Thervan 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Thervan 10 mg film-coated tablets EFG

Thervan 20 mg film-coated tablets EFG

Thervan 30 mg film-coated tablets

Thervan 40 mg film-coated tablets EFG

Thervan 60 mg film-coated tablets

Thervan 80 mg film-coated tablets EFG

Atorvastatin calcium

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Thervan 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 reduce 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 Thervan

Do not take Thervan

• if you are allergic to atorvastatin or 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 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

Talk to your doctor or pharmacist before starting 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 containing 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 pockets in the brain due to prior strokes.
• if you have kidney problems.
• if you have an underactive thyroid gland (hypothyroidism).
• if you have had or currently have unexplained or recurrent muscle pain, or personal or family history of muscle disorders.
• if you previously experienced muscle problems while being treated 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 “Other medicines and Thervan”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or 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 sugar and fats in the blood, are overweight, or have high blood pressure.

Other medicines and Thervan

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 how atorvastatin works, or the effects of these medicines may be altered by atorvastatin. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, they may increase the risk or severity of adverse effects, including a serious condition causing muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to modify the function of your immune system, e.g., cyclosporine.
• Certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other lipid-regulating medicines, e.g., gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem; medicines to regulate heart rhythm, e.g., digoxin, verapamil, amiodarone.
• Letermovir, a medicine that helps prevent cytomegalovirus infections.
• Medicines used in the treatment of AIDS, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines known to interact with atorvastatin include: ezetimibe (cholesterol-lowering), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), 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 must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart atorvastatin 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 bloodstream infections caused by bacteria).

Taking Thervan 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 of grapefruit juice 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

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

Do not take atorvastatin if you are breastfeeding.

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

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

Driving and using 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 machines if this medicine impairs your ability to handle them.

Thervan contains lactose and sodium

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

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

3. How to take Thervan

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

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

The usual recommended 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 appropriate for you. 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.

Your doctor will decide the duration of treatment with Thervan

If you think that the effect of atorvastatin is too strong or too weak, consult your doctor.

If you take more Thervan 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 ingested. Bring any remaining tablets, the outer carton, and the complete packaging so that hospital staff can easily identify the medicine you have taken.

If you forget to take Thervan

If you forget to take a dose, take the next dose at the scheduled time.

Do not take a double dose to make up for a missed dose.

If you stop taking Thervan

Consult your doctor or pharmacist again.

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 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, in the 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 tearing, 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 may 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:

Common: may affect up to 1 in 10 people

• Inflammation of the nasal passages, 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, gas, indigestion, diarrhoea
• 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 sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers or 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 (oedema), increased body temperature
• Urine tests positive for white blood cells.

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

• 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: 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 (breast enlargement 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. 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 or pharmacist, even if it is an 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 Thervan

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 and on the packaging after EXP. The expiry date is 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 any unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to 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 Thervan

• The active substance is atorvastatin.

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

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

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

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

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

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

• The other components (excipients) are: calcium carbonate (E170i), lactose monohydrate, microcrystalline cellulose (E460i), hydroxypropylcellulose (E463), polysorbate 80, sodium croscarmellose (E468) and magnesium stearate (E470b).

The coating contains: partially hydrolyzed poly(vinyl alcohol), titanium dioxide (E171), macrogol 4000 (E1521) and talc (E553b).

Appearance of the medicinal product and contents of the pack

Thervan 10 mg: Film-coated tablets, white, round, biconvex, smooth.

Thervan 20 mg: Film-coated tablets, white, round, biconvex, scored on one side. The score line is not intended to divide the tablet into equal doses.

Thervan 30 mg: Film-coated tablets, white, round, biconvex, marked with "30" on one side.

Thervan 40 mg: Film-coated tablets, white, round, biconvex, marked with a cross on one side.

Thervan 60 mg: Film-coated tablets, white, round, biconvex, scored on one side and marked with "60" on the other. The score line is not intended to divide the tablet into equal doses.

Thervan 80 mg: Film-coated tablets, white, round, biconvex, scored on one side and marked with "80" on the other. The score line is not intended to divide the tablet into equal doses.

Thervan is marketed in blister packs made of PA/Al/PVC-Aluminum or PVC/PVDC/PVC-Aluminum.

Blister packs containing 28 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of the most recent revision of this leaflet: October 2024

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