RAMIPRIL AUROVITAS 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ramipril Aurovitas 10 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Ramipril works in the following way:

• Reducing the production of substances in your body that could increase your blood pressure.
• Relaxing and widening your blood vessels.
• Making it easier for your heart to pump blood around your body.

Ramipril can be used:

• To treat high blood pressure (hypertension).
• To reduce the risk of you having a heart attack or stroke.
• To reduce the risk or delay the worsening of kidney problems (whether you have diabetes or not).
• To treat your heart when it is not pumping enough blood to the rest of your body (heart failure).
• As a treatment after a heart attack (myocardial infarction) complicated by heart failure.

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

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 can include rash, difficulty swallowing or breathing, swelling of the face, lips, throat or tongue.

• If you have ever had a severe allergic reaction called “angioedema”. The symptoms include intense 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 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 areas such as the throat) is high.
• If you are having 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 supply to your kidneys is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see the section on “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 impairment and are being treated with a blood pressure lowering medicine containing aliskiren.
• If you are taking any of the following medicines, the risk of angioedema may be increased:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

Do not take ramipril if any of the above apply to you. If you are not sure, talk to your doctor before taking ramipril.

Warnings and precautions

Talk to your doctor or pharmacist before starting Ramipril Aurovitas:

• If you have heart, liver, or kidney problems.
• If you have lost a lot of body salts or fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, long-term diuretic use, or dialysis).
• If you are going to have treatment to desensitize you to bee or wasp stings.
• If you are going to receive an anesthetic. This may be due to an operation or any dental work. You may need to stop taking ramipril a day before; talk to your doctor.
• If you have high levels of potassium in your blood (as shown by blood tests).
• If you are taking medicines or have a condition that may lower your blood sodium levels. Your doctor may perform regular blood tests to monitor your sodium levels, especially if you are elderly.
• 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 rejection) or vildagliptin or neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Ramipril Aurovitas”.

• If you have a disease of the blood vessels in the skin, such as scleroderma or systemic lupus erythematosus.
• Tell your doctor if you are pregnant (or think 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 the section on “Pregnancy and breastfeeding”.
• If you are taking any of the following medicines used to treat high blood pressure:
• An angiotensin II receptor antagonist (ARA) (also known as “sartans” - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• Aliskiren.

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

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

Children and adolescents

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

If any of the above apply to you (or you are not sure), talk to your doctor before taking ramipril.

Taking Ramipril Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because ramipril may affect the way other medicines work. Also, some medicines may affect the way ramipril works.

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

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

Tell your doctor if you are taking any of the following medicines. These may increase the chance of side effects when 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”).
• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacin, and aspirin).
• Cancer medicines (chemotherapy).
• Medicines to prevent organ rejection after a transplant, such as cyclosporin.
• Diuretics, such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots). • Steroid medicines for inflammation, such as prednisolone.
• Allopurinol (used to lower uric acid in the blood).
• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer).
• Medicines used to prevent organ rejection after a transplant (sirolimus, everolimus, and other medicines that belong to the class of mTOR inhibitors). See the section “Warnings and precautions”.
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used for diarrhea).
• Your doctor may need to change 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” and “Warnings and precautions”).

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

• Medicines to treat diabetes, such as oral medicines to lower blood sugar and insulin. Ramipril may lower your blood sugar levels. Monitor your blood sugar levels carefully while taking ramipril.
• Lithium (for mental health problems). Ramipril may increase the levels of lithium in your blood. Your doctor will monitor your lithium levels closely.

If any of the above apply to you (or you are not sure), talk to your doctor before taking ramipril.

Taking Ramipril Aurovitas with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should tell your doctor if you are pregnant (or think you might be). You should not take ramipril during the first 12 weeks of pregnancy and must not take it after the 13th week of pregnancy, as it may cause harm to your baby.

If you become pregnant while taking ramipril, tell your doctor immediately. If you are planning to become pregnant, you should switch to a different treatment before you become pregnant.

Breastfeeding

You should not take ramipril if you are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Ramipril Aurovitas contains lactose

This medicine contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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

3. How to take Ramipril Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much to take

Treating 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 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 ramipril.

Reducing 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.

Treating 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 take.
• The usual dose is 5 mg or 10 mg once a day.

Treating heart failure

• The usual starting dose is 1.25 mg once a day.
• Your doctor will adjust the amount you take.
• The maximum daily dose is 10 mg per day. It is best to take it twice a day.

Treating after 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 take.
• The usual dose is 10 mg per day. It is best to take it twice a day.

Elderly patients

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

Taking this medicine

• Take this medicine by mouth at the same time each day.
• Swallow the tablets whole with liquid.
• Do not crush or chew the tablets.

If you take more Ramipril Aurovitas than you should

See a doctor immediately or go to the nearest hospital casualty department. Do not drive to the hospital, ask someone to drive you or call an ambulance. Take the medicine pack with you. This will help your doctor know what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Ramipril Aurovitas

• 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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people will experience them.

Stop taking ramipril and go to a doctor immediately if you notice any of the following serious adverse effects, as 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 rash. This can be a symptom of a severe allergic reaction to ramipril.
• Severe skin reactions, including rash, mouth ulcers, worsening of a pre-existing skin disease, redness, blisters, or skin peeling (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, tiredness, 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, low blood pressure (abnormally low blood pressure), especially when standing up or feeling quickly.
• Dry, irritating cough, nasal sinus inflammation (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," which 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 impotence in men, decreased sexual desire in men or women.
• Increased number of certain white blood cells in the blood (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 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 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 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-colored), feeling unwell or nauseous, muscle cramps, confusion, and convulsions, which can be due to inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, see your doctor as soon as possible.
• Fingers and toes changing color when cold and feeling tingling or pain when warming up (Raynaud's phenomenon).
• Chest enlargement in men.
• Slowness or difficulty reacting.
• Burning sensation.
• Change in the smell of things.
• Hair loss.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: 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

Keep this medicine 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 medicine after the expiration date shown on the box, blister pack, and bottle label after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your 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

• The active ingredient is ramipril. Each tablet contains 10 mg of ramipril.
• The other ingredients are: pregelatinized cornstarch, lactose monohydrate, sodium hydrogen carbonate (E500), sodium croscarmellose (E468), sodium stearyl fumarate.

Appearance of the product and package contents

Uncoated white to off-white tablets (8.0 mm in diameter), round, flat, beveled, with the marks "H" and "20" on either side of the score line on one face and smooth on the other. The tablet can be divided into equal doses.

Ramipril Aurovitas tablets are available in blister packs and HDPE bottles with a white opaque cap.

Package sizes:

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

Bottle: 250 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

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 under the following names:

Date of the last revision of this leaflet: April 2023

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/).