ROSULOD 10 mg/5 mg Hard Capsule

Содержание инструкции

1. Rosulod 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules, 20 mg/5 mg hard capsules
   1. What is Rosulod and what is it used for
   2. What you need to know before taking Rosulod
   3. How to take Rosulod
   4. Possible side effects
   5. How to store Rosulod
   6. Package Contents and Other Information

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

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

1. What is Rosulod and what is it used for

Rosulod contains two active substances – rosuvastatin and amlodipine.
Rosulod is indicated in adults for the treatment of high blood pressure and concomitant high cholesterol levels when dietary changes and increased exercise have not been sufficient to correct cholesterol levels and/or to prevent cardiovascular events if other factors are present that increase the risk of heart attack, stroke or related health problems.
Rosulod is indicated in patients who are already taking rosuvastatin and amlodipine at these dosages.
Instead of taking rosuvastatin and amlodipine in separate tablets, you will receive a Rosulod capsule containing both substances at the same dosages.
You should continue with a diet to reduce cholesterol levels and exercise during treatment with Rosulod.

2. What you need to know before taking Rosulod

Do not take Rosulod:

• If you are allergic to rosuvastatin, amlodipine, to any calcium channel blockers or to any of the other ingredients of this medicine (listed in section 6);
• If you are pregnant or breastfeeding. If you become pregnant while taking Rosulod, stop taking it immediately and contact your doctor. Women must avoid pregnancy during treatment with Rosulod, using appropriate contraceptive measures;
• If you have a liver disease;
• If you have severe kidney problems;
• If you have repeated or unexplained muscle aches or pains;
• If you are taking a medicine called cyclosporine (used, for example, after organ transplant);
• If you have severely low blood pressure (severe hypotension);
• If you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide enough blood to the body);
• If you suffer from heart failure following an acute heart attack.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rosulod.

• If you have kidney problems;
• If you have liver problems;
• If you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or if you have had a previous history of muscle problems while taking other medicines that lower cholesterol. Tell your doctor immediately if you have unexplained muscle aches or pains, especially if accompanied by feeling unwell or fever. Also inform your doctor or pharmacist if you have constant muscle weakness;
• If you regularly consume significant amounts of alcohol;
• If your thyroid gland is not functioning properly;
• If you are taking other medicines called fibrates to lower cholesterol. Read carefully

cholesterol;

• If you are taking medicines used to fight HIV infection, for example ritonavir with lopinavir and/or atazanavir, see section “Other medicines and Rosulod”;
• If you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Rosulod can lead to serious muscle problems (rhabdomyolysis). See section “Other medicines and Rosulod”;
• If you have severe respiratory failure;
• If you have had a recent heart attack;
• If you suffer from heart failure;
• If you have a severe increase in blood pressure (hypertensive crisis);
• If you are elderly;
• If you are of Asian origin (i.e. Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor must choose the correct starting dose of Rosulod suitable for you.

Statins can alter liver function in a small number of people. This is
detected with a simple test that monitors the increase in liver enzyme levels in
the blood. For this reason, your doctor will usually request this blood test (liver
function test) before and during treatment with Rosulod.
During treatment with this medicine, your doctor will carefully check if you have
diabetes or are at risk of developing diabetes. You are at risk of developing
diabetes if you have high levels of sugars and fats in your blood, if you are
overweight and if you have high blood pressure.

Children and adolescents
Rosulod should not be used in children and adolescents.

Other medicines and Rosulod
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Rosulod can affect other medicines or other medicines can affect Rosulod,
such as:

• warfarin or clopidogrel (or any other medicine used to prevent blood clots);
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
• remedies for indigestion (used to neutralize stomach acid);
• an oral contraceptive (the pill);
• hormone replacement therapy;
• one of the following medicines used to treat viral infections, including HIV or Hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir, indinavir, nelfinavir;
• ketoconazole, itraconazole (antifungal medicines);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• Hypericum perforatum (St John's Wort);
• verapamil, diltiazem (medicines for the treatment of certain heart diseases);
• dantrolene (by infusion for severe alterations of body temperature);
• Temsirolimus or other cancer medicines (chemotherapy);
• Everolimus, tacrolimus, cyclosporine or other medicines (used to control the immune response, to allow the body to accept the transplanted organ);
• simvastatin (used to reduce cholesterol levels);
• regorafenib (used to treat tumors).

If you need to take oral fusidic acid to treat a bacterial infection, you
should temporarily stop using this medicine. Your doctor will tell you when it is safe
to start taking Rosulod again. Taking Rosulod with fusidic acid can rarely
cause weakness, soreness or muscle pain (rhabdomyolysis). For more information
on rhabdomyolysis, see paragraph 4. Rosulod can further lower blood pressure if
you are already taking other medicines to treat high blood pressure.

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

Rosulod with food and drink
Rosulod can be taken with or without food.
People who are taking Rosulod should not consume grapefruit juice and
grapefruit. 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 the hypotensive effect (reduction in blood pressure) of
Rosulod.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Rosulod if you are pregnant or breastfeeding. If you become pregnant during
treatment with Rosulod, stop taking it immediately and inform your doctor. Women must avoid
pregnancy during treatment with Rosulod by using suitable contraception.
Amlodipine has been shown to pass into breast milk in small amounts.

Driving and operating machinery
Rosulod can affect your ability to drive or operate machinery. Some people may
experience dizziness while taking Rosulod. If the capsules cause you to feel unwell,
dizzy or tired, or give you a headache, do not drive or operate machinery and contact
your doctor immediately.

3. How to take Rosulod

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule a day.
The medicine can be taken before or after food and beverages. You must take the medicine at the same
time each day with a little water. Do not take Rosulod with grapefruit juice.

Use in children and adolescents
Rosulod must not be used in children and adolescents.

Regular checks of cholesterol levels
It is important to return to your doctor to check your cholesterol levels regularly and to ensure
that they have been reached and maintained within normal values. The dose of Rosulod may be
increased by your doctor until the amount you need is reached.

If you take more Rosulod than you should
Contact your doctor or the nearest hospital. Taking too many capsules can cause a lowering
of blood pressure to the point of being dangerous. You may feel dizzy, lightheaded, weak
or faint. If the drop in blood pressure is severe enough, shock may occur. The skin
may become cold and sweaty and the person may lose consciousness. If you go to hospital or
are being treated for another condition, tell the medical staff that you are taking Rosulod.

If you forget to take Rosulod
Do not worry. If you forget to take a capsule, completely skip that
administration. Take the next dose at the correct time. Do not take a double dose to
make up for the missed dose.

If you stop taking Rosulod
Your doctor will advise you how long you should take the medicine. Your cholesterol levels may increase again if you stop taking Rosulod. Your condition may
return if you stop treatment with the medicine before being advised to do so.
If you have any further questions about the use of the 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 Rosulod and consult your doctor immediatelyif you experience any of the
following very rare and serious side effects after taking this medicine.

• Sudden onset of shortness of breath, chest pain, wheezing or difficulty breathing;
• Swelling of the eyelids, face or lips;
• Swelling of the tongue and throat which can cause great difficulty in breathing and / or swallowing;
• Severe skin reactions including intense rash, urticaria, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• Heart attack, abnormal heartbeat;
• Inflamed pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe unwellness.
• Lupus-like syndrome (including rash, joint disorders and effects on blood cells)
• Muscle rupture

Also, stop taking Rosulod and see your doctor immediately if you have
unusual muscle aches and pains,which persist longer than expected .As with
other statins, a very small number of people have experienced unpleasant muscle effects that
rarely progressed to a potentially life-threatening muscle damage known as rhabdomyolysis.
The following common side effectshave been reported. If any of these effects occur
or persist for more than one week, see your doctor.
Related to the use of rosuvastatin

Common: may affect up to 1 in 10 people

• Headache
• Stomach pain
• Constipation
• Feeling unwell
• Muscle pain
• Feeling of weakness
• Dizziness
• Diabetes. This is more likely if you already have high blood sugar and fat levels, 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

• Skin rash, itching, urticaria or other skin reactions.
• Increased amount of protein in the urine - values usually return to normal spontaneously without having to stop taking Rosulod capsules.

Rare:may affect up to 1 in 1,000

• Severe allergic reaction - signs include swelling of the face, lips, tongue and / or throat, difficulty swallowing and breathing, severe skin itching (with raised bumps). If you think you are having an allergic reaction, stop taking Rosulod and seek immediate medical attention.
• Muscle damage in adults - as a precaution, stop taking Rosulod and see your doctor immediately if you have unusual muscle aches or pains that persist longer than expected.
• Severe stomach pain (inflammation of the pancreas).
• Increased liver enzymes in the blood.
• Reduced platelets in the blood, which increases the risk of bleeding or bruising (thrombocytopenia)

Very rare: may affect up to 1 in 10,000

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (inflamed liver)
• Traces of blood in the urine
• Nerve damage in the legs and arms (such as numbness)
• Joint pain
• Memory loss
• Gynecomastia (breast enlargement in men)

Not known: frequency cannot be estimated from available data

• Diarrhea (loose stools)
• Stevens-Johnson syndrome (serious condition manifested by the formation of blisters on the skin, mouth, eyes and genitals)
• Cough
• Shortness of breath
• Edema (swelling)
• Sleep disorders, including insomnia and nightmares
• Sexual problems
• Breathing problems, including persistent cough and / or shortness of breath or fever
• Tendon injury
• A nerve disorder that can cause weakness, tingling or numbness

Related to the use of Amlodipine
The following common side effectshave been reported. If any of these effects occur
or persists for more than one week, see your doctor.

Very common:may affect more than 1 in 10 people

• Edema (swelling)

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of your heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Swelling of the ankles (edema), fatigue
• Diarrhea or constipation
• Impaired digestion
• Muscle cramps
• Feeling of weakness
• Visual disturbances, double vision

In addition, the following side effects have been reported. If any of these effects
worsens or if you notice any side effect not listed in this
leaflet, inform your doctor or pharmacist.

Uncommon: may affect up to 1 in 100

• Mood changes, anxiety, depression, insomnia (difficulty sleeping)
• Tremor, altered taste, fainting, weakness
• Feeling of numbness or tingling in the limbs; loss of sensitivity to pain
• Tinnitus (ringing in the ears)
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Dry mouth, vomiting
• Hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate during the night, increased need to urinate frequently
• Inability to achieve an erection; discomfort or enlargement of the breasts in men
• Abnormal heartbeat
• Shortness of breath
• Cough
• Rash, itching, urticaria
• Pain, chest pain, malaise
• Joint or muscle 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

• Decreased number of white blood cells, decreased platelets in the blood which can cause unusual bruising or a tendency to bleed (red blood cell damage)
• Excess sugar in the blood (hyperglycemia)
• A nerve disorder that can cause weakness, tingling or numbness
• Swelling of the gums
• Abdominal bloating (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzyme which can affect some clinical tests
• Increased muscle tension
• Inflammation of blood vessels, often with a rash
• Sensitivity to light
• Disorders combining rigidity, tremor and / or movement disorders
• Heart attack (myocardial infarction)
• Allergic reaction
• Severe stomach pain (inflamed pancreas)
• Severe skin reactions including intense rash, urticaria, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.

If any of the side effects worsens, or if you notice any side
effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly via the website:
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 Rosulod

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 pack after Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30°C. Store in the original package to protect the
medicine from light.
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 Rosulod contains
The active ingredients are rosuvastatin (as rosuvastatin calcium) and amlodipine (as amlodipine
besilate):
10 mg/5 mg: Each hard capsule contains 10 mg rosuvastatin (as rosuvastatin calcium) and 5 mg
amlodipine (as amlodipine besilate).
10 mg/10 mg: Each hard capsule contains 10 mg rosuvastatin (as rosuvastatin calcium) and 10 mg
amlodipine (as amlodipine besilate).
20 mg/5 mg: Each hard capsule contains 20 mg rosuvastatin (as rosuvastatin calcium) and 5 mg
amlodipine (as amlodipine besilate).
20 mg/10 mg: Each hard capsule contains 20 mg rosuvastatin (as rosuvastatin calcium) and 10 mg
amlodipine (as amlodipine besilate).
The other ingredients are:

Capsule content:corn starch, pregelatinized starch, microcrystalline cellulose, crospovidone
type A, sodium stearyl fumarate.

Capsule coating: gelatin, titanium dioxide (E 171).

Red ink: shellac (E9404), propylene glycol (E1520), strong ammonia solution
(E527), red iron oxide (E172), potassium hydroxide (E525).

Green ink:shellac (E9404), titanium dioxide (E171), indigo carmine, aluminum lake
(E132), yellow iron oxide (E172), strong ammonia solution (E527), propylene glycol
(E1520).

Description of Rosulod’s appearance and package contents
10 mg/5 mg: hard gelatin capsules size 1 and opaque white body with red printing
"Aml 5 mg" and opaque white cap with green imprint "Rsv 10 mg".
10 mg/10 mg: hard gelatin capsules size 00 and opaque white body with red printing
"Aml 10 mg & line" and opaque white cap with green imprint "Rsv 10 mg".
20 mg/5 mg: hard gelatin capsules size 00 and opaque white body with red printing
"Aml 5 mg" and opaque white cap with green imprint "Rsv 20 mg & line".
20 mg/10 mg: hard gelatin capsules size 00 and opaque white body with red printing
"Aml 10 mg and line" and opaque white cap with green imprint "Rsv 20 mg &
line".

Rosulodis available in blisters containing 14 and 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
Adamed Pharma S.A.
Marszałka Józefa Piłsudskiego str.5
Pabianice
95-200, Poland
Adamed Pharma S.A.
Szkolna Street 33
Ksawerów
95-054, Poland

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Poland: Rozuwastatyna + Amlodypina Aristo Italy: Rosulod
Spain: Rosuvastatina/Amlodipino Aristo