Prospecto: information for the user

Atorvastatina Vivanta 10 mg film-coated tablets EFG

Read the entire prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.

If you have any doubts, consult your doctor, pharmacist or nurse.

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

Content of the prospect

1. What is Atorvastatina Vivanta and for what it is used
2. What you need to know before starting to take Atorvastatina Vivanta
3. How to take Atorvastatina Vivanta
4. Possible adverse effects
5. Storage of Atorvastatina Vivanta
6. Contents of the package and additional information

This medication contains an active substance called atorvastatina which belongs to a group of medications known as statins, which are medications that regulate lipids (fats).

Atorvastatina 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, Atorvastatina can 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 atorvastatin:

• If you are allergic to atorvastatin or any of the other ingredients in this medicine

(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 using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

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

• If you have severe respiratory failure.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine 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 brain bleeding, or have small fluid collections 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 repeated or unjustified muscle pain, personal or family history of muscle problems.
• If you have had muscle problems during previous treatment with other medicines to reduce lipids (for example, with another statin or fibrates).
• 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 ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause 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 old.

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 (for example, rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Use of atorvastatin with other medicines”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

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

Other medicines and atorvastatin

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

• Medicines used to modify the functioning of your immune system, for example ciclosporin.
• 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, cholestyramine.
• Some calcium channel blockers used in the treatment of 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.
• Other medicines 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 (analgesic), colchicine (used for treating gout) and antacids (products for indigestion containing aluminum 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 stop taking this medicine temporarily. 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.

Taking atorvastatin with food, drinks and alcohol

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

Orange juice

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

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See the 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 intend to become pregnant.

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

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

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

Atorvastatin Vivanta contains lactose

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

Atorvastatin Vivanta contains sodium

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

Atorvastatin Vivanta contains soy

This medicine contains soy oil. It should not be used in case of allergy to peanuts or soy.

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

The usual initial dose of atorvastatina 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 atorvastatina is 80 mg once a day.

Atorvastatina Vivanta 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.

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

Your doctor will decide the duration of atorvastatina treatment.

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

If you take more atorvastatina than you should.

If you accidentally take too many atorvastatina 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 taken. 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 atorvastatina.

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 atorvastatina treatment.

If you have any other questions about using this medication or want to interrupt treatment, ask your doctor or pharmacist.

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

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

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can make breathing very difficult.
• 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 can 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 can 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 problems, and effects on blood cells).

Other possible side effects with atorvastatin:

Frequent: may affect up to 1 in 10 people

• Inflammation of the nasal passages, sore throat, nasal bleeding
• 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 results from blood tests that may show abnormal liver function

Not very frequent: may affect up to 1 in 100 people

• 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 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)
• Hepatitis (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 bleeding or bruising
• Bile duct obstruction (yellowing of the skin and eyes)
• Tendon damage

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:

• Muscle weakness that persists
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)
• Myasthenia ocular (a disease that causes weakness of the eye muscles)

See your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

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

Communication of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of 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.

This medication does not require special conditions for conservation.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist howto dispose of the packaging and the medications that you no longer need. This will help protect the environment.

Composition of Atorvastatina Vivanta

• The active ingredient is atorvastatina.

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

• The other components (excipients) are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, sepitrap 80 (polysorbate 80 (E443) and magnesium aluminometasilicate), calcium carbonate (E170), hydroxypropylcellulose (E463), magnesium stearate (E572).

Film coating: (Opadry II White 85G68918): partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), macrogol 3350 (E1521), soy lecithin (E322).

Appearance of the product and contents of the packaging

The film-coated tablets of Atorvastatina Vivanta 10 mg are white, oval-shaped (approximately 9 mm x 5 mm x 3 mm), biconvex, with a “MA” mark on one face and “1” on the other.

OPA//PVC//Al blisters:

28, 30, 50, 90, and 100 film-coated tablets.

It may only be marketed in some sizes of packaging.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Vivanta Generics S.R.O.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Responsible for manufacturing

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park, Paola, PLA3000,

Malta

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Local Representative:

Laboratorios Rodio, S.L

C/ Marqués de Urquijo, 11, 1ºB

28008 Madrid

Spain

Last reviewed date of this leaflet:September 2023

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