Patient Information Leaflet

Ramipril Tevagen5mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine. It contains important information for you.

- Keep this leaflet, as 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. Do not give it to others even if they have similar symptoms, 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 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.Contents of the pack and additional information

Ramipril Tevagen contains a medicine called ramipril. This belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

Ramipril works as follows:

- By reducing the body's production of substances that could increase its blood pressure

- By relaxing and widening its blood vessels

- By making it easier for its heart to pump blood through its 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 problems in the kidneys (both if you have diabetes or not)

- 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 Tevagen

• If you are allergic to ramipril, any other ACE inhibitor, or any of the other components of this medicine, including those listed in section 6.
  The symptoms of an allergic reaction may include 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”. The symptoms include itching, urticaria, red spots on your hands, feet, and throat, swelling of your throat and tongue, swelling around your 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 your 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 medicine to lower your blood pressure that contains 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 an area such as the throat) is high.

Do not take Ramipril Tevagen if any of the above conditions apply to you. If you are unsure, speak with 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, being on a low-salt diet, taking diuretics for a long time, or being on 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:
• • -an angiotensin II receptor antagonist (ARA) (also known as “sartanes” for example, valsartan, telmisartan, ibersartan), particularly if you have kidney problems related to diabetes.
  • -Aliskirén.

Your doctor may need to monitor your kidney function, blood pressure, and blood levels of electrolytes (such as potassium), at regular intervals.

• See also the information under the heading “Do not take Ramipril Tevagen”

• If you are to undergo an anaesthetic. This may be due to an operation or any dental work. You may need to stop taking Ramipril Tevagen for a day beforehand; 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 medicines, the risk of angioedema, a severe allergic reaction (rapid swelling under the skin in certain areas such as 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 type 2 diabetes.

• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus
• Inform your doctor if you think you may be (or could become) pregnant. Ramipril Tevagen is not recommended in the first 3 months of pregnancy, and may cause severe 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), speak with your doctor before taking Ramipril Tevagen.

Use of Ramipril Tevagen with other medicines
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because Ramipril Tevagen may affect the way some other medicines work. Also, some medicines may affect the way Ramipril Tevagen works.

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

· 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.

Inform your doctor if you are taking any of the following medicines. 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”).
• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin and aspirin)
• Medicines for cancer treatment (chemotherapy)
• Diuretics such as furosemide
• Supplements of potassium (including salt substitutes), potassium-sparing diuretics, and other medicines 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 medicine used to thin your blood to prevent clots).
• Medicines used to treat inflammation such as prednisolone
• Alopurinol (used to reduce uric acid in your blood)
• Procainamide (to treat heart rhythm problems).
• Medicines used to prevent organ transplant rejection (Sirolimus, everolimus, and other medicines that belong to the mTOR inhibitor group). See section “Warnings and precautions”.
• 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 aliskirén (see also the information under the headings “Do not take Ramipril Tevagen” and “Warnings and precautions”).

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

· Medicines used to treat diabetes such as medicines to reduce glucose and insulin. Ramipril Tevagen may reduce your blood sugar levels. Monitor your blood sugar levels closely while taking Ramipril Tevagen.

· The lithium (to treat mental health problems). Ramipril Tevagen may increase the amount of lithium in your blood. Your doctor will closely monitor your lithium blood levels.

If any of the above conditions apply to you (or you are unsure), speak with 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 disoriented. If you are concerned about how much you can drink while taking Ramipril Tevagen, speak with your doctor about how medicines used to lower blood pressure and alcohol may have additive effects, which may cause excessive lowering of blood pressure.

· Ramipril Tevagen can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or in a breastfeeding period, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you are pregnant (or suspect you may be). Do not take Ramipril Tevagen in the first 12 weeks of pregnancy, and do not take it at all after 13 weeks as its use during pregnancy may cause harm to your baby. If you become pregnant while taking Ramipril Tevagen, consult your doctor immediately. In a planned pregnancy, a suitable alternative treatment should be switched to.

Breastfeeding

Do not take Ramipril Tevagen if you are breastfeeding,

Driving and operating machines

You may feel dizzy while taking Ramipril Tevagen. This is more likely to happen when you first start taking Ramipril Tevagen or when you 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 medicine.

Ramipril Tevagen contains sodium

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

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

How much 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 dose is 10 mg once a day.

· If you are already taking diuretics, your doctor may interrupt or reduce the amount of diuretic you were taking previously 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.

Renal disease treatment

· You may 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.

Heart failure treatment

· 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 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.

How to take this medication

• Take this medication orally at the same time every 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 ingested.

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 forgot to take Ramipril Tevagen

If you forgot to take a dose, take your usual dose when it's time for the next one.

Do not take a double dose to compensate for the missed doses.

If you have any other doubts 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 Tevagen and seek immediate medical attention if you notice any of the following severe side effects - you may need 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 Tevagen.

· 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:

· A faster heart rate, irregular or strong heartbeats (palpitations), chest pain, chest tightness, or more serious problems, including heart attacks and strokes

· Difficulty breathing or coughing. These may be symptoms of lung problems

· The appearance of bruises with increased ease, prolonged bleeding, any sign of bleeding (e.g., bleeding 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 pancreatitis (inflammation of the pancreas)

· Fever, chills, fatigue, loss of appetite, stomach pain, nausea, 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 people)

· Headache or feeling tired

· Dizziness. 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 sitting quickly

· Dry, irritating cough, sinusitis (inflammation of the sinuses), or bronchitis, shortness of breath

· Stomach pain or abdominal pain, diarrhea, indigestion, feeling sick

· Skin rash with or without raised areas.

· Chest pain

· Muscle cramps or pain

· Blood tests showing high levels of potassium in the blood.

Less frequent(may affect up to 1 in 100 people)

· Balance problems (dizziness)

· 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

· Nasal congestion, difficulty breathing, or worsening of asthma

· Swelling in the abdomen known as "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea

· Heartburn, constipation, or dry mouth

· Frequent urination during the day

· Sweating more than normal

· Loss or decrease in appetite (anorexia)

· Increased heart rate 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

· Impotence in men, decreased sex drive in men or women

· Blood tests showing an increase in certain white blood cells (eosinophilia)

· Blood tests showing changes in how your liver, pancreas, or kidneys are functioning.

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

· Feeling insecure or confused

· Redness and swelling of the tongue

· Severe skin peeling or detachment, itching, hives with swelling

· Nail problems (e.g., loss or separation of a nail from its bed)

· Skin rash or bruising

· Redness and cold extremities

· Redness, itching, swelling, and tearing of the eyes

· Hearing problems and ear noises

· Feeling weak

· Blood tests showing a decrease in 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 normal.

Other side effects reported:

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

· Difficulty concentrating

· Swelling of the mouth

· Blood tests showing very few blood cells

· Blood tests showing low sodium levels

· Concentrated urine (dark color), discomfort, muscle cramps, confusion, and seizures that may be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, consult your doctor as soon as possible.

· The fingers of the hands and feet change color when it's cold and feel numbness or pain when warmed (Raynaud's phenomenon)

· Enlargement of the chest in men

· Slowness or difficulty reacting

· Feeling of burning

· Change in the smell of things

· Hair loss.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's possible side effects that don't appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthismedicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after "CAD.:". The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect it from moisture and light.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Ramipril Tevagen

·The active ingredient is ramipril. Each tablet contains5mg of ramipril.

·The other components are sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized cornstarch, sodium stearate fumarate, yellow iron oxide (E172), red iron oxide (E172).

Appearance oflproductand contents of the package

Ramipril Tevagen 5 mg are pink, round, biconvex tablets, with a breaking line on one side and a diameter of 6.5 mm.

Aluminum/Aluminum blister packaging.

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

Only some package sizes may be commercially marketed.

Holder of the Marketing Authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 - Madrid

Responsible for Manufacturing

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 medicinal product is authorized in the Member States with the following names:

Danish:Ramipril Teva

SpainRamipril Tevagen5mg tablets EFG

Greece:Ramipril Teva5mg tablets

Netherlands:Ramipril Teva5mg tablets

Ireland:Ramipril Teva Pharma5mg Tablets

Norway:Ramipril Teva

Poland:Ramiprilum 123ratio

Portugal:Ramipril Teva

United Kingdom:Ramipril5mg Tablets

Romania:Ramipril Teva5mg tablets

Sweden:Ramipril Teva

Last review date of this leaflet: August 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/