Package Insert: Information for the User

RAMIPRIL TARBIS 10 mg Tablets EFG

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

1. What is Ramipril Tarbis and for what it is used

2. Before taking Ramipril Tarbis

3. How to take Ramipril Tarbis

4. Possible adverse effects

5. Storage of Ramipril Tarbis

6. Additional information

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

Ramipril Tarbis works in the following way:

• Reducing the body's production of substances that could increase its blood pressure.
• Relaxing and widening its blood vessels.
• Making it easier for its heart to pump blood throughout its body.

Ramipril Tarbis may 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 (whether or not you have diabetes).
• 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 Tarbis

• if you are allergic (hypersensitive) to ramipril, to any other ACE inhibitor or to any of the other ingredients of Ramipril Tarbis 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 patches 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 Tarbis 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 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 failure and are being treated with a blood pressure-lowering 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 an area such as the throat) is high.
• If you are taking any of the following medications, the risk of angioedema may increase:
• Racecadotril, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.

Do not take Ramipril Tarbis if any of the above conditions apply to you. If you are unsure, speak with 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 problems with your heart, liver or kidneys.
• If you have lost a lot of minerals or fluids (e.g., 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 to receive an anesthetic. This may be due to an operation or any dental work. You may need to stop your treatment a day in advance; consult your doctor.
• If you have high levels of potassium in your blood (shown in blood test results).
• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as "sartanes" - e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in your blood (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Ramipril Tarbis”.

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

Children

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

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

Use of other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those obtained without a prescription (including herbal remedies). This is because Ramipril Tarbis may affect the way some other medications work. Also, some medications may affect the way Ramipril Tarbis works. Inform your doctor if you have taken or are taking any of the following medications, which may make Ramipril Tarbis work less effectively:

• Medications used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin 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.

Inform your doctor if you are taking any of the following medications. These may increase the risk of adverse effects if taken with Ramipril Tarbis:

• Medications used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin and aspirin).
• Chemotherapy medications.
• Medications used to prevent organ transplant rejection, such as ciclosporin.
• Diuretics, such as furosemide.
• Medications that may increase the amount of potassium in your blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to make your blood more liquid).
• Steroid medications for inflammation, such as prednisolone.
• Alopurinol (used to reduce uric acid in your blood).
• Procainamide (to treat heart rhythm problems).
• Your doctor may need to modify 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”).

• Inform your doctor if you are taking any of the following medications. These may be affected by Ramipril Tarbis:

• Medications used to treat diabetes, such as medications to reduce glucose and insulin. Ramipril Tarbis may reduce your blood sugar levels. Monitor your blood sugar levels closely while taking Ramipril Tarbis.
• Lithium (used to treat mental health problems). Ramipril Tarbis may increase the amount 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), speak with your doctor before taking Ramipril Tarbis.

In particular, speak with your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

-Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications 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 medication used to make your blood more liquid).

Taking Ramipril Tarbis with food and drinks

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

Pregnancy and breastfeeding

You should inform your doctor if you are pregnant (or suspect you may be).

You should not take Ramipril Tarbis in the first 12 weeks of pregnancy, and you cannot take it at all after week 13 of pregnancy because its use during pregnancy may cause harm to your baby.

If you become pregnant while taking Ramipril Tarbis, inform your doctor immediately. If you are planning to become pregnant, you should change to an alternative suitable treatment before becoming pregnant. Do not take Ramipril Tarbis if you are breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

You may feel dizzy while taking Ramipril Tarbis, which is more likely to occur when you first start taking Ramipril Tarbis or when you 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 components of this medication

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

Follow exactly the administration instructions for Ramipril Tarbis as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

How to take this medication

• Take this medication orally at the same time every day.
• Swallow the Ramipril Tarbis tablets whole with liquid.
• Do not crush or chew the tablets.

How much medication 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 daily 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 previously taking before starting treatment with Ramipril Tarbis.

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 to reduce or delay worsening of kidney problems

• 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 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 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.

If you take more Ramipril Tarbis than you should

Consult your doctor immediately or go to the nearest hospital emergency department, accompanied by this leaflet. 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.

You can also call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Ramipril Tarbis

• If you forgot to take a dose, take your regular 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 product, ask your doctor or pharmacist.

Like all medicines, Ramipril Tarbis can cause side effects, although not everyone will experience them.

Stop taking Ramipril Tarbis 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 makes it difficult to swallow or breathe, as well as itching and hives. This can be a sign of a severe allergic reaction to Ramipril Tarbis.
• 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 than normal 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 signs of lung problems.
• The appearance of bruises more easily, bleeding for longer than normal, any sign of bleeding (such as from the 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 can be signs of blood or bone marrow problems.
• Severe stomach pain that can radiate to the back. This can be a sign of acute pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (feeling like vomiting), yellowing of the skin or eyes (jaundice). These can be signs 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 for more than a few days.

Frequent(affect less than 1 in 10 patients)

• Headache or feeling tired.
• Dizziness. This is more likely to occur when starting to take Ramipril Tarbis or when starting a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting up quickly.
• Dry, irritating cough, sinusitis (inflammation of the sinuses), or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling sick.
• Hives on the skin, with or without raised areas.
• Chest pain.
• Muscle cramps or pain.
• Blood tests showing higher than normal potassium levels in the blood.

Rare(affect less than 1 in 100 patients)

• Balance problems (vertigo).
• Itching and abnormal sensations in the skin, such as numbness, tingling, pinching, burning, or chills on the skin (paresthesia).
• Loss or changes in the taste of things.
• Difficulty sleeping.
• Feeling sad, anxious, more nervous than normal, or tired.
• Blocked nose, difficulty breathing, or worsening of 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 than normal during the day.
• Sweating more than normal.
• Loss or decrease in 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.
• Joint pain.
• Fever.
• Sexual dysfunction in men, decreased sex drive 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.

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

• Increased sensitivity to the sun.

Other side effects reported

Inform your doctor if any of the following worsen or last for 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.
• 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.
• Loss of hair.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it's a possible side effect that doesn't appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep out of the reach and sight of children.

Do not store at a temperature above 25°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at your local SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Ramipril Tarbis

• The active ingredient is ramipril. Each tablet contains 10 mg of ramipril.
• The other components are: lactose monohydrate, hypromellose, crospovidone, microcrystalline cellulose, and sodium stearyl fumarate.

Appearance of the product and contents of the package

Oval-shaped tablets, white in color, scored on both sides.

They are presented in packages containing a blister pack with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization is:

TARBIS FARMA S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Responsible for manufacturing is:

BLUEPHARMA – Indústria Farmacêutica, S.A.

S. Martinho do Bispo. 3045-016 Coimbra

Portugal

This leaflet was approved in May 2019

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