Package Leaflet: Information for the User

Atorvastatina TecniGen 80mg Film-Coated Tablets

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

- Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

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

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

3. How to take Atorvastatina TecniGen

4. Possible side effects

5. Storage of Atorvastatina TecniGen

6. Contents of the pack and additional information

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 have a high risk of heart disease, Atorvastatina TecniGen may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina TecniGen if:

• You are allergic (hypersensitive) to atorvastatin or to any other medicine used to reduce blood lipids or to any of the other components of this medicine – see more details in Section 6.
• You have or have had any liver disease.
• You have or have had unjustified abnormal results in blood tests for liver function.
• You are a fertile woman and do not use adequate contraceptive measures.
• You are pregnant or trying to become pregnant.
• You are breastfeeding.
• You are using 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 acid fusidic (used for the treatment of bacterial infection) by oral or intravenous route. The combination of acid fusidic and Atorvastatina TecniGen may produce severe muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease that courses with generalized muscle weakness that, in some cases, affects the muscles used to breathe) or myasthenia ocular (a disease that causes weakness of the eye muscles), as statins sometimes can worsen the disease or cause myasthenia (see section 4).

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

• You have had a previous stroke with cerebral bleeding, or have small embolisms of liquid in the brain due to previous strokes.
• You have kidney problems.
• You have a thyroid gland with low activity (hypothyroidism).
• You have repeated or unjustified muscle pain, personal or family history of muscle problems.
• You have had previously muscle problems during treatment with other medicines to reduce lipids (for example, 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:

• Present severe respiratory insufficiency.

While you are taking this medicine your doctor will check if you have diabetes or risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, overweight and high blood pressure.

In any of these cases, your doctor may indicate if blood tests should be performed before and, possibly, during treatment with Atorvastatina TecniGen to predict the risk of suffering adverse effects related to muscle. It is known that the risk of suffering adverse effects related to muscle (for example rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Use of other medicines”).

Inform your doctor or pharmacist if you present constant muscle weakness. Additional tests and medicines may be necessary to diagnose and treat this problem.

Use of Atorvastatina TecniGen with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine.

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

• Daptomycin (a medicine used to treat skin and skin structure infections and bacteria present in the blood).
• Medicines used to modify the functioning of your immune system, for example ciclosporin.
• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, acid fusidic.
• If you have to take acid fusidic orally to treat a bacterial infection you will have to stop using this medicine. Your doctor will indicate when you can restart the treatment with Atorvastatina TecniGen. The use of Atorvastatina with acid fusidic may produce muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis see section 4.
• Other medicines to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• Some calcium channel blockers used in the treatment of angina or high blood pressure, for example, amlodipine, diltiazem; medicines to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Medicines used in the treatment of AIDS, for example, 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 coagulation), oral contraceptives, and stiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and stomach ulcers), phenazone (a painkiller) and antacids (products for indigestion that contain aluminum or magnesium).

• Over-the-counter medicines: St. John's Wort.
• Some 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:

Orange juice

Do not take more than one or two small glasses of orange juice per day as large amounts of orange juice may alter the effects of Atorvastatina TecniGen.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in section 2 “Be careful with Atorvastatina TecniGen”.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Atorvastatina TecniGen if you are fertile unless you take adequate contraceptive measures.

The safety of Atorvastatina TecniGen during pregnancy and breastfeeding has not been demonstrated.

Driving and operating machinery

Do not drive if this medicine affects your ability to drive. Do not handle tools or machinery if this medicine affects your ability to handle them.

Atorvastatina TecniGen contains lactose and saccharose

This medicine contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains saccharose. If your doctor has indicated that you have a intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

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

The usual initial dose of Atorvastatina TecniGen is 10 mg once a day for adults and children aged 10 years and older. Your doctor may increase it if necessary to 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.

Atorvastatina TecniGen tablets 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 every day at the same time.

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 Atorvastatina TecniGen tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicological Information Service, phone 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 the missed doses.

If you interrupt treatment with Atorvastatina TecniGen

If you have any other questions about the use of this medication or want to interrupt treatment, ask your doctor or pharmacist.

Like all medicines, Atorvastatina TecniGen can cause side effects, although not everyone will experience them.

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

Rare: may affect up to 1 in 1000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which may make it difficult to breathe.

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

• Muscle weakness, pain on palpation, pain or rupture or change in color of the urine to brown-red, and especially if you have discomfort or high fever, it may be due to an abnormal muscle rupture that can be fatal and cause kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, 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:

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

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

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

• anorexia (loss of appetite), weight gain, decrease in blood sugar levels (if you are diabetic, continue to carefully monitor your blood sugar levels)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers of the hands and feet, reduction of 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
• positive urine tests for white blood cells

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

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

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

• allergic reaction - symptoms may include sudden hissing while breathing and chest pain or pressure, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (enlargement of breasts in men and women)

Unknown frequency (cannot be estimated from available data): Constant muscle weakness.

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

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

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or eyelid drooping, 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 blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C.

Store in the original packaging.

Do not use this medication after the expiration date (CAD) that appears on the blister and on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of AtorvastatinaTecniGen 80 mg

- The active ingredient is atorvastatina.

Cada comprimido recubierto con película contains 80 mg of atorvastatina (as atorvastatina calcium trihydrate).

The other components (excipients) are:

Core:

Lactose monohydrate,

Magnesium stearate,

Sodium lauryl sulfate,

Microcrystalline cellulose (E-460)

Anhydrous colloidal silica,

Butilhydroxyanisole (E-320),

Crospovidone,

Sodium hydrogen carbonate

Sucrose,

Triester of sorbitan (E-436),

Macrogol 40 stearate,

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

Hydroxypropyl methylcellulose (E-464),

Titanium dioxide (E-171),

Macrogol 4000.

Coating:

Lactose monohydrate

Hydroxypropyl methylcellulose (E-464)

Titanium dioxide (E-171)

Macrogol 4000 (Opadry OYL-28900 White)

Appearance of the product and contents of the packaging

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

Atorvastatina TecniGen 80 mg is presented in blister packs containing 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A

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

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêutica, S.A.

Rua da Tapada Grande nº 2, Abrunheira

2710-089 Sintra

Portugal

Last review date of this leaflet: August 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/