Decreased number of blood platelets, which may cause easy bleeding or unusual bruising
• Increased sensitivity to sunlight
• High blood sugar (hyperglycemia)
• A nerve disorder that may cause muscle weakness, tingling, or numbness
• Gum inflammation, bleeding gums
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Light sensitivity
• Disorders combining stiffness, tremor, and/or movement disorders

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

• Concentrated urine (dark color), feeling unwell or nausea, muscle cramps, confusion, and seizures, which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible
• Tremors, rigid posture, "mask-like" facial expression, slow movements, and unbalanced gait with shuffling steps.

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
• Color changes in fingers and toes when exposed to cold, with tingling or painful sensation in heat (Raynaud's phenomenon)
• Slowness or difficulty reacting
• Burning sensation
• Changes in the perception of smells

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Keep in the original packaging to protect from light.

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 dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipino/ramipril Aristo

• The active substances are:

5 mg/10 mg, hard capsules:

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

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

Appearance of Amlodipino/ramipril Aristo and contents of the pack

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 capsule contents consist of a white or almost white powder.

Amlodipino/ramipril Aristo is available in blisters, in packs containing 28, 30, 32, 50, 56, 60, 90, 91, 96, 98 or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850, Torrejón de Ardoz
Madrid. Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Sweden: Ramipril/Amlodipin Aristo, 10 mg/5mg hårda kapslar
Germany: Ramipril Aristo plus Amlodipin 10 mg/5mg Hartkapseln
Italy: Bisar 10 mg/5 mg capsula rigida
Spain: Amlodipino/Ramipril Aristo 5 mg/10 mg cápsulas duras

Date of the most recent review of this leaflet: February 2023

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