Ramipril Teva-Ratiopharm 5 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ramipril Teva-ratiopharm 2.5 mg tablets

Ramipril Teva-ratiopharm 5 mg tablets

Ramipril Teva-ratiopharm 10 mg tablets

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Ramipril Teva-ratiopharm works in the following ways:

• By decreasing 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 around your body.

Ramipril Teva-ratiopharm can 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 cannot pump enough blood to the rest of your body (heart failure)
• As treatment after a heart attack (myocardial infarction) complicated by heart failure

2. What you need to know before taking Ramipril Teva-ratiopharm

Do not take Ramipril Teva-ratiopharm:

• If you are allergic (hypersensitive) to ramipril, to any other ACE inhibitor medicine, or to any of the other components of Ramipril Teva-ratiopharm (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 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 undergoing 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 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.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, for example in the throat) is high.

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

Warnings and precautions

Check with your doctor or pharmacist before taking this medicine:

• If you have heart, liver, or kidney problems.
• If you have lost large amounts of salts or fluids (due to vomiting, diarrhea, 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 (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), 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 Teva-ratiopharm.”

• If you are to receive anesthesia, for example during surgery or dental treatment. You may need to stop taking this medicine one 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 reduce sodium levels in your blood. Your doctor may perform periodic blood tests, particularly to monitor blood sodium levels, especially in elderly patients.
• If you are of Black race, you may have a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure compared to non-Black patients.
• If you are taking any of the following medicines, the risk of developing angioedema, an allergic reaction (sudden swelling beneath the skin, for example in the throat), may increase:
  • racecadotril, a medicine used to treat diarrhea.
  • 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 collagen vascular disease such as scleroderma or systemic lupus erythematosus.
• Inform your doctor if you are pregnant (or suspect you might be). Ramipril Teva-ratiopharm is not recommended during the first 3 months of pregnancy and can cause serious harm to your baby after 3 months of pregnancy (see section “Pregnancy and breastfeeding”).

Children and adolescents

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

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

Other medicines and Ramipril Teva-ratiopharm

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

Inform your doctor if you have taken or are currently taking any of the following medicines, which may reduce the effectiveness of Ramipril Teva-ratiopharm:

• 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 adverse effects when taken with Ramipril Teva-ratiopharm:

• Sacubitril/valsartan – used to treat a type of 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 indometacina, and aspirin).
• Medicines for the treatment of cancer (chemotherapy).
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Steroid medicines for inflammation such as prednisolone.
• Allopurinol (used to lower uric acid levels in your blood).
• Procainamide (to treat heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent organ transplant rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used for diarrhea).

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 Teva-ratiopharm” and “Warnings and precautions”).

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

• Medicines for 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 (used to treat mental health conditions). Ramipril Teva-ratiopharm may increase lithium levels in your blood. Your doctor will carefully monitor your blood lithium levels.

If you have any of the above conditions (or are unsure), speak with 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 lightheaded. If you are concerned about how much alcohol you can drink while taking Ramipril Teva-ratiopharm, speak with your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.
• Ramipril Teva-ratiopharm can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). You should not take ramipril during the first 12 weeks of pregnancy and must not take it at all after 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 switch to an appropriate alternative treatment should be made before planning a pregnancy.

Breastfeeding

You should not take ramipril if you are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

You may feel dizzy while taking Ramipril Teva-ratiopharm, especially when starting treatment or increasing your dose. If this occurs, do not drive or operate tools or machinery.

Ramipril Teva-ratiopharm contains lactose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

Ramipril Teva-ratiopharm contains sodium

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

3. How to take Ramipril Teva-ratiopharm

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

How much medicine to take

Treatment of high blood pressure

• The recommended 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 diuretic before starting treatment with ramipril.

To reduce the risk of having a heart attack or stroke

• The recommended 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 recommended 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 recommended 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 per day. 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 Ramipril Teva-ratiopharm tablets whole, with liquid.
• Do not crush or chew the tablets.

If you take more Ramipril Teva-ratiopharm than you should

Contact 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 take you or call an ambulance. Bring the medicine packaging with you. This way, your doctor will know what you have taken.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ramipril Teva-ratiopharm

• 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 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 everyone experiences 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 may make it difficult to swallow or breathe, along with itching and rash. This may be a sign of a severe allergic reaction to Ramipril Teva-ratiopharm.
• Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin disease, redness, blisters, or skin peeling (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 signs of lung problems.
• Easy bruising, bleeding that lasts longer than normal, any sign of bleeding (e.g., from gums), purple spots on the skin, or increased susceptibility to infections, sore throat and fever, feeling tired, dizzy, or pale skin. These may be symptoms of blood or bone marrow problems.
• Severe stomach pain that may radiate 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 sick), yellowing of the skin or eyes (jaundice). These may be symptoms of liver problems such as hepatitis (liver inflammation) or liver damage.

Other adverse effects include:

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

Common (may affect up to 1 in 10 patients)

• Headache or feeling tired
• Dizziness. This is more likely when you first start taking Ramipril Teva-ratiopharm 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, nasal sinus inflammation (sinusitis), or bronchitis, shortness of breath
• Stomach or abdominal pain, diarrhea, 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 patients)

• Balance problems (dizziness)
• Itching and abnormal skin sensations such as numbness, tingling, prickling, burning, or chills on your skin (paresthesia)
• Loss or changes in taste
• Trouble sleeping
• Feeling sad, anxious, more nervous than usual, or tired
• Nasal congestion, difficulty breathing, or worsening of asthma
• Swelling in the abdomen known as “intestinal angioedema,” with symptoms such as abdominal pain, vomiting, and diarrhea
• Heartburn, constipation, or dry mouth
• Urinating more than normal during the day
• Kidney failure, acute renal failure
• 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 fluid than normal
• Flushing
• 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 blood tests
• Blood tests show changes in how your liver, pancreas, or kidneys are functioning

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

• Feeling unsteady or confused
• Redness and swelling of the tongue
• Severe skin peeling or shedding, 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 red blood cells or platelets, or in hemoglobin levels

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

Increased sensitivity to sunlight.

Not known: frequency cannot be estimated from the available data

• Concentrated urine (dark-colored), malaise, muscle cramps, confusion, and seizures, which 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 levels of antibodies
• Blood tests show very few blood cells
• Blood tests show lower than normal sodium levels
• Fingers of hands and feet change color 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister and packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

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. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ramipril Teva-ratiopharm 2.5 mg

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

Composition of Ramipril Teva-ratiopharm 5 mg

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

Composition of Ramipril Teva-ratiopharm 10 mg

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

Appearance of the product and contents of the pack

Ramipril Teva-ratiopharm 2.5 mg tablets

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

Ramipril Teva-ratiopharm 5 mg tablets

Pink, round, biconvex tablets with a break 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 break line on one side and a diameter of 9.0 mm.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in the European Economic Area Member States under 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 latest review of this leaflet: March 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66451/P_66451.html

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