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TRIHEXYPHENIDYL HYDROCHLORIDE 5 MG / 5ML SYRUP - patient leaflet, side effects, dosage

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Patient leaflet - TRIHEXYPHENIDYL HYDROCHLORIDE 5 MG / 5ML SYRUP

Trihexyphenidyl Hydrochloride 5mg/5ml Syrup

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 Trihexyphenidyl Syrup is and what it is used for

  • 2. What you need to know before you take Trihexyphenidyl Sy­rup

  • 3. How to take Trihexyphenidyl Syrup

  • 4. Possible side effects

  • 5. How to store Trihexyphenidyl Syrup

  • 6. Contents of the pack and other information

1. what trihexyphenidyl syrup is and what it is used for

Trihexyphenidyl Syrup belongs to a group of medicines called antimuscarinics.

Trihexyphenidyl Syrup is used to treat some of the symptoms of Parkinson's disease such as shakiness or stiffness of the muscles which can cause difficulty moving.

Some medicines can cause side effects which are like the symptoms of Parkinson's disease and it is also used to reduce these side effects.

2. what you need to know before you take trihexyphenidyl syrup

Do not take Trihexyphenidyl Syrup:

  • ■ if you are allergic to trihexyphenidyl hydrochloride or any of the other ingredients of this medicine (listed in section 6) or to similar medicines such as orphenadrine hydrochloride or procyclidine hydrochloride.

Do not give Trihexyphenidyl Syrup to children.

Warnings and precautions

Talk to your doctor before taking Trihexyphenidyl Syrup if:

  • ■ you have glaucoma (increased pressure in the eye)

  • ■ you suffer from high blood pressure

  • ■ you suffer from kidney, heart, liver, bowel or prostate problems

  • ■ you suffer from digestive system or stomach problems

  • ■ you suffer from bladder problems or have difficulty passing urine

  • ■ you suffer from a condition called myasthenia gravis (a rare muscle weakness disorder)

  • ■ you experience unusual movements of the face and tongue as this may be a sign of a serious condition known as tardive dyskinesia

  • ■ you are elderly – this medicine should be used with caution and may cause confusion, delusions and hallucinations.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Trihexyphenidyl Sy­rup.

Other medicines and Trihexyphenidyl Syrup

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription. Tell your doctor or pharmacist if you are taking or have taken any of the following medicines as they may interfere with Trihexyphenidyl Sy­rup:

  • ■ other medicines that have an anti-muscarinic effect such as atropine, hyoscine, oxybutynin and tolterodine used to treat bowel or bladder problems

  • ■ monoamine oxidase inhibitors (MAOIs) used to treat depression, for example isocarboxazid, moclobemide or phenelzine

  • ■ antihistamines used to treat allergies, for example diphenhydramine

  • ■ disopyramide used to treat irregular heartbeat

  • ■ phenothiazines used to treat psychoses or nausea and vomiting, for example chlorpromazine or thioridazine

  • ■ tricyclic antidepressants used to treat depression for example amitriptyline

  • ■ metoclopramide or domperidone used to treat the symptoms of nausea

  • ■ nefopam used to treat pain

  • ■ other medicines used in the treatment of Parkinson's disease for example amantadine and levodopa

  • ■ clozapine used to treat schizophrenia

  • ■ parasympathomimetic medicines used for the treatment of urine retention, for example neostigmine or bethanechol.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Trihexyphenidyl Sy­rup.

Pregnancy, breast-feeding and fertility

Do not take Trihexyphenidyl Syrup if you are breast-feeding.

Tell your doctor if you are pregnant, trying to become pregnant or are breast-feeding.

Driving and using machines

Taking Trihexyphenidyl Syrup may make your vision blurred or make you feel less alert than usual. If you are affected you should not drive or use machines until the effect has worn off.

Trihexyphenidyl Syrup contains sucrose, ethanol, propylene glycol and sodium benzoate

  • ■ sucrose – there is 2.6g of sucrose in every 5ml of syrup. The maximum dose of

Trihexyphenidyl Syrup supplies 10.4g sucrose. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor

that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

  • ■ ethanol – This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml

  • ■ propylene glycol – this medicine contains 19.27mg propylene glycol per 5ml of syrup. If you are pregnant or breast-feeding or if you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine

  • ■ sodium benzoate – this medicine contains 5.9mg sodium benzoate per 5ml of syrup.

    E1V74RBJ2


Continued overleaf

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The source of liquid solutions. A Pgrrl^O* Company


ARTWORK VERSION:

4


1 JOB INFORMATION

JOB SPECIFICATION

Product Name:

Trihexyphenidyl Hydrochloride 5mg/5ml Syrup

Strength: 5mg/5ml New Item Code: E1V74RBJ2

Pack Size: 200ml Previous Item Code: E1V74RBJ1

Bottle Size: 200ml Supplier Code: N/A

Design Icon: N/A Change Control No.: 1132704

Keyline Ref: UKL413 Dimensions: 150 X 500mm Folded Size: 150 X 33mm

Tabbed: NO

Pharmacode: 563

EAN Code: N/A

No. of Colours: 1

Page Number: 1 of 2

MAIN BODY TEXT

Font Type:

Univers Roman

Univers Bold

Font Size:

10pt

COLOURS

Print

Colours:

BLACK

Non-print

Colours:

KEYLINE



3. how to take trihexyphenidyl syrup

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

The usual dose starts with 2mg (2ml) per day. This may be increased by your doctor gradually to a maximum of 20mg (four 5ml spoonfuls) a day.

If you take more Trihexyphenidyl Syrup than you should

If you accidentally take too much syrup, or someone else takes any of your medicine, you should tell your doctor at once or contact the nearest casualty department. Show any left-over medicines or the empty container to the doctor.

If you forget to take Trihexyphenidyl Syrup

Do not worry. If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose (within 1–2 hours). DO NOT take a double dose. Then go on as before.

If you stop taking Trihexyphenidyl Syrup

Do not stop taking this medicine suddenly as your symptoms may get worse.

If you want to stop taking Trihexyphenidyl Syrup ask your doctor who will tell you how to reduce the dose gradually.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Allergic reactions may occur rarely, with symptoms such as rash, itching, swelling of the face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy particularly when standing up. If any of these occur STOP taking the medicine and contact a doctor immediately.

Trihexyphenidyl Syrup sometimes causes the following side effects in some people:

  • ■ dry mouth, difficulty swallowing

  • ■ constipation, feeling or being sick

  • ■ blurred vision, large pupils, lack of near vision, eye discomfort, increased sensitivity to light and painful increased pressure in the eye

  • ■ feeling agitated or nervous

  • ■ confusion

  • ■ hallucinations

  • ■ feeling optimistic

  • ■ inability to sleep or restlessness

  • ■ forgetfulness

  • ■ paranoid delusions (being worried that something bad is happening without any reason)

  • ■ redness and dryness of the skin or skin rashes

  • ■ difficulty passing urine or unable to pass urine

  • ■ feeling thirsty

  • ■ fever (raised body temperature)

  • ■ faster heartbeat

  • ■ worsening of myasthenia gravis (very tired or weak muscles).

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 at 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 trihexyphenidyl syrup

  • ■ Keep Trihexyphenidyl Syrup out of the sight and reach of children.

  • ■ Do not store above 25°C. Do not refrigerate or freeze. Store in the original package.

  • ■ Do not use this medicine after the expiry date which is stated on the carton and bottle label (exp: month, year). 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.

6. contents of the pack and other information

What Trihexyphenidyl Syrup contains

The active substance is trihexyphenidyl hydrochloride.

Each 5ml of Trihexyphenidyl Syrup contains 5mg trihexyphenidyl hydrochloride. The other ingredients are citric acid, sodium benzoate, propylene glycol, glycerol, ethanol, blackcurrant flavour, sucrose and water.

What Trihexyphenidyl Syrup looks like and contents of the pack

Trihexyphenidyl Syrup is a colourless syrup available in bottles of 200ml.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

This leaflet was last revised in: March 2020

E1V74RBJ2


ARTWORK VERSION:

4


1 JOB INFORMATION

JOB SPECIFICATION

Product Name:

Trihexyphenidyl Hydrochloride 5mg/5ml Syrup

Strength: 5mg/5ml New Item Code: E1V74RBJ2

Pack Size: 200ml Previous Item Code: E1V74RBJ1

Bottle Size: 200ml Supplier Code: N/A

Design Icon: N/A Change Control No.: 1132704

Keyline Ref: UKL413 Dimensions: 150 X 500mm Folded Size: 150 X 33mm

Tabbed: NO

Pharmacode: 563

EAN Code: N/A

No. of Colours: 1

Page Number: 1 of 2

MAIN BODY TEXT

Font Type:

Univers Roman

Univers Bold

Font Size:

10pt

COLOURS

Print

Colours:

BLACK

Non-print

Colours:

KEYLINE



3. how to take trihexyphenidyl syrup

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

The usual dose starts with 2mg (2ml) per day. This may be increased by your doctor gradually to a maximum of 20mg (four 5ml spoonfuls) a day.

If you take more Trihexyphenidyl Syrup than you should

If you accidentally take too much syrup, or someone else takes any of your medicine, you should tell your doctor at once or contact the nearest casualty department. Show any left-over medicines or the empty container to the doctor.

If you forget to take Trihexyphenidyl Syrup

Do not worry. If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose (within 1–2 hours). DO NOT take a double dose. Then go on as before.

If you stop taking Trihexyphenidyl Syrup

Do not stop taking this medicine suddenly as your symptoms may get worse.

If you want to stop taking Trihexyphenidyl Syrup ask your doctor who will tell you how to reduce the dose gradually.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Allergic reactions may occur rarely, with symptoms such as rash, itching, swelling of the face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy particularly when standing up. If any of these occur STOP taking the medicine and contact a doctor immediately.

Trihexyphenidyl Syrup sometimes causes the following side effects in some people:

  • ■ dry mouth, difficulty swallowing

  • ■ constipation, feeling or being sick

  • ■ blurred vision, large pupils, lack of near vision, eye discomfort, increased sensitivity to light and painful increased pressure in the eye

  • ■ feeling agitated or nervous

  • ■ confusion

  • ■ hallucinations

  • ■ feeling optimistic

  • ■ inability to sleep or restlessness

  • ■ forgetfulness

  • ■ paranoid delusions (being worried that something bad is happening without any reason)

  • ■ redness and dryness of the skin or skin rashes

  • ■ difficulty passing urine or unable to pass urine

  • ■ feeling thirsty

  • ■ fever (raised body temperature)

  • ■ faster heartbeat

  • ■ worsening of myasthenia gravis (very tired or weak muscles).

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 at 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 trihexyphenidyl syrup

  • ■ Keep Trihexyphenidyl Syrup out of the sight and reach of children.

  • ■ Do not store above 25°C. Do not refrigerate or freeze. Store in the original package.

  • ■ Do not use this medicine after the expiry date which is stated on the carton and bottle label (exp: month, year). 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.

Frequently Asked Questions

What is Trihexyphenidyl Hydrochloride used for?

Trihexyphenidyl Hydrochloride is used to treat symptoms of Parkinson's disease and movement disorders caused by certain medications.

How does Trihexyphenidyl Syrup work in the body?

It works by reducing the effects of a chemical in the brain called acetylcholine, which helps to improve muscle control and reduce tremors.

Can I take Trihexyphenidyl Hydrochloride with other medications?

Always consult your healthcare provider before taking any other medications with Trihexyphenidyl to avoid potential interactions.

What should I do if I miss a dose of Trihexyphenidyl Syrup?

If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and continue with your regular schedule.

Are there any common side effects of Trihexyphenidyl Hydrochloride syrup?

Common side effects include dry mouth, dizziness, blurred vision, and constipation. If these persist or worsen, contact your doctor.

Can Trihexyphenidyl syrup cause allergic reactions?

Yes, if you develop symptoms like rash, itching, or swelling after taking this medication, seek medical attention immediately.

Is it safe to consume alcohol while taking Trihexyphenidyl Hydrochloride syrup?

It's recommended to avoid alcohol as it may enhance side effects such as dizziness and drowsiness.

How should I store Trihexyphenidyl Hydrochloride syrup?

Store the syrup at room temperature away from light and moisture. Keep it out of reach of children.

Can pregnant or breastfeeding women take Trihexyphenidyl Hydrochloride?

Consult your doctor before using this medication if you are pregnant or breastfeeding to discuss potential risks.

What should I do if I overdose on Trihexyphenidyl Hydrochloride syrup?

Seek immediate medical attention if you suspect an overdose. Symptoms may include confusion, hallucinations, or severe drowsiness.

How long does it take for Trihexyphenidyl Hydrochloride syrup to work?

You may start to notice improvement in symptoms within a few hours after taking the medication.

Is weight gain a side effect of taking Trihexyphenidyl Hydrochloride syrup?

Weight gain is not commonly reported but discuss any concerns with your healthcare provider.

Can I stop taking Trihexyphenidyl Hydrochloride suddenly?

Do not stop taking this medication abruptly without consulting your doctor, as it can lead to worsening symptoms.

What should I do if I experience severe side effects while taking this medicine?

Contact your healthcare provider immediately if you experience severe side effects such as difficulty breathing or severe drowsiness.

Does Trihexyphenidyl affect my ability to drive or operate machinery?

Yes, it may cause drowsiness or blurred vision. Use caution and consult your doctor before driving or operating heavy machinery.

Are there specific foods I should avoid while on Trihexyphenidyl Hydrochloride syrup?

There are no specific food restrictions; however, maintain a balanced diet and stay hydrated as dehydration can worsen some side effects.

Can elderly patients use Trihexyphenidyl Hydrochloride safely?

Elderly patients may be more sensitive to the side effects. Discuss individual circumstances with a healthcare provider.

How often can I take Trihexyphenidyl Syrup throughout the day?

Follow your doctor's instructions regarding dosage frequency. It is usually taken several times a day depending on individual needs.

Will taking Trihexyphenidyl affect my daily activities or routine?

Some patients may experience drowsiness; it's important to assess how it affects you personally before engaging in daily activities.

Is there a generic version available for Trihexyphenidyl Hydrochloride syrup?

Yes, generic versions are available. Consult your pharmacist for options that suit your needs and budget.