ATORVASTATIN TECNIGEN 20 mg FILM-COATED TABLETS

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

Do not take Atorvastatin 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

Talk to your doctor or pharmacist before starting to take Atorvastatin TecniGen.

• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Atorvastatin 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), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

For the following reasons, Atorvastatin 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 had muscle problems in the past while taking 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

Talk to your doctor or pharmacist before taking Atorvastatin 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 Atorvastatin 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 "Using other medicines").

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

Using Atorvastatin 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 Atorvastatin TecniGen or the effects of these medicines may be altered by Atorvastatin TecniGen. This type of interaction can reduce 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, for example, cyclosporin
• Certain antibiotics or antifungal medicines, for example, 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 Atorvastatin TecniGen. The use of Atorvastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Other medicines for regulating lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used in the treatment of angina or high blood pressure, for example, amlodipine, diltiazem; medicines for regulating 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 Atorvastatin TecniGen include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating 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 Atorvastatin TecniGen with food, drinks, and alcohol

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

Grapefruit juice

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

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in Section 2 "Be careful with Atorvastatin 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 Atorvastatin TecniGen if you are of childbearing age unless you use adequate contraceptive measures.

The safety of Atorvastatin 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.

Atorvastatin TecniGen contains lactose.

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

3. How to take Atorvastatin 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 Atorvastatin TecniGen.

The initial normal dose of Atorvastatin TecniGen is 10 mg once a day in adults and children from 10 years old. 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 Atorvastatin TecniGen is 80 mg once a day for adults and 20 mg once a day for children.

The tablets of Atorvastatin 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 every day at the same time.

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

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

If you take more Atorvastatin TecniGen than you should

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

If you forget to take Atorvastatin TecniGen

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

If you stop taking Atorvastatin TecniGen

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

4. Possible side effects

Like all medicines, Atorvastatin 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 people:

• 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 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 people:

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

Other possible side effects with Atorvastatin 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 people) include:

• loss of appetite (anorexia), 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
• positive urine tests for white blood cells

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

• vision changes
• unexpected or unusual 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 people) include:

• allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, 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).

Talk to 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 side effects

If you experience any side effects, talk to 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 Atorvastatin TecniGen

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

Do not store above 25°C.

Keep in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atorvastatina TecniGen 20 mg

• The active ingredient is atorvastatin.

Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components (excipients) are:

Core:

lactose monohydrate,

microcrystalline cellulose,

polysorbate 80,

hydroxypropylcellulose,

sodium croscarmellose,

butylhydroxyanisole (E 320),

sodium phosphate,

magnesium stearate.

Coating:

hypromellose,

triacetin,

titanium dioxide (E 171).

Appearance of the Product and Container Content

The film-coated tablets of Atorvastatina TecniGen 20 mg are coated, white, round, and biconvex.

Atorvastatina TecniGen 20 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 - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2 (Abrunheira, Sintra) - 2710-089 – Portugal

Or

MEDINFAR MANUFACTURING, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

Date of the Last Revision of this Leaflet: 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/