Reguchole 5 mg Tablets

REGUCHOLE contains the active medicines ezetimibe and rosuvastatin. REGUCHOLE helps to lower cholesterol levels. It is used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately.

What is high cholesterol

Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.

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.

Do not take REGUCHOLE:

• If you are hypersensitive (allergic) to ezetimibe, rosuvastatin or any of the other ingredients of REGUCHOLE (listed in section 6).
• If you are pregnant or intend to become pregnant. If you are a woman of childbearing age and are taking REGUCHOLE, use a proven method of birth control to avoid pregnancy. The medicine may affect your developing baby if you take it during pregnancy (see Pregnancy, breastfeeding and fertility).
• If you are breastfeeding. REGUCHOLE may pass into breast milk and affect your baby (see Pregnancy, breastfeeding and fertility).
• If you have liver conditions or active liver disease.
• If you have severe kidney disease.
• If you are taking a medicine to suppress your immune system, called ciclosporin (see Other medicines and REGUCHOLE).
• If you have a previous history of muscular problems (myopathy) from using other medicines used to treat high cholesterol.
• If you have gall bladder disease and you are taking another medicine to lower cholesterol levels, called fenofibrate (see Other medicines and REGUCHOLE).
• If you are taking an antibiotic medicine to treat infection, called fusidic acid (see Other medicines and REGUCHOLE).

REGUCHOLE is not recommended for use in children (see Warnings and precautions).

Do not share medicines prescribed for you with any other person. Always take REGUCHOLE exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Once you have been controlled on the individual medicines within REGUCHOLE as separate medicines, then your doctor will prescribe REGUCHOLE. In adults the usual dose of REGUCHOLE is one tablet per day. Cholesterol-lowering medicines are used together with lifestyle changes to help lower cholesterol. Your doctor will tell you how long your treatment with REGUCHOLE will last. If you have the impression that the effect of REGUCHOLE is too strong or too weak, tell your doctor or pharmacist.

If you take more REGUCHOLE than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take REGUCHOLE

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of REGUCHOLE, take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

REGUCHOLE can have side effects. Not all side effects reported for REGUCHOLE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking REGUCHOLE, please consult your healthcare provider for advice.

If any of the following happens, stop taking REGUCHOLE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to REGUCHOLE. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• an elevation in blood glucose levels, a significant increase in your need to urinate or if you are significantly more hungry or thirsty than usual, as these may be signs of diabetes mellitus,
• sudden pain in the upper abdomen, nausea and vomiting or an abnormally fast heart rate, as these may be signs of inflammation of the pancreas (pancreatitis),
• muscle weakness, feeling abnormally tired, body aches, cramping, dark-coloured urine or fever, as these may be signs of muscle breakdown (myopathy or rhabdomyolysis),
• chest pain,
• blood disorders which are usually detected in blood tests but may be seen as bruising or prolonged bleeding after injury, small red spots on the skin or abnormal tiredness (thrombocytopaenia),
• swelling of the liver, including yellowing of your skin and eyes (jaundice), sometimes with fever, pale stools and dark urine (hepatitis or hepatic failure),
• pain in the back or upper abdomen, heartburn, nausea or vomiting, as these may be signs of gallstones (cholelithiasis) or swelling of the gall bladder (cholecystitis).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• viral infection, sore throat (pharyngitis), runny nose or sinus congestion (sinusitis),
• headache, dizziness,
• abdominal pain, nausea, loose stools (diarrhoea), difficulty passing stools (constipation), passing wind (flatulence),
• elevation in some laboratory blood tests of liver,
• muscle pain (myalgia), joint pain (arthralgia),
• tiredness (fatigue).

Less frequent side effects:

• decreased appetite,
• abnormal dreaming, nightmares, sleepwalking,
• hot flush, high blood pressure (hypertension),
• cough,
• burning sensation, bloating or gassiness, nausea or feeling full too quickly after starting to eat (dyspepsia, gastro-oesophageal reflux disease),
• back pain, pain in different parts of the body, muscle spasms, neck pain,
• abnormal physical weakness or lack of energy (asthenia), swelling due to build-up of fluid (oedema),
• elevation in some laboratory blood tests of liver,
• depression,
• paraesthesia,
• memory loss,
• asthenia.

Side effects with an unknown frequency:

• sleep disorders, inability to sleep (insomnia), nightmares,
• breast tissue swelling in males (gynaecomastia).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 30 °C. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).