NELEDIADEN 10 мг Фильм-coated таблетки

Содержание инструкции

1. 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
   1. What is Nelediaden and what is it 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. Contents of the pack and other information

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
Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take Nelediaden
• 3. How to take Nelediaden
• 4. Possible side effects
• 5. How to store Nelediaden
• 6. Contents of the pack and other information

1. What is Nelediaden and what is it 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 successful. If you are at high
risk of cardiovascular disease Nelediaden can also be used to reduce this risk, even if
cholesterol levels are normal. During treatment you should maintain a standard diet to reduce
cholesterol.

2. What you need to know before taking Nelediaden

Do not take Nelediaden

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6)
• if you have or have ever had a liver disease
• if you have had unexplained abnormalities in liver function tests
• if you are a woman of childbearing potential and not using reliable contraception
• if you are pregnant or trying to become pregnant
• if you are breastfeeding
• if you are using the combination of glecaprevir/pibrentasvir in 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 in the last 7 days a medicine called fusidic acid (a medicine used for bacterial infections) orally or by injection. 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 recurrent or unexplained muscle pain, a personal or family history of muscle problems
• if you have had previous muscle problems while taking other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• if you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases the muscles used for breathing), or ocular myasthenia (a disease that causes weakness of the eye muscle) as statins can sometimes worsen this condition or lead to the onset of myasthenia (see section 4).
• if you regularly consume significant amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years of age

If any of these conditions apply to you, your doctor will need to perform a blood test,
before and possibly during treatment with Nelediaden to predict 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 at the same time (see section 2 “Other medicines and
Nelediaden”).
Also inform your doctor or pharmacist if you have persistent muscle weakness. Further
tests and medicines may be needed for the diagnosis and treatment of this condition.
During treatment with this medicine, your doctor will carefully 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 sugars and
fats in your blood, if you are overweight and if you have high blood pressure.

Other medicines and Nelediaden
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Some medicines can change the effect of Nelediaden, or their effect can be changed by
Nelediaden. This type of interaction can make one or both medicines less effective. Conversely,
this 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.
Some antibiotic 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.
Some calcium channel blockers, used for angina or high blood pressure, e.g. amlodipine,
diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone.
Leteremovir, a medicine that helps to avoid getting sick with diseases caused by cytomegalovirus.
Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir,
the combination tipranavir/ritonavir, etc.
Some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination of
elbasvir/grazoprevir, ledipasvir/sofosbuvir.
Other medicines that are 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 upset or peptic ulcer), phenazone
(a pain reliever), colchicine (used to treat gout) and antacids (products against indigestion that
contain aluminium and magnesium).
Medicines available without a prescription: St John's Wort.
If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking
this medicine. Your doctor will tell you when you can safely restart
taking Nelediaden. Taking Nelediaden with fusidic acid can rarely
cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information
on rhabdomyolysis see section 4.
Daptomycin (a medicine used to treat complicated skin and skin structure infections
and bacteria in the blood).

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 of grapefruit juice a day, as high amounts of
grapefruit juice can alter the effects of Nelediaden.

Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details see
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 potential unless you are using effective contraception.
DO NOT take Nelediaden if you are breastfeeding.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The safety of atorvastatin during pregnancy and breastfeeding has not yet been demonstrated.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine usually does not affect your ability to drive or operate machinery. However, do
not drive if you notice that this medicine alters your ability to drive. Do not use tools or machinery if your
ability to use them is altered by this medicine.

Nelediaden contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to take NELEDIADEN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe you a low-cholesterol diet that you will need to
maintain even during therapy with Nelediaden.
The recommended initial dose of Nelediaden is 10 mg once a day in adults and in children with age
equal to or greater than 10 years. If necessary, this dose may be increased by the doctor until
reaching the amount you need. The doctor will adjust the dose at intervals of 4 or more weeks.
The maximum dose of Nelediaden is 80 mg once a day.
The Nelediaden tablets must be swallowed whole with water and can be taken at any
time of the day, with or without food. However, try to take the tablets every day at the same time.
Nelediaden 20 mg, 40 mg and 80 mg
The tablet can be divided into equal doses.

The duration of treatment with Nelediaden is established by the doctor.
If you have the impression 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 (a number higher than the usual 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 doubts about the use of this medicine, or 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 appear, stop taking the tablets and immediately contact your doctor or go to the nearest hospital emergency room.
Rare: may affect up to 1 in 1,000 people:

• Severe allergic reaction causing swelling of the face, tongue and throat, which can cause significant difficulty in breathing.
• Severe illness associated with severe skin peeling and swelling, blisters on skin, mouth, eyes, genitals and fever. Skin rash with reddish spots, especially on the palms of the hands or soles of the feet, which may turn into blisters.
• Weakness, tenderness, pain or tearing of muscles, or reddish-brown discoloration of the urine, and especially if you feel unwell and have a high fever at the same time, this may be caused by an unusual muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always go away, 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 suggest a liver disorder. You should contact your doctor as soon as possible.
• Syndrome resembling lupus erythematosus (including rash, joint disorders and effects on blood cells).

Other side effects that may occur with Nelediaden:
Common: 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 carefully monitor your blood sugar levels), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhea
• Joint pain, muscle pain and back pain
• Changes in laboratory tests for liver function.

Not common: may affect up to 1 in 100 people

• Anorexia (loss of appetite), increased body weight, decreased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels)
• Nightmares, insomnia
• Dizziness, reduced sensitivity or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Tinnitus (ringing in the ears) and/or in the head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas with stomach pain)
• Hepatitis (inflammation of the liver)
• Skin rash, itchy skin rash, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling, especially in the ankles (edema), increased body temperature
• Positive urine analysis 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 that may occur on the skin or sores in the mouth (drug-induced lichenoid reaction)
• Purple lesions on the skin (signs of inflammation of blood vessels, vasculitis).

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

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

Not known: frequency cannot be estimated on the basis of available data:

• Persistent muscle weakness.
• Myasthenia gravis (a disease that causes general muscle weakness, including in some cases the muscles used for breathing)
• Ocular myasthenia (a disease that causes weakness of the eye muscle)
• Contact your doctor if you experience weakness in your 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 (drugs of the same type):

• Sexual dysfunction
• Depression
• Difficulty breathing including persistent cough and/or shortness of breath or fever
• Diabetes. The risk of developing diabetes is higher if you have high blood sugar and fat levels, if you are overweight and if you have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can contribute to providing 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 that is reported on the blister, on the box and on the bottle after
EXP. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nelediaden contains

• The active ingredient 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 ingredients are: Tablet core: microcrystalline cellulose, calcium carbonate (E170), maltose, sodium croscarmellose (E466), polysorbate 80 (E433) and 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-shaped, biconvex, film-coated tablets
with “10” imprinted on one side and smooth on the other side. Size: approximately 8 mm x 4 mm.
Nelediaden 20 mg are white to almost white, elliptical-shaped, biconvex, film-coated tablets
with “20” imprinted on one side and a score line on the other side. Size: approximately 10 mm x 6 mm.
Nelediaden 30 mg are white to almost white, elliptical-shaped, biconvex, film-coated tablets
with “30” imprinted on one side and smooth on the other side. Size: approximately 12 mm x 6 mm.
Nelediaden 40 mg are white to almost white, elliptical-shaped, biconvex, film-coated tablets
with “40” imprinted on one side and a score line on the other side. Size: approximately 13 mm x 7 mm.
Nelediaden 60 mg are white to almost white, elliptical-shaped, biconvex, film-coated tablets
with “60” imprinted on one side and smooth on the other side. Size: approximately 14 mm x 8 mm.
Nelediaden 80 mg are white to almost white, elliptical-shaped, biconvex, film-coated tablets
with “80” imprinted on one side and a score line on the other side. Size: approximately 16 mm x 9 mm.
Nelediaden 10 mg is available in blister packs of 30, 60 to 90 tablets.
Nelediaden 20 mg is available in blister packs of 30, 60 to 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 Authorisation 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 authorised in the Member States of the European Economic Area under the following
denominations:
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 on this medicinal product
are available by scanning the QR code included in the PIL and on the outer packaging with a smartphone/other
device. The same information is available at the following URL: [URL to be included] and

of the national competent authority>.