Atorvastatin Kern Pharma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatina Kern Pharma 10 mg film-coated tablets EFG

Atorvastatina Kern Pharma 20 mg film-coated tablets EFG

Atorvastatina Kern Pharma 30 mg film-coated tablets

Atorvastatina Kern Pharma 40 mg film-coated tablets EFG

Atorvastatina Kern Pharma 60 mg film-coated tablets

Atorvastatina Kern Pharma 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 or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to others, even if they have the same symptoms as yours, as it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Atorvastatina Kern Pharma is and what it is used for

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

Atorvastatin 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, atorvastatin may also be used to reduce this 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 taking Atorvastatin Kern Pharma

Do not take atorvastatin:

• if you are allergic to atorvastatin or to any similar medicine used to lower blood lipids, 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 age and 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

Talk to your doctor or nurse before starting to take atorvastatin:

• 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 into the brain, or have small fluid-filled sacs in the brain due to previous strokes.
• if you have kidney problems.
• if you have an underactive thyroid gland (hypothyroidism).
• if you have repeated or unexplained muscle pain, or 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 regularly drink large amounts of alcohol.
• if you have a history of liver problems.
• if you are over 70 years old.
• 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 disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

In any of these cases, your doctor may recommend blood tests before and possibly during treatment with atorvastatin 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 Kern Pharma 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 of developing diabetes. This risk increases if you have high levels of blood sugar and fats, are overweight, and have high blood pressure.

Taking atorvastatin 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, or their effects may be altered by atorvastatin. This type of interaction may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including 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 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, tipranavir combined with ritonavir, etc.
• Some medicines used for the treatment of hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• 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 stomach burning 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 with atorvastatin. 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 bloodstream infections caused by bacteria).

Taking atorvastatin with food, drinks, and alcohol

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

Grapefruit juice

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

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 atorvastatin if you are pregnant, think you may be pregnant, or are trying to become pregnant.

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

Do not take atorvastatin if you are breastfeeding your baby.

The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

Atorvastatin Kern Pharma contains lactose and sodium.

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

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

3. How to take Atorvastatin Kern Pharma

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

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.

Atorvastatin 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.

Follow exactly the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with atorvastatin

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

If you take more atorvastatin 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 medication and the amount taken. Bring any remaining tablets, the outer carton, and the full pack so that hospital staff can easily identify the medication you have taken.

If you forget to take atorvastatin

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 atorvastatin

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 straight away.

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, particularly if accompanied by malaise or high fever, 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 atorvastatin:

Frequent: may affect up to 1 in 10 people

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (if you are diabetic, monitor your blood sugar levels), increased blood creatine kinase
• Headache
• Nausea, constipation, gas, 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, decreased blood glucose levels (if you are diabetic, continue to monitor your blood glucose levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in the 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 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: 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
• Gynecomastia (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 worsening weakness in the arms or legs 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. This is more likely if you have high levels of sugar 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 adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect 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 Kern Pharma

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatina Kern Pharma

• The active substance is atorvastatin calcium trihydrate.

Each film-coated tablet contains 10 mg of atorvastatin (as 10.83 mg atorvastatin calcium trihydrate).

Each film-coated tablet contains 20 mg of atorvastatin (as 21.66 mg atorvastatin calcium trihydrate).

Each film-coated tablet contains 30 mg of atorvastatin (as 32.49 mg atorvastatin calcium trihydrate).

Each film-coated tablet contains 40 mg of atorvastatin (as 43.32 mg atorvastatin calcium trihydrate).

Each film-coated tablet contains 60 mg of atorvastatin (as 64.98 mg atorvastatin calcium trihydrate).

Each film-coated tablet contains 80 mg of atorvastatin (as 86.64 mg atorvastatin calcium trihydrate).

• The other components (excipients) are:

Monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, microcrystalline cellulose PH 102, sodium croscarmellose, calcium carbonate, magnesium stearate. Coating material: lactose monohydrate, HPMC 2910/hypromellose, titanium dioxide (E171), and macrogol/PEG (E1521).

See section 2: Atorvastatina Kern Pharma contains lactose and sodium.

Appearance of Atorvastatina Kern Pharma and contents of the pack

The 10 mg tablets are white, round, biconvex, marked with a "T" on one side. Tablet dimensions: 5.6 ± 0.5 mm.

The 20 mg tablets are white, round, biconvex, marked with "VT20" on one side. Tablet dimensions: 7.3 ± 0.5 mm.

The 30 mg tablets are white, oval, biconvex, with a score line on one side. Tablet dimensions: 13.0 x 7.5 ± 0.5 mm.

The 40 mg tablets are white, round, biconvex, marked with "VT40" on one side. Tablet dimensions: 9.7 ± 0.5 mm.

The 60 mg tablets are white, round, biconvex. Tablet dimensions: 12.0 ± 0.5 mm.

The 80 mg tablets are white, oval, biconvex, marked with "VT80" on one side. Tablet dimensions: 20.1 x 8.8 ± 0.5 mm.

Presented in aluminum/aluminum blisters.

Contents:

This medicine is available as 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg film-coated tablets.

All strengths are available in boxes with blister packs containing 14, 28, 30, 56, and 90 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Galenicum Health, S.L.U

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

or

SAG Manufacturing, S.L.U.

Crta. N-I, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

France – Atorvastatina Galenicun Health 10/20/40/80 mg comprimé pelliculé

Italy – Atorvastatina Galenicun Health 10/20/40/80 mg filmtabletten

Portugal – Atorvastatina Pharmakern 10/20/30/40/60/80 mg comprimido revestido por película

Spain – Atorvastatina Kern Pharma 10/20/30/40/60/80 mg comprimidos recubiertos por película

Malta – Atorvastatina Galenicun Health 10/20/30/40/60/80 mg film-coated tablets

Date of the most recent review of this leaflet: May 2025.

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/