Package Leaflet: Information for the User

Ramipril Cinfa 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, ask 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 do not appear in this leaflet.See section 4.

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

ramipril cinfa works as follows:

• By reducing the body's production of substances that could increase blood pressure.
• By relaxing and widening blood vessels.
• By making it easier for the heart to pump blood throughout the body.

ramipril cinfa 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 cinfa

• If you are allergic to ramipril, any other angiotensin-converting enzyme (ACE) inhibitor, or any of the other components of this medication (listed in section 6).
  The symptoms of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have ever had a severe allergic reaction called “angioedema”. The symptoms include itching, hives, red patches 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 medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, ramipril cinfa may not be suitable for you.
• If you have kidney problems where the blood supply to the kidneys is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see the next section “Pregnancy and breastfeeding”).
• If your blood pressure is abnormally low or unstable. It is the doctor who should perform this evaluation.
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you are taking any of the following medications, the risk of angioedema may increase:
• Racecadotrilo, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptina, a medication used to treat diabetes.

Do not take ramipril cinfa if you may be affected by any of the above conditions. If you are unsure, speak with your doctor before taking ramipril cinfa.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ramipril cinfa:

• If you have heart, liver, or kidney problems.
• If you have lost a lot of mineral salts or fluids (due to vomiting, diarrhea, excessive sweating, following a low-salt diet, taking diuretics for a long time, or undergoing dialysis).
• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitization).
• If you are to receive an anesthetic. You may be given one due to surgery or any dental work. You may need to stop your treatment a day before; 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 decrease 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 any of the following medications, as they may increase the risk of angioedema (rapid inflammation under the skin in the throat area):

• Temsirolimus, sirolimus, everolimus, and other medications that belong to the class of mTOR inhibitors (used to prevent organ transplant rejection), vildagliptina, neprilysin inhibitors (such as racecadotrilo), or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take ramipril cinfa”.

• If you have a vascular collagen disease, such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you suspect that you are (or may become) pregnant. Ramipril cinfa is not recommended during the first three months of pregnancy and may cause severe damage to the baby if used after the third month of pregnancy (see the section “Pregnancy and breastfeeding”, below).
• If you are taking any of the following medications used to treat high blood pressure:

- an angiotensin II receptor antagonist (ARA) (also known as “sartanes” - for example, valsartan, telmisartan, irbesartan), 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 cinfa”.

Children and adolescents

Administration of ramipril cinfa is not recommended 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 may affect you (or you are unsure), speak with your doctor before taking ramipril cinfa.

Other medications and ramipril cinfa

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

Inform your doctor if you are taking any of the following medications, which may make ramipril cinfa work less effectively:

• Medications used to relieve pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin).
• Medications 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.

Inform your doctor if you are taking any of the following medications, as they may increase the risk of adverse effects if combined with ramipril cinfa:

• Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take ramipril cinfa”).
• Medications used to relieve pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin).
• Chemotherapy medications.
• Medications used to prevent organ transplant rejection such as ciclosporin.
• Diuretics (medications to urinate) such as furosemide.
• Potassium supplements (including salt substitutes), diuretics that save potassium, and other medications that may increase potassium levels in your blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressant medication used to prevent organ transplant rejection; and heparin, a medication used to thin your blood to prevent clots).
• Anti-inflammatory steroids such as prednisolone.
• Alopurinol (used to reduce uric acid levels in your blood).
• Procainamide (to treat heart rhythm problems).
• Temsirolimus (for cancer treatment).
• Medications often used to prevent organ transplant rejection (sirolimus, everolimus, and other medications that belong to the class of mTOR inhibitors). See section “Warnings and precautions”.
• Vildagliptina (used to treat type 2 diabetes).
• Racecadotrilo (used to treat diarrhea).
• Your doctor may need to modify 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 cinfa” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medications. Their effect may be affected by ramipril cinfa:

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

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

Taking ramipril cinfa with food and alcohol

• Consuming alcohol with ramipril cinfa may cause dizziness or drowsiness. If you are concerned about the amount of alcohol you can drink while taking ramipril cinfa, speak with your doctor, as the combination of blood pressure medications and alcohol may have additive effects.
• Ramipril cinfa can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must speak with your doctor if you think you are (or may be) pregnant.Ramipril cinfa should not be taken during the first 12 weeks of pregnancy, and it should not be taken after week 13, as its use during pregnancy may cause damage to the baby.

If you become pregnant during treatment with ramipril cinfa, inform your doctor immediately. The change to an alternative suitable treatment should be made before a planned pregnancy.

Lactation

Do not take ramipril cinfa if you are breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machines

You may feel dizzy while taking ramipril cinfa, which is more likely to occur when starting ramipril cinfa or starting a higher dose. If this occurs, do not drive or operate tools or machines.

Ramipril cinfa tablets contain lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult with your doctor or pharmacist.

ramipril cinfa 10 mg tablets:

This concentration is not suitable for doses lower than 5 mg.

Amount 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 dose is 10 mg once a day.
• If you are already taking diuretics (urine tablets), your doctor may interrupt or reduce the amount of diuretic before starting treatment with ramipril cinfa.

To reduce the risk of heart attack or stroke

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

Renal disease treatment to reduce or delay progression

• 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.

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 dose is 10 mg per day. It is preferable to administer it twice a day.

Post-myocardial infarction treatment

• 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 per 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.

Take this medication

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

If you take more ramipril cinfa than you should

Consult your doctor immediately or go to the nearest hospital emergency room. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915620420, indicating the medication and the amount ingested.

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

If you forgot to take ramipril cinfa

• 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 have any other questions about the use of this product, ask your doctor or pharmacist.

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

Stop taking ramipril cinfa 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 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 cinfa.
• Severe skin reactions, including rashes, ulcers in the 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. They could be a sign of lung problems.
• Easy bruising, prolonged bleeding, any sign of bleeding (e.g., from the gums), purple spots on the skin, or increased susceptibility to infections, sore throat, fever, fatigue, dizziness, or pale skin. They could be signs of blood or bone marrow problems.
• Severe stomach pain that can radiate to the back. It could 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). They could be signs 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(can affect up to 1 in 10 people)

• Headache or feeling tired.
• Dizziness. This is more likely to occur when starting treatment with ramipril cinfa or switching to a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting up quickly.
• Dry, irritating cough, sinusitis (inflammation of the sinuses), or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling or being 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.

Less frequent(can affect up to 1 in 100 people)

• Balance problems (vertigo).
• Itching and abnormal sensations in the skin, such as numbness, tingling, pinching, burning, or chills (paresthesia).
• Loss or changes in the taste of things.
• Difficulty sleeping.
• Feeling sad, anxious, more nervous than usual, or tired.
• Blocked nose, difficulty breathing, or worsening of asthma.
• Abdominal swelling known as "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• More frequent urination during the day.
• Increased sweating.
• 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 white blood cells in the blood (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 people)

• Feeling insecure or confused.
• Redness and swelling of the tongue.
• Severe scaling or peeling of the skin, hives, blisters, or itching.
• Problem with the nails (e.g., loss or separation of the nail from its bed).
• Hives or bruises on the skin.
• Redness, itching, swelling, or 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, white blood cells, or platelets, or in the amount of hemoglobin.

Very rare (can affect up to 1 in 10,000 people)

• Increased sensitivity to the sun.

Other side effects reported:

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

• Difficulty concentrating.
• Inflammation of the mouth.
• Blood tests show very few blood cells.
• Blood tests show lower-than-normal sodium levels in the blood.
• Dark-colored urine, feeling or being sick, muscle cramps, confusion, and attacks 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 it's cold and feel numb or painful when warmed (Raynaud's phenomenon).
• Enlargement of the chest in men.
• Slowness or difficulty reacting.
• Burning sensation.
• Change in the smell of things.
• Loss of hair.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above25ºC.

Store in the original packaging to protect it from moisture.

Keep the HDPE bottle tightly closed to protect the medication from moisture.

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

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

Composition of ramipril cinfa

The active ingredient is ramipril. Each tablet contains 10 mg of ramipril.

• The other componentsare pregelatinized cornstarch, lactose monohydrate, sodium hydrogen carbonate (E500), sodium croscarmellose (E468) and sodium stearate fumarate.

Appearance of the product and contents of the package

ramipril cinfa 10 mg tablets:

Uncoated tablets, white to off-white in color, cylindrical, 8 mm in diameter, with flat, beveled edges, engraved with the letter “H” and the number “20”, separated by a groove on one face and smooth on the other face. The tablet can be divided into two equal doses.

Ramipril cinfa tabletsare available in:

PVC transparent/Aluminum foil blister.

HDPE white opaque bottle with a PP screw cap.

Package sizes:

ramipril cinfa 10 mg tablets:

PVC blister: 20, 28, 30, 50, 56, 60, 90, 98, 100 and 500 tablets

HDPE bottle: 30 and 1,000 tablets (clinical pack)

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Manufacturer responsible:

Galenicum Health S.L.U

50 San Gabriel Street

Esplugues de Llobregat

08950 Barcelona

Spain

Or

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate,

Hal Far BBG 3000

(Birzebbugia)-Malta

Or

Generis Farmacêutica, S.A.,

Rua João de Deus, n.o 19,

Venda Nova, 2700-487

Amadora, Portugal.

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

DanishRamipril Aurobindo

SpanishRamipril Cinfa 10 mg tablets EFG

FinnishRamipril Orion 10 mg tabletti

FrenchRAMIPRIL ARROW LAB 10 mg, comprimé sécable

GreekRAMISYN 10 mgδισκ?α

DutchRamipril Aurobindo 10 mg, tabletten

ItalianRamipril Aurobindo 10 mg compresse

MalteseRamipril Aurobindo 10 mg tablets

RomanianRamipril Aurobindo 10 mg comprimate

SwedishRamipril Aurobindo 10 mg tabletter

Last review date of the prospectus: July 2019

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

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/72290/P_72290.html

QR code to:https://cima.aemps.es/cima/dochtml/p/72290/P_72290.html