Ramipril Aurovitas 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ramipril Aurovitas 5 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, 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 others, 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.

Contents of the leaflet

1. What Ramipril Aurovitas is and what it is used for
2. What you need to know before taking Ramipril Aurovitas
3. How to take Ramipril Aurovitas
4. Possible adverse effects
5. How to store 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 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 around your body.

Ramipril can 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 your heart when it cannot pump enough blood to the rest of your body (heart failure).
• As treatment after a heart attack (myocardial infarction) complicated by heart failure.

2. What you need to know before taking Ramipril Aurovitas

Do not take Ramipril Aurovitas

• If you are allergic to ramipril, to any other ACE inhibitor medicine, 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 the 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 long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, for example in 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 causing reduced blood flow to your kidneys (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 failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

• Racecadotril, a medicine used to treat diarrhoea.

• Medicines used to prevent organ transplant rejection and for 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 unsure, speak with your doctor before taking ramipril.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril Aurovitas:

• If you have heart, liver, or kidney problems.
• If you have lost large amounts of salts or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics, or dialysis).
• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitisation).
• If you are due to receive an anaesthetic. This may be for surgery or dental work. 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 carry out regular blood tests, particularly to monitor blood sodium levels, especially if you are elderly.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling beneath the skin, for example in the throat) is higher:
  • Sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs), 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 vascular collagen 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 from the third month of pregnancy onwards; see the “Pregnancy and breastfeeding” section.
• 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” – for example, 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”.

Children and adolescents

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

If any of the above apply to you (or you are unsure), speak with 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 need to take any other medicines. This is because ramipril may affect how some other medicines work. Likewise, some medicines may affect how ramipril works.

Tell your doctor if you are 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 monitor your blood pressure.

Tell 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”).
• 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 (chemotherapy).
• Medicines to prevent organ rejection after transplantation, such as cyclosporine.
• 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; cyclosporine, an immunosuppressant used to prevent transplant 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 levels in the blood).
• Procainamide (to treat heart rhythm problems).
• Temsirolimus (for cancer).
• Medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used for diarrhoea).
• 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” and “Warnings and precautions”).

Tell 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 (used to treat mental health conditions). Ramipril may increase the amount of lithium in your blood. Your doctor will monitor your blood lithium levels closely.

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

Taking Ramipril Aurovitas with food, drinks, and alcohol

• Drinking alcohol while taking ramipril may make you feel dizzy or lightheaded. If you are concerned about how much alcohol you can drink while taking ramipril, speak with your doctor. Medicines used to lower blood pressure and alcohol may have additive effects.
• Ramipril may 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, consult your doctor or pharmacist before using this medicine.

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 of pregnancy onwards, as its use during pregnancy could harm the unborn baby.

If you become pregnant while taking ramipril, inform your doctor immediately. If you are planning a pregnancy, you should switch to an appropriate alternative treatment beforehand.

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, particularly when you first start taking it or when you start 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 an intolerance to certain sugars, consult with 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 by your doctor or pharmacist 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 as needed to control your blood pressure.
• 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 diuretic before starting ramipril treatment.

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 your dose as needed.
• 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 your dose as needed.
• The maximum daily dose is 10 mg per day. It is preferable to administer it twice daily.

Treatment after a heart attack

• The usual starting dose is 1.25 mg once daily up to 2.5 mg twice daily.
• Your doctor will adjust your dose as needed.
• The usual dose is 10 mg per day. 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 whole with liquid.
• Do not crush or chew the tablets.

If you take more Ramipril Aurovitas 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

• 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 will experience them.

Stop taking ramipril and go immediately to a doctor if you notice any of the following serious adverse effects, as you may require urgent medical treatment:

• Swelling of the face, lips, or throat that may make swallowing or breathing difficult, together with itching or 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 condition, redness, blisters, or skin peeling (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, tightness in the chest, or more serious problems including heart attack and stroke.
• Difficulty breathing or cough. These may be signs of lung problems.
• Easy bruising, bleeding that lasts longer than normal, any sign of bleeding (for example, from the gums), purple spots on the skin, or 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 (liver inflammation) or liver damage.

Other adverse effects include:

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

Common: 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.
• Irritating 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 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.
• Difficulty sleeping.
• 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 heartbeat.
• 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.
• Increase in certain white blood cells (eosinophilia) found during a blood test.
• 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, lumps, 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 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 the amount of hemoglobin.

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 longer 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 nausea, muscle cramps, confusion, and seizures, which may be due to inappropriate antidiuretic hormone (ADH) secretion. If you have these symptoms, contact your doctor as soon as possible.
• Fingers of hands and feet change color when cold, and you feel tingling or pain when they warm up (Raynaud's phenomenon).
• Enlargement of the breast in men.
• Slowness or difficulty reacting.
• Burning sensation.
• Change in the smell of things.
• Hair loss.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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

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

Store below 25°C.

Keep in the original packaging to protect from moisture.

Keep the HDPE bottle tightly closed to protect from moisture.

Do not use this medicine after the expiry date stated on the carton, the blister, and the label of the bottle after EXP. The expiry date is 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 point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Ramipril Aurovitas

• The active substance is ramipril. Each tablet contains 5 mg of ramipril.
• The other components are: pregelatinized maize starch, lactose monohydrate, sodium hydrogen carbonate (E500), sodium croscarmellose (E468), red iron oxide (E172), sodium stearyl fumarate.

Appearance of the product and contents of the container

Uncoated, light pink mottled, round (6.0 mm diameter), flat, bevelled tablet, with the markings “H” and “19” on either side of the score on one side 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 polypropylene screw cap.

Pack sizes:

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

Bottle: 250 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

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Date of the last revision of this leaflet: April 2023

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