Torastin

PACKAGE LEAFLET: INFORMATION FOR THE USER

TORASTIN 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

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, pharmacist, or nurse.
• 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What TORASTIN is and what it is used for

TORASTIN belongs to a class of medicines called statins, which regulate lipid (fat) levels.
TORASTIN is used to lower 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, atorvastatin may also be used to reduce this risk, even if cholesterol
levels are normal. During treatment, you must continue a standard cholesterol-lowering diet.

2. What you need to know before taking TORASTIN

Do not take TORASTIN

• if you are allergic to atorvastatin or to any of the excipients of this medicine (listed in section 6).
• if you have or have 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 TORASTIN:

• if you suffer from severe respiratory failure
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) by mouth or injection. The combination of fusidic acid and TORASTIN can cause serious muscle problems (rhabdomyolysis)
• if you have previously had a stroke with cerebral haemorrhage or have residual fluid in the brain from previous strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have previously experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders
• if you have previously had muscle problems while being treated 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 any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with TORASTIN to assess the risk of muscle-related side 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 TORASTIN”).
Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be necessary to diagnose and manage this condition.
While being treated with this medicine, your doctor will closely 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 your blood, if you are overweight, or if you have high blood pressure.

Other medicines and TORASTIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can alter the effect of TORASTIN or TORASTIN can alter the effect of these medicines. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, they may increase the risk or severity of side effects, including a condition involving 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 antagonists used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate your heart rhythm, e.g. digoxin, verapamil, amiodarone
• Medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir
• Other medicines known to interact with TORASTIN, including ezetimibe (which reduces cholesterol), warfarin (reduces blood clot formation), 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

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 TORASTIN. Taking TORASTIN with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

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

Driving and using machines
This medicine normally does not affect your 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.

TORASTIN contains lactose
If your doctor has told you that you are intolerant to certain sugars, consult your doctor before taking this medicine.

3. How to take TORASTIN

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must follow throughout your therapy with TORASTIN.
The recommended starting dose of TORASTIN is 10 mg once daily for adults and children aged 10 years and older. If necessary, your doctor may increase this dose to the level you require. Your doctor will adjust the dosage at intervals of 4 or more weeks. The maximum dose of TORASTIN is 80 mg once daily.
TORASTIN 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 score line on TORASTIN 20 mg and 80 mg tablets is intended to facilitate splitting if you have difficulty swallowing the tablet whole.
The duration of treatment with TORASTIN will be determined by your doctor. If you feel that the effect of TORASTIN is too strong or too weak, consult your doctor.
If you take more TORASTIN than you should:
If you accidentally take too many TORASTIN tablets (more than your usual dose), contact your doctor or the nearest hospital for advice.
If you forget to take TORASTIN:
If you forget to take a dose, take the next dose at the regular time.
Do not take a double dose to make up for the missed tablet.
If you stop taking TORASTIN:
If you have any doubts about using this medicine or wish to discontinue 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 serious side effects or symptoms listed below,
stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department.

Rare (may affect up to 1 in 1,000 patients)

• severe allergic reaction with swelling of the face, tongue, and throat, which may cause significant breathing difficulties;
• severe skin condition with peeling and swelling of the skin, blistering of the skin, mouth, eyes, genitals, and fever. Pink-red rash, particularly on the palms of the hands or soles of the feet, which may lead to blistering;
• muscle weakness, tenderness, pain, or tearing, especially if accompanied by feeling unwell or having a high fever, which may be due to abnormal muscle damage (rhabdomyolysis). Abnormal muscle damage does not always resolve even after stopping atorvastatin, and may be potentially fatal and lead to kidney problems.

Very rare (may affect up to 1 in 10,000 patients)

• Unexpected or unusual bleeding or bruising, which may indicate a liver disorder. You should consult your doctor as soon as possible.
• Lupus-like disease syndrome (including skin rash, joint disorders, and effects on blood cells).

Other possible side effects with TORASTIN:
Common (may affect up to 1 in 10 patients)

• 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 blood levels of creatine kinase
• headache
• nausea, constipation, flatulence, indigestion, diarrhoea
• joint pain, muscle pain, back pain
• laboratory test results indicating possible future liver function abnormalities

Uncommon (may affect up to 1 in 100 patients)

• 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, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, taste disturbances, 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, rash with itching, urticaria, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially in the ankles (oedema), increased body temperature
• presence of white blood cells in the urine

Rare (may affect up to 1 in 1,000 patients)

• visual disturbances
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon injuries

Very rare (may affect up to 1 in 10,000 patients)

• an allergic reaction – symptoms may include sudden shortness of breath and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, breathing difficulties, collapse
• loss of hearing
• gynaecomastia (enlargement of the breasts in men)

Not known (frequency cannot be estimated from the available data)

• persistent muscle weakness. Possible side effects reported with some statins (medicines of the same type):
• sexual dysfunction
• depression
• respiratory problems including persistent cough and/or shortness of breath or fever
• diabetes: more likely if you have high levels of sugar and fats in the 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TORASTIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) stated on the container and outer packaging. The expiry date refers to the last day of the month.
Store below 30°C.
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 TORASTIN contains

• The active substance is atorvastatin.
  o Each film-coated tablet contains 10 mg of atorvastatin (as calcium).
  o Each film-coated tablet contains 20 mg of atorvastatin (as calcium).
  o Each film-coated tablet contains 40 mg of atorvastatin (as calcium).
  o Each film-coated tablet contains 80 mg of atorvastatin (as calcium).
• The other excipients are:
  o Tablet core: activated attapulgite, monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, hydroxypropylcellulose, magnesium stearate, and anhydrous colloidal silica.
  o Coating: titanium dioxide (E171), monohydrate lactose, macrogol / PEG 4000, hypromellose.

Description of the appearance of TORASTIN and package contents
Film-coated tablets 10 mg:
White, oval, biconvex tablets with dimensions 10.1±0.1 mm x 5.6±0.1 mm and 3.7±0.2 mm thick.
Film-coated tablets 20 mg:
White, oval, biconvex tablets with a score line on one side and dimensions 12.7±0.1 mm x 6.7±0.1 mm and 4.6±0.2 mm thick.
Film-coated tablets 40 mg:
White, oblong, biconvex tablets with dimensions 19.4±0.1 mm x 7.8±0.1 mm and 4.7±0.2 mm thick.
Film-coated tablets 80 mg:
White, oblong, biconvex tablets with a score line on one side and dimensions 22.8±0.1 mm x 10.9±0.1 mm and 5.7±0.2 mm thick.
TORASTIN is available in PA/ALL/PVC blister packs with an aluminum foil lid.
Pack sizes:
10, 14, 28, 30, 50, 60, 84, 90, 96, 98, 100, 500 (hospital pack) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
I.B.N. Savio Srl
Via del Mare, 36 Pomezia (RM) 00071 Italy

Manufacturer
PHARMATHEN S.A., Dervenakion 6, Pallini 15351, Attiki, Greece
or
PHARMATHEN INTERNATIONAL S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Atorvastatin Pharmathen
Netherlands: Atorvastatine Pharmathen
Spain: Atorvastatina Edigen 10 mg, 20 mg, 40 mg, 80 mg Comprimido recubierto con película
Italy: TORASTIN 10 mg, 20 mg, 40 mg, 80 mg Compresse rivestite con film