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 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Ramipril Sandoz

4. Possible side effects

5. Storage of Ramipril Sandoz

6. Contents of the pack and additional information

Ramipril Sandoz contains a medicine called ramipril. This belongs to a group of

medicines called angiotensin-converting enzyme (ACE) inhibitors.

Ramipril Sandoz works in the following way:

• by reducing the production in the body of certain substances that could increase blood pressure,
• by relaxing and widening blood vessels,
• making it easier for the heart to pump blood through the body.

Ramipril Sandoz can 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 Sandoz:

• If you are allergic to ramipril, any angiotensin-converting enzyme (ACE) inhibitor, or any of the other ingredients in this medication (listed in section 6). Symptoms of an allergic reaction may include a 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”. Symptoms include itching, hives, 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 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 undergoing 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 (stenosis),
• If you are more than 3 months pregnant. Additionally, it is best 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 medication to lower blood pressure that contains aliskiren.

If you are taking any of the following medications, the risk of angioedema may increase:

-Racecadotril, a medication used to treat diarrhea.

• Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).

-Vildagliptin, a medication used to treat type 2 diabetes.

Particularly, 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) and diuretics that save potassium, and other medications that may increase the amount of potassium in your blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to thin the blood to prevent clots).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ramipril Sandoz

• If you have heart, liver, or kidney problems,
• If you have lost a lot of minerals or fluids (e.g., due to vomiting, diarrhea, excessive sweating, being on a low-sodium diet, taking diuretics for a long time, or being on dialysis),
• If you are undergoing desensitization treatment for bee or wasp stings,
• If you are to receive an anesthetic. This may be due to surgery 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 a condition that may decrease the levels of sodium in your blood. Your doctor may perform blood tests periodically, particularly to monitor your sodium levels in the blood, especially if you are an elderly patient.
• If you are taking medications that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus) or vildagliptin, NEP inhibitors (e.g., 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 may be). Ramipril is not recommendedduring 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 medications 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 need to monitor your renal function, blood pressure, and electrolyte levels in the blood (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 been established.

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

Taking Ramipril Sandoz 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 may affect how some other medications work. Similarly, some medications may affect how ramipril works.

Inform your doctor if you have taken or are taking any of the following medications, which may make ramipril less effective:

• 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 possibility of adverse effects if taken 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”),

• Medications used to relieve pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin),
• Medications for cancer treatment (chemotherapy),
• Medications to prevent organ transplant rejection such as

ciclosporina,

• Diuretics such as furosemide,
• Medications that may increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to thin the blood),
• Medications for inflammation such as prednisolone,
• Allopurinol (used to decrease uric acid in the 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 modify 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”).

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

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

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

Taking Ramipril Sandoz with food and drinks and alcohol

Drinking alcohol with ramipril may make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking ramipril, speak with your doctor about how medications used to lower blood pressure 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 may be).

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

Breastfeeding

You should not take ramipril if you are breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machines

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

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

How much medication to take

Hypertension treatment

The usual starting dose is 1.25 mg or 2.5 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, your doctor may stop or reduce the amount of diuretic you were taking previously before starting treatment with Ramipril Sandoz.

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 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.

Treatment for 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 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 once a day. It is preferable to administer it twice a day.

Older patients

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

Taking 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 Sandoz than you should

Consult your doctor immediately or go to the nearest hospital emergency room, accompanied by this leaflet. Do not drive to the hospital, ask someone to take you or call an ambulance. Bring the packaging of the medication with you. So your doctor will know what you have taken.

If you have taken more Ramipril Sandoz than you should, consult your doctor, your pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Ramipril Sandoz

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 make up for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Ramipril Sandoz and seek immediate medical attention if you notice any of the following severe side effects, which may require urgent medical treatment:

• Swelling of the face, lips, or throat that may make it difficult to swallow or breathe, as well as itching and hives. This may be a sign of a severe allergic reaction to ramipril,
• Severe skin reactions, including rashes, mouth ulcers, 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 may be symptoms of lung problems,
• Easy bruising, prolonged bleeding, any sign of bleeding (e.g., from the gums), purple spots on the skin, or catching infections more easily than normal, sore throat, and fever, feeling tired, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow problems,
• Severe stomach pain that may radiate to the back. This may be a sign of acute pancreatitis (inflammation of the pancreas),
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (urge to vomit), 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 side effects include

Inform 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,
• Sensation of dizziness. This is more likely to occur when starting to take ramipril or when starting a higher dose,

• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly,
• Irrespiratory cough, sinusitis, or bronchitis, shortness of breath,
• 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 higher-than-normal potassium levels in the blood.

Poorly frequent(may affect up to 1 in 100 patients)

• Balance problems (vertigo),
• Itching and abnormal sensations in the skin, such as numbness, tingling, pinching, burning, or chills (paresthesia),
• Loss or changes in the taste of things,
• Difficulty sleeping,
• Feeling sad, anxious, more nervous than normal, or tired,
• Stuffy 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 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 water than normal.
• Redness,
• Blurred vision,
• Joint pain,
• Fever
• Sexual dysfunction in men, decreased libido in men or women,
• Increased number of 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 patients)

• Feeling insecure or confused,
• Redness and swelling of the tongue,
• Severe scaling or peeling of the skin, hives, swelling,
• Nail problems (e.g., loss or separation of a nail from its bed),
• Hives or bruises on the skin,
• Redness in the skin and cold extremities,
• Redness, itching, swelling, and tearing of the eyes,
• Changes in hearing 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 hemoglobin.

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

• Increased sensitivity to the sun.

Other side effects reported

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

• Difficulty concentrating,
• Swelling of the mouth,
• Blood tests show very few blood cells,
• Blood tests show less sodium than normal,
• Concentrated urine (dark color), feeling unwell or nauseous, muscle cramps, confusion, and seizures that may be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible,
• Fingers of the 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 themdirectly 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 the 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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at 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 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 components are maize pregelatinised starch (maize starch), microcrystalline cellulose, silicon dioxide, glycine hydrochloride, glycerol dibehenate and yellow iron oxide (E-172).

• Ramipril Sandoz 5 mg tablets:

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

• Ramipril Sandoz 10 mg tablets:

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

Appearance of the product and contents of the package

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

Ramipril Sandoz 5 mg tablets are elongated tablets, pinkish in color, slightly speckled, scored on one of the two sides and are presented in packages of 28, 56 or 500 tablets in blisters of aluminum/aluminum or strips of aluminum/aluminum.

Ramipril Sandoz 10 mg tablets are elongated tablets, white or almost white and scored on one of the two sides and are presented in packages of 28 or 500 tablets in blisters of aluminum/aluminum or strips of aluminum/aluminum.

The tablet can be divided into two equal doses.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

LEK, S.A.

Ul Domaniewska 50 C

PL02-672 Warsaw

Poland

or

LEK, S.A.

Ul Podlipie, 16 (Strykow)

PL95 – 010

Poland

Last review date of this leaflet: October 2019

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