CADUET 10 mg/10 mg FILM-COATED TABLETS

2. What you need to know before you take Caduet

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 currently have a disease that affects the liver (if in the past you had a disease that affected the liver, see the "Warnings and precautions" section below)
• if you have had unexplained abnormal results in blood tests for liver function
• 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), telithromycin (an antibiotic)
• if you have low blood pressure (hypotension)
• if you have narrowing of the heart valve (aortic stenosis) or cardiogenic shock (a situation where the heart is unable to provide enough blood to the body)
• if you have heart failure after a heart attack
• if you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking 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) orally or by injection. The combination of fusidic acid and Caduet can cause serious muscle problems (rhabdomyolysis)
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have repeated or unexplained muscle pain, personal or family history of muscle problems
• if you have had muscle problems in the past while taking other cholesterol-lowering medicines (e.g., statins or fibrates)
• if you regularly drink large amounts of alcohol
• if you have had liver disease in the past
• if you are over 70 years old

• if you have had a previous stroke with bleeding in the brain or have small fluid-filled sacs in the brain due to previous strokes
• if you have or have had myasthenia (a disease that causes generalized muscle weakness, which 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 to appear (see section 4).

In any of these cases, your doctor will indicate whether you should have blood tests 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, such as rhabdomyolysis, increases when taken with certain medicines (see "Using Caduet with other medicines").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medicines may be necessary 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 fat in the blood, are overweight, and have high blood pressure.

Other medicines and Caduet

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

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

• Some antibiotics, such as rifampicin, fusidic acid, or "macrolide antibiotics," such as erythromycin, clarithromycin, telithromycin, or medicines used to treat fungal infections, such as ketoconazole, itraconazole
• Medicines to control your lipid levels: fibrates, such as gemfibrozil or colestipol
• Medicines to control your heart rate, such as amiodarone, diltiazem, and verapamil
• Anticonvulsants, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• Medicines used to modify the functioning of your immune system, such as cyclosporine, tacrolimus, sirolimus, temsirolimus, and everolimus
• Medicines used to treat HIV infection, such as 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, such as nefazodone and imipramine
• Medicines used to treat mental disorders, such as neuroleptics
• Medicines used to treat heart failure, such as beta blockers
• Medicines used to treat high blood pressure, such as angiotensin II receptor antagonists, ACE inhibitors, verapamil, and diuretics
• Alpha blockers used to treat high blood pressure and prostate problems
• Other medicines that are known to interact with Caduet include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsants used to treat epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used to treat gout), and antacids (products for indigestion that contain aluminum or magnesium)
• Amifostine (used to treat cancer)
• Sildenafil (for erectile dysfunction)
• Dantrolene and baclofen (muscle relaxants)
• Corticosteroids
• Medicines without a prescription that contain St. John's Wort (Hypericum perforatum)
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Caduet. The use of Caduet with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Taking Caduet with food, drinks, and alcohol

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

Grapefruit juice

Do not drink more than one or two glasses of grapefruit juice per day, as large quantities of grapefruit juice can alter the effects of Caduet.

Alcohol

Avoid drinking too much alcohol while taking Caduet. See the details in the "Warnings and precautions" section.

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 adequate contraceptive measures. Talk to your doctor or pharmacist before using any medicine.

Amlodipine passes into breast milk in small amounts.

Driving and using machines

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 (1 mmol) per tablet, which is essentially "sodium-free".

3. How to take Caduet

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults

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

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 at the same time every day.

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

If you think the effect of the Caduet tablets is too strong or too weak, tell your doctor or pharmacist.

Use in children and adolescents

This medicine 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), talk to your doctor or the nearest hospital or call the Toxicology Information Service, phone 91 562 04 20 (indicating the medicine and the amount taken). Take the remaining tablets, the package, and the complete box so that hospital staff can easily identify the medicine you have taken.

Excess fluid can accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can 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 make up for forgotten doses.

If you stop taking Caduet

Do not stop taking Caduet unless your doctor tells you to. If you have any further questions about the use of this medicine or want to stop treatment, 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.

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

• Swelling of the face, tongue, and airways that can cause great difficulty in breathing.
• If you have unexplained muscle weakness, muscle pain on palpation, pain or rupture in the muscles, or brownish-red urine color, and at the same time, you feel unwell or have a fever. (Very rarely, this combination of effects can become a potentially life-threatening disease called rhabdomyolysis).
• Lupus-like syndrome (including rash, joint disorders, 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, feeling of fatigue, drowsiness
• Irregular heartbeats, flushing
• Palpitations (abnormal sensation of heartbeat), difficulty breathing
• Nasal passage inflammation, sore throat, nosebleeds
• Feeling of discomfort, abdominal pain, indigestion, changes in bowel habits (including diarrhea, constipation, and flatulence)
• Pain in muscles and joints, muscle cramps and spasms, back pain, pain in the limbs, muscle fatigue
• Increased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), increased creatine kinase in the blood, blood test results showing that your liver function may become abnormal
• Vision problems (including double vision), blurred vision

Uncommon: may affect up to 1 in 100 people

• Hepatitis (inflammation of the liver)
• Rhinorrhea, loss of appetite, decreased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), weight gain or loss
• Difficulty sleeping, with nightmares, mood changes (including anxiety), depression, tremors, nervous system disorders (decreased sensitivity) of the arms and legs, memory loss
• Ringing or buzzing in the ears, weakness, increased sweating, low blood pressure
• Dry mouth, taste disturbances, vomiting, belching
• Hair loss, bruising 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 excessive urination at night and increased frequency of urination), impotence, abnormal breast development in men
• Feeling of discomfort, pancreatitis (inflammation of the pancreas that causes stomach 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, very intense muscle pain or cramps, muscle rupture that can rarely 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 life-threatening and cause kidney problems
• Decreased platelet count in the blood
• Liver disorders (yellowing of the skin and whites of the eyes)
• Severe allergic skin reactions, skin redness, blistering rash, skin peeling that can spread rapidly to the rest of the body and may start with symptoms like those of the flu, accompanied by high fever (toxic epidermal necrolysis)
• Inflammation of the deep layers of the skin - including inflammation of the lips, eyelids, and tongue
• Inflammation or swelling of the skeletal muscle, blistering rash, sudden and severe skin inflammation in an area
• Tendon inflammation, tendon injury
• Confusion

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

• Allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Decreased white blood cell count
• Increased muscle tension or stiffness
• Heart attack, inflammation of small blood vessels, stomach pain (gastritis)
• Gum growth, gum bleeding
• Hearing loss, liver failure
• Photosensitivity (skin sensitivity to light)

Frequency not known: cannot be estimated from the available data

• Constant muscle weakness

• Sexual dysfunction
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Disorders combining stiffness, tremors, and/or movement disorders
• Diabetes. It is more likely if you have high sugar and fat levels in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)

Eye myasthenia (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.

Reporting of Adverse Effects

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

5. Storage of Caduet

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

Do not use this medicine after the expiration date shown on the packaging, blister pack, and bottle after "CAD". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Caduet

The active ingredients are amlodipine and atorvastatin. The Caduet 10 mg/10 mg tablets contain 10 mg of amlodipine as amlodipine besylate and 10 mg of atorvastatin as atorvastatin calcium trihydrate.

The other ingredients are: calcium carbonate, sodium croscarmellose, microcrystalline cellulose, pregelatinized maize starch, polysorbate 80, hypromellose, colloidal silicon dioxide (anhydrous), and magnesium stearate.

The coating of the Caduet 10 mg/10 mg tablets contains: Opadry II Blue 85F10919 (polyvinyl alcohol, titanium dioxide (E171), aluminum lake of indigo carmine (E132), and macrogol 3000, talc).

Appearance of the Product and Package Contents

The Caduet 10 mg/10 mg tablets are blue, oval-shaped, marked with "CDT 101" on one side, and smooth on the other.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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 under the following names:

Austria Caduet

Czech Republic Caduet

France Caduet

Hungary Caduet

Latvia Caduet

Malta Caduet

Portugal Caduet

Spain Caduet

Date of the last revision of this prospectus: 03/2023

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/)