FENOCOL

FENOCOL

Active ingredient(s): fenofibrate

---

Consumer Medicine Information (CMI)

This leaflet provides important information about using FENOCOL. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using FENOCOL.

Where to find information in this leaflet:

1. Why am I using FENOCOL?
2. What should I know before I use FENOCOL?
3. What if I am taking other medicines?
4. How do I use FENOCOL?
5. What should I know while using FENOCOL?
6. Are there any side effects?
7. Product details

1. Why am I using FENOCOL?

FENOCOL contains the active ingredient fenofibrate. FENOCOL belongs to a group of medicines known as fibric acid derivatives.

FENOCOL works through the activation of a cell nuclear receptor called PPARα, which reduces the amount of triglycerides and bad cholesterol made in the body and increases the good cholesterol.

Cholesterol is present in many foods and is also made in your body by the liver. If your body does not balance the amount of cholesterol it needs with the amount of cholesterol eaten, then your cholesterol becomes too high.

High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol.

When you have high levels of cholesterol it may ‘stick’ to the inside of your blood vessels instead of being carried to the parts of the body where it is needed.

Over time, this can form hard areas (called plaque) on the walls of your blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to heart disease (such as heart attack and angina), and stroke.

Cholesterol is carried through the body by different proteins, LDL and HDL. LDL cholesterol is the ‘bad’ cholesterol that can block your blood vessels. HDL cholesterol is the ‘good’ cholesterol that is thought to remove the ‘bad’ cholesterol from the blood vessels.

In most patients, FENOCOL reduces the bad cholesterol and can actually raise the good cholesterol.

Patients with type 2 diabetes may have some level of diabetic retinopathy, a complication of diabetes that may lead to vision loss or impairment. FENOCOL has been shown to slow the progression of diabetic retinopathy in patients diagnosed with this condition.

FENOCOL does not reduce the cholesterol that comes from fat in food.

Therefore, when you are taking FENOCOL, you also need to follow a low fat diet and other measures, such as exercise and weight control.

FENOCOL is used to help regulate cholesterol and triglycerides which are fat-like substances in the blood.

2. What should I know before I use FENOCOL?

Warnings

Do not use FENOCOL if:

• you are allergic to fenofibrate, any fibrates (such as gemfibrozil) or any of the ingredients listed at the end of this leaflet.
• Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
• Always check the ingredients to make sure you can use this medicine.
• you are taking another fibrate.
• you are allergic to peanuts, peanut oil, soy lecithin or related products.
• it after the expiry date printed on the pack or if the packaging is damaged or shows signs of tampering.

Check with your doctor if you:

• have any other medical conditions:
  – liver disease
  – severe kidney disease
  – disease of the gallbladder or pancreas
  – experienced muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides.
• take any medicines for any other condition.
• have any allergies to any other medicines, foods, preservatives or dyes.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

It may affect your developing baby if you take it during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

The active ingredient in FENOCOL passes into breast milk and there is a possibility your baby may be affected.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with FENOCOL and affect how it works.

• oral anti-coagulants (medicines used to prevent blood clots)
• other cholesterol regulating medicines including fibrates
• ciclosporin (a medicine which suppresses the immune system)
• glitazones (medicines to reduce sugar levels)

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect FENOCOL.

4. How do I use FENOCOL?

Note: A lower strength fenofibrate 48 mg tablets can be available from other brand/s.

How much to take / use

• The initial recommended dose is 145 mg daily, taken as 1 x 145 mg tablet, your doctor may prescribe a lower dose if you have kidney problems.
• Swallow the tablet(s) whole with a full glass of water.
• Follow the instructions provided and use FENOCOL until your doctor tells you to stop.

When to take / use FENOCOL

• FENOCOL can be taken at any time of the day, with or without food. Any dietary measures started before treatment with FENOCOL should be continued.

If you forget to use FENOCOL

FENOCOL should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, and then go back to taking you medicine as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

• This may increase the chance of getting an unwanted side effect.

If you use too much FENOCOL

If you think that you have used too much FENOCOL you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (Australia telephone 13 11 26) for advice, or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

Symptoms of an overdose may include:

• diarrhoea
• nausea

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using FENOCOL?

Things you should do

Have your blood fats checked when requested by your doctor to make sure FENOCOL is working.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking FENOCOL.

Call your doctor straight away if you:

• become pregnant while you are taking this medicine.

Remind any doctor, surgeon, dentist or pharmacist you visit that you are using FENOCOL.

Things you should not do

• Do not stop using this medicine suddenly.
• Do not use this medicine to treat any other complaints unless your doctor or pharmacist tells you to.
• Do not give this medicine to anyone else, even if they have the same condition as you.
• Do not give FENOCOL to anyone under the age of 18 years.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how FENOCOL affects you.

FENOCOL may cause dizziness in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

Drinking large quantities of alcohol may increase your chance of FENOCOL causing liver problems.

Things that may help you reduce the chance of coronary heart disease

Lowering high cholesterol can help reduce your chances of having Coronary Heart Disease (CHD). However, your chances of having CHD may be increased by several other factors including high blood pressure, cigarette smoking, diabetes, excess weight, family history of CHD, being a male and being a woman who has reached menopause.

Some self-help measures suggested below may help your condition and help reduce your chances of having CHD. Talk to your doctor, pharmacist, or dietician about these measures and for more information.

• Diet – continue the healthy diet recommended by your doctor, dietician or pharmacist.
• Weight – your doctor may advise you to lose weight if you are overweight.
• Exercise – make exercise a part of your routine – walking is good. Ask your doctor for advice before starting exercise.
• Smoking – your doctor will advise you to stop smoking.

Looking after your medicine

• Keep your tablets in the pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well.
• Keep the medicine in a cool, dry place where the temperature stays below 30°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine (as relevant)

If your doctor or pharmacist tells you to stop taking this medicine, or the medicine has passed its expiry date, ask your pharmacist what to do with any that are left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
stomach pain or discomfort back pain headache muscular pain or spasms unusual tiredness or weakness diarrhoea or constipation nausea skin reactions, photosensitivity reactions sexual dysfunction	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
difficulty in breathing severe abdominal pain chest pain temporary paralysis of the muscles yellowing of the skin and eyes and dark coloured urine	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What FENOCOL contains

Active ingredient (main ingredient)	fenofibrate
Other ingredients (inactive ingredients)	Tablets core: sucrose, hypromellose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, docusate sodium, magnesium stearate. Tablets coating OPADRY AMB-White OY-B-28920 (PI no. 10274): Polyvinyl alcohol-part hydrolyzed, titanium dioxide, talc, lecithin (soya), xanthan gum.
Potential allergens	Contains soya bean, sugars as lactose and sucrose.

Do not take this medicine if you are allergic to any of these ingredients.

What FENOCOL looks like

FENOCOL is white to off white coloured, oval shaped, biconvex film coated tablet, debossed with ‘cipla’ on one side and code ‘458’ on other side. (AUST R 288060).

Available in boxes of 10 and 30 tablets.

Who distributes FENOCOL

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne, VIC 3121
Australia
Web: www.arrotex.com.au
Tel: +61-1300927769

This leaflet was prepared in August 2023.