RAMIPRIL STADA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

RamiprilSTADA5 mg EFG tablets

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Ramipril STADA is and what it is used for
2. What you need to know before you take Ramipril STADA
3. How to take Ramipril STADA
4. Possible side effects
5. Storing Ramipril STADA
6. Contents of the pack and other information

1. What Ramipril STADA is and what it is used for

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

Ramipril STADA works by:

• Reducing the production of substances in your body that could increase your blood pressure.
• Relaxing and widening your blood vessels.
• Making it easier for your heart to pump blood around your body.

Ramipril STADA can be used:

• To treat high blood pressure (hypertension).
• To reduce the risk of you having a heart attack or stroke.
• To reduce the risk or delay the worsening of kidney problems (whether you have diabetes or not).
• To treat your heart when it cannot pump enough blood to the rest of your body (heart failure).
• As treatment after a heart attack (myocardial infarction) complicated by heart failure.

2. What you need to know before you take Ramipril STADA

Do not take Ramipril STADA

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

The symptoms of an allergic reaction can include rash, difficulty swallowing or breathing, swelling of your face, lips, throat, or tongue.

• If you have ever had a severe allergic reaction called “angioedema”. The symptoms include itching, rash, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If you are taking or have recently taken 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 having 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 where the blood flow to your kidneys is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see section “Pregnancy and breast-feeding”).
• If your blood pressure is abnormally low or unstable. Your doctor will need to assess this.

• If you have diabetes or kidney problems and are taking a medicine to reduce blood pressure that contains aliskiren.

Do not take Ramipril STADA if any of the above conditions apply to you. If you are not sure, talk to your doctor before taking Ramipril STADA.

Warnings and precautions

Talk to your doctor or pharmacist before starting Ramipril STADA:

• 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, low-salt diet, taking diuretics for a long time, or being on dialysis).
• If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization).
• If you are going to receive an anesthetic. This may be due to an operation or any dental work. You may need to stop taking Ramipril STADA a day before; talk to your doctor.
• If you have high levels of potassium in your blood (shown in blood test results).

• If you are taking medicines or have conditions that may lower the levels of sodium in your blood. Your doctor may perform regular blood tests, especially to monitor the levels of sodium in your blood, particularly if you are elderly.
• 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

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

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

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

See also the information under the heading "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 the safety and efficacy have not been established in this population. If any of the above applies to you (or you are not sure), talk to your doctor before taking Ramipril STADA.

Taking Ramipril STADA with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is because Ramipril STADA may affect the way other medicines work. Also, some medicines may affect the way Ramipril STADA works.

Tell your doctor if you are taking any of the following medicines, as they may make Ramipril STADA 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. These may increase the chance of side effects if taken with Ramipril STADA:

• 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
• Medicines that can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to make your blood more fluid)
• Trimethoprim and co-trimoxazole (for bacterial infections)
• Steroid medicines for inflammation such as prednisolone
• Allopurinol (used to reduce uric acid in the blood)
• Procainamide (for heart rhythm problems)

• Temsirolimus (for cancer)
• Sirolimus, everolimus (for preventing transplant rejection)
• Vildagliptin (used to treat type 2 diabetes)
• Your doctor may need to change your dose and/or take other precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information in the sections "Do not take Ramipril STADA" and "Warnings and precautions").

Tell your doctor if you are taking any of the following medicines, as they may be affected by Ramipril STADA:

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

In particular, talk to your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in your blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; cyclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).

If any of the above applies to you (or you are not sure), talk to 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 faint. If you are concerned about how much you can drink while taking Ramipril STADA, talk to your doctor about how blood pressure medicines and alcohol can have additive effects.
• Ramipril STADA can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

Tell your doctor if you think you might be pregnant (or plan to become pregnant).

You should not take Ramipril STADA during the first 12 weeks of pregnancy, and in no case should you take it after the 13th week, 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.

Breast-feeding

You should not take Ramipril STADA if you are breast-feeding.

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

Driving and using machines

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

3. How to take Ramipril STADA

Follow exactly the instructions of administration of this medicine given by your doctor. If you are not sure, talk to your doctor or pharmacist again.

How much to take

Treating 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 daily dose is 10 mg once a day.
• If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of diuretic you were taking before starting treatment with Ramipril STADA.

Reducing the risk of 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.

Treating or preventing kidney problems

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

Treating heart failure

• The usual starting dose is 1.25 mg once a day.
• Your doctor will adjust the amount you take.
• The maximum daily dose is 10 mg. It is preferable to take it in two divided doses.

Treating after 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 take.
• The usual dose is 10 mg daily. It is preferable to take it in two divided doses.

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 STADA than you should

Consult your doctor immediately or go to the nearest hospital casualty department, taking this leaflet and any remaining tablets with you. Call the Poisons Information Centre (telephone 91-562.04.20) for advice.

Do not drive to the hospital, ask someone to drive you or call an ambulance. Take the medicine pack with you.

If you forget to take Ramipril STADA

• If you forget to take a dose, take your normal dose when it is next due.
• Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Ramipril STADA can cause adverse effects, although not all people will experience them.

Stop taking Ramipril STADA and go to the doctor immediately if you notice any of the following serious adverse 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 rash. This can be a symptom of a severe allergic reaction to Ramipril STADA.
• Severe skin reactions, including rash, ulcers in the mouth, worsening of a pre-existing skin condition, redness, blisters, or skin peeling (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 can 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 getting infections more easily than usual, sore throat, and fever, feeling tired, fainting, dizziness, or paleness of the skin. These can be symptoms of blood or bone marrow problems.
• Severe stomach pain that can radiate to the back. This can be a symptom of acute pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (vomiting), yellowing of the skin or eyes (jaundice). These can 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 adverse effects 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 occur when you start taking Ramipril STADA or when you start taking a higher dose.
• Fainting, low blood pressure (abnormally low blood pressure), especially when standing up or feeling quickly.
• Dry, irritating cough, sinus inflammation (sinusitis), or bronchitis, difficulty breathing.
• Stomach or abdominal pain, diarrhea, indigestion, feeling sick.
• Rash 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.

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 changes 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, called "intestinal angioedema," which presents symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Urinating more than usual 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 usual.
• Redness.
• Blurred vision.
• Joint pain.
• Fever.
• Sexual dysfunction in men, decreased sexual desire in men or women.
• Increased number of a type of white blood cell in the blood (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., loss or separation of the nail from its bed).
• Rash or bruising on the skin.
• Redness on the skin and cold extremities.
• Redness, itching, swelling, and 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.

Frequency Not Known

• Concentrated urine (dark color)
• Feeling or being sick
• Having muscle cramps
• Confusion and seizures that can be due to inadequate secretion of ADH (antidiuretic hormone)

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

Other Adverse Effects Reported:

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

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests showing very few blood cells.
• Blood tests showing lower than normal sodium levels.
• Fingers and toes changing color when cold and feeling tingling or pain when warming up (Raynaud's phenomenon).
• Enlargement of the chest in men.
• Slowness or difficulty reacting.
• Burning sensation.
• Change in the smell of things.
• Hair loss.

Reporting 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 leaflet. You can also report them 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 STADA

Keep out of the reach and sight of children.

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. 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 STADA

• The active ingredient is ramipril.

Each tablet contains 5 mg of ramipril

• The other ingredients are hypromellose, microcrystalline cellulose, pregelatinized cornstarch, yellow iron oxide (E172), and sodium stearyl fumarate.

Appearance of the Product and Package Contents

Ramipril STADA 5 mg are pale yellow to yellow mottled, oblong tablets, 8.1x4.1x3.15 mm in size, scored with the letter "R" and the number "19" on either side of the score on one face and also with a score on the other face.

The tablet can be divided into two equal halves.

Ramipril STADA tablets are available in the following packaging:

Cold-formed blister pack (OPA/Alu/PVC/Alu) and cold-formed blister pack with desiccant (OPA/Alu/PE/Desecant/HDPE/Alu).

Package sizes:

Ramipril STADA 5 mg: 14, 28, 30, 56, 90, or 100 tablets

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) [email protected]

Manufacturer

Terapia SA

Str. Fabricii nr. 124, Cluj Napoca 400 632

Romania

or

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132 JH Hoofddorp

Netherlands

Date of the Last Revision of the Leaflet: May 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es