Astatin^TM belongs to a group of medicines known as statins, which are lipid (fat)
regulating medicines.
Astatin^TM 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, Astatin^TM 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 Astatin^TM
- if you are hypersensitive (allergic) to Astatin^TM 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 Astatin^TM
The following are reasons why Astatin^TM 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 Astatin^TM
- 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 AstatinTM 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”).
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.
Liver function tests should be performed prior to and at 12 week following both the
initiation of therapy and any elevation of dose, and periodically (e .g., semiannually)
thereafter. Liver enzyme changes generally occur in the first 3 months of treatment
with AstatinTM.
Increases in HbAlc and fasting serum glucose levels have been reported with
HMG-CoA reductase inhibitors, including AstatinTM.
Taking other medicines
There are some medicines that may change the effect of AstatinTM or their effect may
be changed by AstatinTM. 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, etc.
- Other medicines known to interact with AstatinTM include ezetimibe (which lowers
cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol
(an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers),
phenazone (a painkiller) and antacids (indigestion products containing aluminium or
magnesium).
- Medicines obtained without a prescription: St John’s Wort.
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Taking AstatinTM with food and drink
See Section 3 for instructions on how to take AstatinTM. 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 AstatinTM.
Pregnancy and breast-feeding
Do not take AstatinTM if you are pregnant, or if you are trying to become pregnant.
Do not take AstatinTM if you are able to become pregnant unless you use reliable
contraceptive measures.
Do not take AstatinTM if you are breast-feeding.
The safety of AstatinTM 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 AstatinTM
One of the ingredient Ludipress of AstatinTM tablets contains lactose. If you have an
intolerance to some sugars, please speak to your pharmacist or 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 Astatin^TM.
The usual starting dose of AstatinTM 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 AstatinTM is 80 mg once daily for adults and 20 mg
once daily for children.
Astatin^TM 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 Astatin^TM 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 Astatin^TM is determined by your doctor.
Please ask your doctor if you think that the effect ofAstatin^TM  is too strong or too
weak.
If you take more Astatin^TM than you should
If you accidently take too many Astatin^TM tablets (more than your usual daily dose),
contact your doctor or nearest hospital for advice.
If you forget to take Astatin^TM
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 Astatin^TM
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, Astatin^TM 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
- 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:
- 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 Astatin^TM :
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, diarrhoea.
- 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
(oedema), raised temperature.
- urine tests that are positive for white blood cells.
Rare side effects (affects 1 to 10 users in 10,000) include:
- visual disturbance.
- unexpected bleeding or bruising.
- cholestasis (yellowing of the skin and whites of the eyes).
- tendon injury.
Very rare side effects (affects less than 1 user in 10,000) 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 and women).
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.
There have been rare post marketing reports of cognitive impairment (e.g., memory
loss, forgetfullness, amnesia, memory impairment and confusion) associated with
statin use. These cognitive issues have been reported for all statins. The reports are
generally non-serious, and reversible upon statin discontinuation, with variable times
to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
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.
Do not store above 30 OC.
Do not use Astatin^TM after the expiry date which is stated on the blister and outer
packaging after {EXP}.
Medicines should not be disposed of via wastewater or household waste. Ask your
Pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.