ASURAMI 10 mg/5 mg Hard Capsules

Содержание инструкции

1. Asurami 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules, 20 mg/5 mg hard capsules, 20 mg/10 mg hard capsules
   1. What is Asurami and what is it used for
   2. What you need to know before taking Asurami
   3. How to take Asurami
   4. Possible side effects
   5. How to store Asurami
   6. Contents of the pack and other information

Asurami 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules, 20 mg/5 mg hard capsules, 20 mg/10 mg hard capsules

rosuvastatin/ramipril

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

1. What is Asurami and what is it used for

Asurami contains two different active ingredients, rosuvastatin and ramipril, in a capsule.
Rosuvastatin belongs to the group of so-called statins, that is, drugs that regulate lipids (fat).
Ramipril is an inhibitor of the angiotensin converting enzyme (ACE). In patients with high blood
pressure, it works by widening blood vessels, allowing the heart to pump blood more
easily through them.
Asurami is used to treat high blood pressure (hypertension) in adult subjects who
also suffer from one of the following conditions:

• high levels of cholesterol (primary hypercholesterolemia), or
• high levels of cholesterol and fat (triglycerides) simultaneously (combined or mixed hyperlipidemia), and/or
• high risk of having a heart attack, stroke or related health problems, which can be reduced by Asurami. Asurami is indicated for patients already being treated with rosuvastatin/ramipril single tablets. Instead of taking rosuvastatin and ramipril as single tablets, you will receive an Asurami capsule containing the two active ingredients at the same concentration. While taking this medicine, you must continue to follow a diet to lower your cholesterol levels. Asurami does not help with weight loss.

2. What you need to know before taking Asurami

Do not take Asurami:

• if you are allergic to ramipril, to any other medicine that inhibits ACE, or rosuvastatin, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction can include skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue;
• if you have had a severe allergic reaction called “angioedema”. The signs include itching, rash (hives), red patches on the hands, feet and in the throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;
• if you have recently taken (within 36 hours) or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults;
• if you are on dialysis or undergoing any other type of blood filtration. Depending on the machinery used, Asurami may not be suitable for you;
• if you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis) or suffer from severe kidney failure;
• if you are pregnant or breastfeeding. If you become pregnant while taking Asurami, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant while taking Asurami by using adequate contraceptive measures (see the section below “Pregnancy and breastfeeding”);
• if your blood pressure is unusually low or unstable. The doctor will be required to make this assessment;
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren;
• if you suffer from a liver disease;
• if you experience repeated unexplained muscle pain or tenderness (myopathy);
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used for the viral liver infection called hepatitis C);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplants);
• if you have ever developed a severe skin rash or peeling of the skin, blistering and/or oral ulcers after taking Asurami or other medicines containing rosuvastatin. Do not take Asurami if any of the above conditions occur. If you are unsure, ask your doctor before taking Asurami. Warnings and precautionsTalk to your doctor or pharmacist before taking Asurami:
• if you have heart, liver or kidney problems;
• if you have lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhea, excessive sweating, or following a low-salt diet, or after taking oral diuretics for a long time or having undergone dialysis);
• if you are about to undergo treatment to reduce the allergy to bee or wasp stings (desensitization);
• if you are about to undergo anesthesia that may be administered for surgery or dental surgery. It may be necessary to stop treatment with Asurami the day before, ask your doctor for advice;
• if you have a high amount of potassium in your blood (shown by a blood test);
• if you are taking medicines or suffer from diseases that can reduce the levels of sodium in your blood. The doctor may perform regular blood tests, especially to check the levels of sodium in the blood and especially if you are elderly;
• if you are taking medicines that can increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP; such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see paragraph 2 “Do not take Asurami”;
• if you have a connective tissue 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 blocker (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes;
• aliskiren. The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is reported in the entry “Do not take Asurami”;
• if you have had repeated or unexplained episodes of muscle soreness or pain, a personal or family history of muscle problems or a previous history of muscle problems while taking other medicines that lower cholesterol. Immediately inform your doctor if you experience unexplained muscle soreness or pain, especially if you do not feel well or have a fever. Also consult your doctor or pharmacist if you experience persistent muscle weakness;
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to occur (see section 4);
• if you regularly drink large amounts of alcohol;
• if your thyroid is not functioning properly (hypothyroidism);
• if you are taking other medicines called fibrates to lower cholesterol (see section “Other medicines and Asurami”);
• if you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir; see paragraph “Other medicines and Asurami”;
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Asurami can cause serious muscle problems (rhabdomyolysis); see paragraph “Other medicines and Asurami”;
• if you are over 70 years of age (as the doctor needs to choose the right dose of Asurami that is suitable for you);
• if you suffer from severe respiratory failure;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). The doctor needs to choose the right dose of Asurami that is suitable for you. If you fall into any of the above conditions (or if you have doubts), consult your doctor or pharmacist before actually starting to take any dose of Asurami. Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with rosuvastatin treatment. Stopusing Asurami and seek urgent medical attentionif you notice any of the symptoms described in paragraph 4. In a small number of people, statins can have effects on the liver. This is checked by a simple test to assess whether there are elevated levels of liver enzymes in the blood. For this reason, the doctor will perform this blood test regularly (liver function test) during treatment with Asurami. It is important that you go to the doctor for the prescribed laboratory tests.

While you are taking this medicine, the doctor will carefully monitor you if you suffer from
diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if
you have high levels of sugar and fats in your blood, if you are overweight and if you have high blood
pressure.

Children and adolescents
The use of Asurami is not recommended in children and adolescents under 18 years of age.

Other medicines and Asurami
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This is because Asurami can affect the mechanism of action of some other
medicines. Also, some medicines can affect the mechanism of action of Asurami.
Tell your doctor if you are taking any of the following:

• 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, norepinephrine or adrenaline. The doctor will need to check your blood pressure;
• sacubitril/valsartan, used to treat a type of long-term (chronic) heart failure in adults (see paragraph 2 “Do not take Asurami”);
• cyclosporine (used, for example, after organ transplants to prevent organ rejection); Do not take Asurami while taking cyclosporine;
• cancer medicines (chemotherapeutic agents such as regorafenib, darolutamide);
• diuretics such as furosemide;
• medicines that can increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections) 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);
• sirolimus, everolimus (for transplant rejection prevention);
• vildagliptin (used to treat type 2 diabetes);
• racecadotril (used against diarrhea);
• the doctor may need to adjust the dose and/or take other precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also what is reported in the entry “Do not take Asurami” and “Warnings and precautions”);
• medicines for diabetes such as oral glucose-lowering medicines and insulin. Asurami can lower blood sugar levels. Measure your blood sugar carefully while taking Asurami;
• lithium (for mental health problems). Asurami can increase the amount of lithium in the blood. Your lithium levels will need to be carefully monitored by the doctor;
• warfarin, ticagrelor or clopidogrel, or any other medicine used to make the blood more fluid (whose blood-thinning effect and risk of bleeding may increase during concomitant use with Asurami);
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe). During concomitant use, the effect of rosuvastatin increases;
• remedies for indigestion containing aluminum and magnesium (used to neutralize stomach acid; they reduce the plasma level of rosuvastatin). This effect can be mitigated by taking this type of medicine 2 hours after rosuvastatin;
• erythromycin (an antibiotic). The effect of rosuvastatin decreases with their concomitant use;
• fusidic acid (an antibiotic). If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. The doctor will tell you when you can safely restart Asurami. Taking Asurami with fusidic acid can rarely cause muscle weakness, soreness or pain (rhabdomyolysis). Further information regarding rhabdomyolysis is reported in paragraph 4;
• if you are over 70 years of age (as the doctor needs to choose the right dose of Asurami that is suitable for you);
• if you suffer from severe respiratory failure;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). The doctor needs to choose the right dose of Asurami that is suitable for you. If you fall into any of the above conditions (or if you are unsure), consult your doctor or pharmacist before actually starting to take any dose of Asurami. Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with rosuvastatin treatment. Stopusing Asurami and seek urgent medical attentionif you notice any of the symptoms described in paragraph 4. In a small number of people, statins can have effects on the liver. This is checked by a simple test to assess whether there are elevated levels of liver enzymes in the blood. For this reason, the doctor will perform this blood test regularly (liver function test) during treatment with Asurami. It is important that you go to the doctor for the prescribed laboratory tests.

Asurami contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, that is to say, it is essentially “sodium-free”.

3. How to take Asurami

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet while taking Asurami.
The recommended daily dose is one capsule of the given strength.

Take Asurami once a day.
Take the medicine at the same time each day, with or without food. Swallow each capsule whole with
a glass of water.

Use in children and adolescents
The use of Asurami is not recommended in children and adolescents under 18 years of age.

If you take more Asurami than you should
Inform your doctor or go to the nearest hospital emergency room as you may need
medical assistance. Do not drive to the hospital, have someone accompany you or call an
ambulance. Bring the medicine package with you. This is because the doctor needs to know what you have
taken.

If you forget to take Asurami
Do not worry; skip the missed dose and take the next scheduled dose at the correct time.
Do not take a double dose to make up for a missed dose.

If you stop taking Asurami
Consult your doctor if you wish to stop taking Asurami.
If you have further questions 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.
It is important that you are aware of what these side effects might be.

Stop taking Asurami and contact your doctor immediately if you notice any serious side effect – you may need urgent medical treatment:

• Swelling of the face, lips, tongue and/or throat making it difficult to swallow or breathe, as well as itching and skin rash. This could be a sign of a severe allergic reaction to Asurami.
• Severe skin reactions including reddish, non-raised, target-shaped or circular patches on the trunk, often with blisters in the centre, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes; these severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), worsening of a pre-existing skin condition (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).
• Widespread rash, high temperature and swollen lymph nodes (DRESS syndrome or drug reaction with eosinophilia and systemic symptoms).
• Unusual muscle aches or tenderness that lasts longer than you would expect. Rarely, this could develop into muscle damage that is potentially life-threatening, known as rhabdomyolysis, leading to feeling unwell, fever and kidney problems.
• Lupus-like syndrome (including skin rash, joint disorders and effects on blood cells).
• Muscle rupture.

Tell your doctor immediately if you experience:

• Fast 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 or cough. These can be signs of lung problems.
• Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums), purple patches on the skin or easy development of infections, sore throat and fever, feeling tired, weak, dizzy or pale skin. These can be signs of problems with blood circulation or the bone marrow.
• Severe stomach pain that may spread to your back. This can 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 can be signs of liver problems such as hepatitis (liver inflammation) or liver damage. Other side effects include:Tell your doctor if any of the following conditions becomes severe or lasts for more than a few days. Common(may affect up to 1 in 10 people)
• headache or feeling weak or tired
• dizziness
• fainting, low blood pressure (blood pressure too low), especially when getting up or sitting up quickly
• dry, tickly cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• stomach or intestinal pain, constipation, diarrhoea, indigestion, feeling sick or actually being sick
• skin rash with or without a raised area
• chest pain
• cramps or muscle pain
• blood tests showing a higher than normal level of potassium in your blood
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, if you are overweight and if you have high blood pressure. Your doctor will monitor you while you are taking this medicine. Uncommon(may affect up to 1 in 100 people)
• problems with balance (vertigo)
• itching and unusual skin sensations such as numbness, tingling, prickling, burning or feeling something crawling on the skin (paresthesia)
• loss or alteration of taste
• problems sleeping, including drowsiness
• feeling depressed, anxious, more nervous than usual or restless
• blocked nose, difficulty breathing or worsening of asthma
• severe stomach pain (inflamed pancreas)
• swelling of the intestine called “intestinal angioedema”, which presents with symptoms such as abdominal pain, vomiting and diarrhoea
• heartburn, dry mouth
• urinating more often than usual during the day
• sweating more than usual
• loss or decrease of appetite (anorexia)
• increased or irregular heartbeat
• swelling of the arms and legs, which can be a sign of more fluid retention than usual
• hot flushes
• blurred vision
• joint pain
• fever
• erectile dysfunction in men, reduced sex drive in men or women
• increased number of certain white blood cells (eosinophilia) found during a blood test
• blood tests showing changes in the function of the liver, pancreas or kidneys
• skin rash, itching or other skin reactions
• increased amount of protein in the urine; this usually goes away on its own without having to stop taking Asurami Rare(may affect up to 1 in 1,000 people)
• feeling of trembling or confusion
• vascular stenosis, reduced perfusion through blood vessels (hypoperfusion), inflammation of the vessels (vasculitis)
• redness and swelling of the tongue
• severe skin peeling or flaking, itchy, irregular skin rash
• problems with nails (e.g. loosening or separation of a nail from its bed)
• skin rash or bruising
• pale and cold patches on the skin
• red, itchy, swollen or watery eyes
• impaired hearing and ringing in the ears
• blood tests showing a decrease in the number of red blood cells or white blood cells or platelets or in the amount of haemoglobin Very rare(may affect up to 1 in 10,000 people)
• increased sensitivity to the sun than usual
• jaundice (yellowing of the skin and eyes), hepatitis (liver inflammation), traces of blood in the urine, nerve damage in the legs and arms (such as numbness), joint pain, memory loss and enlargement of the breasts in men (gynaecomastia) Not known(frequency cannot be estimated from available data)
• difficulty concentrating
• swelling of the mouth
• blood tests showing too little of certain blood cells (all types) in the blood
• blood tests showing a low level of sodium in the blood
• concentrated urine (dark in colour), feeling or being sick, having muscle cramps, confusion and convulsions which may be caused by inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.
• depression
• alteration of the colour of the fingers of the hands and feet when cold and tingling or a sensation of pain when warming up (Raynaud’s phenomenon)
• slowed or altered reactions
• burning sensation
• alteration of the sense of smell
• hair loss
• cough
• sleep disorders, including insomnia and nightmares
• tendon injury and constant muscle weakness
• myasthenia gravis (a disease that causes generalised muscle weakness including, in some cases, the muscles used for breathing).
• ocular myasthenia (a disease that causes weakness of the eye muscles). See your doctor if you experience weakness in your arms or legs that gets worse after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath. Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Asurami

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C in the original packaging to protect the medicine
from light and humidity.
Do not use this medicine after the expiry date, which is reported on the box and blister, after SCAD.
The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Asurami contains
The active ingredients are rosuvastatin and ramipril.
Asurami 10 mg/5 mg hard capsules:
The capsules contain rosuvastatin calcium equivalent to 10 mg of rosuvastatin and 5 mg of ramipril.
Asurami 10 mg/10 mg hard capsules:
The capsules contain rosuvastatin calcium equivalent to 10 mg of rosuvastatin and 10 mg of ramipril.
Asurami 20 mg/5 mg hard capsules:
The capsules contain rosuvastatin calcium equivalent to 20 mg of rosuvastatin and 5 mg of ramipril.
Asurami 20 mg/10 mg hard capsules:
The capsules contain rosuvastatin calcium equivalent to 20 mg of rosuvastatin and 10 mg of ramipril.
The other ingredients are:

Capsule core:microcrystalline cellulose silicified [microcrystalline cellulose (E460), anhydrous colloidal silica (E551)]; magnesium stearate (E572); anhydrous colloidal silica (E551); microcrystalline cellulose (E460); crospovidone type B; hypromellose; sodium stearyl fumarate; hydrophobic colloidal silica; yellow iron oxide (E172).

Capsule coating:
Asurami 10 mg/5 mg hard capsules:
Titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide, gelatin
Asurami 10 mg/10 mg hard capsules:
Titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), gelatin
Asurami 20 mg/5 mg hard capsules:
Titanium dioxide (E171), red iron oxide (E172), black iron oxide, gelatin
Asurami 20 mg/10 mg hard capsules:
Titanium dioxide (E171), red iron oxide (E172), gelatin

Description of the appearance of Asurami and contents of the pack
Asurami 10 mg/5 mg hard capsules:
Hard gelatin capsule, unmarked, type Coni Snap automatic closing and size 2, with a whitish body and brick red cap, containing two tablets.
Asurami 10 mg/10 mg hard capsules:
Hard gelatin capsule, unmarked, type Coni Snap automatic closing and size 0, with a pink body and brick red cap, containing two tablets.
Asurami 20 mg/5 mg hard capsules:
Hard gelatin capsule, unmarked, type Coni Snap automatic closing and size 0, with a whitish body and rust brown cap, containing two tablets.
Asurami 20 mg/10 mg hard capsules:
Hard gelatin capsule, unmarked, type Coni Snap automatic closing and size 0, with a pink body and rust brown cap, containing two tablets.
Pack sizes: hard capsules of 30, 60, 90 or 100 in OPA/Al/PVC//Al blisters,
packaged in a folded cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Largo Umberto Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers
Egis Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
Hungary
Egis Pharmaceuticals PLC
9900 Körmend, Mátyás király u. 65.
Hungary
Lek Pharmaceuticals d.d.
1526 Ljubljana, Verovškova Ulica 57
Slovenia

This medicinal product is authorised in the member states of the EEA under the following denominations:
Hungary Rosuvastatin/ramipril Egis 10 mg/5 mg hard capsule
Rosuvastatin/ramipril Egis 10 mg/10 mg hard capsule
Rosuvastatin/ramipril Egis 20 mg/5 mg hard capsule
Rosuvastatin/ramipril Egis 20 mg/10 mg hard capsule
Greece Rosuvastatin/ramipril Egis (10+5) mg hard capsules
Rosuvastatin/ramipril Egis (10+10) mg hard capsules
Rosuvastatin/ramipril Egis (20+5) mg hard capsules
Rosuvastatin/ramipril Egis (20+10) mg hard capsules
Italy Asurami
Portugal Rosuvastatina + Ramipril Sandoz
Spain Rosuvastatina/Ramipril Egis 10 mg/5 mg hard capsules
Rosuvastatina/Ramipril Egis 10 mg/10 mg hard capsules
Rosuvastatina/Ramipril Egis 20 mg/5 mg hard capsules
Rosuvastatina/Ramipril Egis 20 mg/10 mg hard capsules