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TREMAPECIL 150 MG / 37.5 MG / 200 MG - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - TREMAPECIL 150 MG / 37.5 MG / 200 MG

1. NAME OF THE MEDICINAL PRODUCT

Tremapecil 50 mg/12.5 mg/200 mg film-coated tablets

Tremapecil 75 mg/18.75 mg/200 mg film-coated tablets

Tremapecil 100 mg/25 mg/200 mg film-coated tablets

Tremapecil 125 mg/31.25 mg/200 mg film-coated tablets Tremapecil 150 mg/37.5 mg/200 mg film-coated tablets Tremapecil 200 mg/50 mg/200 mg film-coated tablets levodopa/carbi­dopa/entacapo­ne

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

30 film-coated tablets

100 film-coated tablets

130 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

8. EXPIRY DATE

EXP:

Should be used within 6 months after first opening.

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Accord Healthcare Limited

Sage house, 319 Pinner road,

North Harrow, Middlesex, HA1 4HF, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

Tremapecil 50 mg/12.5 mg/200 mg – PL 20075/0421

Tremapecil 75 mg/18.75 mg/200 mg – PL 20075/0422

Tremapecil 100 mg/25 mg/200 mg – PL 20075/0417

Tremapecil 125 mg/31.25 mg/200 mg – PL 20075/0419

Tremapecil 150 mg/37.5 mg/200 mg – PL 20075/0418

Tremapecil 200 mg/50 mg/200 mg – PL 20075/0420

13. BATCH NUMBER

Lot:

  • 14. GENERAL CLASSIFICATION FOR SUPPLY

POM|

15. INSTRUCTIONS ON USE

Tremapecil #50 /12.5 /200 mg film-coated tablets

Tremapecil #75 /18.75 /200 mg film-coated tablets

Tremapecil #100 /25 /200 mg film-coated tablets

Tremapecil #125 /31.25 /200 mg film-coated tablets

Tremapecil #150 /37.5 /200 mg film-coated tablets

Tremapecil #200 /50 /200 mg film-coated tablets

17. UNIQUE IDENTIFIER - 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

1. NAME OF THE MEDICINAL PRODUCT

Tremapecil 50 mg/12.5 mg/200 mg film-coated tablets

Tremapecil 75 mg/18.75 mg/200 mg film-coated tablets

Tremapecil 100 mg/25 mg/200 mg film-coated tablets

Tremapecil 125 mg/31.25 mg/200 mg film-coated tablets Tremapecil 150 mg/37.5 mg/200 mg film-coated tablets Tremapecil 200 mg/50 mg/200 mg film-coated tablets levodopa/carbi­dopa/entacapo­ne

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

30 film-coated tablets

100 film-coated tablets

130 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

Keep out of the sight and reach of children.

8. EXPIRY DATE

EXP

Should be used within 6 months after first opening.

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Accord Healthcare Limited

Sage house, 319 Pinner road,

North Harrow, Middlesex, HA1 4HF, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

Tremapecil 50 mg/12.5 mg/200 mg – PL 20075/0421

Tremapecil 75 mg/18.75 mg/200 mg – PL 20075/0422

Tremapecil 100 mg/25 mg/200 mg – PL 20075/0417

Tremapecil 125 mg/31.25 mg/200 mg – PL 20075/0419

Tremapecil 150 mg/37.5 mg/200 mg – PL 20075/0418

Tremapecil 200 mg/50 mg/200 mg – PL 20075/0420

13. BATCH NUMBER

Lot:

  • 14. GENERAL CLASSIFICATION FOR SUPPLY

POM|

  • 15. INSTRUCTIONS ON USE

Tremapecil #50 /12.5 /200 mg film-coated tablets

Tremapecil #75 /18.75 /200 mg film-coated tablets

Tremapecil #100 /25 /200 mg film-coated tablets

Tremapecil #125 /31.25 /200 mg film-coated tablets

Tremapecil #150 /37.5 /200 mg film-coated tablets

Tremapecil #200 /50 /200 mg film-coated tablets

  • 17. UNIQUE IDENTIFIER – 2D BARCODE

  • 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number} SN: {number} NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

{LABEL FOR BOTTLE}

  • 1. NAME OF THE MEDICINAL PRODUCT

Tremapecil 50 mg/12.5 mg/200 mg film-coated tablets

Tremapecil 75 mg/18.75 mg/200 mg film-coated tablets

Tremapecil 100 mg/25 mg/200 mg film-coated tablets

Tremapecil 125 mg/31.25 mg/200 mg film-coated tablets Tremapecil 150 mg/37.5 mg/200 mg film-coated tablets Tremapecil 200 mg/50 mg/200 mg film-coated tablets levodopa/carbi­dopa/entacapo­ne

  • 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.

  • 3. LIST OF EXCIPIENTS

  • 4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

30 film-coated tablets

100 film-coated tablets

130 film-coated tablets

  • 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

  • 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

    Keep out of the sight and reach of children.

  • 8. EXPIRY DATE

EXP

Should be used within 6 months after first opening.

  • 9. SPECIAL STORAGE CONDITIONS

  • 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

  • 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOL­DER

Accord Healthcare Limited

Sage house, 319 Pinner road,

North Harrow, Middlesex, HA1 4HF, United Kingdom

  • 12. MARKETING AUTHORISATION NUMBER(S)

Tremapecil 50 mg/12.5 mg/200 mg – PL 20075/0421

Tremapecil 75 mg/18.75 mg/200 mg – PL 20075/0422

Tremapecil 100 mg/25 mg/200 mg – PL 20075/0417

Tremapecil 125 mg/31.25 mg/200 mg – PL 20075/0419

Tremapecil 150 mg/37.5 mg/200 mg – PL 20075/0418

Tremapecil 200 mg/50 mg/200 mg – PL 20075/0420

  • 13. BATCH NUMBER

Lot

  • 14. GENERAL CLASSIFICATION FOR SUPPLY

POM|

  • 15. INSTRUCTIONS ON USE

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

N NERVOUS SYSTEM DRUGS

N04 ANTI-PARKINSON DRUGS

N04B DOPAMINERGIC AGENTS

N04BA Dopa and dopa derivatives

N04BA03 levodopa, decarboxylase inhibitor and COMT inhibitor

Frequently Asked Questions

What is TREMAPECIL used for?

TREMAPECIL is used to manage symptoms of Parkinson's disease by improving movement and reducing stiffness.

How does TREMAPECIL work?

TREMAPECIL combines levodopa, a substance that converts into dopamine in the brain, with a decarboxylase inhibitor and a COMT inhibitor, which help prevent the breakdown of levodopa.

What are the common side effects of taking TREMAPECIL?

Common side effects may include nausea, dizziness, and dry mouth. Always consult your doctor if you experience severe side effects.

Can I take TREMAPECIL with other medications?

You should inform your doctor about all medications you're taking, as some can interact with TREMAPECIL.

Is TREMAPECIL suitable for elderly patients?

TREMAPECIL can be prescribed to elderly patients, but they may require closer monitoring due to sensitivity to effects.

How should I store TREMAPECIL?

Store TREMAPECIL at room temperature, away from moisture and heat, and keep it out of reach of children.

What should I do if I miss a dose of TREMAPECIL?

If you miss a dose, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and return to your regular schedule.

Can I drink alcohol while taking TREMAPECIL?

It's best to avoid alcohol while taking TREMAPECIL as it may increase side effects like dizziness and drowsiness.

Will TREMAPECIL affect my ability to drive?

TREMAPECIL can cause drowsiness or dizziness. Do not drive or operate heavy machinery if you feel affected.

What lifestyle changes should I consider while taking TREMAPECIL?

Consider maintaining a balanced diet and regular exercise routine. Discuss any changes with your healthcare provider.

Is it safe to take TREMAPECIL during pregnancy or breastfeeding?

If you're pregnant or breastfeeding, consult your doctor before starting TREMAPECIL to discuss potential risks.

How long will I need to take TREMAPECIL?

The duration of treatment varies by individual needs; your doctor will determine how long you should take it based on your response.

Can I stop taking TREMAPECIL suddenly?

Do not stop taking TREMAPECIL without consulting your doctor, as stopping suddenly can worsen symptoms.

What happens if I overdose on TREMAPECIL?

In case of overdose, seek immediate medical attention. Symptoms may include severe nausea and confusion.

Does TREMAPECIL have any dietary restrictions?

Certain high-protein diets may interfere with levodopa absorption. Discuss dietary guidelines with your healthcare provider.

Can children take TREMAPECIL?

TREMAPECIL is generally not recommended for children. Consult a healthcare professional for alternatives.

Will my insurance cover TREMAPECIL?

Coverage for TREMAPECIL varies by insurance plan. Check with your insurance provider for specifics on coverage and costs.

What are the long-term effects of using TREMAPECIL?

Long-term use may lead to changes in effectiveness or side effects; regular check-ins with your doctor are essential.

Can I take herbal supplements while on TREMAPECIL?

Always consult your doctor before taking herbal supplements as they may interact with your medication.

Where can I find more information about living with Parkinson's disease and using TREMAPECIL?

You can visit reputable health websites, support groups, or ask your healthcare provider for more resources tailored to living with Parkinson's disease.