Tulip 80 mg

Package leaflet: Information for the patient

Warning! Keep this 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.
This medicine is absolutely contraindicated during pregnancy.
Please read the entire leaflet carefully before taking the 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 doubts, 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 of illness are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Tulip 80 mg belongs to a group of medicines known as statins, which regulate lipid (fat) metabolism.
Tulip 80 mg is used to lower blood lipid levels (cholesterol and triglycerides) when diet low in fat and lifestyle changes alone have proven ineffective. In individuals at increased risk of heart disease, Tulip 80 mg may also be used to reduce this risk, even if their cholesterol levels are within the normal range. During treatment, the standard cholesterol-lowering diet should be continued.

2. Important information before using Tulip 80 mg

When NOT TO USE Tulip 80 mg

• if the patient is allergic to atorvastatin or to any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has or has ever had liver disease;
• if the patient has previously had unexplained abnormalities in liver function tests;
• if the patient is of childbearing age and is not using 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 with your doctor, pharmacist, or nurse if:

• the patient has been diagnosed with severe respiratory failure;
• the patient is taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (a medicine used for bacterial infections). Concomitant use of fusidic acid with Tulip 80 mg may lead to severe muscle damage (rhabdomyolysis);
• the patient has previously experienced a haemorrhagic stroke or has small amounts of fluid in the brain from a previous stroke;
• the patient has kidney function impairment;
• the patient has hypothyroidism;
• the patient has previously experienced recurrent or unexplained muscle pain, or if muscle problems have occurred in the past in the patient or in their relatives;
• the patient has previously experienced muscle disorders while taking lipid-lowering medicines (e.g. other statins or fibrates);
• the patient regularly consumes large amounts of alcohol;
• the patient has previously had liver disease;
• the patient is over 70 years old.

If any of the above situations apply to the patient, the doctor may recommend a blood test before starting treatment and possibly during treatment with Tulip 80 mg to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain other medicines are taken concomitantly with atorvastatin (see below "Tulip 80 mg and other medicines").
The patient should also inform the doctor or pharmacist if they are experiencing persistent muscle weakness.
Diagnosis and treatment of these symptoms may require additional tests and medication.
Patients with diabetes or at risk of developing diabetes will remain under close medical supervision during treatment with Tulip 80 mg. The risk of developing diabetes may affect individuals with high blood sugar and fat levels, overweight, and high blood pressure.

Tulip 80 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Some medicines and Tulip 80 mg may affect each other's actions. This type of interaction may result in reduced effectiveness of one or both medicines. It may also increase the risk of occurrence or worsening of adverse effects, including the very serious muscle damage known as rhabdomyolysis, described in section 4:

• medicines that alter the immune system's function, e.g. cyclosporine;
• certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin;
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestipol;
• 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 in the treatment of HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, letermovir, etc.;
• certain medicines used in the treatment of hepatitis C virus infection, e.g. telaprevir, boceprevir, and the fixed-dose combination containing elbasvir with grazoprevir;
• other medicines that interact with Tulip 80 mg, including ezetimibe (cholesterol-lowering), warfarin (a medicine that reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used for heartburn and peptic ulcer disease), phenazone (a painkiller),

colchicine (used in the treatment of gout), and antacids (medicines used for indigestion, containing aluminium 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, Tulip 80 mg should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Tulip 80 mg. Concomitant use of Tulip 80 mg with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis is provided in section 4.

Tulip 80 mg with food, drink, and alcohol
Section 3 contains instructions on how to take Tulip 80 mg.
Please consider the following information:
Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as large quantities may alter the effect of atorvastatin.
Alcohol
While taking this medicine, avoid drinking excessive amounts of alcohol. Detailed information is provided in section 2, "Warnings and precautions".

Pregnancy and breastfeeding
Women who are pregnant or trying to become pregnant must not use Tulip 80 mg.
Women of childbearing age taking Tulip 80 mg must use appropriate contraceptive methods.
Tulip 80 mg must not be used 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 operating machinery
This medicine usually does not affect the ability to drive or operate machinery. However, if such effects occur, the patient should not drive, use tools, or operate machinery.

Tulip 80 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

Tulip 80 mg contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Tulip 80 mg

Before starting treatment, your doctor will recommend a low-cholesterol diet. This diet should be continued during treatment with Tulip 80 mg.
Tulip 40 mg (40 mg) and Tulip 80 mg (80 mg) are available on the market.
The usual starting dose for adults and children aged 10 years and older is 10 mg once daily. If necessary, your doctor may increase this dose until the required dose for the patient is achieved. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose is 80 mg once daily.
Tulip 80 mg tablets or parts of tablets should be swallowed with a glass of water. The medicine can 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.
Tablets may be divided into equal doses.
This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with Tulip 80 mg is determined by your doctor.
If you feel that the effect of Tulip 80 mg is too strong or too weak, consult your doctor.
Taking more Tulip 80 mg than recommended
If you accidentally take too many Tulip 80 mg tablets (more than the usual daily dose), seek advice from your doctor or go to the emergency department of your nearest hospital.
Missing a dose of Tulip 80 mg
If you forget to take a dose, take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Tulip 80 mg
If you have any further questions about using this medicine or if you intend to stop treatment, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the serious adverse reactions or symptoms listed below occur, stop taking the tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay.

Rare (may occur in fewer than 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 extensive peeling and swelling of the skin, formation of blisters on the skin, inside the mouth, eyes, genital organs, accompanied by fever. Skin rash with pink-red patches, especially on the palms or soles of the feet, possibly progressing to blister formation.
• Muscle weakness, tenderness, pain, or rupture, or red-brown discoloration of urine. If these occur together with malaise or high fever, they may indicate abnormal muscle breakdown (rhabdomyolysis). Such muscle breakdown does not always resolve even after discontinuation of atorvastatin and may be life-threatening and lead to kidney problems.

Very rare (may occur in fewer than 1 in 10,000 people):

• If a 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 function disorders. Medical advice should be sought as soon as possible.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Other possible adverse reactions of Tulip 80 mg:

Common adverse reactions (may occur in fewer than 1 in 10 people):

• Inflammation of the nasal mucosa, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (patients with diabetes should continue to carefully monitor their blood glucose levels), increased blood creatine kinase activity
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, joint swelling, muscle pain, muscle cramps, and back pain
• Test results indicating possible liver dysfunction

Uncommon adverse reactions (may occur in fewer than 1 in 100 people):

• Loss of appetite, weight gain, decreased blood glucose levels (patients with diabetes should continue to carefully monitor their blood glucose levels)
• Nightmares, insomnia
• Dizziness, numbness or tingling of fingers (hands and feet), reduced sensation to pain or touch, taste disturbances, memory loss
• Blurred vision
• Ringing in the ears and (or) head
• Vomiting, bloating, upper and lower abdominal pain, pancreatitis (leading to stomach pain)
• Hepatitis
• Rash, skin eruptions and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Feeling of tiredness, malaise, weakness, chest pain, swelling (especially around the ankles), elevated body temperature
• Presence of white blood cells in urine

Rare adverse reactions (may occur in fewer than 1 in 1,000 people):

• Visual disturbances
• Unexpected bleeding and bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon injury

Very rare adverse reactions (may occur in fewer than 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
• Gynaecomastia (enlargement of breasts in men and women)

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• Persistent muscle weakness

Adverse reactions reported with the use of some statins (medicines of the same class as Tulip 80 mg):

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and (or) shortness of breath or fever
• Diabetes: development is more likely in patients with high blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will monitor your condition during treatment with this medicine.

Reporting of adverse reactions

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tulip 80 mg

• Keep this medicine out of 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 stated month.
• No special storage precautions are required.
• 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 package and other information

What Tulip 80 mg contains

• The active substance 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).
• Other ingredients are: microcrystalline cellulose, calcium carbonate, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, magnesium stearate; coating: hypromellose, polyethylene glycol 6000, titanium dioxide (E 171).

What Tulip 80 mg looks like and contents of the pack
The tablets are white or almost white, round, biconvex, with the imprint "A80" on one side and a cross-score on the other side to facilitate breaking.
Film-coated tablets are packed in aluminium/aluminium blisters or PVC/PE/PVDC/aluminium blisters. Outer packaging: cardboard box.
Pack sizes: 30, 60 or 90 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 authorisation number in Germany, the country of export: 77524.00.00
Parallel import authorisation number: 152/22