Tulip

Package leaflet: information for the patient

Tulip, 10 mg, coated tablets
Tulip, 20 mg, coated tablets
Atorvastatinum
This medicine is contraindicated during pregnancy
Please read carefully all the information in this leaflet 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 questions, please 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 are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

2. Important information before using the medicine Tulip

When not to use the medicine Tulip

Warnings and precautions
Before starting treatment with the medicine Tulip, you should discuss this with your doctor or pharmacist.
The reasons listed below may mean that Tulip is not suitable for the patient:

• history of stroke with bleeding into the brain or presence of a small amount of fluid in the brain from a previous stroke;
• kidney function disorders;
• hypothyroidism;
• recurrent or unexplained muscle pain, muscle problems previously experienced by 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;
• history of liver disease;
• age over 70 years.

Consult your doctor or pharmacist before using Tulip if

• the patient has 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 for bacterial infections). Concomitant use of fusidic acid with Tulip may lead to severe muscle damage (rhabdomyolysis);
• the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the occurrence of myasthenia (see section 4).

You should also inform your doctor or pharmacist if the patient experiences persistent muscle weakness during treatment. Additional tests and appropriate medicines may be necessary.

For patients with any of the above conditions, the doctor will order a blood test before starting treatment with Tulip and, where possible, during treatment to monitor the risk of muscle-related adverse effects. It is known that the risk of such effects (e.g. rhabdomyolysis) increases when certain other medicines are used concomitantly (see below “Tulip and other medicines”).

Patients with diabetes or those at risk of developing diabetes will be under close medical supervision during treatment with this medicine. Patients with high levels of sugar and fats in the blood, overweight, and high blood pressure may be at risk of developing diabetes.

Tulip and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use, including those available without a prescription.

Some medicines and Tulip may interact and affect each other’s action. Such interactions may reduce the effectiveness of one or both medicines. They may also increase the risk of occurrence or worsening of adverse effects, including very serious muscle damage, i.e. rhabdomyolysis, described in section 4:

• medicines used to modify immune system activity, e.g. cyclosporine;
• certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• 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;
• letermovir, a medicine used to prevent cytomegalovirus infection;
• medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, combination of tipranavir with ritonavir, etc.;
• certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and combination medicines containing elbasvir with grazoprevir, ledipasvir with sofosbuvir;
• other medicines known to interact with Tulip, including ezetimibe (reduces cholesterol levels), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and peptic ulcer disease), phenazone (an analgesic), colchicine (used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium);
• over-the-counter medicines: St. John’s wort.
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

If the patient needs to take fusidic acid orally for bacterial infection treatment, Tulip should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Tulip. Concomitant use of Tulip with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis is provided in section 4.

Tulip with food, drink and alcohol
Instructions on how to take Tulip are described in section 3. Please pay attention to the following information:

Grapefruit juice
During treatment, do not consume more than one or two small glasses of grapefruit juice per day, as larger amounts may alter the effect of Tulip.

Alcohol
While taking Tulip, avoid excessive alcohol consumption (see section 2 “Warnings and precautions”).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The safety of Tulip during pregnancy and breastfeeding has not been established.
Women who are pregnant or planning pregnancy must not take Tulip.
Women of childbearing potential who do not use effective contraception methods must not take Tulip.
Breastfeeding women must not take Tulip.

Driving and using machines
Tulip usually does not affect the ability to drive or operate machinery. However, if such effects occur, the patient should not drive or operate any tools or machines.

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

Tulip contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered “sodium-free”.

Tulip contains sorbitol
The medicine contains trace amounts of sorbitol.

3. How to use Tulip

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult a
doctor or pharmacist.
Before starting treatment, the doctor will recommend adopting a low-cholesterol diet. This diet
should be continued throughout the treatment with Tulip.
For adults and children aged 10 years or older, the usual starting dose of Tulip is 10 mg once daily.
If necessary, the doctor may increase this dose until the appropriate dose for the patient is reached.
The doctor will adjust the dose at intervals of at least 4 weeks.
The maximum dose of Tulip for adults is 80 mg once daily, and for children is 20 mg once daily.
Tulip tablets should be swallowed with 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.
The duration of treatment with Tulip is determined by the doctor.
If you feel that the effect of Tulip is too strong or too weak, consult your doctor.
Taking more Tulip than prescribed
If you accidentally take too many Tulip tablets (more than the recommended daily dose),
contact your doctor or nearest hospital for advice immediately.
Missing a dose of Tulip
If you forget to take a dose, simply take the next dose at the scheduled time. Do not take a double
dose to make up for a missed dose.
Stopping Tulip
If you have any further questions about using this medicine or if you intend to stop treatment,
you should 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 the patient experiences any of the serious adverse reactions or symptoms listed below, they should stop taking the medicine immediately and contact their doctor or go to the emergency department of the nearest hospital.

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 skin peeling and swelling, formation of blisters on the skin, inside the mouth, eyes, or genital organs, and fever. Skin rash with pink-red spots, especially on the palms or soles of the feet, possibly progressing to blisters.
• Muscle weakness, tenderness, pain, or rupture, or red-brown discoloration of urine. If these occur together with malaise or high fever, they may indicate pathological muscle breakdown (rhabdomyolysis) — a condition that does not always resolve even after discontinuation of atorvastatin, may be life-threatening, and can lead to kidney problems.

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

• Unexpected or unusual bleeding or bruising, which 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 reactions of Tulip medicine:
Common adverse reactions (may occur in fewer than 1 in 10 people):
nasal mucosal inflammation, sore throat, nosebleeds
allergic reactions
increased blood glucose levels (patients with diabetes should continue to carefully monitor their blood glucose levels), increased creatine kinase activity in blood
headache
nausea, constipation, flatulence, indigestion, diarrhoea
joint pain, muscle pain, 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 in 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 temperature
presence of white blood cells in urine

Rare adverse reactions (may occur in 1 to 10 in 10,000 people):
vision disturbances
unexpected bleeding and bruising
cholestasis (yellowing of the skin and whites of the eyes)
tendon damage
rash which may appear on the skin, or oral ulcers (lichenoid drug reaction)
purple skin lesions (symptoms of vasculitis)

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, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, fainting)
hearing loss
gynaecomastia (breast enlargement in women and men)

Adverse reactions with unknown frequency (cannot be estimated from available data):
immune-mediated necrotizing myopathy (symptoms may include: persistent muscle weakness and increased creatine kinase activity in blood).
myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing).
ocular myasthenia (a disease causing weakness of eye muscles).
Patients should speak to their doctor if they experience worsening weakness in hands or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.

Adverse reactions reported during use of some statins (medicines of the same type as Tulip):
sexual dysfunction
depression
breathing problems, including persistent cough and (or) shortness of breath or fever
diabetes. The risk of developing diabetes is higher in people with high blood glucose and lipid levels, overweight, and high blood pressure. The doctor will monitor the patient's condition during treatment with this medicine.
memory loss.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tulip

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
Do not store above 30\°C. Store in the original packaging to protect from moisture.
Do not use Tulip medicine if visible signs of deterioration are observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tulip contains

• The active substance is atorvastatin. One coated tablet contains 10 mg or 20 mg of atorvastatin in the form of the trihydrate calcium salt.
• Other ingredients are: microcrystalline cellulose, calcium carbonate, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, polysorbate 80 [contains sorbitol (E420)], magnesium stearate. Coating: hypromellose, titanium dioxide, polyethylene glycol 6000.

What Tulip looks like and contents of the pack
10 mg tablets are white or almost white, round, biconvex, marked on one side with
“A 10”, smooth on the other side.
20 mg coated tablets are white or almost white, round, biconvex, marked on one side with “A 20”, with a break line on the other side. The tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium or PVC/LDPE/PVDC/Aluminium, in cardboard boxes.
Pack sizes contain:
Tulip 10 mg: 30, 60 or 90 coated tablets.
Tulip 20 mg: 30, 60, 90 or 100 coated tablets.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
For detailed information, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
tel. 22 209 70 00