1.25 mg, 2.5 mg, 5 mg and 10 mg ramipril tablets
What Ramipril Krka is and what it is used for
Ramipril Krka contains a medicine called ramipril. It belongs to a group of medicines called ACE inhibitors.
Ramipril Krka works by:
- reduce the body’s production of substances that could raise your blood pressure
- make your blood vessels dilate and relax
- make it easier for your heart to pump around the blood in your body
Ramipril Krka can be used:
- to treat high blood pressure ( hypertension )
- to reduce the risk of heart attack or stroke
- to reduce or delay the risk of worsening kidney problems (whether you have diabetes or not)
- for the treatment of the heart when it can not pump around enough blood to the rest of the body ( heart failure )
- as a treatment after a heart attack complicated by heart failure
Ramipril contained in Ramipril Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Ramipril Krka
Do not use Ramipril Krka
- if you are allergic to ramipril or any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6).
- Signs of an allergic reaction may include rash, difficulty swallowing or breathing, and swelling of your face, lips, throat, or tongue.
- if you have ever had a severe allergic reaction called “angioedema”. Signs of this include itching, hives ( urticaria ), red marks on the hands, feet, and neck, swelling of the throat and tongue, swelling around the eyes and lips, and 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 it means that the blood supply to your kidneys is reduced ( stenosis of the renal artery).
- during the last 6 months of pregnancy (see section “Pregnancy and breastfeeding”).
- if your blood pressure is abnormally low or unstable. Your doctor will make this assessment.
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
- if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term ( chronic ) heart failure in adults, it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat).
Do not take Ramipril Krka if any of the above applies to you. If you are not sure, talk to your doctor before taking Ramipril Krka.
Warnings and cautions
Talk to your doctor or pharmacist before taking Ramipril Krka:
- if you have heart, liver, or kidney problems.
- if you have lost a lot of body salts or body fluids (through vomiting, diarrhea, abnormal sweating, strictly low-salt diet, treatment with diuretics for a long time, or have undergone dialysis ).
- if you are going to undergo a treatment to reduce your allergy to wasp or bee stings ( hyposensitization ).
- if you will be given anesthetics. This can be given to you before an operation or dental treatment. You may need to stop taking Ramipril Krka one day before surgery; Ask your doctor for advice.
- if you have high levels of potassium in your blood (shown by a blood test)
- if you are taking medicines or have a condition that can lower the sodium levels in your blood. Your doctor may perform regular blood tests, especially to check your blood sodium levels, especially if you are older
- if you are taking any of the following medicines, the risk of angioedema (rapid onset)
- swelling under the skin in areas such as the throat) higher:
- racecadotril is a medicine used to treat diarrhea.
- temsirolimus, sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors (used to prevent rejection of transplanted organs and against cancer).
- vildagliptin is a medicine used to treat diabetes.
- if you have connective tissue diseases such as scleroderma or SLE ( systemic lupus erythematosus )
- if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
- aliskiren
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Ramipril Krka”.
If you think you may be pregnant (or may become pregnant) during treatment, consult your doctor. The use of Ramipril Krka is not recommended during the first three months of pregnancy, and if used after the third month of pregnancy, may cause serious harm to the baby (see section “Pregnancy and breast-feeding”).
Children and young people
Ramipril Krka is not recommended for use in children and adolescents below 18 years of age because the safety and efficacy of Ramipril Krka have not yet been established in children.
If any of the above applies to you (or you are not sure), talk to your doctor before taking Ramipril Krka.
Other medicines and Ramipril Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription (including herbal medicines). This is because Ramipril Krka can affect the way other medicines work. Some medicines may also affect the way Ramipril Krka works.
Tell your doctor if you are taking any of the following medicines. They can make Ramipril Krka work worse:
- drugs used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs) such as ibuprofen or indomethacin and acetylsalicylic acid.
- medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies such as ephedrine, norepinephrine, or adrenaline. Your doctor will check your blood pressure.
Tell your doctor if you are taking any of the following medicines. They may increase the risk of side effects if you take them with Ramipril Krka:
- drugs used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs) such as ibuprofen or indomethacin and acetylsalicylic acid
- anti-cancer drugs ( chemotherapy )
- diuretics (diuretics) such as furosemide
- potassium supplements (including salt replacement), potassium-sparing diuretics (diuretics, eg spironolactone, triamterene, amiloride), and other medicines that can increase the amount of potassium in your blood (eg heparin, blood thinners used to prevent blood clots; and trimethoprim and also cotrimoxazole, known as trimethoprim/sulfamethoxazole, against infection caused by bacteria; cyclosporine, an immunosuppressive drug that prevents the rejection of transplanted organs)
- steroids used in inflammation such as prednisolone
- allopurinol (used to reduce the amount of uric acid in your blood)
- procainamide (used for heart rhythm disorders)
- vildagliptin (used to treat type 2 diabetes )
- racecadotril (a medicine used to treat diarrhea)
- drugs are most commonly used to prevent rejection of transplanted organs
- (temsirolimus, sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors). See section “Warnings and Precautions”.
Tell your doctor if you are taking any of the following medicines. They can be affected by Ramipril Krka:
- antidiabetic drugs such as oral glucose-lowering drugs and insulin. Ramipril Krka may lower your blood sugar levels. Check your blood sugar levels carefully while you are taking Ramipril Krka.
- lithium (used in mental illness). Ramipril Krka may increase the amount of lithium in your blood. Your lithium levels will need to be monitored closely by your doctor.
If any of the above applies to you (or you are not sure), talk to your doctor before taking Ramipril Krka.
Your doctor may need to change your dose and/or take other precautions:
- If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Ramipril Krka” and “Warnings and precautions”)
Ramipril Krka with food, drink, and alcohol
- If you drink alcohol while taking Ramipril Krka, you may feel dizzy. If you are worried about how much you can drink while taking Ramipril Krka, talk to your doctor as alcohol may increase the effect of antihypertensive drugs.
- Ramipril Krka can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor if you think you may be pregnant (or may become pregnant) during treatment.
You should not use Ramipril Krka during the first 12 weeks of pregnancy, and you should not use Ramipril Krka at all after the 13th week as use may harm the baby.
If you become pregnant while taking Ramipril Krka, talk to your doctor immediately. Before a planned pregnancy, the doctor may decide that the medicine should be replaced with more suitable alternatives.
Breast-feeding
You should not use Ramipril Krka while breastfeeding.
Talk to a doctor or pharmacist before using any medicine.
Driving and using machines
You may feel drowsy or dizzy after taking Ramipril Krka. This is more likely to happen when you start taking Ramipril Krka or if you take a higher dose. If this happens, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ramipril Krka contains lactose and sodium
Ramipril Krka contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Ramipril Krka
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How to take the medicine
- The tablets should be swallowed at the same time each day.
- Swallow the tablets whole with liquid.
- Do not crush or chew the tablets.
How much 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 dose one until your blood pressure is under control.
- The maximum dose is 10 mg once daily.
- If you are already taking diuretics ( diuretics ), your doctor may ask you to stop taking or reduce the dose of one of the diuretics before starting treatment with Ramipril Krka.
To reduce the risk of heart attack and stroke
- The usual starting dose is 2.5 mg once daily.
- Your doctor may then decide to increase this dose.
- The usual dose is 10 mg once daily.
To reduce or delay the worsening of kidney problems:
- Your starting dose maybe 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 a day.
Treatment of heart failure
- The usual starting dose is 1.25 mg once daily.
- Your doctor will adjust your dose.
- The maximum dose is 10 mg daily. Two dosing sessions per day are preferred.
Treatment after a heart attack
- The usual starting dose is 1.25 mg once daily or 2.5 mg twice daily.
- Your doctor will adjust your dose.
- The maximum dose is 10 mg daily. Two dosing sessions per day are preferred.
Older
- Your doctor will reduce the starting dose and adjust your treatment at a slower pace.
If you use more Ramipril Krka than you should
Tell your doctor or see the emergency department at the nearest hospital as soon as possible. Do not drive to the hospital, ask someone else to drive you or call an ambulance. Bring your medicine pack. This is so that the doctor will know what you have taken.
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
If you forget to use Ramipril Krka
- If you forget to take a dose, take your normal dose at the next dose.
- Do not take a double dose to make up for a forgotten tablet.
If you stop using Ramipril Krka
Keep taking this medicine until your doctor tells you to stop. Do not stop taking Ramipril Krka just because you feel better. If you quit, your illness may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ramipril Krka and see a doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention:
- Swelling of the face, lips, or throat which makes it difficult to swallow or breathe, but also itching and rash. This may be a sign of a severe allergic reaction to Ramipril Krka.
- Severe skin reactions include rash, cold sores, worsening of skin conditions, redness, blisters, or skin detachment (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).
Tell your doctor immediately if you experience:
- Increased heart rate, irregular or severe heartbeat ( palpitation ), chest pain, chest tightness, or more serious problems including heart attack and stroke.
- Shortness of breath or cough. This may be a sign of lung problems.
- Bruising that occurs more easily than usual, prolonged bleeding time, signs of bleeding (eg bleeding in the gums), purple spots on the skin or increased susceptibility to infection, sore throat and fever, fatigue, weakness, dizziness, or pale skin. This may be a sign of blood or bone marrow problems.
- Severe abdominal pain can be felt in the back. This may be a sign of pancreatitis ( inflammation of the pancreas).
- Fever, chills, fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). This can be a sign of liver problems such as hepatitis ( inflammation of the liver) or other liver damage.
Other side effects include:
Tell your doctor if any of the following become serious or persist for more than a few days.
Common (may affect up to 1 in 10 people)
- Headache or fatigue
- Dizziness. This is more likely to happen when you start taking Ramipril Krka or if you start taking a higher dose.
- Fainting, abnormally low blood pressure ( hypotension ), especially when standing or getting up quickly
- Dry whooping cough, sinusitis or bronchitis, shortness of breath
- Gastrointestinal pain, diarrhea, indigestion, nausea or vomiting
- Skin rash with or without swelling
- Chest pain
- Cramp or muscle pain
- Blood tests that show more potassium than normal
Uncommon (may affect up to 1 in 100 people)
- Balance problem (fraud)
- Itching and abnormal sensations in the skin such as numbness, tingling, burning sensation, or ant crawling ( paresthesia )
- Changed or lost taste experience
- Sleep disorders
- Depression, anxiety, increased nervousness or restlessness
- Nasal congestion, difficulty breathing, or worsening of asthma
- Swelling in the stomach is called “intestinal angioedema” which causes symptoms such as abdominal pain, vomiting, and diarrhea
- Heartburn, constipation, or dry mouth
- Increased urination
- Increased sweating
- Lost or decreased appetite ( anorexia )
- Increased or irregular heartbeat. Swollen arms and legs. This may be a sign that your body is storing more water than usual
- Hemorrhoids
- Dimsyn
- Joint pain
- Fever
- Sexual inability in men decreased sexual desire in men or women
- Increased number of certain white blood cells ( eosinophilia ) detected by blood tests
- Blood tests that show changes in your liver function, pancreas, or kidney function
Rare (may affect up to 1 in 1,000 people)
- Tremors or confusion
- Red and swollen tongue
- Severe flaking or flaking of the skin, itchy lumpy rash
- Nail problems (eg loose nails or the nail coming loose from its bracket)
- Skin rash or bruising
- Stains on the skin and cold limbs
- Red, itchy, swollen, or watery eyes
- Affected hearing and ringing in the ears
- Feeling weak
- Blood tests show a decrease in the number of red blood cells, white blood cells, or platelets or a decrease in the level of hemoglobin
Very rare (may affect up to 1 in 10,000 people)
- Increased sun sensitivity
Has been reported (occurs in an unknown number of users)
- Concentrated (dark) urine, nausea, and vomiting, muscle cramps, confusion, and seizures, may be due to incorrect secretion of antidiuretic hormone ( ADH ). If you experience these symptoms, contact your doctor as soon as possible.
Other reported side effects:
Tell your doctor if any of the following become serious or persist for more than a few days.
- Concentration difficulties
- Swelling of the mouth
- Blood tests that show too few blood cells in your blood
- Blood tests that show less sodium in your blood than normal
- Color change of fingers and toes when cold and then pain and tingling when warmed up (Raynaud’s phenomenon)
- Enlarged breasts in men
- Slow or worsening reactions
- Burning sensation
- Change of the sense of smell
- Hair loss
How to store 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 after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is ramipril. Each tablet contains 1.25 mg ramipril. Each tablet contains 2.5 mg ramipril. Each tablet contains 5 mg ramipril. Each tablet contains 10 mg ramipril.
- The other ingredients are sodium bicarbonate (E500), lactose monohydrate, croscarmellose sodium, pregelatinized maize starch and sodium stearyl fumarate, and yellow iron oxide (E172) – only 2.5 mg and 5 mg tablets, and red iron oxide (E172) – only 5 mg tablets. See section 2 “Ramipril Krka contains lactose and sodium”.
What the medicine looks like and the contents of the pack
Ramipril Krka 1.25 mg tablets are white to off-white oblong flat tablets, size 8.0 x 4.0 mm.
Ramipril Krka 2.5 mg tablets are yellow oblong flat tablets, size 10.0 x 5.00 mm.
Ramipril Krka 5 mg tablets are pink oblong flat tablets, size 8.8 x 4.4 mm.
Ramipril Krka 10 mg tablets are white to off-white oblong flat tablets, size 11.0 x 5.5 mm.
Ramipril Krka tablets are supplied in cartons of 10, 20, 30, 50, 60, 90, and 100 tablets in blister packs.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Sloveni