Ramipril Alter Genericos 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ramipril Alter Genéricos 1.25 mg tablets EFG

Ramipril Alter Genéricos 2.5 mg tablets EFG

Ramipril Alter Genéricos 5 mg tablets EFG

Ramipril Alter Genéricos 10 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Ramipril Alter Genéricos

3. How to take Ramipril Alter Genéricos

4. Possible side effects

5. How to store Ramipril Alter Genéricos

6. Contents of the pack and other information

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

Ramipril Alter Genéricos 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 decreasing 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 throughout your body.

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

2. What you need to know before taking Ramipril Alter Genéricos

Do not take Ramipril Alter Genéricos

• 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 your 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, and 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.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the type of machine used, ramipril may not be suitable for you.
• If you have renal artery stenosis (narrowing 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 failure and are being 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 unsure, speak with your doctor before taking ramipril.

Warnings and precautions

Consult your doctor or pharmacist before taking ramipril:

• If you have problems with your heart, liver, or kidneys.

• If you have lost significant amounts of mineral salts or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, long-term diuretic use, or dialysis).

• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitization).

• If you are to receive an anesthetic. This may be given for surgery or any dental procedure. You may need to stop your treatment one day before; consult your doctor.

• If you have high levels of potassium in your blood (shown by blood test results).

• If you are taking medications or have a medical condition that may reduce sodium levels in your blood. Your doctor may perform periodic blood tests, particularly to monitor blood sodium levels, especially if you are elderly.

• If you are taking medications that may increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Ramipril Alter Genéricos”.

• 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 pregnant). 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 (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., 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 Alter Genéricos”.

Children and adolescents

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

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

Other Medicines and Ramipril Alter Genéricos

Inform 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 other medicines work. Likewise, some medicines may affect how ramipril works.

Inform your doctor if you have taken or are currently 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.

Inform your doctor if you are taking any of the following medicines. These may increase the likelihood of side effects when taken together with ramipril:

• Sacubitril/valsartan: used to treat a certain type of chronic heart failure in adults (see section 2 “Do not take Ramipril Alter Genéricos”).
• 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 treatment (chemotherapy).
• Medicines to prevent organ rejection after transplantation, such as cyclosporine.
• Diuretics such as furosemide.
• Medicines that may increase blood potassium levels, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (to thin the blood).
• 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).
• Sirolimus, everolimus (to prevent graft rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used for 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 aliskiren (see also information under the headings “Do not take Ramipril Alter Genéricos” and “Warnings and precautions”).

Inform 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 reduce your blood sugar levels. Monitor your blood sugar levels closely while taking ramipril.
• Lithium (used to treat mental health conditions). Ramipril may increase lithium levels in your blood. Your doctor will closely monitor your blood lithium levels.

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

Taking Ramipril Alter Genéricos 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 consume while taking ramipril, speak with your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.
• Ramipril may be taken with or without food.

Pregnancy and Breast-feeding

Pregnancy

You must inform your doctor if you are pregnant (or suspect you might be).

You must not take ramipril during the first 12 weeks of pregnancy, and you must not take it at all from week 13 onwards, as its use during pregnancy may cause harm to your baby. If you become pregnant while taking ramipril, inform your doctor immediately. A switch to an appropriate alternative treatment should occur before planning a pregnancy.

Breast-feeding

You must not take ramipril if you are breast-feeding.

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 starting ramipril treatment or when beginning to take a higher dose of ramipril. If this occurs, do not drive or operate tools or machinery.

Ramipril Alter Genéricos contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., essentially "sodium-free".

3. How to take Ramipril Alter Genéricos

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

Taking 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.

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 previous diuretic before starting treatment with ramipril.

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.
• The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

• The usual starting dose is 1.25 mg once daily.
• Your doctor will adjust your dose.
• The maximum daily dose is 10 mg once daily. It is preferable to take it twice daily.

Treatment after having had 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.
• The usual dose is 10 mg once daily. It is preferable to take it twice daily.

Elderly patients

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

If you take more Ramipril Alter Genéricos 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 can see what you have taken.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ramipril Alter Genéricos

• If you forget to take a dose, take your next scheduled dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Ramipril Alter Genéricos

Continue taking this medicine until your doctor tells you to stop. Do not stop taking this medicine just because you feel better. If you do, your condition may return.

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 experiences them.

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

• Swelling of the face, lips, or throat, which 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 disease, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

• Faster heartbeat, irregular or forceful heartbeats (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke.
• Difficulty breathing or cough. These may be symptoms of lung problems.
• Easy bruising, bleeding longer than normal, any sign of bleeding (e.g., from 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 worsen or last longer than a few days.

Common (may affect up to 1 in 10 patients)

• Headache or feeling tired.
• Dizziness. This is more likely when you first start taking ramipril or when you start taking a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly.
• Dry, irritating cough, 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 muscle pain.
• Blood tests showing higher than normal potassium levels in your blood.

Uncommon (may affect up to 1 in 100 patients)

• 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.

• Sleep problems.

• Feeling sad, anxious, more nervous than usual, or tired.

• Stuffy nose, difficulty breathing, or worsening of asthma.

• Swelling in the abdomen 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.

• 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.

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

• Feeling uneasy or confused.
• Redness and swelling of the tongue.
• Severe skin peeling, rash, lumps, itching.
• Nail problems (e.g., loss or separation of a nail from its bed).
• Rash or bruising on the skin.
• Redness of the 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 hemoglobin levels.

Very rare (may affect up to 1 in 10,000 patients)

• Increased sensitivity to sunlight.

Other reported adverse effects:

Inform your doctor if any of the following conditions 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 ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
• Fingers and toes changing color in cold conditions, with tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement 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, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Alter Genéricos

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ramipril Alter Genéricos

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

The other components 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 contents of the pack

1.25 mg tablets: biconvex, round, white to almost white tablets with bevelled edges, marked with the code "1.25" on one side. Tablet diameter: 6.5 mm.

2.5 mg tablets: light yellowish-brown capsule-shaped tablets with bevelled edges and scored on both sides. On one side of the tablet, the upper half bears the code "2.5" and the lower half the code "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 specks, capsule-shaped with bevelled edges and scored on both sides. On one side of the tablet, the upper half bears the code "5" and the lower half the code "KRK". Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses.

10 mg tablets: capsule-shaped, white to almost white tablets with bevelled edges and scored on both sides. On one side of the tablet, the upper half bears the code "10" and the lower half the code "KRK". Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses.

Ramipril Alter Genéricos is available in packs of 14, 28, 30, 56 or 90 tablets in blister packs.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

Manufacturer:

Krka d.d. Novo Mesto
Šmarješka Cesta 6
Novo Mesto, Jugovzhodna Slovenija, 8501
Slovenia

This medicinal product is authorized in the European Economic Area member states under the following names:

Portugal: Ramipril Ripzen
France: Ramipril Alter
Italy: Ramipril Alter
Spain: Ramipril Alter Genéricos EFG

Date of the most recent review of this leaflet: April 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.