RAMIPRIL ALTER GENERIC 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ramipril Alter Generics 1.25 mg tablets EFG

Ramipril Alter Generics 2.5 mg tablets EFG

Ramipril Alter Generics 5 mg tablets EFG

Ramipril Alter Generics 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 signs of illness are the same as yours.
• If you get 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 is Ramipril Alter Generics and what is it used for
2. What you need to know before you take Ramipril Alter Generics
3. How to take Ramipril Alter Generics
4. Possible side effects
5. Storing Ramipril Alter Generics

1. Contents of the pack and other information

1. What is Ramipril Alter Generics and what is it used for

Ramipril Alter Generics 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:

• By reducing the production of substances in your body 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 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 cannot pump enough blood to the rest of your body (heart failure).
• As a treatment after having a heart attack (myocardial infarction) complicated by heart failure.

2. What you need to know before you take Ramipril Alter Generics

Do not take Ramipril Alter Generics

• 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 your face, lips, throat or tongue.

• If you have ever had a severe allergic reaction called “angioedema”. The symptoms include itching, rash, 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.
• If you are having dialysis or any other type of blood filtration. Depending on what machine is used, ramipril may not be suitable for you.
• If you have kidney artery narrowing (stenosis of the renal artery that reduces blood flow to your kidneys).
• 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.
• If you have diabetes or kidney problems and are treated with a blood pressure-lowering medicine containing aliskiren.

Do not take ramipril if any of the above conditions 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 taking ramipril:

• If you have heart, liver or kidney problems.
• If you have lost a lot of body fluids (for example, because you have been vomiting, had diarrhea, been sweating a lot, been on a low-salt diet, been taking diuretics for a long time, or have been on 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 given for 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 (shown in blood test results).
• If you are taking medicines or have a condition that may lower your blood sodium levels. Your doctor may check your blood periodically, especially if you are elderly.
• If you are taking medicines that can increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus) or vildagliptin, neprilysin inhibitors (NEP) (e.g., racecadotril) or sacubitril/valsartán. For sacubitril/valsartán, see section 2 “Do not take Ramipril Alter Generics”.
• If you have a collagen vascular disease 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 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section “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 check 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 Alter Generics”.

Children and adolescents

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

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

Other medicines and Ramipril Alter Generics

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 have taken or 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 risk of side effects if taken with ramipril:

• Sacubitril/valsartán: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril Alter Generics”).
• 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.
• Medicines that can increase the amount of potassium in your blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (to make your blood more fluid).
• Steroid medicines for inflammation, such as prednisolone.
• Allopurinol (used to reduce uric acid in your blood).
• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent graft rejection).
• 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 Alter Generics” 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 closely while taking ramipril.
• Lithium (for mental health problems). Ramipril may increase the level of lithium in your blood. Your doctor will closely monitor your lithium levels.

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

Taking Ramipril Alter Generics with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant (or think you might be).

Do not take ramipril during the first 12 weeks of pregnancy and do not take it at all after 12 weeks, as it may cause serious harm to your baby. If you become pregnant while taking ramipril, tell your doctor immediately. You should switch to a different treatment before you become pregnant.

Breastfeeding

Do 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 of ramipril. If this happens, do not drive or use tools or machines.

Ramipril Alter Generics contains sodium

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

3. How to take Ramipril Alter Generics

Take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

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.

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 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 slowing 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 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 once a day. It is best taken 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 once a day. It is best taken twice a day.

Elderly patients

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

If you take more Ramipril Alter Generics than you should

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

You can also contact the Poisons Information Centre, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ramipril Alter Generics

• If you forget to take a dose, take your normal dose when it is next due.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Ramipril Alter Generics

Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop, your illness may get worse.

If you have any further questions on 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 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 your mouth, 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 symptoms 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 your back. This can be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea (vomiting), yellow 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 worsen or last more than a few days.

Frequent(may affect up to 1 in 10 patients)

• 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, sinus inflammation, 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 patients)

• Balance problems (vertigo).
• Itching and abnormal sensations on the skin such as numbness, tingling, pinching, burning, or chilliness on your skin (paresthesia).
• Loss or change in taste.
• Sleep problems.
• Feeling sad, anxious, more nervous than usual, or tired.
• Stuffy nose, difficulty breathing, or worsening asthma.

• A swelling in your abdomen called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea.

• Heartburn, constipation, or dry mouth.
• Urinating more often 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 your joints.
• Fever.
• Sexual dysfunction in males, decreased sexual desire in males or females.
• 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 working.

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

• 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 your 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 patients)

• Being more sensitive to the sun than usual.

Other reported adverse effects:

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

• Difficulty concentrating.
• Mouth swelling.
• Blood tests show very few blood cells.
• Blood tests show lower than normal sodium levels.
• Concentrated urine (dark color), feeling unwell or nauseous, muscle cramps, confusion, and convulsions that can be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.
• Fingers on your hands and feet change color when cold and feel tingling or pain when warming up (Raynaud's phenomenon).
• Chest enlargement in males.
• 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, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. 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 Alter Genéricos

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, 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 Alter Genéricos

The active ingredient is ramipril. Each tablet contains 1.25 mg; 2.5 mg; 5 mg, or 10 mg of ramipril.

The other ingredients are: hypromellose 6cP, microcrystalline cellulose, pregelatinized corn starch, sodium stearyl fumarate, yellow iron oxide (E172): only in 2.5 mg tablets, and red iron oxide (E172): only in 5 mg tablets.

Appearance of the product and package contents

1.25 mg tablets: biconvex, round, white to almost white tablets, with beveled edges, engraved with the mark 1.25 on one face of the tablet. Tablet diameter: 6.5 mm.

2.5 mg tablets: light yellow-brown tablets, capsule-shaped, with beveled edges and scored on both faces. On one side of the tablet, on one half of the tablet, the mark 2.5 is engraved, and on the other half of the tablet, the mark KRK. Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses.

5 mg tablets: light pink tablets with individual lighter and darker spots, capsule-shaped, with beveled edges and scored on both faces. On one side of the tablet, on one half of the tablet, the mark 5 is engraved, and on the other half of the tablet, the mark KRK. Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses.

10 mg tablets: capsule-shaped tablets, white to almost white, with beveled edges and scored on both faces. On one side of the tablet, on one half of the tablet, the mark 10 is engraved, and on the other half of the tablet, the mark KRK. Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses.

Ramipril Alter Genéricos are presented in packs of 14, 28, 30, 56, or 90 tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

The manufacturer is:

Krka d.d. Novo Mesto

Šmarješka Cesta 6

Novo Mesto, Jugovzhodna Slovenija, 8501

Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal: Ramipril Ripzen

France: Ramipril Alter

Italy: Ramipril Alter

Spain: Ramipril Alter Genéricos EFG

Date of the last revision of this leaflet:April 2024

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