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

Read all of this leaflet carefully before you start taking 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.

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

What Atorvastatin SUN is and what it is used for

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

Atorvastatin SUN is used in the treatment of high blood fats, so-called cholesterol and triglycerides when the effect of changes in lifestyle and diet is not sufficient. If you have an increased risk of heart disease, Atorvastatin SUN can also be used to reduce this risk, even if your cholesterol levels are normal.

During treatment with Atorvastatin SUN, you should continue with a low cholesterol diet.

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

What you need to know before using Atorvastatin SUN

Do not take Atorvastatin SUN

  • if you are allergic to atorvastatin or any of the other products 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 contraception
  • if you are pregnant or trying to become pregnant
  • if you are breast-feeding
  • if you are using a combination of telaprevir and pibrentasvir to treat hepatitis C.

Warnings and cautions

Talk to your doctor or pharmacist before using Atorvastatin SUN,

  • if you are taking or have taken a medicine called fusidic acid (a medicine for bacterial infection ) orally or by injection for the last 7 days. The combination of fusidic acid and Atorvastatin SUN can lead to severe muscle problems ( rhabdomyolysis ).

In the following situations, Atorvatatin SUN may be inappropriate for you:

  • if you have had a previous stroke with bleeding in the brain, or have small pockets of fluid in the brain from a previous stroke
  • if you have kidney problems
  • if you have hypothyroidism (hypothyroidism)
  • if you have had repeated or 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 or have had any liver disease
  • if you are over 70 years old

Talk to your doctor or pharmacist before taking Atorvastatin SUN

  • if you have severe breathing problems

If any of these apply to you, your doctor will need to take blood samples before and probably during treatment with Atorvastatin SUN to assess the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, increases when certain medicines are taken together (see below “Other medicines and Atorvastatin SUN”).

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

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.

Other medicines and Atorvastatin SUN

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is important that you tell your doctor if you are already being treated with any of the following:

  • if you have to take fusidic acid orally to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to start taking Atorvastatin SUN again. Taking Atorvastatin SUN with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). For more information on rhabdomyolysis, see section 4.

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

  • Drugs that affect the immune system, such as cyclosporine
  • Certain antibiotics or antifungal agents, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, and fusidic acid
  • Other lipid-lowering drugs, such as gemfibrozil, other fibrates, and colestipol
  • Some calcium channel blockers for angina or high blood pressure, such as amlodipine, diltiazem, and medicines to regulate heart rhythm such as digoxin, verapamil, amiodarone
  • Drugs used in the treatment of HIV, eg ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir and ritonavir, etc.
  • Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and a combination of elbasvir and grazoprevir
  • Other medicines that affect or are affected by Atorvastatin SUN include ezetimibe (which lowers cholesterol ), warfarin (blood thinners), birth control pills, stiripentol (antispasmodic for epilepsy ), cimetidine (used for heartburn and stomach ulcers ), phenazone (painkillers), colchicine ( used for gout ) and antacids (medicines for digestive problems that contain aluminum or magnesium )
  • Over-the-counter medicines: St. John’s wort

Atorvastatin SUN with food, drink, and alcohol

See section 3 for instructions on how to take Atorvastatin SUN. 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 Atorvastatin SUN effect.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See above in this section “Warnings and Precautions” for more information.

Pregnancy and breastfeeding

Do not take Atorvastatin SUN during pregnancy or if you are trying to get pregnant.

Do not take Atorvastatin SUN if you are of childbearing potential and do not use a reliable contraceptive.

Do not take Atorvastatin SUN if you are breast-feeding.

The safety of Atorvastatin SUN during pregnancy and lactation has not yet been established.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Normally, this medicine does not affect your ability to drive or use machines. However, you should not drive if you notice that your ability is affected. 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.

Atorvastatin SUN contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.

How to use Atorvastatin SUN

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

The usual starting dose of Atorvastatin SUN is 10 mg daily in adults and children 10 years of age or older.

Dose one can be increased gradually as needed by your doctor until you reach the dose you need. Dose one will be adjusted by the doctor at intervals of 4 weeks or more.

The maximum dose of Atorvastatin SUN is 80 mg daily for adults and 20 mg daily for children.

Atorvastatin SUN 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 the tablet at the same time each day.

Always take Atorvastatin SUN exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The treatment time is determined by your doctor.

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

If you forget to use Atorvastatin SUN

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 SUN

Contact your doctor or pharmacist if you have any further questions on the use of this medicine or wish to discontinue your treatment.

4. Possible side effects

Like all medicines, Atorvastatin SUN can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking the tablets and contact your doctor immediately or go to the nearest emergency department:

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

  • A severe allergic reaction that causes swelling of the face, tongue, and throat, which can lead to great difficulty breathing.
  • The severe condition with severe scaling and swelling of the skin, blisters on the skin, mouth, eyes, and genitals, and fever. Skin rash with pink-red spots, especially on palms or soles of the feet, which may rupture.
  • Muscle weakness, soreness, or pain, especially if you also feel unwell or have a high fever. This may be due to an abnormal muscle breakdown. The abnormal muscle breakdown does not always go away and can continue despite discontinuation of atorvastatin. It can be life-threatening and lead to kidney problems.

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

  • If you have problems with unexpected or unusual bleeding or bruising, this may be due to a liver effect. You should then contact your doctor as soon as possible.
  • L lupus-like disease picture (including rash, joint problems, and effects on blood cells )

Other possible side effects are with Atorvastatin SUN :

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

  • inflammation of the nasal mucosa, pain in the throat, nosebleeds
  • allergic reactions
  • increase in blood sugar levels (if you have diabetes you should carefully monitor your blood sugar levels), increased creatine kinase in the blood
  • headache
  • nausea, constipation, gas, indigestion, diarrhea
  • joint pain, muscle aches, and back pain
  • blood test results that show that your liver function may be abnormal

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 tingling 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, pain in the upper and lower abdomen, pancreatitis ( inflammation of the pancreas leading to abdominal pain)
  • hepatitis (inflammation of the liver)
  • rash, rash and itching, hives, hair loss
  • neck pain, muscle fatigue
  • fatigue, malaise, weakness, chest pain, swelling especially in the ankles ( edema ), elevated temperature
  • white blood cells in the urine

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

  • visual disturbances
  • unexpected bleeding or bruising
  • bile stasis (yellowing of the skin and whites of the eyes)
  • senskada

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

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

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

  • Muscle weakness that is persistent.

Possible side effects reported for certain statins (medicines of the same type):

  • Sexual difficulties
  • Depression
  • Respiratory problems 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 SUN

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

This medicine does not require any special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP and 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 as atorvastatin calcium trihydrate. Each tablet contains 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin.

Other ingredients are

tablet core: calcium carbonate (E170), microcrystalline cellulose (E460), lactose monohydrate, croscarmellose sodium, polysorbate 80 (E433), hydroxypropyl cellulose (E463), magnesium stearate (E470b).

film coating: hypromellose (E464), macrogol 8000, titanium dioxide (E 171), talc (E553b), simethicone emulsion and Candelilavax (only in 10 mg, 20 mg and 40 mg) (E 902).

What the medicine looks like and the contents of the pack

10 mg: White to off-white, oval tablet about 5 mm wide and 10 mm long, marked “AS 10” on one side and smooth on the other side.

20 mg: White to off-white, oval tablet about 6 mm wide and 12 mm long, marked “AS 20” on one side and smooth on the other side.

40 mg: White to off-white, oval tablet about 8 mm wide and 15 mm long, marked “AS 40” on one side and smooth on the other side.

80 mg: White to almost white, oval tablet about 10 mm wide and 19 mm long, marked “AS 80” on one side and smooth on the other side.

Blister packs, cold-pressed: Aluminum foil / PVC / polyamide, coated with aluminum foil, heat-sealed.

Blister packs, cold-pressed with desiccant: Polyamide/aluminum foil/polyethylene + desiccant with HDPE coating, sealed with aluminum foil laminate.

Pack sizes: 10, 14, 20, 28, 30, 50, 84, 90, 98 and 100

Number of tablets per blister: 5, 6, 7, 10

Number of blisters in outer carton: 1,2, 3, 4, 5, 6, 7, 9, 10, 12, 14

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

Therapy SA

124 Fabricii Street

400632 Cluj- Napoca 313 Splaiui, Bucharest

Romania

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

This medicinal product is authorized under the European Economic Area under the names:

Belgium : Atorvastatin SUN 10mg, 20mg, 40mg and 80mg film-coated tablets

Germany: ATORVASTATIN BA10mg, 20mg, 40mg and 80mg Film tablets

Italy: Atorvastatin Mylan Italia10mg, 20mg, 40mg and 80mg

Netherlands: Atorvastatine Momaja 10mg, 20mg, 40mg and 80mg

Muhammad Nadeem

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