TULIP (ATORVASTATIN) TBL 10MG N30

ATC code: C10AA05 

Active substances: Atorvastatinum

Vendor, principal: Lek. 
TULIP (ATORVASTATIN) TBL 10MG N30 is compensated medicine in Latvia. 

 Prescription drug (℞) 

TULIP 10MG N30

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tulip 10 mg film-coated tablets Tulip 20 mg film-coated tablets Tulip 40 mg film-coated tablets Tulip 80 mg film-coated tablets
Atorvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-   Keep this leaflet. You may need to read it again.
-   If you have any further questions, ask your doctor or your pharmacist.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.   What Tulip is and what it is used for
2.   What you need to know before you take 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 known as statins, which are lipid (fat) regulating medicines. Tulip is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Tulip can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment.

2. What you need to know before you take Tulip DO NOT take Tulip:

-   if you are allergic to Tulip or to any similar medicines used to lower blood lipids or to any of the other ingredients of this medicine (listed in section 6).
-   if you have or have ever had a disease which affects the liver
-   if you have had any unexplained abnormal blood tests for liver function
-   if you are a woman able to have children and not using reliable contraception
-   if you are pregnant or trying to become pregnant
-   if you are breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Tulip
The following are reasons why Tulip may not be suitable for you:
-   if you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes
-   if you have kidney problems
-   if you have an under-active thyroid gland (hypothyroidism)
-   if you have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems
-   if you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other ‘-statin’ or ‘-fibrate’ medicines)
-   if you regularly drink a large amount of alcohol
-   if you have a history of liver disease
-   if you are older than 70 years.

Check with your doctor or pharmacist before taking Tulip

-   if you have severe respiratory failure.
If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your Tulip treatment to predict your risk of muscle related side effects. The risk of muscle related side effects e.g rhabdomyolysis is known to increase when certain medicines are taken at the same time (see Section 2 “Other medicines and Tulip”).
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Other medicines and Tulip

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. There are some medicines that may change the effect of Tulip or their effect may be changed by Tulip. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side-effects, including the important muscle wasting condition known as rhabdomyolysis described in Section 4:
-   Medicines used to alter the way your immune system works, e.g. ciclosporin
-   Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid
-   Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
-   Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem,; medicines to regulate your heart rhythm e.g. digoxin, verapamil, amiodarone
- Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir etc.
-   Some medicines used in the treatment of hepatitis C e.g. telaprevir.
-   Other medicines known to interact with Tulip include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout) and antacids (indigestion products containing aluminium or magnesium) and boceprevir (used to treat liver disease such as hepatitis C)
-   Medicines obtained without a prescription: St John’s Wort

Tulip with food, drink and alcohol

See Section 3 for instructions on how to take Tulip. Please note the following:
Grapefruit juice
Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Tulip.
Alcohol
Avoid drinking too much alcohol while taking this medicine. See Section 2 “Warnings and precautions” for details.

Pregnancy and breast-feeding

Do not take Tulip if you are pregnant, or if you are trying to become pregnant.
Do not take Tulip if you are able to become pregnant unless you use reliable contraceptive measures. Do not take Tulip if you are breast-feeding.
The safety of Tulip during pregnancy and breast-feeding has not yet been proven. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Normally this medicine does not affect your ability to drive or operate machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.

3. How to take Tulip

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Tulip.
The usual starting dose of Tulip is 10 mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of Tulip is 80 mg once daily for adults and 20 mg once daily for children.
Tulip tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The duration of treatment with Tulip is determined by your doctor.
Please ask your doctor if you think that the effect of Tulip is too strong or too weak.

If you take more Tulip than you should

If you accidently take too many Tulip tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.

If you forget to take Tulip

If you forget to take a dose, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Tulip

If you have any further questions on the use of this medicine or wish to stop your treatment, 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 your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

Rare: may affect up to 1 in 1,000 people:
-   Serious allergic reaction which causes swelling of the face, tongue and throat that can cause great difficulty in breathing.
-   Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes genitals and fever. Skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.
-   Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown. The abnormal muscle breakdown does not always go away, even after you have stopped taking atorvastatin, and it can be life-threatening and lead to kidney problems.
Very rare: may affect up to 1 in 10,000 people:
-   If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint. You should consult your doctor as soon as possible.

Other possible side effects with Tulip:

Common side effects (may affect up to 1 in 10 people) include:
•   Inflammation of the nasal passages, pain in the throat, nose bleed
•   Allergic reactions
•   Increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase
•   Headache
•   Nausea, constipation, wind, indigestion, diarrhoea
•   Joint pain, muscle pain and back pain
•   Blood test results that show your liver function can become abnormal
Uncommon side effects (may affect up to 1 in 100 people) include:
•   Anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels)
•   Having nightmares, insomnia
•   Dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch, change in sense of taste, loss of memory
•   Blurred vision
•   Ringing in the ears and/or head
•   Vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain)
•   Hepatitis (liver inflammation)
•   Rash, skin rash and itching, hives, hair loss
•   Neck pain, muscle fatigue
•   Fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature
•   Urine tests that are positive for white blood cells
Rare side effects (may affect up to 1 in 1,000 people) include:
•   Visual disturbance
•   Unexpected bleeding or bruising
•   Cholestasis (yellowing of the skin and whites of the eyes)
•   Tendon injury
Very rare side effects (may affect up to 1 in 10,000 people) include:
•   An allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
•   Hearing loss
•   Gynecomastia (breast enlargement in men).
Side effects of unknown frequency (frequency cannot be estimated from the available data)
•   Muscle weakness that is constant
Possible side effects reported with some statins (medicines of the same type):
•   Sexual difficulties
•   Depression
•   Breathing problems including persistent cough and/or shortness of breath or fever
•   Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tulip

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated and the carton and the blister after EXP. The expiry date refers to the last day of that month.
Store in the original package, in order to protect from moisture.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.

6.

Contents of the pack and other information

What Tulip contains

The active substance is atorvastatin. Each film-coated tablet of Tulip contains 10 mg , 20 mg , 40 mg and 80 mg atorvastatin (as atorvastatin calcium).
The other ingredients are:
Tablet core: Sodium laurilsulfate, microcrystalline cellulose, colloidal anhydrous silica, pregelatinised maize starch, trometamol, ferric oxide yellow (E 172), magnesium stearate, talc, sodium starch glycolate (type A)
Tablet film-coating: Carmellose sodium, glycerol, trometamol, sodium laurilsulfate, hydroxyethylcellulose

What Tulip looks like and contents of the pack

10 mg film-coated tablets:
Light yellow, dappled, glossy, round biconvex film-coated tablets, debossed with “HLA 10” on one side measuring 7.2 mm in diameter
20 mg film-coated tablets:
Light yellow, dappled, glossy, round biconvex film-coated tablets, debossed with “HLA 20” on one side measuring 9.2 mm in diameter
40 mg film-coated tablets:
Light yellow, dappled, glossy, round biconvex film-coated tablets, debossed with “HLA 40” on one side measuring 11.2 mm in diameter
80 mg film-coated tablets:
Light yellow, dappled, glossy, oval biconvex film-coated tablets, debossed with “HLA 80” on one side measuring 19.3 mm in length
Aluminium/aluminium blister Pack sizes;
10 mg   film-coated tablets:    7,    14,    28,    30, 56,    60,    63, 90, 91,    100
20 mg   film-coated tablets;    7,    14,    28,    30, 56,    60,    63, 90, 91,    100
40 mg   film-coated tablets;    7,    14,    28,    30, 56,    60,    63, 90, 91,    100
80 mg   film-coated tablets;    7,    28,    30,    50, 60,    90,    98, 100
Not all pack size may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:
Sandoz d.d.
Verovškova 57 SI-1000 Ljubljana Slovenia
Manufacturers:
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana Slovenia
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany
Lek SA
Ul.Podlipie 16, 95-010 Strykow Poland

This leaflet was last approved in June 2016.