Prospect: information for the patient

Ramipril Aurovitas Spain 2.5 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Ramipril Aurovitas Spain

4.Possible adverse effects

5.Storage of Ramipril Aurovitas Spain

6.Contents of the package and additional information

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

Ramipril works in the following way:

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

?By relaxing and widening blood vessels.

?By making it easier for the heart to pump blood around the body.

Ramipril may be used:

?To treat high blood pressure (hypertension).

?To reduce the risk of suffering a heart attack or stroke.

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

?To treat the heart when it cannot pump enough blood to the rest of the body (heart failure).

?As treatment after a heart attack (myocardial infarction) complicated with heart failure.

Do not take Ramipril Aurovitas Spain

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

The symptoms of an allergic reaction may include skin 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 your hands, feet, and throat, swelling of your throat and tongue, swelling around your eyes and lips, difficulty breathing and swallowing.

?If you have taken or are taking sacubitrilo/valsartán, 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 your 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.

?Ifyou have diabetes or kidney failure and are being treated with a medication to lower your blood pressure that contains aliskirén.

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

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 mineral salts or fluids (due to vomiting, diarrhea, excessive sweating, being on a low-salt diet, taking diuretics for a long time, or being on dialysis).

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

?If you are about to receive an anesthetic. This may be due to surgery or any dental work. You may need to stop your treatment a day before; 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 may lower sodium levels in your blood. Your doctor may perform blood tests periodically, particularly to monitor sodium levels in your blood, especially if you are an elderly patient.

?If you are taking medications that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (such as temsirolimus, everolimus, sirolimus), vildagliptin, NEP inhibitors (such as racecadotrilo), or sacubitrilo/valsartán. For sacubitrilo/valsartán, see section 2 “Do not take Ramipril Aurovitas Spain”.

?If you have a vascular collagen disease, such as scleroderma or systemic lupus erythematosus.

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

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

-An angiotensin II receptor antagonist (ARA) (also known as “sartanes” - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.

-Aliskirén.

Your doctor may need to monitor your renal function, blood pressure, and electrolyte levels in your blood (such as potassium) at regular intervals.

See also the information under the heading “Do not take RamiprilAurovitas 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 medicationsandRamipril Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because ramipril may affect the way some other medications work. Similarly, some medications may affect the way 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. nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina, and aspirin).

?Medications used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as efedrina, noradrenalina, or adrenalina. 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:

?Sacubitrilo/valsartán: 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. nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina, and aspirin).

?Chemotherapy medications.

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

?Diuretics such as furosemida.

?Medications that may increase potassium levels in your blood, such as espironolactona, triamtereno, amilorida, potassium salts, trimetoprim alone or in combination with sulfametoxazol (for infections), and heparina (to make your blood more liquid).

?Glucocorticoids for inflammation, such as prednisolona.

?Alopurinol (used to reduce uric acid in your blood).

?Procainamida (to treat heart rhythm problems).

?Trimetoprim and cotrimoxazol (for infections caused by bacteria).

?Temsirolimus (for cancer).

?Sirolimus, everolimus (to prevent graft rejection).

?Racecadotrilo (used to treat diarrhea).

?Your doctor may need to adjust your dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (ARA) oraliskirén(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 glucose 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 your lithium levels in your blood. Your doctor will monitor your lithium levels in your blood carefully.

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, drinksand alcohol

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or suspect you may be).

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

If you become pregnant while taking ramipril, inform your doctor immediately. A change to an alternative suitable 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 operating machinery

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

Ramipril Aurovitas Spain contains lactose

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

Ramipril Aurovitas Spain contains sodium

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

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

How much medication to take

Hypertension treatment

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

?Your doctor will adjust the amount you should 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 previously before starting treatment with ramipril.

To reduce the risk of suffering a 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.

Renal disease treatment to reduce or delay worsening

?You may 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.

Heart failure treatment

?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 daily. It is preferable to administer it twice a day.

Treatment after a heart attack

?The recommended usual 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 daily. It is preferable to administer it twice a day.

Older 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 every 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 nearest hospital emergency room. Do not drive to the hospital, ask someone to take you or call an ambulance. Bring the medication packaging with you. This way your doctor will know 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 taken.

If you forgot to take Ramipril Aurovitas Spain

?If you forgot to take a dose, take your usual dose when it's time for the next one.

?Do not take a double dose to compensate for the missed doses.

If you have any other questions 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 ramipril and seek immediate medical attention if you notice any of the following serious side 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 sign of a severe allergic reaction to ramipril.

•Severe skin reactions, including rashes, ulcers in the mouth, worsening of an existing skin condition, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Inform your doctor immediately if you experience:

•Fast or irregular heartbeat, 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.

•Appearance of bruises with ease, bleeding for longer than normal, any sign of bleeding (e.g., from the gums), purple patches on the skin, or catching infections more easily than normal, sore throat, and fever, feeling tired, dizziness, or paleness of the skin. These can be symptoms of blood or bone marrow problems.

•Severe stomach pain that can radiate to your back. This can be a sign of pancreatitis (inflammation of the pancreas).

•Fever, chills, fatigue, loss of appetite, stomach pain, nausea (urge to vomit), 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 side effects include:

Inform 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

•Sensation of dizziness. 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 sitting up quickly

•Dry, irritating cough, nasal congestion (sinusitis), or bronchitis, shortness of breath

•Stomach or abdominal pain, diarrhea, indigestion, feeling sick

•Hives on the skin, with or without raised areas

•Chest pain

•Muscle cramps or pain

•Blood tests showing higher-than-normal potassium levels in your blood

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

•Balance problems (dizziness)

•Abnormal sensations in the skin, such as numbness, tingling, pinching, burning, or chills (paresthesia)

•Loss or change in the taste of things

•Difficulty sleeping

•Feeling sad, anxious, more nervous than normal, or restless

•Congestion, difficulty breathing, or worsening of asthma

•Abdominal swelling known as "intestinal angioedema" that presents 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 can be a sign that your body is retaining more water than normal

•Redness

•Blurred vision

•Pain in the joints

•Fever

•Sexual dysfunction in men, decreased libido in men or women

•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

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

•Increased sensitivity to the sun

Other side effects reported:

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 few blood cells

•Blood tests show less sodium than normal

•Dark-colored urine, feeling unwell or nauseous, muscle cramps, confusion, and convulsions, which may be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible

•Fingers and toes change color when it's cold and feel numb or painful when warmed (Raynaud's phenomenon)

•Enlargement of the chest in men

•Slowness or difficulty reacting

•Sensation of burning

•Change in the smell of things

•Loss of hair

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's a possible side effect that doesn't appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side 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 store at a temperature 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 medication 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.

Medications should not be disposed of through drains or trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ramipril Aurovitas Spain

-The active ingredient is ramipril. Each tablet contains 2.5 mg of ramipril.

-The other components are: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized cornstarch, sodium stearate fumarate, and yellow iron oxide (E172).

Appearance of the product and content of the container

Extended, flat, yellow-colored tablet, scored on one face, with the mark R2.

Container sizes:

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

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

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

Actavis Ltd.

BLB015, BLB016 Bulebel Industrial Estate

ZTN 3000 Zejtun

Malta

Or

Balkanpharma – Dupnitsa AD

3 Samokovsko Schosse Str.

Dupnitsa 2600

Bulgaria

Last review date of this leaflet:January 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).