Lambrinex

Patient Information Leaflet: User Manual

Lambrinex, 10 mg, film-coated tablets

Lambrinex, 20 mg, film-coated tablets

Lambrinex, 40 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Lambrinex and what is it used for

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

2. Important information before taking Lambrinex

When not to take Lambrinex:

• if the patient is allergic to atorvastatin or any other similar medicine used to lower lipid levels in the blood or to any of the other ingredients of the 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 taking Lambrinex, the patient should talk to their doctor or pharmacist:

• if they 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 they have kidney problems,
• if they have hypothyroidism,
• if they have had repeated or unexplained muscle pain or muscle problems in the past or similar problems in relatives,
• if they have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms or lead to myasthenia (see section 4),
• if they have had muscle problems while taking other lipid-lowering medicines in the past,
• if they are currently taking or have taken fusidic acid orally or by injection in the last 7 days (an antibiotic used to treat bacterial infections). Taking Lambrinex with fusidic acid can rarely lead to serious muscle problems (rhabdomyolysis),
• if they regularly drink large amounts of alcohol,
• if they have had liver disease in the past,
• in patients over 70 years of age.

Consult a doctor or pharmacist before taking Lambrinex:

• in case of severe respiratory failure.

In patients who are affected by any of the above situations, the doctor will prescribe a blood test before starting treatment with Lambrinex 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 "Other medicines and Lambrinex").
The patient should also inform their doctor or pharmacist if they have persistent muscle weakness. Additional tests and medicines may be needed to diagnose and treat muscle weakness.
During treatment with this medicine, the patient's health will be closely monitored if they have diabetes or are at risk of developing diabetes. The patient is at risk of developing diabetes if they have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Other medicines and Lambrinex

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
If the patient needs to take fusidic acid orally for a bacterial infection, they will need to temporarily stop taking Lambrinex. The doctor will inform them when it is safe to restart Lambrinex. Taking Lambrinex with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
Certain medicines can change the effect of Lambrinex or the effect of these medicines on the body can be changed by Lambrinex. 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 serious muscle damage known as rhabdomyolysis, described in section 4:

• medicines that modify the immune system, such as cyclosporine,
• certain antibiotics and 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, and certain heart rhythm regulators, such as digoxin, verapamil, amiodarone,
• 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, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir,
• other medicines that are known to interact with Lambrinex, such as 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 (used to treat gout), and antacids (medicines used for indigestion, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort.

Taking Lambrinex with food and drink

Information on taking Lambrinex 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 Lambrinex.
Alcohol
The patient should avoid drinking excessive amounts of alcohol while taking Lambrinex.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Taking Lambrinex during pregnancy or breastfeeding is contraindicated.
Taking Lambrinex in women of childbearing age is contraindicated if they do not use effective methods of contraception.
The safety of taking Lambrinex during pregnancy and breastfeeding has not been established.
Before taking any medicine, the patient should consult a 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 drive. The patient should not use any tools or machines if taking the medicine affects their ability to use them.

Lambrinex contains lactose

Patients who have been informed by their doctor about intolerance to certain sugars should contact their doctor before taking Lambrinex.

3. How to take Lambrinex

Lambrinex should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Lambrinex.
The recommended initial dose of Lambrinex for adults and children over 10 years of age is 10 mg once a day. This dose may be increased by the doctor if necessary to a dose suitable for the patient. The doctor will adjust the dose of Lambrinex at intervals of 4 weeks or more. The maximum dose of Lambrinex is 80 mg once a day for adults and 20 mg once a day for children.
The tablets of Lambrinex should be swallowed 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.
The duration of treatment with Lambrinex is determined by the doctor.
If the patient feels that the effect of Lambrinex is too strong or too weak, they should consult their doctor.

Taking a higher dose of Lambrinex than recommended

In case of accidental ingestion of more tablets of Lambrinex than the usual daily dose, the patient should consult their doctor or the nearest hospital for advice.

Missing a dose of Lambrinex

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 Lambrinex

In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lambrinex 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.

Raremay occur in 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, especially if accompanied by malaise or high fever, may be caused by abnormal muscle breakdown. Abnormal muscle breakdown may not always resolve, even after stopping atorvastatin, and may be life-threatening and cause kidney problems.

Very raremay occur in 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 (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Lambrinex:

Common(may occur in 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 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 occur in 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 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 occur in 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 occur in 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 growth of breast tissue in men).

Side effects of unknown frequency:

• 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.

The following side effects have been reported with other statins:

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 development of diabetes is more likely if the patient has high levels of sugars and fats in the blood, is overweight, and has high blood pressure. The doctor will monitor the patient's condition during treatment with this medicine.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lambrinex

Keep out of the reach and sight of children.
Store in a temperature below 30°C.
Do not take Lambrinex after the expiry date stated on the carton after the expiry date (EXP). The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Lambrinex contains

• The active substance of Lambrinex is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin (in the form of atorvastatin calcium). Each film-coated tablet contains 20 mg of atorvastatin (in the form of atorvastatin calcium). Each film-coated tablet contains 40 mg of atorvastatin (in the form of atorvastatin calcium).
• The other ingredients of Lambrinex are: Core: activated attapulgite, lactose monohydrate, microcrystalline cellulose, maize starch, hydroxypropylcellulose (HPC-L), magnesium stearate, anhydrous colloidal silica. Coating: titanium dioxide (E171), lactose monohydrate, macrogol 4000, hypromellose 15 cP (E464), hypromellose 3cP (E464), hypromellose 50cP (E464).

What Lambrinex looks like and contents of the pack

10 mg film-coated tablets
white, oval, biconvex tablets with dimensions 10.1 ± 0.1 mm x 5.6 ± 0.1 mm and 3.7 ± 0.2 mm thickness.
20 mg film-coated tablets
white, elongated, biconvex tablets with a score line on one side and dimensions 12.7 ± 0.1 mm x 6.7 ± 0.1 mm and 4.6 ± 0.2 mm thickness.
40 mg film-coated tablets
white, elongated, biconvex tablets with dimensions 19.4 ± 0.1 mm x 7.8 ± 0.1 mm and 4.7 ± 0.2 mm thickness.
Lambrinex is packaged in PA/ALL/PVC/Aluminum blisters.
The pack sizes are as follows:
10, 14, 28, 30, 50, 60, 84, 90, 96, 98, 100.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Manufacturer:
PHARMATHEN S.A., 6 Dervenakion str, GR-15351 Pallini, Attikis, Greece
or
PHARMATHEN INTERNATIONAL S.A, Industrial Park Sapes, Rodopi Prefecture, Block No 5,
Rodopi 69300, Greece
or
McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange State, Dublin 13, Ireland
or
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire. EN6 1TL, United Kingdom
or
SUPROBION Sp. z o.o., Sp. k., ul. Kiełczowska 2, Mirków, 55-095, Poland (only 10 mg, 20 mg, 40 mg)

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

Denmark:
Atorvastatin Generics
Netherlands:
Atorvastatine 10 A, film-coated tablets 10 mg, Atorvastatine 20 A, film-coated tablets 20 mg, Atorvastatine 40 A, film-coated tablets 40 mg, Atorvastatine 80 A, film-coated tablets 80 mg
Cyprus, Poland:
Lambrinex
Germany:
Atorvastatin Mylan 10 mg, 20 mg, 40 mg, 80 mg film-coated tablets
Spain:
Atorvastatina Amneal 10 mg, 20 mg, 40 mg, 80 mg coated tablet EFG
France:
Atorvastatin Mylan Pharma 10 mg, 20 mg, 40 mg, 80 mg film-coated tablet
Ireland:
Atorvastatin Pharmathen 10 mg, 20 mg, 40 mg, 80 mg film-coated tablet
United Kingdom: Atorvastatin 10 mg, 20 mg, 40 mg, 80 mg film-coated tablet
Greece:
Lambrinex 10 mg, 20 mg, 40 mg, 80 mg

Date of last revision of the leaflet: 04/2023