LARUS 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Larus, 20 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Larus and what is it used for
4. Important information before taking Larus
   1. When not to take Larus:
   2. Warnings and precautions
   3. Children and adolescents
   4. Larus and other medicines
   5. Taking Larus with food, drink, and alcohol
   6. Pregnancy and breast-feeding
   7. Driving and using machines
   8. Larus contains sodium
5. How to take Larus
   1. What to do if you take more Larus than you should
   2. What to do if you forget to take Larus
   3. What to do if you want to stop taking Larus
6. Possible side effects
   1. If you experience any of the following serious side effects or symptoms, stop taking the tablets and contact your doctor or go to the emergency department of your nearest hospital immediately.
   2. Other possible side effects of Larus:
   3. Reporting side effects
7. How to store Larus
8. Contents of the pack and other information
   1. What Larus contains
   2. What Larus looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Date of last revision of the package leaflet: September 2021

Package Leaflet: Information for the User

Larus, 20 mg, Film-Coated Tablets

Atorvastatin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Larus and what is it used for

Larus belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Larus 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. Larus may 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 maintained.

2. Important information before taking Larus

When not to take Larus:

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had liver disease,
• if you have unexplained abnormal liver function tests,
• in women who are able to become pregnant and are not using effective contraception,
• in pregnant or breast-feeding women,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Larus, discuss 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. Combination treatment with fusidic acid and Larus may lead to serious muscle disorders (rhabdomyolysis),
• in case of a stroke with bleeding in the brain or if there are small fluid-filled spaces in the brain from a previous stroke,
• in case of kidney problems,
• in case of hypothyroidism,
• in case of recurring or unexplained muscle pain or muscle problems in the past or similar problems in relatives,
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• in case of regular consumption of large amounts of alcohol,
• in case of a history of liver disease,
• in patients over 70 years of age.

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Larus and, if possible, during treatment to monitor the risk of muscle side effects. The risk of muscle side effects, such as rhabdomyolysis (breakdown of skeletal muscle tissue), is higher when certain medicines are taken at the same time (see section 2 "Larus and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition.
Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. Patients with high blood sugar and lipid levels, overweight, and high blood pressure may be at risk of developing diabetes.

Children and adolescents

Children and adolescents should only be treated with Larus by doctors experienced in treating children with high lipid levels.
Patients should undergo regular examinations to assess treatment progress.
Atorvastatin is not indicated for the treatment of patients under 10 years of age.

Larus 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 may change the effect of Larus, and Larus may affect the action of other medicines.
Such interactions can lead to reduced efficacy of one or both medicines. At the same time, they can increase the risk or severity of side effects, including serious muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressants, 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 (e.g., fenofibrate), colestyramine,
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem, as well as heart rhythm regulators, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, combination treatment with tipranavir/ritonavir, etc., as well as certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir.
• other medicines known to interact with atorvastatin, including 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 to treat heartburn, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort,
• if you need to take fusidic acid orally to treat bacterial infections, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely resume taking Larus. Taking Larus with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Larus with food, drink, and alcohol

See section 3 for recommendations on taking the medicine. Also, consider 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 Larus.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. More information on this can be found in section 2 "Warnings and precautions”.

Pregnancy and breast-feeding

Taking Larus during pregnancy or if you are planning to become pregnant is contraindicated.
Taking Larus during breast-feeding is contraindicated.
The safety of atorvastatin during pregnancy and breast-feeding has not been established.
If you are pregnant, breast-feeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

Larus contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is considered "sodium-free”.

3. How to take Larus

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Larus.
Usually, the initial dose of Larus is 10 mg* once a day for adults and children over 10 years of age. This dose may be increased by your doctor if necessary up to the dose you need. Your doctor will adjust the dose of Larus at intervals of 4 weeks or more.
The maximum dose of Larus is 80 mg once a day.
* 10 mg doses are not available for this medicine. To achieve a dose of 10 mg, an alternative product with the same active substance should be used.
Take the film-coated tablets 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 Larus is determined by your doctor.
If you feel that the effect of Larus is too strong or too weak, talk to your doctor.

What to do if you take more Larus than you should

If you have taken more than the recommended dose of Larus (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

What to do if you forget to take Larus

If you miss a dose of Larus, simply take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

What to do if you want to stop taking Larus

If you have any further questions about taking this medicine or want to stop taking it, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Larus can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects or symptoms, stop taking the tablets 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 lead to 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 palms or soles, with possible blisters.
• Muscle weakness, tenderness, pain, or rupture, or brownish discoloration of the urine. If you also feel unwell or have a high fever, it may be due to an unusual breakdown of muscle tissue (rhabdomyolysis). Unusual muscle breakdown does not always go away, even after stopping atorvastatin, and can be life-threatening and lead to kidney problems.

Very rare (may affect up to 1 in 10,000 people):

• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• If you experience unexpected or unusual bleeding or bruising, it may indicate liver problems. You should see your doctor as soon as possible.

Other possible side effects of Larus:

Common side effects (may affect up to 1 in 10 people):

• nosebleeds, sore throat, nasal inflammation;
• 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 and swelling, muscle cramps, muscle pain, and back pain, limb pain;
• blood test results indicating abnormal liver function.

Uncommon side effects (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, reduced sensitivity to pain and touch, changes in taste, memory loss;
• blurred vision;
• ringing in the ears and/or head;
• vomiting, belching, upper and lower abdominal pain, pancreatitis (causing abdominal pain);
• hepatitis;
• 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 analysis.

Rare side effects (may affect up to 1 in 1,000 people):

• vision disorders;
• unexpected bleeding or bruising (bruises);
• jaundice (yellowing of the skin and whites of the eyes);
• tendon damage,
• weakness, numbness, and pain in the hands and feet (peripheral neuropathy).

Very rare side effects (may affect up to 1 in 10,000 people):

• allergic reactions - symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, tongue, or throat, difficulty breathing, collapse;
• hearing loss;
• gynecomastia (breast enlargement in men). Frequency not known (cannot be estimated from the available data):
• persistent muscle weakness.

Other possible side effects of Larus 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 diabetes is higher in people with high blood sugar and lipid levels, overweight, and 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 package 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,
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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Larus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Larus contains

The active substance of Larus is atorvastatin. Each film-coated tablet contains 20 mg of atorvastatin (in the form of atorvastatin calcium)
The other ingredients are:
Tablet core: mannitol, microcrystalline cellulose, calcium carbonate, povidone (K-30), sodium croscarmellose, sodium lauryl sulfate, silica colloidal anhydrous, magnesium stearate,
Coating: hypromellose, titanium dioxide (E171), macrogol 6000.

What Larus looks like and contents of the pack

Larus, film-coated tablets, 20 mg: white, round, biconvex, 9 mm, film-coated tablets.
30 or 100 film-coated tablets in blisters, in a cardboard box
Not all pack sizes may be marketed.
The medicine is available in a 20 mg film-coated tablet strength.

Marketing authorization holder:

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer:

Actavis ehf.,
Reykjavikurvegur 76-78,
IS-220 Hafnarfjörður, Iceland.
Balkanpharma – Dupnitsa AD
Samokovsko Shosse 3
Dupnitsa 2600, Bulgaria
To obtain more detailed information on the medicine and its names in other EU member states, contact the local representative of the marketing authorization holder:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
[email protected]

Date of last revision of the package leaflet: September 2021