Atorvastatin Laboratori Alter

Package leaflet: Information for the user

ATORVASTATIN LABORATORI ALTER 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Atorvastatin
Equivalent medicine
Please 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What ATORVASTATINA LABORATORI ALTER is and what it is used for

ATORVASTATINA LABORATORI ALTER belongs to a class of medicines called statins, which
regulate lipid (fat) levels.
ATORVASTATINA LABORATORI ALTER is used to reduce lipid levels in the blood, known as
cholesterol and triglycerides, when a low-fat diet and lifestyle changes have not been effective.
If you are at high risk of cardiovascular disease, ATORVASTATINA LABORATORI ALTER
may also be used to reduce this risk, even if cholesterol levels are normal. During treatment,
you must continue to follow a standard cholesterol-lowering diet.

2. What you need to know before taking ATORVASTATIN LABORATORI ALTER

Do not take ATORVASTATIN LABORATORI ALTER

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6)
• if you have or have previously had liver disease
• if liver function tests have shown unexplained abnormal results
• if you are a woman of childbearing age and are not using a reliable method of contraception
• if you are pregnant or planning 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, pharmacist, or nurse before taking ATORVASTATIN LABORATORI ALTER:

• if you suffer from severe respiratory insufficiency
• if you are taking or have taken within the last 7 days oral or injectable fusidic acid (a medicine for bacterial infections). The combination of fusidic acid and ATORVASTATIN LABORATORI ALTER may lead to serious muscle problems (rhabdomyolysis)
• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebral fluid reserves due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• if you regularly consume large amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years old
• if you have or have previously had myasthenia (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen myasthenia or trigger its onset (see section 4).

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with ATORVASTATIN LABORATORI ALTER 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 ATORVASTATIN LABORATORI ALTER”).
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and treatments may be required to diagnose and manage this condition.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high levels of sugar and fats in the blood, being overweight, and having high blood pressure.

Other medicines and ATORVASTATIN LABORATORI ALTER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may alter the effect of ATORVASTATIN LABORATORI ALTER, or the effect of these medicines may be altered by ATORVASTATIN LABORATORI ALTER. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, they may increase the risk or severity of adverse effects, including a condition of muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to modify the way the immune system works, e.g. cyclosporine

• Certain antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid

• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol

• Certain calcium channel blockers used for 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 diseases caused by cytomegalovirus

• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.

• Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir

• Other medicines known to interact with ATORVASTATIN LABORATORI ALTER include ezetimibe (a cholesterol-lowering agent), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (dyspepsia products containing aluminium or magnesium)

• Over-the-counter medicines: St. John’s wort (Hypericum perforatum)

• 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 resume taking ATORVASTATIN LABORATORI ALTER. Taking ATORVASTATIN LABORATORI ALTER with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

• Daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteraemia).

ATORVASTATIN LABORATORI ALTER with food and drink
Refer to section 3 for instructions on how to take ATORVASTATIN LABORATORI ALTER. Please keep the following in mind:
Grapefruit juice
You should 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 LABORATORI ALTER.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, refer to section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take ATORVASTATIN LABORATORI ALTER if you are pregnant or planning to become pregnant.
Do not take ATORVASTATIN LABORATORI ALTER if you are of childbearing age unless you are using an effective method of contraception.
Do not take ATORVASTATIN LABORATORI ALTER if you are breastfeeding.
The safety of ATORVASTATIN LABORATORI ALTER during pregnancy and breastfeeding has not yet been established. Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
This medicine usually does not affect the ability to drive or operate machinery. However, do not drive if this medicine impairs your ability to do so. Do not use tools or machinery if your ability to operate them is impaired by this medicine.

ATORVASTATIN LABORATORI ALTER contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take ATORVASTATINA LABORATORI ALTER

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must continue this diet during treatment with ATORVASTATINA LABORATORI ALTER.
The usual starting dose of ATORVASTATINA LABORATORI ALTER is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose gradually until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 or more weeks. The maximum dose of ATORVASTATINA LABORATORI ALTER is 80 mg once daily.
ATORVASTATINA LABORATORI ALTER tablets must be swallowed whole with water and may be taken at any time of day, with or without food. However, try to take the tablets at the same time each day.
Always take this medicine exactly as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATINA LABORATORI ALTER is determined by your doctor.
If you feel that the effect of ATORVASTATINA LABORATORI ALTER is too strong or too weak, consult your doctor.
If you take more ATORVASTATINA LABORATORI ALTER than you should
If you accidentally take too many ATORVASTATINA LABORATORI ALTER tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATINA LABORATORI ALTER
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for the forgotten tablet.
If you stop taking ATORVASTATINA LABORATORI ALTER
If you have any questions about using this medicine, or if you wish to stop treatment, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects or symptoms, stop taking your tablets immediately and contact your doctor right away or go to the nearest hospital emergency department.

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

• Severe allergic reaction causing swelling of the face, tongue, and windpipe, which may lead to significant breathing difficulties;
• A serious condition associated with severe peeling and swelling of the skin, skin blisters, mouth sores, eye inflammation, genital lesions, and fever. Skin rash with red spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters;
• If you experience muscle weakness, tenderness, pain, or red-brown discoloration of the urine—especially if you also feel unwell and have a high fever—this may be due to abnormal breakdown of muscle tissue (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin; it can be life-threatening and may lead to kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may indicate a liver disorder. You should contact your doctor as soon as possible.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Other side effects that may occur with ATORVASTATINA LABORATORI ALTER

Common side effects (may affect up to 1 in 10 people) include:

• Inflammation of the nasal airways, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels closely), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Changes in liver function laboratory tests

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

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels closely)
• Nightmares, insomnia
• Dizziness, reduced sensation or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain)
• Hepatitis (inflammation of the liver)
• Skin rash, skin eruption and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling, especially in the ankles (oedema), increased body temperature
• Positive urine test for white blood cells

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

• Vision disorders
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon damage
• Skin rash that may appear on the skin or mouth ulcers (drug-induced lichenoid reaction)
• Purple skin lesions (signs of blood vessel inflammation, vasculitis)

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

• Allergic reaction – symptoms may include sudden wheezing, chest pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of the breast in men)

Not known: frequency cannot be determined from available data:

• Persistent muscle weakness
• Myasthenia gravis (a condition causing generalized muscle weakness, including in some cases the muscles used for breathing)
• Ocular myasthenia (a condition causing weakness of the eye muscles)

Contact your doctor if you experience worsening weakness in your arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.

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

• Sexual dysfunction
• Depression
• Breathing difficulties, including persistent cough and/or shortness of breath or fever
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following address:
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ATORVASTATIN ALTER LABORATORIES

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or outer packaging after {Exp.}. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ATORVASTATINA LABORATORI ALTER contains

• The active substance is atorvastatin.

Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin-calcium trihydrate).
Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin-calcium trihydrate).
Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin-calcium trihydrate).
Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin-calcium trihydrate).

• Other components are:
  Tablet core
  Calcium carbonate (E170)
  Lactose monohydrate
  Microcrystalline cellulose (E 460(i))
  Hydroxypropyl cellulose (E 463)
  Polysorbate 80 (E433)
  Sodium croscarmellose (E468)
  Magnesium stearate (E572)

Film coating
Partially hydrolysed polyvinyl alcohol
Macrogol
Titanium dioxide (E171)
Talc (E 553b)

Description of the appearance of ATORVASTATINA LABORATORI ALTER and contents of the pack
10 mg: round, biconvex, film-coated tablets, white to off-white in colour, without any marking, 6 mm in diameter.
20 mg: round, biconvex, film-coated tablets, white to off-white in colour, with a score line on one side and 8 mm in diameter.
40 mg: round, biconvex, film-coated tablets, white to off-white in colour, with a cross on one side and 11 mm in diameter.
80 mg: round, biconvex, film-coated tablets, white to off-white in colour, with a score line on one side and the imprint “80” on the other, 12 mm in diameter.

The film-coated tablets are packaged in blisters made of a base sheet of polyamide/aluminum/PVC and an aluminum foil lid, both heat-sealed.
or
alternatively, the film-coated tablets are packaged in blisters made of a transparent base sheet of PVC/PVDC/PVC and an aluminum foil lid, both heat-sealed.

Pack sizes: blisters containing 14, 28, 30, 56 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan
Italy

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

February 2026