Package leaflet: Information for the patient

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
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Asurami is and what it is used for
What you need to know before taking Asurami
How to take Asurami
Possible side effects
How to store Asurami
Contents of the pack and other information

1. What Asurami is and what it is used for

Asurami contains two different active substances, rosuvastatin and ramipril, in one capsule.
Rosuvastatin belongs to the group of medicines known as statins, which are drugs that regulate lipids (fats).
Ramipril is an angiotensin-converting enzyme (ACE) inhibitor. In patients with high blood pressure, it works by dilating blood vessels, allowing the heart to pump blood more easily through them.
Asurami is used to treat high blood pressure (hypertension) in adult patients who also have one or more of the following conditions:

high cholesterol levels (primary hypercholesterolaemia), or
high cholesterol and fat (triglyceride) levels at the same time (combined or mixed hyperlipidaemia), and/or
high risk of having a heart attack, stroke, or related health problems, which may be reduced by Asurami.

Asurami is indicated for patients already being treated with rosuvastatin and ramipril as separate tablets. Instead of taking rosuvastatin and ramipril as individual tablets, you will receive one capsule of Asurami containing both active substances at the same concentrations. While taking this medicine, you must continue to follow a cholesterol-lowering diet. Asurami does not help with weight loss.

2. What you should know before taking Asurami

Do not take Asurami:

if you are allergic to ramipril, 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 may include skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue;
if you have previously experienced a severe allergic reaction called "angioedema". Signs include itching, skin rash (urticaria), red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing or 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 equipment 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 renal impairment;
if you are pregnant or breastfeeding. If you become pregnant while taking Asurami, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant while taking Asurami by using adequate contraceptive measures (see section below “Pregnancy and breastfeeding”);
if your blood pressure is unusually low or unstable. Your doctor will need to assess this;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
if you have liver disease;
if you repeatedly experience 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, skin peeling, blistering, and/or oral ulcers after taking Asurami or other medicines containing rosuvastatin. Do not take Asurami if any of the above conditions apply. If you are unsure, ask your doctor before taking Asurami.

Warnings and precautions
Talk to your doctor or pharmacist before taking Asurami:

if you have heart, liver, or kidney problems;
if you have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhea, excessive sweating, or due to a low-salt diet, prolonged use of oral diuretics, or after dialysis);
if you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization);
if you are about to undergo anesthesia that may be administered during surgery or dental procedures. You may need to stop taking Asurami the day before; consult your doctor;
if you have high levels of potassium in your blood (shown by a blood test);
if you are taking medicines or have diseases that may reduce sodium levels in your blood. Your doctor may perform regular blood tests, especially to monitor your blood sodium levels, particularly if you are elderly;
if you are taking medicines that may increase the risk of angioedema, a serious 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 section 2 “Do not take Asurami”;
if you have a vascular collagen disorder 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 have kidney problems related to diabetes;
- aliskiren. Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals. See also section “Do not take Asurami”;
if you have had repeated or unexplained episodes of muscle tenderness or pain, a personal or family history of muscle disorders, or a previous history of muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or tenderness, especially if you feel unwell 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 causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4);
if you regularly drink large amounts of alcohol;
if your thyroid gland 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 section “Other medicines and Asurami”;
if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine to treat bacterial infections). The combination of fusidic acid and Asurami can cause serious muscle problems (rhabdomyolysis); see section “Other medicines and Asurami”;
if you are over 70 years old (as your doctor must choose the appropriate dose of Asurami for you);
if you suffer from severe respiratory insufficiency;
if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must choose the appropriate dose of Asurami for you. If any of the above conditions apply (or if you are unsure), consult your doctor or pharmacist before starting any dose of Asurami.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with rosuvastatin. Stop using Asurami and seek urgent medical help if you notice any of the symptoms described in section 4.

In a small number of people, statins may affect the liver. This is checked by a simple blood test to assess whether liver enzyme levels are elevated. For this reason, your doctor will perform this blood test regularly (liver function tests) during treatment with Asurami. It is important that you attend all scheduled laboratory check-ups.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You may be at increased risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, or 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Asurami may affect how some other medicines work. In addition, some medicines may affect how Asurami works. Inform 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 indomethacin, and acetylsalicylic acid);
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;
sacubitril/valsartan, used to treat a type of long-term (chronic) heart failure in adults (see section 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 (chemotherapeutics such as regorafenib, darolutamide);
diuretics such as furosemide;
medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (used to thin the blood);
steroid medicines used to treat inflammation, such as prednisolone;
allopurinol (used to lower uric acid levels in the blood);
procainamide (for heart rhythm disorders);
temsirolimus (for cancer);
sirolimus, everolimus (to prevent transplant rejection);
vildagliptin (used to treat type 2 diabetes);
racecadotril (used for diarrhea);
your doctor may consider it necessary to adjust the dose and/or take additional precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also section “Do not take Asurami” and “Warnings and precautions”);
diabetes medicines such as oral glucose-lowering agents and insulin. Asurami may lower blood sugar levels. Monitor your blood sugar levels carefully while taking Asurami;
lithium (for mental health conditions). Asurami may increase lithium levels in the blood. Your doctor must closely monitor your lithium levels;
warfarin, ticagrelor, or clopidogrel, or any other medicine used to thin the blood (the blood-thinning effect and risk of bleeding may increase when taken concomitantly with Asurami);
fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe). The effect of rosuvastatin increases during concomitant use;
antacids containing aluminium and magnesium (used to neutralize stomach acid; they reduce rosuvastatin plasma levels). This effect can be minimized by taking these medicines 2 hours after rosuvastatin;
erythromycin (an antibiotic). The effect of rosuvastatin decreases when taken concomitantly;
fusidic acid (an antibiotic). If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Asurami. Taking Asurami with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). Further information on rhabdomyolysis is provided in section 4;
an oral contraceptive (birth control pill). Levels of sex hormones absorbed from the pill may increase;
capmatinib (used in cancer treatment);
hormone replacement therapy (increased hormone levels in the blood);
fostamatinib (used to treat low platelet counts);
febuxostat (used to treat and prevent high uric acid levels in the blood);
teriflunomide (used to treat multiple sclerosis);
antiviral medicines such as ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir (used to treat infections, including HIV or hepatitis C infection). See sections “Do not take Asurami” and “Warnings and precautions”. If any of the above conditions apply (or if you are unsure), consult your doctor before taking Asurami. If you go to hospital or receive treatment for another condition, inform the medical staff that you are taking Asurami.

Asurami and alcohol
Taking alcohol with Asurami may cause dizziness or a feeling of lightheadedness. If you are concerned about how much alcohol you can drink while taking Asurami, discuss this with your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.

Pregnancy and breastfeeding
Pregnancy
Do not take Asurami if you are pregnant, trying to become pregnant, or think you might be pregnant, as its use during pregnancy could potentially harm the baby. If you become pregnant while taking Asurami, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant while taking Asurami by using adequate contraception.

Breastfeeding
Do not take Asurami if you are breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines
You may experience dizziness after taking Asurami. If you experience dizziness, discuss this with your doctor before driving or operating machinery.

Asurami contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e., it is essentially "sodium-free".

3. How to take Asurami

Take this medicine exactly as instructed by 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 daily.
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 department, as you may require
medical attention. Do not drive to the hospital; have someone accompany you or call an
ambulance. Bring the medicine pack with you, as 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 the missed dose.

If you stop taking Asurami
Consult your doctor if you wish to stop taking Asurami.

If you have any further questions about the use of this medicine, consult 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 possible side effects might be.
Stop taking Asurami and contact your doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

Swelling of the face, lips, tongue and/or throat causing difficulty swallowing or breathing, together with itching and skin rash. This could be a sign of a serious allergic reaction to Asurami.
Severe skin reactions including flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers; these serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), or worsening of a pre-existing skin disease (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).
Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Unusual or prolonged muscle pain or tenderness. Rarely, this could progress to potentially life-threatening muscle damage known as rhabdomyolysis, which leads to malaise, fever and kidney impairment.
Lupus-like syndrome (including skin rash, joint disorders and effects on blood cells).
Muscle rupture.

Contact your doctor immediately if you experience:

Rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, feeling of chest tightness, or more serious problems including heart attack and stroke.
Shortness of breath or cough. These may be signs of lung problems.
Easy bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizzy or pale skin. These may be signs of circulatory or bone marrow problems.
Severe stomach pain that may spread to the back. This could 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 (liver inflammation) or liver damage.

Other side effects include:
Inform your doctor if any of the conditions listed below become severe or persist for longer than a few days.

Common (may affect up to 1 in 10 people)

Headache or feeling weak or tired
Dizziness
Fainting, low blood pressure (hypotension), especially when standing up or sitting down quickly
Dry, tickly cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
Stomach or intestinal pain, constipation, diarrhoea, indigestion, feeling unwell or actual malaise
Skin rash with or without raised areas
Chest pain
Muscle cramps or muscle pain
Blood tests showing higher than normal potassium levels in the blood
Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon (may affect up to 1 in 100 people)

Balance problems (dizziness)
Itching and unusual skin sensations such as numbness, tingling, pricking, burning or crawling sensations on the skin (paraesthesia)
Loss or change in taste sensation
Sleep problems, including drowsiness
Feeling depressed, anxious, more nervous than usual or restless
Stuffy nose, difficulty breathing or worsening of asthma
Severe stomach pain (inflamed pancreas)
Swelling in the intestine called “intestinal angioedema”, presenting with symptoms such as abdominal pain, vomiting and diarrhoea
Heartburn, dry mouth
Increased urination during the day
Excessive sweating
Loss or decrease in appetite (anorexia)
Increased or irregular heartbeat
Swelling in the arms and legs, which may be a sign of more than usual fluid retention
Hot flushes
Blurred vision
Joint pain
Fever
Sexual dysfunction in men, reduced sexual desire in men or women
Increased number of certain white blood cells (eosinophilia) found during a blood test
Blood tests showing changes in liver, pancreas or kidney function
Skin rash, itching or other skin reactions
Increased amount of protein in the urine; this usually returns to normal on its own without stopping Asurami

Rare (may affect up to 1 in 1,000 people)

Feeling of tremor or confusion
Vascular stenosis, reduced perfusion through blood vessels (hypoperfusion), inflammation of blood vessels (vasculitis)
Redness and swelling of the tongue
Severe peeling or shedding of the skin, itchy and irregular rash
Nail problems (e.g. loosening or separation of a nail from its bed)
Skin rash or bruising
Skin patches and cold extremities
Red, itchy, swollen or watery eyes
Hearing impairment and ringing in the ears
Blood tests showing a decrease in the number of red blood cells, 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 sunlight
Jaundice (yellowing of the skin and eyes), hepatitis (liver inflammation), blood in the urine, nerve damage in the arms and legs (such as numbness), joint pain, memory loss and breast enlargement in men (gynaecomastia)

Not known (frequency cannot be estimated from available data)

Difficulty concentrating
Swelling of the mouth
Blood tests showing too few blood cells (all types) in the blood
Blood tests showing lower than normal sodium levels in the blood
Concentrated urine (dark in colour), feeling or being sick, muscle cramps, confusion and seizures which could be due to inadequate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
Depression
Change in the colour of fingers and toes when cold, and tingling or painful sensation when warming up (Raynaud's phenomenon)
Slowed or altered reactions
Burning sensation
Change in sense of smell
Hair loss
Cough
Sleep disorders, including insomnia and nightmares
Tendon injury and persistent muscle weakness
Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing).
Ocular myasthenia (a disease causing weakness of the eye muscles). Contact your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via [appropriate reporting system]. By reporting side effects, you can help 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 below 25°C in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date, which is stated on the carton and on the blister after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 Asurami contains
The active substances 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: silicified microcrystalline cellulose [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:
Unmarked hard gelatin capsule of Coni Snap type with automatic closure, size 2, with whitish body and brick-red cap, containing two tablets.
Asurami 10 mg/10 mg hard capsules:
Unmarked hard gelatin capsule of Coni Snap type with automatic closure, size 0, with pink body and brick-red cap, containing two tablets.
Asurami 20 mg/5 mg hard capsules:
Unmarked hard gelatin capsule of Coni Snap type with automatic closure, size 0, with whitish body and rust-brown cap, containing two tablets.
Asurami 20 mg/10 mg hard capsules:
Unmarked hard gelatin capsule of Coni Snap type with automatic closure, size 0, with pink body and rust-brown cap, containing two tablets.

Pack sizes: 30, 60, 90 or 100 hard capsules in OPA/Al/PVC//Al blisters, packed in a folded cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization 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 has been authorised in EEA Member States under the following names:
Hungary Rosuvastatin/ramipril Egis 10 mg/5 mg kemény kapszula
Rosuvastatin/ramipril Egis 10 mg/10 mg kemény kapszula
Rosuvastatin/ramipril Egis 20 mg/5 mg kemény kapszula
Rosuvastatin/ramipril Egis 20 mg/10 mg kemény kapszula
Greece Rosuvastatin/ramipril Egis (10+5) mg καψάκια, σκληρά
Rosuvastatin/ramipril Egis (10+10) mg καψάκια, σκληρά
Rosuvastatin/ramipril Egis (20+5) mg καψάκια, σκληρά
Rosuvastatin/ramipril Egis (20+10) mg καψάκια, σκληρά
Italy Asurami
Portugal Rosuvastatina + Ramipril Sandoz
Spain Rosuvastatina/Ramipril Egis 10 mg/5 mg cápsulas duras
Rosuvastatina/Ramipril Egis 10 mg/10 mg cápsulas duras
Rosuvastatina/Ramipril Egis 20 mg/5 mg cápsulas duras
Rosuvastatina/Ramipril Egis 20 mg/10 mg cápsulas duras