Lambrinex

Lambrinex, 10 mg, film-coated tablets
Lambrinex, 20 mg, film-coated tablets
Lambrinex, 40 mg, film-coated tablets
Atorvastatin
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Lambrinex is and what it is 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 Lambrinex is and what it is used for

Lambrinex belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Lambrinex is used to reduce blood levels of lipids known as cholesterol and triglycerides when a low-fat diet and lifestyle changes alone are not effective. Lambrinex may also be used to reduce the risk of heart disease, even when cholesterol levels are within the normal range. During treatment, the patient should continue to follow a standard low-cholesterol diet.

2. Important information before using Lambrinex

When not to use Lambrinex:

• if the patient is allergic to atorvastatin or to any other similar medicine used to lower blood lipid levels, 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,
• if the patient has unexplained abnormal liver function test results,
• 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
Talk to your doctor or pharmacist before starting to take Lambrinex:

• if the patient has had a stroke with bleeding into 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,
• if the patient has had recurrent or unexplained muscle pain or muscle problems in the past, or if family members have had similar problems,
• if the patient currently has or has previously had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4),
• if the patient has had muscle problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient is currently taking or has taken within the last 7 days fusidic acid taken orally or by injection (a medicine used to treat bacterial infections). Concomitant use of fusidic acid and Lambrinex may lead to serious muscle problems (rhabdomyolysis),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has had liver disease in the past,
• in patients over 70 years of age.

Contact your doctor or pharmacist before taking Lambrinex:

• in case of severe respiratory insufficiency.

In patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Lambrinex and, whenever possible, 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 "Other medicines and Lambrinex").
You should also inform your doctor or pharmacist if the patient suffers from chronic muscle weakness. Additional tests and medicines may be needed to diagnose and treat muscle weakness.
While taking 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 levels of blood sugar and lipids, overweight, and high blood pressure.

Other medicines and Lambrinex
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
If the patient needs to take fusidic acid orally to treat a bacterial infection, temporary discontinuation of Lambrinex is necessary. The doctor will advise when it is safe to resume treatment with Lambrinex. Concomitant use of Lambrinex with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis is provided in section 4.
Some medicines may alter the effect of Lambrinex or their effect may be altered by Lambrinex. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressive medicines, e.g. cyclosporine,
• certain antibiotics and 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 also medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• 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, e.g. telaprevir, boceprevir, and the fixed combination containing elbasvir with grazoprevir,
• other medicines known to interact with Lambrinex 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 (an analgesic), colchicine (used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium),
• over-the-counter medicines: St. John's wort (Hypericum perforatum).

Taking Lambrinex with food and drink
Information on how to take Lambrinex is provided in section 3. However, please note the following:

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 Lambrinex.

Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Further information on this topic is provided in section 2 "Warnings and precautions".

Pregnancy and breastfeeding
Use of Lambrinex in women who are pregnant or planning to become pregnant is contraindicated.
Use of Lambrinex in women of childbearing age is contraindicated if they are not using effective methods of contraception.
Use of Lambrinex during breastfeeding is contraindicated.
The safety of using Lambrinex during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Lambrinex usually does not affect the ability to drive or operate machinery. However, patients should not drive if this medicine affects their ability to do so. Do not use any tools or machines if taking this medicine impairs your ability to operate them safely.

Lambrinex contains lactose
Patients who have been informed by their doctor that they have an intolerance to certain sugars should consult their doctor before taking this medicine.

3. How to use Lambrinex

Lambrinex must always be taken as prescribed by the doctor. If in doubt,
consult the doctor or pharmacist again.
Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued
during treatment with Lambrinex.
The recommended starting dose of Lambrinex in adults and children aged 10 years or older is 10 mg once daily.
This dose may be increased by the doctor, if necessary, up to the dose appropriate for the patient.
The doctor adjusts the dose at intervals of 4 weeks or longer.
The maximum dose of Lambrinex is 80 mg once daily for adults and 20 mg once daily for children.
Lambrinex tablets should be swallowed whole with water; they may 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.
The duration of treatment with Lambrinex is determined by the doctor.
If you feel that the effect of Lambrinex is too strong or too weak, consult your doctor.
Taking more Lambrinex than prescribed
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 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 Lambrinex
If you have any doubts about using Lambrinex, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Lambrinex can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the serious adverse reactions or symptoms listed below, they must
stop taking the medicine immediately and contact a doctor 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 may lead to severe breathing difficulties.
• Severe illness characterized by skin peeling and swelling, skin blisters, and sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, possibly with blisters.
• Muscle weakness, tenderness or pain, muscle tears, or red-brown discoloration of urine, particularly if accompanied by malaise or high fever—this may be due to abnormal muscle breakdown. Abnormal muscle breakdown does not always resolve even after discontinuation of atorvastatin and may be life-threatening and lead to kidney problems.

Very rare – may affect up to 1 in 10,000 people

• Unexpected or unusual bleeding or bruising, which may indicate liver problems. Medical advice should be sought immediately.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse reactions of Lambrinex:
Common – may affect 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 monitored carefully), 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 affect 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 monitored carefully),
• 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 or head,
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain),
• Hepatitis,
• Rash, skin eruptions and itching, urticaria, hair loss,
• Neck pain, muscle fatigue,
• Fatigue, malaise, weakness, chest pain, swelling (especially of the ankles), elevated body temperature,
• Presence of white blood cells in urine.

Rare – may affect 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.

Very rare – may affect up to 1 in 10,000 people

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, breathing difficulties, collapse.
• Hearing loss,
• Gynaecomastia (excessive development of breast gland tissue in men).

Adverse reactions with unknown frequency:

• 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 the eye muscles).

Talk to a doctor if the patient experiences weakness in the arms or legs that worsens with activity, double vision, drooping eyelids, difficulty swallowing, or shortness of breath.
The following adverse reactions have been reported with treatment using other statins:
Possible adverse reactions reported during treatment with certain statins (medicines of the same type):

• Sexual dysfunction,
• 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 blood sugar and fats, overweight, and high blood pressure. The doctor will monitor the patient's condition during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Lambrinex

Keep out of the reach and sight of children.
Store below 30°C.
Do not use Lambrinex after the expiry date stated on the carton after 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 in Lambrinex is atorvastatin.
  o Each coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium).
  o Each coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium).
  o Each coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium).
• Other ingredients in Lambrinex are:
  o Tablet core: activated attapulgite, monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, hydroxypropylcellulose (HPC-L), magnesium stearate, colloidal anhydrous silica.
  o Coating: titanium dioxide (E171), monohydrate lactose, macrogol 4000, hypromellose 15 cP (E464), hypromellose 3 cP (E464), hypromellose 50 cP (E464).

What Lambrinex looks like and contents of the pack
10 mg film-coated tablets
White, oval, biconvex tablets measuring 10.1 ± 0.1 mm x 5.6 ± 0.1 mm and 3.7 ± 0.2 mm in thickness.
20 mg film-coated tablets
White, elongated, biconvex tablets with a central break line on one side, measuring 12.7 ± 0.1 mm x 6.7 ± 0.1 mm and 4.6 ± 0.2 mm in thickness.
40 mg film-coated tablets
White, elongated, biconvex tablets measuring 19.4 ± 0.1 mm x 7.8 ± 0.1 mm and 4.7 ± 0.2 mm in thickness.
Lambrinex is packed in blisters made of PA/ALL/PVC/Aluminium.
Pack sizes are as follows:
10, 14, 28, 30, 50, 60, 84, 90, 96, 98, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Poland

Manufacturers:
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 for 10 mg, 20 mg, 40 mg)

This medicinal product is authorised in the European Economic Area under the following names:
Denmark: Atorvastatin Generics
Netherlands: Atorvastatine 10 A, filmomhulde tabletten 10 mg, Atorvastatine 20 A, filmomhulde tabletten 20 mg, Atorvastatine 40 A, filmomhulde tabletten 40 mg, Atorvastatine 80 A, filmomhulde tabletten 80 mg
Cyprus, Poland: Lambrinex
Germany: Atorvastatin Mylan 10 mg, 20 mg, 40 mg, 80 mg Filmtabletten
Spain: Atorvastatina Amneal 10 mg, 20 mg, 40 mg, 80 mg Comprimido recubierto con película EFG
France: Atorvastatin Mylan Pharma 10 mg, 20 mg, 40 mg, 80 mg Comprimé pelliculé
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