Atorvastatin TecniGen 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatina TecniGen 20mg film-coated tablets EFG

Read the entire 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, pharmacist or nurse.
  • This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
  • If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Atorvastatina TecniGen is used to lower lipid levels such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, Atorvastatina TecniGen may also be used to reduce this risk, even if your cholesterol levels are normal. A standard cholesterol-lowering diet should be followed during treatment.

2. What you need to know before taking 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 are not using adequate contraceptive measures.
• you are pregnant or trying to become pregnant.
• you are breastfeeding.
• you are taking 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 within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Atorvastatin TecniGen may cause serious muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), since statins may sometimes worsen the disease or trigger the onset of myasthenia (see section 4).

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

• you have previously had a 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, or personal or family history of muscle disorders.
• you previously experienced muscle problems during treatment with other lipid-lowering medicines (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 insufficiency.

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

In any of these cases, your doctor may recommend blood tests before and possibly during treatment with Atorvastatin TecniGen to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g., rhabdomyolysis) increases when certain medicines are taken concomitantly (see section 2 "Use with other medicines").

Inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Use of Atorvastatin TecniGen with other medicines

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

Some medicines may interfere with the proper functioning of Atorvastatin TecniGen, or the effects of these medicines may be altered by Atorvastatin TecniGen. Such interactions may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including severe muscle damage known as rhabdomyolysis described in Section 4:

• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

• Medicines used to modify the function of your immune system, for example, cyclosporine.

• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.

• If you need to take oral fusidic acid to treat a bacterial infection, you must stop using this medicine. Your doctor will advise you when you can restart treatment with Atorvastatin TecniGen. Using Atorvastatin with fusidic acid may cause muscle weakness, tenderness, 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 to treat 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 HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.

• Other medicines known to interact with Atorvastatin TecniGen include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), and antacids (indigestion remedies containing aluminium 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 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 may alter the effects of Atorvastatin TecniGen.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in Section 2 “Take special care with Atorvastatin TecniGen”.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 are using adequate contraceptive measures.

The safety of Atorvastatin TecniGen during pregnancy and breastfeeding has not been established.

Driving and using machines

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

Atorvastatin TecniGen contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Atorvastatin TecniGen

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment, your doctor will place you on a cholesterol-lowering diet, which you must continue to follow during treatment with Atorvastatin TecniGen.

The usual starting dose of Atorvastatin TecniGen is 10 mg once daily in adults and children from 10 years of age. Your doctor may increase this dose if necessary to reach the dose appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin TecniGen is 80 mg once daily for adults and 20 mg once daily for children.

Atorvastatin TecniGen tablets should be swallowed whole with a glass of water and may be taken at any time of 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 Atorvastatin TecniGen.

Ask your doctor if you think that 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 Atorvastatin TecniGen tablets (more than your usual daily dose), consult your doctor or the nearest hospital, or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Atorvastatin TecniGen

If you miss a dose, take the next scheduled dose at the correct 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 about using this medicine or wish to stop treatment, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Atorvastatatin TecniGen can cause adverse effects, although not everyone experiences them.

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

Rare: may affect up to 1 in 1,000 patients:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe difficulty breathing.

• Serious illness with severe skin peeling and inflammation; skin blisters, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which may develop into blisters.

• Muscle weakness, tenderness, pain, or muscle rupture, or change in urine color to red-brown, especially if accompanied by malaise or high fever, which may be due to abnormal muscle breakdown that can be life-threatening and cause kidney problems.

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

• If you experience problems with unexpected or unusual bleeding or bruising, this may indicate 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 adverse effects with Atorvastatin TecniGen:

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

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased blood creatine kinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Blood test results that may show abnormal liver function

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

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain)
• Hepatitis (liver inflammation)
• Rash, skin rash and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, feeling unwell, weakness, chest pain, swelling, especially in the ankles (edema), increased body temperature
• Urine tests positive for white blood cells

Rare adverse effects (may affect up to 1 in 1,000 patients) include:

• Vision disturbances
• Unexplained bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon injury
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)
• Purple-colored skin lesions (signs of blood vessel inflammation, vasculitis)

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

• Allergic reaction – symptoms may include sudden wheezing and chest pain or tightness, eyelid, facial, lip, mouth, tongue or throat swelling, difficulty breathing, collapse
• Hearing loss
• Gynecomastia (enlargement of the breasts in men and women)

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

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

Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience arm or leg weakness 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. 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.

Reporting of adverse effects

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

5. Storage of Atorvastatin TecniGen

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

Do not store above 25°C.

Store in the original packaging.

Do not use this medicine after the expiry date (EXP) stated on the blister and the outer package. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure how to dispose of medicines and packaging you no longer need, consult your pharmacist. This helps protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin TecniGen 20 mg

• The active substance 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),

trisodium phosphate,

magnesium stearate.

Coating:

hypromellose,

triacetin,

titanium dioxide (E 171).

Appearance of the medicinal product and contents of the pack

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

Atorvastatin TecniGen 20 mg is available in cardboard boxes containing blisters with 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 most recent review of this leaflet: August 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/