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 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Ramipril Alter Genéricos contains a medication called ramipril. This belongs to a group of medications called angiotensin-converting enzyme (ACE) inhibitors.

Ramipril works as follows:

• Decreasing the body's production of substances that could increase blood pressure.
• Relaxing and widening blood vessels.
• Making it easier for the heart to pump blood throughout the body.

Ramipril may be used:

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

Do not take Ramipril Alter Genéricos

• If you are allergic to ramipril, any other angiotensin-converting enzyme (ACE) inhibitor, or any of the other ingredients in this medication listed in section 6.

The symptoms of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of your lips, face, throat, or tongue.

• If you have ever had a severe allergic reaction called “angioedema”. The symptoms include itching, hives, red spots on your hands, feet, and throat, swelling of your throat and tongue, swelling around your eyes and lips, difficulty breathing and swallowing.
• If you have taken or are taking sacubitrilo/valsartán, a medication 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 machine used, ramipril may not be suitable for you.
• If you have a narrowing of the renal artery (renal artery stenosis) 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 medication to lower blood pressure that contains aliskirén.

Do not take ramipril if any of the above conditions apply. 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 heart, liver, or kidney problems.
• If you have lost a lot of minerals or fluids (due to vomiting, diarrhea, excessive sweating, being on a low-sodium diet, taking diuretics for a long time, or being on 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 for surgery or any dental work. You may need to stop your treatment a day in advance; consult your doctor.
• If you have high levels of potassium in your blood (shown in blood test results).
• If you are taking medications or have a condition that may lower sodium levels in your blood. Your doctor may perform blood tests periodically, particularly to monitor sodium levels in your blood, especially if you are an elderly patient.
• If you are taking medications that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (such as temsirolimus, everolimus, sirolimus) or vildagliptin, NEP inhibitors (such as racecadotrilo) or sacubitrilo/valsartán. For sacubitrilo/valsartán, 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 may 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 medications used to treat high blood pressure (hypertension):

- an angiotensin II receptor antagonist (ARA) (also known as “sartanes” - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.

- aliskirén.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (such as 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 is not recommended because the safety and efficacy of ramipril in children have not been established.

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

Other medications and Ramipril Alter Genéricos

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because ramipril may affect how other medications work. Similarly, some medications may affect how ramipril works.

Inform your doctor if you have taken or are taking any of the following medications, which may make ramipril less effective:

• Medications used to relieve pain and inflammation (e.g. nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina, and aspirin).
• Medications used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as efedrina, noradrenalina, or adrenalina. Your doctor will need to check your blood pressure.

Inform your doctor if you are taking any of the following medications. These may increase the risk of side effects if taken with ramipril:

• Sacubitrilo/valsartán: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril Alter Genéricos”).
• Medications used to relieve pain and inflammation (e.g. nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina, and aspirin).
• Chemotherapy medications.
• Medications used to prevent organ rejection after a transplant, such as ciclosporina.
• Diuretics, such as furosemida.
• Medications that may increase potassium levels in your blood, such as espironolactona, triamtereno, amilorida, potassium salts, trimetoprim alone or in combination with sulfametoxazol (for infections) and heparina (to make your blood more liquid).
• Steroid medications for inflammation, such as prednisolona.
• Alopurinol (used to lower uric acid levels in your blood).
• Procainamida (used to treat heart rhythm problems).
• Temsirolimus (used for cancer).
• Sirolimus, everolimus (used to prevent graft rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotrilo (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 aliskirén (see also the 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 medications. These may be affected by ramipril:

• Medications used to treat diabetes, such as oral medications to lower glucose and insulin. Ramipril may lower your blood sugar levels. Monitor your blood sugar levels closely while taking ramipril.
• Lithium (used to treat mental health problems). Ramipril may increase lithium levels in your blood. Your doctor will closely monitor your lithium levels in your blood.

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

Taking Ramipril Alter Genéricos with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or suspect you may be).

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

Breastfeeding

You should not take ramipril if you are breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Ramipril Alter Genéricos contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Medication intake

• Take this medication orally at the same time every day.
• Swallow the tablets whole with liquid.
• Do not crush or chew the tablets.

How much medication to take

Hypertension treatment

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you should 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 previously before starting treatment with ramipril.

To reduce the risk of suffering a 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.

Kidney disease treatment to reduce or delay worsening

• You may 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.

Heart failure treatment

• 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 once a day. It is preferable to administer 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 once a day. It is preferable to administer it twice a day.

Older patients

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

If you take more Ramipril Alter Genéricos than you should

Consult your doctor immediately or go to the nearest hospital emergency room. Do not drive to the hospital, ask someone to take you or call an ambulance. Bring the medication packaging with you. This way, your doctor will know what you have taken.

You can also call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Ramipril Alter Genéricos

• If you forgot to take a dose, take your regular dose when it's time for the next one.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ramipril Alter Genéricos

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking ramipril and seek immediate medical attention if you notice any of the following severe side 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 hives. This can be a sign of a severe allergic reaction to ramipril.
• Severe skin reactions, including rashes, ulcers in the mouth, worsening of a pre-existing skin condition, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Inform your doctor immediately if you experience:

• Fast or irregular heartbeat, palpitations, chest pain, shortness of breath, or more serious problems, including heart attack and stroke.
• Difficulty breathing or coughing. These can be symptoms of lung problems.
• Appearance of bruises with ease, bleeding for longer than normal, any sign of bleeding (e.g., from the gums), purple spots on the skin, or catching infections more easily than normal, sore throat, and fever, feeling tired, dizziness, 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 sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (urge to vomit), yellow skin or eyes (jaundice). These can be symptoms of liver problems, such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:

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

Frequent(can affect up to 1 in 10 patients)

• Headache or feeling tired.
• Feeling dizzy. This is more likely to occur when starting to take ramipril or when starting a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting quickly.
• Irrespiratory cough, sinusitis, or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling sick.
• Hives on the skin, with or without raised areas.
• Chest pain.
• Muscle cramps or pain.
• Blood tests showing higher than normal potassium levels in the blood.

Infrequent(can affect up to 1 in 100 patients)

• Balance problems (dizziness).
• Itching and abnormal sensations in the skin, such as numbness, tingling, pinching, burning, or shivering (paresthesia).
• Loss or changes in the taste of things.
• Difficulty sleeping.
• Feeling sad, anxious, more nervous than normal, or tired.
• Blocked nose, difficulty breathing, or worsening of asthma.

• A 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 normal during the day.
• Sweating more than normal.
• 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.
• Joint pain.
• Fever.
• Sexual dysfunction in men, decreased libido 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(can affect up to 1 in 1,000 patients)

• Feeling insecure or confused.
• Redness and swelling of the tongue.
• Severe skin peeling, hives, swelling, itching.
• Nail problems (e.g., loss or separation of a nail from its bed).
• Hives or bruises on the skin.
• Redness in the skin and cold extremities.
• Redness, itching, swelling, and tearing of the eyes.
• Changes in hearing 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 (can affect up to 1 in 10,000 patients)

• Being more sensitive to the sun than normal.

Other side effects reported:

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

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests show very few blood cells.
• Blood tests show less sodium than normal.
• Concentrated urine (dark color), feeling unwell or nausea, muscle cramps, confusion, and seizures that may be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.
• Fingers and toes change color when it's cold and feel numb or painful when warmed (Raynaud's phenomenon).
• Enlargement of the chest in men.
• Slowness or difficulty reacting.
• Feeling burned.
• Change in the smell of things.
• Loss of hair.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's a possible side effect that doesn't appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ramipril Alter Generics

The active ingredient 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 cornstarch, sodium stearate 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 package

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: yellowish light brown tablets, capsule-shaped, with beveled edges and scored on both faces. On one side of the tablet, in the middle, the mark 2.5 is engraved, and on the other half of the tablet the mark KRK is engraved. 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 points, capsule-shaped tablets with beveled edges, scored on both faces. On one side of the tablet, in the middle, the mark 5 is engraved, and on the other half of the tablet the mark KRK is engraved. 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, in the middle, the mark 10 is engraved, and on the other half of the tablet the mark KRK is engraved. Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses.

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

The marketing authorization holder is:

Alter Laboratories, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

The responsible manufacturer is:

Krka d.d. Novo Mesto

Šmarješka Cesta 6

Novo Mesto, Southeastern Slovenia, 8501

Slovenia

This medicine is authorized in the member states of the European Economic Area with the following names:

Portugal:Ramipril Ripzen

France: Ramipril Alter

Italy: Ramipril Alter

Spain: Ramipril Alter Generics EFG

Last review date of this leaflet:April 2024

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