Ramipril Aurovitas Spain 2.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ramipril Aurovitas Spain 2.5 mg tablets EFG

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, 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.

Leaflet contents

1. What Ramipril Aurovitas Spain is and what it is used for
2. What you need to know before taking Ramipril Aurovitas Spain
3. How to take Ramipril Aurovitas Spain
4. Possible side effects
5. How to store Ramipril Aurovitas Spain
6. Contents of the pack and other information

1. What Ramipril Aurovitas Spain is and what it is used for

Ramipril Aurovitas Spain contains a medicine called ramipril. This belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors).

Ramipril works in the following ways:

• By reducing the body's production of substances that could increase your blood pressure.

• By relaxing and widening your blood vessels.

• By making it easier for your heart to pump blood throughout your body.

Ramipril may be used:

• To treat high blood pressure (hypertension).

• To reduce the risk of heart attack or stroke.

• To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes).

• To treat heart failure, when your heart cannot pump enough blood to the rest of your body.

• As treatment following a heart attack (myocardial infarction) complicated by heart failure.

2. What you need to know before starting to take Ramipril Aurovitas Spain

Do not take Ramipril Aurovitas Spain

• If you are allergic to ramipril, to any other ACE inhibitor, or to any of the other ingredients 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 ever had a serious allergic reaction called “angioedema.” 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 currently taking sacubitril/valsartan, a medicine used to treat a type of 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 due to reduced blood flow to the kidneys (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 medicine containing aliskiren.

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

Warnings and precautions

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

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

• If you have lost large amounts of salts or fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, prolonged use of diuretics, or dialysis).

• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitization).

• If you are going to receive an anesthetic. This may be due to surgery or dental procedures. You may need to stop taking ramipril one day before; consult your doctor.

• If you have high levels of potassium in your blood (shown in blood test results).

• If you are taking medicines or have a disease that may reduce sodium levels in your blood. Your doctor may perform periodic blood tests, particularly to monitor blood sodium levels, especially if you are elderly.

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

• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus.

• Inform your doctor if you are pregnant (or suspect you might be). Ramipril is not recommended during the first three months of pregnancy and may cause serious harm to your baby after the third month of pregnancy (see section “Pregnancy and breastfeeding”).

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

• an angiotensin II receptor antagonist (ARA) (also known as “sartans” – e.g., 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 (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), speak with your doctor before taking ramipril.

Other medicines and Ramipril Aurovitas Spain

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

Inform your doctor if you have taken or are currently taking any of the following medicines, which may make ramipril less effective:

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

• Medicines 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 medicines. These may increase the likelihood of side effects when taken with ramipril:

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

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

• Medicines for cancer treatment (chemotherapy).

• Medicines to prevent organ rejection after transplantation, such as cyclosporine.

• Diuretics such as furosemide.

• Medicines that may increase blood potassium levels, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (to thin the blood).

• Steroid medicines for inflammation, such as prednisolone.

• Allopurinol (used to lower uric acid levels in your blood).

• Procainamide (to treat heart rhythm problems).

• Trimethoprim and cotrimoxazole (for bacterial infections).

• Temsirolimus (for cancer).

• Sirolimus, everolimus (to prevent graft rejection).

• Vildagliptina (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 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 medicines. These may be affected by ramipril:

• Medicines for diabetes, such as oral glucose-lowering medicines and insulin. Ramipril may lower your blood sugar level. Monitor your blood sugar level carefully while taking ramipril.

• Lithium (for mental health conditions). Ramipril may increase the level of lithium in your blood. Your doctor will closely monitor your blood lithium levels.

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

Taking Ramipril Aurovitas Spain with food, drinks, and alcohol

• Drinking alcohol with ramipril may make you feel dizzy or lightheaded. If you are concerned about how much alcohol you can drink while taking ramipril, talk to your doctor, as blood pressure-lowering medicines and alcohol may 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 suspect you might be).

You should not take ramipril during the first 12 weeks of pregnancy, and must not take it at all from week 13 onwards, as its use during pregnancy may cause harm to your baby.

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

Breastfeeding

You should not take ramipril while breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

You may feel dizzy while taking ramipril, which is more likely when you first start taking ramipril or when you start taking a higher dose. If this happens, do not drive or operate tools or machinery.

Ramipril Aurovitas Spain contains lactose

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

Ramipril Aurovitas Spain contains sodium

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

3. How to take Ramipril Aurovitas Spain

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

How much medicine to take

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.

• Your doctor will adjust the dose you need until your blood pressure is controlled.

• The maximum daily dose is 10 mg once daily.

• If you are already taking diuretics, your doctor may stop or reduce the dose of your previous diuretic before starting treatment with ramipril.

To reduce the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once daily.

• Your doctor may decide to increase your dose.

• The usual dose is 10 mg once daily.

Treatment to reduce or delay worsening of kidney problems

• You may start with a dose of 1.25 mg or 2.5 mg once daily.

• Your doctor will adjust the dose you are taking.

• The usual dose is 5 mg or 10 mg once daily.

Treatment for heart failure

• The usual starting dose is 1.25 mg once daily.

• Your doctor will adjust the dose you are taking.

• The maximum daily dose is 10 mg daily. It is preferable to administer it twice daily.

Treatment after having had a heart attack

• The recommended usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.

• Your doctor will adjust the dose you are taking.

• The usual dose is 10 mg daily. It is preferable to administer it twice daily.

Elderly patients

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

How to take this medicine

• Take this medicine orally at the same time each day.

• Swallow the tablets with liquid.

• Do not crush or chew the tablets.

• The tablet may be divided into equal doses.

If you take more Ramipril Aurovitas Spain than you should

Contact your doctor immediately or go to the nearest hospital emergency department. Do not drive to the hospital; ask someone to take you or call an ambulance. Take the medicine packaging with you so your 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 telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ramipril Aurovitas Spain

• If you forget to take a dose, take your next dose at the usual time.

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

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 experiences 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, which may make swallowing or breathing difficult, together with itching and rash. These may be symptoms of a severe allergic reaction to ramipril.
• Severe skin reactions including rash, mouth ulcers, 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).

Contact your doctor immediately if you experience:

• Faster heartbeat, irregular or strong heartbeats (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke.
• Difficulty breathing or cough. These may be signs of lung problems.
• Easy bruising, bleeding longer than normal, any sign of bleeding (e.g., from gums), purple spots on the skin, increased susceptibility to infections, sore throat and fever, feeling tired, dizzy, or pale skin. These may be symptoms of blood or bone marrow problems.
• Severe stomach pain that may radiate to your back. This may be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea (feeling like vomiting), yellowing of the skin or eyes (jaundice). These may 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.

Common (may affect up to 1 in 10 people)

• Headache or feeling tired
• Dizziness. This is more likely when you first start taking ramipril or when you start taking a higher dose
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly
• Irritative dry cough, nasal sinus inflammation (sinusitis), or bronchitis, shortness of breath
• Stomach or abdominal pain, diarrhea, indigestion, feeling unwell
• Skin rash, with or without raised areas
• Chest pain
• Muscle 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 (dizziness)
• Itching and abnormal skin sensations such as numbness, tingling, pricking, burning, or chills 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
• Abdominal swelling known as “intestinal angioedema,” with symptoms such as abdominal pain, vomiting, and diarrhea
• Heartburn, constipation, or dry mouth
• Urinating more than normal during the day
• Sweating more than normal
• Loss or decrease in appetite (anorexia)
• Increased or irregular heartbeats
• Swelling of arms and legs. This may be a sign that your body is retaining more fluid 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 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 unsteady or confused
• Redness and swelling of the tongue
• Severe skin peeling or shedding, rash, swelling, itching
• Nail problems (e.g., loss or separation of a nail from its bed)
• Rash or bruising on the skin
• Redness of the skin and cold extremities
• Redness, itching, swelling, and watering of the eyes
• Hearing disturbances and ringing in the ears
• Feeling weak
• Blood tests show a decrease in the number of red blood cells or platelets, or in hemoglobin levels

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

• Increased sensitivity to sunlight

Other reported adverse 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 show very low numbers of blood cells
• Blood tests show lower than normal sodium levels
• Concentrated urine (dark-colored), feeling unwell or nauseous, 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
• Fingers of hands and feet change color in cold conditions, with tingling or pain upon warming (Raynaud's phenomenon)
• Enlargement of the breasts in men
• Slowness or difficulty reacting
• Burning sensation
• Change in the smell of things
• Hair loss

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Ramipril Aurovitas Spain

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

Do not store above 30°C.

Blister packs: keep in the original packaging to protect from moisture.

Bottles: keep the bottle tightly closed to protect from moisture.

Do not use this medicine after the expiry date stated on the carton, blister pack, or label after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Ramipril Aurovitas Spain

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

Appearance of the product and contents of the container

Yellow, elongated, flat tablet, scored on one side, with the mark R2.

Pack sizes:

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

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

Only some pack 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

Or

Balkanpharma – Dupnitsa AD

3 Samokovsko Schosse Str.

Dupnitsa 2600

Bulgaria

Date of the most recent revision of this leaflet: January 2024

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