RAMIPRIL TEVAGEN 10 mg TABLETS

Introduction

Patient Information Leaflet: Information for the Patient

Ramipril Tevagen10mg tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you

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

Contents of the Leaflet

1. What Ramipril Tevagen tablets are and what they are used for
2. What you need to know before taking Ramipril Tevagen tablets
3. How to take Ramipril Tevagen tablets
4. Possible side effects
5. Storage of Ramipril Tevagen tablets
6. Package contents and additional information

1. What Ramipril Tevagen tablets are and what they are used for

Ramipril Tevagen contains a medication called ramipril. This belongs to a group of medications called ACE inhibitors (Angiotensin-Converting Enzyme Inhibitors).

Ramipril works as follows:

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

Ramipril 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 (both in patients with and without 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 Tevagen tablets

Do not take Ramipril Tevagen

• If you are allergic to ramipril, any other ACE inhibitor, or any of the other components of this medication listed in section 6. The symptoms of an allergic reaction can include rash, swallowing or breathing problems, 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 are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Ramipril Tevagen may not be suitable for you.
• If you have kidney problems when the blood flow to your kidneys is reduced (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 medication that contains aliskiren.
• 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 areas such as the throat) is high.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ramipril Tevagen:

• If you have heart, liver, or kidney problems
• If you have lost a lot of minerals or fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, long-term diuretic use, or dialysis)
• If you are going to undergo treatment to reduce your allergy to bee or wasp stings (desensitization)
• If you are taking any of the following medications used to treat high blood pressure:
• • An angiotensin II receptor antagonist (ARA) (also known as "sartans", e.g., valsartan, telmisartan, ibersartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren.

Your doctor may need to 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 Tevagen"

• If you are going to receive an anesthetic. This may be due to an operation or any dental work. You may need to stop taking Ramipril Tevagen 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 any of the following medications, the risk of angioedema, a severe allergic reaction (sudden swelling under the skin in areas such as the throat), may increase:
• • Racecadotril, a medication used to treat diarrhea.
  • Medications used to prevent organ transplant rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medication used to treat diabetes.

• If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus
• Tell your doctor if you think you are (or might become) pregnant. Ramipril Tevagen is not recommended in the first 3 months of pregnancy, and it may cause serious harm to your baby if used after 3 months of pregnancy (see section "Pregnancy and breastfeeding").

Children and adolescents

The use of Ramipril Tevagen in children and adolescents under 18 years of age is not recommended because the safety and efficacy of Ramipril Tevagen in children have not yet been established.

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

Using Ramipril Tevagen with other medicationsInform your doctor or pharmacist if you are taking, have recently taken, or might take any other medication. This is because Ramipril Tevagen may affect how some other medications work. Similarly, some medications may affect how Ramipril Tevagen works.

Tell your doctor if you are taking any of the following medications. These may make Ramipril Tevagen work less effectively:

• Medications used to relieve pain and inflammation (e.g., non-steroidal 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.

Tell your doctor if you are taking any of the following medications. These may increase the risk of side effects if taken with Ramipril Tevagen:

• Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 "Do not take Ramipril Tevagen").
• Medications used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin)
• Cancer medications (chemotherapy)
• Diuretics such as furosemide
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to thin the blood to prevent clots).
• Steroid medications for inflammation such as prednisolone
• Allopurinol (used to decrease uric acid in your blood)
• Procainamide (for treating heart rhythm problems).
• Medications used to prevent organ transplants (Sirolimus, everolimus, and other medications belonging to the group of mTOR inhibitors). See section "Warnings and precautions".
• Vildagliptin (used to treat type 2 diabetes)
• Racecadotril (used for diarrhea)

Your doctor may need to adjust your dose and/or take other precautions:

Tell your doctor if you are taking any of the following medications. These may be affected by Ramipril Tevagen:

• Medications for treating diabetes such as glucose-lowering medications and insulin. Ramipril Tevagen may lower your blood sugar levels. Monitor your blood sugar levels closely while taking Ramipril Tevagen.
• Lithium (for treating mental health problems). Ramipril Tevagen may increase the levels of lithium in your blood. Your doctor will closely monitor your lithium levels in your blood.

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

Taking Ramipril Tevagen with food, drinks, and alcohol

• Drinking alcohol with Ramipril Tevagen may make you feel dizzy or drowsy. If you are concerned about how much you can drink while taking Ramipril Tevagen, talk to your doctor about how blood pressure medications and alcohol can have additive effects, which may cause excessive blood pressure reduction.
• Ramipril Tevagen can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You must inform your doctor if you are pregnant (or think you might be). You should not take Ramipril Tevagen during the first 12 weeks of pregnancy, and you should not take it at all after the 13th week, as its use during pregnancy may harm your baby. If you become pregnant while taking Ramipril Tevagen, consult your doctor immediately. In a planned pregnancy, a switch to an alternative treatment should be made.

Breastfeeding

You should not take Ramipril Tevagen if you are breastfeeding.

Driving and using machines

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

Ramipril Tevagen contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Ramipril Tevagen contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

3. How to take Ramipril Tevagen tablets

Follow the administration instructions for this medication indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much to take

Treatment of 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 should take to control your blood pressure.
• The maximum 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.

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 dose is 10 mg once a day. It is preferable to administer it twice a day.

Treatment after having 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.

Elderly 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 each day.
• Swallow the tablets with liquid.
• Do not crush or chew the tablets.
• The tablets can be divided into equal doses

If you take more Ramipril Tevagen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

Do not drive to the hospital, ask someone to take you or call an ambulance. Bring the medication packaging with you. This way, your doctor will know what you have taken.

If you forget to take Ramipril Tevagen

If you forget to take a dose, take your normal dose when it is time for your next one.

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

If you have any other questions about the use of this medication, 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 Tevagen 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 Tevagen.
• Severe skin reactions including rash, ulcers in your mouth, 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).

Inform 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., bleeding 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 pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, 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:

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

Frequent(may affect up to 1 in 10 people)

• Headache or feeling tired.
• Feeling dizzy. This is more likely to occur when you start taking Ramipril Tevagen or when you start taking a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or feeling quickly.
• Dry, irritating cough, sinus inflammation, or bronchitis, shortness of breath.
• Stomach 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 people)

• 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.
• Nasal congestion, difficulty breathing, or worsening asthma.
• 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.
• Pain in your joints.
• Fever.
• Sexual dysfunction in males, decreased sexual desire in males or females.
• Increased number of certain white blood cells in the blood (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 people)

• Feeling insecure or confused.
• Redness and swelling of the tongue.
• Severe peeling or shedding of the skin, itching, rash with lumps.
• Nail problems (e.g., loss or separation of a nail from its bed).
• Rash on the skin or bruising.
• Redness on your skin and cold extremities.
• Redness, itching, swelling, and tearing of the eyes.
• Hearing disturbances and noises in your ears.
• Feeling weak.
• Blood tests show a decrease in the number of red blood cells, white blood cells, or platelets, or in the amount of hemoglobin.

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

• Being more sensitive to the sun than usual.

Other reported adverse effects:

Inform your doctor if any of the following effects 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-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.
• Fingers on your hands and feet change color when cold and feel tingling or pain when warming up (Raynaud's phenomenon).
• Enlargement of the chest in males.
• Slowness or difficulty reacting.
• Burning sensation.
• Change in the smell of things.
• Hair loss.

Reporting of 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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ramipril Tevagen Tablets

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the blister pack after "EXP.". 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 and light.

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 way, you will help protect the environment.

6. Package contents and additional information

Composition of Ramipril Tevagen

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

Appearance of theproductand package contents

Ramipril Tevagen 10 mg are white or almost white, round, biconvex tablets with a break line on one side and a diameter of 9.0 mm.

Blister packs (Aluminum/Aluminum).

Packages with 7, 20, 21, 28, 30, 50, 56, 60, 90, 98, 100, 50x1 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 - Madrid

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

Teva Operations Poland S.p. z.o.o.

Ul. Mogilska 80, 31-546 Kraków

Poland

This medicine is authorized in the Member States under the following names:

Denmark: Ramipril Teva

Spain: Ramipril Tevagen 10 mg EFG tablets

Greece: Ramipril Teva 10 mg δισκ?α

Netherlands: Ramipril Teva 10 mg tablets

Ireland: Ramipril Teva Pharma 10 mg Tablets

Norway: Ramipril Teva

Poland: Ramiprilum 123ratio

Portugal: Ramipril Teva

United Kingdom: Ramipril 10 mg Tablets

Romania: Ramipril Teva 10 mg comprimate

Sweden: Ramipril Teva

Date of the last revision of this prospectus: August 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/