Ramipril Tarbis 10 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

RAMIPRIL TARBIS 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 and should not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Ramipril Tarbis is and what it is used for
2. Before you take Ramipril Tarbis
3. How to take Ramipril Tarbis
4. Possible side effects
5. How to store 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 known as ACE inhibitors (angiotensin-converting enzyme inhibitors).

Ramipril Tarbis 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 Tarbis 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. BEFORE TAKING RAMIPRIL TARBIS

Do not take Ramipril Tarbis

• if you are allergic (hypersensitive) to ramipril, to any other ACE inhibitor medicine, or to any of the other ingredients of Ramipril Tarbis listed in section 6.
• 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 serious 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 Tarbis 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 on "Pregnancy and breastfeeding" below).
• 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 long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin, for example in the throat) is high.
• If you are taking any of the following medicines, the risk of developing angioedema may increase:
• Racecadotril, a medicine used to treat diarrhoea.
• Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine 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.

Take special care 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 significant amounts of minerals 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 to receive an anesthetic. This may be due to surgery or dental procedures. You may need to stop your treatment one day before; 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 medicines used to treat high blood pressure (hypertension):
• 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 Tarbis”.

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

Children

Ramipril Tarbis is not recommended for use in children and adolescents under 18 years of age, as there is no available information in 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 medicines

Inform 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 how some other medicines work. Likewise, some medicines may affect how Ramipril Tarbis works. Inform your doctor if you have taken or are taking any of the following medicines, which may make Ramipril Tarbis 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.

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

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacina, and aspirin).
• Medicines for cancer treatment (chemotherapy).
• Medicines to prevent organ rejection after transplantation such as cyclosporine.
• Diuretics such as furosemide.
• Medicines that may increase blood potassium levels such as spironolactone, triamterene, amiloride, potassium salts, and heparin (used to thin the blood).
• Steroid medicines for inflammation such as prednisolone.
• Allopurinol (used to lower uric acid levels in your blood).
• Procainamide (to treat heart rhythm problems).

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 the information under the headings “Do not take Ramipril Tarbis” and “Take special care with Ramipril Tarbis”).

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

• Medicines for treating diabetes such as glucose-lowering medicines and insulin. Ramipril Tarbis may lower your blood sugar levels. Monitor your blood sugar levels closely while taking Ramipril Tarbis.

• Lithium (used to treat mental health conditions). Ramipril Tarbis may increase the amount of lithium 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 Tarbis.

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

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g., 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).

Taking Ramipril Tarbis with food and drinks

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

Pregnancy and breastfeeding

You must inform your doctor if you are pregnant (or suspect you might be).

You should not take Ramipril Tarbis during the first 12 weeks of pregnancy, and you must not take it at all from week 13 of pregnancy onwards, as its use during pregnancy could harm the unborn baby.

If you become pregnant while taking Ramipril Tarbis, inform your doctor immediately. If you are planning to become pregnant, you should switch to an appropriate alternative treatment beforehand. 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 occur when you first start taking Ramipril Tarbis or when you start taking a higher dose. If this happens, do not drive or operate tools or machinery.

Important information about some of the ingredients of this medicine

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. HOW TO TAKE RAMIPRIL TARBIS

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

How to take this medicine

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

How much medicine 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 until your blood pressure is controlled.
• The maximum daily dose is 10 mg once daily.
• If you are already taking diuretics, your doctor may interrupt or reduce the dose of your previous diuretic before starting treatment with Ramipril Tarbis.

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 for heart failure

• The usual starting dose is 1.25 mg once daily.
• Your doctor will adjust your dose.
• The maximum daily 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.

If you take more Ramipril Tarbis than you should

Contact your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you. Do not drive to the hospital; ask someone to take you or call an ambulance. Bring the medicine packaging with you. This way, your doctor will know what you have taken.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ramipril Tarbis

• 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 missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Ramipril Tarbis may cause adverse effects, although not everyone experiences them.

Stop taking Ramipril Tarbis 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 may make swallowing or breathing difficult, along with itching and rash. This could be a sign of a severe allergic reaction to Ramipril Tarbis.
• Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin disease, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Tell your doctor immediately if you experience

• Faster heartbeat, irregular or strong 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. from gums), purple spots on the skin, or increased susceptibility to infections, sore throat and fever, feeling tired, dizzy, or pale skin. These may be symptoms of blood or bone marrow problems.
• Severe stomach pain that may radiate to your back. This could be a symptom of acute pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea (feeling sick), 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 worsen or last longer than a few days.

Common (affect less than 1 in 10 patients)

• Headache or feeling tired.
• Dizziness. This is more likely when you first start taking Ramipril Tarbis or when you start taking a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly.
• Dry, irritating cough, sinus inflammation (sinusitis), or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, 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 (affect less than 1 in 100 patients)

• Balance problems (dizziness).
• Itching and abnormal skin sensations such as numbness, tingling, prickling, burning, or chills on the skin (paresthesia).
• Loss or changes in taste.
• Trouble sleeping.
• Feeling sad, anxious, more nervous than usual, or tired.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• Swelling in the abdomen called "intestinal angioedema," with 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 heartbeat. Swelling in 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.
• Increase in certain white blood cells (eosinophilia) found during a blood test.
• Blood tests show changes in how your liver, pancreas, or kidneys are functioning.

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

• Feeling uneasy or confused.
• Redness and swelling of the tongue.
• Severe skin peeling or shedding, raised rash, 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 disturbances and ringing in the ears.
• Feeling weak.
• Blood tests show a decrease in the number of red blood cells or platelets, or in hemoglobin levels.

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

• Increased sensitivity to sunlight.

Other reported adverse effects

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

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests show very low blood cell counts.
• Blood tests show lower than normal sodium levels.
• Fingers on hands and feet change color when cold, and feel tingling or pain when warmed (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 or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Ramipril Tarbis

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

Appearance of the medicinal product and contents of the pack

Oblong white tablets, scored on both sides.

They are presented in packs containing a blister with 28 tablets.

Marketing Authorization Holder and Manufacturer

The Marketing Authorization Holder is:

TARBIS FARMA S.L.

Gran Vía Carlos III, 94

08028 Barcelona

The Manufacturer is:

BLUEPHARMA – Indústria Farmacêutica, S.A.

• Martinho do Bispo. 3045-016 Coimbra

Portugal

This leaflet was approved in May 2019

Detailed and up-to-date 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/