Patient Information Leaflet

Thervan 10 mg Film-Coated Tablets

Thervan 20 mg Film-Coated Tablets

Thervan 30 mg Film-Coated Tablets

Thervan 40 mg Film-Coated Tablets

Thervan 60 mg Film-Coated Tablets

Thervan 80 mg Film-Coated Tablets

Atorvastatin Calcium

Read this leaflet carefully before you start to take 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Atorvastatin belongs to a group of medications known as statins, which are medications that regulate lipids (fats).

Atorvastatin is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have failed. If you present a high risk of heart disease, atorvastatin may also be used to reduce this risk even though your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Thervan

• if you are allergic to atorvastatin or any of the other ingredients in this medication (listed in section 6).
• if you have or have had any liver disease.
• if you have or have had abnormal results in liver function blood tests.
• if you are a fertile woman and do not use 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 hepatitis C treatment.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have severe respiratory insufficiency.
• if you are taking or have taken within the last 7 days a medication containing fusidic acid (a medication used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis).
• if you have had a previous stroke with cerebral bleeding, or have small fluid embolisms in the brain due to previous strokes.
• if you have kidney problems.
• if you have a thyroid gland with low activity (hypothyroidism).
• if you have or have had repeated or unjustified muscle pain, personal or family history of muscle problems.
• if you have had muscle problems during previous treatment with other lipid-lowering medications (e.g., 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 that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with atorvastatin to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (e.g., rhabdomyolysis) increases when certain medications are taken at the same time (see section 2 “Other medications and Thervan”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While taking this medication, your doctor will monitor if you have diabetes or a risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, overweight, and high blood pressure.

Other medications and Thervan

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. There are some medications that may affect the proper functioning of atorvastatin or the effects of these medications may be modified by atorvastatin. This type of interaction may reduce the effect of one or both medications. Alternatively, it may increase the risk or severity of adverse effects, including a serious condition that causes muscle deterioration known as rhabdomyolysis, described in section 4:

• Medications used to modify the functioning of your immune system, for example, cyclosporine.
• Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine.
• Some calcium channel blockers used in the treatment of angina or hypertension, for example, amlodipine, diltiazem; medications to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Letermovir, a medication that helps prevent diseases caused by cytomegalovirus.
• Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir
• Other medications that are known to interact with atorvastatin include: ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used for treating gout) and antacids (products for indigestion containing aluminum or magnesium).
• Over-the-counter medications: 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 medication. Your doctor will instruct you when it is safe to restart treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and soft tissue infections and bacteria present in the blood).

Thervan with food, drinks, and alcohol

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

Orange juice

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

Alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are trying to become pregnant, consult your doctor or pharmacist before using this medication.

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 your child.

Do not take atorvastatin if you are fertile unless you take adequate contraceptive measures.

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

Driving and operating machinery

Normally, this medication does not affect your ability to drive or operate machinery. However, do not drive if this medication affects your ability to drive. Do not operate tools or machinery if this medication affects your ability to operate them.

Thervan contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you must also follow during atorvastatin treatment.

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

Atorvastatin tablets 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 Thervan

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

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the remaining tablets, the packaging, and the complete box so that the hospital staff can easily identify the medication you have taken.

If you forget to take Thervan

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Thervan

Consult your doctor or pharmacist again.

If you have any other questions about the use of this medication or want to discontinue treatment, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following side effects or severe symptoms, stop taking these tablets and inform your doctor immediately or go to the nearest hospital emergency service.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat that may cause severe difficulty breathing.
• Severe disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet that may form blisters.
• Muscle weakness, pain on palpation, pain, urine discoloration, or brownish-red color, and especially if you have discomfort or high fever, it may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown may not always disappear, 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 unexpected or unusual bleeding or bruising, this may suggest liver problems. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects with atorvastatin:

Common: may affect up to 1 in 10 people

• nasal congestion, sore throat, nosebleeds
• Allergic reactions
• Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in the blood
• Headache
• Nausea, constipation, gas, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Abnormal blood test results that may show abnormal liver function.

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, 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
• Tinnitus in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain)
• Heptatitis (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: may affect up to 1 in 1,000 people

• Visual disturbances
• Unexpected or unusual bleeding or bruising
• Bile duct obstruction (yellowing of the skin and white of the eyes)
• Tendon damage.
• Skin rash or ulcers in the mouth (drug reaction)
• Lesions on the skin or ulcers in the mouth (signs of inflammation of blood vessels, vasculitis)

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

• Allergic reaction - symptoms may include sudden hissing while breathing and chest pain or pressure, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Loss of hearing
• Gynecomastia (breast enlargement in men).

Frequency not known: cannot be estimated from available data:

• Constant muscle weakness
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)
• Myasthenia gravis (a disease that causes 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, eyelid drooping, 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. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Thervan

• The active ingredient is atorvastatina.

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

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

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

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

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

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

• The other components (excipients) are: calcium carbonate (E170i), lactose monohydrate, microcrystalline cellulose (E460i), hydroxypropylcellulose (E463), polisorbate 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 product and contents of the package

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

Thervan 20 mg: Film-coated tablets, white, round, biconvex, scored on one face. The score should not be used to break the tablet.

Thervan 30 mg: Film-coated tablets, white, round, biconvex, marked with “30” on one face.

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

Thervan 60 mg: Film-coated tablets, white, round, biconvex, scored on one face and marked with “60” on the other. The score should not be used to break the tablet.

Thervan 80 mg: Film-coated tablets, white, round, biconvex, scored on one face and marked with “80” on the other. The score should not be used to break the tablet.

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

Blister packs containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: October 2024

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