RAMIPRIL TEVA-RATIOPHARM 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Ramipril Teva-ratiopharm 2.5 mg Tablets

Ramipril Teva-ratiopharm 5 mg Tablets

Ramipril Teva-ratiopharm 10 mg Tablets

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

1. What is Ramipril Teva-ratiopharm and what is it used for

Ramipril Teva-ratiopharm contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).

Ramipril Teva-ratiopharm works in the following way:

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

Ramipril Teva-ratiopharm 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 is not pumping 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 you take Ramipril Teva-ratiopharm

Do not take Ramipril Teva-ratiopharm:

• If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor or any of the other ingredients of Ramipril Teva-ratiopharm (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 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 are having dialysis or any other type of blood filtration. Depending on the machine used, Ramipril Teva-ratiopharm may not be suitable for you.
• If you have kidney problems when the blood supply 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 impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
• 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 areas such as the throat) is increased.

Do not take Ramipril Teva-ratiopharm if you have any of the above conditions. If you are unsure, talk to your doctor before taking Ramipril Teva-ratiopharm.

Warnings and precautions

Check with your doctor or pharmacist before taking your medicine:

• 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, long-term diuretic use, or dialysis)

If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization).

• 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), especially if you have diabetes-related kidney problems.
• aliskiren.

Your doctor may need to check 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 Teva-ratiopharm”

• If you are going to receive an anesthetic. This may be due to an operation or any dental treatment. You may need to stop taking Ramipril Teva-ratiopharm a day before; consult your doctor.

• If you have high levels of potassium in your blood (detected in blood test results)
• If you are taking medicines or have conditions that decrease sodium levels in your blood. Your doctor may perform periodic blood tests, especially to monitor sodium levels in your blood, particularly in elderly patients.

• If you are black, you may have a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure in non-black patients.

• If you are taking any of the following medicines, the risk of angioedema, an allergic reaction (sudden swelling under the skin in areas such as the throat), may increase:
• • racecadotril, a medicine used to treat diarrhea.
  • medicines used to prevent organ transplant 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.
• Tell your doctor if you are pregnant (or think you might be). Ramipril Teva-ratiopharm is not recommended in the first 12 weeks of pregnancy and should not be taken after the 13th week, as it may cause harm to your baby. If you become pregnant while taking ramipril, inform your doctor immediately. A switch to a suitable alternative treatment should be made before planning a pregnancy.

Children and adolescents

Ramipril Teva-ratiopharm is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy of Ramipril Teva-ratiopharm in children have not yet been established.

If you have any of the above conditions (or are unsure), talk to your doctor before taking Ramipril Teva-ratiopharm.

Other medicines and Ramipril Teva-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril Teva-ratiopharm may affect the way some other medicines work. Also, some medicines may affect the way Ramipril Teva-ratiopharm works.

Tell your doctor if you have taken or are taking any of the following medicines, as they may make Ramipril Teva-ratiopharm 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. They may increase the chance of side effects when taken with Ramipril Teva-ratiopharm:

• Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril Teva-ratiopharm”
• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin and aspirin).
• Cancer medicines (chemotherapy)

• Diuretics such as furosemide.
• 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; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots).

• Steroid medicines for inflammation such as prednisolone.
• Allopurinol (used to decrease uric acid in your blood)

• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer)
• Sirolimus, everolimus (for preventing transplant rejection)
• Vildagliptin (used to treat type 2 diabetes)
• Racecadotril (used for 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 Teva-ratiopharm” and “Warnings and precautions”).

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

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

If you have any of the above conditions (or are unsure), talk to your doctor before taking Ramipril Teva-ratiopharm.

Taking Ramipril Teva-ratiopharm with food, drinks, and alcohol

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

Pregnancy and breast-feeding

Pregnancy

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

Breast-feeding

You should not take ramipril if you are breast-feeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

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

Ramipril Teva-ratiopharm contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Ramipril Teva-ratiopharm contains sodium

This medicine contains less than 1mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Ramipril Teva-ratiopharm

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

How much to take

Treatment of high blood pressure

• The recommended 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.

Reducing the risk of heart attack or stroke

• The recommended 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 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 recommended 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. It is preferable to administer it twice a day.

Treatment after having a heart attack

• The recommended 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 a day. It is preferable to administer it twice a day.

Elderly patients

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

Taking this medicine

• Take this medicine orally at the same time each day.
• Swallow the Ramipril Teva-ratiopharm tablets whole, with liquid.
• Do not crush or chew the tablets.

If you take more Ramipril Teva-ratiopharm than you should

Consult your doctor immediately or go to the nearest hospital emergency 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. This will help your doctor know what you have taken.

You can also call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Ramipril Teva-ratiopharm

• 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 forgotten doses.

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

4. Possible Adverse Effects

Like all medicines, Ramipril Teva-ratiopharm can cause adverse effects, although not all people suffer from them.

Stop taking Ramipril Teva-ratiopharm and go to a doctor immediately if you notice any of the following serious adverse effects, as 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 Teva-ratiopharm.
• 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 signs of lung problems.
• Easy bruising, bleeding for a longer time 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 the back. This can be a symptom of acute pancreatitis (inflammation of the pancreas)
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (vomiting), yellow 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 symptoms 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 Teva-ratiopharm 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, 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 the 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 chills on the skin (paresthesia)
• Loss or changes in taste
• Sleep problems
• Feeling sad, anxious, more nervous than usual, or tired
• Nasal congestion, 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 often during the day
• Kidney failure, acute kidney failure
• 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
• Pain in the joints
• Fever
• Sexual dysfunction in men, decreased sexual desire in men or women
• Increased number of certain white blood cells in the blood (eosinophilia) found during a blood test.
• Blood tests show changes in how the 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.
• Severe skin peeling or shedding, rash, swelling, itching,
• Nail problems (e.g., loss or separation of a 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 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)

Being more sensitive to the sun than usual.

Unknown:cannot be estimated from the available data

• Concentrated urine (dark-colored), discomfort, muscle cramps, confusion, and convulsions that may be due to inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, consult your doctor as soon as possible.
• Difficulty concentrating
• Mouth pain
• Blood tests may show elevated antibody levels
• Blood tests show very few blood cells
• Blood tests show lower than normal sodium levels
• Fingers on the hands and feet change color when cold and feel tingling or pain when warming up (Raynaud's phenomenon)
• Chest enlargement 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, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. 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 Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and carton after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C

Keep in the original packaging to protect it from moisture.

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. 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 Teva-ratiopharm 2.5 mg

• The active ingredient is ramipril. Each tablet contains 2.5 mg of ramipril.
• The other ingredients (excipients) are: lactose monohydrate, sodium hydrogen carbonate, sodium croscarmellose, pregelatinized starch (from corn), sodium stearyl fumarate, and yellow iron oxide (E-172).

Composition of Ramipril Teva-ratiopharm 5 mg

• The active ingredient is ramipril. Each tablet contains 5 mg of ramipril.
• The other ingredients (excipients) are: lactose monohydrate, sodium hydrogen carbonate, sodium croscarmellose, pregelatinized starch (from corn), sodium stearyl fumarate, yellow iron oxide (E-172), and red iron oxide (E-172).

Composition of Ramipril Teva-ratiopharm 10 mg

• The active ingredient is ramipril. Each tablet contains 10 mg of ramipril.
• The other ingredients (excipients) are: lactose monohydrate, sodium hydrogen carbonate, sodium croscarmellose, pregelatinized starch (from corn), sodium stearyl fumarate.

Appearance of the Product and Package Contents

Ramipril Teva-ratiopharm 2.5 mg tablets

Yellow, round, biconvex tablets with a score line on one side and a diameter of 8.0 mm.

Ramipril Teva-ratiopharm 5 mg tablets

Pink, round, biconvex tablets with a score line on one side and a diameter of 6.5 mm.

Ramipril Teva-ratiopharm 10 mg tablets

White or almost white, round, biconvex tablets with a score line on one side and a diameter of 9.0 mm

Packages containing 10, 14, 20, 28, 30, 42, 50, 56, 98, and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren (Germany)

or

ACTAVIS LIMITED.BLB016

Bulebel Industrial Estate

Zejtun (Malta)

This medicine is authorized in the Member States of the European Economic Area with the following names:

Ramipril 2.5 mg tablets

Portugal: Ramipril ratiopharm 2.5 mg tablets

Spain: Ramipril Teva-ratiopharm 2.5 mg tablets

Ramipril 5 mg tablets

Portugal: Ramipril ratiopharm 5 mg tablets

Spain: Ramipril Teva-ratiopharm 5 mg tablets

Ramipril 10 mg tablets

Portugal: Ramipril ratiopharm 10 mg tablets

Spain: Ramipril Teva-ratiopharm 10 mg tablets

Date of the Last Revision of this Leaflet:March 2023

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