Torvacol

Package leaflet: Information for the user

TORVACOL 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

atorvastatin
Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TORVACOL is and what it is used for

TORVACOL belongs to a class of medicines called statins, which regulate lipid (fat) levels.
TORVACOL 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, TORVACOL 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 should know before taking TORVACOL

Do not take TORVACOL

• if you are allergic to atorvastatin or to similar medicines used to reduce lipid levels in the blood, or to any of the other ingredients of this medicine (listed in section 6)
• if you have or have had a liver disease
• if liver function tests have shown unexplained abnormal results
• if you are a woman of childbearing age and do not use a reliable method of contraception
• 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 taking TORVACOL.
The following are reasons why TORVACOL may not be suitable for you:

• if you suffer from severe respiratory failure
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and TORVACOL can cause serious muscle problems (rhabdomyolysis)
• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebrospinal fluid reserves due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have previously experienced unexplained or recurrent muscle pain, or have a personal or family history of muscle disorders
• if you have previously had 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 had myasthenia (a disease characterised by generalised muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as 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 TORVACOL 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 TORVACOL”).
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. You are at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Other medicines and TORVACOL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may alter the effect of TORVACOL, or their effect may be altered by TORVACOL. This type of interaction may make one or both medicines less effective. Conversely, it could also increase the risk or severity of adverse effects, including a condition of muscle breakdown known as rhabdomyolysis described in section 4:

• Medicines used to alter immune system activity, e.g. cyclosporine.
• Certain antibiotics and antifungal medicines, 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, ledipasvir/sofosbuvir.
• Other medicines known to interact with TORVACOL, including ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset or peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium and 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 resume TORVACOL. Taking TORVACOL with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections).

TORVACOL with food and drink
See section 3 for instructions on how to take TORVACOL. Please note the following:
Grapefruit juice
Do not drink more than one or two small glasses per day of grapefruit juice, as large quantities of grapefruit juice may alter the effects of TORVACOL.
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 TORVACOL if you are pregnant or trying to become pregnant.
Do not take TORVACOL if you think you could become pregnant unless you are using an effective method of contraception.
Do not take TORVACOL if you are breastfeeding.
The safety of TORVACOL during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine usually does not affect the ability to drive or use 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.

TORVACOL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take TORVACOL

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must follow throughout your therapy with TORVACOL.
The recommended initial dose of TORVACOL is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 or more weeks.
The maximum dose of TORVACOL is 80 mg once daily for adults and 20 mg once daily for children.
TORVACOL tablets should 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.
The duration of treatment with TORVACOL is determined by your doctor.
If you feel that the effect of TORVACOL is too strong or too weak, consult your doctor.
If you take more TORVACOL than you should
If you accidentally take too many TORVACOL tablets (more than your usual dose), contact your doctor or the nearest hospital for advice.
If you forget to take TORVACOL
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 missed dose.
If you stop treatment with TORVACOL
If you have any doubts 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 will experience them.
If you notice any of the following serious side effects or symptoms listed below,
stop taking the tablets immediately and contact your doctor or go to the nearest hospital emergency department.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause significant breathing difficulties.
• A serious condition associated with severe peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with red spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters.
• Muscle weakness, tenderness, pain or tearing, or red-brown discoloration of urine, especially if accompanied by feeling unwell and high fever; this may be due to unusual muscle breakdown (rhabdomyolysis). Abnormal muscle deterioration does not always resolve even after stopping atorvastatin; it can be life-threatening and may lead to kidney problems.

Very rare side effects (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 problems, and effects on blood cells).

Other side effects that may occur with TORVACOL

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

• Inflammation of the nasal passages, 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
• Abnormal liver function tests.

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

• 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 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)
• Rash, skin rash 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 leukocytes (white blood cells).

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

• Vision disorders
• Unexpected bleeding or bruising
• Jaundice (yellowing of the skin and whites of the eyes)
• Tendon damage
• Skin rash 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)

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

Side effects with unknown frequency (frequency cannot be estimated from the available data)

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

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

• Sexual difficulties
• 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. HOW TO STORE TORVACOL

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month.
This medicine requires no 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. PACKAGING CONTENTS AND OTHER INFORMATION

What TORVACOL contains

• The active substance is atorvastatin as atorvastatin calcium. Each film-coated tablet of 10 mg, 20 mg or 40 mg contains 10 mg, 20 mg or 40 mg of atorvastatin, respectively.
• The other components are: Tablet core: mannitol, microcrystalline cellulose, crospovidone, anhydrous sodium carbonate, povidone, methionine, magnesium stearate. Tablet coating: hypromellose 6 cP, titanium dioxide (E171), macrogol 6000, talc.

Description of the appearance of TORVACOL and packaging contents
Film-coated tablets
10 mg: White, oval, biconvex film-coated tablets, 4.9 x 9.1 mm in size, printed with “10” on one side and “A” on the other.
20 mg: White, oval, biconvex film-coated tablets, 6.2 x 11.5 mm in size, printed with “20” on one side and “A” on the other.
40 mg: White, oval, biconvex film-coated tablets, 7.8 x 14.5 mm in size, printed with “40” on one side and “A” on the other.
Packaging: blisters:
TORVACOL 10 mg film-coated tablets: 10, 30, 60, 90 tablets.
TORVACOL 20 mg film-coated tablets: 10, 30, 60, 90 tablets.
TORVACOL 40 mg film-coated tablets: 10, 30, 60, 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
EBERLIFE FARMACEUTICI S.p.A.
Via G. Porzio snc
80143 Napoli
Italy
Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: TORVACOL

This summary of product characteristics was last updated in 04/2026