Leaflet: Information for the user

Ramipril Krka 2.5 mg tablets EFG

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

5Storage of Ramipril Krka

6.Contents of the pack and additional information

RamiprilKrkacontains the active ingredient ramipril. This belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

RamiprilKrka works in the following way:

• 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

RamiprilKrka 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 takeRamiprilKrka

• if you are allergic to ramipril, or to any of the other ingredients of this medicine (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, RamiprilKrkamay 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 below 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 failure and are being treated with a blood pressure-lowering medicine that contains 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 in an area such as the throat) is high.

Do not takeRamiprilKrkaif any of the above conditions apply to you. If you are unsure, speak to your doctor before takingRamiprilKrka.

Warnings and precautions

Consult your doctor or pharmacist before starting to take RamiprilKrka:

• if you have heart, liver or kidney problems
• if you have lost a lot of minerals or fluids (e.g. due to vomiting, diarrhoea, a low-salt diet, long-term use of diuretics or dialysis)

• if you are undergoing desensitisation treatment for bee or wasp stings
• if you are to receive an anaesthetic. This may be for an operation or any dental work. You may need to stop taking RamiprilKrkaa 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 condition that may lower the levels of sodium in your blood. Your doctor may perform blood tests periodically, particularly to monitor your sodium levels in the blood, especially if you are an elderly patient.
• if you are taking one of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhoea
• temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent organ rejection after transplantation 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:

• a receptor antagonist of angiotensin II (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 renal function, blood pressure and electrolyte levels in the blood (e.g. potassium) at regular intervals.

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

You must inform your doctor if you are (or may be) pregnant. Ramipril is not recommended in 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

RamiprilKrkais not recommended for use in children and adolescents under 18 years of age because the safety and efficacy of RamiprilKrkahave not yet been established in children.

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

Use of RamiprilKrkawith other medicines

Inform your doctor or pharmacist that you are using, have used recently or may need to take any other medicine, including non-prescription medicines (including herbal medicines). This is because Ramipril HCS may affect the way other medicines work. Similarly, some medicines may affect the way RamiprilKrkaworks.

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

• 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 check your blood pressure.

Inform your doctor if you are taking any of the following medicines. They may increase the risk of side effects if taken with RamiprilKrka:

• 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 cancer (chemotherapy),

• Diuretics such as furosemide,
• potassium supplements (including salt substitutes), potassium-sparing diuretics Medicines that may increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, and other medicines that may increase the amount of potassium in the blood, potassium salts (e.g. heparin (to make the blood more fluid) trimetoprima and co-trimoxazol also known as trimetoprim/sulfamethoxazole, for infections caused by bacteria; ciclosporin a medicine used to prevent organ rejection after transplantation and heparin, a medicine used to dilute the blood and prevent clots),
• steroid medicines for inflammation such as prednisolone,
• Alopurinol (used to reduce uric acid in the blood),

• Procainamide (to treat heart rhythm problems),
• Trimetoprim and co-trimoxazol (for bacterial infections),
• Vildagliptin (used to treat type 2 diabetes).
• medicines that are more frequently used to prevent organ rejection after transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See the section “Warnings and precautions”.

Inform your doctor if you are taking any of the following medicines. They may be affected by RamiprilKrka:

• Medicines used to treat diabetes such as medicines to lower glucose and insulin.RamiprilKrkamay lower your blood sugar levels. Monitor your blood sugar levels closely while taking RamiprilKrka.
• Lithium (to treat mental health problems).RamiprilKrkamay increase the amount of Lithium in your blood. Your doctor will closely monitor your Lithium levels in the blood.

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

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 RamiprilKrka” and “Warnings and precautions”)

Taking RamiprilKrkawith food and alcohol

• Drinking alcohol with RamiprilKrkamay make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking RamiprilKrka, speak to your doctor about how medicines used to lower blood pressure and alcohol may have additive effects.
• You can take ramipril with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you are pregnant (or suspect you may be). Do not take RamiprilKrkain the first 12 weeks of pregnancy and do not take it until after week 13 as its use during pregnancy may cause harm to the baby.

If you become pregnant while taking RamiprilKrka, inform your doctor immediately. Before a planned pregnancy, you should change to an alternative suitable treatment.

Breastfeeding

You must not take RamiprilKrkaif you are breastfeeding.

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

Driving and operating machines

You may feel drowsy or dizzy while taking RamiprilKrka. This is more likely to occur when you first start taking RamiprilKrkaor when you start taking a higher dose of Ramipril HCS. If this happens, do not drive or operate tools or machines.

Ramipril Krka contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

Medication intake

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

How much medication to take

Hypertension treatment

• The usual starting dose is 1.25mg or 2.5mg once a day.
• Your doctor will adjust the amount you should take until your blood pressure is controlled.
• 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 taking previously before starting treatment with RamiprilKrka.

To reduce the risk of suffering a heart attack or stroke

• The usual starting dose is 2.5mg 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

• You may start with a dose of 1.25mg or 2.5mg once a day.
• Your doctor will adjust the amount you are taking.
• The usual dose is 5 or 10 mg once a day.

Heart failure treatment

• The usual starting dose is 1.25mg 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 1.25mg or 2.5mg once 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 RamiprilKrkathan 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 packaging of the medication 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 RamiprilKrka

• If you forgot to take a dose, take your regular dose when it is next due.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with RamiprilKrka

Continue taking your medication until your doctor tells you to. Do not stop taking Ramipril HCS even if you feel better. If you stop treatment, your disease may return.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Ramipril Krka 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 may make it difficult to swallow or breathe, as well as itching and hives. This can be a sign of a severe allergic reaction to Ramipril Krka.
• Severe skin reactions, including rashes, ulcers in the mouth, 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:

• Fast or irregular heartbeat, chest pain, shortness of breath, or more serious problems, including heart attack and stroke.
• Difficulty breathing or coughing. These may be symptoms of lung problems.
• Easy bruising, prolonged bleeding, any sign of bleeding (e.g., from the gums), purple spots on the skin, or catching infections more easily than usual, sore throat, and fever, feeling tired, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow problems.
• Severe stomach pain that can radiate to the back. This may be a sign of acute pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, feeling sick, yellowing of the skin or eyes (jaundice). These may be symptoms 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 more than a few days.

Frequent (may affect up to 1 in 10 people)

• Headache or feeling tired
• Feeling dizzy. This is more likely to occur when starting to take Ramipril Krka or when increasing the dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting up quickly
• Dry, irritating cough, sinusitis, 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 (may affect up to 1 in 100 people)

• Balance problems (vertigo)
• Itching and abnormal sensations in the skin, such as numbness, tingling, pinpricks, burning, or chills (paresthesia)
• Loss or changes in the taste of things
• Difficulty sleeping
• Feeling sad, anxious, more nervous than usual, or tired
• Blocked nose, difficulty breathing, or worsening of asthma
• Abdominal swelling called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea
• Heartburn, constipation, or dry mouth
• Urinating more frequently during the day
• Sweating more than usual
• Loss or decrease in appetite (anorexia)
• Increased or irregular heartbeats. Swelling of arms and legs. This may be a sign that your body is retaining more water than normal
• Redness
• Blurred vision
• Joint pain
• Fever
• Sexual dysfunction in men, decreased libido 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 (may affect up to 1 in 10,000 people)

• Increased sensitivity to the sun.

Unknown (frequency cannot be estimated from available data)

• Concentrated urine (dark color), feeling sick, muscle cramps, confusion, and seizures that may be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.

Other side effects reported:

Inform your doctor if any of the following side effects 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 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 of suspected adverse reactions

It is essential to report suspected adverse reactions to the medicine after its authorization. This allows for continuous monitoring of the benefit-risk ratio of the medicine. Healthcare professionals are invited to report suspected adverse reactions via the Spanish System for Pharmacovigilance of Medicines for Human Use:Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, bottle label, and blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE point of your pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ramipril Krka

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

The other components (excipients) arehypromellose 6cP, microcrystalline cellulose, pregelatinized maize starch, sodium stearate and yellow iron oxide (E172). See section 2 “Ramipril Krka Krka contains sodium”

Appearance of the product and contents of the pack

Tablet

Ramipril Krka 2.5 mg tablet, brownish-yellow in color, in the form of a capsule with beveled edges, scored on both faces. One of the faces is marked with a 2.5 on one half and KRK on the other half. Dimensions of the tablet: 8 x 5mm. The tablet can be divided into equal doses.

Rampril 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 Authorization Holder

Krka, d.d., Novo mesto,

Šmarješka cesta 6, 8501 Novo mesto,

Slovenia.

Responsible for manufacturing

Krka, d.d., Novo mesto,

Šmarješka cesta 6, 8501 Novo mesto,

Slovenia.

O

r TAD Pharma GmbH, Heinz-Lohmann - Straβe 5,

27472 Cuxhaven,

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:marketing authorization holder:

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

This medicine is authorized in the member states of the European Economic Area with the following trade names:

Last review date of this leaflet: May 2019

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es