Ramipril Krka 10 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ramipril Krka 10 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, consult 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, since it may 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 Ramipril Krka is and what it is 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 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 a 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 the 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 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 below "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 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 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 taking 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 procedures. 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 can lower sodium levels in your blood. Your doctor may perform periodic blood tests, particularly to monitor 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 could 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 below “Pregnancy and Breastfeeding”).

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 has not yet been established.

If any of the above conditions apply to you (or you are unsure), talk to 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 remedies). This is because Ramipril Krka may affect how other medicines work. Likewise, some medicines may affect how Ramipril Krka works.

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

• Medicines used to treat pain or 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 Krka:

• 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, medicines that can increase potassium levels in blood such as spironolactone, triamterene, amiloride, and other medicines that can increase potassium levels including potassium salts (e.g., heparin (to make blood more fluid), trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole, for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection, and heparin, a medicine used to thin 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".

Tell your doctor if you are taking any of the following medicines. They 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 treating mental health conditions). Ramipril Krka 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), talk to 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 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

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.

Seek advice from your doctor or pharmacist 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 happens, 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, which is essentially "sodium-free."

3. How to take Ramipril Krka

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. 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 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 are taking until your blood pressure is controlled.
• The maximum daily 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 Krka.

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 the dose you are taking.
• 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 the dose you are taking.
• 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 the dose you are taking.
• 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 a missed dose.

If you stop taking Ramipril Krka

Keep taking your medicine as directed by your doctor. 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 everybody will experience 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, as well as 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 peeling of the skin (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 that lasts 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 symptom 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:

Tell your doctor if any of the following get worse 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, 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, pricking, burning or chills on your skin (paraesthesia)
• Loss or changes in taste
• Difficulty 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 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
• Flushing
• Blurred vision
• Joint pain
• Fever
• Erectile 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 (may affect up to 1 in 1,000 people)

• Feeling unsteady or confused
• Redness and swelling of the tongue
• Severe skin peeling or shedding, rash with lumps and itching
• 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 noises in the ears
• Feeling weak
• Blood tests show a decrease in the number of red 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.

Unknown (frequency cannot be estimated from available data)

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

Other reported adverse effects:

Inform your doctor if any of the following adverse effects worsens or lasts more 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
• 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 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 Medicines: www.notificaram.es.

5. Storage of Ramipril Krka

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, bottle label, and blister pack after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store in the original container to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Ramipril Krka

• The active substance is Ramipril. Each tablet contains 10 mg of ramipril.

The other components (excipients) are hypromellose 6cP, microcrystalline cellulose, pregelatinized maize starch and sodium stearyl fumarate. See section 2 “Ramipril Krka contains sodium”.

Appearance of the product and contents of the container

Tablet

Ramipril Krka 10 mg tablet is white to almost white, capsule-shaped, bevelled-edged tablet, scored on both sides. One side is marked with "10" 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 10 mg is available in blisters (OPA/Al/PVC//Al): 20, 28, 30, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization 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

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

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

This medicinal product is authorized 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es