Prospect: information for the user

Caduet 10mg/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.

1.What is Caduet and for what it is used

2.What you need to know before starting totake Caduet

3.How to take Caduet

4.Adverse effects

5.Storage of Caduet

6.Contents of the package and additional information

Caduet is used to prevent cardiovascular events (for example, angina, heart attack) in patients withhigh 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 foundnaturally 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 situation 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 embolisms of fluid 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 myasthenic eye (a disease that causes weakness of the eye muscles), as statins sometimes can 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 at the same time as 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 your 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 can interact with Caduet. This interaction may mean that one or both medicines are less effective. It can 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 treat high 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 Caduetincluding ezetimibe (which reduces cholesterol),warfarin (which reduces blood clotting), oral contraceptives, andstiripentol(anticonvulsants to treat 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)
• Steroids
• Over-the-counter medicines that contain St. John's Wort (Hipericum perforatum)
• If you have to take oral fusidic acid 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 in large quantities orange juice can alter the effects of Caduet.

Alcohol

Avoid drinking a lot 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. If in doubt, consult your doctor or pharmacist again.

Adults

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

Caduet should be swallowed whole with a little water. The tablets can be taken orally at 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 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 discontinue 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 experience unexplained muscle weakness, muscle pain on palpation, muscle pain or rupture, or brownish-red urine discoloration, and at the same time you feel unwell or have a fever. (This combination of side effects is very rarely a potentially life-threatening disease called rhabdomyolysis).
• Lupus-like syndrome (including rash, joint problems, and effects on blood cells).

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Allergic reaction
• Headache (especially at the beginning of treatment), dizziness,fatigue sensation,drowsiness
• Irregular heartbeat, flushing
• Palpitations (abnormal heart beating sensation),difficulty breathing
• Inflammationof the nasal passages, sore throat, nasal bleeding
• Unpleasant sensation, abdominal pain, indigestion, change in bowel habits (including diarrhea, constipation, and flatulence)
• Muscle and joint pain, cramps, and spasms, back pain, limb pain, muscle fatigue
• Increased blood sugar levels (if you have diabetes, continue to closely monitor your blood sugar levels), increased creatine kinase levels in blood, abnormal liver function test results
• Vision problems(including double vision), blurred vision

Uncommon: may affect up to 1 in 100 people

• Hepatitis (liver inflammation)
• Runny nose, loss of appetite,decreased blood sugar levels (if you have diabetes, continue to closely monitor your blood sugar levels),weight gain or loss
• Difficulty sleeping, nightmares, mood changes(including anxiety), depression, tremors, numbness or tingling in the arms and legs, memory loss
• Tinnitus or buzzing in the ears, weakness, increased sweating, low blood pressure
• Dry mouth, altered 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 and toes, skin rash, urticaria, or itching
• Urinary problems (including nocturia and increased urination frequency), impotence, abnormal breast development in men
• Unpleasant sensation, 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

Rare: may affect up to 1 in 1,000 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) andabnormal muscle rupture. Abnormal muscle rupture may not always resolve even after stopping Caduet, and can be fatal and cause kidney problems
• Decreased platelet count in blood
• Liver problems (yellow skin discoloration andwhite eye discoloration)
• Severe allergic dermatological reactions, skin redness, rash with blisters, skin peeling that can rapidly spread to the rest of the body and may 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

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

• Allergic reaction - symptoms may include sudden hissing while breathing and chest pain or pressure, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Decreased white blood cell count in blood
• Increased muscle tension
• Heart attack, inflammation of small blood vessels, stomach pain (gastritis)
• Encysted gums, gum bleeding
• Loss of hearing, liver insufficiency
• Sensitivity to light (photosensitivity)

Frequency not known:cannot be estimated from available data

• Constant muscle weakness

• Sexual dysfunction
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Combination of rigidity, tremors, 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 medicine
• 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 eye muscles).

Consult your doctor if you experience weakness in your 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 leaflet. You can also report them directly through the Spanish System for 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 medicine.

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.

Do not dispose of medications through the drains or trash. Deposit 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. Caduet 10mg/10mg tablets contain 10mg 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 Caduet 10mg/10mg tablets contains: Opadry II Blue 85F10919 (polyvinyl alcohol, titanium dioxide (E171), aluminium lake of indigo carmine (E132) and macrogol 3000, talc).

Product appearance and packaging contents

Caduet 10mg/10mg tablets are blue, oval-shaped, marked with “CDT 101” 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 packaging sizes may be commercially available.

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

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

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

This medicine 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

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)