Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Trihexyphenidyl Hydrochloride 5mg/5ml Syrup

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Trihexyphenidyl hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Trihexyphenidyl hydrochloride
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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.

What you need to know before you take it

e 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 medicine contains 0.817 mg of alcohol (ethanol) in each 5 mL, which is equivalent to 0.1634 mg/ml. The amount in 5mL of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. ■ 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 5.9 mg sodium benzoate in each 5ml, which is equivalent to 1.18 mg/ml. ■ sodium – this medicine contains less than 1mmol sodium (23 mg) per 5mL, that is to say essentially 'sodium-free'.

E1V74RBJ3

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Trihexyphenidyl Hydrochloride 5mg/5ml Syrup

Dimensions:

Steve

–

UKL413

759

150 x 500mm

EAN Code:

N/A

Folded Size:

150 x 33mm

No. of Colours: 1

NO

Page Number:

Third Party Approval Required

5mg/5ml

New Item Code:

E1V74RBJ3

Pack Size:

200ml

Previous Item Code:

E1V74RBJ2

MAIN BODY TEXT

200ml

Supplier Code:

N/A

Font Type:

Font Size:

Change Control No.:

CR-00591

Univers Roman Univers Bold

10pt

877

Non-print Colours:

Design Icon: N/A

Print Colours:

TICK APPLICABLE BOX

Signature:

BLACK

PANTONE BLACK

485

Authority Approval Supplied

TICK APPLICABLE BOX

Regulatory Sign-off

KEYLINE

BRAILLE

NO

YES

N/A

Date:

Name: PANTONE

YES

Name:

1 of 2

Strength:

COLOURS

–

APPROVALS Pharmacode:

Tabbed:

Date: Operator:

100

JOB SPECIFICATION

Date: Operator:

90

Keyline Ref:

Bottle Size:

09/11/22

80

Product Name:

PREFLIGHT VERSION:

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70

JOB INFORMATION

ARTWORK VERSION:

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60

Continued overleaf

SUBSTRATE

Signature:

Date:

How to take it

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.

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 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.

How to store it

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.

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. See Section 2 'Trihexyphenidyl Syrup contains sucrose, ethanol, propylene glycol and sodium benzoate' 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: October 2022

E1V74RBJ3

0

10

20

30

40

50

UKL413

Pharmacode:

759

Trihexyphenidyl Hydrochloride 5mg/5ml Syrup

Dimensions:

150 x 500mm

EAN Code:

N/A

Folded Size:

150 x 33mm

No. of Colours: 1

NO

Page Number:

Steve

–

Third Party Approval Required

5mg/5ml

New Item Code:

E1V74RBJ3

Pack Size:

200ml

Previous Item Code:

E1V74RBJ2

MAIN BODY TEXT

200ml

Supplier Code:

N/A

Font Type:

Font Size:

Change Control No.:

CR-00591

Univers Roman Univers Bold

10pt

Design Icon: N/A

Print Colours:

TICK APPLICABLE BOX

Signature:

BLACK

PANTONE BLACK

877

485

Non-print Colours:

Authority Approval Supplied

TICK APPLICABLE BOX

Regulatory Sign-off

KEYLINE

BRAILLE

NO

YES

N/A

Date:

Name: PANTONE

YES

Name:

2 of 2

Strength:

COLOURS

–

APPROVALS

Tabbed:

Date: Operator:

100

JOB SPECIFICATION

Date: Operator:

90

Keyline Ref:

Bottle Size:

09/11/22

80

Product Name:

PREFLIGHT VERSION:

–

70

JOB INFORMATION

ARTWORK VERSION:

2

60

SUBSTRATE

Signature:

Date:

Frequently asked questions about Trihexyphenidyl Hydrochloride 5mg/5ml Syrup

How do I take Trihexyphenidyl Hydrochloride 5mg/5ml Syrup?

Trihexyphenidyl Hydrochloride 5mg/5ml Syrup comes as oral solution containing 5mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Trihexyphenidyl Hydrochloride 5mg/5ml Syrup?

The active substance in Trihexyphenidyl Hydrochloride 5mg/5ml Syrup is trihexyphenidyl hydrochloride.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Trihexyphenidyl Hydrochloride 5mg/5ml Syrup, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Trihexyphenidyl Hydrochloride 5mg/5ml Syrup without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Trihexyphenidyl hydrochloride (1 medicine)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Parkinsonism and drug induced extrapyramidal syndrome.

4.2. Posology and method of administration

Posology

Adults and Elderly:

Initial dose 2mg. Subsequent doses up to 20mg as recommended by a physician.

Children:

Not recommended.

Method of administration

For oral administration

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Precautions: Since the use of trihexyphenidyl may, in some cases, continue indefinitely, the patient should be under careful observation over the long term. It should be administered with care to avoid allergic or other untoward reactions.

Except in the case of vital complications, abrupt discontinuation of the drug should be avoided.

Incipient glaucoma may be precipitated by para-sympatholytic drugs such as trihexyphenidyl.

Hypertension, cardiac, liver or kidney disorders are not contraindicated, but such patients should be followed closely. As trihexyphenidyl may provoke or exacerbate tardive dyskinesia, it is not recommended for use in patients with this condition.

Trihexyphenidyl should be used with caution in patients with glaucoma, obstructive disease of the gastro-intestinal or genito-urinary tracts, and in elderly males with possible prostatic hypertrophy.

Since trihexyphenidyl has been associated with clinical worsening of myasthenia gravis, the drug should be avoided or used with great caution in patients with this condition.

Since certain psychiatric manifestations such as confusion, delusions and hallucinations, all of which may occur with any of the atropine-like drugs, have been reported rarely with trihexyphenidyl, it should be used with extreme caution in elderly patients (see section 4.2).

Warnings: Trihexyphenidyl may be the subject of abuse (on the basis of hallucinogenic and euphoriant properties, common to all anti-cholinergic drugs) if given in sufficient amounts.

Excipient Warnings:

This product contains –

• Sucrose – 2.6g per 5ml. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

• Ethanol – this medicine contains 0.817 mg of alcohol (ethanol) in each 5ml, which is equivalent to 0.1634 mg/ml. The amount in 5ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

• Propylene glycol – this medicine contains 19.27mg per 5ml. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.

While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.

Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.

• Sodium benzoate – this medicine contains 5.9 mg sodium benzoate in each 5ml, which is equivalent to 1.18 mg/ml.

• Sodium – this medicine contains less than 1mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'.

4.5. Interaction with other medicinal products and other forms of interaction

Extra care should be taken when trihexyphenidyl is given concomitantly with phenothiazines, clozapine, antihistamines, disopyramide, nefopam and amantadine because of the possibility of increased antimuscarinic side-effects.

Synergy has been reported between trihexyphenidyl and tricyclic antidepressants, probably because of an additive effect at the receptor site.

This can cause dry mouth, constipation and blurred vision. In the elderly, there is a danger of precipitating urinary retention, acute glaucoma or paralytic ileus.

Monoamine oxidase inhibitors can interact with concurrently administered anticholinergic agents including trihexyphenidyl. This can cause dry mouth, blurred vision, urinary hesitancy, urinary retention and constipation.

In general, anticholinergic agents should be used with caution in patients who are receiving tricyclic antidepressants or monoamine oxidase inhibitors. In patients who are already on antidepressant therapy the dose of trihexyphenidyl should be initially reduced and the patient reviewed regularly.

Trihexyphenidyl may be antagonistic with the actions of metoclopramide and domperidone on gastro-intestinal function.

The absorption of levodopa may possibly be reduced when used in conjunction with trihexyphenidyl.

Trihexyphenidyl may be antagonistic with the actions of parasympathomimetics.

4.6. Fertility, pregnancy and lactation

Pregnancy

There is inadequate information regarding the use of trihexyphenidyl in pregnancy. Animal studies are insufficient with regard to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Trihexyphenidyl should not be used during pregnancy unless clearly necessary.

Breastfeeding

It is unknown whether trihexyphenidyl is excreted in human breast milk. The excretion of trihexyphenidyl in milk has not been studied in animals. Infants may be very sensitive to the effects of antimuscarinic medications. Trihexyphenidyl should not be used during breast feeding.

4.7. Effects on ability to drive and use machines

Trihexyphenidyl hydrochloride may affect the performance of skilled tasks such as driving and operating machinery as it can cause blurring of vision, dizziness and mild nausea. Also mental confusion in some cases.

4.8. Undesirable effects

Modern clinical data required to determine the frequency of undesirable effects are lacking for trihexyphenidyl. Minor side effects such as dryness of mouth, constipation, blurring of vision, dizziness, mild nausea or nervousness will be experienced by 30-50% of all patients. These reactions tend to become less pronounced as treatment continues. Patients should be allowed to develop a tolerance using the smaller initial dose until an effective level is reached.

Immune system disorders: Hypersensitivity.

Psychiatric disorders: Nervousness, restlessness, confusional states, agitation, delusions, hallucinations, insomnia, especially in the elderly and patients with arteriosclerosis. The development of psychiatric disturbances may necessitate discontinuation of treatment.

Euphoria may occur. There have been reports of abuse of trihexyphenidyl due to its euphoric and hallucinogenic properties.

Nervous system disorders: Dizziness.

Impairment of immediate and short-term memory function has been reported.

Worsening of myasthenia gravis may occur (see section 4.4).

Eye disorders: Dilatation of the pupils with loss of accommodation and photophobia, raised intraocular pressure (see section 4.4). Cardiac disorders: Tachycardia.

Respiratory, thoracic and mediastinal disorders: Decreased bronchial secretions.

Gastrointestinal disorders: Dry mouth with difficulty swallowing, constipation, nausea, vomiting.

Skin and subcutaneous tissue disorders: Flushing and dryness of skin, skin rashes.

Renal and urinary disorders: Urinary retention, difficulty in micturition.

General disorders: Thirst, pyrexia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professional are asked to report any suspected adverse reactions via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

Symptoms of overdose with antimuscarinic agents include flushing and dryness of the skin, dilated pupils, dry mouth and tongue, tachycardia, rapid respiration, hyperpyrexia, hypertension, nausea, vomiting. A rash may appear on the face or upper trunk. Symptoms of CNS stimulation include restlessness, confusion, hallucinations, paranoid and psychotic reactions, incoordination, delirium and occasionally convulsions. In severe overdose, CNS depression may occur with coma, circulatory and respiratory failure and death.

Treatment

Treatment should always be supportive. An adequate airway should be maintained. Diazepam may be administered to control excitement and convulsions but the risk of central nervous system depression should be considered. Hypoxia and acidosis should be corrected. Antiarrhythmic drugs are not recommended if dysrhythmias occur.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • ROMPARKIN 2 mg prescriptionTRIHEXYPHENIDYLUM · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

💬 Ask about this leaflet

Ask anything about Trihexyphenidyl Hydrochloride 5mg/5ml Syrup. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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