CODIPAR 15MG/500MG CAPSULES

Active substance: PARACETAMOL

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Patient Information Leaflet

Codipar 15mg/500mg Capsules
®

Codeine Phosphate/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 become
serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The product is known by the name above but will be referred to as Codipar Capsules throughout the rest of this leaflet.
In this leaflet:
1. What Codipar Capsules are and what they are used for
2. Before you take Codipar Capsules
3. How to take Codipar Capsules
4. Possible side effects
5. How to store Codipar Capsules
6. Further information
1. WHAT CODIPAR CAPSULES ARE AND WHAT THEY ARE USED FOR
Codipar Capsules contain paracetamol and codeine. Paracetamol is an analgesic (relieves pain) and an antipyretic (lowers raised temperatures).
Codeine is a strong painkiller. Codipar Capsules are used for the relief of moderate pain.
2. BEFORE YOU TAKE CODIPAR CAPSULES
Do not take with any other paracetamol-containing products. 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.
Do not take Codipar Capsules if:
• you know that you are allergic to paracetamol or codeine, or any of the other ingredients (refer to section 6 below)
• you suffer from severe kidney or liver disease
• you suffer from asthma or any other breathing problems, for example chronic bronchitis or emphysema
• you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within the last two weeks. MAOIs. such as phenelzine or
isocarboxazid are medicines used to treat depression
• you have just had a head injury or suffer from increased pressure on the brain
• you drink a lot of alcohol, or have done in the past
• you have recently had an operation to your gall bladder.
Codipar Capsules should not be taken by children under 12 years of age.
Take special care and tell your doctor or pharmacist before taking Codipar Capsules if:
• you are elderly or weak
• you have any stomach pains or other sudden problems in your abdomen (belly)
• you have an underactive thyroid gland
• you have liver, kidney or thyroid problems, because the dose might need to be lower
• you have problems with your adrenal glands (Addison’s disease – your doctor will advise you)
• you suffer from an enlarged prostate gland (if male) or narrowing of your urethra (tube through which urine is passed)
• you feel you have taken Codipar Capsules for a long time. You may develop a dependence on Codipar Capsules which may be harmful.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines interact with each other and this can alter their effect. It is particularly important to tell your doctor or pharmacist if you are taking
the following medicines:
• MAOIs used to treat depression, taken within the last 14 days (refer to “do not take if” in section 2 above)
• Sedatives and sleeping tablets, eg temazepam and diazepam
• Medicines for irregular heart beats (mexiletine, quinine or quinidine)
• Drugs used to dry fluids in the mouth and lungs known as anticholinergics
• Medicines to treat diarrhoea or sickness (metoclopramide, domperidone)
• Medicines used to treat problems of the stomach, gall bladder, heart burn or sickness, (e.g. cimetidine, colestyramine)
• Other strong painkillers called opioids
• Medicines which prevent blood clotting (anticoagulants such as warfarin)
• Codipar Capsules must not be taken with any other medicines containing paracetamol or codeine. Some products which can be bought without
a prescription may contain paracetamol or codeine, so always check the labels for ingredients.
Codipar Capsules can interfere with some laboratory tests used for determining some diseases.
Taking Codipar Capsules with food and drink
Do not drink alcohol whilst taking Codipar Capsules.

Date of Approval:

PROOF

1

To be implemented by:

13/03/2012
Product Description:

Originated by

Codipar® 15mg/500mg Capsules
Component:

Date:

Tech Approved

07/12/2011 No
Revised by

Version:

Leaflet

10982/LF/2

Manufacturer:

File Name:

Bristol

10982LF CodiparCaps Bristol v2_1 QA.CRF.066.2012

Market:

Software Package:

Barcode:

UK

Quark Xpress 9

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

8pt Swiss 721CN BT

180 x 256mm

N/A

Colours:

CRF No.:

PMS
Black

Key Line: PMS

Cyan

Date:

Pregnancy and breast-feeding
Codipar Capsules should not be used during pregnancy as they can affect the baby and can cause breathing problems when the baby is born.
Usually it is safe to take Codipar Capsules while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to
cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in
their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling
sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing. Ask your
doctor or pharmacist before taking any medicine.
Driving and using machines
Codipar Capsules may cause dizziness or drowsiness and you should not drive or operate machinery if you are affected this way. Codeine may disturb
your vision.
3. HOW TO TAKE CODIPAR CAPSULES
Always take Codipar Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Take the
capsules with a glass of water. Do not bite or chew the capsules.
Dose
The usual dosage is one or two capsules every four hours as needed. You should not take more than 8 capsules in 24 hours. If you feel the effect
of Codipar Capsules is too strong or too weak, speak to your doctor or pharmacist. A lower dosage may be needed if you are elderly or have other
medical problems. Check with your doctor about this. Codipar Capsules are not recommended for children under 12 years. Do not take with any
other paracetamol-containing products.
If you take more Codipar Capsules than you should
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.
Bring the remaining capsules and this leaflet with you so that the medical staff know what you have taken.
If you forget to take Codipar Capsules
Do not take more than one dose at a time. If you forget to take a dose then take your next dose at the usual time. Never take two doses at the same time.
If you stop taking Codipar Capsules
Codipar Capsules can become habit forming. This is called dependence, if you stop taking your medicine suddenly it can cause symptoms such as
restlessness and irritability. Your doctor will stop your capsules gradually to avoid you having these withdrawal symptoms. If you have any further
questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Codipar Capsules can cause side effects, although not everybody gets them.
Possible side effects are:
• feeling sick (nausea) and being sick (vomiting)
• light headedness, dizziness, sleepiness
• shortness of breath
• stomach pains, constipation.
Lying down may help these effects if they happen.
Other side effects include:
• allergic reactions, including skin rashes and itching of the skin
• a feeling of extra well being, or of disorientation
• small eye pupils, problems with vision, headaches
• slowing of the pulse
• difficulty in passing urine
• liver damage, especially in heavy drinkers
• changes in blood cells, such as low number of cells which fight infection and of cells which are involved in blood clotting
• problems with breathing.
If a pain killer is used too long for headaches, it can make them worse. If any of the side effects become serious, or if you notice any side effect not
listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CODIPAR CAPSULES
• Keep this medicine out of the sight and reach of children.
• Do not use Codipar Capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Keep this medicine in a dry place.
• Do not store above 25˚C.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.
6. FURTHER INFORMATION
What Codipar Capsules contain
• The active substances are paracetamol 500mg and codeine phosphate 15mg.
• The other ingredients are maize starch, sodium lauryl sulfate, cross carmellose sodium, purified talc, magnesium stearate, gelatin, titanium
dioxide (E171), erythrosine (E127) and red iron oxide (E172).
What Codipar Capsules look like and contents of the pack
Codipar Capsules are red (cap) and white (body) coloured hard gelatin oblong capsules with no markings.
Codipar Capsules are available in packs of 30, 32 or 100 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mercury Pharmaceuticals Ltd., No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK
Manufactured By:
Bristol Laboratories Ltd., Laporte Way, Luton, Bedfordshire, LU4 8WL, UK
This leaflet was last revised in March 2012
10982/LF/2
Codipar is the registered trade mark of Mercury Pharma Group Ltd.

Date of Approval:

PROOF

1

To be implemented by:

13/03/2012
Product Description:

Originated by

Codipar® 15mg/500mg Capsules
Component:

Date:

Tech Approved

07/12/2011 No
Revised by

Version:

Leaflet

10982/LF/2

Manufacturer:

File Name:

Bristol

10982LF CodiparCaps Bristol v2_1 QA.CRF.066.2012

Market:

Software Package:

Barcode:

UK

Quark Xpress 9

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

8pt Swiss 721CN BT

180 x 256mm

N/A

Colours:

CRF No.:

PMS
Black

Key Line: PMS

Cyan

Date:

Expand view ⇕

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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