Nelip

Package leaflet: Information for the user

NELIP 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What NELIP is and what it is used for

NELIP belongs to a class of medicines called statins, which regulate lipid (fat) levels.
NELIP 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, NELIP 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 NELIP

Do not take NELIP

• 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 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 or pharmacist before taking NELIP:

• if you suffer from severe respiratory insufficiency;
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections), taken orally or by intramuscular injection. The combination of fusidic acid with NELIP may cause serious muscle problems (rhabdomyolysis);
• if you have previously had a stroke with cerebral haemorrhage or if you have low levels of fluid in the brain due to 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 of age. If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with NELIP to assess the risk of muscle-related adverse effects. It is known that taking certain medicines concomitantly with atorvastatin increases the risk of musculoskeletal side effects (see section “Other medicines and NELIP”).

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.
During treatment 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, are overweight, and have high blood pressure.
Other medicines and NELIP
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 NELIP, or the effect of these medicines may be altered by NELIP. This type of interaction may reduce the effectiveness of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects, including the serious muscle disorder known as rhabdomyolysis described in section 4:

• Medicines used to modify the way the immune system works, e.g. cyclosporine;
• Some 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;
• 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;
• Letermovir, a medicine that helps prevent cytomegalovirus infection;
• Medicines used for the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of 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 known to interact with NELIP include ezetimibe (which lowers 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.

NELIP with food, drinks and alcohol
See section 3. How to take NELIP.
Please consider the following information:
Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effects of NELIP.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, refer to the section “Warnings and precautions”.
Pregnancy, breastfeeding and fertility
Do not take this medicine if you are pregnant or planning to become pregnant.
Do not take this medicine if you think you could become pregnant unless you are using an effective method of contraception.
Do not take this medicine if you are breastfeeding.
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 your ability to drive or operate machinery. However, do not drive if this medicine impairs your ability to drive. Do not use tools or machinery if your ability to operate them is impaired by this medicine.
NELIP contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
NELIP contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to take NELIP

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must follow this diet during treatment with NELIP.
The usual dose of NELIP is 10 mg once daily in adults and children from the age of 10 years. 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 NELIP is 80 mg once daily.
NELIP tablets must be swallowed whole with water and can be taken at any time of day, with or without food. However, try to take the tablets at the same time each day.
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with NELIP is determined by your doctor.
If you feel that the effect of NELIP is too strong or too weak, consult your doctor.
If you take more NELIP than you should
If you accidentally take too many NELIP tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take NELIP
If you forget to take a dose, take the next dose at the correct time. Do not take a double dose to make up for the missed dose.
If you stop taking NELIP
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, NELIP can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects or symptoms listed below,
stop taking your tablets immediately and inform your doctor or go to the nearest hospital emergency department.

Rare side effects: may affect up to 1 in 1,000 patients:

• Severe allergic reaction causing swelling of the face, tongue, and windpipe, which may lead to significant breathing difficulties.
• A serious condition associated with severe peeling and swelling of the skin, skin blisters, and sores in the mouth, eyes, genitals, accompanied by 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, pain, muscle breakdown, or red-brown discoloration of the urine, especially if you also feel unwell and have a high fever. This may be due to abnormal muscle deterioration (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin, and may be life-threatening and cause kidney problems.

Very rare side effects: may affect up to 1 in 10,000 patients:

• 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 (which may include skin rash, joint problems, and effects on blood cells).

Other side effects that may occur with NELIP
Common side effects (may affect up to 1 in 10 patients) include:

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (if you have diabetes, you should continue to monitor your blood sugar levels closely), increased blood creatine kinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Changes in liver function laboratory tests.

Uncommon side effects (may affect up to 1 in 100 patients) 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, reduced sensation or tingling in the 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 or 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. Rare side effects (may affect up to 1 in 1,000 patients) include:
• Vision disorders
• Unexpected bleeding or bruising
• Jaundice (yellowing of the skin and whites of the eyes)
• Tendon damage.

Very rare side effects (may affect up to 1 in 10,000 patients) include:

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

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

• Persistent muscle weakness.

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 the following website: 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 NELIP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
Do not store above 30ºC.

6. Package contents and other information

What NELIP contains
The active substance is atorvastatin.
Each 10 mg tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each 20 mg tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each 40 mg tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each 80 mg tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).
The other components are:
monohydrate lactose, microcrystalline cellulose, calcium carbonate E170, copovidone, crospovidone type B,
sodium croscarmellose, sodium lauryl sulfate, anhydrous colloidal silica, talc and magnesium stearate.
The coating contains: hypromellose (E464), titanium dioxide (E171) and macrogol 400.
This medicine is available as film-coated tablets of 10 mg, 20 mg, 40 mg and 80 mg.

Description of the appearance of NELIP and contents of the pack
10 mg: NELIP film-coated tablets are white, round, biconvex, with a breakline on one side and "10" imprinted on the other side. The size of each tablet is approximately 7.0 mm. The breakline is intended only to facilitate breaking the tablet for easier swallowing and not for dividing into equal doses.
20 mg: NELIP film-coated tablets are white, round, biconvex, with a breakline on one side and "20" imprinted on the other side. The size of each tablet is approximately 9.0 mm. The breakline is intended only to facilitate breaking the tablet for easier swallowing and not for dividing into equal doses.
40 mg: NELIP film-coated tablets are white, round, biconvex, with a breakline on one side and "40" imprinted on the other side. The size of each tablet is approximately 11.0 mm. The breakline is intended only to facilitate breaking the tablet for easier swallowing and not for dividing into equal doses.
80 mg: NELIP film-coated tablets are white, round, biconvex, with a breakline on one side and "80" imprinted on the other side. The size of each tablet is approximately 18.5 mm. The breakline is intended only to facilitate breaking the tablet for easier swallowing and not for dividing into equal doses.
NELIP is available in packs of 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group s.r.l.
Via Tiburtina, 1143
00156 – Roma
Italy

Manufacturer responsible for batch release
Laboratorios Liconsa, S.A.
Avda. Miralcampo 7, Polígono Industrial Miralcampo,
19200 – Azuqueca de Henares, Guadalajara,
Spain

This medicinal product is authorized in the EEA Member States under the following names:
Denmark NELIP
Italy NELIP