TWICOR 10 MG / 10 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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 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 TWICOR is and what it is used for

• 2. What you need to know before you take TWICOR

• 3. How to take TWICOR

• 4. Possible side effects

• 5. How to store TWICOR

• 6. Contents of the pack and other information

1. what twicor is and what it is used for

TWICOR contains two different active substances in one film-coated tablet. One of the active substances is rosuvastatin, belonging to the group of so called statins, the other active substance is ezetimibe.

TWICOR is a medicine used in adult patients to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. In addition, it also raises levels of “good” cholesterol (HDL cholesterol). This medicine works to reduce your cholesterol in two ways: it reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself.

For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow.

Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related health problems.

This medicine is used in patients whose cholesterol levels cannot be controlled by a cholesterol lowering diet alone. You should stay on your cholesterol lowering diet while taking this medicine.

Your doctor may prescribe TWICOR if you are already taking both rosuvastatin and ezetimibe at the same dose level.

This medicine does not help you lose weight.

Do not take TWICOR if you

• are allergic to rosuvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6).
• have liver disease.
• have severe kidney impairment.
• have repeated, unexplained muscle aches or pains (myopathy).
• take a medicine called ciclosporin (used for example, after organ transplants).
• are pregnant or breast-feeding. If you become pregnant while taking TWICOR, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking this medicine by using suitable contraceptive measures.

If any of the above applies to you (or you are in doubt), please contact your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking TWICOR if you:

• have problems with your kidneys.
• have problems with your liver.
• have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever. Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
• are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the right dose to suit you.
• take medicines used to fight infections, including HIV or hepatitis C infection e.g. lopinavir/ritonavir and/or atazanavir or simeprevir, please see “Other medicines and TWICOR”.
• have severe respiratory failure.
• take other medicines called fibrates to lower your cholesterol. Please see “Other medicines and TWICOR ”.
• regularly drink large amounts of alcohol.
• suffer from hypothyroidism, where your thyroid gland is underactive.
• are over 70 (as your doctor needs to choose the right dose of TWICOR to suit you).
• are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for

bacterial infection) orally or by injection. The combination of fusidic acid and TWICOR can lead to serious muscle problems (rhabdomyolysis).

If any of the above applies to you (or if you are not sure): check with your doctor or pharmacist before you actually start taking any dose of this medicine.

In a small number of people, statins can affect the liver. This is identified by a simple test which looks for increased levels of liver enzymes in the blood. For this reason, your doctor will regularly carry out this blood test (liver function test) during treatment with this medicine. It is important to go to the doctor for the prescribed laboratory checks.

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.

Children and adolescents

The use of this medicine is not recommended in children and adolescents under the age of 18 years.

Other medicines and TWICOR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following:

• Ciclosporin (used for example, after organ transplants to prevent rejection of the transplanted organ. The effect of rosuvastatin is increased if used together with ciclosporin). Do not take TWICOR while taking ciclosporin.
• Blood thinners e.g. warfarin, acenocoumarol or fluindione (their blood thinning effect and the risk of bleeding may be increased while taken together with this medicine), or clopidogrel.
• Other medicines to lower your cholesterol called fibrates, which correct also blood triglyceride levels (e.g. gemfibrozil and other fibrates). When gemfibrozil is taken together with this medicine, the effect of rosuvastatin is increased.
• Colestyramine (a medicine for lowering cholesterol), because it affects the way ezetimibe works.
• Any of the following drugs used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (please see “Warnings and precautions”): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Indigestion remedies containing aluminium and magnesium (used to neutralise acid in your stomach; they decrease the plasma level of rosuvastatin.) This effect may be mitigated with taking this type of medicine 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin is reduced when taken together with this antibiotic.
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart TWICOR. Taking this medicine with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• An oral contraceptive (the pill). The levels of sexual hormones absorbed from the pill are increased.
• Hormone replacement therapy (increased hormone levels in the blood).
• Regorafenib (used to treat cancer).

If you go into hospital or receive treatment for another condition, tell the medical staff that you are taking TWICOR.

Pregnancy and breast-feeding

Do not take TWICOR if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking this medicine, stop taking it immediately and tell your doctor. Women should use contraceptive measures during the treatment with this medicine.

Do not take TWICOR, if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

Driving and using machines

This medicine is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking this medicine. If you get dizzy you should not drive or use machines.

TWICOR contains sodium:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take twicor

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is not suitable to start a treatment. Treatment initiation should only be done by giving the active substances separately and after setting the appropriate doses the switch to TWICOR of the appropriate strength is possible.

You should keep on being on low-cholesterol diet and doing exercises while taking TWICOR.

The recommended daily dose for adults is one film-coated tablet.

Take TWICOR once daily.

You can take it at any time of the day, with or without food. Take your medicine at the same time every day. Swallow each film-coated tablet whole with a drink of water.

Regular cholesterol checks

It is important to go back to your doctor for regular cholesterol checks to make sure your cholesterol has reached and is staying at the correct level.

If you take more TWICOR than you should

Contact your doctor or the emergency department of the nearest hospital because you might need medical help.

If you forget to take TWICOR

Do not worry, skip the missed dose and 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 TWICOR

Talk to your doctor if you want to stop taking this medicine. Your cholesterol levels might increase again if you stop taking this medicine.

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.

It is important that you are aware of what these side effects may be.

Stop taking TWICOR and seek medical help immediately if you experience any of the following:

Allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing and swallowing, lupus-like disease syndrome (including rash, joint disorders and effects on blood cells) and muscle rupture.

Unusual muscle aches or pains which go on for longer than you might expect. Rarely this can develop into potentially life threatening muscle damage known as rhabdomyolysis, which leads to malaise, fever and kidney impairment.

Not known (frequency cannot be estimated from the available data):

Ulcers or blistering of the skin, mouth, eyes and genitals. These could be signs of Stevens-Johnson syndrome (a life-threatening allergic reaction affecting the skin and mucous membranes).

Other side effects

• headache
• constipation
• feeling sick
• muscle pain
• feeling weak
• dizziness
• 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.
• stomach ache
• diarrhoea
• flatulence (excess gas in the intestinal tract)
• feeling tired
• elevations in some laboratory blood tests of liver function (transaminases)

Uncommon side effects (may affect up to 1 in 100 people)

• rash, itching, hives
• elevations in some laboratory blood tests of muscle function (Creatine Kinase test)
• cough
• indigestion
• heartburn
• joint pain
• muscle spasms
• neck pain
• decreased appetite
• pain
• chest pain
• hot flush
• high blood pressure
• tingling sensation
• dry mouth
• inflammation of the stomach
• back pain
• muscle weakness
• pain in arms and legs
• swelling, especially in the hands and feet

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

• inflammation of the pancreas, which causes a severe stomach pain which can extend to the back
• reduction in blood platelets

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

• jaundice (yellowing of the skin and eyes)
• inflammation of the liver (hepatitis)
• traces of blood in your urine
• damage to the nerves of your legs and arms (such as numbness)
• memory loss
• breast enlargement in men (gynecomastia)

Not known (frequency cannot be estimated from the available data)

• shortness of breath
• oedema (swelling)
• sleep disturbances, including insomnia and nightmares
• sexual difficulties
• depression
• breathing problems including persistent cough and/or shortness of breath or fever
• tendon injury
• muscle weakness that is constant
• gallstones or inflammation of the gallbladder (which may cause stomach ache, nausea, vomiting)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store twicor

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date “EXP” which is stated on the carton box and the blister.

The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.

Do not throw away any medicines via wastewater or household waste. 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- the active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe.

• – Each film-coated tablet contains rosuvastatin calcium equivalent to 10 mg or 20 mg rosuvastatin and 10 mg ezetimibe.

• – The other ingredients are:

What TWICOR looks like and contents of the pack

TWICOR 10 mg/10 mg are pink coloured round shaped film-coated tablets with a diameter of 10.1 mm embossed with “AL” on one side.

TWICOR 20 mg/10 mg are pink coloured round shaped film-coated tablets with a diameter of 10.7 mm, plain on both sides.

OPA/Al/PVC-Al blister packs

Packs of 10, 30, 60, 90 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Products Limited

20 Station Close

Potters Bar

Herts

EN6 1TL, UK

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA3000

Malta

Mylan Hungary Kft.

Mylan utca 1.,

Komarom, 2900

Hungary

and

McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin

Unit 35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

This leaflet was last revised in September 2020.

Detailed information on this medicinal product is available on the website of Medicines and Healthcare products Regulatory Agency.

7