RAMIPRIL TARBIS 2.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

RAMIPRIL TARBIS 2.5 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Ramipril Tarbis is and what it is used for
2. Before taking Ramipril Tarbis
3. How to take Ramipril Tarbis
4. Possible side effects
5. Storing Ramipril Tarbis
6. Further information

1. What RAMIPRIL TARBIS is and what it is used for

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

Ramipril Tarbis works in the following way:

• By reducing the production of substances in your body 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 Tarbis 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 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. BEFORE TAKING RAMIPRIL TARBIS

Do not take Ramipril Tarbis

• if you are allergic (hypersensitive) to ramipril, any other ACE inhibitor or any of the other ingredients of Ramipril Tarbis 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 itching, hives, red patches 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 Tarbis may not be suitable for you.
• If you have kidney problems where the blood flow to your kidneys is reduced (renal artery stenosis)
• During the last 6 months of pregnancy(see also the section on “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 problems and are taking a medicine to lower your blood pressure that contains aliskiren.
• If you have taken or are 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 increased.
• If you are taking any of the following medicines, the risk of angioedema may be increased:
• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

Do not take Ramipril Tarbis if any of the above applies to you. If you are not sure, talk to your doctor before taking Ramipril Tarbis.

Be especially careful with Ramipril Tarbis

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

• If you have heart, liver, or kidney problems.
• If you have lost a lot of body fluids (e.g., 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 going to receive an anesthetic. This may be due to an operation or any dental work. You may need to stop your treatment a day before; consult your doctor.
• If you have high levels of potassium in your blood (shown in blood test results).
• If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus.
• 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" - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• 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 Tarbis”.

• Tell your doctor if you are pregnant (or think you might be). Ramipril Tarbis is not recommended during the first three months of pregnancy and may cause serious harm to your baby after three months of pregnancy; see section “Pregnancy and breastfeeding”.

Children

Ramipril Tarbis is not recommended for use in children and adolescents under 18 years because there is no available information for this population.

If any of the above applies to you (or you are not sure), talk to your doctor before taking Ramipril Tarbis.

Using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription (including herbal medicines). This is because Ramipril Tarbis may affect the way some other medicines work. Also, some medicines may affect the way Ramipril Tarbis works. Tell your doctor if you are taking any of the following medicines, as they may make Ramipril Tarbis 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. These may increase the risk of side effects if taken with Ramipril Tarbis:

• 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).
• Medicines to prevent organ rejection after a transplant, such as cyclosporin.
• Diuretics such as furosemide.
• Medicines that can increase the amount of potassium in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to make the blood more fluid).
• Steroid medicines for inflammation, such as prednisolone.
• Allopurinol (used to decrease uric acid in the blood).
• Procainamide (for heart rhythm problems).
• 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 Tarbis” and “Be especially careful with Ramipril Tarbis”).

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

• Medicines to treat diabetes, such as medicines to lower blood sugar and insulin. Ramipril Tarbis may lower your blood sugar levels. Monitor your blood sugar levels closely while taking Ramipril Tarbis.
• Lithium (for mental health problems). Ramipril Tarbis may increase the amount of lithium in your blood. Your doctor will closely monitor your lithium blood levels.
• If any of the above applies to you (or you are not sure), talk to your doctor before taking Ramipril Tarbis.

In particular, talk to your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

-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; cyclosporin, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots).

Taking Ramipril Tarbis with food and drink

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

Pregnancy and breastfeeding

You must tell your doctor if you are pregnant (or think you might be).

You should not take Ramipril Tarbis during the first 12 weeks of pregnancy, and you must not take it after the 13th week of pregnancy, as its use during pregnancy may cause harm to your baby.

If you become pregnant while taking Ramipril Tarbis, tell your doctor immediately. If you are planning to become pregnant, you should switch to an alternative treatment before you become pregnant. You must not take Ramipril Tarbis if you are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Important information about some of the ingredients of this medicine

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

3. HOW TO TAKE RAMIPRIL TARBIS

Take Ramipril Tarbis exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Taking this medicine

• Take this medicine by mouth at the same time each day.
• Swallow the Ramipril Tarbis tablets whole with liquid.
• Do not crush or chew the tablets.

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 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 diuretic you were taking before starting treatment with Ramipril Tarbis.

Reducing the risk of 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 take.
• 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 take.
• The maximum daily 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 take.
• 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.

If you take more Ramipril Tarbis than you should

Consult your doctor immediately or go to the nearest hospital casualty 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, indicating the medicine and the amount taken.

If you forget to take Ramipril Tarbis

• 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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

Stop taking Ramipril Tarbis and go to a doctor immediately 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 Tarbis.
• Severe skin reactions including rash, ulcers in the 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).

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 symptoms of lung problems.
• Easy bruising, bleeding for longer 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 worsen or last more than a few days.

Frequent(affect less than 1 in 10 patients)

• Headache or feeling tired.
• Feeling dizzy. This is more likely to occur when you start taking Ramipril Tarbis 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, 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(affect less than 1 in 100 patients)

• Balance problems (vertigo).
• Itching and abnormal sensations on the skin such as numbness, tingling, pinching, burning, or chilliness on the skin (paresthesia).
• Loss or changes in taste.
• Sleep problems.
• Feeling sad, anxious, more nervous than usual, or tired.
• Stuffy nose, difficulty breathing, or worsening asthma.
• A swelling in the abdomen called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Urinating more often 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 the joints.
• 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 working.

Rare(affect less than 1 in 1,000 patients)

• Feeling insecure or confused.
• Redness and swelling of the tongue.
• Severe scaling or peeling of the skin, 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 changes and noises in the ears.
• Feeling weak.
• Blood tests show a decrease in the number of red blood cells or platelets or the amount of hemoglobin.

Very Rare(affect less than 1 in 10,000 patients)

• Being more sensitive to the sun than usual.

Other Adverse Effects Reported

Tell your doctor if any of the following conditions 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.
• Fingers on the hands and feet change color when cold and feel tingling or pain when warming up (Raynaud's phenomenon).
• Enlargement of the chest 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 or pharmacist, 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: 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 TARBIS

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Ramipril Tarbis after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point of your usual pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Ramipril Tarbis

• The active ingredient is ramipril. Each tablet contains 2.5 mg of ramipril.
• The other ingredients are: lactose monohydrate, hypromellose, crospovidone, microcrystalline cellulose, sodium stearyl fumarate, and yellow iron oxide (E-172).

Appearance of the Product and Packaging Contents

Oblong tablets, yellow in color, scored on both sides.

They are presented in packages containing blisters with 28, 56, or 500 tablets.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

TARBIS FARMA S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Manufacturer:

BLUEPHARMA – Indústria Farmacêutica, S.A.

• Martinho do Bispo. 3045-016 Coimbra

Portugal

Date of the Last Revision of this Prospectus: May 2019

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