Ramipril Krka 2.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ramipril Krka 2.5 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ramipril Krka is and what it is used for
2. What you need to know before taking Ramipril Krka
3. How to take Ramipril Krka
4. Possible side effects
5. Storage of Ramipril Krka
6. Contents of the pack and other information

1. What is Ramipril Krka and what is it used for?

Ramipril Krka contains the active substance ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).

Ramipril Krka 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 around the body

Ramipril Krka may 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 Krka

Do not take Ramipril Krka

• if you are allergic to ramipril or to any of the other ingredients of this medicine (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 patches 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 Krka 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 Lactation” 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.

Do not take Ramipril Krka if any of the above conditions apply to you. If you are unsure, speak with your doctor before taking Ramipril Krka.

Warnings and precautions

Talk to your doctor or pharmacist before starting Ramipril Krka:

• if you have heart, liver, or kidney problems

• if you have lost large amounts of salts or fluids (due to vomiting, diarrhea, a low-salt diet, long-term use of diuretics, 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 for surgery or dental work. You may need to stop taking Ramipril Krka one day before; consult your doctor.

• if you have high levels of potassium in your blood (shown in blood test results)

• if you are taking medicines or have a disease that may reduce sodium levels in your blood. Your doctor may perform periodic blood tests, particularly to monitor blood sodium levels, especially if you are elderly.

• if you are taking any of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhea.

• temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs 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.

• 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), 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 Krka”.

You must inform your doctor if you are (or might be) pregnant. Ramipril 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 lactation” below).

Children and adolescents

Ramipril Krka is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of Ramipril Krka 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 Krka.

Taking Ramipril Krka with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines (including herbal medicines). This is because Ramipril Krka may affect how other medicines work. Likewise, some medicines may affect how Ramipril Krka works.

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

• Medicines used to treat pain or 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 monitor your blood pressure.

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

• 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,

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, medicines that may increase potassium levels in blood such as spironolactone, triamterene, amiloride, and other medicines that may increase potassium levels in blood, potassium salts (e.g., heparin (to make blood less thick), trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole, for bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent rejection of organ transplants, and heparin, a medicine used to thin the blood and prevent clots),

• Steroid medicines for inflammation such as prednisolone,

• Allopurinol (used to reduce uric acid in your blood),

• Procainamide (to treat heart rhythm problems),

• Trimethoprim and co-trimoxazole (for bacterial infections),

• Vildagliptin (used to treat type 2 diabetes).

• Medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions".

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

• Medicines for treating diabetes such as glucose-lowering medicines and insulin. Ramipril Krka may lower your blood sugar level. Monitor your blood sugar level closely while taking Ramipril Krka.
• Lithium (for mental health conditions). Ramipril Krka 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 Krka.

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 Krka” and “Warnings and precautions”)

Taking Ramipril Krka with food and alcohol

• Drinking alcohol with Ramipril Krka may make you feel dizzy or lightheaded. If you are concerned about how much alcohol you can drink while taking Ramipril Krka, talk to your doctor about how blood pressure-lowering medicines and alcohol may have additive effects.
• You may take ramipril with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 Krka during the first 12 weeks of pregnancy and should not take it beyond week 13, as its use during pregnancy may harm the unborn baby.

If you become pregnant while taking Ramipril Krka, inform your doctor immediately. Before planning a pregnancy, you should switch to an appropriate alternative treatment.

Breastfeeding

You should not take Ramipril Krka if you are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel drowsy or dizzy while taking Ramipril Krka. This is more likely when you first start taking Ramipril Krka or when you start taking a higher dose of Ramipril Krka. If this occurs, do not drive or operate tools or machinery.

Ramipril Krka 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 Krka

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Taking this medicine

• Take this medicine orally at the same time each day.
• Swallow the 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 you need until your blood pressure is controlled.
• The maximum daily dose is 10 mg once daily.
• If you are already taking diuretics, your doctor may discontinue or reduce the dose of your previous diuretic before starting treatment with Ramipril Krka.

To reduce the risk of having a 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 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 or 2.5 mg once 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 Krka 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 Krka

• If you forget to take a dose, take your next scheduled dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Ramipril Krka

Continue taking your medicine as long as your doctor instructs you to do so. Do not stop taking Ramipril Krka even if you feel better. If you stop treatment, your condition may return.

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 experiences them.

Stop taking Ramipril Krka 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 and rash. This may be a sign of a severe allergic reaction to Ramipril Krka.
• 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).

Contact your doctor immediately if you experience:

• Faster heartbeat, irregular or strong heartbeats (palpitations), chest pain, chest tightness, 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 may be a sign of acute pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, feeling unwell, 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:

Inform your doctor if any of the following worsen or last more 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 Krka 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, 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 (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 (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 your 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 decreased 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
• Flushing
• 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

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

• Feeling unsteady or confused
• Redness and swelling of the tongue
• Severe skin peeling or blistering, rash with swelling and itching
• Nail problems (e.g., loss or separation of a nail from its nail bed)
• Rash or bruising on the skin
• 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 or platelets, or in hemoglobin levels

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

• Increased sensitivity to sunlight

Unknown (frequency cannot be estimated from available data)

• Concentrated (dark-colored) urine, feeling sick or unwell, muscle cramps, confusion, and seizures which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.

Other reported adverse effects:

Inform your doctor if any of the following adverse effects worsen or last more 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 of hands and feet change color in cold conditions and feel tingling or pain when warming up (Raynaud's phenomenon)
• Enlargement of the breasts in men
• Slowness or difficulty reacting
• Burning sensation
• Change in the smell of things
• Hair loss

Reporting suspected adverse reactions

It is important to report suspected adverse reactions to the medicine after it has been authorized. This enables continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals are encouraged to report suspected adverse reactions via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

5. Storage of Ramipril Krka

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, label of the bottle and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original container to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ramipril Krka

• The active substance is Ramipril. Each tablet contains 2.5 mg of ramipril.

The other components (excipients) are hypromellose 6 cP, microcrystalline cellulose, pregelatinized maize starch, sodium stearyl fumarate and yellow iron oxide (E172). See section 2 "Ramipril Krka contains sodium".

Nature and contents of the container

Tablet

Ramipril Krka 2.5 mg tablet is a light yellowish-brown, capsule-shaped tablet with bevelled edges, scored on both sides. One side is marked with "2.5" on one half and "KRK" on the other half. Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses.

Ramipril Krka 5 mg is available in blisters (OPA/Al/PVC//Al): 20, 28, 30, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Krka, d.d., Novo mesto,
Šmarješka cesta 6, 8501 Novo mesto,
Slovenia.

Manufacturer

Krka, d.d., Novo mesto,
Šmarješka cesta 6, 8501 Novo mesto,
Slovenia.

Or

TAD Pharma GmbH, Heinz-Lohmann-Straße 5,
27472 Cuxhaven,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: May 2019

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