Tulip 40 mg

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Tulip 40 mg (Atorvastatin - 1 A Pharma)
40 mg, film-coated tablets
Atorvastatinum
Tulip 40 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 for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Tulip 40 mg is and what it is used for
2. Important information before taking Tulip 40 mg
3. How to take Tulip 40 mg
4. Possible side effects
5. How to store Tulip 40 mg
6. Contents of the pack and other information

1. What Tulip 40 mg is and what it is used for

Tulip 40 mg belongs to a group of medicines known as statins, which regulate lipid (fat) metabolism.
Tulip 40 mg is used to lower blood lipid levels (cholesterol and triglycerides) when a low-fat diet and lifestyle changes alone have proven ineffective. In individuals at increased risk of heart disease, Tulip 40 mg may also be used to reduce this risk, even if their cholesterol levels are within the normal range. During treatment, patients should continue to follow a standard cholesterol-lowering diet.

2. Important information before using Tulip 40 mg

When NOT TO USE Tulip 40 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 has or has ever had liver disease;
• if the patient has previously had unexplained changes in liver function test results;
• if the patient is of childbearing age and is not using effective contraception;
• if the patient is pregnant or trying to become pregnant;
• if the patient is breastfeeding;
• if the patient is concurrently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting to take Tulip 40 mg, consult a doctor, pharmacist, or nurse if:

• the patient has been diagnosed with severe respiratory insufficiency;
• the patient is taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (a medicine used to treat bacterial infections). Concomitant use of fusidic acid with Tulip 40 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 prior stroke;
• the patient has kidney function disorders;
• 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 had muscle disorders during treatment with 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 of age.

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 40 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 at the same time as atorvastatin (see below "Tulip 40 mg and other medicines").
The patient should also inform the doctor or pharmacist if they constantly feel 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 40 mg. The risk of developing diabetes may affect individuals with high levels of blood sugar and fats, overweight, and high blood pressure.

Tulip 40 mg and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

Some medicines and Tulip 40 mg may interact and affect each other's actions. Such interactions may lead to reduced effectiveness of one or both medicines. They may also increase the risk or severity of adverse effects, including very serious muscle damage, known as rhabdomyolysis, described in section 4:

• medicines that alter the immune system 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, 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 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 40 mg, including ezetimibe (a cholesterol-lowering agent), warfarin (a medicine that reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used in the treatment of heartburn and peptic ulcer disease), phenazone (an analgesic),

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 (Hypericum perforatum).

If the patient needs to take oral fusidic acid for the treatment of a bacterial infection, Tulip 40 mg
should be temporarily discontinued. The doctor will inform the patient when it is safe to restart
Tulip 40 mg. Concurrent use of Tulip 40 mg with fusidic acid may rarely lead to muscle weakness,
tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in
section 4.
Tulip 40 mg with food, drink, and alcohol
Instructions on how to take Tulip 40 mg are provided in section 3.
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 can be found in section 2, "Warnings and precautions".

Pregnancy and breastfeeding
Women who are pregnant or trying to become pregnant must not use Tulip 40 mg.
Women of childbearing age taking Tulip 40 mg must use appropriate contraceptive methods.
Tulip 40 mg must not be used during breastfeeding.
The safety of atorvastatin use 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 any machinery.

Tulip 40 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 40 mg contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to take Tulip 40 mg

Before starting treatment, your doctor will recommend a low-cholesterol diet. This diet should be continued during treatment with Tulip 40 mg.
Tulip 40 mg (40 mg) and Tulip 80 mg (80 mg) are available on the market.
The usual starting dose of the medicine for adults and children aged 10 years or older is 10 mg once daily. If necessary, your doctor may increase this dose until the required dose for the patient is reached. Your 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.
Tulip 40 mg tablets or parts of them 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 taken according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The duration of treatment with Tulip 40 mg will be determined by your doctor.
If you feel that the effect of Tulip 40 mg is too strong or too weak, consult your doctor.
Taking more Tulip 40 mg than recommended
If you accidentally take too many Tulip 40 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 40 mg
If you forget to take a dose, take the next prescribed dose at the correct time. Do not take a double dose to make up for a missed dose.
Stopping Tulip 40 mg
If you have any further questions about the use of this medicine or if you intend to stop treatment, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If any of the serious adverse effects or symptoms listed below occur, stop taking the tablets immediately and contact your doctor or go to the emergency department of the nearest hospital.
Rare (may affect 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, and accompanied by fever. Skin rash with pink-red spots, 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 affect fewer than 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 function disorders. Medical advice should be sought as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse effects of Tulip 40 mg:
Common adverse effects (may affect fewer than 1 in 10 people):

• Nasal mucosal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (patients with diabetes should continue to monitor their blood glucose levels carefully), 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 function abnormalities

Uncommon adverse effects (may affect fewer than 1 in 100 people):

• Loss of appetite, weight gain, decreased blood glucose levels (patients with diabetes should continue to monitor their blood glucose levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling of fingers (hands and feet), reduced sensation to pain or touch, taste disturbances, memory loss
• Blurred vision
• Tinnitus and/or headache
• 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 fatigue, malaise, weakness, chest pain, swelling (especially of the ankles), elevated temperature
• Presence of white blood cells in urine

Rare adverse effects (may affect 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 effects (may affect fewer than 1 in 10,000 people):

• Allergic reaction (symptoms may include: sudden wheezing and chest pain or tightness, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, fainting)
• Hearing loss
• Gynaecomastia (enlargement of breasts in men and women)

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

• Persistent muscle weakness

Adverse effects reported with the use of certain statins (medicines of the same type as Tulip 40 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 fat levels, overweight, and high blood pressure. During treatment with this medicine, your doctor will monitor your condition.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects helps to provide more information on the safety of the medicine.

5. How to store Tulip 40 mg

• Keep this 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 stated month.
• No special storage conditions are required.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

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

6. Contents of the pack and other information

What Tulip 40 mg contains

• The active substance is atorvastatin (in the form of atorvastatin calcium trihydrate).
• Each coated tablet contains 40 mg of atorvastatin (as 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 40 mg looks like and contents of the pack
The tablets are white or almost white, round, biconvex, with the symbol "A40" embossed on one side and a cross-score on the other side to facilitate breaking.
The coated tablets are packed in aluminium/aluminium blisters or in PVC/PE/PVDC/aluminium blisters. Outer packaging: cardboard box.
Pack sizes: 30, 60 or 90 coated tablets.
For further information, please contact the responsible party 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., 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
Aeropharm GmbH, François-Mitterand-Allee 1 and Theodor-Neubauer-Strasse 33/36, 07407 Rudolstadt, Germany
Parallel Importer:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Germany, the country of export: 71990.00.00
Parallel Import Authorisation Number: 153/22