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

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

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 reduces high cholesterol levels. Tulip Combo contains ezetimibe and atorvastatin.
Tulip Combo is used in adults to reduce the levels of total cholesterol, "bad" cholesterol (LDL) and fatty substances called triglycerides in the blood.
Additionally, Tulip Combo increases the levels of "good" cholesterol (HDL).
Tulip Combo reduces cholesterol levels 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 the 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 the arteries and prevents heart disease.
Triglycerides are other fats found in the blood that can increase the risk of heart disease.
Your doctor may prescribe Tulip Combo if you are already taking atorvastatin and ezetimibe in the doses contained in this medicine, in addition to a cholesterol-lowering diet, in cases of:

• high levels of cholesterol in the blood (primary heterozygous familial and non-familial hypercholesterolaemia) or high levels of fats in the blood (mixed hyperlipidaemia).
• a hereditary disorder (homozygous familial hypercholesterolaemia) that causes high levels of cholesterol in the blood.

Tulip Combo does not affect weight loss.

2. Important information before taking Tulip Combo

When not to take Tulip Combo

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

Warnings and precautions

Before taking Tulip Combo, talk to your doctor or pharmacist if:

• you have had a haemorrhagic stroke or if there are small cavities in the brain after previous strokes.
• you have kidney disease.
• you have hypothyroidism (underactive thyroid gland).
• you have had recurring or unexplained muscle pain or had muscle disease or if it occurred in your family.
• you have had muscle problems while taking other medicines to lower cholesterol (e.g. other "statins" or "fibrates").
• you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).
• you are currently taking or have taken in 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 muscle problems (rhabdomyolysis).
• you regularly drink large amounts of alcohol.
• you have had liver disease in the past.
• you are over 70 years old.

You should contact your doctor immediately if you 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, you should tell your doctor or pharmacist. Additional tests may be necessary to diagnose these problems and to use medicines.
Before taking Tulip Combo, you should consult your doctor or pharmacist:

• if you have severe respiratory failure.

If any of the above situations apply to you (or if you are not sure), you should consult your doctor or pharmacist before taking Tulip Combo, as your 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, your doctor will closely monitor your health if you 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.
You should inform your doctor about all diseases, including allergies.

Children and adolescents

Tulip Combo should not be used in children and adolescents.

Tulip Combo and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
You 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 a serious muscle condition called "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 (antifungal medicines).
• gemfibrozil, other fibrates and fenofibrate derivatives, nicotinic acid, colestyramine, colestipol (medicines used to regulate fat levels).
• certain calcium channel blockers used to treat angina and high blood pressure, such as amlodipine, diltiazem.
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm).
• 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 soft tissue infections and bacteremia).
• if you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely 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 (medicines used to prevent pregnancy).
• styrene (an antiepileptic medicine used to treat epilepsy).
• cimetidine (a medicine used to treat heartburn and stomach ulcers).
• phenazone (a painkiller).
• antacids (medicines containing aluminium 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 to find out how to take Tulip Combo. You should be aware of the following:

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

Pregnancy, breastfeeding and fertility

Do not take Tulip Combo if you are pregnant, planning to become pregnant or think you may be pregnant.
Do not take Tulip Combo if you are a woman of childbearing age and are not using reliable contraception. If you become pregnant while taking Tulip Combo, you must stop taking it immediately and tell your doctor.
Do not take Tulip Combo while breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You should not expect Tulip Combo to affect your ability to drive or use machines. However, you should bear in mind that some people may experience dizziness after taking this medicine. If you experience dizziness after taking this medicine, do not drive or use machines.

Tulip Combo contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this 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

This medicine should always be taken exactly as your doctor has told you. Your doctor will decide on a dose of the medicine that is right for you, depending on your current treatment and individual risk.
If you are not sure, ask your doctor or pharmacist.

• Before starting to take Tulip Combo, you should be on a cholesterol-lowering diet.
• While taking Tulip Combo, you should continue to follow a cholesterol-lowering diet.

How to take the medicine
The recommended dose of Tulip Combo is one tablet per day, 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 your doctor has prescribed Tulip Combo and another cholesterol-lowering medicine containing the active substance cholestyramine or another bile acid sequestrant (medicines that lower cholesterol), you should take Tulip Combo at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Tulip Combo than you should

Contact your doctor or pharmacist.

If you forget to take Tulip Combo

If you miss a dose, do not take a double dose to make up for the missed dose. Take the next tablet at the right time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking Tulip Combo and contact your doctor immediately or go to the emergency department at your nearest hospital and take the packaging with you.

• A severe allergic reaction causing swelling of the face, tongue and throat, which can lead to great difficulty in breathing.
• A severe skin condition characterized by blistering and peeling of the skin, blisters on the skin, mouth, around the eyes, genitals and fever, skin rash with reddish-purple spots, especially on the palms or soles, with possible blisters.
• Weakness, tenderness, pain, muscle rupture or reddish-brown urine, and in particular, if you also feel unwell or have 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).

You should contact your doctor as soon as possible if you experience unexpected or unusual bleeding or bruising, as this 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, if you have diabetes, you should carefully monitor your blood glucose levels,
• headache,
• nausea, constipation, bloating, diarrhoea, indigestion, abdominal pain,
• sore throat and/or larynx,
• joint pain and/or pain in hands or feet, back pain, muscle pain, muscle spasms, joint swelling,
• increased results of laboratory tests of muscle function (creatine kinase) in the blood,
• abnormal liver function test results, increased results of laboratory tests of liver function (aminotransferase) 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, gastritis, 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, restlessness 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 with clearly 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 fibre 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, cholecystitis, gallstones,
• physical weakness, loss of strength, loss of muscle mass due to the action of antibodies,
• depression
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
• myasthenic syndrome (a disease that causes muscle weakness in the eyes).

You should talk to your doctor if you experience weakness in your 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 disorders.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your 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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tulip Combo

The medicine should be stored out of the sight and reach of children.
Do 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. Ask your 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 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/Aluminium/PVC/Aluminium foil containing 30 film-coated tablets.
Perforated single-dose blisters of OPA/Aluminium/PVC/Aluminium foil containing 30 x 1 film-coated tablet.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 authorised 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, contact the local representative of the marketing authorisation 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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