Pill Identifier App

CO-CARELDOPA 10 MG/100 MG TABLETS

Active substance: LEVODOPA

View full screen / Print PDF » Download PDF ⇩

Transcript
9 mm

30 mm

30 mm

Carbidopa/Levodopa
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 or pharmacist.
• 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 or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. What this medicine is and what it is used for
The name of your medicine is Co-Careldopa. It contains two different active
ingredients Carbidopa and Levodopa.
Co-Careldopa improves the signs of Parkinson’s disease. Parkinson’s
disease is a long-term illness where:
• you become slow and unsteady
• your muscles feel stiff
• you may develop shaking or trembling (called ‘tremor’).
If not treated, Parkinson’s disease can make it hard for you to continue your
normal daily activities.
Levodopa turns into a material called ‘dopamine’ in your brain. The dopamine
helps to improve the signs of your Parkinson’s disease.
Carbidopa belongs to a group of medicines called ‘aromatic amino acid
decarboxylase inhibitors’. It helps levodopa work more effectively by slowing
the speed at which levodopa is broken down in your body.

2. What you need to know before you take this medicine
Do not take this medicine if:
• you are allergic (hypersensitive) to carbidopa or levodopa or any of the
other ingredients of this medicine (listed in Section 6)
• you have ever had skin cancer or you have any unusual moles which
have not been examined by your doctor
• you are taking certain medicines called ‘MAOIs’ (Monoamine Oxidase
Inhibitors) used for depression. You need to stop using these medicines
at least two weeks before you start this medicine (see also under ‘Other
medicines and Co-Careldopa below).
• you have a condition called ‘narrow-angle glaucoma’ that may cause a
sudden build up of pressure in the eye
• you have a severe mental disorder
Co-Careldopa should not be given in situations in which a sympathomimetic
compound is contraindicated.

If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking this medicine.
Tell your doctor if you or your family/carer notices you are developing urges
or cravings to behave in ways that are unusual for you or you cannot resist
the impulse, drive, or temptation to carry out certain activities that could harm
yourself or others. These behaviours are called impulse control disorders
and can include addictive gambling, excessive eating or spending, an
abnormally high sex drive or an increase in sexual thoughts or feelings.
Your doctor may need to review your treatments
Other medicines and Co-Careldopa
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
This is because Co-Careldopa can affect the way some other medicines
work. Also some other medicines can affect the way Co-Careldopa works.
In particular tell your doctor or pharmacist if you are taking any of the following
medicines:
• Medicines for Parkinson’s disease containing levodopa: - If they are ‘slow
release’, you will need to wait 24 hours after your last dose before starting
Co-Careldopa. If they are ‘normal release’, you will need to wait 12 hours
after your last dose before starting Co-Careldopa.
• Tell the doctor or pharmacist even if you have only taken them in the past.
• Medicines for Parkinson’s disease which do not contain levodopa will
usually be continued. However, your dose may be changed.
• Medicines for mental problems (including depression), tuberculosis (TB),
high blood pressure, muscle spasms, epilepsy or to treat low iron. Your
dose may need to be changed.
• Medicines called ‘MAOIs’ (see also ‘Do not take Co-Careldopa if’).
• Anticholinergic medicines (such as orphenadrine, trihexyphenidyl,
benzatropine and procyclidine). Your dose may need to be changed.
• Phenytoin which is used to treat fits (convulsions).
• Papaverine which is used to treat impotence in men.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking this medicine. Your doctor or pharmacist has a
more complete list of medicines to avoid while taking this medicine.
Co-Careldopa with food and drink
Try to avoid taking your tablets with a heavy meal. If your diet contains too
much protein (meat, eggs, milk, cheese) this medicine may not work as well
as it should.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.

30 mm

Do not take this medicine if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions
Check with your doctor or pharmacist before taking your medicine if:
• you have a history of fits (convulsions)
• you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or
have vomited blood
• you have had a heart attack, heart beat problems, circulation or breathing
problems
• you have had kidney, liver or hormonal problems
• you have had depression or other mental problems
• you have a condition called ‘chronic wide-angle glaucoma’ that may cause
a build-up of pressure in the eye. You will need to have regular checks on
the pressure in your eye.
• you sometimes have sudden sleep attacks or sometimes feel very sleepy
• you are due to have surgery.

270 mm

SAME SIZE ARTWORK
Front

- Any woman of childbearing potential who is receiving this medicine
must practise effective contraception.
- Not enough is known about the use of Co-Careldopa during human
pregnancies. It was shown to be harmful in animal experiments. Do
not - take this medicine if you are pregnant, or trying to conceive.
- Levodopa is excreted into breast milk. You must therefore not
breastfeed during treatment with Co-Careldopa.
Driving and using machines
This medicine affects different people in different ways. Some people
have side effects which affect their ability to drive or use tools or machines
(see section 4). Do not drive or use tools or machines if you get these
effects.
This medicine can also make you sleepy or cause ‘sudden sleep attacks’.
If this happens to you, you must not drive or use tools or machines. Your
doctor will tell you if you can start driving again if these attacks stop.
Laboratory tests
This medication can affect some laboratory tests that your doctor may
perform on blood or urine samples. Please remind your doctor if you are
taking carbidopa/levodopa and are having any tests.

3. How to take this medicine
Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth.
• Although your medicine can have an effect after one day, it may take
up to seven days to work.
• Take them at regular time intervals according to your doctor’s
instructions.
• Do not change the times at which you take your tablets or take any
other medicines for Parkinson’s disease without first consulting your
doctor.
• Try to avoid taking your tablets with a heavy meal.

250 mm

Co-Careldopa 10 mg/100 mg Tablets
Co-Careldopa 12.5 mg/50 mg Tablets
Co-Careldopa 25 mg/100 mg Tablets
Co-Careldopa 25 mg/250 mg Tablets

If you have not had levodopa before
The usual starting dose for Co-Careldopa 12.5 mg/50 mg Tablets is one
tablet three or four times a day.
If you have had levodopa before
Your doctor will ask you to stop taking your medicine for Parkinson’s
disease before you start taking this medicine.
The usual starting dose will depend on what you were taking before.
More than one Co-Careldopa product may be prescribed by your doctor.
If you have been given different Co-Careldopa tablets to take make sure
that you are taking the correct one at the right time.
Children under 18 years of age
This medicine is not suitable for children under the age of 18 years.
The tablet can be divided into equal halves.
If you take more of this medicine than you should
If you take too many tablets see your doctor immediately.
If you forget to take this medicine
Do not take a double dose to make up for a forgotten dose.
If you stop taking this medicine
Do not stop taking this medicine or change your dose without talking to
your doctor first. When you stop taking this medicine the following can
occur: stiff muscles, high temperature (fever) and mental changes.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

IXXXXXX

Package leaflet: Information for the patient

9 mm

30 mm

30 mm

Stop taking this medicine and see your doctor straight away, if you
notice any of the following side effects:
• allergic reaction, the signs may include hives (nettle rash), itching, rash,
swelling of your face, lips, tongue or throat. This may cause difficulty in
breathing or swallowing
• chest pain
• uneven (irregular) heart beat or palpitations
• dizziness on standing-up quickly
• bleeding from your gut which may be seen as blood in your faeces or
darkened faeces (gastro-intestinal bleeding)
• blood problems, the signs may include pale skin (pallor), tiredness, fever,
sore throat or mild bruising and prolonged bleeding after injury
• stiff muscles, high fever
• mental changes including delusions, hallucinations and depression
• fits (convulsions).
The most common side effects are
• abnormal movements such as twitching or spasms (which may or may not
be like your Parkinson’s symptoms)
• nausea.
Other side effects include
• fainting, anorexia, high blood pressure
• inflammation of the veins, being sick (vomiting) diarrhoea, discoloration of
urine, sweat or saliva
• on-off phenomenon, characteristic of some people with long-standing
Parkinson’s disease. This is when you can have unpredictable changes
from being mobile - “on” - to a sudden inability to move - “off”. “Off” to “on”
can occur just as suddenly.
• dizziness; sleepiness (including excessive drowsiness or sudden sleep
onset episodes), pins and needles
• dream abnormalities, confusion, feeling agitated, shortness of breath,
hair loss
You may experience the following side effects:
• inability to resist the impulse to perform an action that could be harmful,
which may include: strong impulse to gamble excessively despite serious
personal or family consequences
• altered or increased sexual interest and behaviour of significant concern
to you or to others, for example, an increased sexual drive
• uncontrollable excessive shopping or spending
• binge eating (eating large amounts of food in a short time period) or
compulsive eating (eating more food than normal and more than is needed
to satisfy your hunger)
Tell your doctor if you experience any of these behaviours; he/she will
discuss ways of managing or reducing the symptoms.
Side effects that have been reported with medicines containing
levodopa.

Sexual:
• persistent abnormal erection of the penis
Urinary:
• difficulty passing urine or incontinence (inability to control urine flow)
Skin:
• changed patches of pigmented skin, including, irritated or irregular moles,
or moles in which you have noticed changes (melanoma)
General:
• weight gain or loss, swelling in the limbs
• flushing, hot flushes, increased sweating
• feeling weak, faint or tired
• hoarseness, general feeling of being unwell
• increased energy or activity, unusual breathing pattern
Reporting of side effects
If you get any side effect, talk to your doctor. 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 this medicine
• Keep this medicine out of the sight and reach of children
• This medicinal product does not require any special storage conditions.
• Do not use this medicine after the expiry date which is stated on the carton
after {EXP. }. The expiry date refers to the last day of that month.
• 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.

25 mg/250 mg Tablets are light blue coloured, oval shaped scored tablet
with C and break line on one side and 20 on other side.
Co-Careldopa tablets are available in:
10 mg/100 mg – Alu-Alu blister packs of 90 and 100 tablets
12.5 mg/50 mg – Alu-Alu blister packs of 30, 50, 90 and 100 tablets
25 mg/100 mg – Alu-Alu blister packs of 30, 50, 56, 60, 90, 98, 100, 196
and 200 tablets
25 mg/250 mg – Alu-Alu blister packs of 30, 50, 60, 90, 98, 100, 120, 196
and 200 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Co-Careldopa 12.5mg/50mg tablets; PL 17907/0471
Co-Careldopa 10mg/100mg tablets; PL 17907/0470
Co-Careldopa 25mg/100mg tablets; PL 17907/0472
Co-Careldopa 25mg/250mg tablets; PL 17907/0473
This leaflet was last revised in October 2014.
To request a copy of this leaflet in Braille, large print or audio format then
please contact the licence holder at the address (or telephone, fax,
email) above.

6. Contents of the pack and other information

Each 12.5mg/50mg tablet contains 13.5 mg carbidopa monohydrate
(equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa.
Each 25mg/100mg tablet contains 27.0 mg carbidopa monohydrate
(equivalent to 25 mg of anhydrous carbidopa) and 100 mg levodopa.
Each 25mg/250mg tablet contains 27.0 mg carbidopa monohydrate
(equivalent to 25 mg of anhydrous carbidopa) and 250 mg levodopa.
• The other ingredients are:
10 mg/100 mg Tablets and 25mg /250mg Tablets:
Crospovidone (E1202), Indigo carmine lake (E132), Magnesium stearate
(E572), Microcrystallinecellulose (E460), Pre gelatinised starch (maize)
12.5mg/50 mg Tablets and 25 mg/ 100 mg Tablets:
Crospovidone (E1202), Quinoline Yellow lake (E104), Magnesium stearate
(E572), Microcrystalline cellulose (E460), Pre gelatinised starch (maize).
What this medicine looks like and contents of the pack
10mg /100 mg Tablets are light blue coloured, oval shaped scored tablet
with C and break line on one side and 18 on other side.

270 mm
SAME SIZE ARTWORK
270 x 250mm
Back

25 mg/100 mg Tablets are yellow coloured, oval shaped scored tablet
with C and break line on one side and 19 on other side.

What this medicine contains
• The active substances are carbidopa and levodopa.
• Each 10mg/100mg tablet contains 10.8 mg carbidopa monohydrate
(equivalent to 10 mg of anhydrous carbidopa) and 100 mg levodopa.

30 mm

These may be experienced when taking Co-Careldopa.
Nervous system:
• loss of control over the voluntary movements of everyday life
• numbness, increased hand tremor, muscle twitching, muscle cramp,
irregular movement of jaw muscles resulting in difficulty opening the mouth
• difficulty sleeping, feeling anxious or high, falling over and abnormal
walking patterns
• headache

Digestive system:
• indigestion, dry mouth, bitter taste
• swelling of the salivary glands, difficulty swallowing, grinding of the teeth
• hiccups, abdominal pain and distress, constipation, wind
• burning sensation of the tongue

12.5 mg/50 mg Tablets are light yellow coloured, oval shaped scored
tablet with C and break line on one side and 17 on other side.

250 mm

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

Eyes:
• drooping eyelid and dilated pupil
• changes in vision, irregular movement of the eye

V5 07-11-14 D0

IXXXXX

4. Possible side effects

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.

Hide
(web1)