RAMIPRIL 5 mg/5 mg Hard Capsule

Содержание инструкции

1. Ramipril and Amlodipine Krka 5 mg/5 mg hard capsules, 5 mg/10 mg hard capsules, 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules
   1. What is Ramipril and Amlodipine Krka and what is it used for
   2. What you need to know before taking Ramipril and Amlodipine Krka
   3. How to take Ramipril and Amlodipina Krka
   4. Possible side effects
   5. How to store Ramipril and Amlodipina Krka
   6. Package Contents and Other Information

Ramipril and Amlodipine Krka 5 mg/5 mg hard capsules, 5 mg/10 mg hard capsules, 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules

ramipril/amlodipine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet

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

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

Ramipril and Amlodipine Krka contains two active ingredients called ramipril and amlodipine. Ramipril
belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme
Inhibitors), while amlodipine belongs to a group of medicines called calcium channel blockers.
Ramipril works by:

• Decreasing the production, by the body, of substances that can cause an increase in blood pressure.
• Relaxing and widening the blood vessels.
• Making it easier for the heart to pump blood around the body. Amlodipine works by:
• Relaxing and widening the blood vessels, so that blood can pass through more easily.

Ramipril and Amlodipine Krka can be used for the treatment of high blood pressure (hypertension) in
patients who are adequately controlled by taking the individual medicines, such as
separate tablets, but with the same dosage as their combination.

2. What you need to know before taking Ramipril and Amlodipine Krka

Do not take Ramipril and Amlodipine Krka:

• If you are allergic to ramipril or amlodipine (the active ingredients), to any other ACE inhibitor or calcium channel blocker, or to any of the other components of this medicine (listed in section

6).

• Signs of an allergic reaction can include skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue, itching or redness of the skin.
• If you have ever had a severe allergic reaction called “angioedema”. The signs include itching, hives, red marks 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 being used, Ramipril and Amlodipine Krka may not be suitable for you.
• If you have kidney problems when the blood supply to the kidneys is reduced (renal artery stenosis)
• During the last 6 months of pregnancy (see the section below on "Pregnancy and breastfeeding").
• If your blood pressure is abnormally low (hypotension) or unstable. Your doctor will need to make this assessment.
• If you have diabetes or impaired kidney function and are being treated with a medicine to lower blood pressure called aliskiren.
• If you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide enough blood for the body).
• If you suffer from heart failure after a heart attack.
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Do not take Ramipril and Amlodipine Krka if any of these apply to you. If you are not sure, ask your doctor before taking Ramipril and Amlodipine Krka.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ramipril and Amlodipine Krka. Tell your doctor if any of the following apply to you:
If you have problems with your heart, liver or kidneys
If you have lost a large amount of salts or body fluids (due to illness (vomiting), having diarrhea, excessive sweating, following a low-salt diet, taking diuretics (water tablets) for a long period or have undergone dialysis)
If you are about to undergo treatment for reducing allergy to bees or wasps
(desensitization)
If you are about to have an anesthetic. This may be given for an operation or dental work. You may need to stop taking Ramipril and Amlodipine Krka one day before; ask your doctor for advice.
If you have high levels of potassium in your blood (shown by blood tests).
If you are taking medicines or are in conditions that may decrease sodium levels in your blood. Your doctor may perform regular blood tests, especially for monitoring sodium levels in the blood, particularly if you are elderly.
If you think you are (or might become) pregnant. Ramipril and Amlodipine Krka is not recommended during the first 3 months of pregnancy and can cause serious harm to the baby after 3 months of pregnancy (see section below on "Pregnancy and breastfeeding").
If you have a collagen vascular disease, such as scleroderma or systemic lupus erythematosus
If you have a severe increase in blood pressure (hypertensive crisis).
If you are elderly and your dose needs to be reduced.
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 - e.g. valsartan, telmisartan, irbesartan), especially if you have liver problems due to diabetes.
• aliskiren. If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater:
• racecadotril, a medicine used to treat diarrhea
• medicines used to prevent organ transplant rejection and to treat cancer (such as temsirolimus, sirolimus, everolimus)
• vildagliptin, a medicine used to treat diabetes.

Your doctor may need to change the dosage and/or take other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information in the sections “Do not take Ramipril and Amlodipine Krka” and “Warnings and precautions”).
If any of the conditions described above occur (or you have any doubts), ask your doctor before taking Ramipril and Amlodipine Krka.

Children and adolescents
The use of Ramipril and Amlodipine Krka is not recommended in children and adolescents under 18 years of age as the safety and efficacy of Ramipril and Amlodipine Krka have not yet been established.

Other medicines and Ramipril and Amlodipine Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines.

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin and acetylsalicylic acid).
• Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, noradrenaline or adrenaline. Your doctor should check your blood pressure.
• Cancer medicines (chemotherapy).
• Medicines to prevent organ rejection after transplantation, such as cyclosporine.
• Diuretics (water tablets) such as furosemide.
• Medicines that can increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (used to make the blood more fluid).
• Steroid medicines for the treatment of inflammation, such as prednisolone.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Temsirolimus for cancer.
• Vildagliptin (used for type 2 diabetes).
• Medicines for diabetes such as oral hypoglycemic agents and insulin. Ramipril and Amlodipine Krka can lower blood sugar levels. Carefully monitor your blood sugar levels when taking Ramipril and Amlodipine Krka.
• Lithium (for psychiatric problems). Ramipril and Amlodipine Krka can increase the amount of lithium in the blood. Your doctor should carefully monitor the lithium level in your blood.
• Ketoconazole, itraconazole (anti-fungal medicines)
• Ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV)
• Rifampicin, erythromycin, clarithromycin (antibiotics used for infections caused by bacteria)
• Hypericum perforatum(St John's Wort)
• Verapamil, diltiazem (medicines for the treatment of heart disorders or high blood pressure).
• Dantrolene (infusion for severe abnormalities in body temperature).
• Tacrolimus (used to control the body's immune response, enabling the body to accept organ transplants).
• Simvastatin (medicine to lower cholesterol).
• Medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions".
• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent organ rejection; and heparin, a medicine used to thin the blood and prevent blood clots)

Your doctor may need to change the dosage and/or take other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information in the sections “Do not take Ramipril and Amlodipine Krka” and “Warnings and precautions”).
If any of the conditions described above occur (or you have any doubts), ask your doctor before taking Ramipril and Amlodipine Krka.

Ramipril and Amlodipine Krka with food, drinks and alcohol
Ramipril and Amlodipine Krka can be taken with or without food.

• Drinking alcoholic beverages together with Ramipril and Amlodipine Krka can cause dizziness or lightheadedness. If you are concerned about how much you can drink while taking Ramipril and Amlodipine Krka, talk to your doctor, as medicines used to lower blood pressure and alcohol can have additive effects.

Grapefruit and grapefruit juice should not be consumed by people taking Ramipril and Amlodipine Krka.
This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which can cause an unpredictable increase in blood pressure, reducing the effect of Ramipril and Amlodipine Krka.

Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you think you are pregnant (or might become pregnant).
You must not take Ramipril and Amlodipine Krka during the first 12 weeks of pregnancy and must not take it at all after the 13th week because its use can be harmful to the baby.
If you become pregnant while taking Ramipril and Amlodipine Krka, tell your doctor immediately. Before planning a pregnancy, you should switch to an alternative medicine that is suitable.

Breastfeeding
You must not take Ramipril and Amlodipine Krka if you are breastfeeding.
Amlodipine has been shown to pass into breast milk in small amounts. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Ramipril and Amlodipine Krka can affect your ability to drive and use machines.
If the capsules make you feel unwell or you experience dizziness, fatigue or headache, do not drive or use machines and contact your doctor immediately. This is more likely to happen when you start taking Ramipril and Amlodipine Krka or when you take a higher dose.

3. How to take Ramipril and Amlodipina Krka

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Take this medicine by mouth at the same time of day, before or after meals.
Swallow the tablets with some liquid.
Do not take Ramipril and Amlodipina Krka with grapefruit juice.
Ramipril and Amlodipina Krka must be administered once a day.

Elderly
The doctor will reduce the initial dose and adjust the treatment very slowly.

If you take more Ramipril and Amlodipina Krka than you should
Taking too many capsules can cause a lowering of blood pressure or even
dangerous lowering. You may feel dizziness, lightheadedness, fainting or weakness. If the
drop in blood pressure is severe, shock may occur. You may feel cold and clammy skin and
may lose consciousness. Inform your doctor or go to the nearest hospital emergency room.
Do not drive to the hospital, ask someone else to take you or call an ambulance. Bring the
package of the medicine. This is so the doctor knows what you have taken.

If you forget to take Ramipril and Amlodipina Krka
If you forget to take a capsule, leave it and do not take the dose. Take the next dose at the
same time.
Do not take a double dose to make up for a missed dose.

If you stop taking Ramipril and Amlodipina Krka
The doctor will advise you how long you should take the medicine. Your condition may
return if you stop taking the medicine before you are told to.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ramipril and Amlodipina Krka and contact your doctor immediatelyif you notice the appearance of any of the following serious side effects – you may need urgent medical treatment:
Swelling of the face, lips or throat that makes it difficult to swallow or breathe, as well as itching and skin rashes. This could be a sign of a severe allergic reaction to Ramipril and Amlodipina Krka.
Severe skin reactions including skin rashes, ulcers in the mouth, worsening of a pre-existing skin condition, redness, blisters or detachment of the skin, itching, blisters, scaling and swelling of the skin, inflammation of the mucous membranes (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience:
Accelerated heartbeat, irregular or strengthened heartbeat (palpitations), chest pain, feeling of tightness in the chest or more serious problems including heart attack and stroke.
Shortness of breath, cough, sudden dyspnea, chest pain or difficulty breathing. These may be signs of lung problems.
Easier formation of bruises, bleeding that lasts longer than normal, any sign of bleeding (e.g. bleeding gums), purple spots, spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizziness or pale skin. These may be signs of circulatory or bone marrow problems.
Severe stomach pain that can extend to the back. This may be a sign of pancreatitis (inflammation of the pancreas).
Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.
Swelling of the eyelids or tongue.
Allergic reactions.
Related to ramipril:

Common (may affect up to 1 in 10 people)
Headache or feeling of weakness.
Feeling dizzy. This is more likely when you have just started taking Ramipril and Amlodipina Krka or have just increased the dose.
Fainting and hypotension (unusually low blood pressure), especially when standing up or getting up quickly.
Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath.
Stomach or intestinal pain, diarrhea, indigestion, feeling and being sick.
Skin rash with or without swelling.
Chest pain.
Muscle cramps or pain.
Blood tests showing more potassium than usual in the blood.

Uncommon (may affect up to 1 in 100 people)
Problems with balance (vertigo).
Itching and unusual skin sensations such as numbness, tingling, itching, burning or chafing on the skin (paresthesia).
Loss or change of taste.
Problems sleeping.
Depressed mood, anxiety, increased nervousness than usual or restlessness.
Blocked nose, difficulty breathing or worsening of asthma.
Swelling of the intestine called "intestinal angioedema" which presents with symptoms such as abdominal pain, vomiting and diarrhea.
Heartburn, constipation or dry mouth.
Increased amount of water (urine) than usual during the day.
Increased sweating than usual.
Loss or decrease of appetite (anorexia).
Increased or irregular heartbeat.
Swollen arms and legs. This may be a sign that your body is retaining more water than usual.
Flushing.
Blurred vision.
Joint pain.
Fever.
Impotence in males, reduced sexual desire in men or women.
Decreased number of white blood cells in the blood (eosinophilia), found during blood tests.
Changes in liver, pancreas or kidney function highlighted by blood tests.

Rare (may affect up to 1 in 1,000):
Feeling unstable and confused.
Redness and swelling of the tongue.
Severe flaking or scaling of the skin, itching, skin rashes with the presence of bumps.
Nail problem (e.g. loss or separation of a nail from its site).
Skin rash or bruising.
Spots on the skin and cold extremities.
Red, swollen or watery eyes, itching.
Disturbed hearing and ringing in the ears.
Feeling of weakness.
Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or the amount of hemoglobin.

Very rare (may affect up to 1 in 10,000)
Feeling more sensitive to the sun than normal.

Not known (frequency cannot be estimated from available data)
Concentrated urine (dark color), feeling or being sick, muscle cramps, confusion and seizures which may be caused by inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms contact your doctor as soon as possible.

Other side effects reported:
Tell your doctor if any of the following conditions becomes serious or persists for more than a few days.
Difficulty concentrating.
Swollen mouth.
Blood tests showing a decrease in blood cells.
Blood tests showing a decrease in sodium in the blood.
Fingers of the hands and feet that change color when cooled and that tingle or hurt when warmed (Raynaud's phenomenon).
Enlargement of the breasts in men.
Slowed or altered reactions.
Burning sensation.
Change in the perception of smells.
Hair loss.
Related to amlodipine:

Very common (may affect more than 1 in 10 people)

• Swelling of the ankles (edema)

Common (may affect up to 1 in 10 people)
Headache, dizziness, drowsiness (especially at the beginning of treatment).
Palpitations (awareness of your heartbeat), hot flushes.
Abdominal pain, feeling unwell (nausea).
Altered bowel habits, diarrhea, constipation, indigestion.
Fatigue, weakness.
Visual disturbances, double vision.
Muscle cramps.

Other side effectsthat have been reported are included in the following list. If any of these becomes serious or if you notice any effect not listed in this leaflet, tell your doctor or pharmacist.

Uncommon (may affect up to 1 in 100 people)
Changes in mood, anxiety, depression, insomnia.
Tremor, changes in taste, fainting.
Numbness or tingling in the limbs, loss of pain sensation.
Ringing in the ears.
Low blood pressure.
Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis).
Cough.
Dry mouth, vomiting (being sick).
Hair loss, increased sweating, itching, red spots on the skin, change in skin color.
Difficulty urinating, increased need to urinate during the night, increased number of times of urination.
Inability to get an erection, discomfort or enlargement of the breasts in men.
Pain, malaise.
Muscle or joint pain, back pain.
Weight gain or loss.

Rare (may affect up to 1 in 1,000):
Confusion

Very rare (may affect up to 1 in 10,000)
Decrease in the number of white blood cells, decrease in platelets which may cause bruising or easy bleeding (red blood cell damage).
Excess sugar in the blood (hyperglycemia)
Nerve disorder that can cause weakness, tingling or numbness.
Swelling of the gums.
Abdominal swelling (gastritis).
Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect some medical tests.
Increased muscle tension.
Inflammation of blood vessels, often with skin rash.
Sensitivity to light.
Diseases that associate disorders of rigidity, tremor, and/or movement.

Not known (frequency cannot be estimated from available data)
Tremor, rigid posture, mask-like face, slow and dragging movements, unbalanced walking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ramipril and Amlodipina 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 packaging after EXP. The
expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ramipril and Amlodipina Krka contains

• The active ingredients are ramipril and amlodipine (as amlodipine besylate). 5 mg/5 mg hard capsules: Each hard capsule contains 5 mg of ramipril and 5 mg of amlodipine (as amlodipine besylate). 5 mg/10 mg hard capsules: Each hard capsule contains 5 mg of ramipril and 10 mg of amlodipine (as amlodipine besylate). 10 mg/5 mg hard capsules: Each hard capsule contains 10 mg of ramipril and 5 mg of amlodipine (as amlodipine besylate). 10 mg/10 mg hard capsules: Each hard capsule contains 10 mg of ramipril and 10 mg of amlodipine (as amlodipine besylate).
• The other ingredients are hypromellose 6cP, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate (E470b) inside the capsule. The other ingredients of 5 mg/5 mg hard capsules and 10 mg/5 mg hard capsules are titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), gelatin, black ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172)) in the capsule coating. The other ingredients of 5 mg/10 mg hard capsules are titanium dioxide (E171), red iron oxide (E172), gelatin, black ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172)) in the capsule coating. The other ingredients of 10 mg/10 mg hard capsules are titanium dioxide (E171), red iron oxide (E172), gelatin, white ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) in the capsule coating.

Description of the appearance of Ramipril and Amlodipina Krka and package contents
5 mg/5 mg capsules (capsules): the capsule body is orange-brown in color with the black imprint 0505. The capsule cap is orange-brown in color. The capsule contents are white to almost white powder with possible crystals. Capsule size n° 2.
5 mg/10 mg capsules (capsules): the capsule body is white to almost white with the gray imprint 0510. The capsule cap is red-brown in color. The capsule contents are white to almost white powder with possible crystals. Capsule size n° 0.
10 mg/5 mg capsules (capsules): the capsule body is white to almost white with the black imprint 1005. The capsule cap is orange-brown in color. The capsule contents are white to almost white powder with possible crystals. Capsule size n° 0.
10 mg/10 mg capsules (capsules): the capsule body is red-brown in color with the white imprint 1010. The capsule cap is red-brown in color. The capsule contents are powder from white to almost white with possible crystals. Capsule size n° 0.
Ramipril and Amlodipina Krka is available in packs containing:

• 30, 50, 60, 90 and 100 hard capsules in blisters,
• 30 x 1, 50 x 1, 60 x 1, 90 x 1 and 100 x 1 hard capsules in single-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturers responsible for batch release
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
More detailed information on this medicine is available on the website of the Italian Medicines Agency, http://www.aifa.gov.it