RAMIPRIL CINFA 5 mg TABLETS

2. What you need to know before you take ramipril cinfa

Do not take ramipril cinfa

• 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, 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 medicine 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 following section “Pregnancy and breastfeeding”).
• If your blood pressure is abnormally low or unstable. This will be assessed by your doctor.
• If you have diabetes or kidney impairment and are being treated with a medicine to lower blood pressure that contains aliskiren.
• If you are taking any of the following medicines, the risk of angioedema may increase:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

Do not take ramipril cinfa if any of the above conditions apply to you. If you are unsure, talk to 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 body 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 going to undergo 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 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 medicines or have a disease that can lower sodium levels in your blood. Your doctor may perform periodic blood tests, particularly to monitor sodium levels in your blood, especially if you are an elderly patient.
• If you are taking any of the following medicines, as they increase the risk of angioedema (rapid swelling under the skin in the throat area):

• Temsirolimus, sirolimus, everolimus, and other medicines that belong to the class of mTOR inhibitors (used to prevent organ rejection), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see section 2 "Do not take ramipril cinfa".

• If you suffer from a disease of the collagen vascular system, such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you suspect that you are (or might 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 medicines used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in your blood (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take ramipril cinfa”.

Children and adolescents

The administration of ramipril cinfa to children and adolescents under 18 years of age is not recommended, 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 unsure), talk to your doctor before taking ramipril cinfa.

Other medicines and ramipril cinfa

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

Tell your doctor if you are taking any of the following medicines, which may make ramipril cinfa work less well:

• 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 check your blood pressure.

Tell your doctor if you are taking any of the following medicines, as they may increase the risk of side 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").
• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin).
• Cancer medicines (chemotherapy).
• Medicines to prevent organ rejection after a transplant such as cyclosporin.
• Diuretics (water tablets) such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that can increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Steroid medicines for inflammation such as prednisolone.
• Allopurinol (used to reduce uric acid in the blood).
• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer treatment).
• Medicines often used to prevent organ rejection after transplantation (sirolimus, everolimus, and other medicines that belong to the class of mTOR inhibitors). See section “Warnings and precautions”.
• 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 cinfa” and “Warnings and precautions”).

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

• Medicines to treat diabetes such as glucose-lowering medicines and insulin. ramipril cinfa may lower your blood sugar levels. Monitor your blood sugar levels closely while taking ramipril cinfa.
• Lithium (for mental health problems). ramipril cinfa may increase the levels 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 unsure), talk to your doctor before taking ramipril cinfa.

Taking ramipril cinfa with food and drink

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

Pregnancy and breastfeeding

Pregnancy

You should talk to your doctor if you think you are (or might become) pregnant. You should not take ramipril cinfa during the first 12 weeks of pregnancy, and you must not take it after the 13th week, as its use during pregnancy could harm the baby.

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

Breastfeeding

Do not take ramipril cinfa if you are breastfeeding.

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

Driving and using machines

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

The ramipril cinfa tablets contain lactose monohydrate.If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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

3. How to take ramipril cinfa

Follow exactly the instructions of administration of this medicine given to you by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

ramipril cinfa 5 mg tablets:

This strength is not suitable for doses below 2.5 mg.

Amount to take

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 treatment with ramipril cinfa.

Reducing the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once a day.
• Later, 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 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 per day. It is preferable to administer it twice a day.

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 per day. It is preferable to administer it twice a day.

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.
• 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 casualty department of the nearest hospital. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 915620420, indicating 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 allow the doctor to know what medicine you have taken.

If you forget to take ramipril cinfa

• If you forget to take a dose, take your normal dose when it is time for your next dose.
• 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 cinfa and go to a doctor immediately if you notice any of the following serious adverse effects, as you may need urgent medical treatment:

• Swelling of the face, lips, or throat that can make swallowing or breathing difficult, as well as itching and hives. This can be a symptom of a severe allergic reaction to ramipril cinfa.
• Severe skin reactions, including rash, ulcers in the mouth, worsening of a pre-existing skin condition, redness, blisters, or peeling of the skin (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. These could be symptoms 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 tired, fainting, dizziness, or paleness of the skin. These could be symptoms of blood or bone marrow problems.
• Severe stomach pain that can radiate to the back. This could be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea (vomiting), yellowing of the skin or eyes (jaundice). These 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 tired.
• Feeling dizzy. This is more likely to happen when starting treatment with ramipril cinfa or changing to a higher dose.
• Fainting, low blood pressure (abnormally low blood pressure), especially when standing up or sitting down quickly.
• Dry, irritating cough, sinus inflammation (sinusitis), or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling sick or being sick.
• Rash on the skin, with or without raised 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 change in taste.
• Sleep problems.
• Feeling sad, anxious, more nervous than usual, or tired.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• Swelling in the abdomen, known as "intestinal angioedema," which presents symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• More frequent urination than normal during the day.
• More frequent sweating than normal.
• Loss or decreased appetite (anorexia).
• Increased or irregular heartbeats.
• Swelling of arms and legs. This may be a sign that your body is retaining more water than normal.
• Redness.
• Blurred vision.
• Joint pain.
• Fever.
• Sexual dysfunction in men, decreased sexual desire in men or women.
• Increased white blood cell count (eosinophilia) found during a blood test.
• Blood tests showing changes in how your liver, pancreas, or kidneys are functioning.

Rare(may 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, rash, bumps, itching.
• Nail problems (e.g., nail loss or separation from the nail 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 weak.
• Blood tests showing 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.

Other reported adverse effects:

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

• Difficulty concentrating.
• Mouth inflammation.
• Blood tests showing very few blood cells.
• Blood tests showing lower than normal sodium levels in the blood.
• Concentrated urine (dark-colored), feeling sick or being sick, having muscle cramps, confusion, and seizures, which may be due to inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible.
• Fingers on the hands and feet 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 cinfa

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

Do not store above 25°C.

Keep in the original package to protect it from moisture.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of ramipril cinfa

The active ingredient is ramipril. Each tablet contains 5 mg of ramipril.

• The other ingredients are pregelatinized cornstarch, lactose monohydrate, sodium hydrogen carbonate (E500), sodium croscarmellose (E468), red iron oxide (E172), and sodium stearyl fumarate.

Appearance of the product and package contents

ramipril cinfa 5 mg tablets:

Uncoated tablets, pale pink speckled, cylindrical, 6 mm in diameter, with beveled edges, flat, engraved with the letter "H" and the number "19", separated by a score line on one side and smooth on the other side. The tablet can be divided into two equal doses.

Ramipril cinfa tablets are available in:

PVC transparent/Aluminum blister pack.

White opaque HDPE bottle with a PP screw cap.

Package sizes

ramipril cinfa 5 mg tablets:

Blister pack: 7, 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 98, 100, and 500 tablets

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

Not all package 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:

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 under the following names:

Denmark Ramipril Aurobindo

Spain Ramipril Cinfa 5 mg tablets EFG

Finland Ramipril Orion 5 mg tablets

France RAMIPRIL ARROW LAB 5 mg, scored tablet

Greece RAMISYN 5 mg tablets

Netherlands Ramipril Aurobindo 5 mg tablets

Italy Ramipril Aurobindo 5 mg tablets

Malta Ramipril Aurobindo 5 mg tablets

Romania Ramipril Aurobindo 5 mg tablets

Sweden Ramipril Aurobindo 5 mg tablets

Date of the last revision of this prospectus:July 2019

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

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/72289/P_72289.html

QR code to: https://cima.aemps.es/cima/dochtml/p/72289/P_72289.html