Atorvastatin medical valley

Package leaflet: 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
Atorvastatinum
Please read all of 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Atorvastatin Medical Valley is and what it is used for
2. What you need to know 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 Atorvastatin Medical Valley is and what it is 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 levels of lipids known as cholesterol and triglycerides in the blood when diet low in fat and lifestyle changes alone are not effective. Atorvastatin Medical Valley may also be used to reduce the risk of heart disease, even when cholesterol levels are normal. You should continue to follow a standard low-cholesterol diet during treatment.

2. Important information before using Atorvastatin Medical Valley

When not to use Atorvastatin Medical Valley

• if the patient is allergic to atorvastatin or to any of the other ingredients of this medicine (listed in section 6),
• if the patient currently has or has previously had liver disease, or if the patient has had unexplained abnormal results of liver function tests,
• in women of childbearing age who are not using effective methods of contraception,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women,
• if the patient is concurrently 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 the patient has severe respiratory insufficiency,
• if the patient is taking or has taken fusidic acid orally or by injection within the last 7 days (a medicine used to treat bacterial infections). Concomitant use of fusidic acid with Atorvastatin Medical Valley may lead to serious muscle problems (rhabdomyolysis),
• if the patient has previously had a haemorrhagic stroke, 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 previously experienced recurrent or unexplained muscle pain or muscle problems, or if such problems occur in family members,
• if the patient has previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient currently has or has previously had myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has previously had liver disease,
• if the patient is over 70 years of age.

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Atorvastatin Medical Valley and, as appropriate, during treatment, to monitor the risk of muscle-related adverse effects.
It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is higher when certain medicines are used concomitantly (see section 2 “Atorvastatin Medical Valley and other medicines”).
Inform your doctor or pharmacist also if muscle weakness persists.
Additional tests and additional medicines may be necessary to diagnose and treat this condition.
During treatment, the doctor will closely monitor the patient for the development of diabetes or risk of developing diabetes. Patients with high blood sugar and lipid levels, overweight patients, and those with high blood pressure may be susceptible to the risk of developing diabetes.

Atorvastatin Medical Valley and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Some medicines may alter the effect of Atorvastatin Medical Valley or the effect of these medicines may be altered by Atorvastatin Medical Valley. This type of interaction may result in reduced effectiveness of one or both medicines. In addition, it may increase the risk of serious adverse effects, including serious muscle damage known as rhabdomyolysis, described in section 4:

• Immunosuppressive medicines, e.g. cyclosporine;
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• Other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine;
• Certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone;
• Letermovir, a medicine used to prevent cytomegalovirus infection;
• Medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.;
• Certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and combination medicines containing elbasvir with grazoprevir, ledipasvir with sofosbuvir;
• Daptomycin (a medicine used to treat complicated skin and skin tissue infections and bacteraemia);
• Other medicines known to interact with Atorvastatin Medical Valley include ezetimibe (which lowers cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a pain-relieving medicine), colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium);
• Over-the-counter medicines: St. John's wort (Hypericum perforatum);
• If the patient needs to take oral fusidic acid to treat a bacterial infection, treatment with this medicine should be temporarily discontinued. The doctor will inform the patient when it is safe to restart treatment with Atorvastatin Medical Valley. Taking Atorvastatin Medical Valley together with fusidic acid may 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 the use of Atorvastatin Medical Valley can be found in section 3. However, please pay attention to the following information:
Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Atorvastatin Medical Valley.
Alcohol
Avoid consuming excessive amounts of alcohol while taking this medicine. Further information on this topic is provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not use Atorvastatin Medical Valley in pregnant women or in women planning to become pregnant.
Do not use Atorvastatin Medical Valley in women of childbearing age who are not using effective methods of contraception.
Do not use Atorvastatin Medical Valley during 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 operating machinery
Usually, this medicine does not affect the ability to drive or operate machinery. However, the patient should not drive if this medicine affects their ability to do so. Do not use any tools or machinery if taking this medicine affects your ability to operate them.

Atorvastatin Medical Valley contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Atorvastatin Medical Valley contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use 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 in adults and children aged 10 years or older is 10 mg once daily. This dose may be adjusted by the doctor as needed to achieve the appropriate dose for the patient. The doctor will adjust the dose 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 and can be taken at any time of day, with or without food. However, it is advisable to take the tablet at the same time each day.
This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The duration of treatment with Atorvastatin Medical Valley is determined by the doctor.
If you feel that the effect of Atorvastatin Medical Valley is too strong or too weak, consult your doctor.
Taking more Atorvastatin Medical Valley than prescribed
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 your dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping Atorvastatin Medical Valley
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the serious adverse reactions or symptoms listed below, they should
stop taking the medicine immediately and contact their doctor or go to the emergency department
of the nearest hospital.

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

• Severe allergic reaction causing swelling of the face, tongue and throat, which may lead to severe breathing difficulties.
• Severe illness characterized by skin peeling and swelling, skin blisters, sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters.
• Muscle weakness, tenderness, pain or muscle rupture, or red-brown discoloration of urine. If accompanied by malaise or high fever, this may indicate breakdown of striated muscles (rhabdomyolysis). Rhabdomyolysis may not always resolve even after discontinuation of atorvastatin, and may be life-threatening and lead to kidney problems.

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

• If the patient experiences unexpected or unusual bleeding or bruising, this may indicate liver abnormalities. Medical advice should be sought as soon as possible.
• Lupus-like syndrome (including rash, joint disorders and effects on blood cells).

Other possible adverse reactions of Atorvastatin Medical Valley:
Common: may occur in up to 1 in 10 people

• Nasopharyngitis, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• Headache
• Nausea, constipation, bloating, indigestion, diarrhoea
• Joint pain, muscle pain and back pain
• Blood test results indicating abnormal liver function

Uncommon: may occur in up to 1 in 100 people

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin rash and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles, elevated temperature
• Presence of white blood cells in urine analysis

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

• Visual disturbances
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Skin rash or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

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

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast tissue in males)

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 weakness of eye muscles)

Talk to a doctor if the patient experiences weakness in arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathlessness.
Other possible adverse reactions reported during treatment with some statins (medicines of the same type):

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Diabetes. The likelihood of developing diabetes is higher in patients with high levels of blood sugar and lipids, overweight patients, and those with high blood pressure. During treatment with this medicine, the doctor will perform appropriate tests in the patient.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atorvastatin Medical Valley

Keep this 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect the environment.
PVC/PE/PVDC/Aluminium blister: Store below 25 °C.

6. Package contents and other information

What Atorvastatin Medical Valley contains

• The active substance is atorvastatin. Each coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate). Each coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate). Each coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate). Each coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate).
• 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 monodicaprylocaprate, polyvinyl alcohol, talc, titanium dioxide (E 171), and a polyethylene glycol (PEG)-grafted copolymer of polyvinyl alcohol.

What Atorvastatin Medical Valley looks like and contents of the pack
10 mg: Atorvastatin Medical Valley coated tablets are white, round, biconvex, with a break line on one side and the imprint "10" on the other side. The tablet diameter is approximately 7 mm.
20 mg: Atorvastatin Medical Valley coated tablets are white, round, biconvex, with a break line on one side and the imprint "20" on the other side. The tablet diameter is approximately 9.0 mm.
40 mg: Atorvastatin Medical Valley coated tablets are white, round, biconvex, with a break line on one side and the imprint "40" on the other side. The tablet diameter is approximately 11.0 mm.
80 mg: Atorvastatin Medical Valley coated tablets are white, round, biconvex, with a break line on one side and the imprint "80" on the other side. The tablet diameter is approximately 13 mm.
Atorvastatin Medical Valley coated tablets are available in blisters, in packages containing 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Spain: Atorvastatina Sandoz 10 mg comprimidos recubiertos con película EFG
Atorvastatina Sandoz 20 mg comprimidos recubiertos con película EFG
Atorvastatina Sandoz 40 mg comprimidos recubiertos con película EFG
Atorvastatina Sandoz 80 mg comprimidos recubiertos con película EFG

Netherlands: Atorvastatine Liconsa 10 mg Filmomhulde tabletten
Atorvastatine Liconsa 20 mg Filmomhulde tabletten
Atorvastatine Liconsa 40 mg Filmomhulde tabletten
Atorvastatine Liconsa 80 mg Filmomhulde tabletten

Germany: Atorvastatin Laboratorios Liconsa 10 mg Filmtabletten
Atorvastatin Laboratorios Liconsa 20 mg Filmtabletten
Atorvastatin Laboratorios Liconsa 40 mg Filmtabletten
Atorvastatin Laboratorios Liconsa 80 mg Filmtabletten

Poland: Atorvastatin Medical Valley