Leaflet: information for the user

Ramipril Normon 5 mg tablets EFG

Ramipril

Read this leaflet carefully before you start taking this medicine, as 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; do not give it 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.

1. What is Ramipril Normon and what it is used for

2. What you need to know before starting to take Ramipril Normon

3. How to take Ramipril Normon

4. Possible side effects

5. Storage of Ramipril Normon

6. Contents of the pack and additional information

Ramipril Normon contains a medicine called ramipril. This belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

Ramipril Normon works in the following way:

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

Ramipril Normon 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 problems in the kidneys (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 Normon

• If you are allergic to ramipril, to any other angiotensin-converting enzyme (ACE) inhibitor, or to any of the other ingredients of 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 patches 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/valsartan, 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 Normon may not be suitable for you.
• If you have a narrowing of the renal artery (renal artery stenosis). 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 Normon if any of the above conditions apply to you. If you are unsure, speak with your doctor before taking Ramipril Normon.

Warnings and precautionsConsult your doctor or pharmacist before taking Ramipril Normon:

• If you have problems with your heart, liver, or kidneys.
• If you have lost a lot of minerals or fluids (by vomiting, having diarrhea, sweating more than usual, 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 an operation 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 any 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 Normon.”
• 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 Normon 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 Normon.”

Children and adolescents

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

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

Use of Ramipril Normon with other medications:

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

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

• Sacubitrilo/valsartán: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril Normon”).
• Medications used to relieve pain and inflammation (e.g. nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina, and aspirin).
• Cancer medications (chemotherapy)
• 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, trimetropim 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 (to treat heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent graft rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotrilo (used to treat 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 Normon” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medications. These may be affected by Ramipril Normon:

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

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

Taking Ramipril Normon with food and alcohol

• Drinking alcohol with Ramipril Normon may make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking Ramipril Normon, speak with your doctor, as medications used to lower blood pressure and alcohol may have additive effects.
• Ramipril Normon 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 Normon 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 Normon, inform your doctor immediately. A suitable alternative treatment should be changed before planning a pregnancy.

Breastfeeding

You should not take Ramipril Normon if you are breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Ramipril Normon contains sodium

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

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

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 Normon.

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.

Treatment to reduce or delay the progression 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 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.

Taking this medication

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

If you take more Ramipril Normon 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 Normon

• 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 make up for the missed doses.

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 Normon and seek immediate medical attention if you notice any of the following severe side effects - you may need urgent medical treatment:

• Swelling of the face, lips, or throat that may 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 Normon.
• Severe skin reactions, including rashes, ulcers in your mouth, worsening of an 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, chest tightness, or more serious problems, including heart attack and stroke.
• Difficulty breathing or coughing. These can be symptoms of lung problems.
• Appearance of bruises more easily, bleeding for longer than normal, any sign of bleeding (for example, from the gums), purple spots on the skin, or catching infections more easily than normal, sore throat, and fever, feeling tired, dizziness, or paleness of the skin. These can be symptoms of blood or bone marrow problems.
• Severe stomach pain that can reach your back. This can be a sign of acute 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 symptoms 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 Normon or when you start taking a higher dose.
• Fainting, low blood pressure, especially when you get up or sit up quickly.
• Dry, irritating cough, inflammation of your nasal sinuses (sinusitis), or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling sick.
• Hives on your skin, with or without raised areas.
• Chest pain.
• Muscle cramps or pain.
• Blood tests showing higher than normal potassium levels in your blood.

Rare(may affect up to 1 in 100 patients)

• Balance problems (dizziness).
• Itching and abnormal sensations in your skin, such as numbness, tingling, pins and needles, burning, or chills.
• 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.
• Abdominal swelling 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 heartbeat. 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 sex drive 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.

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

• Increased sensitivity to the sun.

Other side effects reported:

Inform your doctor if any of the following conditions 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 of the hands and feet change color when it's cold and feel numbness or pain when warmed (Raynaud's phenomenon).
• Enlargement of the chest in men.
• Slowness or difficulty reacting.
• Feeling of burning.
• 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 the Spanish System for Pharmacovigilance of Medicines for Human Use, Website: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 25°C.

Store in the original packaging to protect it from light and moisture.

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

Ramipril Normon Composition

• The active ingredient is ramipril. Each tablet contains 5 mg of ramipril.
• The other components are: Microcrystalline cellulose, pregelatinized cornstarch, low-substitution hydroxypropyl cellulose, red iron oxide (E-172), sodium hydrogen carbonate, and magnesium stearate.

Product Appearance and Packaging Content

Pinkish-colored, elongated, biconvex, and scored tablets.

They are presented in packaging containing 28 or 56 tablets.

Marketing Authorization Holder and Responsible Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (SPAIN)

Last Review Date of this Leaflet:July 2024

This leaflet does not contain all the information about your medicine. If you have any questions or are unsure about something, ask your doctor or pharmacist.

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/68275/P_68275.html