ROSUVASTATIN/AMLODIPINE ARISTO 20 mg/10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Rosuvastatin/Amlodipine Aristo 20 mg/10 mg Hard Capsules

Read all of this leaflet carefully before you start 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

1. What Rosuvastatin/Amlodipine Aristo is and what it is used for
2. What you need to know before you take Rosuvastatin/Amlodipine Aristo
3. How to take Rosuvastatin/Amlodipine Aristo
4. Possible side effects
5. Storage of Rosuvastatin/Amlodipine Aristo
6. Package Contents and Further Information

1. What Rosuvastatin/Amlodipine Aristo is and what it is used for

Rosuvastatin/Amlodipine Aristo is a product that contains two active substances called rosuvastatin and amlodipine.

Rosuvastatin/Amlodipine is indicated in adult patients for the concomitant treatment of high blood pressure and high levels of cholesterol when changes made to their diet and increased physical exercise have not been sufficient to correct their cholesterol levels and/or for the prevention of cardiovascular events if they have other risk factors for having a heart attack, stroke, or related health problems.

Rosuvastatin/Amlodipine is indicated in patients who are already taking rosuvastatin and amlodipine at the same dose level. Instead of taking rosuvastatin and amlodipine separately, you will take one capsule of rosuvastatin/amlodipine that contains both active substances at the same concentration.

You should continue with your diet and exercise to reduce cholesterol while taking Rosuvastatin/Amlodipine.

2. What you need to know before you take Rosuvastatin/Amlodipine Aristo

Do not take Rosuvastatin/Amlodipine

• If you are allergic to rosuvastatin, amlodipine, or any other calcium antagonist 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 rosuvastatin/amlodipine, stop taking the medicine immediately and inform your doctor. Women must avoid becoming pregnant while taking rosuvastatin/amlodipine using appropriate contraceptive measures.
• If you have liver disease.
• If you have severe kidney problems.
• If you have suffered repeated muscle pains or weaknesses.
• If you are taking a medicine called ciclosporin (used, for example, after an organ transplant).
• If you have severe low blood pressure (severe hypotension).
• If you suffer from narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart cannot distribute enough blood to your body).
• If you suffer from heart failure and acute myocardial infarction.
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking Rosuvastatin/Amlodipine Aristo or other medicines that contain rosuvastatin.

Warnings and Precautions

Consult your doctor or pharmacist before taking rosuvastatin/amlodipine

• If you have kidney problems.
• If you have liver problems.
• If you have had unexplained muscle pains or weaknesses, a family or personal history of muscle problems, or a history of muscle problems when taking other cholesterol-lowering medicines. Consult your doctor immediately if you suffer unexplained muscle pains, especially if you do not feel well or have a fever. You should also tell your doctor or pharmacist if you feel constant muscle weakness.
• If you frequently drink large amounts of alcohol.
• If your thyroid gland does not function correctly.
• If you are taking other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even if you have taken other cholesterol-lowering medicines before.
• If you are taking medicines used to fight HIV infection, e.g., ritonavir with lopinavir and/or atazanavir, please see "Other medicines and Rosuvastatin/Amlodipine Aristo".
• If you are taking or have taken in the last 7 days medicines that contain fusidic acid (used to treat bacterial infections) orally or by injection; the combination of rosuvastatin/amlodipine with fusidic acid can cause serious muscle problems (rhabdomyolysis); see "Other medicines and Rosuvastatin/Amlodipine Aristo".
• If you have suffered severe respiratory failure.
• If you have recently had a heart attack.
• If you suffer from heart failure.
• If you have a severe increase in blood pressure (hypertensive crisis).
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).
• If you are an elderly patient.
• If you are of Asian origin – this is Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian. Your doctor may need to choose an initial dose that suits your size.

Be careful with Rosuvastatin/Amlodipine Aristo

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Rosuvastatin/Amlodipine Aristo treatment. Stop using Rosuvastatin/Amlodipine Aristo and seek immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins can affect the liver. This is identified by a simple blood test that checks for increased levels of liver enzymes in the blood. For this reason, your doctor will normally carry out a blood test (liver function test) before and during treatment with rosuvastatin/amlodipine.

While you are taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are more likely to be 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

Rosuvastatin/Amlodipine should not be administered to children and adolescents.

Other medicines and Rosuvastatin/Amlodipine Aristo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Rosuvastatin/Amlodipine can affect or be affected by other medicines, such as:

• anticoagulants, e.g., warfarin, acenocoumarol, or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with this medicine), ticagrelor, or clopidogrel.

Rosuvastatin/Amlodipine may increase the effect of anticoagulants and the risk of bleeding if taken together.

• 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,
• 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 (for bacterial infections),
• Hypericum perforatum(St. John's Wort),
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe body temperature abnormalities)
• temsirolimus or other cancer medicines (chemotherapy)
• Everolimus, tacrolimus, ciclosporin, or other medicines (used to control your body's immune response, allowing your body to accept a transplanted organ)
• simvastatin (used to lower cholesterol levels)
• regorafenib (used to treat cancer)

If you need to take oral fusidic acid to treat a bacterial infection, you will have to temporarily stop taking rosuvastatin/amlodipine. Your doctor will tell you when you can restart treatment with this medicine. Taking rosuvastatin/amlodipine with fusidic acid can rarely cause serious muscle problems (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Rosuvastatin/Amlodipine may lower your blood pressure even further if you are already taking other medicines to treat high blood pressure.

Taking Rosuvastatin/Amlodipine with Food and Drink

You can take rosuvastatin/amlodipine with or without food.

People taking rosuvastatin/amlodipine should not consume grapefruit juice and grapefruit. This is because grapefruit juice and grapefruit can lead to an increase in the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the blood-pressure-lowering effect of this medicine.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine if you are pregnant or breastfeeding. If you become pregnant while taking this medicine, stop taking it immediately and consult your doctor.

Women must avoid becoming pregnant while taking rosuvastatin/amlodipine using an appropriate contraceptive method.

Amlodipine has been shown to pass into breast milk in small amounts.

Driving and Using Machines

Rosuvastatin/Amlodipine may affect your ability to drive or use machines. Some people feel dizzy during treatment with this medicine. If the capsules make you feel sick, dizzy, or tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

Sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to Take Rosuvastatin/Amlodipine Aristo

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule per day.

This medicine can be taken before and after meals. You should take your medicine always at the same time each day with a glass of water. Do not take this medicine with grapefruit juice.

Use in Children and Adolescents

Rosuvastatin/Amlodipine should not be administered to children and adolescents.

Regular Cholesterol Checks

It is important that you return to your doctor for regular cholesterol checks to ensure that your cholesterol has reached and remains at the correct level.

Your doctor may decide to increase your dose so that you are taking the correct amount of rosuvastatin/amlodipine for you.

If you Take More Rosuvastatin/Amlodipine than You Should

Contact your doctor or the nearest hospital for advice.

Taking too many capsules can cause your blood pressure to become too low or even dangerously low. You may feel dizzy, confused, pale, or weak. If your low blood pressure is severe enough, it can cause a collapse.

Your skin may become cold and sweaty, and you may lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you Forget to Take Rosuvastatin/Amlodipine

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

If you Interrupt Treatment with Rosuvastatin/Amlodipine

Your doctor will advise you on how long you need to take your medicine. Your cholesterol levels may increase again if you stop taking Rosuvastatin/Amlodipine. Your disease may return if you stop taking your medicine before your doctor advises.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Rosuvastatin/Amlodipine and consult your doctor immediatelyif you experience any of the following serious adverse effects or symptoms, which are very rare after taking this medicine.

• Sudden whistling when breathing (sudden wheezing), chest pain, shortness of breath or difficulty breathing
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat that causes great difficulty breathing and/or swallowing.
• Severe skin reactions that include intense skin rash, hives, redness of the skin all over the body, itching, blistering, peeling and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions
• Red, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome)
• Heart attack, abnormal heartbeat
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort
• Lupus-like syndrome (including skin rash, joint disorders and effects on blood cells)
• Muscle rupture
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
• Muscle weakness, sensitivity, pain or change in urine color to reddish-brown and especially, if it occurs at the same time, a feeling of discomfort or high temperature that can be caused by abnormal muscle destruction that can be potentially fatal and trigger kidney problems.

Also, stop taking rosuvastatin/amlodipine and consult your doctor immediatelyif you experience unjustified muscle pain and crampsthat last longer than expected. As with other statins, a very small number of people have suffered unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis.

The following common adverse effectshave been reported. If any of these cause problems or last more than a week, consult your doctor.

Related to rosuvastatin

Common adverse effects: may affect up to 1 in 10 people

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• Diabetes. This is more likely if you have high blood sugar and lipid levels, are overweight and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Uncommon adverse effects: may affect up to 1 in 100 people

• Rash, itching, hives and other skin reactions.
• An increase in the amount of protein in the urine – this usually reverses itself without the need to interrupt treatment with the capsules

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

• Severe allergic reaction – symptoms include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, intense itching of the skin (with hives). If you think you are having an allergic reaction, stop taking this medicineand seek medical attention immediately.
• Muscle injury in adults – as a precaution, stop taking this medicine and consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Decreased platelet count in the blood, which can increase the risk of bleeding or bruising (thrombocytopenia).

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

• Jaundice (yellowing of the skin and eyes).
• Hepatitis (inflamed liver).
• Traces of blood in the urine.
• Nerve damage in the legs and arms (with numbness or tingling).
• Joint pain.
• Memory loss.
• Gynecomastia (enlargement of the breasts in men).

Adverse effects of unknown frequency(frequency cannot be estimated from available data):

• Diarrhea (loose stools).
• Cough.
• Shortness of breath.
• Edema (swelling).
• Sleep disorders, including insomnia and nightmares.
• Sexual difficulties
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injuries.
• A nerve disorder that can cause weakness, tingling or numbness.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing), myasthenic ocular (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or difficulty breathing.

Related to amlodipine

The following common adverse effectshave been reported. If any of these cause problems or last more than a week, consult 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 (feeling the heartbeat), flushing
• Abdominal pain, feeling of discomfort (nausea)
• Swelling of the ankles (edema), fatigue
• Diarrhea or constipation.
• Indigestion
• Muscle cramps
• Weakness
• Visual disturbances, double vision.

Other adverse effects have been reported that are included in the following list. If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon:may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting, weakness
• Numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Decreased blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Dry mouth, vomiting (nausea)
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration
• Urination disorder, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or enlargement of the breasts in men
• Abnormal heartbeat
• Difficulty breathing
• Cough
• Rash, itching, hives
• Pain, chest pain, feeling of discomfort
• Joint or muscle pain, back pain.
• Weight gain or loss

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

• Confusion

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

• Decreased white blood cell count, decreased platelet count in the blood that can cause easy bleeding or unusual bruising (red blood cell damage)
• High blood sugar (hyperglycemia)
• A nerve disorder that can cause weakness, tingling or numbness
• Gingivitis
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests
• Increased muscle tension
• Vasculitis, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, tremors and/or movement disorders
• Heart attack
• Allergic reactions
• Severe stomach pain (pancreatitis)
• Severe skin reactions that include intense skin rash, hives, redness of the skin all over the body, itching, blistering, peeling and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome) or other allergic reactions

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Rosuvastatin/Amlodipine Aristo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging/blister/label after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from light.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Rosuvastatin/Amlodipine Aristo

The active ingredients are rosuvastatin (as rosuvastatin calcium) and amlodipine (as amlodipine besylate).

• Each capsule contains 20 mg rosuvastatin (as rosuvastatin calcium) and 10 mg amlodipine (as amlodipine besylate).
• Other excipients:

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

• Capsule shell:gelatin, titanium dioxide (E 171).

• Red ink:shellac (E904), propylene glycol (E1520), strong ammonia solution (E527), red iron oxide (E172), potassium hydroxide (E525)

• Green ink:shellac (E904), titanium dioxide (E171), aluminum lake indigo carmine (E132), yellow iron oxide (E172), strong ammonia solution (E527), propylene glycol (E1520)

Appearance of the product and package contents

Hard gelatin capsules, size 00, with a white opaque body printed in red with "Aml 10 mg and a line" and a white opaque cap printed in green with "Rsv 20 mg and a line".

They are presented in blisters of 14 and 30 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aristo Pharma GmbH

Wallenroder Str. 8­­-10

13435 Berlin

Germany

Manufacturer:

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

O

Adamed Pharma S.A.

ul. Szkolna 33

95-054 Ksawerów

Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

IT Rosulod

ES Rosuvastatina/amlodipino Aristo 20 mg/10 mg hard capsules

Date of the last revision of this leaflet:May 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/