0 mg, 20 mg, 40 mg, 80 mg film-coated tablets 
atorvastatin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Atorvastatin Teva is and what it is used for 
2. What you need to know before you use Atorvastatin Teva 
3. How to use Atorvastatin Teva 
4. Possible side effects 
5. How to store Atorvastatin Teva 
6. Contents of the pack and other information 

What Atorvastatin Teva is and what it is used for

Atorvastatin Teva belongs to a group of medicines called statins, which regulate lipids(fats).

Atorvastatin Teva is used to treat high blood fats, also called cholesterol and triglycerides , when the effects of lifestyle changes and diet are insufficient. If you have an increased risk of heart disease, Atorvastatin Teva can also be used to reduce the risk, even if your cholesterol levels are normal. You should maintain a low cholesterol diet during treatment.

Atorvastatin contained in Atorvastatin Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Atorvastatin Teva

Do not use Atorvastatin Teva

  • if you are allergic to atorvastatin or any of the other medicines used to lower blood fats or any of the other ingredients of this medicine (listed in section 6).
  • if you have or have had diseases that affect the liver.
  • if you have had unexplained abnormal liver function values.
  • if you are a woman of childbearing potential and do not use a reliable contraceptive.
  • if you are pregnant or trying to become pregnant.
  • if you are breast-feeding.
  • if you are using a combination of glekaprevir and pibrentasvir to treat hepatitis C.

Warnings and cautions

Talk to your doctor or pharmacist before taking Atorvastatin Teva.

  • If you are taking or have taken a medicine called fusidic acid (a medicine for bacterial infections ) by mouth or by injection within the last 7 days . The combination of fusidic acid and Atorvastatin Teva can lead to severe muscle problems ( rhabdomyolysis ).
  • If you have previously had a stroke with bleeding in the brain, or have small pockets of fluid in the brain from previous strokes
  • If you have kidney problems
  • If you have an underactive thyroid gland ( hypothyroidism )
  • If you have had repeated and unexplained muscle pain or muscle problems in person or in the family
  • If you have previously had muscle problems during treatment with other lipid-lowering drugs (eg other statins or fibrates)
  • If you regularly drink large amounts of alcohol
  • If you have had liver disease
  • If you are over 70 years old.

During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes . You are more likely to get diabetes if you have high blood sugar and high blood fat levels, are overweight and have high blood pressure .

Talk to your doctor or pharmacist before taking Atorvastatin Teva

  • If you have severe lung function.

If any of these apply to you, your doctor will need to perform blood tests before and possibly during your treatment with Atorvastatin Teva to assess the risk of muscle-related side effects . It is known that the risk of muscle-related side effects , e.g. rhabdomyolysis , increases when certain medicines are taken with atorvastatin (see section 2 “Other medicines and Atorvastatin Teva”).

Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.

Other medicines and Atorvastatin Teva

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

Some medicines may affect the effect of Atorvastatin Teva, or their effect may be affected by Atorvastatin Teva. This type of interaction may make one or both drugs less effective. Alternatively, interaction may increase the risk of, and severity of side effects , including the severe condition of muscle breakdown, rhabdomyolysis , described in section 4.

  • If you have to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to take Atorvastatin Teva again. The use of Atorvastatin Teva in combination with fusidic acid may in rare cases lead to muscle weakness, tenderness or pain ( rhabdomyolysis ). See more information on rhabdomyolysis in section 4 .
  • Drugs that affect the immune system, e.g. cyclosporine.
  • Other antibiotics (medicines for bacterial infections ) or medicines for fungal infections, such as erythromycin, clarithromycin, telithromycin, ketoconazole , itraconazole, voriconazole, fluconazole , posaconazole, rifampicin.
  • Other lipid-lowering drugs, e.g. gemfibrozil, other fibrates, colestipol.
  • Some calcium channel blockers (used to treat angina and high blood pressure ), e.g. amlodipine, diltiazem, and medicines that regulate the heart rhythm, e.g. digoxin, verapamil, amiodarone.
  • Drugs used in HIV treatment, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, combination of tipranavir and ritonavir and others. 
  • Some medicines used to treat hepatitis C, such as telaprevir, boceprevir and a combination of elbasvir and grazoprevir.
  • Other medicines known to interact with atorvastatin include ezetimibe (cholesterol-lowering medicines), warfarin (blood thinners), oral contraceptives ( birth control pills ), stiripentol (antispasmodic for epilepsy ), cimetidine (medicines for heartburn and stomach ulcers ), phenazone (colic) (used for gout ), and antacids (medicines containing aluminum or magnesium and used for digestive problems).
  • Over-the-counter medicines: St. John’s wort .

Atorvastatin Teva with food, drink and alcohol

See section 3 “How to use Atorvastatin Teva” for instructions on how to use Atorvastatin Teva.

Note the following:

Grapefruit juice 
Do not take more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice may affect the effect of Atorvastatin Teva.

Alcohol 
Avoid drinking too much alcohol while taking this medicine. See section 2 “Warnings and precautions” for more information.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Atorvastatin Teva during pregnancy or if you are trying to conceive. 
Do not use Atorvastatin Teva if you are a woman of childbearing potential unless you are using a reliable contraceptive.

Do not use Atorvastatin Teva if you are breast-feeding.

The safety of Atorvastatin Teva during pregnancy and lactation has not yet been established. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine does not normally affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

This medicine contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free ‘.

How to use Atorvastatin Teva

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you should continue with during treatment with Atorvastatin Teva.

The recommended starting dose of Atorvastatin Teva is 10 mg daily for adults and children 10 years of age or older . Dose one can be increased gradually by your doctor until you reach the dose you need. Dose one can be adjusted by the doctor at intervals of 4 weeks or more. The maximum dose of Atorvastatin Teva is 80 mg daily.

Atorvastatin Teva tablets should be swallowed whole with water and can be taken at any time of the day with or without food. However, try to take a dose at the same time each day.

The duration of treatment with Atorvastatin Teva is determined by your doctor.

Talk to your doctor if you think the effect of Atorvastatin Teva is too strong or too weak.

Use for children and adolescents

The recommended starting dose is 10 mg once daily in children 10 years of age or older . Dose one can be increased by the doctor to a maximum dose of 20 mg once daily.

The use of Atorvastatin Teva is not recommended for use in children below 10 years of age.

If you forget to use Atorvastatin Teva

If you forget to take a dose , just take the next dose at the correct time. Do not take a double dose to make up for a forgotten dose .

If you stop using Atorvastatin Teva

If you have any further questions on the use of this product or want to stop treatment, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects or symptoms, stop taking your tablets and contact a doctor immediately or see your nearest emergency department.

Rare side effects (may affect up to 1 in 1,000 people):

  • Severe allergic reaction with swelling of the face, tongue and throat which can cause severe breathing difficulties.
  • Severe disease with severe scaling and swelling of the skin, blistering of the skin, mouth, eyes, genitals and fever. Pink-red spotty rashes, especially on the palms or soles of the feet which can turn into blisters.
  • Muscle weakness, soreness, pain, muscle strain or red-brown urine, especially if you also feel unwell or have a high fever. This may be due to abnormal muscle breakdown ( rhabdomyolysis ). The abnormal muscle breakdown does not always go away despite the end of treatment and can be life-threatening and lead to kidney problems.

Very rare side effects (may affect up to 1 in 10,000 people):

  • If you experience problems with unexpected or unusual bleeding or bruising, this may indicate liver damage. Talk to your doctor as soon as possible.
  • Lupus-like syndrome (including rash, joint disease and effects on blood cells)

Other possible side effects with Atorvastatin Teva:

Common side effects (may affect up to 1 in 10 people):

  • inflammation of the nasal passages, sore throat, nosebleeds.
  • allergic reactions.
  • increase in blood sugar levels (if you have diabetes you should closely monitor your blood sugar levels), increase in creatine kinase in the blood.
  • headache.
  • nausea, constipation, gas in the stomach, indigestion, diarrhea.
  • joint pain, muscle aches and back pain.
  • changes in blood test results that show how your liver works.

Uncommon side effects (may affect up to 1 in 100 people):

  • anorexia (loss of appetite), weight gain, decrease in blood sugar levels (if you have diabetes , you should carefully monitor your blood sugar levels).
  • nightmares, insomnia.
  • dizziness, numbness or ant crawling in fingers and toes, decreased sensation of pain or touch, changes in taste experience, memory loss.
  • dimsyn.
  • ringing in the ears and / or head.
  • vomiting, belching, abdominal pain (upper and lower), pancreatitis ( inflammationof the pancreas which causes abdominal pain).
  • hepatitis ( inflammation of the liver).
  • skin rash and itching , hives , hair loss.
  • pain in the neck, muscle weakness.
  • fatigue, malaise, weakness, chest pain, swelling especially at the ankles ( edema ), fever.
  • urine tests showing white blood cells .

Rare side effects (may affect up to 1 in 1,000 people):

  • visual impact.
  • unexpected bleeding or bruising.
  • cholestasis (skin and whites of the eyes turn yellow).
  • senskada.

Very rare side effects (may affect up to 1 in 10,000 people):

  • an allergic reaction – symptoms that may occur are sudden wheezing and chest pain or pressure over the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse.
  • hearing loss.
  • gynecomastia (breast augmentation in men).

Has been reported (occurs in an unknown number of users):

  • Muscle weakness that is persistent.

The following side effects have been reported with certain statins (medicines of the same type):

  • impaired sexual ability.
  • Depression.
  • breathing difficulties, including persistent cough and / or shortness of breath or fever.
  • diabetes . This is more likely if you have high blood sugar and high blood fat levels, are overweight, and have high blood pressure. Your doctor will check you while you are taking this medicine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Atorvastatin Teva

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

Do not store above 30 ° C.

Do not use this medicine after the expiry date which is stated on the can or on the blister and carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is atorvastatin. 
    Each tablet contains atorvastatin calcium equivalent to 10, 20, 40 or 80 mg of atorvastatin.
  • The other ingredients in the tablet core are microcrystalline cellulose, sodium carbonate, maltose, croscarmellose sodium and magnesium stearate. 
    The other ingredients in the film coating are hypromellose (E464), hydroxypropylcellulose, triethyl citrate (E1505), polysorbate 80 and titanium dioxide (E171).

What the medicine looks like and the contents of the pack

  • 10 mg: Atorvastatin Teva film-coated tablets are white to off-white, oval, biconvex with a smooth surface. The dimensions of each tablet are approximately 9.7 x 5.2 mm. 
    20 mg: Atorvastatin Teva film-coated tablets are white to off-white, oval, biconvex with a smooth surface. The dimensions of each tablet are approximately 12.5 x 6.6 mm. 
    40 mg: Atorvastatin Teva film-coated tablets are white to off-white, oval, biconvex with a smooth surface. The dimensions of each tablet are approximately 15.6 x 8.3 mm. 
    80 mg: Atorvastatin Teva film-coated tablets are white to off-white, oval, biconvex with a smooth surface. The dimensions of each tablet are approximately 18.8 x 10.3 mm.
  • Atorvastatin Teva is available in aluminum / aluminum blisters in pack sizes of 7, 10, 14, 15, 20, 28, 30, 50, 50×1, 56, 60, 84, 90, 98, 100 or 200 tablets and in HDPE cans containing 50 or 100 tablets and as a multipack containing 100 tablets (2 cans of 50 tablets each).
  • Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Muhammad Nadeem

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