Panadol Night Tablets

500mg Paracetamol & 25 mg Diphenhydramine Hydrochloride

Consumer Medicine Information

This leaflet answers some common questions about PANADOL Night. It does not contain all the available information.

It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking PANADOL Night against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your pharmacist or doctor.

Keep this leaflet with the medicine.

You may need to read it again.

PANADOL Night is used to give temporary relief of pain when associated with sleeping difficulty.

It is useful for headache, migraine, backache, arthritis, rheumatic and muscle pain, neuralgia, toothache or period pain.

Paracetamol is an analgesic. It works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever.

Diphenhydramine hydrochloride is an antihistamine that helps you sleep.

Ask your pharmacist or doctor if you have any questions about this medicine.

Your pharmacist or doctor may have given you this for another reason.

This medicine is only available from your pharmacist.

Do not take more than the recommended dose as it may cause serious harm to your liver.

Do not take PANADOL Night if you have an allergy to:

any medicine containing paracetamol or diphenhydramine hydrochloride

any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin

Do not use this medicine if you are taking any other prescription or non-prescription medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep.

Always read and follow the label.

Do not take PANADOL Night if you have or have had any of the following medical conditions:

glaucoma (high pressure in the eyes)

stomach or duodenal ulcer or other stomach problems

prostate problems

bladder problems

Do not take PANADOL Night if you are taking monoamine oxidase inhibitors (MAOIs), a type of medicine used to treat depression.

Do not take PANADOL Night if you have taken other medicine containing paracetamol in the last 4 hours.

Do not take PANADOL Night if you are breastfeeding or plan to breastfeed.

It passes into the breast milk and there is a possibility that the baby may be affected.

Do not give PANADOL Night to newborn or premature babies.

Do not give PANADOL Night to children under 12 years of age.

Do not take this medicine after the expiry date (EXP) printed on the pack. If you take it after the expiry has passed, it may not work as well.

Do not take PANADOL Night if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor.

Tell your pharmacist or doctor if you have or have had any of the following medical conditions:

Liver or kidney disease

Underweight or malnourished

Regularly drink alcohol

You may need to avoid using this product altogether or limit the amount of paracetamol that you take.

You have a severe infection, are severely malnourished or are a chronic heavy alcohol user as this may increase the risk of metabolic acidosis

Signs of metabolic acidosis include:

deep, rapid, difficult breathing

feeling sick (nausea), being sick (vomiting)

loss of appetite

Contact a doctor immediately if you get a combination of these symptoms

Epilepsy

Myasthenia gravis (a muscle dysfunction)

Prostate gland enlargement or difficulty urinating

Glaucoma

Asthma

Bronchitis or chronic lung disease

Tell your pharmacist or doctor if you take sedatives.

Tell your pharmacist or doctor if you are pregnant or plan to become pregnant.

Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

Consider taking the lowest effective dose for the shortest period of time.

If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking PANADOL Night.

Please see your doctor if your symptoms do not improve.

Keep out of sight and reach of children.

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

Some medicines and PANADOL Night may interfere with each other. These include:

Warfarin, a medicine used to prevent blood clots

Metoclopramide, a medicine used to control nausea and vomiting

Medicines used to treat epilepsy or fits

Chloramphenicol, an antibiotic used to treat ear and eye infections

Alcohol

Medicines used to treat depression, especially monoamine oxidase inhibitors and tricyclic antidepressants

Medicines used to help you sleep or relax (sedatives and hypnotics)

Opioid analgesics, medicines used to treat pain

Other antihistamine medicines including cough and cold medicines and those you use on your skin

Medicines which make you drowsy or give you a dry mouth (sometimes called anticholinergics). Taking such medicines while you are taking this medicine may increase the chances of side effects

Probenecid, a medicine used to treat gout or sometimes given with an antibiotic

Cholestyramine, a medicine used to treat high cholesterol levels in the blood

These medicines may be affected by PANADOL Night or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your pharmacist or doctor will have more information on these and other medicines to be careful with or avoid while taking this medicine.

This product contains paracetamol. If you are taking any other medicine containing paracetamol, you must make sure you do not take more than 4000mg paracetamol (including this product) in any 24 hour period. If in doubt, consult your doctor or pharmacist.

Do not exceed the stated dose.

Use the smallest dose that you need to treat your symptoms and use the medicine for the shortest period of time necessary.

Follow all directions given to you by your pharmacist or doctor carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your pharmacist or doctor for help.

Take two caplets.

Do not take more than the stated dose.

If you are over 65 years of age, talk to your pharmacist or doctor about how much to use. Elderly patients are more likely to have side effects from taking this medicine. Carers should be aware that this medicine should not be given to elderly patients with confusion.

Take with water or other fluid.

Take the caplets at bedtime.

Adults should not take this medicine for more than a few days at a time unless your doctor tells you to take it for longer.

Children aged 12 to 17 years should not take this medicine for more than 48 hours unless on the advice of a doctor.

Children under 12 years of age should not be given PANADOL Night unless a doctor has told you to.

If you forget to take PANADOL Night at bedtime, you may take it through the night. Do not take a second dose.

If you are not sure what to do, ask your pharmacist or doctor.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much PANADOL Night. Do this even if there are no signs of discomfort or poisoning because of the risk of liver failure.

You may need urgent medical attention. Keep telephone numbers of these places handy.

Talk to your pharmacist or doctor if your symptoms do not improve.

Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.

Use PANADOL Night exactly as your pharmacist or doctor has told you to.

Tell all your doctors, dentists and pharmacists that you are using PANADOL Night.

Children 12 to 17 years:

Do not give paracetamol for more than 48 hours unless a doctor has told you to.

Adults:

Do not take for more than a few days at a time unless your doctor tells you to.

Do not use this medicine to treat any other complaint unless your pharmacist or doctor tells you to.

Do not give this medicine to anyone else even if they have the same condition as you.

Do not take more than the stated dose unless your doctor tells you to.

Do not drink alcohol while taking PANADOL Night.

This product may cause dizziness, drowsiness, difficulty concentrating or blurred vision. Be careful driving or operating machinery until you know how the medicine affects you.

Please see your doctor if your symptoms do not improve.

Keep out of sight and reach of children.

This medicine may cause sleepiness in some people. If this happens, do not drive or operate machinery.

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking PANADOL Night.

This medicine helps most people with pain when associated with sleeping difficulty, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Tell your pharmacist or doctor to answer any questions you may have.

Tell your pharmacist or doctor if you notice any of the following and they worry you:

nausea or dyspepsia

drowsiness or sleepiness

dry mouth, nose and throat

constipation

nervousness and irritability

anxiety

hallucinations

twitching or jerking muscles

fast heart beat

tiredness

dizziness

difficulty concentrating

unsteadiness

The above list includes the more common side effects of your medicine. They are usually mild.

Tell your doctor as soon as possible if you notice any of the following:

difficult or painful urination

seizures (fits)

The above list includes serious side effects that may require medical attention. These side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue, throat or other parts of the body

rash, peeling, itching or hives on the skin or mouth ulcers

previous breathing problems with aspirin or non-steroidal anti-inflammatories, and you experience a similar reaction with this product.

unexplained bruising or bleeding

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your pharmacist or doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Keep your medicine in the original pack until it is time to take it.

If you keep the caplets out of their packaging, they will not keep well.

Keep your medicine in a cool, dry place where the temperature stays below 30°C. Protect from moisture.

Do not store PANADOL Night or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children and pets cannot reach it.

A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Ask your pharmacist what to do with any medicine that is left over, or if the expiry date has passed.

PANADOL Night is a blue, film coated caplet.

It is marked “Panadol” on the front face and “Night” on the back.

PANADOL Night is supplied in packs of 20 caplets.

Each PANADOL Night caplet contains 500 mg paracetamol and 25 mg diphenhydramine hydrochloride as active ingredients.

It also contains:

Starch-maize

Starch-pregelatinized maize

Povidone

Potassium sorbate

Magnesium stearate

Talc-purified

Cellulose-microcrystalline

Water-purified

Carnauba wax

Opadry II complete film coating system 85G60844 Blue

PANADOL Night contains no sugar, lactose, alcohol or wheat starch.

GlaxoSmithKline Consumer Healthcare

82 Hughes Avenue,

Ermington NSW 2115, Australia

 

AUST R 167596 (PANADOL NIGHT)

This leaflet was prepared in May 2018.

 

Trademarks are owned by or licensed to the GSK group of companies.

© 2018 GSK group of companies or its licensor.

Managing pain at night can often be complicated by affecting your ability to get to sleep. When your sleep pattern is affected, pain at night can seem stronger than normal. For this reason we have included some helpful advice on managing pain and getting to sleep.

1.Application of gentle heat to the painful area. This increases the blood flow to the affected area which works to relieve the sensation of pain and aids the healing process. Hot water bottles, hot showers and heat bags can be useful.

2.Pain as a result of inflammation can also be treated by the application of cold to the affected area. Cold packs can often be more effective in the early stages of an injury than heat. See your doctor or pharmacist for advice on the best way to treat your pain.

3.For some people, massage can also help to increase blood flow to an area and contribute to increasing flexibility of joints and muscles. Massage oils may help.

1.Avoid alcohol, caffeine products and nicotine before bedtime.

2.Avoid large meals before bedtime.

3.Develop a regular bed time routine. This helps signal to your mind that it is time to go to sleep.

4.Practice relaxation techniques. There are many useful books and courses available to instruct you on simple, effective techniques.

5.Ensure your bed is comfortable. Sometimes changing a mattress or pillows can increase your comfort and ability to get to sleep, particularly if you suffer from muscle or joint pain.

Suffering from night time pain can be a lonely experience if it also stops you sleeping. Just remember, many people suffer from night time pain, you are not alone. Try some of the above techniques which could help you manage your night time pain.