Tulip

Package Leaflet: Information for the Patient

Tulip, 10 mg, Film-Coated Tablets

Tulip, 20 mg, Film-Coated Tablets

Atorvastatin
Medicine that is 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 pack and other information

1. What is Tulip and what is it used for

Tulip belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Tulip is used to reduce the levels of lipids - cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes are not effective. Tulip may also reduce the risk of developing heart disease, even if the patient's blood cholesterol level is normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Tulip

When not to take Tulip

Warnings and precautions

Before starting to take Tulip, the patient should discuss it with their doctor or pharmacist.
The following are reasons why Tulip may not be a suitable medicine for the patient:
a history of stroke with bleeding into the brain or the presence of a small amount of fluid in the brain from a previous stroke;
kidney function disorders;
hypothyroidism;
repeated or unexplained muscle pain, muscle problems that have occurred in the patient or their relatives;
muscle problems during previous use of other lipid-lowering medicines (e.g. other statins or fibrates);
regular consumption of large amounts of alcohol;
a history of liver disease;
age over 70 years.

Before taking Tulip, the patient should consult a doctor or pharmacist if

the patient has severe respiratory failureThe patient should also tell their doctor or pharmacist if they experience muscle weakness that does not go away while taking the medicine. Additional tests and the use of appropriate medicines may be necessary.
In patients who are affected by any of the above situations, the doctor will order a blood test before starting treatment with Tulip and, if possible, during treatment to monitor the risk of muscle-related side effects. It is known that the risk of such effects (e.g. rhabdomyolysis) increases when taking certain other medicines at the same time (see below "Tulip and other medicines").
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high blood sugar and lipid levels, overweight, and high blood pressure may be at risk of developing diabetes.

Tulip and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those that are available without a prescription.
Some medicines and Tulip can 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 used to modify the immune system, e.g. cyclosporine;
certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
other lipid-lowering medicines, e.g. gemfibrozil, other fibrates, colestyramine;
certain calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem, as well as medicines that regulate heart rhythm, e.g. digoxin, verapamil, amiodarone;
letermovir, a medicine used to prevent cytomegalovirus disease;
medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir with ritonavir, etc.;
certain medicines used to treat hepatitis C virus infection, e.g. 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, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Tulip with food, drink, and alcohol

The way to take Tulip is described in section 3. The patient should pay attention to the following information:
Grapefruit juice
During treatment, the patient should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts may change the effect of Tulip.
Alcohol
While taking Tulip, the patient should avoid consuming excessive amounts of alcohol (see section 2 "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
The safety of using Tulip during pregnancy and breastfeeding has not been established.
Pregnant or breastfeeding women should not take Tulip.
Women of childbearing age who do not use effective methods of contraception should not take Tulip.
Women who are breastfeeding should not take Tulip.

Driving and using machines

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

Tulip contains lactose

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

Tulip contains sodium

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

Tulip contains sorbitol

The medicine contains trace amounts of sorbitol.

3. How to take Tulip

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Before starting treatment, the doctor will recommend a low-cholesterol diet. This diet should be continued while taking Tulip.
In adults and children aged 10 years or older, the usual starting dose of Tulip 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 in adults is 80 mg once a day, and in children, it is 20 mg once a day.
Tulip tablets should be swallowed with 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 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 more than the recommended dose of Tulip (more than the daily dose), they should contact their doctor or the nearest hospital for advice.

Missing a dose of Tulip

If the patient forgets to take a dose, they should simply take the next dose at the scheduled 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 medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.

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

• A severe allergic reaction that causes swelling of the face, tongue, and throat, which can lead to severe breathing difficulties.
• A 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 hands or soles of the feet, 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 pathological muscle breakdown (rhabdomyolysis) - a condition that may not always resolve even after discontinuation of atorvastatin, may be life-threatening, and may lead to kidney problems.

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

• If the patient experiences unexpected or unusual bleeding or bruising, they should consult their doctor as soon as possible.
• Systemic lupus erythematosus (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 closely monitor their blood sugar levels), increased creatine kinase activity in the blood
headache
nausea, constipation, gas, indigestion, diarrhea
joint pain, muscle pain, and back pain
blood 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 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)
hepatitis
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 1,000 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 less than 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):
immunological necrotizing myopathy (symptoms may include: persistent muscle weakness and increased creatine kinase activity in the blood).
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. The risk of developing diabetes is higher in people who have high blood sugar and lipid levels, are overweight, and have high blood pressure. The doctor will monitor the patient's condition while taking this medicine.
memory loss.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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
tel.: +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 the medicine.

5. How to store Tulip

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Do not store above 30°C. Store in the original package to protect from moisture.
Do not use Tulip if visible signs of deterioration are observed.
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 pack and other information

What Tulip contains

• The active substance of the medicine is atorvastatin. One film-coated tablet contains 10 mg or 20 mg of atorvastatin in the form of a trihydrate calcium salt.
• The other ingredients are: microcrystalline cellulose, calcium carbonate, lactose monohydrate, sodium croscarmellose, hydroxypropyl cellulose, polysorbate 80 [contains sorbitol [E420]), magnesium stearate. Coating: hypromellose, titanium dioxide, macrogol 6000.

What Tulip looks like and what the pack contains

The 10 mg tablets are white or almost white, round, biconvex, marked with "A 10" on one side, and smooth on the other side.
The 20 mg film-coated tablets are white or almost white, round, biconvex, marked with "A 20" on one side, and with a score line on the other side. The tablets are packaged in blisters of OPA/Aluminum/PVC/Aluminum or PVC/LDPE/PVDC/Aluminum in a cardboard box.
The packs contain:
Tulip 10 mg: 30, 60, or 90 film-coated tablets.
Tulip 20 mg: 30, 60, 90, or 100 film-coated tablets.
Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
To obtain detailed information, the patient should contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:10/2024
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