Zocozet 10/10 – 10/20 mg oral tablets

Zocozet (ezetimibe /simvastatin) is a lipid-lowering product that selectively inhibits the intestinal absorption of cholesterol and related plant sterols and inhibits the endogenous synthesis of cholesterol.

Zocozet contains ezetimibe and simvastatin, two lipid-lowering compounds with complementary mechanisms of action. Zocozet reduces elevated total cholesterol (total-C), LDL-C, apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and increases high-density lipoprotein cholesterol (HDL-C) through dual inhibition of cholesterol absorption and synthesis.

CONTACT YOUR DOCTOR IMMEDIATELY IF YOU EXPERIENCE UNEXPLAINED MUSCLE PAIN, TENDERNESS, OR WEAKNESS. THIS IS BECAUSE ON RARE OCCASIONS, MUSCLE PROBLEMS CAN BE SERIOUS, INCLUDING MUSCLE BREAKDOWN RESULTING IN KIDNEY DAMAGE; AND VERY RARE DEATHS HAVE OCCURRED.

Indications

Zocozet is a film coated tablets used for:

Prevention of Cardiovascular Events: Zocozet is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), either previously treated with a statin or not.

Hypercholesterolaemia: Zocozet is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) Hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:

  • patients not appropriately controlled with a statin alone.
  • patients already treated with a statin and ezetimibe.

Homozygous Familial Hypercholesterolaemia(HoFH): Zocozet is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g., low-density lipoprotein [LDL] apheresis).

Shall I take Zocozet at bedtime?

There is no specific time of the day that is best to take Zocozet, as it works exactly the same whether you take in the morning, afternoon or at night. Zocozet is taken once a day, at the same time each day and it can be taken with or without food.

What time of day should I take Zocozet?

Take Zocozet exactly as your doctor tells you to. You will be prescribed one tablet to take every day. You can take the tablet at whatever time of day you find easiest to remember, but do try to take your doses at about the same time of day each day. This will help you to remember to take the tablets regularly.

Can I just stop taking Zocozet?

If you take your medicine as prescribed, your cholesterol levels should drop within 2 weeks. Usually, treatment with Zocozet is for life. You will need to keep taking it for it to work. Do not stop taking your medicine without speaking to a doctor first.

Possible side effects

The following common side effects were reported (may affect up to 1 in 10 people):

  • muscle aches.
  • elevations in laboratory blood tests of liver (transaminases) and/or muscle (ck) function.

The following uncommon side effects were reported (may affect up to 1 in 100 people):

  • elevations in blood tests of liver function; elevations in blood uric acid; elevations in the time it takes for blood to clot; protein in urine; weight decreased.
  • dizziness; headache; tingling sensation.
  • abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; diarrhoea; dry mouth; heartburn.
  • rash; itching; hives.
  • joint pain; muscle pain, tenderness, weakness or spasms; neck pain; pain in arms and legs; back pain.
  • unusual tiredness or weakness; feeling tired; chest pain; swelling, especially in the hands and feet.
  • sleep disorder; trouble sleeping.

Additionally, the following side effects have been reported in people taking either Zocozet:

  • low red blood cell count (anaemia); reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopaenia).
  • numbness or weakness of the arms and legs; poor memory, memory loss, confusion.
  • breathing problems including persistent cough and/or shortness of breath or fever.
  • constipation.
  • inflammation of the pancreas often with severe abdominal pain.
  • inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark coloured urine or pale coloured stool, feeling tired or weak, loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting).
  • hair loss; raised red rash, sometimes with target-shaped lesions (erythema multiforme).
  • blurred vision and impaired vision (which each may affect up to 1 in 1000 people).
  • rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions) (which each may affect up to 1 in 10000 people).
  • hypersensitivity reactions including some of the following: allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing and requires treatment immediately (angioedema), pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing, shortness of breath and feeling unwell, lupus-like disease picture (including rash, joint disorders, and effects on white blood cells).¬†A serious very rare allergic reaction (which may affect up to 1 in 10000 people) may occur that causes difficulty in breathing or dizziness and requires immediate treatment (anaphylaxis).
  • muscle pain, tenderness, weakness or cramps; muscle breakdown; muscle rupture (which may affect up to 1 in 10000 people); tendon problems, sometimes complicated by rupture of the tendon.
  • gynaecomastia (breast enlargement in men) (which may affect up to 1 in 10000 people).
  • decreased appetite.
  • hot flush; high blood pressure.
  • pain.
  • erectile dysfunction.
  • depression.
  • ¬†alterations in some laboratory blood tests for liver function.

Additional possible side effects reported with some statins:

  • sleep disturbances, including nightmares.
  • sexual difficulties.
  • 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.
  • muscle pain, tenderness, or weakness that is constant that may not go away after stopping Zocozet (frequency not known).