Atorvastatin Medical Vallei

Leaflet accompanying 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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 cholesterol levels are 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 you are allergic to atorvastatin or any other ingredient of this medicine (listed in section 6),
• if you have or have had liver disease, if you have had unexplained, abnormal liver function tests,
• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or breastfeeding women,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

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

• if you have severe respiratory failure,
• if you are taking or have taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with Atorvastatin Medical Valley can cause serious muscle problems (rhabdomyolysis),
• if you have 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 you have kidney problems,
• if you have hypothyroidism (underactive thyroid),
• if you have had repeated or unexplained muscle pain, muscle problems, or if similar problems occur in your family,
• if you have had muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• if you have had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing muscle weakness in the eyes), as statins can sometimes exacerbate symptoms or cause myasthenia (see section 4),
• if you regularly drink large amounts of alcohol,
• if you have had liver disease,
• if you are over 70 years old.

In patients with any of the above conditions, your 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 greater 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.
Additional tests and medications may be necessary to diagnose and treat this condition.
During treatment with Atorvastatin Medical Valley, your doctor will closely monitor you for the development of diabetes or the risk of developing diabetes. Patients with high sugar and fat levels in the blood, patients who are overweight, and those with high blood pressure may be at risk of developing diabetes.

Atorvastatin Medical Valley and other medicines

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 medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone;
• Letermowir, 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), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion, containing aluminum or magnesium);
• Over-the-counter medicines: St. John's Wort;
• If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking Atorvastatin Medical Valley. Your doctor will tell you when you can safely resume treatment with Atorvastatin Medical Valley. Taking Atorvastatin Medical Valley with fusidic acid can rarely cause 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 the use of Atorvastatin Medical Valley can be found in section 3. However, pay attention to the following information:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may change the effect of Atorvastatin Medical Valley.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. More information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Do not take Atorvastatin Medical Valley if you are pregnant or planning to become pregnant.
Do not take Atorvastatin Medical Valley if you are of childbearing age and do not use effective methods of contraception.
Do not take Atorvastatin Medical Valley while breastfeeding.
The safety of Atorvastatin Medical Valley during pregnancy and breastfeeding has not been established. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, do 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 intolerance to some sugars, consult 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.
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 your doctor if necessary, up to a dose suitable for you. Your 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.
Atorvastatin Medical Valley tablets should be swallowed whole with water; they can be taken at any time of day, with or without food. However, try to take the tablet at the same time each day.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask 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, consult your doctor.

Taking more than the recommended dose of Atorvastatin Medical Valley

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

Missing a dose of Atorvastatin Medical Valley

If you forget to take a dose, 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 questions about taking this medicine, ask 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 following serious side effects or symptoms, stop taking the medicine and contact your doctor immediately or go to the emergency department of your 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 skin disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, or pain, or muscle rupture, or reddish-brown urine. If you also feel unwell or have a high fever, this could be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown does not always resolve, even if you stop taking atorvastatin, and it can be life-threatening and cause 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 liver problems. Consult your 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 inflammation, 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 of 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 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 urine tests

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 available data

• persistent muscle weakness
• myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease causing muscle weakness in the eyes)

Tell 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 sugar and fat levels in the blood, patients who are overweight, and those 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 those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

Keep the medicine out of the 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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
PVC/PE/PVDC/Aluminum blister: 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 (as trihydrate calcium salt of atorvastatin). Each film-coated tablet contains 20 mg of atorvastatin (as trihydrate calcium salt of atorvastatin).

Each film-coated tablet contains 40 mg of atorvastatin (as trihydrate calcium salt of atorvastatin).
Each film-coated tablet contains 80 mg of atorvastatin (as 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: glycerol mono- and di-caprylocaprate, polyvinyl alcohol, talc, titanium dioxide (E 171), and a copolymer of methoxy 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