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KAPAKE 30MG/500MG CAPSULES

Active substance(s): CODEINE PHOSPHATE HEMIHYDRATE / 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 because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Kapake 30mg/500mg Capsules are and what they are used for
What you need to know before you take Kapake 30mg/500mg Capsules
How to take Kapake 30mg/500mg Capsules
Possible side effects
How to store Kapake 30mg/500mg Capsules
Contents of the pack and other information

1. What Kapake 30mg/500mg Capsules are and what they are used for
Kapake 30mg/500mg Capsules contain codeine, an opioid analgesic, in combination
with paracetamol. Kapake 30mg/500mg Capsules are one of a group of medicines
called analgesics or painkillers. They are used to relieve severe pain in adults.
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. What you need to know before you take Kapake 30mg/500mg Capsules
Do not take Kapake 30mg/500mg Capsules:
- if you are allergic to codeine phosphate hemihydrate, paracetamol or any of the
other ingredients of this medicine (listed in section 6).
- if you are suffering from increased pressure on the brain or a head injury.
- if you have been told by your doctor that you have a severe breathing difficulty
called respiratory depression.
- if you suffer from severe but usually short-lasting asthma attacks (acute asthma).
- if you consume excessive amounts of alcohol on a regular basis.

- if you 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.
- if you are pregnant or breast-feeding.
- if you know that you metabolise very rapidly codeine into morphine.
Talk to your doctor if any of the above apply to you.
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.
Do NOT give this product to children under 12 years of age.
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.
Talk to your doctor, pharmacist or nurse before taking Kapake 30mg/500mg
Capsules:
- if you are elderly and/or in poor health
- if you suffer from an enlarged prostate
- if you suffer from any bowel problems
- if you suffer from Addison’s disease
- if you suffer from any liver or kidney problems.
If any of the above apply to you, it is important that you speak to your doctor,
pharmacist or nurse before taking this medicine and they will decide what to do.
It may still be safe for you to take this medicine.
- 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.
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.
Other medicines and Kapake 30mg/500mg Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is especially important if you are taking:
- medicines called Monoamine Oxidase Inhibitors (MAOIs) used to treat
depression, or have taken them in the last two weeks (see section 2 “Do not
take Kapake 30mg/500mg Capsules….”). MAOIs are medicines such as
moclobemide, phenelzine and tranylcypromine.
- medicines for depression, anxiety, other medicines known as tranquillisers, or
hypnotics (medicines to help you sleep). You may experience more drowsiness
if you take these medicines with codeine.
- domperidone or metoclopramide (medicines to stop you feeling sick or vomiting).
The speed of absorption of paracetamol may be increased by these medicines.
- colestyramine (medicine for high cholesterol levels or diarrhoea).
The absorption of paracetamol is reduced by this medicine.
- anticoagulants, e.g. warfarin (medicine to prevent blood clots). There may be
an increased risk of bleeding caused by prolonged regular use of paracetamol.
- 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.
Kapake 30mg/500mg Capsules with food and alcohol
You should avoid alcohol when taking this product.
Food has no influence on Kapake 30mg/500mg Capsules.
Pregnancy and breast-feeding
Do not use this product or any other codeine-containing products if you are pregnant.
Do not take codeine while you are breast-feeding. 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.
This medicine 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
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to
drive while taking this medicine.

PX2700

Kapake 30mg/500mg Capsules contain Cochineal Red A (E124)
This may cause an allergic reaction in some patients.
3. How to take Kapake 30mg/500mg Capsules
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended 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.
Use in children and adolescents
The recommended 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.
This medicine should not be taken by children below the age of 12 years, due to
the risk of severe breathing problems.
This medicine should be taken orally (by mouth).
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. Talk to a
doctor at once if you take too much of this medicine even if you feel well. This is
because too much paracetamol can cause 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 this medicine 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 experience any of these symptoms, please tell your doctor or pharmacist
immediately:
- allergic reaction (skin rash, itching, swelling or shortness of breath)
- serious skin reactions (very rare cases of serious skin reactions have been reported)
- sudden pain in the upper part of your abdomen, if you have previously had your
gall bladder removed
The following side effects have been reported:
- dizziness or drowsiness
- feeling sick or vomiting
Lying down may relieve these effects.
-

constipation
bladder problems
light headedness
confusion or changes in your mood
narrowing of your pupils
slow heart beat
stomach pains
itchy skin
low blood cell counts (platelets and white blood cells) but these were not
necessarily related to paracetamol

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 website: www.mhra.gov.uk/yellowcard or
search for MHRA Yellow Card in the Google Play or Apple App Store.

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 (type A) and magnesium
stearate. The capsule shells are made of gelatin and contain cochineal red A
(E124) (see section 2 “Kapake 30mg/500mg Capsules contain …” for information
about this ingredient), 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 30mg/500mg Capsules are available in packs of 100 capsules.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK

5. How to store Kapake 30mg/500mg Capsules

Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK

Keep this medicine out of the sight and reach of children.

This leaflet was last revised in 07/2017.

Do not use this medicine after the expiry date, which is stated on the carton and
blister foil. The expiry date refers to the last day of that month.

Kapake is a Trade Mark.

By reporting side effects you can help provide more information on the safety of
this medicine.

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.

Do not store this medicine above 30oC.

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

Do not use this medicine if you notice that the pack or any of the capsules are
damaged.

4. Possible side effects

Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

Like all medicines, this medicine can cause side effects, although not everybody
gets them.

6. Contents of the pack and other information

PX2700

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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