Caduet (Atorvastatin) 30 Tablets

The active substance contains

amlodipine besylate equivalent to amlodipine base and atorvastatin calcium equivalent  atorvastatin base.

Excipients

Calcium Carbonate (E 170), Croscarmellose sodium (E468),

Microcrystalline cellulose (E460), Pregelatinized Starch, Polysorbate 80 (E433),

Hydroxypropyl Cellulose (E463), Silicon dioxide, Colloidal (E551), Magnesium stearate (E572), Opadry II Blue 85F10919 (Colorcon) (partially hydrolyzed polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol (E 1521), talc (E553b) FD & C Blue # 2 / Indigo mosque Aluminum lake (E 132)) , Opadry Clear YS-2-19114-A (Colorcon) (hypromellose (E463), triacetin / glycerol triacetate (El 518)), Pure water

Before you start using this medication, please read this NI carefully because it contains important information for you.

Keep these instructions for use. You can need to read again.

If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital. •

Follow the instructions in this manual. Do not use high or low dpz other than the recommended dose for the drug.

2. What is CADUET and what is it used for?

CADUET is available in blister pack of 30 tablets. Blue, oval-film-coated tablet, "Pfizer" on one side and "CDT" and "101" on the other.

CADUET is taken orally and contains 10 mg amlodipine equivalent to 10 mg amlodipine and atorvastatin calcium equivalent to 10 mg atorvastatin base. In combination with amlodipine (a drug with calcium channel blocker) and another drug called atorvastatin (statin), your doctor will give you this medicine when you think it is appropriate to use both drugs: Amlodipine has high blood pressure (hypertension) and / or or used in the treatment of angina called specific type of chest pain.

lowers atorvastatin cholesterol and triglycerides, if you have an increased risk for heart disease, may also be used to reduce this risk.

High blood pressure (hypertension), blood pressure comprises of being an abnormally persistent form of high medical condition and stay P-vascular disease (angina, heart attack, stroke) is a risk factor

Hypertension: High blood pressure, blood pressure of blood vessels. Amlodipine reduces blood pressure by allowing blood vessels to expand, making blood circulate more easily in the vessels.

Angina is a feeling of pain or discomfort that occurs when there is not enough blood to a part of the cardiovascular muscle. Angina is usually felt in the form of chest pressure or compressive pain. Sometimes this pain is felt on the arms, shoulders, neck and back; amlodipine can pass this pain.

Cholesterol is a naturally occurring substance in the body, which is necessary for normal growth. However, if you have too much cholesterol in your blood; it may accumulate on your blood vessel walls to increase the risk of blood clots and cardiovascular events, and may result in narrowing of the vessels and eventually occlusion. Heart disease was one of the most common causes. ,

How to use 3.CADUET?

Instructions for proper use and dose / frequency of

administration The usual initial dose is 5 mg / 10 mg CADUET tablet once a day. The maximum dose is 10 mg / 80 mg. Your doctor has a dose of CADUET; It will decide by evaluating your individual situation.

When using CADUET, always follow the instructions of the physician strictly. Ask your doctor or pharmacist if you are unsure. -

It is important to keep the tablets you will use. Do not wait until your tablets are finished before you see your doctor.

The route and method of

administration are taken orally. All must be taken with the water.

CADUET should be administered as a single dose at any time of the day in a single dose. However, try to get your tablet at the same time every day.

Observe your doctor's dietary recommendations, especially if you have a low-fat diet, do not smoke and exercise regularly.

Use in the

elderly The use of

CADUET in children and adolescents is not recommended.

Use in the elderly:

Consult your doctor.

Specific use:

casesSince amlodipine is a highly binding component of blood proteins from CADUETMn, blood dialysis is not expected to significantly increase amlodipine clearance.

Since atorvastatin, another active ingredient of CADUET, also binds to high blood proteins, blood dialysis is not expected to significantly increase atorvastatin clearance (clearance).

Liver failure:

CADUET should not be used in patients with hepatic impairment.

If you have an impression that the effect of CADUET is too strong or weak, talk to your doctor or pharmacist.

If you use more CADUETs than you should use,use from

talk to a doctor or pharmacist if you have used more than you should CADUET.

Take the tablets, packaging and box you don't use, so hospital staff can easily tell you how much medicine you take. . -

CADUET

If you forget to take, if you forget to take a dose, take it at the time you need to use the next dose. Do not take double doses to compensate for forgotten doses.

Effects after cessation of treatment with CADUET

Your doctor will tell you how long you should use CADUET. Do not interrupt your medicine unless your doctor tells you.

If you have any questions about how to use CADUET, ask your doctor or pharmacist.

4. What are the possible side effects?

Like all medicines, CADUET may have side effects in people who are sensitive to substances in the content.

Very common (> 1/10), common (> 1/100 to <1/10), uncommon (> 1/1000 to <1/100), sparse (> 1/10000 to <1/1000), very sparse (<1/10000) and unknown (cannot be estimated from the available data)

If one of the following occurs, stop using CADUET and IMMEDIATELY tell your doctor or contact your nearest hospital emergency department:

• Face, tongue and breath that can cause great difficulty in breathing swelling in the tubing

* Unexplained muscle weakness; if you have muscle tenderness or pain in your muscles and you feel uncomfortable at any time, or if you have a high fever (very rarely these effects are signs of a serious life-threatening condition called rhabdomyolysis.)

These are all very serious side effects. If you have one of these, you may need emergency medical care or hospitalization.

All these very serious side effects are rare.

Side effects (less than 1 person in 10 people):

• Difficulty in sleep, headache, dizziness, dizziness, tired feeling, drowsiness

• Touch or pain sensation in the skin, numbness or tingling in the fingers and toes

• Irregular heartbeat, chest pain Allergic rupture

•• Patient feeling, abdominal pain, indigestion, altered bowel condition (including diarrhea, constipation and gas)

• Skin rash or itching

• Muscle and joint pain, back pain, swelling of ankles, chest pain, pain in the arms and legs, joints Swelling

• Inflammation of the nasal area between the nose and the pharynx (nasopharyngitis)Pain in the pharynx region (pharyngeal lesion)

••

Nose bleeding

Uncommon side effects (less than 1 person in 100 people):

• Reduction in blood count in the blood

• Allergic reaction and hives, Inflammation of the nose (rhinitis, runny nose)

• Loss of appetite, weight gain or loss, increase or decrease in blood glucose levels

• Emotional state changes, tremor, damage to sensory sinuses leading to arms and legs (decreased sensitivity), memory loss

• vision problems, blurred vision, a kind of eye inflammation (conjunctivitis), double vision, eye pain ringing in ears and buzzing

• Shortness of breath, fainting sensation, increased sweating, low blood pressure

• Dry mouth, changes in taste sensation, vomiting

• Inflammation of the pancreas (symptoms of pain starting at the top of the cam and increasing with time, fever, nausea and vomiting, sensitivity in the upper region of the cam, increase in heart rate)

• Hair loss, scar on the skin or small spots, coloration of skin

• Urinary diseases (increase in urination at night and increase in urine frequency)

• Sexual weakness, breast enlargement in men

• State of restlessness, muscle cramps, pain

• Out of vessels red blood cells skin and mucosal lesion or purpura.

• Forgetfulness

•vision

• Reduction of blood circulation in the arms and legs (Peripheral ischemia)

Night• Difficulty in eating or swallowing (dysphagia)

• Stomach discomfort

• Joint disease (arthrosis)

• Neck pain

• Hot flashes

• Contractions

Rare side effects (1,000 people) Less than 1 person:

• Liver problems (liver inflammation, yellowing of the skin, abnormal liver test results)

• Inflammation or swelling of the skeletal muscles, blistering redness

• Breastfeeding

• Face and throat swelling (angioedema) as a result of allergy

• Muscle weakness

• Fever

• White blood in urine cells (in laboratory follow-up)

• Confusion •

Very rare side effects (less than 1 person in 10,000 people):

• Reduction of the number of white cells in your blood

• Muscle stiffness and tension, tendon inflammation, tendon injury

• Abnormal heart rhythm, heart attack,Inflammation of small blood vessels

• gingival enlargement, cough

• the lips, in the deeper skin layers containing the swelling of the eyelids and tongue swelling against light sensitivity

• allergic origin, severe skin reactions, redness in skin blister redness, capable of rapidly starting the whole body yayılabilep and fever with flu-like symptoms peeling

• Severe muscle inflammation, very rare musculoskeletal or cramps that can lead to rhabdomyolysis (destruction of muscle cells)

• Eye disorders, hearing loss, liver failure

The following events account for <% 0. Tinde was observed: cardiac failure, stroke disorder, extrasystole, skin discoloration, skin dryness, urticaria, dermatitis, muscle weakness, twitch, movement and balance disorders (ataxia), excessive tension of the muscles (hypertonia), migraine, cold and moist skin, painful urination (dysuria), agitation, amnesia, excessive urination (polyuria), non-smell (parosmi), increased appetite, cough, cold, taste disorders, adaptation to different distances of eye lens (accommodation)disorder

If any of these side effects become serious or if you encounter any side effects other than those specified in this leaflet, please ask your doctor or pharmacist.

2.CADUET should bebefore using Do not use

considered CADUET

if: ■

• You are allergic to amlodipine or atorvastatin or any calcium channel blocker (hypersensitivity)you are allergic to

•any component of this drug (at beginning of these instructions

listed the)

• if you have or have had a disease that affects your liver.

• if you have abnormal results that cannot be explained in your liver function tests.

• If you have the potential to bear children and do not use the appropriate method of birth control,

• are pregnant, if you are trying to get pregnant or if you are breastfeeding,

• used in the treatment of fungal infections ketoconazole,itraconazole or

if you are using telithromycin with antibiotic

Caduet the follow that USE CAREFULLY cases

you;

• if you have kidney problems

• your thyroid gland is working less than normal (hypothyroidism)

• recurrent or unexplained muscle pain, personal or family history of genetic muscle problems

• other cholesterol (lipid) lowering drugs (eg. Other 'statins' or 'fibrate' drugs) with've experienced previously muscle problems during treatment

• regular large amount you drink alcohol

• If you have had a disease that affects your past liver

• 70 years or older if you

• If you have risk factors for diabetes

if your risk for any of these side effects associated with current and muscle system for you your doctor will need to perform blood tests before and during CADUET treatment. It is known that muscle-related side effects, such as rhabdomyolysis, are increased at the same time by taking certain drugs (see in Use with other drugs Kas). Immediately inform your physician about unidentified muscle pain, tenderness or weakness, especially if it is accompanied by malaise or fever.

Tell your doctor if you have had a stroke before; Your doctor will take this into consideration when deciding the most appropriate treatment and dose for you.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using CADUET with food and drink You can take

CADUET on a full or full stomach at any time of the day.

Grapefruit juice: Do not eat grapefruit or drink grapefruit juice when using CADUET.

Alcohol: Avoid taking high amounts of alcohol when using CADUET. See ”Use CADUET with care Daha for more information. '

Pregnancy

Consult your doctor or pharmacist before using the medication.

Do not use CADUET if you are pregnant or if you are trying to conceive.

Women with childbearing potential should take adequate contraception when using CADUET or any medication. If you become pregnant while taking this medicine, the treatment will be discontinued and your doctor will inform you of the potential danger associated with the fetus.

"Please Consult your doctor or pharmacist before using any medicine.

If you notice that you are pregnant during treatment, consult your doctor or pharmacist.

taking any

Consult Medicine your doctor or your pharmacist before use.

Caduet of vehicles and machinery use)studies to determine the impact

There are noon.However, on the basis of pharmacodynamic properties of Caduet amlodipine component, dizziness during the use of tools and machinery must be taken into consideration that may occur.

important information about some of the ingredients found in the Caduet content

contains this medicinal product sodium. in this case, controls must be taken into consideration for patients on a sodium diet .

for use in combination with other

drugs,including prescription drugs, or if you are using other recently.

drugs,tell your doctor or pharmacist if you have used  some drug that can interact with Caduet This interaction may reduce the effect of one or both drugs. Alternatively, it may increase the risk of an important skeletal muscle destruction known as rhabdomyolysis, and the risk or severity of side effects including myopathy (described in Section 4.) ■ -

• Some antibiotics, eg. rifampin or 'macrolide antibiotics'.erythromycin,

treatment ofclarithromycin, telithromycin or fungal infections

Some drugs used in theketoconazole, itraconazole

• Drugs used to control lipid levels: fibrates (amphibrosil), niacin or cholestipol

• Drugs used to control heart rhythm amidarone, diltiazem

• Anticonvulsant drugs. carbamazepine, phenobarbital, phenytoin, fosfenitoin,

primidone

• Drugs used to alter the functioning of your immune system. Ö.

cyclosporin

• Drugs used in the treatment of human immunodeficiency virus (HIV)

• Warfarin (a blood thinning drug)

• Antacids (for indigestion)

• Oral medications used for contraception

• Drugs used in the treatment of depression nefazodon and imipramine

• Drugs used in the treatment of mental disorders. Neuroleptics (such as chlorpromazine)

• Drugs used in the treatment of heart failure beta blockers (such as bisoprolol, carvedilol, metoprolol)

• Drugs used in the treatment of high blood pressure. angiotensin II antagonists (such as losartan, irbesartan, olmesartan), ACE inhibitors (such as benazepril, lisinopril, ramipril) and diuretics (urinary flow-enhancing drugs) (such as hydrochlorothiazide)

• Hypertension or angina some calcium channel blockers used for chest pain; for example, verapamil, diltiazem,

• Hypertension and alpha blockers used in the treatment of prostate (prazosin, alfuzosin, doxazosin, tamsulosin, such as terazosin)

• Amifostine (used to treat cancer)

• Sildenafil (penis for erectile dysfunction)

• dantrolene and baclofen (muscle relaxants)

• Steroids (medications that prevent or suppress the immune response) (such as prednisolone)

•counter medicines called

• Colchicine (a drug used for gout)

Over-the-yellowwort5. Storage of

CADUET Keep CADUET out of the reach of children, and in its packaging.

Store at room temperature below 25 ° C.

Use in accordance with expiration dates.

Drugs should not be disposed of with wastewater or household waste. Ask your pharmacist about how to dispose of the medications you don't need. These measures will contribute to the protection of the environment.