Atorvastatin Almus Pharma: detailed information

Package leaflet: Information for the user

ATORVASTATIN ALMUS PHARMA 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could 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:

What ATORVASTATIN ALMUS PHARMA is and what it is used for
What you need to know before taking ATORVASTATIN ALMUS PHARMA
How to take ATORVASTATIN ALMUS PHARMA
Possible side effects
How to store ATORVASTATIN ALMUS PHARMA
Contents of the pack and other information

1. What ATORVASTATINA ALMUS PHARMA is and what it is used for

ATORVASTATINA ALMUS PHARMA belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATINA ALMUS PHARMA 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, ATORVASTATINA ALMUS PHARMA 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 ATORVASTATIN ALMUS PHARMA

Do not take ATORVASTATIN ALMUS PHARMA

if you are allergic to atorvastatin or to any other lipid-lowering medicines, 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 you 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 ATORVASTATIN ALMUS PHARMA:

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 for bacterial infection). The combination of fusidic acid and ATORVASTATIN ALMUS PHARMA may lead to serious muscle problems (rhabdomyolysis).
If you have previously had a stroke with cerebral haemorrhage or if you have low cerebral fluid reserves due to previous strokes.
If you have kidney problems.
If you have an underactive thyroid gland (hypothyroidism).
If you have had repeated or unexplained muscle pain, or a personal or family history of muscle disorders.
If you have previously experienced muscle problems during treatment 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 ATORVASTATIN ALMUS PHARMA to assess 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 concomitantly (see Section 2 “Other medicines and ATORVASTATIN ALMUS PHARMA”).
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and medicines may be needed to diagnose and treat this condition.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high levels of sugar and fats in the blood, being overweight, and having high blood pressure.

Other medicines and ATORVASTATIN ALMUS PHARMA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may alter the effect of ATORVASTATIN ALMUS PHARMA, or the effect of these medicines may be altered by ATORVASTATIN ALMUS PHARMA.
This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse 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 lipid-regulating medicines, 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
Medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc.
Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination elbasvir/grazoprevir.
Other medicines known to interact with ATORVASTATIN ALMUS PHARMA include ezetimibe (cholesterol-lowering), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium and magnesium).
Over-the-counter medicines: St. John’s wort
If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart ATORVASTATIN ALMUS PHARMA. Taking ATORVASTATIN ALMUS PHARMA with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see Section 4. Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.

ATOVASTATIN ALMUS PHARMA with food, drinks and alcohol
See Section 3 for instructions on how to take ATORVASTATIN ALMUS PHARMA.
Please note the following:
Grapefruit juice
Do 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 ATORVASTATIN ALMUS PHARMA.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see Section 2 “Warnings and precautions”.

Pregnancy, breastfeeding and fertility
Do not take ATORVASTATIN ALMUS PHARMA if you are pregnant or planning to become pregnant.
Do not take ATORVASTATIN ALMUS PHARMA if you are of childbearing age unless you are using an effective method of contraception.
Do not take ATORVASTATIN ALMUS PHARMA if you are breastfeeding.
The safety of ATORVASTATIN ALMUS PHARMA 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 use machines.
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.

ATOVASTATIN ALMUS PHARMA contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
For the full list of ingredients, see Section 6 Package contents and other information.

3. How to take ATORVASTATINA ALMUS PHARMA

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must follow throughout your therapy with ATORVASTATINA ALMUS PHARMA.
The usual starting dose of ATORVASTATINA ALMUS PHARMA is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose to achieve the required dose. Your doctor will adjust the dosage at intervals of 4 or more weeks. The maximum dose of ATORVASTATINA ALMUS PHARMA is 80 mg once daily for adults.
The ATORVASTATINA ALMUS PHARMA 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.
Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATINA ALMUS PHARMA will be determined by your doctor.
If you feel that the effect of ATORVASTATINA ALMUS PHARMA is too strong or too weak, consult your doctor.
If you take more ATORVASTATINA ALMUS PHARMA than you should
If you accidentally take too many ATORVASTATINA ALMUS PHARMA tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATINA ALMUS PHARMA
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for the forgotten tablet.
If you stop taking ATORVASTATINA ALMUS PHARMA
If you have any doubts 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 everyone will experience them.
If you experience any of the following serious side effects or symptoms, stop taking your tablets immediately and contact your doctor right away 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 significant breathing difficulties.
A serious condition associated with severe peeling and swelling of the skin, skin blisters, and sores in the mouth, eyes, and genital area, accompanied by fever. Skin rash with reddish spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters.
If you experience muscle weakness, tenderness, pain, tearing sensation, 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 breakdown. Abnormal muscle breakdown does not always resolve even after stopping ATORVASTATIN ALMUS PHARMA; it can be life-threatening and may 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. Consult your doctor as soon as possible.
Lupus-like syndrome (including skin rash, joint problems, and effects on blood cells).

Other side effects that may occur with ATORVASTATIN ALMUS PHARMA
Common side effects (may affect up to 1 in 10 people) 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 levels in the blood
Headache
Nausea, constipation, flatulence, indigestion, diarrhoea
Joint pain, muscle pain, and back pain
Blood tests showing possible abnormalities in liver function.

Uncommon side effects (may affect up to 1 in 100 people) 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 sensitivity or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste sensation, 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, skin eruption and itching, hives, hair loss
Neck pain, muscle fatigue
Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (oedema), increased body temperature
Urine test positive for white blood cells.

Rare side effects (may affect up to 1 in 1,000 people) include:

Vision disorders
Unexpected bleeding or bruising
Cholestasis (yellowing of the skin and whites of the eyes)
Tendon damage.

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

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

Side effects of unknown frequency:

Persistent muscle weakness.

Possible side effects reported with some statins (medicines of the same type):

Sexual dysfunction
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, pharmacist, or nurse. 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 ATORVASTATIN ALMUS PHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after "Exp.:". The expiry date refers to the last day of that month.
10 mg and 80 mg:
Store below 25 °C.
20 mg and 40 mg:
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 ATORVASTATINA ALMUS PHARMA contains

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

Description of the appearance of ATORVASTATINA ALMUS PHARMA and package contents
10 mg: ATORVASTATINA ALMUS PHARMA film-coated tablets, white, round,
biconvex, with a break line on one side and engraved "10" on the other side. The size of
each tablet is approximately 7.0 mm.
20 mg: ATORVASTATINA ALMUS PHARMA film-coated tablets, white, round,
biconvex, with a break line on one side and engraved "20" on the other side. The size of
each tablet is approximately 9.0 mm.
40 mg: ATORVASTATINA ALMUS PHARMA film-coated tablets, white, round,
biconvex, with a break line on one side and engraved "40" on the other side. The size of
each tablet is approximately 11.0 mm.
80 mg: ATORVASTATINA ALMUS PHARMA film-coated tablets, white,
oblong, biconvex, with a break line on one side and engraved "80" on the other side. The size of
each tablet is approximately 20.0 mm.
ATORVASTATINA ALMUS PHARMA film-coated tablets are available in blister packs containing 28, 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa
Italy

Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, nº 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares
Guadalajara
Spain
ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče
Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: ATORVASTATINA ALMUS PHARMA 10 mg, 20 mg, 40 mg, 80 mg film-coated tablets
Spain: ATORVASTATINA ALMUS PHARMA 10 mg, 20 mg, 40 mg, 80 mg film-coated tablets EFG
France: ATORVASTATINE ALMUS PHARMA 10 mg, 20 mg, 40 mg, 80 mg film-coated tablet