ATORVASTATIN TEVA-RATIOPHARM 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatina Teva-ratiopharm 60 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Atorvastatina Teva-ratiopharm and what is it used for
2. What you need to know before you take Atorvastatina Teva-ratiopharm
3. How to take Atorvastatina Teva-ratiopharm
4. Possible side effects
5. Storage of Atorvastatina Teva-ratiopharm
6. Contents of the pack and other information

1. What is Atorvastatina Teva-ratiopharm and what is it used for

Atorvastatina Teva-ratiopharm belongs to a group of medicines called statins, which are used to lower blood lipid levels.

Atorvastatina Teva-ratiopharm is used as an adjunct to diet for the reduction of blood lipid levels such as cholesterol and triglycerides, when diet and other non-pharmacological treatments (such as exercise and lifestyle changes) have not been sufficient.

Atorvastatina Teva-ratiopharm is also used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis: a procedure to lower LDL cholesterol in the blood) or when these treatments are not available.

If you are at high risk of cardiovascular disease, Atorvastatina Teva-ratiopharm can also be used to reduce this risk even if your cholesterol levels are normal.

Cholesterol is a substance that occurs naturally in the body and is needed for normal growth. However, if there is too much cholesterol in the blood, it can build up on the walls of the blood vessels, which can become blocked. This is one of the most common causes of heart disease. It is accepted that high cholesterol levels increase the risk of heart disease. Other factors that increase the risk of heart disease include high blood pressure, diabetes, being overweight, lack of exercise, smoking, or a family history of heart disease.

2. What you need to know before you take Atorvastatina Teva-ratiopharm

Do not take Atorvastatina Teva-ratiopharm

• if you are allergic to atorvastatin, to any other similar medicine used to lower blood lipid levels, or to any of the other ingredients of this medicine (listed in section 6).
• if you have or have had liver disease.
• if you have or have had unexplained abnormal results in blood tests for liver function.
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
• if you have a muscular disorder called myopathy
• if you are pregnant or breast-feeding.
• if you are a woman of childbearing age and are not using adequate contraceptive measures

Warnings and precautions

Consult your doctor or pharmacist before taking Atorvastatina Teva-ratiopharm:

• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Atorvastatina Teva-ratiopharm can cause serious muscle problems (rhabdomyolysis)
• if you have a history of liver problems or if you drink large amounts of alcohol
• if you have impaired renal function
• 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 while taking other medicines to lower lipid levels (e.g. another statin or fibrates).
• if you are over 70 years old.
  • if you have or have had myasthenia (a disease that causes general 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 (see section 4)

If you experience unexplained muscle pain, cramps, pain, or fatigue, especially if accompanied by malaise or fever, contact your doctor immediately, as treatment with Atorvastatina Teva-ratiopharm may need to be interrupted or the dose reduced.

In any of these cases, your doctor may indicate that blood tests should be performed before and during treatment to measure your cholesterol, blood levels, and liver function.

Consult your doctor or pharmacist before taking Atorvastatina Teva-ratiopharm if you:

• Have severe respiratory failure

While you are 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.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Further tests and medication may be necessary to diagnose and treat this problem.

Use of Atorvastatina Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

There are some medicines that can change the effect of Atorvastatina Teva-ratiopharm, or the effects of these medicines may be altered by Atorvastatina Teva-ratiopharm. This type of interaction can reduce the effect of one or both medicines. Your doctor will take this into account when deciding the dose of Atorvastatina Teva-ratiopharm.

Tell your doctor if you are taking any of the following medicines:

• 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 Atorvastatina Teva-ratiopharm. The use of Atorvastatina Teva-ratiopharm with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Medicines used to modify the functioning of your immune system, such as cyclosporin.
• Certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, ketoconazole, itraconazole, rifampicin, fusidic acid.
• Other medicines to regulate lipid levels, such as gemfibrozil, other fibrates, nicotinic acid derivatives, and colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, such as nifedipine, diltiazem, amlodipine.
• Medicines to regulate your heart rhythm, such as digoxin, amiodarone.

• Protease inhibitors used to treat HIV infection (AIDS medicines), such as nelfinavir, efavirenz.
• Certain benzodiazepines used for anxiety and other diseases, such as nefazodone.

Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.

• Other medicines that are known to interact with Atorvastatina Teva-ratiopharm include: ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant to treat epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazon (a pain reliever), colchicine (used to treat gout), and antacids (indigestion products containing aluminum or magnesium).
  • Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).

Taking Atorvastatina Teva-ratiopharm with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina. Please note the following:

Grapefruit juice:

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

This medicine can be taken with or without food.

Alcohol:

Avoid drinking large amounts of alcohol while taking this medicine. See section 2 Warnings and precautions.

Pregnancy and breast-feeding

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.

Pregnancy

Do not take Atorvastatina Teva-ratiopharm if you are pregnant or trying to become pregnant. If you are of childbearing age, you should use reliable contraceptives during treatment with Atorvastatina Teva-ratiopharm.

Breast-feeding

Do not take Atorvastatina Teva-ratiopharm if you are breast-feeding.

Driving and using machines

Do not drive if this medicine affects your ability to drive. Do not use tools or machines if your ability to use them is affected by this medicine.

Excipients

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Atorvastatina Teva-ratiopharm

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor again.

Atorvastatina Teva-ratiopharm is taken once a day. The medicine can be taken at any time of the day, with or without food. Remember that you should follow a special diet and change your lifestyle during treatment with Atorvastatina Teva-ratiopharm.

The initial dose is based on the level of cholesterol and the treatment goal. The initial normal dose is 10 mg per day. Your doctor may increase this dose after 4 weeks or more if necessary.

The maximum dose is 80 mg once a day.

The daily dose should be taken in a single dose.

Your doctor will determine the duration of treatment with Atorvastatina Teva-ratiopharm. Ask your doctor if you think the effect of atorvastatin is too strong or too weak.

Liver failure

Atorvastatina Teva-ratiopharm should be used with caution in patients with liver failure and is contraindicated in patients with active liver disease.

Children and adolescents from 4 to 17 years

The use of Atorvastatina Teva-ratiopharm in children should be done under strict supervision of a specialist.

If you take more Atorvastatina Teva-ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Atorvastatina Teva-ratiopharm

If you have forgotten to take a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next one when it is due.

Do not take a double dose to make up for forgotten doses.

If you stop taking Atorvastatina Teva-ratiopharm

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Atorvastatina Teva-ratiopharm can cause side effects, although not everybody gets them.

The following side effects are important and if you experience one of them, you will need to take immediate action. Stop taking Atorvastatina Teva-ratiopharm and see your doctor immediately if you experience any of the following symptoms:

• swelling of the face, tongue, trachea that can cause difficulty breathing (angioedema). This is a very rare reaction, which can be serious if it occurs. Stop taking atorvastatin and inform your doctor immediately if it occurs.
• In some cases, patients have presented with muscle destruction or inflammation, and very rarely this has led to a potentially life-threatening disease (called rhabdomyolysis). If you have muscle weakness, pain on palpation, pain, or rupture, change in urine color to reddish-brown, and especially if you feel unwell or have a fever, stop taking atorvastatin and inform your doctor.

Very rare side effects (may affect less than 1 in 10,000 patients):

• if you experience bleeding or bruising problems, this may suggest a liver problem. You should consult your doctor as soon as possible.
• Lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells).

Other side effects have also been reported:

Common side effects (may affect between 1 and 10 in 100 patients):abdominal pain, constipation, gas, indigestion, nausea, diarrhea, allergic reactions, difficulty sleeping, headache, dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to touch or pain, rash, itching, muscle pain and joint pain, weakness, chest pain, back pain, and swelling of the hands and feet.

Uncommon side effects (may affect between 1 and 10 in 1,000 patients):loss of appetite, vomiting, muscle cramps, bruising or bleeding due to low levels of cells that prevent bleeding, hair loss, pancreatitis (inflammation of the pancreas causing stomach pain), hives, skin rash, memory loss, ringing or buzzing in the ears, malaise, weight gain, impotence, increased and decreased blood sugar levels (if you have diabetes, you should have strict control of your blood sugar levels).

Rare side effects (may affect between 1 and 10 in 10,000 patients):muscle pain on palpation, liver inflammation (hepatitis), yellowing of the skin and whites of the eyes (jaundice), rhabdomyolysis (severe muscle pain and weakness often associated with fever):

Very rare side effects (may affect less than 1 in 10,000 patients):

Angioneurotic edema (swelling of the face, tongue, and trachea that can cause great difficulty breathing), Stevens-Johnson syndrome (a serious disease with blisters on the skin, mouth, eyes, and genitals), erythema multiforme (irregular rash with red spots), vision and taste disorders, hearing loss, breast growth in men (gynecomastia), tendon fractures, liver failure.

Side effects of unknown frequency:

Constant muscle weakness.

Severe myasthenia (a disease that causes general muscle weakness, which in some cases affects the muscles used for breathing).

Ocular myasthenia (a disease that causes weakness of the eye muscles).

Tell 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.

Other possible side effects:

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Diabetes. This is more likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
  • Drug-induced lichenoid eruption or mouth ulcers
  • Purple-colored skin lesions (signs of blood vessel inflammation, vasculitis)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatina Teva-ratiopharm

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

Store below 30°C.

Do not use Atorvastatina Teva-ratiopharm after the expiry date stated on the packaging after "CAD". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atorvastatina Teva-ratiopharm

The active ingredient is atorvastatin. Each tablet contains 60 mg of atorvastatin as atorvastatin calcium.

The other components are:

• Microcrystalline cellulose
• Anhydrous sodium carbonate
• Maltose
• Sodium croscarmellose
• Magnesium stearate
• Hypromellose (Pharmacoat Gr. 606)
• Hydroxypropylcellulose
• Triethyl citrate
• Polysorbate 80
• Titanium dioxide (E-171)

Product Appearance and Container Content

Film-coated tablets.

The tablets are white or almost white, elliptical, biconvex, and marked with "60" on one side.

The containers hold 28 tablets packaged in blisters or in an HDPE bottle.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 - Edificio Albatros B, 1ª planta.

28108 – Alcobendas (Madrid)

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica, Calle C nº 4.

50016 Zaragoza, Spain.

Date of the Last Revision of this Leaflet:March 2023

"Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77297/P_77297.html