Nelediaden

Patient Information Leaflet

Nelediaden 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets, 40 mg film-coated tablets, 60 mg film-coated tablets, 80 mg film-coated tablets

atorvastatin
Generic medicine
Please read this leaflet carefully before using this medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• 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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Nelediaden is and what it is used for
2. What you need to know before taking Nelediaden
3. How to take Nelediaden
4. Possible side effects
5. How to store Nelediaden
6. Package contents and other information

1. What Nelediaden is and what it is used for

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

2. What you need to know before taking Nelediaden

Do not take Nelediaden

• if you are allergic to atorvastatin or to any of the other ingredients of this medicine (listed in section 6)
• if you have or have ever had liver disease
• if you have had unexplained abnormal results in liver function tests
• 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 using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nelediaden

• 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 Nelediaden can cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with cerebral haemorrhage or if you have small pockets of fluid in the brain due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid (hypothyroidism)
• if you have experienced repeated or unexplained 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 have or have had myasthenia (a disease causing 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 this condition or lead to the onset of myasthenia (see section 4).
• 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 Nelediaden 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 Nelediaden”).
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and treatments may be necessary to diagnose and manage this condition.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is higher if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Other medicines and Nelediaden
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 Nelediaden, or their effects may be altered by Nelediaden. This type of interaction may make one or both medicines less effective. Conversely, it could also increase the risk or severity of side effects, including a condition of muscle breakdown known as rhabdomyolysis described in section 4:
Medicines used to alter the activity of the immune system, 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 cytomegalovirus infections.
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 Nelediaden, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach pain or peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (products against indigestion 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 Nelediaden. Taking Nelediaden 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 skin structure infections and bloodstream infections caused by bacteria).

Nelediaden with food and drink
See section 3 for instructions on how to take Nelediaden. Please note the following:
Grapefruit juice
You should 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 Nelediaden.
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 Nelediaden if you are pregnant or trying to become pregnant.
DO NOT take Nelediaden if you are of childbearing age unless you are using an effective method of contraception.
DO NOT take Nelediaden if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of atorvastatin 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 machines. However, do not drive if you notice that this medicine impairs your ability to drive safely. Do not use tools or machinery if your ability to operate them is impaired by this medicine.

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

3. How to take NELEDIADEN

Take this medicine exactly as directed 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 continue during treatment with Nelediaden.
The recommended starting dose of Nelediaden is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose gradually to reach the amount you need. Your doctor will adjust the dose at intervals of 4 weeks or more.
The maximum dose of Nelediaden is 80 mg once daily.
Nelediaden 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.
Nelediaden 20 mg, 40 mg and 80 mg
The tablet may be divided into equal doses.
The duration of treatment with Nelediaden is determined by your doctor.
If you feel that the effect of Nelediaden is too strong or too weak, consult your doctor.
If you take more Nelediaden than you should
If you accidentally take too many Nelediaden tablets (more than your prescribed dose), contact your doctor or the nearest hospital for advice.
If you forget to take Nelediaden
If you forget to take a dose, take the next scheduled dose at the correct time. DO NOT take a double dose to make up for the missed dose.
If you stop taking Nelediaden
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 everybody gets them.
If you notice any of the following 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 people

• Severe allergic reaction causing swelling of the face, tongue and throat, which may lead to severe breathing difficulties.
• Severe illness associated with extensive peeling and swelling of the skin, 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.
• Weakness, tenderness, pain or tearing of muscles, or red-brown colouration of the urine; especially if you also feel unwell and have a high fever. This may be due to an unusual breakdown of muscle tissue (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin, and can be life-threatening and 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 illness syndrome (including skin rash, joint problems and effects on blood cells).

Other side effects that may occur with Nelediaden:
Common: may affect up to 1 in 10 people

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), 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: 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 carefully)
• Nightmares, insomnia
• Dizziness, reduced sensation or tingling in the fingers of hands and feet, 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, itchy rash, hives, hair loss
• Neck pain, muscle fatigue
• Tiredness, malaise, weakness, chest pain, swelling, especially in the ankles (oedema), increased body temperature
• Positive urine test for leukocytes (white blood cells).

Rare: 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 sores (drug-induced lichenoid reaction)
• Purple skin lesions (signs of blood vessel inflammation, vasculitis).

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

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

Not known: frequency cannot be estimated from the available data

• Persistent muscle weakness.
• Severe myasthenia (a disease causing generalised 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 with 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. The risk of developing diabetes is higher 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 get any side effects, 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 Nelediaden

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, packaging, and bottle after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Nelediaden contains

• The active substance is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin. Each film-coated tablet contains 20 mg of atorvastatin. Each film-coated tablet contains 30 mg of atorvastatin. Each film-coated tablet contains 40 mg of atorvastatin. Each film-coated tablet contains 60 mg of atorvastatin. Each film-coated tablet contains 80 mg of atorvastatin.
• The other components are:
  Tablet core: microcrystalline cellulose, calcium carbonate (E170), maltose, croscarmellose sodium (E466), polysorbate 80 (E433), magnesium aluminium silicate, and magnesium stearate (E470b).
  Tablet coating: hypromellose (E464), hydroxypropylcellulose (E463), triethyl citrate (E1505), polysorbate 80 (E433), titanium dioxide (E171).

Description of the appearance of Nelediaden and contents of the pack
Nelediaden 10 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "10" on one side and plain on the other side. Size: approximately 8 mm x 4 mm.
Nelediaden 20 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "20" on one side and a breakline on the other side. Size: approximately 10 mm x 6 mm.
Nelediaden 30 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "30" on one side and plain on the other side. Size: approximately 12 mm x 6 mm.
Nelediaden 40 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "40" on one side and a breakline on the other side. Size: approximately 13 mm x 7 mm.
Nelediaden 60 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "60" on one side and plain on the other side. Size: approximately 14 mm x 8 mm.
Nelediaden 80 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "80" on one side and a breakline on the other side. Size: approximately 16 mm x 9 mm.

Nelediaden 10 mg is available in blister packs of 30, 60, and 90 tablets.
Nelediaden 20 mg is available in blister packs of 30, 60, and 90 tablets.
Nelediaden 30 mg is available in blister packs of 28 tablets.
Nelediaden 40 mg is available in blister packs of 30, 60, and 90 tablets.
Nelediaden 60 mg is available in blister packs of 28 tablets.
Nelediaden 80 mg is available in blister packs of 30, 60, and 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Sigillata Limited
Inniscarra, Main Street
Rathcoole, Co. Dublin - D24 E029
Ireland

Manufacturer
TEVA PHARMA S.L.U.,
C/C, n. 4, Poligono Industrial Malpica,
50016 Zaragoza,
Spain
Teva Operations Poland Sp. z.o.o,
ul. Mogilska 80, 31-546,
Krakow,
Poland

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: Nelediaden 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg Filmtabletten
Italy: Nelediaden

Other sources of information
The most recently approved product information and educational material for this medicinal product are available by scanning the QR code included in the PIL and on the outer carton using a smartphone or other device. The same information is available at the following URL: [URL to be included] and on the website of the relevant National Competent Authority.