Ramipril Tevagen 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ramipril Tevagen 5 mg tablets EFG

Read the entire 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, 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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. How to store Ramipril Tevagen tablets
6. Contents of the pack and other information

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

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

Ramipril works in the following ways:

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

Ramipril 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 heart failure (when the heart cannot pump enough blood to the rest of the body)
• As treatment following 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, to any other ACE inhibitor medicine, or to any of the other ingredients of this medicine 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 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 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 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

Talk to your doctor or pharmacist before starting Ramipril Tevagen:

• If you have heart, liver, or kidney problems
• If you have lost large amounts of salts or fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, long-term diuretic use, 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:
  • -an angiotensin II receptor antagonist (ARA) (also known as "sartans" – for example, 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 Tevagen"

• If you are to receive an anaesthetic. This may be for surgery or dental work. You may need to stop taking Ramipril Tevagen one 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 developing angioedema, a serious 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 for cancer (e.g., temsirolimus, sirolimus, everolimus).
  • vildagliptin, a medicine used to treat diabetes.

• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus

• Inform your doctor if you think you are (or could become) pregnant. Ramipril Tevagen is not recommended during the first 3 months of pregnancy and 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, as the safety and efficacy of Ramipril Tevagen in children has 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.

Taking Ramipril Tevagen with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Ramipril Tevagen may affect how some other medicines work. Likewise, some medicines may affect how Ramipril Tevagen works.

Tell your doctor if you are taking any of the following medicines. These may make Ramipril Tevagen less effective:

• 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.

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

• Sacubitril/valsartan: used to treat a type of 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 indomethacin, and aspirin)
• Medicines for cancer treatment (chemotherapy)
• Diuretics such as furosemide
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (for example, 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 in your blood)
• Procainamide (to treat heart rhythm problems)
• Medicines commonly used to prevent organ rejection (sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor group). 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:

• if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings "Do not take Ramipril Tevagen" and "Warnings and precautions").

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

• Medicines for diabetes such as glucose-lowering medicines and insulin. Ramipril Tevagen may lower your blood sugar levels. Monitor your blood sugar levels closely while taking Ramipril Tevagen.
• Lithium (for mental health conditions). Ramipril Tevagen may increase lithium levels in your blood. Your doctor will monitor your blood lithium levels closely.

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 lightheaded. If you are concerned about how much alcohol you can drink while taking Ramipril Tevagen, talk to your doctor about how blood pressure-lowering medicines and alcohol may have additive effects, potentially causing excessive lowering of blood pressure.
• 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 are planning 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 might be). You should not take Ramipril Tevagen 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 the unborn baby. If you become pregnant while taking Ramipril Tevagen, consult your doctor immediately. For planned pregnancies, a switch to an appropriate 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 when you first start taking Ramipril Tevagen or when you start taking a higher dose. If this occurs, do not drive or operate tools or machinery.

Ramipril Tevagen contains lactose

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

Ramipril Tevagen contains sodium

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

3. How to take Ramipril Tevagen tablets

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, 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 daily.
• Your doctor will adjust the dose you need until your blood pressure is controlled.
• The maximum dose is 10 mg once daily.
• If you are already taking diuretics, your doctor may stop or reduce the dose of your previous diuretic before starting treatment with ramipril.

To reduce the risk of heart attack or stroke

• The usual 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 of heart failure

• The usual starting dose is 1.25 mg once daily.
• Your doctor will adjust your dose.
• The maximum dose is 10 mg once daily. It is preferable to administer it twice daily.

Treatment after having had a heart attack

• The usual 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 once daily. It is preferable to administer 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 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Do not drive to the hospital; have someone take you or call an ambulance. Bring the medicine 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 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, this medicine can cause adverse effects, although not everyone will experience 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, which may make swallowing or breathing difficult, together with itching or rash. These may be symptoms of a serious allergic reaction to Ramipril Tevagen.
• Severe skin reactions including rash, mouth ulcers, 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).

Tell your doctor immediately if you experience:

• Faster heartbeat, irregular or forceful heartbeats (palpitations), chest pain, tightness in the chest or more serious problems including heart attack and stroke.
• Difficulty breathing or cough. These may be symptoms of lung problems.
• Easy bruising, bleeding longer than normal, any sign of bleeding (e.g. bleeding gums), purple spots on the skin, or getting infections more easily than usual, sore throat and fever, feeling tired, dizzy or pale. These may be symptoms of blood or bone marrow problems.
• Severe stomach pain that may extend to your back. This may be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea, 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 get worse or last longer than a few days.

Common (may affect up to 1 in 10 people)

• Headache or feeling tired
• Dizziness. This is more likely when you first start taking Ramipril Tevagen or when you start taking a higher dose
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting up quickly
• Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• Stomach or abdominal pain, diarrhoea, indigestion, feeling unwell
• Skin rash with or without raised areas
• Chest pain
• Muscle 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 (dizziness)
• Itching and abnormal skin sensations such as numbness, tingling, prickling, burning or chills on the skin (paraesthesia)
• 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 called "intestinal angioedema" with symptoms such as abdominal pain, vomiting and diarrhoea
• 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 heartbeat, swelling of arms and legs. This may be a sign that your body is retaining more fluid than normal
• Redness
• Blurred vision
• Joint pain
• Fever
• Sexual dysfunction in men, decreased sexual desire 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 people)

• Feeling uneasy or confused
• Redness and swelling of the tongue
• Severe skin peeling or shedding, itching, rash with raised bumps
• Nail problems (e.g. loss or separation of a nail from its bed)
• Skin rash or bruising
• 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 the number of red blood cells, white blood cells or platelets, or in the amount of haemoglobin

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

• Increased sensitivity to sunlight.

Other reported adverse effects:

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

• Difficulty concentrating
• Swelling of the mouth
• Blood tests show very low numbers of blood cells
• Blood tests show lower than normal sodium levels
• Concentrated urine (dark in colour), discomfort, muscle cramps, confusion and seizures, which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you have these symptoms, consult your doctor as soon as possible.
• Fingers of hands and feet change colour in cold conditions, and you feel tingling or pain when warming up (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 via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ramipril Tevagen Tablets

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

Do not use this medicine after the expiry date which is stated on the carton and on the blister 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 and light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ramipril Tevagen

• The active substance is ramipril. Each tablet contains 5 mg of ramipril.
• The other components are sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized starch (from corn starch), sodium stearyl fumarate, yellow iron oxide (E172), red iron oxide (E172).

Nature of the product and contents of the container

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

Aluminum/Aluminum blister packs.

Packs containing 7, 20, 21, 28, 30, 50, 56, 60, 90, 98, 100, or 50x1 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 - Madrid

Spain

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

Denmark: Ramipril Teva
Spain: Ramipril Tevagen 5 mg tablets EFG
Greece: Ramipril Teva 5 mg δισκ?α
Netherlands: Ramipril Teva 5 mg tabletten
Ireland: Ramipril Teva Pharma 5 mg Tablets
Norway: Ramipril Teva
Poland: Ramiprilum 123ratio
Portugal: Ramipril Teva
United Kingdom: Ramipril 5 mg Tablets
Romania: Ramipril Teva 5 mg comprimate
Sweden: Ramipril Teva

Date of the most recent review of this leaflet: August 2023

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