Atorvastatin Tecnigen

PATIENT LEAFLET: INFORMATION FOR THE USER

ATORVASTATIN TECNIGEN 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before using this medicine.

• 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. Never give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What ATORVASTATIN TECNIGEN is and what it is used for.
2. Before you take ATORVASTATIN TECNIGEN.
3. How to take ATORVASTATIN TECNIGEN.
4. Possible side effects.
5. How to store ATORVASTATIN TECNIGEN.
6. Further information.

1. WHAT ATORVASTATIN TECNIGEN IS AND WHAT IT IS USED FOR

ATORVASTATIN TECNIGEN belongs to a group of medicines called statins, which are lipid-regulating (fat) drugs.
ATORVASTATIN TECNIGEN is used to reduce lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes without other measures have failed. If you are at increased risk of heart disease, ATORVASTATIN TECNIGEN may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard cholesterol-lowering diet must be continued.

2. BEFORE TAKING ATORVASTATIN TECNIGEN

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, if you are overweight, or if you have high blood pressure.

DO NOT USE ATORVASTATIN TECNIGEN

• If you are allergic (hypersensitive) to atorvastatin or to similar medicines used to reduce blood fats, or to any of the excipients of this medicine – see section 6 for details.
• If you suffer or have suffered from any liver disease.
• If you have had unexplained abnormal blood test results indicating liver function problems.
• If you are a woman of childbearing age who is not using adequate 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.

TAKE SPECIAL CARE WITH ATORVASTATIN TECNIGEN
ATORVASTATIN TECNIGEN may not be suitable for you for the following reasons:

• if you have previously had a stroke with bleeding in the brain or have small fluid-filled pockets in the brain following previous strokes;
• if you have kidney problems;
• if your thyroid gland is underactive (hypothyroidism);
• if you suffer from recurrent or unexplained muscle pain, or if you or a family member have had muscle disorders;
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g. other medicines known as “statins” or “fibrates”);
• if you have severe respiratory insufficiency;
• if you regularly consume large amounts of alcohol;
• if you have a history of liver disease;
• if you are over 70 years old.

Check with your doctor or pharmacist before taking ATORVASTATIN TECNIGEN

• If you have or have had myasthenia gravis (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), as statins may sometimes worsen myasthenia or trigger its onset (see section 4).
• If you have severe respiratory insufficiency.
• 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 ATORVASTATIN TECNIGEN may lead to serious muscle problems (rhabdomyolysis). If any of the above apply to you, your doctor may need to perform blood tests before and possibly during your treatment with ATORVASTATIN TECNIGEN to assess the risk of muscle-related side effects. The risk of muscle-related adverse effects, such as rhabdomyolysis, is known to increase when certain medicines are taken concomitantly (see section 2 “Taking ATORVASTATIN TECNIGEN with other medicines”). In addition, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and treatments may be required to diagnose and manage this condition.

Taking ATORVASTATIN TECNIGEN with other medicines
Some medicines may alter the effect of ATORVASTATIN TECNIGEN, or their effect may be altered by ATORVASTATIN TECNIGEN. Such interactions may make one or both medicines less effective. Conversely, this may also increase the risk or severity of adverse effects, including a serious condition involving muscle breakdown known as rhabdomyolysis, described in section 4.

• Medicines used to modify the activity of the immune system, e.g. cyclosporine.

• Certain antibiotics and antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, 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 used to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone.

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

• Other medicines known to interact with ATORVASTATIN TECNIGEN, including ezetimibe (cholesterol-lowering), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), and antacids (indigestion remedies 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 resume ATORVASTATIN TECNIGEN. Taking ATORVASTATIN TECNIGEN with fusidic acid may rarely cause fatigue, weakness, or muscle pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

• Certain medicines used to treat liver problems such as hepatitis C, e.g. telaprevir, boceprevir, and the elbasvir/grazoprevir combination.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those without a prescription.
Taking ATORVASTATIN TECNIGEN with food and drink
See section 3 for instructions on how to take ATORVASTATIN TECNIGEN.
Please note the following:
Grapefruit juice
Do 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 TECNIGEN.
Alcohol
Avoid drinking alcohol while taking this medicine. See section 2 Take special care with ATORVASTATIN TECNIGEN for further information.
Pregnancy and breastfeeding
Do not take ATORVASTATIN TECNIGEN if you are pregnant or planning to become pregnant.
Do not take ATORVASTATIN TECNIGEN if you are a woman of childbearing potential and are not using reliable contraception.
Do not take ATORVASTATIN TECNIGEN if you are breastfeeding.
The safety of ATORVASTATIN TECNIGEN during pregnancy and breastfeeding has not been established.
Consult your doctor or pharmacist before taking any medicine during pregnancy.
Driving and using machines
This medicine normally does not affect the ability to drive or operate machinery.
However, do not drive if this medicine affects your ability to do so. Do not use tools or machinery if your ability to operate them is impaired by this medicine.
Important information about some excipients in ATORVASTATIN TECNIGEN
This medicine contains lactose: if you know you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE ATORVASTATIN TECNIGEN

Before starting treatment, your doctor will advise you to follow a cholesterol-lowering diet. You must continue this diet during treatment with ATORVASTATIN TECNIGEN.
The usual dose of ATORVASTATIN TECNIGEN is 10 mg once daily in adults and children over 10 years of age. This dose may be increased by your doctor if necessary until the required amount is reached. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of ATORVASTATIN TECNIGEN is 80 mg once daily for adults and 20 mg once daily for children.
ATOVASTATIN TECNIGEN tablets should be swallowed whole with a glass of water and may be taken at any time of day, with or without food. However, try to take the tablet at the same time every day.
Always take ATORVASTATIN TECNIGEN exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATIN TECNIGEN will be determined by your doctor.
If you think the effect of ATORVASTATIN TECNIGEN is too strong or too weak, speak to your doctor.
If you take more ATORVASTATIN TECNIGEN than you should
If you accidentally take too many ATORVASTATIN TECNIGEN tablets (more than the usual daily dose), contact your doctor or the nearest emergency department immediately.
If you forget to take ATORVASTATIN TECNIGEN
If you miss a dose, take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.
If you stop taking ATORVASTATIN TECNIGEN
If you have any questions about using this medicine or if you wish to discontinue treatment, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ATORVASTATIN TECNIGEN can cause adverse reactions, although not everyone experiences them.
If you experience any of the following serious adverse reactions, stop taking the tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay.
Rare: affects 1 to 10 users in 10,000:

• severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties;
• severe illness with extensive skin peeling and swelling, blisters on the skin, mouth, eyes, genitals, and fever;
• skin rash with reddish spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters;
• muscle weakness, tenderness or pain, muscle breakdown, or red-brown discoloration of urine, especially if you also feel unwell or have a fever; this may be due to abnormal muscle breakdown, which can be life-threatening and may lead to kidney problems.

Very rare: affects fewer than 1 user in 10,000:

• if you experience unusual or unexpected bleeding or bruising, this may indicate a liver disorder. You should consult your doctor as soon as possible.

Other possible adverse reactions with ATORVASTATIN TECNIGEN

Common adverse reactions (affecting 1 to 10 users in 100) include:

• 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 blood;
• headache;
• nausea, constipation, flatulence, indigestion, diarrhea;
• joint and muscle pain, back pain;
• abnormal liver function test results in blood tests.

Uncommon adverse reactions (affecting 1 to 10 users in 1,000) 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, numbness or tingling in fingers and toes, reduced sensation to pain or touch, altered sense of taste, memory loss;
• blurred vision;
• ringing in the ears and/or head;
• vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain);
• hepatitis (inflammation of the liver);
• rash, skin eruptions and itching, urticaria, hair loss;
• neck pain, muscle fatigue;
• fatigue, feeling unwell, weakness, chest pain, swelling especially of the ankles (edema), increased body temperature;
• positive urine tests for white blood cells.

Rare adverse reactions (affecting 1 to 10 users in 10,000) include:

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

Very rare adverse reactions (affecting fewer than 1 user in 10,000) include:

• 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, difficulty breathing, collapse;
• hearing loss;
• gynecomastia (breast enlargement in men and women);
• lupus-like syndrome (symptoms may include rash, joint disorders, and effects on blood cells).

Adverse reactions of unknown frequency:

• 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 adverse reactions 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
The risk is higher 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 adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ATORVASTATIN TECNIGEN

Do not use ATORVASTATIN TECNIGEN after the expiry date (Exp.) stated on the blister pack or
the carton. The expiry date refers to the last day of the month.
This medicine should be stored at a temperature not exceeding 30°C.
Keep ATORVASTATIN TECNIGEN out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What ATORVASTATIN TECNIGEN 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 excipients are: Tablet core: monohydrate lactose, microcrystalline cellulose, polysorbate 80, hydroxypropylcellulose, sodium croscarmellose, butylhydroxyanisole, trisodium phosphate, magnesium stearate. Film coating: hypromellose, titanium dioxide, glyceryl triacetate.

Description of the appearance of ATORVASTATIN TECNIGEN and pack contents
Film-coated tablets in blister packs.
10 mg tablets: White, round, biconvex tablets, 6 mm in diameter, in packs of 10 or
30 tablets.
20 mg tablets: White, round, biconvex tablets, 8 mm in diameter, in packs of 10 or
30 tablets.
40 mg tablets: White, round, biconvex tablets, 11 mm in diameter, in packs of 30
tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Tecnigen S.r.l., Via Galileo Galilei 40, 20092 Cinisello Balsamo (MI), Italy.

Manufacturer
Atlantic Pharma – Produções Farmacêuticas S.A.
Rua da Tapada Grande, nº 2, Abrunheira, 2710 – 089 Sintra, Portugal.

This Patient Information Leaflet was last approved on.