RAMIPRIL AUROVITAS SPAIN 2.5 mg TABLETS

2. What you need to know before taking Ramipril Aurovitas Spain

Do not take Ramipril Aurovitas Spain

? If you are allergic to ramipril, any other ACE inhibitor, or any of the other ingredients of this medication (listed in section 6).

The symptoms of an allergic reaction can include a rash, difficulty swallowing or breathing, swelling of your lips, face, throat, or tongue.

? If you have ever had a severe allergic reaction called “angioedema”. The symptoms include itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

? If you have taken or are taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults.

? If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, ramipril may not be suitable for you.

? If you have kidney problems when the blood flow to your kidneys is reduced (renal artery stenosis).

? During the last 6 months of pregnancy (see section “Pregnancy and Breastfeeding” below).

? If your blood pressure is abnormally low or unstable. Your doctor will need to assess this.

? If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication that contains aliskiren.

Do not take ramipril if any of the above situations apply to you. If you are unsure, talk to your doctor before taking Ramipril Aurovitas Spain.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ramipril Aurovitas Spain:

? If you have heart, liver, or kidney problems.

? If you have lost a lot of minerals or fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, long-term diuretic use, or dialysis).

? If you are going to undergo treatment to reduce your allergy to bee or wasp stings (desensitization).

? If you are going to receive an anesthetic. This may be due to an operation or any dental work. You may need to stop your treatment a day in advance; consult your doctor.

? 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 can decrease sodium levels in your blood. Your doctor may perform periodic blood tests, especially to monitor sodium levels in your blood, particularly if you are an elderly patient.

? If you are taking medications that can increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (e.g., racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Ramipril Aurovitas Spain”.

? 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). Ramipril is not recommended during the first three months of pregnancy, and it may cause serious harm to your baby after three months of pregnancy (see section “Pregnancy and Breastfeeding” below).

? If you are taking any of the following medications used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARA) (also known as a “sartan” - e.g., valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
• Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in your blood (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Ramipril Aurovitas Spain”

Children and Adolescents

The use of ramipril in children and adolescents under 18 years of age is not recommended because the safety and efficacy of ramipril in children have not yet been established.

If any of the above conditions apply to you (or you are unsure), talk to your doctor before taking ramipril.

Other Medications and Ramipril Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is because ramipril can affect how some other medications work. Similarly, some medications can affect how ramipril works.

Inform your doctor if you have taken or are taking any of the following medications, which may make ramipril work less effectively:

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

? 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.

Inform your doctor if you are taking any of the following medications. These may increase the risk of side effects if taken with ramipril:

? Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril Aurovitas Spain”).

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

? Medications used to treat cancer (chemotherapy).

? Medications used to prevent organ rejection after a transplant, such as cyclosporine.

? Diuretics, such as furosemide.

? Medications that can increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (to make the blood more fluid).

? Steroid medications for inflammation, such as prednisolone.

? Allopurinol (used to decrease uric acid in your blood).

? Procainamide (to treat heart rhythm problems).

? Trimethoprim and cotrimoxazole (for bacterial infections).

? Temsirolimus (for cancer).

? Sirolimus, everolimus (to prevent graft rejection).

• Vildagliptin (used to treat type 2 diabetes).

? Racecadotril (used for diarrhea).

? 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 Ramipril Aurovitas Spain” and “Warnings and Precautions”).

Inform your doctor if you are taking any of the following medications. These may be affected by ramipril:

? Medications used to treat diabetes, such as oral medications to lower blood sugar and insulin. Ramipril may lower your blood sugar levels. Monitor your blood sugar levels carefully while taking ramipril.

? Lithium (to treat mental health problems). Ramipril may increase lithium levels in your blood. Your doctor will carefully monitor your lithium levels in your blood.

If any of the above conditions apply to you (or you are unsure), talk to your doctor before taking ramipril.

Taking Ramipril Aurovitas Spain with Food, Drinks, and Alcohol

• Drinking alcohol with ramipril may make you feel dizzy or drowsy. If you are concerned about how much you can drink while taking ramipril, talk to your doctor, as blood pressure medications and alcohol can have additive effects.
• Ramipril can be taken with or without food.

Pregnancy and Breastfeeding

Pregnancy

You must inform your doctor if you are pregnant (or think you may be).

You should not take ramipril during the first 12 weeks of pregnancy, and you should not take it at all after 12 weeks, as it may cause serious harm to your baby.

If you become pregnant while taking ramipril, inform your doctor immediately. A switch to an alternative treatment should be made before planning a pregnancy.

Breastfeeding

You should not take ramipril if you are breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

You may feel dizzy while taking ramipril, which is more likely to occur when starting to take ramipril or when starting to take a higher dose of ramipril. If this happens, do not drive or operate tools or machines.

Ramipril Aurovitas Spain contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Ramipril Aurovitas Spain contains Sodium

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

3. How to Take Ramipril Aurovitas Spain

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

How Much Medication to Take

Treatment of High Blood Pressure

? The usual starting dose is 1.25 mg or 2.5 mg once a day.

? Your doctor will adjust the amount you need to take to control your blood pressure.

? The maximum daily dose is 10 mg once a day.

? If you are already taking diuretics, your doctor may stop or reduce the amount of diuretic you were taking before starting treatment with ramipril.

To Reduce the Risk of Heart Attack or Stroke

? The usual starting dose is 2.5 mg once a day.

? Your doctor may decide to increase the amount you take.

? The usual dose is 10 mg once a day.

Treatment to Reduce or Delay the Worsening of Kidney Problems

? You can start with a dose of 1.25 mg or 2.5 mg once a day.

? Your doctor will adjust the amount you are taking.

? The usual dose is 5 mg or 10 mg once a day.

Treatment for Heart Failure

? The usual starting dose is 1.25 mg once a day.

? Your doctor will adjust the amount you are taking.

? The maximum daily dose is 10 mg per day. It is preferable to administer it twice a day.

Treatment after a Heart Attack

? The recommended starting dose is 1.25 mg once a day to 2.5 mg twice a day.

? Your doctor will adjust the amount you are taking.

? The usual dose is 10 mg per day. It is preferable to administer it twice a day.

Elderly Patients

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

Taking this Medication

? Take this medication orally at the same time each day.

? Swallow the tablets with liquid.

? Do not crush or chew the tablets.

? The tablet can be divided into equal doses.

If You Take More Ramipril Aurovitas Spain than You Should

Consult your doctor immediately or go to the emergency department of the nearest hospital. Do not drive to the hospital, ask someone to take you or call an ambulance. Bring the medication packaging with you. This will allow your doctor to know 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 taken.

If You Forget to Take Ramipril Aurovitas Spain

? If you forget to take a dose, take your normal dose when it is time for your next dose.

? Do not take a double dose to make up for forgotten doses.

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 ramipril and go immediately to a doctor if you notice any of the following serious adverse effects, you may need urgent medical treatment:

• Swelling of the face, lips, or throat that can make it difficult to swallow or breathe, as well as itching and hives. This can be a symptom of a severe allergic reaction to ramipril.
• Severe skin reactions including rash, ulcers in the mouth, worsening of a pre-existing skin disease, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Tell your doctor immediately if you experience:

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

Other adverse effects include:

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

Frequent(may affect up to 1 in 10 people)

• Headache or feeling tired
• Feeling dizzy. This is more likely to occur when you start taking ramipril or when you start taking a higher dose
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or feeling quickly
• Dry, irritating cough, inflammation of the nasal passages (sinusitis) or bronchitis, shortness of breath
• Stomach or abdominal pain, diarrhea, indigestion, feeling sick
• Rash on the skin, with or without raised areas
• Chest pain
• Cramps or muscle pain
• Blood tests showing higher than normal potassium levels in your blood

Uncommon(may affect up to 1 in 100 people)

• Balance problems (vertigo)
• Itching and abnormal sensations on the skin, such as numbness, tingling, pinching, burning, or chilliness on the skin (paresthesia)
• Loss or changes in taste
• Sleep problems
• Feeling sad, anxious, more nervous than usual, or restless
• Nasal congestion, difficulty breathing, or worsening of asthma
• Swelling in the abdomen called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea
• Heartburn, constipation, or dry mouth
• Urinating more than usual during the day
• Sweating more than usual
• Loss or decreased appetite (anorexia)
• Increased or irregular heartbeats
• Swelling of arms and legs. This can be a sign that your body is retaining more water than normal
• Redness
• Blurred vision
• Joint pain
• Fever
• Sexual dysfunction in men, decreased sexual desire in men or women
• Increased number of certain white blood cells (eosinophilia) found during a blood test
• Blood tests showing changes in the way your liver, pancreas, or kidneys are working

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

• Feeling insecure or confused
• Redness and swelling of the tongue
• Severe scaling or peeling of the skin, rash, swelling, itching
• Nail problems (e.g., loss or separation of a nail from its bed)
• Rash or bruising on the skin
• Redness on your skin and cold extremities
• Redness, itching, swelling, and tearing of the eyes
• Hearing disturbances and noises in the ears
• Feeling weak
• Blood tests showing a decrease in the number of red blood cells or platelets or in the amount of hemoglobin

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

• Being more sensitive to the sun than usual

Other reported adverse effects:

Tell 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 very few blood cells
• Blood tests showing lower than normal sodium levels
• Concentrated urine (dark color), feeling unwell or nauseous, muscle cramps, confusion, and convulsions, which can be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible
• Fingers on the hands and feet changing color when cold and feeling tingling or pain when warming up (Raynaud's phenomenon)
• Enlargement of the chest in men
• Slowness or difficulty reacting
• Burning sensation
• Change in the smell of things
• Hair loss

Reporting of adverse effects

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

5. Storage of Ramipril Aurovitas Spain

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Blister: store in the original packaging to protect it from moisture.

Bottles: keep the bottle perfectly closed to protect it from moisture.

Do not use this medicine after the expiration date that appears on the carton, blister, or label after CAD.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE 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 Ramipril Aurovitas Spain

• The active ingredient is ramipril. Each tablet contains 2.5 mg of ramipril.
• The other ingredients are: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized corn starch, sodium stearyl fumarate, and yellow iron oxide (E172).

Appearance of the product and package contents

Flat, elongated tablet, yellow in color, scored on one side, with the mark R2.

Package sizes:

Al/Al/Poliamida/PVC blisters: 10, 14, 20, 28, 30, 42, 50, 98, and 100 tablets.

Polypropylene bottles with LDPE cap and desiccant: 100 and 500 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Actavis Ltd.

BLB015, BLB016 Bulebel Industrial Estate

ZTN 3000 Zejtun

Malta

O

Balkanpharma – Dupnitsa AD

3 Samokovsko Schosse Str.

Dupnitsa 2600

Bulgaria

Date of the last revision of this leaflet:January 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).