Tulip Combo

Leaflet accompanying the packaging: patient information

Tulip Combo, 10 mg + 10 mg, film-coated tablets

Tulip Combo, 10 mg + 20 mg, film-coated tablets

Tulip Combo, 10 mg + 40 mg, film-coated tablets

Tulip Combo, 10 mg + 80 mg, film-coated tablets

Ezetimibe +Atorvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Tulip Combo is a medicine that lowers high cholesterol. Tulip Combo contains ezetimibe and atorvastatin.
Tulip Combo is used in adults to lower the level of total cholesterol, "bad" cholesterol (LDL) and fatty substances called triglycerides in the blood.
Additionally, Tulip Combo increases the level of "good" cholesterol (HDL).
Tulip Combo lowers cholesterol in two ways. It reduces the absorption of cholesterol in the gut and its production in the body.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of "bad" (LDL) and "good" (HDL) cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of arteries and form plaques. Over time, this plaque can lead to narrowing of the arteries. This narrowing can slow down or block the flow of blood to vital organs such as the heart and brain. Blocking the flow of blood can lead to a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of "bad" cholesterol in the walls of arteries and prevents heart disease.
Triglycerides are other fats found in the blood that can increase the risk of heart disease.
A doctor may prescribe Tulip Combo if the patient is already taking atorvastatin and ezetimibe in the doses contained in this medicine, as an addition to a cholesterol-lowering diet in cases of:

• high blood cholesterol (primary heterozygous and non-familial hypercholesterolemia) or high blood fat levels (mixed hyperlipidemia).
• a hereditary disorder (homozygous familial hypercholesterolemia) that causes high blood cholesterol levels.

Tulip Combo does not affect weight loss.

2. Important information before taking Tulip Combo

When not to take Tulip Combo

• if the patient is allergic to atorvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6)
• if the patient has or has had liver disease;
• if the patient has unexplained, abnormal liver function test results;
• if the patient is a woman of childbearing age and is not using effective methods of contraception;
• if the patient is pregnant, plans to become pregnant or is breastfeeding;
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before taking Tulip Combo, the patient should discuss with their doctor or pharmacist if:

• the patient has had a hemorrhagic stroke or has small fluid-filled cavities in the brain after previous strokes.
• the patient has kidney disease.
• the patient has hypothyroidism (underactive thyroid).
• the patient has recurring or unexplained muscle pain or has had muscle disease or has a family history of muscle disease.
• the patient has had muscle problems while taking other cholesterol-lowering medicines (e.g. other "statins" or "fibrates").
• the patient has or 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 can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).
• the patient is currently taking or has taken within the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and a medicine containing ezetimibe and atorvastatin may lead to serious consequences, including muscle problems (rhabdomyolysis).
• the patient regularly consumes large amounts of alcohol.
• the patient has had liver disease in the past.
• the patient is over 70 years old.

The patient should contact their doctor immediately if they experience unexplained

muscle pain, tenderness or weakness while taking Tulip Combo.In rare cases, muscle problems can be serious, including muscle breakdown leading to kidney damage. It is known that atorvastatin causes muscle problems. Muscle problems have also been reported with ezetimibe.
If muscle weakness persists, the patient should tell their doctor or pharmacist. Additional tests may be needed to diagnose these problems and medication may be necessary.
Before taking Tulip Combo, the patient should consult their doctor or pharmacist:

• if the patient has severe respiratory failure.

If any of the above situations apply to the patient (or the patient is unsure), they should consult their doctor or pharmacist before taking Tulip Combo, as the doctor will need to perform a blood test before starting treatment and, if possible, during treatment, to assess the risk of muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis (breakdown of skeletal muscle), increases when taking certain medicines at the same time (see section 2 "Tulip Combo and other medicines").
During treatment, the doctor will closely monitor the patient's health if they have diabetes or are at risk of developing diabetes. The likelihood of developing diabetes is higher in people with high blood sugar and fat levels, overweight and high blood pressure.
The patient should inform their doctor about all their illnesses, including allergies.

Children and adolescents

Tulip Combo is not recommended for use in children and adolescents.

Tulip Combo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken or might take.
The patient should avoid taking Tulip Combo and fibrates (cholesterol-lowering medicines) at the same time.
There are several medicines that can affect the action of Tulip Combo or whose action may be affected by Tulip Combo (see section 3). This type of interaction can reduce the effectiveness of one or both medicines. It can also increase the risk or severity of side effects, including serious muscle damage, known as "rhabdomyolysis", described in section 4:

• cyclosporin (a medicine often used in patients who have had an organ transplant).
• erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin (antibiotics).
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (antifungals).
• gemfibrozil, other fibrates and fenofibrate derivatives, nicotinic acid, colestyramine, colestipol (lipid-regulating medicines).
• certain calcium channel blockers used in angina and high blood pressure, such as amlodipine, diltiazem.
• digoxin, verapamil, amiodarone (heart rhythm regulators).
• letermovir, a medicine used to prevent cytomegalovirus disease
• medicines used to treat HIV, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir with ritonavir (used to treat AIDS).
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir and the combination of elbasvir and grazoprevir.
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).
• if oral fusidic acid is necessary to treat a bacterial infection, the patient should temporarily stop taking Tulip Combo. The doctor will indicate when it is safe to resume taking Tulip Combo. Taking Tulip Combo with fusidic acid can rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Other medicines that interact with the combination product:

• oral contraceptives (birth control pills).
• styrene (an antiepileptic medicine used to treat epilepsy).
• cimetidine (a medicine used to treat heartburn and stomach ulcers).
• phenazone (a pain reliever).
• antacids (medicines containing aluminum or magnesium).
• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines used to prevent blood clots).
• colchicine (used to treat gout).
• St. John's Wort (Hypericum perforatum) (a medicine used to treat depression).

Tulip Combo with food and drink

See section 3 for information on how to take Tulip Combo. The patient should be aware of the following:

Grapefruit juice
The patient should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts may affect the action of the combination medicine.
Alcohol
The patient should avoid drinking too much alcohol while taking this medicine. See section 2 "Warnings and precautions".

Pregnancy, breastfeeding and fertility

The patient should not take Tulip Combo if they are pregnant, plan to become pregnant or think they may be pregnant.
Tulip Combo should not be taken by women of childbearing age unless they use effective methods of contraception. If the patient becomes pregnant while taking Tulip Combo, they should stop taking the medicine immediately and inform their doctor.
The patient should not take Tulip Combo while breastfeeding.
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.

Driving and using machines

The patient should not expect Tulip Combo to affect their ability to drive or use machines. However, the patient should bear in mind that some people may experience dizziness after taking Tulip Combo. If the patient experiences dizziness after taking this medicine, they should not drive or use machines.

Tulip Combo contains lactose

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

Tulip Combo contains sodium

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

3. How to take Tulip Combo

The patient should always take this medicine exactly as their doctor has told them. The doctor will determine the dose of Tulip Combo that is right for the patient, depending on their current treatment and individual risk.
In case of doubt, the patient should consult their doctor or pharmacist.

• Before starting to take Tulip Combo, the patient should follow a cholesterol-lowering diet.
• While taking Tulip Combo, the patient should continue to follow a cholesterol-lowering diet.

How to take the medicine
The recommended dose of Tulip Combo is one tablet taken orally, once a day, preferably at the same time every day. The tablet should be swallowed with a sufficient amount of liquid (e.g. one glass of water).
When to take the medicine
Tulip Combo can be taken at any time of day, with or without food.
If the doctor has prescribed Tulip Combo and another cholesterol-lowering medicine containing cholestyramine or another bile acid sequestrant (cholesterol-lowering medicines), the patient should take Tulip Combo at least 2 hours before or 4 hours after taking the bile acid sequestrant.

What to do if the patient takes more Tulip Combo than they should

The patient should contact their doctor or pharmacist.

What to do if the patient forgets to take Tulip Combo

If the patient misses a dose, they should not take a double dose to make up for the missed dose. The next tablet should be taken at the right time.
If the patient has any further questions on the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking the medicine and contact their doctor or go to the emergency department at their nearest hospital and take the packaging with them.

• Severe allergic reaction causing swelling of the face, tongue and throat, which can cause great difficulty in breathing.
• Severe skin disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, around the eyes, genitals, and fever, skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Weakness, tenderness, pain, muscle rupture or reddish-brown urine, and in particular, if the patient feels unwell or has a high fever; this may be due to muscle breakdown. This condition can be life-threatening and lead to kidney disease.
• Lupus-like syndrome (including rash, joint disorders and effects on blood cells).

The patient should consult their doctor as soon as possible if they experience unexpected or unusual bleeding or bruising, which may indicate liver problems.

Other possible side effects of Tulip Combo:

Common (may affect up to 1 in 10 people):

• nasal congestion, sore throat, nosebleeds,
• allergic reactions,
• increased blood glucose levels, in diabetes, blood glucose levels should be carefully monitored,
• headache,
• nausea, constipation, bloating, diarrhea, indigestion, abdominal pain,
• throat and (or) larynx pain,
• joint pain and (or) pain in hands or feet, back pain, muscle pain, muscle spasms, joint swelling,
• increased laboratory test results for muscle function (creatine kinase activity) in the blood,
• abnormal liver function test results, increased laboratory test results for liver function (aminotransferase activity) in the blood
• feeling tired.

Uncommon (may affect up to 1 in 100 people):

• swelling due to allergic reactions,
• decreased blood glucose levels (patients with diabetes should carefully monitor their blood glucose levels),
• loss of appetite, weight gain,
• cough,
• muscle weakness, neck pain, chest pain,
• hot flushes, high blood pressure, decreased heart rate
• vomiting, belching, pancreatitis and liver inflammation, heartburn, stomach inflammation, dry mouth, bloating.
• redness of the skin, hives, skin rash and itching, hair loss,
• nightmares, difficulty sleeping,
• dizziness, numbness, taste disorders, memory loss (amnesia), sensory disturbances,
• blurred vision,
• ringing in the ears,
• feeling of general discomfort, anxiety or pain,
• weakness,
• increased activity of the liver enzyme gamma-glutamyltransferase
• presence of white blood cells in the urine test.

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

• decreased platelet count,
• swelling of the deeper layers of the skin of the face, tongue, throat, abdomen, hands or feet (angioedema),
• widespread rash forming sharply defined red spots or rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals due to an allergic reaction,
• inflammation of skeletal muscle, tendon inflammation sometimes with tendon rupture, muscle weakness as a symptom of muscle fiber loss,
• vision disorders,
• yellowing of the skin and whites of the eyes.

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

• anaphylactic shock due to an allergic reaction,
• hearing loss,
• liver failure,
• breast enlargement in men.

Frequency not known (cannot be estimated from the available data):

• allergic reactions, including rash and swelling of the deeper layers of the skin,
• shortness of breath, gallbladder inflammation, gallstones,
• physical weakness, loss of strength, loss of muscle tissue due to the action of antibodies,
• depression
• 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.
Additionally, after the medicine has been on the market, the following side effects have been reported with the use of some statins (cholesterol-lowering medicines):

• breathing difficulties, including chronic cough and (or) shortness of breath or fever,
• diabetes: the risk of developing diabetes is higher in patients with high blood sugar and fat levels, overweight and high blood pressure.
• sexual function disorders.

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:
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 Combo

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
The medicine should be stored in its original packaging. There are no special storage instructions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Tulip Combo contains

Tulip Combo, 10 mg + 10 mg
Each film-coated tablet contains 10 mg of ezetimibe (Ezetimibum) and 10 mg of atorvastatin (Atorvastatinum) in the form of atorvastatin calcium trihydrate.
Tulip Combo, 10 mg + 20 mg
Each tablet contains 10 mg of ezetimibe (Ezetimibum) and 20 mg of atorvastatin (Atorvastatinum) in the form of atorvastatin calcium trihydrate.
Tulip Combo, 10 mg + 40 mg
Each film-coated tablet contains 10 mg of ezetimibe (Ezetimibum) and 40 mg of atorvastatin (Atorvastatinum) in the form of atorvastatin calcium trihydrate.
Tulip Combo, 10 mg + 80 mg
Each film-coated tablet contains 10 mg of ezetimibe (Ezetimibum) and 80 mg of atorvastatin (Atorvastatinum) in the form of atorvastatin calcium trihydrate.
The other ingredients are: microcrystalline cellulose, mannitol, calcium carbonate, sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, yellow iron oxide (E 172), magnesium stearate, povidone K29/32, sodium lauryl sulfate.
Tablet coating
Tulip Combo 10 mg + 10 mg, Tulip Combo 10 mg + 20 mg, Tulip Combo 10 mg + 40 mg, film-coated tablets
Opadry White OY-L28900:
Lactose monohydrate
Hypromellose 2910
Titanium dioxide (E 171)
Macrogol 4000
Tulip Combo 10 mg + 80 mg film-coated tablets
DrCoat FCU:
Hypromellose 2910
Titanium dioxide (E 171)
Talc (E553b)
Macrogol 400
Yellow iron oxide (E 172)

What Tulip Combo looks like and contents of the pack

Tulip Combo, 10 mg + 10 mg
White, round, biconvex film-coated tablets with a diameter of about 8.1 mm.
Tulip Combo, 10 mg + 20 mg
White, oval, biconvex film-coated tablets with dimensions of about 11.6 mm x 7.1 mm.
Tulip Combo, 10 mg + 40 mg
White, biconvex film-coated tablets in the shape of a capsule, with dimensions of about 16.1 mm x 6.1 mm.
Tulip Combo, 10 mg + 80 mg
Yellow, elongated, biconvex film-coated tablets with dimensions of about 19.1 mm x 7.6 mm.
Blisters of OPA/Aluminum/PVC/Aluminum foil containing 30 film-coated tablets.
Perforated single-dose blisters of OPA/Aluminum/PVC/Aluminum foil containing 30 x 1 film-coated tablet.

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
ELPEN Pharmaceutical Co. Inc.,
Marathonos Ave. 95, Pikermi Attiki,
19009, Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary
Ezetimibe/Atorvastatin Sandoz 10 mg/40 mg filmtabletta
Ezetimibe/Atorvastatin Sandoz 10 mg/80 mg filmtabletta
Ezetimibe/Atorvastatin Sandoz 10 mg/10 mg filmtabletta
Ezetimibe/Atorvastatin Sandoz 10 mg/20 mg filmtabletta
Spain
Ezetimiba/Atorvastatina Sandoz 10 mg/10 mg comprimidos recubiertos con película
Ezetimiba/Atorvastatina Sandoz 10 mg/20 mg comprimidos recubiertos con película
Ezetimiba/Atorvastatina Sandoz 10 mg/40 mg comprimidos recubiertos con película
Ezetimiba/Atorvastatina Sandoz 10 mg/80 mg comprimidos recubiertos con película
Poland
Tulip Combo
Slovakia
Tulip Plus 10 mg/20 mg
Tulip Plus 10 mg/40 mg

For more information about this medicine, the patient should contact their local representative of the marketing authorization holder:

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:04/2023
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