Leaflet: Information for the User

Ramipril Aristogen 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 Aristogen and what it is used for

2.What you need to know before starting to take Ramipril Aristogen

3.How to take Ramipril Aristogen

4.Possible side effects

5Storage of Ramipril Aristogen

6.Contents of the pack and additional information

Ramipril Aristogencontains the active ingredient ramipril. This belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

Ramipril Aristogenacts in the following way

• 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 Aristogenmay 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 takeRamipril Aristogen

• If you are allergic to ramipril or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to another medicine that is an angiotensin-converting enzyme (ACE) inhibitor. The symptoms of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of your lips, face, throat, or tongue.
• If you have ever had a severe allergic reaction called “angioedema”. The symptoms include itching, hives, red patches on your hands, feet, and throat, swelling of your throat and tongue, swelling around your eyes and lips, difficulty breathing and swallowing.
• If you have taken or are currently 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 Aristogen may not be suitable for you.
• If you have kidney problems when the blood that reaches your kidneys is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see section “Pregnancy and breastfeeding”).
• 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 medicine to lower your blood pressure that contains aliskiren.

Do not take Ramipril Aristogen if any of the above conditions apply to you. If you are unsure, speak with your doctor before taking Ramipril Aristogen.

Warnings and precautions

Consult your doctor or pharmacist before taking Ramipril Aristogen:

• If you have heart, liver, or kidney problems.
• If you have lost a lot of minerals or fluids (due to vomiting, diarrhea, excessive sweating, being on a low-salt diet, taking diuretics for a long time, or being on dialysis).
• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitization).
• If you are to receive an anesthetic. This may be for an operation or any dental work. You may need to stop taking Ramipril Aristogen 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 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 have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
• Inform your doctor if you are pregnant (or suspect you may be). Ramipril Aristogen is not recommended during the first three 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 “sartanes” - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• 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 transplant rejection and for cancer (for example, temsirolimus, sirolimus, everolimus);
• Vildagliptin, a medicine used to treat type 2 diabetes.

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 2 “Do not take Ramipril Aristogen”.

Children and adolescents

The use of Ramipril Aristogen in children and adolescents under 18 years is not recommended because the safety and efficacy of Ramipril Aristogen in children have not been established.

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

Other medicines and Ramipril Aristogen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because Ramipril Aristogen may affect how other medicines work. Similarly, some medicines may affect how Ramipril Aristogen works.

Inform your doctor if you are taking any of the following medicines. They may make Ramipril Aristogen work less effectively:

• Medicines used to relieve pain and inflammation (for example, 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.

Inform your doctor if you are taking any of the following medicines. They may increase the risk of side effects if taken with Ramipril Aristogen:

• Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril Aristogen”);
• Medicines used to relieve pain and inflammation (for example, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin and aspirin);
• Cancer medicines (chemotherapy);
• Medicines used to prevent organ transplant rejection such as ciclosporin;
• Diuretics such as furosemide;
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (for example, spironolactone, triamterene, amiloride), and other medicines that may increase potassium levels in your blood (for example, trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ rejection after a transplant; and heparin, a medicine used to thin your blood and prevent blood clots);
• Anti-inflammatory steroids such as prednisolone;
• Alopurinol (used to reduce uric acid levels in your blood);
• Procainamide (for heart rhythm problems);
• Temsirolimus (for cancer);
• Sirolimus, everolimus (to prevent organ rejection);
• Vildagliptin (used to treat type 2 diabetes);
• Racecadotril (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 aliskiren (see also the information under the headings “Do not take Ramipril Aristogen” and “Warnings and precautions”).

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

• Medicines used to treat diabetes such as oral medicines to lower glucose and insulin. Ramipril Aristogen may lower your blood sugar levels. Monitor your blood sugar levels closely while taking Ramipril Aristogen.
• Lithium (for mental health problems). Ramipril Aristogen may increase your lithium levels. Your doctor will closely monitor your lithium levels in your blood.

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

Taking Ramipril Aristogen with food and alcohol

Drinking alcohol with Ramipril Aristogen may make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking Ramipril Aristogen, speak with your doctor as medicines used to lower blood pressure and alcohol may have additive effects.

Ramipril Aristogen can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant (or suspect you may be). You should not take ramipril Aristogen during the first 12 weeks of pregnancy and should not take it at all from week 13, as its use during pregnancy may cause harm to your baby.

If you become pregnant while taking Ramipril Aristogen, inform your doctor immediately. A suitable alternative treatment should be changed before planning a pregnancy.

Breastfeeding

You should not take Ramipril Aristogen if you are breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machines

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

Ramipril Aristogen contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

This concentration is not suitable for doses less than 2.5 mg.Other medications with ramipril are available in the suitable concentration.Your doctor will advise you.

Administration of this medication

• Take this medication orally at the same time every day.
• RamiprilAristogencan be taken with or without food.
• Swallow the whole tablets with liquid.
• Do not crush or chew the tablets.

How much medication to take

Hypertension treatment

• The usual starting dose is 1.25mg or 2.5mg once a day.
• Your doctor will adjust the amount you should take to control your blood pressure.
• The maximum daily dose is 10 mg once a day.
• If you are already taking diuretics, your doctor may stop or reduce the amount of diuretic you were taking previously before starting treatment with RamiprilAristogen.

To reduce the risk of suffering a heart attack or stroke

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

Renal disease treatment to reduce or delay worsening

• You may start with a dose of 1.25mg or 2.5mg once a day.
• Your doctor will adjust the amount you are taking.
• The usual dose is 5 or 10 mg once a day.

Heart failure treatment

• The usual starting dose is 1.25mg once a day.
• Your doctor will adjust the amount you are taking.
• The maximum daily dose is 10 mg once a day. It is preferable to administer it twice a day.

Treatment after a heart attack

• The usual starting dose is 1.25mg once a day or 2.5mg twice a day.
• Your doctor will adjust the amount you are taking.
• The usual dose is 10 mg once a 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.

If you take more Ramipril Aristogen than you should

Consult your doctor immediately or go to the nearest hospital emergency department, accompanied by this leaflet. Do not drive to the hospital, ask someone to take you or call an ambulance. Bring the packaging of the medication with you. This way your doctor will know what you have taken.

You can also call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Ramipril Aristogen

• If you forgot to take a dose, take your usual dose when it is time for the next one.
• Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Stop taking Ramipril Aristogen 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 may 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 Aristogen.
• Severe skin reactions, including rashes, mouth ulcers, 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. These can be signs of lung problems.
• Easy bruising, prolonged bleeding, any sign of bleeding (such as gum bleeding), purple spots on the skin, or catching infections more easily than normal, sore throat, and fever, fatigue, dizziness, or pale skin. These can be signs of blood or bone marrow problems.
• Severe stomach pain that can radiate to the back. This can be a sign of acute pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (urge to vomit), yellow skin or eyes (jaundice). These can 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 worsen or last more than a few days.

Frequent(may affect up to 1 in 10 people)

• Headache or feeling tired.
• Dizziness. This is more likely to occur when starting to take Ramipril Aristogen or when starting a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting up quickly.
• Dry, irritating cough, sinusitis, or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling 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, pinpricks, burning, or chills.
• 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 called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea.
• 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 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 certain white blood cells (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 worsen or last more than a few days.

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests show very few blood cells.
• Blood tests show lower-than-normal sodium levels.
• Concentrated urine (dark color), feeling unwell or nauseous, muscle cramps, confusion, and seizures that may be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.
• Fingers of the hands and feet 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.
• Hair loss.

Reporting 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Store below 25 °C. Store in the original packaging to protect it from moisture.

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

Do not use this medication after the expiration date that appears on the box, bottle label, and blister 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.Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Ramipril Aristogen

The active ingredient is ramipril.

Each tablet contains 5 mg of ramipril.

The other components are:

Pregelatinized cornstarch;

Monohydrate lactose;

Sodium hydrogen carbonate (E500);

Sodium croscarmellose (E468)

Red iron oxide (E172);

Sodium fumarate estearate.

See section 2 “Ramipril Aristogen contains lactose and sodium”

Appearance of the product and contents of the package

Uncoated, round, biconvex, pale pink speckled tablets, unengraved and with a notch on one side.The tablet can be divided into two equal doses.

Ramipril Aristogen tablets are available in:

-Blister presentation (PVC transparent-Aluminium).

- White opaque HDPE bottle with PP closure.

U

Package sizesU:

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

Bottle presentation: 30 and 1000 tablets (clinical pack)

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

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

DenmarkRamipril Aristo

SpainRamipril Aristogen 5 mg tablets EFG

MaltaRamipril Aristo 5 mg tablets

SwedenRamipril Aristo 5 mg tablets

NorwayRamipril Aristo 5 mg tablets

Last revision date of this leaflet: November 2021

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es