Package Insert: Information for the User

RamiprilSTADA5 mg tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert,as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Ramipril STADA contains a medicine called Ramipril.This belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).

Ramipril STADA 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 STADA 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 STADA

• If you are allergic (hypersensitive) to Ramipril, to any other ACE inhibitor or to any of the other components of Ramipril STADA listed in section 6.

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, urticaria, 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 medication used to treat a type of 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 STADA 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 medication to reduce blood pressure that contains aliskiren.

Do not take Ramipril STADA if you are affected by any of the above conditions. If you are unsure, speak with your doctor before taking Ramipril STADA.

Warnings and precautions

Consult with your doctor or pharmacist before starting to take Ramipril STADA:

• If you have heart, liver or kidney problems.
• If you have lost a lot of minerals or fluids (by vomiting, having diarrhea, sweating excessively, 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 about to receive an anesthetic. This may be due to an operation or any dental work. You may need to stop your treatment a day in advance; 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 conditions that may decrease sodium levels in the blood. Your doctor may perform regular blood tests, especially to monitor sodium levels in the blood, especially if you are an elderly person.

·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 type 2 diabetes.

• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
• You should inform your doctor if you think you are (or could be) pregnant. Ramipril is not recommended during the first 3 months of pregnancy and may cause serious harm to your baby from the 3rd month of pregnancy (see section on “Pregnancy and breastfeeding”).
• If you are taking any of the following medications used to treat high blood pressure:

•A blocker of the angiotensin II receptor (ARA II) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.

•Aliskiren

Your doctor may check your renal function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals.

See also the information under the title "Do not take Ramipril STADA"

Children and adolescents

Ramipril STADA is not recommended for use in children and adolescents under 18 years of age as its safety and efficacy have not yet been established in this population.If any of the above applies (or you are unsure), speak with your doctor before taking Ramipril STADA.

Taking Ramipril STADA with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

This is because Ramipril STADA may affect the way some other medications work. Similarly, some medications may affect the way Ramipril STADA works.

Inform your doctor if you are taking any of the following medications, which may make Ramipril STADA 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. These may increase the likelihood of adverse effects if taken with Ramipril STADA:

• Medications used to relieve pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin).
• Cancer medications (chemotherapy).
• Medications used to prevent organ transplant rejection such as ciclosporin.
• Diuretics (urine tablets) such as furosemide.
• Medications that may increase potassium levels in the blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (to make the blood more liquid).
• Trimetoprima and co-trimoxazol (for bacterial infections)
• Medications used to treat inflammation such as prednisolone.
• Alopurinol (used to reduce uric acid in the blood).
• Procainamide (to treat heart rhythm problems).

· Temsirolimus (for cancer)

· Sirolimus, everolimus (for organ transplant rejection prevention)

· Vildagliptina (used to treat type 2 diabetes)

·Your doctor may need to change your dose and/or take other precautions if you are taking any angiotensin II receptor blocker (ARA II) or aliskiren (see also the information in the sections "Do not take Ramipril STADA" and "Warnings and precautions".

Inform your doctor if you are taking any of the following medications. Since these may be affected by Ramipril STADA:

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

In particular, speak with your doctor or pharmacist if you are taking, have taken recently or may need to take any of the following medications:

• Supplements of potassium (including salt substitutes), potassium-sparing diuretics and other medications that may increase potassium levels in the blood (e.g., trimetoprima and co-trimoxazol for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to make the blood more liquid).

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

Taking Ramipril STADA with food, drinks and alcohol

• Drinking alcohol with Ramipril STADA may make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking Ramipril STADA, speak with your doctor about how medications used to reduce blood pressure and alcohol may have additive effects.
• Ramipril STADA can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you may be pregnant (or intend to become pregnant).

You should not take Ramipril STADA during the first 12 weeks of pregnancy, and in any case, you should not take it from the 13th week onwards, as its use during pregnancy may harm your baby. If you become pregnant during treatment with Ramipril STADA, inform your doctor immediately. If you plan to become pregnant, your doctor will change your treatment.

Breastfeeding

You should not take Ramipril STADA if you are breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again if you have any doubts.

How much medication to take

Hypertension treatment

• The usual starting dose is 1.25 mgor2.5 mg 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 (urine tablets), your doctor may stop or reduce the amount of diuretic you were taking previously before starting treatment with Ramipril STADA.STADA.

To reduce the risk of suffering a heart attack or stroke

• The usual starting dose is 2.5 mg once a day.
• 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

• You may start with a dose of 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 daily dose is 10 mg. It is preferable to administer it twice a day.

Treatment after having had 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 daily. 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 STADA than you should

Consult your doctor immediately or go to the nearest hospital emergency room, accompanied by this leaflet or call the Toxicological Information Service (phone 91-562.04.20).

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

If you forgot to take Ramipril STADA

• 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Ramipril STADA can cause side effects, although not everyone will experience them.

Stop taking Ramipril STADA 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 STADA.
• 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. These can be symptoms of lung problems.
• Easy bruising, prolonged bleeding, any sign of bleeding (such as gum bleeding), purple patches on the skin, or catching infections more easily than usual, sore throat, fever, feeling tired, dizziness, or pale skin. These can be symptoms 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 symptoms 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 side effects worsen or last more than a few days.

Frequent

(can affect up to 1 in 10 people)

• Headache or feeling tired.
• Feeling dizzy. This is more likely to occur when starting to take Ramipril STADA or when starting a higher dose.
• Fainting, low blood pressure, especially when standing up or sitting down quickly.
• Dry, irritating cough, sinusitis (inflammation of the sinuses), or bronchitis, difficulty breathing.
• 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 high potassium levels in the blood.

Rare(can affect up to 1 in 100 people)

• Balance problems (dizziness).
• Abnormal sensations in the skin, such as numbness, tingling, pins and needles, burning, or chills.
• Loss or changes in the sense of taste.
• 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.
• Urinating more frequently during the day.
• Sweating more 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 dysfunction in men, decreased libido in men or women.
• Increased eosinophils, a type of white blood cell, found during a blood test.
• Blood tests show changes in how your liver, pancreas, or kidneys are functioning.

Very rare

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

• Increased sensitivity to the sun.

Frequency not known

• Dark-colored urine.
• Feeling or being sick.
• Having muscle cramps.
• Confusion and attacks that may be due to inadequate secretion of ADH (antidiuretic hormone).

If you have these symptoms, consult your doctor as soon as possible.

Other side effects reported:

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

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests show very few blood cells.
• Blood tests show low sodium levels.
• 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.
• Feeling 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 a possible side effect that doesn't appear in this leaflet. You can also report them 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 out of reach and sight of children.

Do not use Ramipril STADA after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of RamiprilSTADA

• The active ingredient isramipril.

Each tablet contains 5 mg oframipril

• The other components are hypromellose,carboxymethylcellulose, maize starch pregelatinised,órange of iron yellow (E172) andethyl stearate sodium.

Appearance of the product and contents of the package

RamiprilSTADA5 mg are yellowish pale to yellow speckled tablets, with a size of 8.1x4,1x3.15 mm, oval, engraved with the letter “R” and the number “19” on each side of the groove on one face and also with a groove on the other.

The tablet can be divided into two equal halves.

The RamiprilSTADAtablets are presented in the following packages:

Blister of formation in freeze-dried (OPA/Alu/PVC/Alu) and blister of formation in freeze-dried with desiccant (OPA/Alu/PE/Desiccant/HDPE/ Alu).

Packaging sizes:

RamiprilSTADA5 mg:14, 28, 30, 56, 90or100 tablets

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder

STADA,S.L.

FredericMompou,5

08960SantJustDesvern(Barcelona)
[email protected]

Responsible for manufacturing

Terapia SA

Str. Fabricii nr. 124, Cluj Napoca 400 632

Romania

or

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132 JH Hoofddorp

Netherlands

Last review date of the leaflet: May 2019

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es