RAMIPRIL CINFAMED 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ramipril Cinfamed 2.5 mg Tablets EFG

Ramipril Cinfamed 5 mg Tablets EFG

Ramipril Cinfamed 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.

• Keep this leaflet, as 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 and other information

1. What is Ramipril Cinfamed and what is it used for
2. What you need to know before you take Ramipril Cinfamed
3. How to take Ramipril Cinfamed
4. Possible side effects
5. Storage of Ramipril Cinfamed
6. Contents of the pack and other information

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

Ramipril Cinfamed contains an active substance called ramipril. This belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).

Ramipril Cinfamed 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 Cinfamed 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 Cinfamed

Do not take Ramipril Cinfamed

• 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 the 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 the machine used, Ramipril Cinfamed may not be suitable for you.
• If you have kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see the following section “Pregnancy and breast-feeding”).
• If your blood pressure is abnormally low or unstable. It is your doctor who will assess this.
• If you have diabetes or kidney problems and are being treated with a medicine to lower your blood pressure that contains aliskiren.

Do not take Ramipril Cinfamed if any of the above conditions apply to you. If you are not sure, talk to your doctor before taking Ramipril Cinfamed.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ramipril Cinfamed:

• If you have heart, liver, or kidney problems.
• If you have lost a lot of body salts or fluids (due to vomiting, diarrhea, excessive sweating, following a low-salt diet, taking diuretics for a long time, or having 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. You may be given this due to an operation or any dental work. It may be necessary to stop your treatment one day beforehand; talk to your doctor.
• If you have high levels of potassium in your blood (as shown by blood test results).
• If you are taking medicines or have a disease that may lower your blood sodium levels. Your doctor may perform regular blood tests to monitor your sodium levels, especially if you are an elderly patient.
• If you are taking medicines that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (e.g., racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see the section 2 "Do not take Ramipril Cinfamed".
• If you have a disease of the collagen vascular system, such as scleroderma or systemic lupus erythematosus.
• You should inform your doctor if you think you are (or might become) pregnant. Ramipril Cinfamed is not recommended during the first three months of pregnancy and may cause serious harm to your baby if used after the third month of pregnancy (see the section “Pregnancy and breast-feeding”).
• 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 Cinfamed”.

Children and adolescents

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

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

Other medicines and Ramipril Cinfamed

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Ramipril Cinfamed may affect the way they work. Also, some medicines may affect the way Ramipril Cinfamed works.

Tell your doctor if you are taking any of the following medicines, which may make Ramipril Cinfamed 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, which may increase the risk of side effects if combined with Ramipril Cinfamed:

• Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 "Do not take Ramipril Cinfamed").
• 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 (water tablets) such as furosemide.
• Medicines that may 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 thin the blood).
• Steroid medicines for inflammation such as prednisolone.
• Allopurinol (used to decrease uric acid in the blood).
• Procainamide (for irregular heartbeats).
• Temsirolimus (for cancer treatment).
• Medicines often used to prevent organ rejection after transplantation (sirolimus, everolimus)
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used to treat 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 Cinfamed” and “Warnings and precautions”).

Tell your doctor if you are taking any of the following medicines. Their effect may be altered by Ramipril Cinfamed:

• Medicines to treat diabetes such as glucose-lowering medicines and insulin. Ramipril Cinfamed may lower your blood sugar levels. Monitor your blood sugar levels closely while taking Ramipril Cinfamed.
• Lithium (for mental health problems). Ramipril Cinfamed 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 Cinfamed.

Taking Ramipril Cinfamed with food and drink

• Drinking alcohol with Ramipril Cinfamed may cause dizziness or fainting. If you are concerned about the amount of alcohol you can drink while taking Ramipril Cinfamed, talk to your doctor, as the combination of blood pressure-lowering medicines and alcohol may have additive effects.
• Ramipril Cinfamed can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should talk to your doctor if you think you are (or might be) pregnant.

You should not take Ramipril Cinfamed during the first 12 weeks of pregnancy, and you must not take it after the 13th week, as its use during pregnancy may harm your baby.

A switch to an alternative treatment should be made before a planned pregnancy.

Breast-feeding

Do not take Ramipril Cinfamed if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy while taking Ramipril Cinfamed, which is more likely to happen when you start taking Ramipril Cinfamed or start taking a higher dose. If this happens, do not drive or use tools or machines.

Ramipril Cinfamed 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 Cinfamed

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Dose

Ramipril Cinfamed cannot be divided into equal doses. For doses that cannot be achieved with Ramipril Cinfamed, other concentrations of ramipril are available.

Treatment of 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 dose is 10 mg once a day.
• If you are already taking diuretics (water tablets), your doctor may stop or reduce the diuretic before starting you on Ramipril Cinfamed.

Reducing the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once a day.
• Your doctor may then decide to increase the amount you take.
• The usual dose is 10 mg once a day.

Treatment to reduce or delay the worsening of kidney problems

• The starting dose may be 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.

Treatment of heart failure

• The usual starting dose is 1.25 mg once a day.
• Your doctor will adjust the amount you are taking.
• The maximum dose is 10 mg a day, which is usually taken in two divided doses.

Treatment after having 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 a day, which is usually taken in two divided doses.

Elderly patients

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

Taking this medicine

• Take this medicine by mouth at the same time each day.
• Ramipril Cinfamed can be taken with or without food.
• Swallow the tablets whole with liquid.

Do not crush or chew the tablets as they have an unpleasant taste.

If you take more Ramipril Cinfamed than you should

Consult your doctor immediately or go to the casualty department of your nearest hospital. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 915620420, stating the medicine and the amount taken.

Do not drive to the hospital, ask someone to drive you or call an ambulance. Take the medicine pack with you. This will help the doctor to know what medicine you have taken.

If you forget to take Ramipril Cinfamed

• 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 forgotten doses.

If you have any further questions on the use of this product, 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 cinfamed 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 cinfamed.
• Severe skin reactions including rash, ulcers in the 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. They could be a symptom 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 infections that occur more easily than normal, sore throat, and fever, feeling of tiredness, fainting, dizziness, or paleness of the skin. They could be symptoms of blood or bone marrow problems.
• Severe stomach pain that can reach the back. It could be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea (vomiting), yellow skin or eyes (jaundice). They could 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.

Frequent(may affect up to 1 in 10 people)

• Headache or feeling of tiredness.
• Feeling of dizziness. This is more likely to occur when starting treatment with Ramipril cinfamed or when changing to a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when getting up or sitting down quickly.
• Dry, irritating cough, sinus inflammation (sinusitis), or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling sick.
• Rash on the skin, with or without elevated areas.
• Chest pain.
• Cramps or muscle pain.
• Blood tests showing higher than normal potassium levels in the blood.

Uncommon(may affect up to 1 in 100 people)

• Balance problems (vertigo).
• Itching and abnormal sensations on the skin such as numbness, tingling, pinching, burning, or chilliness on the skin (paresthesia).
• Loss or changes in the taste of things.
• Sleep problems.
• Feeling of sadness, anxiety, more nervous than usual, or tiredness.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• Swelling in the abdomen called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• More frequent urination than usual during the day.
• More frequent sweating 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.
• Joint pain.
• Fever.
• Sexual impotence in men, decreased sexual desire in men or women.
• Increased number of white blood cells in the blood (eosinophilia) found during a blood test.
• Blood tests show changes in the way your liver, pancreas, or kidneys are working.

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

• Feeling of insecurity or confusion.
• Redness and swelling of the tongue.
• Severe skin peeling or shedding, rash, bumps, itching.
• Nail problems (e.g., loss or separation of the nail from its bed).
• Rash or bruising on the skin.
• Redness on the skin and cold extremities.
• Redness, itching, swelling, or tearing of the eyes.
• Hearing disturbances and noises in the ears.
• Feeling of weakness.
• Blood tests show a decrease in the number of red blood cells, white blood cells, or platelets, or in the amount of hemoglobin.

Very Rare(may affect up to 1 in 10,000 people)

• Increased sensitivity to the sun than normal.

Frequency Not Known(cannot be estimated from the available data):

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

• Difficulty concentrating.
• Mouth inflammation.
• Blood tests show very few blood cells.
• Blood tests show lower than normal sodium levels in the blood.
• Concentrated urine (dark-colored), feeling sick, having muscle cramps, confusion, and seizures that may be due to inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible.
• Fingers and toes change color when cold and feel tingling or pain when warming up (Raynaud's phenomenon).
• Chest 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ramipril cinfamed

Keep this medicine out of the sight and reach of children.

Ramipril cinfamed 2.5 mg and Ramipril cinfamed 5 mg

Store below 30°C. Store in the original packaging to protect it from light.

Ramipril cinfamed 10 mg

This medicine does not require any special storage temperature. Store in the original packaging to protect it from light.

Do not use this medicine after the expiration date that appears on the packaging, label, or blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ramipril cinfamed

Ramipril cinfamed 2.5 mg

• The active ingredient is ramipril. Each tablet contains 2.5 mg of ramipril.
• The other ingredients are hydroxypropylcellulose, microcrystalline cellulose 101, cornstarch, mannitol (E-421), pregelatinized cornstarch, yellow iron oxide (E-172), sodium stearyl fumarate.

Ramipril cinfamed 5 mg

• The active ingredient is ramipril. Each tablet contains 5 mg of ramipril.
• The other ingredients are hydroxypropylcellulose, microcrystalline cellulose 101, cornstarch, mannitol (E-421), pregelatinized cornstarch, red iron oxide (E-172), sodium stearyl fumarate.

Ramipril cinfamed 10 mg

• The active ingredient is ramipril. Each tablet contains 10 mg of ramipril.
• The other ingredients are hydroxypropylcellulose, microcrystalline cellulose 101, cornstarch, mannitol (E-421), pregelatinized cornstarch, sodium stearyl fumarate.

Appearance of the Product and Package Contents

Ramipril cinfamed 2.5 mg

Uncoated tablets, yellowish to yellow spotted, round, biconvex, and 7 mm in diameter. The tablet cannot be divided into two equal doses.

Ramipril cinfamed 5 mg

Uncoated tablets, pink spotted, round, biconvex, and 7 mm in diameter. The tablet cannot be divided into two equal doses.

Ramipril cinfamed 10 mg

White to off-white tablets, round, biconvex, and 7 mm in diameter. The tablet cannot be divided into two equal doses.

Ramipril cinfamed tablets are available in:

Cardboard box with OPA-Al-PVC blister pack of 10 tablets.

Presentation:

30, 100, 250, and 500 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

Antibiotice SA

1, Valea Lupului Street, Iasi 707410,

Romania

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

Sweden Ramiliv 2.5 mg, 5 mg, 10 mg tablets

Denmark Ramiliv

Spain Ramipril cinfamed 2.5 mg, 5 mg, 10 mg EFG tablets

Date of the Last Revision of this Prospectus:May 2025

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

Ramipril cinfamed 2.5 mg EFG tablets

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/xxxxx/P_xxxxx.html

QR code to: https://cima.aemps.es/cima/dochtml/p/xxxxx/P_xxxxx.html

Ramipril cinfamed 5 mg EFG tablets

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/xxxxx/P_xxxxx.html

QR code to: https://cima.aemps.es/cima/dochtml/p/xxxxx/P_xxxxx.html

Ramipril cinfamed 10 mg EFG tablets

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/xxxxx/P_xxxxx.html

QR code to: https://cima.aemps.es/cima/dochtml/p/xxxxx/P_xxxxx.html