RAMIPRIL AUROVITAS 5 mg TABLETS

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, urticaria, 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 that contains aliskiren.
• If you are taking any of the following medicines, the risk of angioedema may increase:

• 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 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 before; talk to your doctor.
• If you have high levels of potassium in your blood (as shown by blood test results).
• If you are taking medicines or have a condition that may lower your blood sodium levels. Your doctor may perform regular blood tests, especially to check your sodium levels in the blood, particularly 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 rejection) or vildagliptin or neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Ramipril Aurovitas”.

• An angiotensin II receptor antagonist (ARA) (also known as a “sartan” - 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 should not be used in children and adolescents under 18 years of age because the safety and efficacy of its use 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 can affect the way some other medicines work. Also, some medicines can 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 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.

Tell your doctor if you are taking any of the following medicines. These may increase the chance 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”).
• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, 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 immunosuppressant 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 reduce 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 glucose-lowering medicines 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 carefully.

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, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 its use during pregnancy 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 an alternative treatment before you become pregnant.

Breastfeeding

You should not take ramipril if you are breastfeeding.

Consult your doctor or pharmacist 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, consult 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

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, talk to 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 or preventing 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.

Treating 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 a day. It is best to take it twice a day.

Treatment 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 are taking.
• The usual dose is 10 mg a 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

Consult your 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 immediately 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 your next dose is due.
• 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 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 rash. 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).

Inform 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.
• Appearance of bruises more easily, 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 of tiredness, dizziness, or paleness of the skin. These can be symptoms of problems in the blood or bone marrow.
• Severe stomach pain that can reach your 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:

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

Frequent:can affect up to 1 in 10 people

• Headache or feeling of tiredness.
• Feeling 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 feeling quickly.
• Dry, irritating cough, inflammation of the nasal sinuses (sinusitis), or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling of being 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:can 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 the taste of things.
• Sleep problems.
• Feeling of sadness, anxiety, more nervous than usual, or restlessness.
• 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 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 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 show changes in the way your liver, pancreas, or kidneys are working.

Rare:can affect up to 1 in 1,000 people

• Feeling of insecurity or confusion.
• Redness and swelling of the tongue.
• Severe peeling or shedding 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 of weakness.
• Blood tests show a decrease in the number of red blood cells or platelets or in the amount of hemoglobin.

Very Rare:can affect up to 1 in 10,000 people

• Being more sensitive to the sun than usual.

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 few blood cells.
• Blood tests show lower than normal sodium levels.
• Concentrated urine (dark color), feeling of discomfort or nausea, muscle cramps, confusion, and convulsions, which can be due to inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible.
• Fingers and toes change color when cold and feel 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 or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. 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

Keep this medicine out of sight and reach of children.

Store below 25°C.

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

Medicines should not be thrown away 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

• 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 stearyl fumarate.

Appearance of the product and package contents

Uncoated tablet, pale pink speckled, round (6.0 mm in diameter), flat, beveled, with the marks "H" and "19" 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 in white opaque HDPE bottles with a screw 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 prospectus: 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/).