Ramipril cinfa 2,5 mg comprimidos efg
Introduction
Leaflet: information for the user
Ramipril Cinfa 2.5 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, and you must 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 Cinfa and what it is used for
2.What you need to know before you start taking Ramipril Cinfa
3.How to take Ramipril Cinfa
4.Possible side effects
5.Storage of Ramipril Cinfa
6.Contents of the pack and additional information
1. What is Ramipril Cinfa and what is it used for
Ramipril Cinfa contains an active ingredient called ramipril. This belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.
Ramipril Cinfa works in the following way:
- Reducing 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 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.
2. What you need to know before starting to take Ramipril Cinfa
- 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 the lips, face, throat, or tongue. - If you have ever had a severe allergic reaction called “angioedema”.The symptoms include itching, urticaria, 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 sacubitrilo/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.This evaluation should be performed by your doctor.
- If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication that contains aliskiren.
- If you are taking any of the following medications, as 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 minerals or fluids (due to vomiting, diarrhea, excessive sweating, following a low-sodium 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 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 any of the following medications, as they may increase the risk of angioedema:
- 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 sacubitrilo/valsartán. For sacubitrilo/valsartán, see section 2 “Do not take ramipril cinfa”.
- If you have a vascular collagen disease, such as scleroderma or systemic lupus erythematosus.
- You should 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 serious harm 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, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
- aliskirén.
Your doctor may need to 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 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, as they may increase the risk of adverse effects if combined with Ramipril Cinfa:
- Sacubitrilo/valsartán: 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 indometacina and aspirin).
- Chemotherapy medications for cancer.
- Medications used to prevent organ transplant rejection such as ciclosporina.
- Diuretics (medications to urinate) such as furosemida.
- Potassium supplements (including salt substitutes), diuretics that save potassium, and other medications that may increase potassium levels in your blood (e.g., trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant medication used to prevent organ transplant rejection; and heparina, a medication used to dilute blood to prevent clots).
- Anti-inflammatory steroids such as prednisolona.
- Alopurinol (used to reduce uric acid levels in your blood).
- Procainamida (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 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 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 glucose and insulin. Ramipril Cinfa may reduce blood glucose levels. Monitor your blood glucose levels closely while taking Ramipril Cinfa.
- Litio (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-lowering medications and alcohol may have additive effects.
- Ramipril Cinfa can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You should speak with your doctor if you think you are (or may be) pregnant.Do not take Ramipril Cinfa during the first 12 weeks of pregnancy, and do not take it after week 13, as its use during pregnancy may cause harm to the baby.
If you become pregnant while taking 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.Do not drive or operate tools or machines if this occurs.
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”.
3. How to take Ramipril Cinfa
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 2.5 mg tablets:
This concentration is not suitable for doses lower than 1.25 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 stop 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: 91 562 04 20, 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.
4. Possible Adverse Effects
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 rash, ulcers in your 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, chest tightness, or more serious problems including heart attack and stroke.
- Difficulty breathing or coughing. They could be a sign 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 infections that occur more easily than normal, sore throat, and fever, feeling tired, dizziness, or paleness of the skin. They could be signs of blood or bone marrow problems.
- Severe stomach pain that can reach 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(may affect up to 1 in 10 people)
- Headache or feeling tired.
- Sensation of dizziness. This is more likely to occur when starting treatment with Ramipril Cinfa or changing to a higher dose.
- Fainting, hypotension (abnormally low blood pressure), especially when getting up or sitting 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.
Rare(may 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 on your skin (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.
- 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.
- More frequent 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.
Very rare(may 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.
- Mouth inflammation.
- Blood tests show very few blood cells.
- Blood tests show less sodium than normal 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 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.
- Sensation 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 or pharmacist, even if it's about possible side effects that don'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 about the safety of this medicine.
5. Conservation of Ramipril Cinfa
Keep this medication out of the sight and reach of children.
Do not store at a temperature above250C. Store in the original packaging to protect it from moisture.
Bottle 1,000 tablets: Shelf life once opened: Use within 12 months of first opening the HDPE bottle.
Keep the HDPE bottle tightly closed to protect the medication from moisture.
Do not use this medication after 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 trash.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.In case of doubt, ask your pharmacist how to dispose ofthepackaging andmedications that you no longerneed. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Ramipril Cinfa
- The active ingredient is ramipril.Each tablet contains 2.5 mg of ramipril.
- The other components are pregelatinized cornstarch, lactose monohydrate, sodium hydrogen carbonate (E500), sodium croscarmellose (E468), yellow iron oxide (E172), and sodium stearyl fumarate.
Appearance of the product and contents of the package
Ramipril Cinfa 2.5 mg tablets:
Uncoated tablets, yellowish to yellow in color, cylindrical, 5 mm in diameter, with flat, beveled edges, engraved with the letter “H” and the number “18”, separated by a groove on one face and smooth on the other face. The tablet can be divided into two equal doses.
The Ramipril Cinfa tablets are available in:
Blister (PVC transparent/Aluminum).
-HDPE white opaque bottle with a PP screw cap.
Packaging sizes:
Ramipril Cinfa 2.5 mg tablets:
Blister: 20, 28, 30, 50, 60, 90, 98, 100, and 500 tablets
HDPE bottle: 30 and 1,000 tablets (clinical packaging)
Only some packaging sizes may be marketed.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder:
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Industrial Estate Areta.
31620 Huarte (Navarra)-Spain
Responsible manufacturer:
Galenicum Health S.L.U
Calle San Gabriel, 50
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:
FranceRAMIPRIL ARROW LAB 2.5 mg tablet
ItalyRamipril Aurobindo 2.5 mg tablets
MaltaRamipril Aurobindo 2.5 mg tablets
PolandAWERPIL, 2.5mg
SpainRamipril Cinfa 2.5 mg tablets EFG
Revision date of this leaflet: July 2019
More 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 leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/77383/P_77383.html
QR code to:https://cima.aemps.es/cima/dochtml/p/77383/P_77383.html
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