Ramipril Sandoz 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ramipril Sandoz 2.5 mg tablets EFG

Ramipril Sandoz 5 mg tablets EFG

Ramipril Sandoz 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; 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Ramipril Sandoz works in the following ways:

• by reducing the production in the body 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 around your body.

Ramipril Sandoz can be used:

• for the treatment of 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),
• for the treatment of your heart when it cannot pump enough blood to the rest of your body
  (heart failure),
• as a treatment after a heart attack (myocardial infarction) complicated by heart failure.

2. What you need to know before taking Ramipril Sandoz

Do not take Ramipril Sandoz:

• if you are allergic to ramipril, to any other angiotensin-converting enzyme (ACE) inhibitor, or to any of the other components of this medicine (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 severe allergic reaction called “angioedema.” Symptoms include itching, hives, 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 have taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, since the risk of angioedema (rapid swelling beneath the skin, for example in the throat) is high,
• if you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, ramipril may not be suitable for you,
• if you have renal artery stenosis (narrowing of the renal artery that reduces blood flow to your kidneys),
• if you are more than 3 months pregnant. In addition, it is better to avoid ramipril at the beginning 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.

If you are taking any of the following medicines, the risk of developing 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.

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 the blood (for example, trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots).

Do not take ramipril if any of the above conditions apply to you. If you are unsure, consult your doctor before taking ramipril.

Warnings and precautions

Talk to your doctor or pharmacist before starting Ramipril Sandoz:

• if you have problems with your heart, liver, or kidneys,
• 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, or dialysis),
• if you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitisation),
• if you are going to receive an anaesthetic. This may be due to surgery or dental procedures. You may need to stop taking ramipril 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 a disease that may reduce sodium levels in your blood. Your doctor may perform regular blood tests, particularly to monitor blood sodium levels, especially if you are elderly,
• if you are taking medicines that may increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus) or vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Ramipril Sandoz”,
• if you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus,
• inform your doctor if you are pregnant (or suspect you might be). Ramipril is not recommended during the first 3 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 "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 blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Ramipril Sandoz.”

Children

The use of ramipril in children and adolescents under 18 years of age is not recommended, as the safety and efficacy of ramipril in children has not yet been established.

If any of the above conditions apply to you (or you are unsure), talk to your doctor before taking ramipril.

Taking Ramipril Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because ramipril may affect how some other medicines work. Likewise, some medicines may affect how ramipril works.

Inform your doctor if you have taken or are taking any of the following medicines, which may make ramipril 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.

Inform your doctor if you are taking any of the following medicines. These may increase the likelihood of side effects if taken together with ramipril:

• Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril Sandoz”),
• medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacina, and aspirin),
• medicines for cancer treatment (chemotherapy),
• medicines to prevent organ transplant rejection such as cyclosporine,
• diuretics such as furosemide,
• medicines that may increase potassium levels in the blood such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to thin the blood),
• steroid medicines for inflammation such as prednisolone,
• allopurinol (used to lower uric acid levels in your blood),
• procainamide (for treating heart rhythm problems),
• temsirolimus (for cancer),
• sirolimus, everolimus (to prevent graft rejection),
• vildagliptin (used to treat type 2 diabetes),
• racecadotril (used for diarrhoea).

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 information under the headings “Do not take Ramipril Sandoz” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medicines. These may be affected by ramipril:

• medicines for treating diabetes such as glucose-lowering medicines and insulin. Ramipril may reduce your blood sugar levels. Monitor your blood sugar levels closely while taking ramipril,
• lithium (for treating mental health conditions). Ramipril may increase lithium levels in your blood. Your doctor will closely monitor your blood lithium levels.

If any of the above conditions apply to you (or you are unsure), talk to your doctor before taking ramipril.

Taking Ramipril Sandoz with food, drink, and alcohol

Drinking alcohol while taking ramipril may make you feel dizzy or lightheaded. If you are concerned about how much alcohol you can drink while taking ramipril, talk to your doctor about how blood pressure-lowering medicines and alcohol may have additive effects. Ramipril can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant (or suspect you might be).

You must not take ramipril during the first 12 weeks of pregnancy and must not take it at all from week 13 onwards, as its use during pregnancy may cause harm to your baby. If you become pregnant while taking ramipril, inform your doctor immediately. A switch to an appropriate alternative treatment should be made before planning a pregnancy.

Breastfeeding

You must not take ramipril if you are breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

3. How to take Ramipril Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, 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 you need until your blood pressure is controlled.

The maximum daily dose is 10 mg once daily.

If you are already taking diuretics, your doctor may stop or reduce the dose of your previous diuretic before starting treatment with Ramipril Sandoz.

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 accordingly.

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 once daily. It is preferable to administer it twice daily.

Treatment after 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 once daily. It is preferable to administer 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 Sandoz than you should

Contact your doctor immediately or go to the nearest hospital emergency department, bringing this leaflet with you. Do not drive to the hospital; ask someone to take you or call an ambulance. Bring the medicine packaging with you so your doctor knows what you have taken.

If you have taken more Ramipril Sandoz than you should, contact your doctor, pharmacist, or call the Poison Information Service at telephone: 91 562 04 20, indicating the medicine and amount taken.

If you forget to take Ramipril Sandoz

If you forget to take a dose, take your next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Stop taking Ramipril Sandoz and go immediately to a doctor if you notice any of the following serious adverse effects, as you may need urgent medical treatment:

• swelling of the face, lips or throat which may make swallowing or breathing difficult, as well as itching and rash. This may be a sign of a serious allergic reaction to ramipril,
• 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).

Contact your doctor immediately if you experience:

• faster heartbeat, irregular or forceful 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 longer than normal, any sign of bleeding (e.g. from the gums), purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, dizzy or pale. These may be symptoms of blood or bone marrow problems,
• severe stomach pain that may spread to your back. This may be a sign of acute pancreatitis (inflammation of the pancreas),
• fever, chills, tiredness, loss of appetite, stomach pain, nausea (feeling like vomiting), 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 get worse or last longer than a few days.

Common (may affect up to 1 in 10 people)

• headache or feeling tired,
• dizziness. This is more likely when you first start taking ramipril 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, shortness of breath,
• stomach or abdominal pain, diarrhoea, indigestion, feeling unwell,
• skin rash, with or without raised areas,
• chest pain,
• muscle cramps or pain,
• blood tests showing higher than normal potassium levels in your blood.

Uncommon (may affect up to 1 in 100 people)

• balance problems (dizziness),
• itching and abnormal skin sensations such as numbness, tingling, pricking, burning, chills on your skin (paraesthesia),
• loss or changes in taste,
• difficulty sleeping,
• feeling sad, anxious, unusually nervous or tired,
• stuffy nose, difficulty breathing or worsening of asthma,
• swelling in your abdomen known as “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 heartbeat,
• 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,
• increase in certain 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 peeling or shedding of the skin, raised rash, itching,
• nail problems (e.g. loss or separation of a 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 or platelets or in the amount of haemoglobin.

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

• increased sensitivity to sunlight.

Other reported adverse effects

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

• difficulty concentrating,
• swelling of the mouth,
• blood tests show very low numbers of blood cells,
• blood tests show lower than normal sodium levels,
• concentrated urine (dark colour), feeling unwell or nausea, muscle cramps, confusion and seizures which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible,
• fingers of hands and feet change colour in cold conditions 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 directly 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 Sandoz

Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original packaging.

Do not use Ramipril Sandoz after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, 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 Sandoz

• The active substance is ramipril.

Ramipril Sandoz 2.5 mg tablets: each tablet contains 2.5 mg of ramipril.

Ramipril Sandoz 5 mg tablets: each tablet contains 5 mg of ramipril.

Ramipril Sandoz 10 mg tablets: each tablet contains 10 mg of ramipril.

• Ramipril Sandoz 2.5 mg tablets:

The other components are pregelatinized corn starch (corn starch), microcrystalline cellulose, silicon dioxide, glycine hydrochloride, glycerol dibehenate and yellow iron oxide (E-172).

• Ramipril Sandoz 5 mg tablets:

The other components are pregelatinized corn starch (corn starch), microcrystalline cellulose, silicon dioxide, glycine hydrochloride, glycerol dibehenate and red iron oxide (E-172).

• Ramipril Sandoz 10 mg tablets:

The other components are pregelatinized corn starch (corn starch), microcrystalline cellulose, silicon dioxide, glycine hydrochloride and glycerol dibehenate.

Appearance of the product and contents of the pack

Ramipril Sandoz 2.5 mg tablets are elongated, yellowish, slightly mottled tablets, scored on one side, supplied in packs of 28, 56 or 500 tablets packed in aluminium/aluminium blisters or strips.

Ramipril Sandoz 5 mg tablets are elongated, pink, slightly mottled tablets, scored on one side, supplied in packs of 28, 56 or 500 tablets packed in aluminium/aluminium blisters or strips.

Ramipril Sandoz 10 mg tablets are elongated, white or almost white tablets, scored on one side, supplied in packs of 28 or 500 tablets packed in aluminium/aluminium blisters or strips.

The tablet can be divided into two equal doses.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A. Parque Norte Business Park Roble Building C/ Serrano Galvache, 56 28033 Madrid Spain

Manufacturer

LEK, S.A. Ul Domaniewska 50 C PL02-672 Warsaw Poland

or

LEK, S.A. Ul Podlipie, 16 (Stryków) PL95 – 010 Poland

Date of the most recent revision of this summary: October 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es