Carbidopa-levodopa Manx 25/100 mg tablets – patient leaflet, side effects, dosage

1. WHAT CARBIDOPA-LEVODOPA MANX IS AND WHAT IT IS USED FOR

Carbidopa-Levodopa Manx improves the signs of Parkinson’s disease. Parkinson’s disease is a long-term illness where:

It is used to treat epilepsy in infants, children and adults. 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.

Carbidopa-Levodopa Manx contains two different medicines called: levodopa and carbidopa.

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 CARBIDOPA-LEVODOPA MANX

Do not take Carbidopa-Levodopa Manx if:

you are allergic (hypersensitive) to carbidopa or levodopa or any of the other ingredients of Carbidopa-Levodopa Manx (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 Carbidopa-Levodopa Manx (see also under ‘Other medicines and Carbidopa-Levodopa Manx’ 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

you are pregnant, might become pregnant, or are breast-feeding. Do not take Carbidopa-Levodopa Manx if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Carbidopa-Levodopa Manx..

Warnings and precautions

Talk to 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.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Carbidopa-Levodopa Manx.

Treatment with high doses of carbidopa/levodopa may lead to low levels of vitamin B6, which can increase the risk of seizures. If you are receiving high doses of this medicine, your doctor may perform blood tests to check your vitamin B6 levels. Tell your doctor if you experience signs of low levels of vitamin B6, such as pale skin, weakness or breathlessness (anemia), nerve pain or tingling in the hands and feet (polyneuropathy), or seizures.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Carbidopa-Levodopa Manx and other medicines used to treat Parkinson’s disease. 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 Carbidopa-Levodopa Manx

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Carbidopa-Levodopa Manx can affect the way some other medicines work. Also some other medicines can affect the way Carbidopa-Levodopa Manx 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 Carbidopa-Levodopa Manx.
• If they are ‘normal release’, you will need to wait 12 hours after your last dose before starting Carbidopa-Levodopa Manx.
• 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 other diseases related to involuntary movements. Your dose may need to be changed.

Medicines to treat low iron. Your dose may need to be changed. Medicines called ‘MAOIs’ (see also ‘Do not take Carbidopa-Levodopa Manx 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 Carbidopa-Levodopa Manx.

Tests while you are taking Carbidopa-Levodopa Manx 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 Manx and are having any tests. Carbidopa-Levodopa Manx 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) Carbidopa-Levodopa Manx may not work as well as it should.

Pregnancy and breast-feeding

Do not take Carbidopa-Levodopa Manx if you are pregnant, might become pregnant or are breastfeeding. Levodopa, one of the substances in Carbidopa-Levodopa Manx, is passed into human milk. Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.

Driving and using machines

Carbidopa-Levodopa Manx 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 Possible side effects). Do not drive or use tools or machines if you get these effects. Carbidopa-Levodopa Manx 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.

3. HOW TO TAKE CARBIDOPA-LEVODOPA MANX

Always take Carbidopa-Levodopa Manx exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine

If the tablet breaks when you remove it from the blister pack, make sure you have all of the tablet pieces (the full dose). If you do not have all the pieces of a broken tablet, throw away the pieces and take another tablet from the blister pack.

Taking only part of a tablet (a partial dose) may cause symptoms to get worse.

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.

If you have not had levodopa before

The usual starting dose for Carbidopa-Levodopa Manx 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 Carbidopa-Levodopa Manx. The usual starting dose will depend on what you were taking before. More than one Carbidopa-Levodopa products may be prescribed by your doctor. If you have been given different Carbidopa-Levodopa tablets to take make sure that you are taking the correct one at the right time.

(Continued overleaf) For doses not realisable/practicable with this medicinal product, other medicinal products are available.

Use in children and adolescents

Carbidopa-Levodopa Manx is not suitable for children under the age of 18 years.

If you take more Carbidopa-Levodopa Manx than you should If you take too many tablets see your doctor immediately.

If you forget to take Carbidopa-Levodopa Manx

Do not take a double dose to make up for a forgotten dose. If you stop taking Carbidopa-Levodopa Manx

Do not stop taking Carbidopa-Levodopa Manx or change your dose until your doctor tells you to. If you stop taking Carbidopa-Levodopa Manx the following can occur: stiff muscles, high temperature (fever) and mental changes.

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

4. POSSIBLE SIDE EFFECTS

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

Stop taking Carbidopa-Levodopa Manx 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.

urinary tract infections (frequency: very common).

having too little vitamin B6 (frequency: common)

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:

Craving for large doses of carbidopa-levodopa in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings or other side effects after taking large doses of carbidopa-levodopa. inability to resist the impulse to perform an action that could be harmful, which may include:

o strong impulse to gamble excessively despite serious personal or

family consequences.

o altered or increased sexual interest and behaviour of significant

concern to you or to others, for example, an increased sexual drive.

o uncontrollable excessive shopping or spending.

o 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.

These may be experienced when taking Carbidopa-Levodopa Manx. 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

Eyes:

drooping eyelid and dilated pupil

changes in vision, irregular movement of the eye

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.

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 effects, talk to your doctor or pharmacist. 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.

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

5. HOW TO STORE CARBIDOPA-LEVODOPA MANX

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the tablet blister foil after ‘EXP.’ The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Carbidopa-Levodopa Manx contains

The active substance are carbidopa and levodopa.

Each tablet of Carbidopa-Levodopa Manx 12.5/50 mg contains 13.5 mg carbidopa monohydrate (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa.

Each tablet of Carbidopa-Levodopa Manx 25/100 mg contains 27 mg carbidopa monohydrate (equivalent to 25 mg of anhydrous carbidopa) and 100 mg levodopa.

The other ingredients are: crospovidone, microcrystalline cellulose, pregelatinised starch, magnesium stearate and yellow iron oxide. What Carbidopa-Levodopa Manx looks like and contents of the pack Carbidopa-Levodopa Manx are round shaped, light yellow coloured tablets

The 12.5/50 mg tablets are marked with ‘C” on one side and “17” on other side of tablet.

The 25/100 mg tablets are marked with ‘C” on one side and “19” on other side of tablet.

Carbidopa-Levodopa Manx 12.5/50 mg and 25/100 mg Tablets are packed in Alu-Alu blisters.

Carbidopa-Levodopa Manx 12.5/50 mg is available in a pack size of 90 tablets.

Carbidopa-Levodopa Manx 25/100 mg is available in a pack size of 100 tablets.

Marketing Authorisation Holder and Manufacturer

Manx Healthcare Ltd

Unit 2, Bosworth Avenue, Tournament Fields, Warwick, CV34 6UQ, United Kingdom

Other formats

To request a copy of this leaflet in Braille, large print or audio, please call 01926 482511.

This leaflet was last revised in September 2026

URN: GCA001-PIL-03-140926