Amlodipine/ramipril Aristo 5 mg/5 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Amlodipine/Ramipril Aristo 5mg/5mg hard capsules

Please read all of this 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, ask 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

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. How to store Amlodipine/Ramipril Aristo

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

Amlodipine works by:

• Relaxing and widening blood vessels, so that blood can flow 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 Amlodipine/Ramipril Aristo combination.

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, calcium antagonists, or any of the other components of this medicine (listed in section 6). Symptoms of an allergic reaction may include 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, since the risk of angioedema (rapid swelling under the skin, for example in the throat) is high (see section “Other medicines and Amlodipino/ramipril Aristo”).

• If you have ever had a severe allergic reaction known as "angioedema". Symptoms include itching, hives, red patches on 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 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 must evaluate 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 enough 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 situations 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, during 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 reduce blood sodium levels. Your doctor should carry out periodic blood tests, especially to monitor blood 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 pregnant). 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 breastfeeding”)

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

• 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), this may be a sign 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. Contact 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 organ transplant rejection 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, indomethacin, and acetylsalicylic acid)

• Cancer medicines (chemotherapy)

• Potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, triamterene, and amiloride), and other medicines that may increase blood potassium levels (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 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 (medicines for the heart)

• Dantrolene (given 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 lower your blood sugar levels. Monitor your blood sugar levels while taking Amlodipine/ramipril Aristo.
• Lithium (for mental health conditions). Amlodipine/ramipril Aristo may increase blood lithium levels. Your doctor should closely monitor your blood lithium levels.
• Simvastatin (a cholesterol-lowering medicine). Amlodipine/ramipril may increase blood levels of simvastatin.

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

If any of the above situations apply to you (or if you are unsure), speak with your doctor or pharmacist before taking Amlodipine/ramipril Aristo.

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

Drinking alcohol while taking 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 are planning 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 using 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 use machines 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; essentially, it is “sodium-free”.

3. How to take Amlodipine/ramipril Aristo

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

If you think 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 may be taken with or without food.

Swallow the capsule whole with a liquid.

Do not take Amlodipine/ramipril Aristo with grapefruit juice.

Amlodipine/ramipril Aristo should be administered 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 slowly.

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.

Inform your doctor or go to the nearest hospital emergency department immediately. Do not drive to the hospital; have someone take you or call an ambulance. Take the medicine packaging with you so you can show the doctor 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 correct 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 medicine. Your condition may return if you stop treatment with this medicine before your doctor advises you to do 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, making swallowing or breathing difficult, together with 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, mouth ulcers, hives, redness of the skin all over the body, severe itching, skin peeling and swelling, inflammation of mucous membranes, worsening of a pre-existing skin condition, blisters or skin peeling or shedding (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme), or other allergic reactions.

Contact your doctor immediately if you experience:

• Faster heartbeat, 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, 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 extend 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:

Tell your doctor if any of the following symptoms worsen or persist for 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, feeling weak or tired
• Dizziness. This is more likely when you first start taking Amlodipine/Ramipril Aristo or begin a higher 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 discomfort, 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, skin itching, red spots on the skin, skin discoloration
• Urinary disorders: increased need to urinate at night, increased frequency of urination, passing more urine than usual during the day
• Impotence, sexual dysfunction in men, reduced sexual desire in men or women
• Breast discomfort or enlargement 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, or 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 with 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 water 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, or 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 a skin rash
• Light sensitivity
• Disorders combining stiffness, tremor, and/or movement disorders

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

• Concentrated urine (dark-colored), feeling unwell or nauseous, muscle cramps, confusion, and seizures, which 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 unbalanced gait with shuffling steps

Other side effects:

Tell your doctor if any of the following symptoms worsen or last longer 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 sensations when exposed to 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 effects, consult your doctor or pharmacist, even if they are possible side effects 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 container to protect from light.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Amlodipino/Ramipril Aristo

• The active substances are:

5 mg/5 mg, hard capsules:

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

• The other components are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized corn starch, sodium potato 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/5 mg hard capsules are size No. 1 gelatin hard capsules, approximately 19.1–19.7 mm in length, with an opaque pink cap and an opaque white body. The capsule contents consist of a white or almost white powder.

Amlodipino/Ramipril Aristo is available in blister packs, in containers 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, 5 mg/5mg hard capsules
Germany: Ramipril Aristo plus Amlodipin 5 mg/5mg Hartkapseln
Italy: Bisar 5 mg/5 mg capsula rígida
Spain: Amlodipino/Ramipril Aristo 5 mg/5 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/