RAMIPRIL SANDOZ 2.5 mg TABLETS

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

1. What is Ramipril Sandoz and what is it 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 by:

• reducing the production in your body of substances 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 Sandoz 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 or not you have diabetes),

• to treat your heart when it cannot pump enough blood to the rest of your body (heart failure),

(heart failure),

• as a treatment following a heart attack (myocardial infarction) complicated by heart failure.

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

Do not take Ramipril Sandoz:

• if you are allergic to ramipril, any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction can include a 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 intense itching, urticaria, 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 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 may not be suitable for you,
• if you have a narrowing of the renal artery (renal artery stenosis) which reduces blood flow to your kidneys,
• if you are more than 3 months pregnant. In addition, it is recommended to avoid ramipril at the start 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 impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are taking any of the following medicines, the risk of angioedema may be increased:

• 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.

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 cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Ramipril Sandoz

• if you have heart, liver or kidney problems,
• if you have lost a lot of body fluids (e.g. due to vomiting, diarrhea, excessive sweating, low-salt diet, long-term diuretic use, or dialysis),
• if you are going to have a 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 your treatment one day beforehand; talk to your doctor,
• if you have high levels of potassium in your blood (as shown by blood test results),
• if you are taking medicines or have a condition that may lower sodium levels in your blood. Your doctor may perform regular blood tests, particularly to monitor sodium levels in your blood, especially if you are an elderly patient.
• if you are taking medicines that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin, neprilysin inhibitors (NEP) (e.g. racecadotril) or sacubitril/valsartán. For sacubitril/valsartán, see section 2 “Do not take Ramipril Sandoz”.
• if you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus,
• tell your doctor if you are pregnant (or think 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:
• 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 because the safety and efficacy of ramipril in children have not yet been established.

If any of the above conditions apply to you (or you are not sure), 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 take any other medicines. This is because ramipril may affect the way some other medicines work. Also, some medicines may affect the way ramipril works.

Tell your doctor if you have taken or are taking any of the following medicines, which may make ramipril work less well:

• medicines used to relieve pain and inflammation (e.g. 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.

Tell your doctor if you are taking any of the following medicines. These may increase the chance of side effects when taken with ramipril:

• Sacubitril/valsartán: 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 indometacin and aspirin),
• medicines used to treat cancer (chemotherapy),
• medicines used to prevent organ rejection after a transplant such as ciclosporin,

• diuretics such as furosemide,
• medicines that may increase potassium levels in your blood such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to thin the blood),
• steroid medicines for inflammation such as prednisolone,
• allopurinol (used to reduce uric acid in your blood),
• procainamide (for heart rhythm problems),
• temsirolimus (for cancer),
• sirolimus, everolimus (to prevent graft rejection),
• vildagliptin (used to treat type 2 diabetes),
• racecadotril (used to treat diarrhea),
• your doctor may need to change 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 Sandoz” and “Warnings and precautions”).

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

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

If any of the above conditions apply to you (or you are not sure), talk to your doctor before taking ramipril.

Taking Ramipril Sandoz with food and drink and alcohol

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

Pregnancy and breastfeeding

Pregnancy

You should tell your doctor if you are pregnant (or think you might be).

You must not take ramipril during the first 12 weeks of pregnancy and you must not take it at all after the 13th week, as it may cause serious harm to your baby. If you become pregnant while taking ramipril, tell your doctor immediately. A switch to a suitable alternative treatment should be made before planning a pregnancy.

Breastfeeding

You must not take ramipril if you are breastfeeding.

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

Driving and using machines

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

3. How to take Ramipril Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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, your doctor may stop or reduce the amount of diuretic you were taking before starting treatment with Ramipril Sandoz.

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 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 are taking.

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 are taking.

The maximum daily dose is 10 mg once a day. It is best taken twice a day.

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 are taking.

The usual dose is 10 mg once a day. It is best taken twice a day.

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 Sandoz than you should

Consult your doctor immediately or go to the nearest hospital casualty department, taking this leaflet with you. Do not drive to the hospital, ask someone to drive you or call an ambulance. Take the medicine pack with you.

If you have taken more Ramipril Sandoz than you should, contact your doctor, pharmacist, or poison control center immediately, stating the medicine and the amount taken.

If you forget to take Ramipril Sandoz

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, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Ramipril Sandoz and go immediately to a doctor 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,
• severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin condition, 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 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 normal, sore throat, and fever, feeling tired, dizzy, or pale skin. These can be symptoms of blood or bone marrow problems,
• severe stomach pain that can radiate to your back. This can be a symptom of acute pancreatitis (inflammation of the pancreas),
• fever, chills, tiredness, 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 worsen or last more than a few days.

Frequent(may affect up to 1 in 10 patients)

• headache or feeling tired,
• feeling dizzy. This is more likely to occur when you start taking ramipril 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, or bronchitis, shortness of breath,
• stomach pain or abdominal pain, diarrhea, indigestion, feeling sick,
• rash on the skin, with or without raised areas,
• chest pain,
• cramps or muscle pain,
• blood tests showing higher than normal potassium levels in your blood.

Uncommon(may affect up to 1 in 100 patients)

• balance problems (vertigo),
• itching and abnormal sensations on the skin such as numbness, tingling, pinching, burning, or chilliness on your 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,
• a swelling in your abdomen called "intestinal angioedema" that 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 decreased 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 impotence in males, decreased sexual desire in males or females,
• increased number of certain white blood cells (eosinophilia) found during a blood test,
• blood tests show changes in the way your liver, pancreas, or kidneys are working.

Rare(may affect up to 1 in 1,000 patients)

• feeling insecure or confused,
• redness and swelling of the tongue,
• scaling or severe peeling of the skin, rash, swelling, itching,
• nail problems (e.g., loss or separation of a nail from its bed),
• rash or bruising on the skin,
• redness on your skin and cold extremities,
• redness, itching, swelling, and tearing of the eyes,
• hearing changes and noises in your ears,
• feeling weak,
• blood tests show a decrease in the number of red blood cells or platelets or the amount of hemoglobin.

Very Rare(may affect up to 1 in 10,000 patients)

• being more sensitive to the sun than usual.

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 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 convulsions that can be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible,
• your fingers and toes change color when cold and feel tingling or pain when warming up (Raynaud's phenomenon),
• enlargement of the breast in males,
• 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 does not appear in this prospectus. You can also report them directly 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 Sandoz

Keep out of sight and reach of children.

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

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ramipril Sandoz

• The active ingredient 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 ingredients are pregelatinized cornstarch, microcrystalline cellulose, silicon dioxide, glycine hydrochloride, glycerol dibehenate, and yellow iron oxide (E-172).

• Ramipril Sandoz 5 mg tablets:

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

• Ramipril Sandoz 10 mg tablets:

The other ingredients are pregelatinized cornstarch, microcrystalline cellulose, silicon dioxide, glycine hydrochloride, and glycerol dibehenate.

Appearance and Packaging of the Product

Ramipril Sandoz 2.5 mg tablets are elongated, yellowish in color, slightly speckled, scored on one side, and come in packages of 28, 56, or 500 tablets packaged in aluminum/aluminum blisters or strips.

Ramipril Sandoz 5 mg tablets are elongated, pink in color, slightly speckled, scored on one side, and come in packages of 28 or 500 tablets packaged in aluminum/aluminum blisters or strips.

Ramipril Sandoz 10 mg tablets are elongated, white or almost white, and scored on one side, and come in packages of 28 or 500 tablets packaged in aluminum/aluminum blisters or strips.

The tablet can be divided into two equal doses.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A. Centro Empresarial Parque Norte

Edificio Roble

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 (Strykow)

PL95 – 010

Poland

Date of the Last Revision of this Prospectus: October 2019

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