LD-NOR belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.

LD-NOR 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, LD-NOR 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.

Do not take LD-NOR

-  If you are hypersensitive (allergic) to LD-NOR or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine – see Section 6 for details.

-  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.

Take special care with LD-NOR

The following are reasons why LD-NOR 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.

All patients treated with LD-NOR should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

Check with your doctor or pharmacist before taking LD-NOR

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 LD-NOR 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 “Taking other medicines”).

Taking other medicines

There are some medicines that may change the effect of LD-NOR or their effect may be changed by LD-NOR. 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:

1. 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.

2. Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol

3. 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

4. Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.

5. Other medicines known to interact with LD-NOR 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) and antacids (indigestion products containing aluminium or magnesium).

6. Medicines obtained without a prescription: St John’s Wort.

7. Colchicine: Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin co-administered with colchicine, and caution should be exercised when prescribing atorvastatin with colchicine.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking LD-NOR with food and drink

See Section 3 for instructions on how to take LD-NOR. 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 LD-NOR.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See Section 2 “Take special care with LD-NOR” for details

Pregnancy and breast-feeding

Do not take LD-NOR if you are pregnant, or if you are trying to become pregnant.

Do not take LD-NOR if you are able to become pregnant unless you use reliable contraceptive measures.

Do not take LD-NOR if you are breast-feeding.

The safety of LD-NOR 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.

Important information about some of the ingredients of LD-NOR

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

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with LD-NOR.

The usual starting dose of LD-NOR 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 LD-NOR is 80 mg once daily for adults and 20 mg once daily for children.

LD-NOR 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 LD-NOR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The duration of treatment with LD-NOR is determined by your doctor.

Please ask your doctor if you think that the effect of LD-NOR is too strong or too weak.

If you take more LD-NOR than you should

If you accidently take too many LD-NOR tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.

If you forget to take LD-NOR

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 LD-NOR

If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist.

Like all medicines, LD-NOR 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: affects 1 to 10 users in 10,000:

-  Visual disturbance.

-  Unexpected bleeding or bruising.

-  Cholestasis (yellowing of the skin and whites of the eyes).

-  Tendon injury.

-  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 which can be life-threatening and lead to kidney problems.

Very rare: affect less than 1 user in 10,000:

-  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 and women).

-  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 LD-NOR:

Common side effects (affects 1 to 10 users in 100) 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, diarrhea.

-  Joint pain, muscle pain and back pain.

-  Blood test results that show your liver function can become abnormal.

Uncommon side effects (affects 1 to 10 users in 1000) 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 (edema), raised temperature.

-  Urine tests that are positive for white blood cells.

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.

Endocrine Function:

-  Increase in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LD-NOR

The following additional side effects have been reported with LD-NOR:

Tiredness, tendon problems, memory loss, and confusion.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Store below 30º C.

Do not use LD-NOR after the expiry date which is stated on the container and outer packaging after {EXP}.