Ramipril Stada 10 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Ramipril STADA 10 mg tablets EFG

Read the entire 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 must not be given to other people, 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 effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Ramipril STADA is and what it is used for.
2. What you need to know before taking Ramipril STADA.
3. How to take Ramipril STADA.
4. Possible adverse effects.
5. How to store 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 known as ACE inhibitors (angiotensin-converting enzyme inhibitors).

Ramipril STADA works in the following ways:

• By reducing the body's production of substances that could increase your blood pressure.
• By relaxing and widening your blood vessels.
• By making it easier for your heart to pump blood throughout your body.

Ramipril STADA may be used:

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

2. What you need to know before taking Ramipril STADA

Do not take Ramipril STADA

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

Symptoms of an allergic reaction may include rash, difficulty swallowing or breathing, swelling of your lips, face, throat, or tongue.

• If you have ever had a serious allergic reaction called “angioedema”. Symptoms include itching, hives, red patches on 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 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 beneath the skin, such as in 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 due to reduced blood flow to your kidneys (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 blood pressure-lowering medicine containing aliskiren.

Do not take Ramipril STADA if any of the above conditions apply to you. If you are unsure, speak with 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 large amounts of salts or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics (water tablets), or dialysis).

• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitisation).

• If you are to receive an anaesthetic. This may be due to surgery or dental procedures. You may need to stop taking Ramipril STADA one 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 conditions that may lower sodium levels in your blood. Your doctor may perform regular blood tests, especially to monitor blood sodium levels, 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 diarrhoea
  • Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.

• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.

• You must inform your doctor if you think you are (or might become) pregnant. Ramipril is not recommended during the first 3 months of pregnancy and can cause serious harm to your baby from the 3rd month of pregnancy onwards (see section on “Pregnancy and breastfeeding”).

• 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 – for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.

• aliskiren

Your doctor may check your kidney function, blood pressure, and levels 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 safety and efficacy have not yet been established in this population. If any of the above apply to you (or you are unsure), 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 need to take any other medicine.

This is because Ramipril STADA may affect how some other medicines work. Likewise, some medicines may affect how Ramipril STADA works.

Tell your doctor if you are taking any of the following medicines, which may make Ramipril STADA less effective:

• 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 monitor your blood pressure.

Tell your doctor if you are taking any of the following medicines. These may increase the likelihood of side effects when 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).

• Medicines for cancer treatment (chemotherapy).

• Medicines to prevent organ rejection after transplant, such as ciclosporin.

• Diuretics (water tablets) such as furosemide.

• Medicines that may increase potassium levels in blood such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to make blood less likely to clot).

• Trimethoprim and co-trimoxazole (for bacterial infections)

• Steroid medicines for inflammation such as prednisolone.

• Allopurinol (used to lower uric acid in blood).

• Procainamide (to treat heart rhythm problems).

• Temsirolimus (for cancer)

• Sirolimus, everolimus (to prevent graft rejection)

• Vildagliptin (used to treat type 2 diabetes)

• Your doctor may need to adjust your dose and/or take other precautions if you are taking any angiotensin II receptor blocker (ARB) or aliskiren (see also information in 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 for diabetes such as glucose-lowering medicines and insulin. Ramipril STADA may reduce blood sugar levels. Monitor blood sugar levels closely while taking Ramipril STADA.
• Lithium (for mental health conditions). Ramipril STADA may increase lithium levels in blood. Your doctor will closely monitor your blood lithium levels.

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

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

If any of the above apply to you (or you are unsure), 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 lightheaded. If you are concerned about how much alcohol you can drink while taking Ramipril STADA, speak with your doctor about how blood pressure-lowering medicines 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 must not take Ramipril STADA during the first 12 weeks of pregnancy, and under no circumstances should you take it from week 13 onwards, as its use during pregnancy may harm the unborn baby. If you become pregnant while taking Ramipril STADA, inform your doctor immediately. If you plan to become pregnant, your doctor will change your treatment.

Breastfeeding

You must not take Ramipril STADA if you are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

3. How to take Ramipril STADA

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How much medicine to take

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust the dose until your blood pressure is controlled.
• The maximum daily dose is 10 mg once daily.
• If you are already taking diuretics (water tablets), your doctor may stop or reduce the dose of your previous diuretic before starting treatment with Ramipril STADA.

To reduce the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once daily.
• Your doctor may decide to increase your dose.
• The usual dose is 10 mg once daily.

Treatment to reduce or delay worsening of kidney problems

• You may start with a dose of 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust your dose.
• The usual dose is 5 mg or 10 mg once daily.

Treatment for heart failure

• The usual starting dose is 1.25 mg once daily.
• Your doctor will adjust your dose.
• The maximum daily dose is 10 mg. It is preferable to take it twice daily.

Treatment after having had a heart attack

• The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will adjust your dose.
• The usual dose is 10 mg daily. It is preferable to take it twice daily.

Elderly patients

Your doctor will reduce the initial dose and adjust your treatment more slowly.

How to take this medicine

• Take this medicine orally 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

Contact your doctor immediately or go to the nearest hospital emergency department, bringing this leaflet with you, or call the Toxicology Information Service (telephone 91-562.04.20).

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

If you forget to take Ramipril STADA

• If you forget to take a dose, take your next scheduled dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, Ramipril STADA may cause adverse effects, although not everybody gets them.

Stop taking Ramipril STADA and go to a 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 which may make swallowing or breathing difficult, together with itching and rash. These may be symptoms of a severe allergic reaction to Ramipril STADA.
• Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin disease, 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 heartbeat, irregular or strong heartbeats (palpitations), chest pain, chest tightness or more serious problems including heart attack and stroke.
• Difficulty breathing or cough. These may 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 becoming more prone to infections than usual, sore throat and fever, feeling tired, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow problems.
• Severe stomach pain which may extend to the back. This may be a symptom of acute pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea (feeling sick), yellowing of the skin or eyes (jaundice). These may 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 for more than a few days.

Common

(may affect up to 1 in 10 people)

• Headache or feeling tired.
• Dizziness. This is more likely when you start taking Ramipril STADA or when you start taking a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly.
• Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, difficulty breathing.
• Stomach or abdominal pain, diarrhoea, indigestion, feeling unwell.
• Skin rash, with or without raised areas.
• Chest pain.
• Muscle 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 (dizziness).
• Itching and abnormal sensations in the skin such as numbness, tingling, pricking, burning or chills on the skin (paraesthesia).
• Loss or changes in taste.
• Difficulty sleeping.
• Feeling sad, anxious, more nervous than usual or tired.
• Stuffy nose, difficulty breathing or worsening of asthma.
• Abdominal swelling called "intestinal angioedema" with symptoms such as abdominal pain, vomiting and diarrhoea.
• 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 may be a sign that your body is retaining more fluid than normal.
• Redness.
• Blurred vision.
• Joint pain.
• Fever.
• Sexual dysfunction in men, decreased sexual desire in men or women.
• Increase in the number of a type of white blood cells (eosinophilia) found during a blood test.
• Blood tests show changes in how your liver, pancreas or kidneys are functioning.

Rare

(may affect up to 1 in 1,000 people)

• Feeling uneasy or confused.
• Redness and swelling of the tongue.
• Severe skin peeling or shedding, rash, lumps, itching.
• Nail problems (e.g.: loss or separation of the nail from its bed).
• Rash or bruising on the skin.
• Redness of the skin and cold extremities.
• Redness, itching, swelling and watering of the eyes.
• Hearing disturbances and ringing in the ears.
• Feeling weak.
• Blood tests show a decrease in the number of red blood cells, white blood cells or platelets, or in the amount of haemoglobin.

Very rare (may affect up to 1 in 10,000 people)

• Increased sensitivity to sunlight.

Frequency not known

• Concentrated urine (dark colour)
• Feeling or being unwell
• Having muscle cramps
• Confusion and seizures which may be due to inappropriate ADH (antidiuretic hormone) secretion

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

Other reported adverse effects:

Tell your doctor if any of the following conditions worsen or last for 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.
• Fingers of hands and feet change colour when cold and feel tingling or pain when warmed (Raynaud's phenomenon).
• Breast 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ramipril STADA

• The active substance is ramipril.

Each tablet contains 10 mg of ramipril.

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

Appearance of the product and contents of the pack

Ramipril STADA 10 mg are pale yellow to mottled yellow tablets, sized 12.1 x 6.0 x 3.75 mm, oblong-shaped, marked with the letter “R” and the number “20” on either side of the score line on one side, and also with a score line on the other side.

The tablet can be divided into two equal parts.

Ramipril STADC tablets are available in the following pack sizes:

Cold-formed blisters (OPA/Alu/PVC/Alu) and cold-formed blisters with desiccant (OPA/Alu/PE/Desiccant/HDPE/Alu).

Pack sizes:

Ramipril STADA 10 mg: 28, 30, 56 or 90 tablets

Only some pack 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

The Netherlands

Date of the most recent revision of the leaflet: May 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es