Tulip 40 mg

Leaflet attached to the packaging: patient information

Tulip 40 mg, coated tablets

Tulip 80 mg, coated tablets

Atorvastatin
Medicine absolutely contraindicated in pregnancy

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 and what is it used for
• 2. Important information before taking Tulip
• 3. How to take Tulip
• 4. Possible side effects
• 5. How to store Tulip
• 6. Contents of the packaging and other information

1. What is Tulip and what is it used for

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

2. Important information before taking Tulip

When NOT to take Tulip

if the patient is allergic to atorvastatin or 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 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, the patient should discuss it with their 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 (a medicine used to treat bacterial infections). Taking fusidic acid at the same time as Tulip may 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 function disorders;
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 use of medicines that lower blood lipid levels (e.g., other statins or fibrates);
the patient has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4).
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 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 below "Tulip 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.

Tulip and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription.
Some medicines and Tulip may interact with each other. This type of interaction may be the cause of reduced efficacy of one or both medicines. It may 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, fusidic acid;
other medicines that regulate blood lipid levels, such as gemfibrozil, other fibrates, cholestyramine;
certain calcium channel blockers used to treat angina or high blood pressure, such as amlodipine, diltiazem, as well as medicines that regulate heart rhythm, 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, 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, ledipasvir with sofosbuvir;
other medicines that interact with Tulip, including ezetimibe (which lowers cholesterol), warfarin (a medicine that reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine used to treat epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium);
over-the-counter medicines: St. John's wort.
daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

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

Fusidic acid may rarely cause muscle weakness, muscle tenderness, or pain (rhabdomyolysis) when taken with Tulip. More information about rhabdomyolysis can be found in section 4.

Tulip with food, drink, and alcohol

Instructions on how to take Tulip can be found in section 3.
The following information should be taken into account:
Grapefruit juice
The patient should not drink more than one or two small glasses of grapefruit juice per day, as large amounts may affect the action of atorvastatin.
Alcohol
The patient should avoid drinking excessive amounts of alcohol while taking this medicine. More information can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Women who are pregnant or trying to become pregnant should not take Tulip.
Women of childbearing age taking Tulip should use appropriate methods of contraception.
Tulip should not be taken during breastfeeding.
The safety of atorvastatin during pregnancy and breastfeeding has not been established.
The patient should consult their doctor or pharmacist before taking any medicine.

Driving and using machines

The medicine does not normally affect the ability to drive or use machines. However, if this occurs, the patient should not drive or operate any tools or machines.

Tulip contains sodium

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

Tulip 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

Before starting treatment, the doctor will recommend a low-cholesterol diet. This diet should be continued during the use of Tulip.
The usual starting dose of Tulip for adults and children over 10 years old is 10 mg once a day. If necessary, the doctor may increase this dose up to the dose the patient needs. The doctor will adjust the dose of Tulip at intervals of at least 4 weeks. The maximum dose of Tulip is 80 mg once a day.
Tulip 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, the patient should 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 the patient has any doubts, they should consult their doctor or pharmacist.
The duration of treatment with Tulip is determined by the doctor.
If the patient feels that the effect of Tulip is too strong or too weak, they should consult their doctor.

Taking a higher dose of Tulip than recommended

If the patient has accidentally taken too many Tulip tablets (more than the usual daily dose), they should consult their doctor or the emergency department of the nearest hospital.

Missing a dose of Tulip

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

Stopping treatment with Tulip

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

4. Possible side effects

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

If the patient experiences any of the following serious side effects or symptoms, they should stop taking the tablets and contact their 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 significant skin peeling and swelling, blistering of the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blistering.
• Muscle weakness, tenderness, pain, or rupture, or reddish-brown urine. If these occur along 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), they should consult their doctor as soon as possible.
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Tulip:

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 carefully monitor their blood sugar levels), increased creatine kinase activity in the blood
headache
nausea, constipation, gas, indigestion, diarrhea
joint pain, joint swelling, muscle pain, muscle spasms, and back pain
test results indicating possible liver dysfunction
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 carefully 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
skin 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
skin rash that may occur on the skin or ulcers in the mouth (lichenoid drug reaction)
purple skin changes (symptoms of vasculitis)
Very rare side effects (may affect up to 1 in 10,000 people):
allergic reaction (symptoms may include: sudden wheezing and pain or tightness in the chest, 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 the available data):
persistent muscle weakness
myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
ocular myasthenia (a disease that causes muscle weakness in the eyes).
The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
Side effects that have been reported with the use of some statins (medicines of the same type as Tulip):
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 blood sugar and fat levels, with overweight and high blood pressure. During the use of this medicine, the doctor will monitor the patient's condition.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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:
Jerozolimskie Avenue 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 gather more information on the safety of the medicine.

5. How to store Tulip

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the carton and blister after EXP. The expiration date refers to the last day of the specified month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tulip contains

• The active substance of the medicine is atorvastatin (in the form of atorvastatin calcium trihydrate).
• Each coated tablet contains 40 mg or 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, hypromellose, macrogol 6000, titanium dioxide (E 171).

What Tulip looks like and what the packaging contains

Tulip 40 mg coated tablets are white or almost white, round, biconvex, with the symbol "A40" embossed on one side and a cross-score on the other side. The tablet can be divided into equal doses.
Tulip 80 mg coated 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 tablet can be divided into equal doses.
The coated tablets are packaged in aluminum/aluminum blisters or PVC/PE/PVDC/aluminum blisters. The outer packaging is a cardboard box.
The packaging contains 30, 60, or 90 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Lek S.A.
Domaniewska 50 C
02-672 Warsaw
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
Podlipie 16
95-010 Stryków

To obtain more detailed information about the medicine and its names in other European Economic Area member states, please contact:

Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00
Date of last revision of the leaflet:05/2025
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