KAPAKE 30MG/500MG TABLETS

Active substance: PARACETAMOL

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

30mg/500mg Tablets
(Codeine Phosphate and Paracetamol)

Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
- 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.
See section 4.
In this leaflet:
1. What Kapake 30mg/500mg Tablets are and what they are used for
2. Before you take Kapake 30mg/500mg Tablets
3. How to take Kapake 30mg/500mg Tablets
4. Possible side effects
5. How to store Kapake 30mg/500mg Tablets
6. Further information
1. WHAT KAPAKE 30mg/500mg TABLETS ARE AND WHAT THEY ARE
USED FOR
Kapake 30mg/500mg Tablets are one of a group of medicines called
analgesics or painkillers. They are used to relieve severe pain in adults.
Kapake 30mg/500mg Tablets contain codeine, an opioid analgesic, in
combination with paracetamol.
Codeine can be used in children over 12 years of age for the short-term
relief of moderate pain that is not relieved by other painkillers such as
paracetamol or ibuprofen alone.
2. BEFORE YOU TAKE KAPAKE 30mg/500mg TABLETS
Do not take Kapake 30mg/500mg Tablets if you
- are allergic (hypersensitive) to codeine phosphate, paracetamol or any
of the other ingredients in Kapake 30mg/500mg Tablets.
- are suffering from head injuries.
- have been told by your doctor that you have a severe breathing difficulty
called respiratory depression.

- are taking, or have taken in the last two weeks, medicine to relieve
depression (Monoamine Oxidase Inhibitors/MAOIs). Ask your doctor or
pharmacist if you are not sure what types of medicine you are taking.
- consume excessive amounts of alcohol on a regular basis.
- are pregnant or breastfeeding.
- suffer from severe but usually short-lasting asthma attacks (acute
asthma).
- know that you metabolise very rapidly codeine into morphine.
Talk to your doctor if any of the above apply to you.
Do NOT give this product to children under 12 years of age.
Do not use this product for pain relief in children and adolescents (0-18
years of age) after removal of their tonsils or adenoids due to
obstructive sleep apnoea syndrome.
Warnings and precautions
Codeine is transformed to morphine in the liver by an enzyme.
Morphine is the substance that produces pain relief. Some people have
a variation of this enzyme and this can affect people in different ways.
In some people, morphine is not produced or produced in very small
quantities, and it will not provide enough pain relief. Other people are
more likely to get serious side effects because a very high amount of
morphine is produced. If you notice any of the following side effects,
you must stop taking this medicine and seek immediate medical advice:
slow or shallow breathing, confusion, sleepiness, small pupils, feeling or
being sick, constipation, lack of appetite.
Children and adolescents
Use in children and adolescents after surgery
Codeine should not be used for pain relief in children and adolescents
after removal of their tonsils or adenoids due to obstructive sleep
apnoea syndrome.
Use in children with breathing problems
Codeine is not recommended in children with breathing problems, since
the symptoms of morphine toxicity may be worse in these children.
Take special care with Kapake 30mg/500mg Tablets if you
- are elderly and/or in poor health
- suffer from an enlarged prostate
- suffer from any bowel problems
- suffer from Addison’s disease
- suffer from any liver or kidney problems.
If any of the above apply to you, it is important that you speak to your
doctor or pharmacist before taking Kapake 30mg/500mg Tablets and they
will decide what to do. It may still be safe for you to take Kapake
30mg/500mg Tablets.

- Do not take for longer than directed by your prescriber.
- Taking codeine regularly for a long time can lead to addiction, which
might cause you to feel restless and irritable when you stop the tablets.
- Taking a painkiller for headaches too often or for too long can make
them worse.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any of the following medicines, including those medicines obtained
without a prescription:
- medicines for depression or anxiety or other medicines known as
tranquillisers
- medicines to help you sleep
- cholestyramine (medicine for high cholesterol levels or diarrhoea)
- domperidone or metoclopramide (medicines to stop you feeling sick or
vomiting)
- anticoagulants, e.g. warfarin (medicine to prevent blood clots)
- medicines that you have bought yourself such as cough/cold remedies
or other painkillers. Many of these will contain paracetamol and/or
codeine and should not be taken while you are taking Kapake
30mg/500mg Tablets.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Taking Kapake 30mg/500mg Tablets with food and drink
You should avoid alcohol when taking this product.
Food has no influence on Kapake 30mg/500mg Tablets.
Pregnancy, breastfeeding and fertility
Do not use this product or any other codeine-containing products if
you are pregnant.
Do not take codeine while you are breastfeeding. Codeine and
morphine passes into breast milk.
Driving and using machines
Kapake 30mg/500mg Tablets may make you feel drowsy. Do not drive
or use machines until you know how they affect you.

PX716/2

3. HOW TO TAKE KAPAKE 30mg/500mg TABLETS

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Kapake 30mg/500mg Tablets should be taken orally (by mouth).

Like all medicines, Kapake 30mg/500mg Tablets can cause side effects,
although not everybody gets them.

What Kapake 30mg/500mg Tablets contain
The active substances are codeine phosphate and paracetamol. Each
tablet contains 30mg of codeine phosphate and 500mg of paracetamol.

Always take Kapake 30mg/500mg Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not sure.
The usual dose for adults and the elderly is one to two tablets taken every
four hours. You should not take more than eight tablets in any 24-hour
period.
The dose for children aged 12 and over is one tablet taken every six
hours, up to a maximum of four tablets in any 24-hour period.
Doctors sometimes prescribe different doses to this. Read the
pharmacist’s label, it will tell you exactly how many you should take.
Kapake 30mg/500mg Tablets should not be taken by children below the
age of 12 years, due to the risk of severe breathing problems.
This medicine should only be taken when necessary. Do not take more
than the stated dose and do not take for more than three days. If the pain
does not improve after three days, talk to your doctor for advice.
If you take more Kapake 30mg/500mg Tablets than you should
It is always important to follow the dose recommended on the label. If
you take too many tablets, contact your nearest hospital casualty
department or doctor immediately.
Immediate medical advice should be sought in the event of an
overdose, even if you feel well, because of the risk of delayed, serious
liver damage.
If you forget to take Kapake 30mg/500mg Tablets
If you forget to take a dose, it may be because your symptoms have
been relieved and you may not need to take Kapake 30mg/500mg
Tablets any more. However, if you still suffer from pain take your dose
as soon as you remember and then carry on as before. It is important
that you do not take a double dose to make up for the forgotten dose.
If you stop taking Kapake 30mg/500mg Tablets
Taking codeine regularly for a long time can lead to addiction, which
might cause you to feel restless and irritable when you stop the tablets.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

The following side effects have been reported:
- dizziness or drowsiness
- feeling sick or vomiting
Lying down may relieve these effects.

The other ingredients are microcrystalline cellulose, povidone, sodium
starch glycolate and magnesium stearate.

- allergic reaction (skin rash, itching, swelling or shortness of breath)
If you experience any of these symptoms please tell your doctor or
pharmacist immediately.
- low blood cell counts (platelets and white blood cells) but these were
not necessarily related to paracetamol
- slow heart beat
- constipation
- stomach pains
- sudden pain in the upper part of your abdomen, if you have
previously had your gall bladder removed
- bladder problems
- light headedness
- narrowing of your pupils
- confusion or changes in your mood
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE KAPAKE 30mg/500mg TABLETS
Keep out of the reach and sight of children.

What Kapake 30mg/500mg Tablets look like and contents of the pack
Kapake 30mg/500mg Tablets are oblong, white uncoated tablets
marked “Kapake” with a scoreline on one side, the other side is plain
and unmarked.
Kapake 30mg/500mg Tablets are available in packs of 30 and 100.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK
Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
This leaflet was last approved in 09/2013.
Kapake is a trade mark.

Do not use Kapake 30mg/500mg Tablets after the expiry date, which is
stated on the carton and blister foil. The expiry date refers to the last
day of that month.
Store this product below 25ºC. Store in the original packaging in order
to protect the tablets from moisture and light.
Do not use Kapake 30mg/500mg Tablets if you notice that the pack or
any of the tablets are damaged.
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.

PIL: Kapake 30mg/500mg Capsules
Ink Colour:

Fold Configuration:

Black

Dimensions: 238 x 155mm
PX No:

716/2

Pharmacode: 7162
Supplied:

Unfolded

Folded Size: N/A
APPROVED BY:

Date:

100mm verification bar

PX716/2
11/10/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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