Ramipril Normon 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ramipril Normon 10 mg tablets EFG

Ramipril

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 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. It could 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 Normon is and what it is used for
2. What you need to know before taking Ramipril Normon
3. How to take Ramipril Normon
4. Possible adverse effects
5. How to store Ramipril Normon
6. Contents of the pack and other information

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

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

Ramipril Normon 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 throughout your body.

Ramipril Normon 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 your heart when it is unable to pump enough blood to the rest of your body (heart failure).
• As treatment following a heart attack (myocardial infarction) complicated by heart failure.

2. What you need to know before taking Ramipril Normon

Do not take Ramipril Normon

• 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 skin rash, difficulty swallowing or breathing, or 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 hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

• If you are taking or have previously taken sacubitril/valsartan, a medicine used to treat 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 Normon may not be suitable for you.

• If you have renal artery stenosis (narrowing of the artery to the kidney 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 Normon if any of the above conditions apply to you. If you are unsure, speak with your doctor before taking Ramipril Normon.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril Normon:

• 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 about to undergo treatment to reduce your allergy to bee or wasp stings (desensitisation).

• if you are going to receive an anaesthetic. This may occur during surgery or dental procedures. You may need to stop taking Ramipril Normon 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 medicines that may increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Ramipril Normon”.

• if you have a connective tissue disease such as scleroderma or systemic lupus erythematosus.

• inform your doctor if you are pregnant (or suspect you might 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 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 Normon”.

Children and adolescents

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

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

Taking Ramipril Normon 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 Normon may affect how some other medicines work. Likewise, some medicines may affect how Ramipril Normon works.

Inform your doctor if you have taken or are taking any of the following medicines, which may make Ramipril Normon 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 risk of side effects when taken with Ramipril Normon:

• Sacubitril/valsartan: used to treat chronic heart failure in adults (see section 2 “Do not take Ramipril Normon”).

• 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 transplant, such as ciclosporin.

• Diuretics such as furosemide.

• Medicines that may increase potassium levels in blood 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 in your 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 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 Normon” and “Warnings and precautions”).

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

• Medicines for treating diabetes such as oral glucose-lowering medicines and insulin. Ramipril Normon may lower your blood sugar level. Monitor your blood sugar levels closely while taking Ramipril Normon.
• Lithium (for treating mental health conditions). Ramipril Normon may increase the amount of lithium in your blood. Your doctor will monitor your blood lithium levels closely.

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

Taking Ramipril Normon with food and alcohol

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

Pregnancy and breastfeeding

Pregnancy

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

You must not take Ramipril Normon during the first 12 weeks of pregnancy and 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 Normon, inform your doctor immediately. A switch to an appropriate alternative treatment should be made before planning a pregnancy.

Breastfeeding

You must not take Ramipril Normon if you are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Ramipril Normon contains sodium

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

3. How to take Ramipril Normon

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

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 until your blood pressure is controlled.
• The maximum daily dose is 10 mg taken 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 Normon.

To reduce the risk of having a 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 divide this dose and take it twice daily.

Treatment after having had a heart attack

• The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will adjust your dose.
• The usual dose is 10 mg once daily. It is preferable to divide this dose and take 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 Ramipril Normon tablets whole with liquid.
• Do not crush or chew the tablets.

If you take more Ramipril Normon than you should

Contact your doctor immediately or go to the nearest hospital emergency department. Do not drive to the hospital; have someone take you or call an ambulance. Take the medicine packaging with you so your doctor knows 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 Normon

• 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 experiences them.

Stop taking Ramipril Normon 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, which may make swallowing or breathing difficult, as well as itching and rash. This could be a sign of a serious allergic reaction to Ramipril Normon.
• 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 that lasts longer than normal, any sign of bleeding (e.g., 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 could be a symptom of acute pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea (feeling sick), yellowing of the skin or eyes (jaundice). These may 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 symptoms worsen or last more 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 Normon or when you start taking a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting up quickly.
• Dry, irritating cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhoea, indigestion, feeling sick.
• 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 your skin (paraesthesia).
• Loss or changes in taste.
• Trouble sleeping.
• Feeling sad, anxious, more nervous than usual, or tired.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• Swelling in your abdomen called "intestinal angioedema," with symptoms such as abdominal pain, vomiting, and diarrhoea.
• 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.
• Flushing.
• 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 blood tests.
• Blood tests show changes in how your liver, pancreas, or kidneys are functioning.

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

• Feeling unsteady or confused.
• Redness and swelling of the tongue.
• Severe peeling or shedding of the skin, raised rash, itching.
• Nail problems (e.g., loss or separation of a nail from its bed).
• Skin rash or bruising.
• 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 the amount of haemoglobin.

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 more 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 nauseous, 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 change color in cold conditions and you feel tingling or pain when warming up (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, consult 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 at: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ramipril Normon

Keep out of sight and reach of children.

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

Do not store above 25°C.

Store in the original packaging to protect from light and 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 you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Ramipril Normon

• The active substance is ramipril. Each tablet contains 10 mg of ramipril.
• The other components are: microcrystalline cellulose, pregelatinized corn starch, low-substituted hydroxypropylcellulose, red iron oxide (E-172), sodium hydrogen carbonate, and magnesium stearate.

Appearance of the medicinal product and contents of the pack

Rosy-colored, round, biconvex, scored tablets.

Presented in packs containing blisters with 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision 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 anything, consult your doctor or pharmacist.

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/68276/P_68276.html