Prospect: information for the user

Caduet 5mg/10mg film-coated tablets

amlodipine besylate/atorvastatin calcium trihydrate

Read this prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect,as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacistor nurse.
• This medicine has been prescribedonlyto you, and you must notgive it to other people even if they have the same symptoms as you, as it may harm them.
• Ifyou experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospect.See section 4.

Content ofthe prospect

1.What is Caduet and forwhat it is used

2.What you need to know before starting totakeCaduet

3.How to take Caduet

4.Possible adverse effects

5.Storage of Caduet

6. Contents of the package and additionalinformation

Caduet is used to prevent cardiovascular events (for example, angina, heart attack) in patients with high blood pressure and who also have risk factors for cardiovascular disease, such as smoking, being overweight, high levels of cholesterol in the blood, a family history of heart disease, or diabetes. The presence of these risk factors associated with high blood pressure makes patients more likely to experience cardiovascular events.

Caduet is a product that contains two active ingredients, amlodipine (calcium antagonist) and atorvastatin (statin), and is used when your doctor considers it appropriate to take both medications. Amlodipine is used to treat high blood pressure (hypertension), and atorvastatin reduces cholesterol levels.

High blood pressure (hypertension) is a disease in which the blood pressure is permanently elevated in an abnormal manner and is one of the risk factors for experiencing cardiovascular events (angina, heart attack, stroke).

Cholesterol is a substance that is naturally found in the body necessary for normal growth. However, if there is too much cholesterol in the blood, it can deposit in the walls of blood vessels, increasing the risk of forming blood clots and experiencing cardiovascular events. This is one of the most common causes of heart disease..

Do not take Caduet

• if you are allergic (hypersensitive) to amlodipine or atorvastatin or to any other calcium channel blocker or to any of the other ingredients of this medicine (listed in section 6)
• if you have a liver disease (if you had a liver disease in the past, see the section “Warnings and precautions” below)
• if you have had unjustified abnormal results in liver function blood tests
• if you are pregnant, trying to become pregnant or breastfeeding
• if you are taking any of the following medicines: ketoconazole, itraconazole (medicines used to treat fungal infections or mycosis), telithromycin (an antibiotic)
• if you have low blood pressure (hypotension)
• if you haveaortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition where the heart is unable to provide enough blood to the body)
• if you suffer fromheart failure after a myocardial infarction
• if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Caduet

• if you have severe respiratory failure
• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections), by mouth or by injection. The combination of fusidic acid and Caduet may cause severe muscle problems (rhabdomyolysis)
• if you have kidney problems
• if you have a thyroid gland with low activity (hypothyroidism)
• if you have repeated or unjustified muscle pains, personal or family history of hereditary muscle problems
• if you have had muscle problems during treatment with other medicines to reduce cholesterol (lipids) (for example, medicines with “statins” or “fibrates”)
• if you regularly drink large amounts of alcohol
• if you had a liver disease in the past
• if you are over 70 years old

• if you havehad a previous stroke with bleeding in the brain, or have small blood clots in the brain due to previous strokes
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

In any of these cases, your doctor will tell you if blood tests should be done before and possibly during treatment with Caduet, to calculate the risk of muscle side effects. It is known that the risk of muscle side effects, for example rhabdomyolysis, increases when taken with certain medicines (see section “Use of Caduet with other medicines”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

While taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fats in the blood, overweight and high blood pressure.

Other medicines and Caduet

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

There are some medicines that may interact with Caduet. This interaction may mean that one or both medicines are less effective. It may also increase the risk or severity of side effects, including the important muscle deterioration known as rhabdomyolysis and myopathy (described in section 4):

• Some antibiotics, for example rifampicin, fusidic acid or “macrolide” antibiotics, for example erythromycin, clarithromycin, telithromycin, or medicines to treat fungal infections, for example, ketoconazole, itraconazole
• Medicines to control your lipid levels: fibrates, for example gemfibrozil or cholestyramine
• Medicines to control your heart rhythm, for example amiodarone, diltiazem and verapamil
• Anticonvulsants, for example carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• Medicines used to modify the functioning of your immune system, for example ciclosporin, tacrolimus, sirolimus, temsirolimus and everolimus
• Medicines used in the treatment of HIV infection, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc, nelfinavir
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus
• Medicines used to treat depression, for example nefazodone and imipramine
• Medicines used in the treatment of mental disorders, for example neuroleptics
• Medicines to treat heart failure, for example beta blockers
• Medicines to treathigh blood pressure, for example angiotensin II receptor antagonists, ACE inhibitors, verapamil and diuretics
• Alpha blockers used in the treatment of high blood pressure and prostate problems
• Other medicines that are known to interact with Caduetinclude ezetimibe (which reduces cholesterol),warfarin (which reduces blood clotting), oral contraceptives, andstiripentol(anticonvulsants for treating epilepsy), cimetidine (used for heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout) and antacids (products for indigestion that contain aluminium or magnesium
• Amifostine (used to treat cancer)
• Sildenafil (for erectile dysfunction)
• Dantrolene and baclofen (muscle relaxants)
• Glucocorticoids
• Over-the-counter medicines that contain St. John's Wort (Hipericum perforatum)
• If you have to take fusidic acid orally to treat a bacterial infection, you will have to stop taking this medicine. Your doctor will tell you when you can restart treatment with Caduet. The use of Caduet with fusidic acid may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Caduet may lower your blood pressure even more if you are already taking other medicines to treat high blood pressure.

Inform your doctor or pharmacist if you are using or have used recently other medicines, even those bought without a prescription.

Taking Caduet with food, drinks and alcohol

Caduet can be takenat any time of the day, with or without food.

Orange juice

Do not drink more than one or two glasses of orange juice per day because large amounts of orange juice may alter the effects of Caduet.

Alcohol

Avoid drinking large amounts of alcohol while taking Caduet. See the details in the section “Warnings and precautions”.

Pregnancy, breastfeeding and fertility

Do not take Caduet if you are pregnant, breastfeeding or trying to become pregnant. When taking Caduet or any other medicine, women of childbearing age should take the necessary contraceptive measures. Consult your doctor or pharmacist before using any medicine.

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

Driving and operating machinery

Do not drive or operate machinery if you feel dizzy after taking this medicine.

Caduet contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

The usual initial dose of Caduet for adults is one daily tablet of 5mg/10mg. If necessary, your doctor may increase the dose to one daily tablet of Caduet 10mg/10mg.

Caduet should be swallowed whole, with a little water. The tablets can be taken orallyat any time of the day, with or without food. However, try to take your tablet every day at the same time.

Follow your doctor's dietary recommendations, especially regarding dietary fat restriction, quitting smoking, and regular exercise.

If you estimate that the effect of Caduet tablets is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

This medication is not recommended for children and adolescents.

If you take more Caduet than you should

If you accidentally take too many Caduet tablets (more than your usual daily dose), consult your doctor immediately or go to the nearest hospitalor call the Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).Bring the remaining tablets, the packaging, and the complete box so that hospital staff can easily identify the medication you have taken.

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

If you forget to take Caduet

If you forget to take a dose, take the next scheduled dose at the correct time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Caduet

Do not stop taking Caduet unless your doctor tells you to. If you have any other questions about the use of this medication or want to interrupt treatment, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If any of the following occur, stop taking Caduet and inform your doctor immediately

• Swelling of the face, tongue, and airways that may cause severe difficulty breathing.
• If you have, unexplained muscle weakness, muscle pain on palpation, pain or rupture in the muscles or brownish-red discoloration of the urine and at the same time you feel unwell or have a fever. (Very rarely, this combination of side effects can become a potentially life-threatening serious disease called rhabdomyolysis).
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very common: can affect more than 1 in 10 people

• Swelling of arms, hands, legs, joints, or feet

Common: can affect up to 1 in 10 people

• Allergic reaction
• Headache (especially at the beginning of treatment), dizziness, sensation of fatigue, drowsiness
• Irregular heartbeat, flushing
• Palpitations (abnormal sensation of heartbeats), difficulty breathing
• Inflammation of the nasal passages, sore throat, nasal bleeding
• Sensation of discomfort, abdominal pain, indigestion, change in bowel habits (including diarrhea, constipation, and flatulence)
• Pain in muscles and joints, cramps, and muscle spasms, back pain, pain in the limbs, muscle fatigue
• Increased blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully), increased creatine kinase in the blood, abnormal blood test results showing that your liver function may become abnormal
• Visual disturbances (including double vision), blurred vision

Rare: can affect up to 1 in 100 people

• Heptatitis (liver inflammation)
• Sneezing, loss of appetite, decreased blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully), weight gain or loss
• Difficulty sleeping, nightmares, mood changes (including anxiety), depression, tremor, sensory neuropathy (decreased sensitivity) of the arms and legs, memory loss
• Tinnitus or buzzing in the ears, weakness, increased sweating, low blood pressure
• Dry mouth, alterations in taste, vomiting, belching
• Hair loss, bruises or small spots on the skin, skin discoloration, decreased skin sensitivity to touch or pain, numbness or tingling in the fingers of the hands and feet, skin rash, urticaria or itching
• Urinary disorders (including nocturia and increased urination frequency), impotence, abnormal breast development in men
• Sensation of discomfort, pancreatitis (inflammation of the pancreas that causes abdominal pain), pain, neck pain, chest pain
• Positive urine tests for white blood cells
• Abnormal heart rhythm
• Cough

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

• Unexpected bleeding or bruising
• Severe muscle inflammation, intense muscle pain or cramps, muscle rupture that rarely can lead to rhabdomyolysis (destruction of muscle cells) and abnormal muscle rupture. Abnormal muscle rupture may not always disappear even after stopping Caduet, and can be fatal and cause kidney problems
• Decreased platelet count in the blood
• Liver disorders (yellowing of the skin and white of the eyes)
• Severe allergic dermatological reactions, skin redness, rash with blisters, skin peeling that can spread rapidly to the rest of the body and can start with symptoms like the flu, accompanied by high fever (toxic epidermal necrolysis)
• Deep skin layer inflammation - including inflammation of the lips, eyelids, and tongue
• Swelling or inflammation of the skeletal muscle, rash with blisters, sudden and severe skin inflammation in a specific area
• Tendon inflammation, tendon injury
• Confusion

Unknown frequency: cannot be estimated from available data

• Constant muscle weakness

• Sexual dysfunction
• Respiratory problems including persistent cough and/or difficulty breathing or fever
• Movement disorders combining rigidity, tremor, and/or movement disorders
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Myasthenia ocular (a disease that causes weakness of the ocular muscles).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging, blister, and bottle after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Caduet Composition

The active ingredients are amlodipine and atorvastatina. The Caduet 5mg/10mg tablets contain 5mg of amlodipine as amlodipine besilate and 10mg of atorvastatina as atorvastatina calcium trihydrate.

The other components are: calcium carbonate, sodium croscarmellose, microcrystalline cellulose, pregelatinized cornstarch (cornstarch), polisorbate 80, hypromellose, colloidal anhydrous silica (silicon dioxide) and magnesium stearate.

The coating of the Caduet 5mg/10mg tablets contains: Opadry II White 85F28751 (polyvinyl alcohol, titanium dioxide (E171) and macrogol 3000, talc).

Product Appearance and Packaging Contents

The Caduet 5mg/10mg tablets are white, oval-shaped, marked with “CDT051”on one side and smooth on the other.

Caduet tablets are available in blister packs containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 tablets or child-resistant bottles containing 30 or 90 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

AustriaCaduet

Czech RepublicCaduet

FranceCaduet

HungaryCaduet

LatviaCaduet

MaltaCaduet

PortugalCaduet

SpainCaduet

Last review date of this leaflet: 03/2023

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)