Tulip 80 mg

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Tulip 80 mg(Atorvastatin - 1 A Pharma)

80 mg, film-coated tablets

Atorvastatinum
Tulip 80 mg and Atorvastatin - 1 A Pharma are different trade names for the same medicine.
The medicine is absolutely contraindicated in pregnancy

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Tulip 80 mg and what is it used for
• 2. Important information before taking Tulip 80 mg
• 3. How to take Tulip 80 mg
• 4. Possible side effects
• 5. How to store Tulip 80 mg
• 6. Contents of the pack and other information

1. What is Tulip 80 mg and what is it used for

Tulip 80 mg belongs to a group of medicines known as statins, which regulate lipid metabolism (fatty acid metabolism).
Tulip 80 mg is used to reduce the level of lipids (cholesterol and triglycerides) in the blood, if a low-fat diet and lifestyle changes have proven ineffective. In people with an increased risk of heart disease, Tulip 80 mg may also be used to reduce this risk, even if their cholesterol level is normal. During treatment, a standard cholesterol-reducing diet should be continued.

2. Important information before taking Tulip 80 mg

When NOT to take Tulip 80 mg

• if the patient is allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has liver disease;
• if the patient has had unexplained changes in liver function tests in the past;
• if the patient is of childbearing age and does not use effective contraception;
• if the patient is pregnant, trying to become pregnant;
• if the patient is breastfeeding;
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting to take Tulip 80 mg, discuss it with your doctor, pharmacist, or nurse if:

• the patient has severe respiratory failure;
• the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (an antibiotic used to treat bacterial infections). Taking fusidic acid at the same time as Tulip 80 mg can lead to severe muscle damage (rhabdomyolysis);
• the patient has had a stroke with bleeding into the brain or the presence of a small amount of fluid in the brain from a previous stroke;
• the patient has kidney problems;
• the patient has hypothyroidism;
• the patient has had recurring or unexplained muscle pain, or muscle problems have occurred in the past in the patient or their relatives;
• the patient has had muscle diseases during previous treatment with lipid-lowering medicines (e.g., other statins or fibrates);
• the patient regularly consumes large amounts of alcohol;
• the patient has had liver disease in the past;
• the patient is over 70 years old.

If any of the above situations apply to the patient, the doctor will recommend a blood test before treatment and probably during the use of Tulip 80 mg to assess the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, increases if certain other medicines are taken at the same time as atorvastatin (see "Tulip 80 mg and other medicines").
The patient should also tell their doctor or pharmacist if they constantly feel muscle weakness.
Additional tests and medication may be necessary to diagnose and treat these symptoms.
Patients with diabetes or at risk of developing diabetes will be closely monitored by their doctor while taking Tulip 80 mg. The risk of developing diabetes may affect people with high sugar and fat levels in the blood, with overweight and high blood pressure.

Tulip 80 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
Some medicines and Tulip 80 mg may interact with each other. This type of interaction can be the cause of reduced efficacy of one or both medicines. It can also increase the risk of side effects, including very serious muscle damage, known as rhabdomyolysis, described in section 4:

• medicines that affect the immune system, such as cyclosporine;
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin;
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, cholestyramine;
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem, as well as medicines that 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 virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir;
• other medicines that interact with Tulip 80 mg, including ezetimibe (a cholesterol-lowering medicine), warfarin (a blood thinner), 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.

If the patient needs to take fusidic acid orally for the treatment of a bacterial infection, they should temporarily stop taking Tulip 80 mg. The doctor will inform the patient when they can safely start taking Tulip 80 mg again. Taking Tulip 80 mg with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Tulip 80 mg with food, drink, and alcohol

Instructions on how to take Tulip 80 mg can be found in section 3.
Consider the following information:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts can change the effect of atorvastatin.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. More information can be found in section 2, "Warnings and precautions".

Pregnancy and breastfeeding

Pregnant or breastfeeding women should not take Tulip 80 mg.
Women of childbearing age taking Tulip 80 mg must use appropriate methods of contraception.
Tulip 80 mg should not be taken during breastfeeding.
The safety of atorvastatin during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

The medicine does not normally affect the ability to drive or use machines. However, if it does, do not drive or operate any tools or machines.

Tulip 80 mg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

Tulip 80 mg contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Tulip 80 mg

Before starting treatment, the doctor will recommend a low-cholesterol diet. This diet should be continued while taking Tulip 80 mg.
Tulip 40 mg (40 mg) and Tulip 80 mg (80 mg) are available.
The usual starting dose for adults and children over 10 years old is 10 mg once daily. If necessary, the doctor may increase this dose up to the dose the patient needs. The doctor will adjust the dose of the medicine at intervals of at least 4 weeks. The maximum dose of the medicine is 80 mg once daily.
The tablets or their parts should be swallowed with a glass of water. The medicine can be taken at any time of day, with or without food. However, try to take the tablet at the same time every day.
The tablets can be divided into equal doses.
This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The duration of treatment with Tulip 80 mg is determined by the doctor.
If the patient feels that the effect of Tulip 80 mg is too strong or too weak, they should consult a doctor.

Taking a higher dose of Tulip 80 mg than recommended

In case of accidental ingestion of too many tablets of Tulip 80 mg (more than the usual daily dose), consult a doctor or the emergency department of the nearest hospital.

Missing a dose of Tulip 80 mg

If the patient forgets to take a dose, they should take the next scheduled dose at the right time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Tulip 80 mg

If the patient has any further doubts about taking this medicine or wants to stop treatment, they should consult a doctor or pharmacist.

4. Possible side effects

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

In case of any of the following serious side effects or symptoms, stop taking the tablets and contact a doctor or go to the emergency department of the nearest hospital immediately.

Rare (may affect up to 1 in 1000 people)

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can lead to severe breathing difficulties.
• Severe disease characterized by severe peeling and swelling of the skin, blistering of the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the hands or soles of the feet, with possible blistering.
• Muscle weakness, tenderness, pain, or rupture, or brownish discoloration of the urine. If these occur together with malaise or high fever, they may be caused by abnormal muscle breakdown (rhabdomyolysis). This muscle breakdown may not always resolve 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)

• if the patient experiences: unexpected or unusual bleeding, bruising, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice), this may indicate liver problems. Consult a doctor as soon as possible.
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Tulip 80 mg:

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

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood sugar levels (patients with diabetes should continue to closely monitor their blood sugar levels), increased blood creatine kinase activity
• headache
• nausea, constipation, gas, indigestion, diarrhea
• joint pain, joint swelling, muscle pain, muscle cramps, and back pain
• laboratory tests indicating possible liver problems

Uncommon side effects (may affect up to 1 in 100 people):

• loss of appetite (loss of appetite), weight gain, decreased blood sugar levels (patients with diabetes should continue to closely monitor their blood sugar levels)
• nightmares, insomnia
• dizziness, numbness or tingling of fingers (hands and feet), decreased sensation of pain or touch, taste disorders, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, bloating, abdominal pain, pancreatitis (leading to stomach pain)
• liver inflammation
• rash, skin rash, and itching, hives, hair loss
• neck pain, muscle fatigue
• feeling tired, malaise, weakness, chest pain, swelling (especially of the ankles), elevated temperature
• presence of white blood cells in the urine

Rare side effects (may affect up to 1 in 1000 people):

• vision disorders
• unexpected bleeding and bruising
• bile duct obstruction (yellowing of the skin and whites of the eyes)
• tendon damage

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

• allergic reaction (symptoms may include: sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, fainting)
• hearing loss
• gynecomastia (breast enlargement in men and women)

Side effects with unknown frequency (frequency cannot be estimated from available data):

• persistent muscle weakness

Side effects that have been reported with some statins (medicines of the same type as Tulip 80 mg):

• sexual disorders
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• diabetes: its development is more likely in patients with high sugar and fat levels in the blood, with overweight and high blood pressure. During treatment with this medicine, the doctor will monitor the patient's condition.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Tulip 80 mg

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• No special precautions for storage are necessary.
• 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.

Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung– batch number/expiry date: see imprint.

6. Contents of the pack and other information

What Tulip 80 mg contains

• The active substance of the medicine is atorvastatin (in the form of atorvastatin calcium trihydrate). Each film-coated tablet contains 80 mg of atorvastatin (in the form of atorvastatin calcium trihydrate).
• The other ingredients are: microcrystalline cellulose, calcium carbonate, lactose monohydrate, sodium croscarmellose, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, coating: hypromellose, macrogol 6000, titanium dioxide (E 171).

What Tulip 80 mg looks like and what the pack contains

The tablets are white or almost white, round, biconvex, with the symbol "A80" embossed on one side and a cross-score on the other side.
The film-coated tablets are packaged in aluminum/aluminum blisters or PVC/PE/PVDC/aluminum blisters. Outer packaging: cardboard box.
Packages contain 30, 60, or 90 film-coated tablets.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany

Manufacturer:

Lek S.A., ul. Podlipie 16, 95-010 Stryków, Poland
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:77524.00.00

Parallel import authorization number: 152/22 Date of leaflet approval: 04.04.2022

[Information about the trademark]