Atorvastatin Medical Vallei

Leaflet attached to the packaging: information for the user

Atorvastatin Medical Valley, 10 mg, film-coated tablets

Atorvastatin Medical Valley, 20 mg, film-coated tablets

Atorvastatin Medical Valley, 40 mg, film-coated tablets

Atorvastatin Medical Valley, 80 mg, film-coated tablets

Atorvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Atorvastatin Medical Valley and what is it used for
• 2. Important information before taking Atorvastatin Medical Valley
• 3. How to take Atorvastatin Medical Valley
• 4. Possible side effects
• 5. How to store Atorvastatin Medical Valley
• 6. Contents of the pack and other information

1. What is Atorvastatin Medical Valley and what is it used for

Atorvastatin Medical Valley belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvastatin Medical Valley is used to lower the levels of lipids, known as cholesterol and triglycerides, in the blood when a low-fat diet and changes in lifestyle are not effective on their own. Atorvastatin Medical Valley can also be used to reduce the risk of heart disease, even if the cholesterol level is normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Atorvastatin Medical Valley

When not to take Atorvastatin Medical Valley

• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or breastfeeding women,

Warnings and precautions

Before starting treatment with Atorvastatin Medical Valley, the patient should discuss it with their doctor, pharmacist, or nurse:

In patients who are affected by any of the above situations, the doctor will order a blood test before starting treatment with Atorvastatin Medical Valley and, if possible, during treatment to monitor the risk of muscle side effects.
It is known that the risk of muscle side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "Atorvastatin Medical Valley and other medicines").
The patient should also tell their doctor or pharmacist if they experience persistent muscle weakness.
To diagnose and treat this condition, additional tests and medications may be necessary.
During treatment with Atorvastatin Medical Valley, the doctor will closely monitor the patient for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atorvastatin Medical Valley and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. Some medicines can change the effect of Atorvastatin Medical Valley or the effect of these medicines on the body may be changed by Atorvastatin Medical Valley. This type of interaction can lead to reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• Immunosuppressants, such as cyclosporine;
• Certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• Other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine;
• Certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem; as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone;
• Letermovir, a medicine used to prevent cytomegalovirus disease;
• Medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.;
• Certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir and grazoprevir, ledipasvir and sofosbuvir;
• Other medicines that are known to interact with Atorvastatin Medical Valley include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium);
• Over-the-counter medicines: St. John's Wort;
• If the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Atorvastatin Medical Valley. The doctor will inform the patient when it is safe to restart treatment with Atorvastatin Medical Valley. Taking Atorvastatin Medical Valley with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Atorvastatin Medical Valley with food, drink, and alcohol

Information on taking Atorvastatin Medical Valley can be found in section 3. However, the patient should pay attention to the following information:
Grapefruit juice
The patient should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Atorvastatin Medical Valley.
Alcohol
The patient should avoid drinking excessive amounts of alcohol while taking this medicine. More information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Atorvastatin Medical Valley should not be taken by pregnant or breastfeeding women.
Atorvastatin Medical Valley should not be taken by women of childbearing age who do not use effective methods of contraception.
Atorvastatin Medical Valley should not be taken during breastfeeding.
The safety of Atorvastatin Medical Valley during pregnancy and breastfeeding has not been established. Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, the patient should not drive if the medicine affects their ability to do so. The patient should not use any tools or machines if taking the medicine affects their ability to use them.
Atorvastatin Medical Valley contains lactose.If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Atorvastatin Medical Valley contains sodium.This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Atorvastatin Medical Valley

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin Medical Valley.
The usual starting dose of Atorvastatin Medical Valley for adults and children over 10 years old is 10 mg once daily. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose of Atorvastatin Medical Valley at intervals of at least 4 weeks. The maximum dose of Atorvastatin Medical Valley is 80 mg once daily.
The patient should swallow the tablets whole, with water; they can be taken at any time of day, with or without food. However, the patient should try to take the tablet at the same time every day.
This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

The duration of treatment with Atorvastatin Medical Valley is determined by the doctor.

If the patient feels that the effect of Atorvastatin Medical Valley is too strong or too weak, they should consult their doctor.

Taking a higher dose of Atorvastatin Medical Valley than recommended

If the patient accidentally takes too many tablets of Atorvastatin Medical Valley (more than the usual daily dose), they should contact their doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin Medical Valley

If the patient forgets to take a dose, they should simply take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Atorvastatin Medical Valley

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvastatin Medical Valley can cause side effects, although not everybody gets them.

If the patient experiences any of the serious side effects or symptoms, they should stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.

Rare: may affect up to 1 in 1,000 people

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• Severe disease characterized by skin peeling and swelling, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the hands or feet, with possible blisters.
• Muscle weakness, tenderness, or pain, or muscle rupture, or reddish-brown urine. If the patient also experiences malaise or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if the patient stops taking atorvastatin, and it can be life-threatening and cause kidney problems.

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

• If the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. The patient should consult their doctor as soon as possible.
• Systemic lupus erythematosus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Atorvastatin Medical Valley:

Common: may affect up to 1 in 10 people

• nose and throat infections, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• headaches
• nausea, constipation, bloating, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating abnormal liver function

Uncommon: may affect up to 1 in 100 people

• loss of appetite, weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and (or) head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• liver inflammation
• skin rash, skin itching, and hives
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
• presence of white blood cells in the urine

Rare: may affect up to 1 in 1,000 people

• vision disorders
• unexpected bleeding or bruising (bruises)
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon rupture

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

• allergic reactions - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (excessive breast tissue growth in men)

Unknown: frequency cannot be estimated from the available data

• persistent muscle weakness
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• myasthenic syndrome (a disease that causes muscle weakness in the eyes)

The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
Other possible side effects reported during treatment with some statins (medicines of the same type):

• Sexual disorders
• Depression
• Breathing problems, including persistent cough and (or) shortness of breath or fever
• Diabetes. The risk of developing this disease is higher in patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, the doctor will perform the necessary tests on the patient.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Atorvastatin Medical Valley

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the blister or carton after:
"Expiry date" or "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Blister pack: Store in a temperature below 25°C.

6. Contents of the pack and other information

What Atorvastatin Medical Valley contains

• The active substance of the medicine is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin (in the form of a trihydrate calcium salt of atorvastatin). Each film-coated tablet contains 20 mg of atorvastatin (in the form of a trihydrate calcium salt of atorvastatin).

Each film-coated tablet contains 40 mg of atorvastatin (in the form of a trihydrate calcium salt of atorvastatin).
Each film-coated tablet contains 80 mg of atorvastatin (in the form of a trihydrate calcium salt of atorvastatin).

• The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium carbonate, copovidone, crospovidone type B, sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, talc, and magnesium stearate. Tablet coating: glycerol mono- and di-caprylocaprate, polyvinyl alcohol, talc, titanium dioxide (E 171), and a copolymer of polyethylene glycol (PEG) and polyvinyl alcohol.

What Atorvastatin Medical Valley looks like and contents of the pack

10 mg: Atorvastatin Medical Valley film-coated tablets are white, round, biconvex, with a score line on one side and the inscription "10" on the other side. The diameter of the tablet is approximately 7 mm.
20 mg: Atorvastatin Medical Valley film-coated tablets are white, round, biconvex, with a score line on one side and the inscription "20" on the other side. The diameter of the tablet is approximately 9.0 mm.
40 mg: Atorvastatin Medical Valley film-coated tablets are white, round, biconvex, with a score line on one side and the inscription "40" on the other side. The diameter of the tablet is approximately 11.0 mm.
80 mg: Atorvastatin Medical Valley film-coated tablets are white, round, biconvex, with a score line on one side and the inscription "80" on the other side. The diameter of the tablet is approximately 13 mm.
Atorvastatin Medical Valley film-coated tablets are available in blisters, in packs containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
Email: [email protected]

Manufacturer

Laboratorios Liconsa, S.A
Avenida Miralcampo 7
Polígono Industrial Miralcampo

• 19200 – Azuqueca de Henares, Guadalajara, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Atorvastatina Sandoz 10 mg film-coated tablets EFG
Atorvastatina Sandoz 20 mg film-coated tablets EFG
Atorvastatina Sandoz 40 mg film-coated tablets EFG
Atorvastatina Sandoz 80 mg film-coated tablets EFG
Netherlands: Atorvastatine Liconsa 10 mg film-coated tablets
Atorvastatine Liconsa 20 mg film-coated tablets
Atorvastatine Liconsa 40 mg film-coated tablets
Atorvastatine Liconsa 80 mg film-coated tablets
Germany:
Atorvastatin Laboratorios Liconsa 10 mg film-coated tablets
Atorvastatin Laboratorios Liconsa 20 mg film-coated tablets
Atorvastatin Laboratorios Liconsa 40 mg film-coated tablets
Atorvastatin Laboratorios Liconsa 80 mg film-coated tablets
Poland:
Atorvastatin Medical Valley
Date of last revision of the leaflet:05.2024