Rosulod

Package leaflet: Information for the patient

Rosulod 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/Amlodipine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, talk to 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 taking 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 Rosulod is and what it is 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 changes in diet and increased physical activity have not been sufficient to correct cholesterol levels and/or to prevent cardiovascular events if other risk factors for heart attack, stroke, or related health problems are present.
Rosulod is indicated for patients who are already taking rosuvastatin and amlodipine at these doses.
Instead of taking rosuvastatin and amlodipine as separate tablets, you will receive one Rosulod capsule containing both substances at the same doses.
You must continue with a cholesterol-lowering diet and regular physical exercise during treatment with Rosulod.

2. What you should know before taking Rosulod

Do not take Rosulod:

• If you are allergic to rosuvastatin, amlodipine, any of the calcium antagonists, 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 by using appropriate contraceptive measures;
• If you have liver disease;
• If you have severe kidney problems;
• If you have repeated or unexplained muscle cramps or pain;
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
• If you suffer from severe low blood pressure (severe hypotension);
• If you have narrowing of the aortic valve of the heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body);
• If you have heart failure following an acute heart attack.

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

• You have kidney problems;
• You have liver problems;
• You have experienced repeated or unexplained muscle cramps or pain, have a personal or family history of muscle disorders, or have previously had muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle cramps or pain, especially if accompanied by malaise or fever. Also inform your doctor or pharmacist if you have persistent muscle weakness;
• You regularly consume large amounts of alcohol;
• Your thyroid gland is not functioning properly;
• You are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol levels;
• You are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir; see section “Other medicines and Rosulod”;
• You are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). The combination of fusidic acid and Rosulod may lead to serious muscle problems (rhabdomyolysis). See section “Other medicines and Rosulod”;
• You have severe respiratory insufficiency;
• You have recently had a heart attack;
• You suffer from heart failure;
• You have a severe increase in blood pressure (hypertensive crisis);
• You are elderly;
• You are of Asian origin (i.e. Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must choose the appropriate starting dose of Rosulod for you.

Statins may affect liver function in a small number of people. This is detected by a simple blood test that monitors increases in liver enzyme levels. 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 closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Children and adolescents
Rosulod must 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 may affect other medicines, or other medicines may 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);
• antacids (used to neutralize stomach acid);
• an oral contraceptive (the pill);
• hormone replacement therapy;
• any 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 used to treat certain heart conditions);
• dantrolene (administered intravenously for severe disturbances in 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 a transplanted organ);
• simvastatin (used to reduce cholesterol levels);
• regorafenib (used to treat tumours).

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 Rosulod. Taking Rosulod with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4. Rosulod may 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 may be taken with or without food.
People taking Rosulod must not consume grapefruit or grapefruit juice. Grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the hypotensive effect (reduction in blood pressure) of Rosulod.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Rosulod if you are pregnant or breastfeeding. If you become pregnant while taking Rosulod, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosulod by using a suitable contraceptive method.
It has been shown that amlodipine passes into breast milk in small amounts.

Driving and using machines
Rosulod may affect your ability to drive or operate machinery. Some people may experience dizziness during treatment with Rosulod. If the capsules make you feel unwell, dizzy, tired, or give you headaches, do not drive or operate machinery and contact your doctor immediately.

3. How to take Rosulod

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule daily.
This medicine can be taken before or after food and drink. You should take the medicine at the same
time each day with a glass of water. Do not take Rosulod with grapefruit juice.
Use in children and adolescents
Rosulod must not be used in children and adolescents.
Regular monitoring of cholesterol levels
It is important to return to your doctor regularly to monitor your cholesterol levels and ensure
they have reached and remain within normal target values. Your doctor may increase the dose of Rosulod
until the required amount is achieved.
If you take more Rosulod than you should
Contact your doctor or go to the nearest hospital immediately. Taking too many capsules may cause
a drop in blood pressure severe enough to become dangerous. You may experience dizziness, lightheadedness, weakness, or fainting. If the drop in blood pressure is severe enough, shock may occur. The skin may become cold and clammy, and you may lose consciousness. If you go to hospital or are being treated for another condition, inform medical staff that you are taking Rosulod.
If you forget to take Rosulod
Do not worry. If you forget to take a capsule, simply skip that dose. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Rosulod
Your doctor will advise you on how long you should continue taking the medicine. Your cholesterol
levels may rise again if you stop taking Rosulod. Your condition may recur if you stop treatment
before being advised to do so by your doctor.
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.
Stop taking Rosulod and contact your doctor immediately if you experience any of the following very rare and serious side effects after taking this medicine:

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

Also, stop taking Rosulod and contact your doctor immediately if you experience unusual muscle tenderness or pain that lasts longer than expected. As with other statins, a very small number of people have experienced unpleasant muscle effects, which in rare cases have progressed to potentially life-threatening muscle damage known as rhabdomyolysis.

The following common side effects have been reported. If any of these side effects occur or persist for more than one week, contact 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 levels of sugar and fats in your 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

• Rash, itching, hives, or other skin reactions.
• Increased amount of protein in the urine – values usually return to normal spontaneously without needing to stop taking Rosulod capsules.

Rare: may affect up to 1 in 1,000 people

• Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing, severe skin itching (with raised lumps). If you think you are having an allergic reaction, stop taking Rosulod and seek immediate medical help.
• Muscle damage in adults – as a precaution, stop taking Rosulod and contact your doctor immediately if you have unusual muscle tenderness or pain that lasts longer than expected.
• Severe stomach pain (inflammation of the pancreas).
• Increased liver enzymes in the blood.
• Reduced platelet count in the blood, increasing the risk of bleeding or bruising (thrombocytopenia).

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

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

Not known: frequency cannot be estimated from the available data

• Diarrhoea (loose stools)
• Stevens-Johnson syndrome (a serious condition characterized by blistering of the skin, mouth, eyes, and genitals)
• Cough
• Shortness of breath
• Oedema (swelling)
• Sleep disorders, including insomnia and nightmares
• Sexual problems
• Respiratory problems, including persistent cough and/or breathlessness or fever
• Tendon injury
• A nerve disorder that may cause weakness, tingling, or numbness

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

Very common: may affect more than 1 in 10 people

• Oedema (swelling)

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)
• Swelling of the ankles (oedema), fatigue
• Diarrhoea or constipation
• Indigestion
• Muscle cramps
• Feeling of weakness
• Visual disturbances, double vision

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

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia (lack of sleep)
• Tremors, taste disturbances, fainting, weakness
• Numbness or tingling sensation in limbs; loss of sensitivity to pain
• 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, skin itching, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Inability to achieve an erection; discomfort or breast enlargement in men
• Abnormal heartbeat
• Shortness of breath
• Cough
• Rash, itching, hives
• Pain, chest pain, malaise
• Joint or muscle pain, back pain
• Weight gain or weight loss

Rare: may affect up to 1 in 1,000 people

• Confusion

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

• Decrease in white blood cell count, decrease in platelet count in blood which may cause unusual bruising or tendency to bleed (damage to red blood cells)
• Excess sugar in the blood (hyperglycaemia)
• A nerve disorder that may cause weakness, tingling, or numbness
• Swelling of the gums
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increase in liver enzyme which may affect certain clinical tests
• Increased muscle tension
• Inflammation of blood vessels, often with rash
• Light sensitivity
• Disorders combining stiffness, tremor, and/or movement disturbances
• Heart attack (myocardial infarction)
• Allergic reaction
• Severe stomach pain (inflamed pancreas)
• Severe skin reactions including intense rash, hives, widespread skin redness, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. 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 stated on the pack after "Exp". The expiry date refers to the last day of that month.
Store below 30°C. Keep in the original packaging to protect the medicine from light.
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 Rosulod Contains
The active substances are rosuvastatin (as rosuvastatin calcium) and amlodipine (as amlodipine
besylate):
10 mg/5 mg: Each hard capsule contains 10 mg rosuvastatin (as rosuvastatin calcium) and 5 mg
amlodipine (as amlodipine besylate).
10 mg/10 mg: Each hard capsule contains 10 mg rosuvastatin (as rosuvastatin calcium) and 10 mg
amlodipine (as amlodipine besylate).
20 mg/5 mg: Each hard capsule contains 20 mg rosuvastatin (as rosuvastatin calcium) and 5 mg
amlodipine (as amlodipine besylate).
20 mg/10 mg: Each hard capsule contains 20 mg rosuvastatin (as rosuvastatin calcium) and 10 mg
amlodipine (as amlodipine besylate).

The other components are:
Capsule contents: maize starch, pregelatinized starch, microcrystalline cellulose, crospovidone
type A, sodium stearyl fumarate.
Capsule shell: gelatin, titanium dioxide (E 171).
Red ink: shellac (E9404), propylene glycol (E1520), strong ammonia solution (E527), iron oxide red (E172), potassium hydroxide (E525).
Green ink: shellac (E9404), titanium dioxide (E171), indigo carmine, aluminium lake (E132), iron oxide yellow (E172), strong ammonia solution (E527), propylene glycol (E1520).

Description of the Appearance of Rosulod and the Contents of the Pack
10 mg/5 mg: Hard gelatin capsules, size 1, with an opaque white body printed in red "Aml 5 mg" and an opaque white cap imprinted in green "Rsv 10 mg".
10 mg/10 mg: Hard gelatin capsules, size 00, with an opaque white body printed in red "Aml 10 mg & line" and an opaque white cap imprinted in green "Rsv 10 mg".
20 mg/5 mg: Hard gelatin capsules, size 00, with an opaque white body printed in red "Aml 5 mg" and an opaque white cap imprinted in green "Rsv 20 mg & line".
20 mg/10 mg: Hard gelatin capsules, size 00, with an opaque white body printed in red "Aml 10 mg & line" and an opaque white cap imprinted in green "Rsv 20 mg & line".

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 authorized in the European Economic Area countries under the
following names:
Poland: Rozuwastatyna + Amlodypina Aristo
Italy: Rosulod
Spain: Rosuvastatina/Amlodipino Aristo