Alipza (pitavastatin) 30 Tablets

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INSTRUCTIONS FOR USE

Active substance: Contains 4,18 mg pitavastatin calcium equivalent to 4 mg pitavastatin.

Excipients: lactose monohydrate (derived from bovine milk), hydroxypropyl cellulose, Hypromellose (E646), titanium dioxide (E171), triethyl citrate (E1505), magnesium aluminum metasilicate, magnesium stearate, colloidal anhydrous silica

these instructions for use before starting to use this drug Please read 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 doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is ALIPZA and what is it used for?

2 Things to consider before using ALIPZA

3. How to use ALIPZA?

4. What are the possible side effects?

5. TheALIPZA are

headings of included.

1. What is ALIPZA and what is it used for?

ALIPZA contains pitavastatin. belongs to a group called 'statins'. ALIPZA is used to correct blood (lipids) levels in adults and children aged 6 years and older. ALIPZA is used to reduce total cholesterol (TC), LDL-C and triglyceride ratios and to increase the HDL-C ratio. It provides protection from major cardiovascular events in patients with high risk of cardiovascular events. An imbalance in your fats can lead to a heart attack or stroke, especially cholesterol.

ALIPZA is given to you because there is imbalance in your oils and changes in your diet and making changes in your lifestyle are not enough to correct this situation.

While taking ALIPZA, you should continue to change your cholesterol-lowering diet and lifestyle.

ALIPZA is available in boxes containing 30 or 90 film tablets containing round, biconvex, white, film-coated tablets with 'KC' on one side and '4' on the other.

2. Things to consider before using ALIPZA DO NOT use ALIPZA in the following cases

:

• If you are allergic (hypersensitive) to Pitavastatin or other statins or other substances in ALIPZA If you are

•pregnant or breastfeeding,If you are a

•child of childbearing age and are not using a safe method of contraception (see section 'Pregnancy and breastfeeding'),

• If you have liver problems,If you are

•using cyclosporine - after organ transplantation

• If you have recurrent or unexplained muscle pains or pains,

do not use ALIPZA.

USE ALIPZA CAREFULLY in the following cases

:

• If you have serious respiratory failure (if you have serious problems with breathing)If you have had problems with your

•kidneys

before. Bilir Statins ler may affect the liver in a small number of individuals. Usually your doctor will conduct a blood test (liver function test) before and during ALIPZA treatment.

• Previously thyroid if you have had problems with gland

• you or if your family has a muscle problem story

• before other cholesterol-lowering drugs (such as statins or fibrates) If you've experienced while muscle problems

• Excessive amounts you consume alcohol

• fusidic by injection or by mouth acid (bacteria-borne infections If you are taking the drug or used it within the last 7 days, please tell your doctor about this. Combination of ALIPZA with fusidic acid can cause serious muscle problems (rhabdomyolysis).

• If you need to use ALIPZA in combination with fusidic acid, erythromycin or other macrolide antibiotics, ALIPZA should be discontinued during the use of these drugs.

• ALIPZA should be used with other drugs known to make myopathy (eg lipid regulators, fibrates or niacin (vitamin B3), another group of drugs.

• Blood sugar levels increased in patients treated with statins; An increase in the prevalence of diabetes with statins has been reported in patients with risk factors for diabetes. When using this medicine; If you have diabetes or are likely to develop diabetes (if your blood sugar and fat levels are high, you are overweight and your blood pressure is high), your doctor will monitor your condition with biochemical tests.

• As with other statins, there is a possibility that serious muscle problems such as myopathy and rarely rhabdomyolysis may occur with ALIPZA. If you have a persistent muscle weakness, tell your doctor about this. Additional tests and medicines can be applied to detect and treat this condition.

Children and adolescent patients should

ALIPZA not be used in children under 6 years of age. Adolescent girl patients should receive guidance and counseling on contraception before using ALIPZA.

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

Using ALIPZA with food and drink can be

ALIPZA opened to full or full.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

Do not use ALIPZA if you are pregnant. If you intend to become pregnant, consult your doctor before using the drug. If you are trying to become pregnant, treatment should be discontinued at least 1 month before you become pregnant. If you become pregnant during ALIPZA use, the treatment should be discontinued immediately.

If you are in childbearing age, you should use a reliable method of contraception when receiving ALIPZA.

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

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Do not use ALIPZA if you are breastfeeding your baby.

Vehicle and machine use

ALIPZA is not expected to affect your ability to drive or use machines.

However, if you turn your head or sleep when receiving ALIPZA do not use tools or machines.

Important information on some excipients contained in

ALIPZA ALIPZA contains 252,34 mg of lactose (one type of sugar) per dose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Use with other drugs

If you are taking any other medication or have recently taken any other medication, please tell your doctor or pharmacist. You should also specify non-prescription medicines and herbal remedies. Some drugs may prevent each other from acting properly.

You should tell your doctor or pharmacist, especially if you are using the following drugs:

• Cyclosporine (a drug used to prevent organ rejection after organ transplants)Medications

•called ibr Fibrates ilaç (such as gemfibrozil and fenofibrate)

• Erythromycin or rifampicin - infections antibiotics for use

• Warfarin or any other medication used to thin the blood

Drugs used in the treatment of HIV (AIDS) called us Protease inhibitors

•• Niacin (Vitamin B3)

lar• If you need to use fusidic acid to treat bacterial infection, you may need to take a break from using ALIPZA. Your doctor will tell you when to safely restart ALIPZA. Ally with the use of ALIPZA with fusidic acid, muscle weakness, muscle tenderness and pain (rhabdomyolysis) may rarely occur.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medication or if you have recently used it.

3. How to use ALIPZA?

Instructions for proper use and dose / frequency of administration:instructed by

Always use ALIPZA ask your doctor. Consult your doctor or pharmacist if you are unsure.

The normal starting dose is 1 mg per day. Your doctor may increase your dose within a few weeks. The maximum daily dose for adults and children over 10 years of age is 4 mg.

The maximum daily dose in children under 10 years is 2 mg.

If you have problems in your liver should not exceed 2 mg per day.

Method and method of:

administration Open the tablet or swallow the whole stomach together with water. If necessary, the tablets should be dissolved in a glass of water and then immediately drunk. Correct dosing of

to the reception, again filled with water washing of the cup must be provided and this water must be ingested immediately. Tablets should not be dissolved in acidic juices or milk

can get at any time of the day. However, try to get your tablet at the same time every day. Statin therapy is more effective when administered at night due to the 24-hour biological cycle of lipid metabolism.

Different age groups:

Use in children:

ALIPZA is not recommended for children under 6 years of age.

The maximum daily dose in children under 10 years is 2 mg.

Use in the elderly:

Dose adjustment is not required.

Special Use Cases:

Renal Failure:

Dose adjustment is not required for mild renal failure, but ALIPZA should be used with caution.

Regardless of the degree of renal failure, the 4 mg dose can be used only under the close supervision of the physician following a gradual increase in the dose.

In severe renal failure, 4 mg dose is not recommended.

Hepatic Failure:

4 mg dose is not recommended for mild to moderate hepatic impairment.

A maximum of 2 mg per day of treatment is recommended during the doctor's follow-up.

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

If you have used more ALIPZA than you should use:

If you have used more than you should use from ALIPZA, talk to a doctor or pharmacist.

Take the medicine box with you.

If you forget to use ALIPZA:

Do not take double doses to compensate for forgotten doses.

Do not worry and take your next dose at the right time.

Effects when treatment with ALIPZA is stopped:

Do not stop taking ALIPZA without consulting your doctor. Otherwise your cholesterol levels may increase.

Consult your doctor or pharmacist if you have further questions about the use of the drug.

4. What are the possible side effects?

As with all medicines, there may be side effects in people who are sensitive to the substances contained in the content of ALIPZA.

If you have any of the following, stop using ALIPZA and IMMEDIATELY tell your doctor or contact the emergency department of the hospital nearest you:

• Allergic reaction - difficulty in breathing, swelling of the face, lips, tongue or throat, difficulty swallowing, severe itching (swelling) It may contain.

• Unexplained muscle pain or weakness; especially if you feel unwell, if you have a fever, or if your urine is reddish brown, ALIPZA may rarely cause undesirable muscle effects (less than 1 in 1000 people). These can cause serious problems such as abnormal muscle breakdown (rhabdomyolysis), which can lead to kidney problems if not investigated.

• Persistent cough, shortness of breath or breathing problems with fever.

• Liver problems that cause skin and eyes to be yellowed (jaundice).

• Pancreatitis (serious pain in the abdomen and back)

These are all very serious side effects. If you have one of these, you have a serious allergy to ALIPZA. You may need urgent medical attention or hospitalization.

All of these very serious side effects are very rare.

Tell your doctor if you notice any of the following:

Common (affects less than 1 in 10 people)

• Joint pain, muscle pain

• Constipation, diarrhea, indigestion, bad feeling, nausea

• Headache

Uncommon (less than 1 in 100 people) effects

• Muscle spasms

• Fever, exhausted or feeling bad

• Swelling of the ankles, feet or fingers

• Abdominal pain, dry mouth, vomiting, loss of appetite, change in the sense of taste,

• The skin is pale and sluggish or breath is stopped (anemia)

• Itching or rash

• tinnitus

• dizziness or drowsiness, insomnia (other sleep disturbances including nightmares)

• increases in liver enzymes

• increased frequency go to the toilet (urinary frequency)

• hands, toes, legs and facial numbness and numbness

7/8

Rare (affects less than 1 in 1000 people)

• Redness, swelling and itchy skin

• Reduced Opinions power

• Pain Language

• Restlessness sensation or discomfort in the stomach

• Deep  to receive a yellow color

Unknown(can not be estimated from the data available)

• Persistent muscle weakness (immune-mediated necrotizing myopathy)

Other possible side effects

• Memory loss

• Sexual difficulties

• Depression

• Diabetes. This effect is likely to occur if your blood is high in fat and sugar, if you are overweight and your blood pressure is high.

These are mild side effects of ALIPZA.

Please inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions.

Report side effects side effects that are

If you experience any included in the instructions for use or not, talk to your doctor, pharmacist or nurse. Also located on the side effects www.titck.gov.t site you encounter "Drug Side Impact Statement" by clicking on the icon or 0800314 00 08 number of side effects by calling the notification line Turkey Pharmacovigilance Center (TÜFAM) 'What do you notice. By informing you of any side effects, you will contribute to further information on the safety of the drug you are using.

5. Storage of

ALIPZA Keep ALIPZA out of the reach of children and in its packaging.

Store the product in the box and at room temperature below 25 ° C.

Use in accordance with expiration dates.

Do not use ALIPZA after the expiration date indicated in the box and blister.

Do not use ALIPZA if you notice any defects in the product and / or its packaging.

Do not throw away any expired o