LAMBRINEX 20 mg Tablets

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. Lambrinex, 10 mg, coated tablets
3. Lambrinex, 20 mg, coated tablets
4. Lambrinex, 40 mg, coated tablets
   1. Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
5. What is Lambrinex and what is it used for
6. Important information before taking Lambrinex
   1. When not to take Lambrinex:
   2. Warnings and precautions
   3. Consult your doctor or pharmacist before taking Lambrinex:
   4. Other medicines and Lambrinex
   5. Taking Lambrinex with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Lambrinex contains lactose
7. How to take Lambrinex
   1. Taking a higher dose of Lambrinex than recommended
   2. Missing a dose of Lambrinex
   3. Stopping treatment with Lambrinex
8. Possible side effects
   1. If you experience any of the following serious side effects or symptoms, stop taking the medicine and contact your doctor or go to the emergency department of your nearest hospital immediately.
   2. Other possible side effects of Lambrinex:
   3. The following side effects have been reported with other statins:
   4. Reporting side effects
9. How to store Lambrinex
10. Contents of the pack and other information
    1. What Lambrinex contains
    2. What Lambrinex looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    6. Date of last revision of the leaflet: 04/2023

Patient Information Leaflet: User Information

Lambrinex, 10 mg, coated tablets

Lambrinex, 20 mg, coated tablets

Lambrinex, 40 mg, coated tablets

Atorvastatin

Read the contents of 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 or pharmacist.
• 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 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 reduce the levels of lipids known as cholesterol and triglycerides in the blood when a low-fat diet and changes in lifestyle are not effective. Lambrinex can also be used to reduce the risk of heart disease, even if cholesterol levels are normal. During treatment, you should continue a standard low-cholesterol diet.

2. Important information before taking Lambrinex

When not to take Lambrinex:

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

Warnings and precautions

You should talk to your doctor or pharmacist before taking Lambrinex:

• in patients over 70 years of age.

Consult your doctor or pharmacist before taking Lambrinex:

In patients who are affected by any of the above conditions, your doctor will order 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").
You should also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to diagnose and treat muscle weakness.
During treatment with this medicine, the patient's health will be closely monitored if the patient has diabetes or is at risk of developing diabetes. The patient is at risk of developing diabetes if they have high blood sugar and fat levels, are overweight, and have high blood pressure.

Other medicines and Lambrinex

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.
If you need to take fusidic acid orally for the treatment of a bacterial infection, it will be necessary to temporarily stop taking Lambrinex. Your doctor will inform you 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.
Some medicines may affect the way Lambrinex works or the way these medicines work may be affected 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 severe 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 medicines used to regulate heart rhythm, 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 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 (used to treat gout), and antacids (medicines used to treat 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, please note the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may affect the way Lambrinex works.
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

Taking Lambrinex during pregnancy or if you are planning to become pregnant is contraindicated.
Taking Lambrinex in women of childbearing age is contraindicated if they do not use effective methods of contraception.
Taking Lambrinex during breastfeeding is contraindicated.
The safety of taking Lambrinex 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 if the medicine affects your ability to drive. Do not use any tools or machines if taking the medicine affects your ability to use them.

Lambrinex contains lactose

Patients who have been informed by their doctor about intolerance to some sugars should contact their doctor before taking this medicine.

3. How to take Lambrinex

Always take Lambrinex exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Before starting treatment, your 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 your doctor if necessary, up to a dose suitable for you. Your 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.
Lambrinex 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.
The duration of treatment with Lambrinex is determined by your doctor.
If you feel that the effect of Lambrinex is too strong or too weak, talk to your doctor.

Taking a higher dose of Lambrinex than recommended

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

Missing a dose of Lambrinex

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 a missed dose.

Stopping treatment with Lambrinex

If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lambrinex 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 or go to the emergency department of your 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 skin disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with reddish-purple spots, especially on the hands or feet, 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 go away, even after stopping atorvastatin, and 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. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Lambrinex:

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 or head,
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain),
• hepatitis,
• 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).

Side effects of unknown frequency:

• 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).

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.

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 onset of diabetes is more likely if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor your condition while taking this medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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 this medicine.

5. How to store Lambrinex

Keep out of the sight and reach 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. Ask your pharmacist how to dispose of medicines no longer required. 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 coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium). Each coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium). Each coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium).
• The other ingredients of Lambrinex are: Core: attapulgite, lactose monohydrate, microcrystalline cellulose, maize starch, hydroxypropylcellulose (HPC-L), magnesium stearate, silica colloidal anhydrous. 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 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 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 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.
Pack sizes are: 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