Prospect: Information for the user

Ramipril Aurovitas 5 mg tablets EFG

Read this prospect carefully before starting to take this medicine, because 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 must 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 and what it is used for

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

3.How to take Ramipril Aurovitas

4.Adverse effects

5.Storage of Ramipril Aurovitas

6.Contents of the package and additional information

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

Ramipril works as follows:

•By reducing the production of certain substances by the body that could increase blood pressure.

•By relaxing and widening blood vessels.

•By making it easier for the heart to pump blood through the body.

Ramipril can 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

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

The symptoms of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

•If you have ever had a severe allergic reaction called “angioedema”. Symptoms include itching, urticaria, 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 have taken or are taking sacubitrilo/valsartán, 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 in an area such as the throat) is high.

•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 a kidney problem where the blood flow to your kidneys is reduced (renal artery stenosis).

•During the last 6 months of pregnancy (see more information in the section on “Pregnancy and breastfeeding”).

•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 that contains aliskirén.

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

-Racecadotrilo, a medicine used to treat diarrhea.

-Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).

-Vildagliptina, a medicine used to treat type 2 diabetes.

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

Warnings and precautions

Consult your doctor or pharmacist beforestarting totake Ramipril Aurovitas:

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

•If you have lost a lot of mineral salts or fluids (e.g., 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 for an operation 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 medicines or have a condition that may lower sodium levels in your blood. Your doctor may perform blood tests regularly, particularly to monitor sodium levels in the blood, especially if you are an elderly patient.

•If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is higher:

-Sirolimus, everolimus, and other medicines that belong to the class of mTOR inhibitors (used to prevent organ transplant rejection) or vildagliptina or NEP inhibitors (such as racecadotrilo) or sacubitrilo/valsartán. For sacubitrilo/valsartán, see section 2 “Do not take Ramipril Aurovitas”.

•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 severe harm to your baby from 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 “sartanes” - e.g., valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.

-Aliskirén.

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

See also the information under the heading “Do not take RamiprilAurovitas”

Children and adolescents

Ramipril is not recommended for use in children and adolescents under 18 years of age because its safety and efficacy have not yet been established in children.

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

Taking Ramipril Aurovitas with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because ramipril may affect the way some other medicines work. Similarly, some medicines may affect the way ramipril works.

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

•Pain-relieving and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina, and aspirin).

•Medicines 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 medicines. 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”).

•Pain-relieving and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina, and aspirin).

•Cancer medicines (chemotherapy).

•Medicines used to prevent organ transplant rejection, such as ciclosporina.

•Diuretics such as furosemida.

•Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimetoprim and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparina, a medicine used to thin the blood to prevent clots).

•Anti-inflammatory steroids, such as prednisolona.

•Alopurinol (used to reduce uric acid levels in the blood).

•Procainamida (for heart rhythm problems).

•Temsirolimus (for cancer).

•Medicines often used to prevent organ transplant rejection (sirolimus, everolimus, and other medicines that belong to the class of mTOR inhibitors). See section “Warnings and precautions”.

•Vildagliptina (used to treat type 2 diabetes).

•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) or aliskirén (see also the information under the headings “Do not take Ramipril Aurovitas” and “Warnings and precautions”).

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

•Diabetes medicines, such as oral glucose-lowering medicines and insulin. Ramipril may reduce your blood sugar levels. Monitor your blood sugar levels carefully while taking ramipril.

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

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

Taking Ramipril Aurovitas with food, drinks, and 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. Blood pressure medicines and alcohol can have additive effects.

•Ramipril can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Inform your doctor or pharmacist 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 inform your doctor if you are pregnant (or suspect you may be). Do not take ramipril in the first 12 weeks of pregnancy and do not take it at all after week 13 of pregnancy, as its use during pregnancy may cause harm to your baby.

If you become pregnant while taking ramipril, inform your doctor immediately. If you are planning to become pregnant, you should change to an alternative suitable treatment before becoming pregnant.

Breastfeeding

You must not take ramipril if you are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

You may feel dizzy while taking ramipril, which is more likely to occur 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 contains lactose

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

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

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

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.

Treatment to reduce or delay the worsening of kidney problems

•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 per day. It is preferable to administer it twice a day.

Treatment after having had a heart attack

•The 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 per day. It is preferable to administer it twice a day.

Older patients

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

Take this medication

•Take this medication orally at the same time every day.

•Swallow the tablets whole with liquid.

•Do not crush or chew the tablets.

If you take more Ramipril Aurovitas 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 packaging of the medication 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

•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 doubts 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 severe side effects, as you may need urgent medical treatment:

•Swelling of the face, lips, or throat that may 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, mouth ulcers, 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 may be signs of lung problems.

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

•Severe stomach pain that can radiate to your back. This may 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 may be signs 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.

•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.

•Abdominal pain or cramps, 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 100 people

•Balance problems (dizziness).

•Itching and 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 may 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

•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 have these symptoms, contact your doctor as soon as possible.

•Changes in the color of the fingers and toes when it's cold and a tingling or painful sensation when they warm up (Raynaud's phenomenon).

•Enlargement of the chest in men.

•Slowness or difficulty reacting.

•Burning sensation.

•Change in the smell of things.

•Loss of hair.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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.

Store below 25°C.

Store in the original packaging to protect it from moisture.

Keep the HDPE bottle perfectly closed to protect it from moisture.

Do not use this medication after the expiration date that appears on the box, in the blister pack, and on the bottle label after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of 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

-The active ingredient is ramipril. Each tablet contains 5 mg of ramipril.

-The other components are: pregelatinized cornstarch, lactose monohydrate, sodium hydrogen carbonate (E500), sodium croscarmellose (E468), red iron oxide (E172), sodium stearate fumarate.

Appearance of the product and contents of the package

Uncoated pinkish-colored speckled tablet, round (6.0 mm in diameter), flat, beveled, with the marks “H” and “19” on either side of the groove on one face and smooth on the other. The tablet can be divided into equal doses.

Ramipril Aurovitas tablets are available in blister packaging and in a HDPE opaque white bottle with a PP screw cap.

Package sizes:

Blister: 14, 28, 30, 56, and 98 tablets.

Bottle: 250 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: April 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).