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KAPAKE 30MG/500MG CAPSULES

Active substance: PARACETAMOL

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

30mg/500mg Capsules
(Codeine Phosphate Hemihydrate 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 Capsules are and what they are used for
2. Before you take Kapake 30mg/500mg Capsules
3. How to take Kapake 30mg/500mg Capsules
4. Possible side effects
5. How to store Kapake 30mg/500mg Capsules
6. Further information
1. WHAT KAPAKE 30mg/500mg CAPSULES ARE AND WHAT THEY
ARE USED FOR
Kapake 30mg/500mg Capsules are one of a group of medicines called
analgesics or painkillers. They are used to relieve severe pain in adults.
Kapake 30mg/500mg Capsules 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 CAPSULES
Do not take Kapake 30mg/500mg Capsules if you
- are allergic (hypersensitive) to codeine phosphate hemihydrate,
paracetamol or any of the other ingredients in Kapake 30mg/500mg
Capsules.
- 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 Capsules 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 Capsules and
they will decide what to do. It may still be safe for you to take Kapake
30mg/500mg Capsules.
- 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
capsules.

- 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 Capsules.
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 Capsules with food and drink
You should avoid alcohol when taking this product.
Food has no influence on Kapake 30mg/500mg Capsules.
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 Capsules may make you feel drowsy. Do not
drive or use machines until you know how they affect you.
Kapake 30mg/500mg Capsules can affect your ability to drive as it may
make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects
you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental
problem and
- You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
- It was not affecting your ability to drive safely
PX664/4

Talk to your doctor or pharmacist if you are not sure whether it is safe
for you to drive while taking this medicine.

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

Important information about some of the ingredients of Kapake
30mg/500mg Capsules
Kapake 30mg/500mg Capsules contain the colouring agent cochineal
red A (E124) which may cause an allergic reaction in some patients.

4. POSSIBLE SIDE EFFECTS

3. HOW TO TAKE KAPAKE 30mg/500mg CAPSULES
Kapake 30mg/500mg Capsules should be taken orally (by mouth).
Always take Kapake 30mg/500mg Capsules 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 or two capsules taken every
four hours. You should not take more than eight capsules in any 24-hour
period.
The dose for children aged 12 and over is one capsule taken every six
hours, up to a maximum of four capsules 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 Capsules 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 Capsules than you should
It is always important to follow the dose recommended on the label. If
you take too many capsules, 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 Capsules
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
Capsules 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 Capsules
Taking codeine regularly for a long time can lead to addiction, which
might cause you to feel restless and irritable when you stop the capsules.

Like all medicines, Kapake 30mg/500mg Capsules can cause side effects,
although not everybody gets them.
The following side effects have been reported:
- dizziness or drowsiness
- feeling sick or vomiting
Lying down may relieve these effects.
- allergic reaction (skin rash, itching, swelling or shortness of breath)
- serious skin reactions (very rare cases of serious skin reactions have
been reported)
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.

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.
6. FURTHER INFORMATION
What Kapake 30mg/500mg Capsules contain
The active substances are codeine phosphate hemihydrate and
paracetamol. Each capsule contains 30mg of codeine phosphate
hemihydrate and 500mg of paracetamol.
The other ingredients are sodium starch glycolate and magnesium
stearate. The capsule shells are made of gelatin and contain cochineal
red A (E124), brilliant blue (E133) and titanium dioxide (E171) as
colouring agents. The ink on the capsule shells contains shellac, black
iron oxide (E172) and propylene glycol.
What Kapake 30mg/500mg Capsules look like and contents of the pack
Kapake 30mg/500mg Capsules are hard gelatin capsules which have a
red cap and a white body, printed “G 30/500” on both the cap and body.
Kapake Capsules are available in packs of 100 capsules.
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 revised in 05/2014.
Kapake is a Trade Mark.

5. HOW TO STORE KAPAKE 30mg/500mg CAPSULES
Keep out of the reach and sight of children.
Do not use Kapake 30mg/500mg Capsules after the expiry date, which
is stated on the carton and blister foil. The expiry date refers to the last
day of that month.
Do not store this product above 30ºC.
Do not use Kapake 30mg/500mg Capsules if you notice that the pack or
any of the capsules are damaged.

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

Fold Configuration:

Black

Dimensions: 238 x 155mm
PX No:

664/4

Pharmacode: 6644
Supplied:

Unfolded

Folded Size: N/A
APPROVED BY:

Date:

100mm verification bar

PX664/4
06/05/2014

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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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