Atorvastatin Normogen 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatina Normogen 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Atorvastatin Normogen is and what it is used for

Atorvastatin Normogen belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

This medicine is used to lower lipids 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, this medicine may also be used to reduce that risk, even if your cholesterol levels are normal. A standard low-cholesterol diet should be followed during treatment.

2. What you need to know before starting to take Atorvastatin Normogen

Do not take Atorvastatin Normogen

• If you are allergic to atorvastatin or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had unexplained abnormal results in liver function blood tests.
• If you are a woman of childbearing potential and you are not using adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.
• If you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine:

• If you have severe respiratory insufficiency.
• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis).
• If you have previously had a stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to prior strokes.
• If you have kidney problems.
• If you have an underactive thyroid gland (hypothyroidism).
• If you have recurrent or unexplained muscle pain, or a personal or family history of muscle disorders.
• If you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., with another statin or fibrates).
• If you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you regularly drink large amounts of alcohol.
• If you have a history of liver problems.
• If you are over 70 years of age.

In any of these cases, your doctor may recommend blood tests before and possibly during treatment with this medicine 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 of Atorvastatin Normogen with other medicines”).

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

While taking this medicine, your doctor will monitor you for diabetes or risk factors for developing diabetes. This risk is higher if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure.

Other medicines and Atorvastatin Normogen

Inform 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 function of atorvastatin, or the effects of these medicines may be altered by atorvastatin. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including the serious muscle damage known as rhabdomyolysis described in section 4:

• 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.
• Other medicines used 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.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Medicines used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines known to interact with atorvastatin 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), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
• Over-the-counter medicines: St. John’s wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment. Taking atorvastatin together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

Taking Atorvastatin Normogen with food, drinks, and alcohol

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

Grapefruit juice

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

Alcohol

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

Pregnancy, breastfeeding, and fertility

Do not take this medicine if you are pregnant, think you might be pregnant, or are planning to become pregnant.

Do not take atorvastatin if you are of childbearing potential unless you are using adequate contraceptive measures.

Do not take this medicine if you are breastfeeding your child.

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

This medicine normally does not affect your ability to drive or operate machinery. However, do not drive if this medicine impairs your ability to do so. Do not operate tools or machines if this medicine affects your ability to use them safely.

Atorvastatin Normogen contains lactose

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Atorvastatina Normogen

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you must continue during treatment with this medicine.

The usual starting dose of atorvastatin is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose you require. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

The tablets of this medicine 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 Atorvastatina Normogen

Ask your doctor if you think that the effect of this medicine is too strong or too weak.

If you take more Atorvastatina Normogen than you should

If you accidentally take too many atorvastatin 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, indicating the medicine and the amount taken. Take any remaining tablets, the outer carton, and the full pack so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatina Normogen

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 forgotten doses.

If you stop taking Atorvastatina Normogen

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, this medicine can produce adverse effects, although not everyone will experience them.

If you notice any of the following adverse effects or serious symptoms, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay.

Rare (may affect up to 1 in 1,000 people):

• 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, muscle rupture, or brownish-red discoloration of the urine, especially if accompanied by malaise or high fever, which may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin, and can be fatal and cause kidney problems.

Very rare (may affect up to 1 in 10,000 people):

• 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 Atorvastatina Normogen

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

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

Uncommon (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), weight gain, decrease in blood glucose levels (if you are diabetic, continue to monitor your blood glucose 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 (inflammation of the liver).
• Rash, skin eruptions 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 (may affect up to 1 in 1,000 people):

• Vision disturbances.
• Unexpected 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 (may affect up to 1 in 10,000 people):

• 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.
• Gynaecomastia (enlargement of the breasts in men).

Frequency not known: cannot be estimated from available data:

• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a disease causing 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 drooping eyelids, difficulty swallowing, or difficulty breathing.

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

• Sexual difficulties.
• Depression.
• Respiratory problems such as persistent cough and/or difficulty breathing or fever.
• Diabetes: 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 effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin Normogen

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

Do not use this medicine after the expiry date which is stated on the blister pack and container after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the container and other information

Composition of Atorvastatin Normogen

The active substance is atorvastatin.

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

The other components are: Calcium carbonate, microcrystalline cellulose, lactose monohydrate, polysorbate 80, hydroxypropylcellulose, sodium croscarmellose, and magnesium stearate.

The tablet coating contains: Opadry II White OYL-28900 (containing lactose monohydrate, hypromellose, titanium dioxide, and macrogol) and talc.

Appearance of the product and contents of the container

Film-coated tablets of Atorvastatin Normogen 80 mg are white or almost white, elliptical and biconvex, with a break line and marked with "AT80" on one side and smooth on the other, with a diameter of 17.7 x 9.7 mm ± 10%.

Atorvastatin Normogen 80 mg is available in a carton with blisters containing 28 film-coated tablets and in a clinical pack containing 500 film-coated tablets.

Atorvastatin Normogen 80 mg is also available in a bottle containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: September 2024

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/86793/P_86793.html