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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a 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 reduce the levels of lipids, known as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes 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, you should continue to follow a standard low-cholesterol diet.

2. Important information before taking Atorvastatin Medical Valley

When not to take Atorvastatin Medical Valley

• if the patient is allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if the patient has or has had liver disease, if the patient has unexplained, abnormal liver function test results,
• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or breastfeeding women,
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Atorvastatin Medical Valley, you should discuss this with your doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection in the last 7 days. Taking fusidic acid with Atorvastatin Medical Valley can lead to serious muscle problems (rhabdomyolysis),
• if the patient has had a stroke with bleeding in the brain, or if there is a small amount of fluid in the brain from a previous stroke,
• if the patient has kidney problems,
• if the patient has hypothyroidism (underactive thyroid),
• if the patient has had recurring or unexplained muscle pain, muscle problems, or if similar problems occur in relatives,
• if the patient has had muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• if the patient has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has had liver disease in the past,
• if the patient is over 70 years old.

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-related side effects.
It is known that the risk of muscle-related 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").
You should also tell your doctor or pharmacist if muscle weakness persists.
In order to diagnose and treat this condition, additional tests and medications may be necessary.
During treatment, your doctor will closely monitor you 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

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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 heart rhythm regulators, 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 known to interact with Atorvastatin Medical Valley include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine used to treat epilepsy), 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 this medicine. 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, you should pay attention to the following information:
Grapefruit juice
You 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
You 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, you should consult a doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, you should not drive or use machines if the medicine affects your ability to do so.
Atorvastatin Medical Valley contains lactose.If you have been diagnosed with an intolerance to some sugars, you should contact your 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 essentially "sodium-free".

3. How to take Atorvastatin Medical Valley

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

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

If you feel that the effect of Atorvastatin Medical Valley is too strong or too weak, you should consult your doctor.

Taking a higher dose of Atorvastatin Medical Valley than recommended

If you accidentally take too many tablets of Atorvastatin Medical Valley (more than the usual daily dose), you should contact your doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin Medical Valley

If you forget to take a dose, you should simply take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Atorvastatin Medical Valley

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the serious side effects or symptoms, you should stop taking the medicine and contact your doctor immediately or go to the emergency department of the nearest hospital.

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 this is accompanied by a feeling of illness 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, this may indicate liver problems. The patient should consult their doctor as soon as possible.
• Systemic lupus erythematosus (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

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased creatine kinase levels in the blood
• 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 of the hands and feet, 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 rash, and itching, hives, hair loss
• 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, mouth, 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)
• ocular myasthenia (a disease that causes muscle weakness in the eyes)

You should talk to your doctor if you experience weakness in your 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, your doctor will perform the necessary tests.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 will help gather more information on the safety of this medicine.

5. How to store Atorvastatin Medical Valley

The medicine should be stored out of sight and reach of children.
Do not use 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. You should ask your 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).

• Other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium carbonate, copovidone, crospovidone type B, sodium croscarmellose, sodium lauryl sulfate, colloidal silica anhydrous, talc, and magnesium stearate. Tablet coating: 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 dividing 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 dividing 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 dividing 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 dividing 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 for use 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