ATORVASTATIN TECNIGEN 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatina TecniGen 80 mg film-coated tablets EFG

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 or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Atorvastatina TecniGen and what is it used for
2. What you need to know before you take Atorvastatina TecniGen
3. How to take Atorvastatina TecniGen
4. Possible side effects
5. Storing Atorvastatina TecniGen
6. Contents of the pack and further information

1. What is Atorvastatina TecniGen and what is it used for

Atorvastatina TecniGen belongs to a group of medicines known as statins, which are medicines that regulate lipids (fats).

Atorvastatina TecniGen is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have failed. If you are at high risk of heart disease, Atorvastatina TecniGen can also be used to reduce this risk even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet.

2. What you need to know before you take Atorvastatina TecniGen

Do not take Atorvastatina TecniGen if:

• you are allergic (hypersensitive) to atorvastatin or to any other similar medicine used to lower blood lipids or to any of the other ingredients of this medicine – see more details in Section 6.
• you have or have had any liver disease.
• you have or have had unexplained abnormal results in blood tests for liver function.
• you are a woman of childbearing age and do not use adequate contraceptive measures.
• you are pregnant or trying to become pregnant
• you are breast-feeding
• if you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorvastatina TecniGen.

• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Atorvastatina TecniGen can cause serious muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), since statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

For the following reasons, Atorvastatina TecniGen may not be suitable for you if:

• you have had a previous stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to previous strokes
• you have kidney problems
• you have an underactive thyroid gland (hypothyroidism)
• you have repeated or unexplained muscle pain, personal or family history of muscle problems
• you have previously had muscle problems during treatment with other medicines to lower lipids (e.g., with another statin or fibrates)
• you regularly drink large amounts of alcohol
• you have a history of liver problems
• you are over 70 years old

Consult your doctor or pharmacist before taking Atorvastatina TecniGen 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 sugars and fats in the blood, are overweight, and have high blood pressure.

In any of these cases, your doctor may indicate that you should have blood tests before and, possibly, during treatment with Atorvastatina TecniGen to predict the risk of suffering from muscle-related side effects. It is known that the risk of suffering from muscle-related side effects (e.g., rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 "Use of other medicines").

Tell your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medications may be necessary to diagnose and treat this problem.

Use of Atorvastatina TecniGen with other medicines

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

There are some medicines that can affect the proper functioning of Atorvastatina TecniGen or the effects of these medicines may be modified by Atorvastatina TecniGen. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including important muscle damage, known as rhabdomyolysis, described in Section 4:

• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).
• Medicines used to modify the functioning of your immune system, e.g., cyclosporin
• Certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. Your doctor will tell you when you can restart treatment with Atorvastatina TecniGen. The use of Atorvastatina with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Other medicines to regulate lipid levels, e.g., gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem; medicines to regulate your heart rate, e.g., digoxin, verapamil, amiodarone
• Medicines used to treat AIDS, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Other medicines that are known to interact with Atorvastatina TecniGen include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), and antacids (products for indigestion that contain aluminum or magnesium)

• Medicines obtained without a prescription: St. John's Wort
• Certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir

Taking Atorvastatina TecniGen with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina TecniGen. 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 Atorvastatina TecniGen.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in Section 2 "Be careful with Atorvastatina TecniGen".

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Atorvastatina TecniGen if you are of childbearing age unless you use adequate contraceptive measures.

The safety of Atorvastatina TecniGen during pregnancy and breast-feeding has not been established.

Driving and using machines

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

Atorvastatina TecniGen contains lactose and sucrose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Atorvastatina TecniGen

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

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you should also follow during treatment with Atorvastatina TecniGen.

The initial dose of Atorvastatina TecniGen is 10 mg once a day in adults and children from 10 years of age. Your doctor may increase it if necessary until you reach the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatina TecniGen is 80 mg once a day for adults and 20 mg once a day for children.

The tablets of Atorvastatina TecniGen should be swallowed whole with a glass of water and can be taken at any time of the day with or without food. However, try to take your tablet at the same time every day.

Your doctor will decide the duration of treatment with Atorvastatina TecniGen.

Ask your doctor if you think the effect of Atorvastatina TecniGen is too strong or too weak.

If you take more Atorvastatina TecniGen than you should

If you accidentally take too many tablets of Atorvastatina TecniGen (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Atorvastatina TecniGen

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

If you stop taking Atorvastatina TecniGen

If you have any further questions about the use of this medicine or want to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvastatina TecniGen can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking these tablets and inform your doctor immediately or go to the emergency department of the nearest hospital.

Rare: may affect up to 1 in 1000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty breathing.

• Severe disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.

• Muscle weakness, pain on palpation, pain or rupture or change in urine color to reddish-brown, and especially if you also have discomfort or have a high fever, may be due to abnormal muscle breakdown, which can be fatal and cause kidney problems.

Very rare: may affect up to 1 in 10,000 patients:

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

Other possible side effects with Atorvastatina TecniGen:

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

• inflammation of the nasal passages, sore throat, nosebleeds
• allergic reactions
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increase in creatine kinase in the blood
• headache
• nausea, constipation, gas, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results that may show abnormal liver function

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

• loss of appetite, weight gain, decrease in blood sugar levels (if you are diabetic, you should continue to carefully monitor your blood sugar levels)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers of the hands and feet, reduced sensitivity to pain or touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain)
• hepatitis (inflammation of the liver)
• rash, skin rash, and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, feeling unwell, weakness, chest pain, inflammation, especially in the ankles (edema), increased temperature
• urine tests positive for white blood cells

Rare side effects(may affect up to 1 in 1000 patients) include:

• vision changes
• unexpected bleeding or bruising
• jaundice (yellowing of the skin and whites of the eyes)
• tendon injury
• skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
• purple-colored skin lesions (signs of inflammation of the blood vessels, vasculitis)

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

• allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, or tongue, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men and women).

Frequency not known(cannot be estimated from the available data): Constant muscle weakness.

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

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

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible side effects of some statins (medicines of the same type):

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them 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. Storing Atorvastatina TecniGen

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

Do not store above 30°C.

Keep in the original packaging.

Do not use this medicine after the expiry date (CAD) that appears on the blister pack and carton. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, 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 AtorvastatinTecniGen 80 mg

• The active ingredient is atorvastatin.

Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components (excipients) are:

Core:

Lactose monohydrate,

Magnesium stearate,

Sodium lauryl sulfate,

Microcrystalline cellulose (E-460)

Anhydrous colloidal silica,

Butylhydroxyanisole (E-320),

Crospovidone,

Sodium hydrogen carbonate

Sucrose,

Sorbitan triester (E-436),

Macrogol 40 stearate,

Dimethicone, 2, Bromo-2-Nitropropano-1,3-diol,

Hypromellose (E-464),

Titanium dioxide (E-171),

Macrogol 4000.

Coating:

Lactose monohydrate

Hypromellose (E-464)

Titanium dioxide (E-171)

Macrogol 4000 (Opadry OYL-28900 White)

Product Appearance and Container Content

The film-coated tablets of Atorvastatin TecniGen 80 mg are oblong, biconvex, and white in color.

Atorvastatin TecniGen 80 mg is presented in boxes with blisters containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Manufacturer

Atlantic Pharma – Produções Farmacêutica, S.A.

Rua da Tapada Grande nº 2, Abrunheira

2710-089 Sintra

Portugal

Date of the Last Revision of this Prospectus: August 2024

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/