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.
Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v Topical Solution
⚠ 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 Lidocaine hydrochloride, Phenylephrine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 2. What you need to know before you are given Lidocaine and Phenylephrine topical solution 3. How you will be given Lidocaine and Phenylephrine topical solution 4. Possible side-effects 5. How to store Lidocaine and Phenylephrine topical solution 6. Contents of the pack and other information.
Driving and using machines: It is unlikely that after using Lidocaine and Phenylephrine topical solution, your ability to drive and use machines will be affected. However, if you feel unwell you must speak to your doctor before driving or operating machinery.
What you need to know before you take it
Lidocaine and Phenylephrine Topical Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
These serious side effects are rare. Other side effects Tell your doctor if you notice any of the following: Excessive saliva, headache, reduced appetite, sweating and weakness, difficulty in sleeping, feeling sick or being sick, anxiety, confusion, excitement, fear, nervousness, restlessness, fits and tinnitus. These are all mild side effects of Lidocaine and Phenylephrine topical solution. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
How to take it
Lidocaine and Phenylephrine topical solution Your doctor or nurse will administer this medicine onto the area inside your nose or throat, using the pump spray dispenser supplied with the product. Dose: Adults, and Children over 12 years: Up to a maximum of 8 sprays in total. Children below 12 years of age: Not recommended.
Possible side effects
The name of this product is Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v topical solution. The active ingredients are local anaesthetic (lidocaine) which causes numbness and a sympathomimetic drug (phenylephrine) that reduces bleeding.
Like all medicines Lidocaine and Phenylephine topical solution can cause side effects, although not everybody gets them. Serious Side effects The anaesthetic effect induced by lidocaine may cause numbness of the tongue and mouth and may interfere with swallowing. Do not eat or drink until the effect has worn off. If used on damaged or inflamed skin Lidocaine and Phenylephrine topical solution may cause the following effects: Breathing difficulties, fits, coma, heart attack, chest pain, bradycardia (slow heart rate), cardiac arrhythmias (irregular heart beat) and low blood pressure (with dizziness, fainting and flushing) or high blood pressure. These are all very serious side effects and are very rare.
Lidocaine and phenylephrine topical solution is applied to the area inside your nose and throat to numb the area, and reduce bleeding prior to performing certain surgical procedures.
If any of the above happens, tell your doctor immediately or go to the casualty department at your nearest hospital as you may need urgent medical attention.
It is also used to aid in the removal of foreign bodies from the nose.
Tell your doctor or go to the casualty department at your nearest hospital if you notice any of the following: Difficulty in passing urine (particularly if you have problems with your prostate), blurred vision, dizziness, drowsiness, irritability, extremely high temperature, muscle twitching and shaking.
1. What Lidocaine and Phenylephrine Topical Solution is and what it is used for
How to store it
Lidocaine and Phenylephrine Topical Solution You should not be given this medicine if the expiry date on the label has passed or if it shows signs of deterioration. The doctor or nurse will check that the expiry date on the label has not passed and that the medicine does not show signs of deterioration. Do not store this medicine above 25°C. Keep this medicine out of the sight and reach of children. Keep in the original container. Do not throw away any medicines via wastewater. 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 Lidocaine and Phenylephrine Topical Solution contains: The active ingredients in Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v topical solution are Lidocaine Hydrochloride and Phenylephrine Hydrochloride. Each bottle contains 2.5ml of topical solution containing 50mg/ml of lidocaine hydrochloride and 5mg/ml of phenylephrine hydrochloride in Water for Injections, with sodium hydroxide and hydrochloric acid to adjust the pH. What Lidocaine and Phenylephrine Topical Solution looks like and contents of the pack: Lidocaine and Phenylephrine Topical Solution is licensed to be available in one bottle containing 2.5ml of solution, in a single box. Each 2.5ml of solution contains 125mg of Lidocaine Hydrochloride and 12.5mg of Phenylephrine Hydrochloride respectively. Marketing Authorisation Holder: Aurum Pharmaceuticals Ltd, Bampton Road, Romford, RM3 8UG, United Kingdom. Manufacturers: University Hospitals of Derby and Burton NHS Foundation Trust Queen's Hospital Burton, Pharmacy Manufacturing Unit, Belvedere Road, Burton-on-Trent, DE13 0RB, United Kingdom Martindale Pharmaceuticals Ltd, Bampton Road, Romford, RM3 8UG, England, United Kingdom. Product Licence No.: PL 12064/0027 The leaflet was last revised in: July 2020
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Lidocaine Hydrochloride 5 % w/v and Phenylephrine Hydrochloride 0.5 % w/v Topical Solution
Instructions For Assembly Of Pump + Actuator To Bottle. Priming the Pump. While holding the bottle upright, the pump should be activated three times before use to prime it.
Actuator
1. Immediately before use. remove the screw cap and rubber stopper from the bottle. 2. Screw the pump onto the bottle. 3. Push the actuator onto the top of the pump. 4. Press down on the pump-actuator 3 times to prime the pump before use. 5. The pump spray is now ready for use. Refer to the Patient Information Leaflet or Summary of Product Characteristics for dosing instructions.
Other Information. The pump dispenser will deliver a dose volume of 130μl in each spray. Thus, each spray is equivalent to 6.5mg of Lidocaine Hydrochloride and 0.65mg of Phenylephrine Hydrochloride. Always hold the bottle upright to ensure dip-tube is immersed in the solution at its tip. This product is sterile until opened, and contains no preservative. Use once for one patient only and discard the bottle and any remaining topical solution in an appropriate manner. Do not use if packaging is damaged. Keep out of the sight and reach of children. This product also contains Water for Injections, with Sodium Hydroxide and /or Hydrochloric Acid to adjust pH. Black C
Pump
Black C
User Guide
Bottle
You may need medical attention.
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Do not use Lidocaine and Phenylephrine topical solution if:
- you are allergic to Lidocaine, local anaesthetics similar to lidocaine, Phenylephrine or any of the ingredients of this medicine (listed in section 6)
- you are pregnant or breastfeeding.
- you have a low amount of blood in your body (hypovolaemia);
- you suffer from high blood pressure;
- you suffer from a type of heart disease known as acute ischaemic heart disease;
- you have some problems with electrical signals in your heart e.g. you need a pacemaker (a device that regulates heart beats);
- you suffer from problems with your thyroid gland (thyrotoxicosis);
- you suffer from glaucoma (increased pressure in the eyeball);
- you have difficulty passing urine.
- you are taking a type of medicine known as sympathomimetics, this can include medicines used to treat asthma, colds, flu, glaucoma, heart problems, blood pressure and premature labour;
- you are taking monoamine oxidase inhibitors, (drugs used to treat depression) or have taken them within the last two weeks. Warnings and precautions Talk to your doctor or pharmacist before you are given Lidocaine and Phenylephrine topical solution if:
- you have any condition affecting the heart or blood vessels (cardiovascular disease);
- you suffer from diabetes;
- you suffer from high blood pressure
- you have an overactive thyroid gland;
- you suffer from low blood oxygen level or a high blood carbon dioxide level (for example you suffer from any lung disease);
- you suffer from porphyria (a hereditary disorder that affects some enzymes in the blood and liver);
- you have any cut or sore area in your nose or throat;
- you suffer from fits;
- you suffer from heart conditions which includes a slow heart rate;
- you have liver problems;
- you are suffering from severe shock (sweating, feel unwell, feeling your heartbeat, fainting);
- you suffer from angina. Other medicines and Lidocaine and Phenylephrine topical solution: You MUST NOT use Lidocaine and Phenylephrine topical solution if you are taking
- MAOIs or if you have taken them within the last two weeks
- drugs for treatment of irregular heart beat (heart arrhythmias), such as lidocaine, digoxin or tocainide. Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines including:
- beta-blockers (drugs used in the treatment of heart problems or high blood pressure);
- debrisoquine, reserpine, methyldopa and guanethide (used to treat high blood pressure);
- quinupristin/dalfopristin (used to treat bacterial infections resistant to antibiotics);
- diuretics (drugs used to treat difficulty in passing urine and water retention);
- reboxetine (used to treat depression);
- suxamethonium (a muscle relaxant);
- ergot alkaloids (used to treat migraine);
- doxapram (used to treat severe breathing difficulties);
- oxytocin (used to induce labour);
- anaesthetics such as chloroform, halothane or isoflurane;
- phenothiazines (used to treat certain mental disorders);
- drugs used to treat depression known as tricyclic antidepressants. These include amitriptyline, clomipramine and imipramine• monoamine oxidase inhibitors (MAOIs) (drugs used to treat depression). If you have any doubts about whether this medicine should be administered to you, discuss this more fully with your doctor or nurse. Pregnancy, breast feeding and fertility: You should not be given Lidocaine and Phenylephrine Topical solution when pregnant or breast-feeding.
MA Number/Holder PL 12064/0027 Aurum Pharmaceuticals Ltd, Bampton Road, Romford, RM3 8UG, England, United Kingdom. For further information contact: Aurum Pharmaceuticals Ltd, Bampton Road, Romford, RM3 8UG, England, United Kingdom. D05307
100mm Measurement Verification Bar
Frequently asked questions about Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v Topical Solution
How do I take Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v Topical Solution?
Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v Topical Solution comes as solution. 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 Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v Topical Solution?
The active substance in Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v Topical Solution is lidocaine hydrochloride, phenylephrine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v Topical Solution, 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 Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v Topical Solution 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.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: lidocaine hydrochloride, phenylephrine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
* Preparation of nasal mucosa for surgery or endoscopy
* Aid in removal of foreign bodies from the nose
* Analgesia of the pharynx prior to indirect or direct laryngoscopy
4.2. Posology and method of administration
Each bottle contains 2.5ml of solution to be used as a spray; equivalent to 125mg of Lidocaine Hydrochloride and 12.5mg of Phenylephrine Hydrochloride .
Prime the pump dispenser by activating the pump 3 times.
The pump dispenser will deliver a dose volume of 130μl in each spray. Each spray is equivalent to 6.5mg of Lidocaine Hydrochloride and 0.65mg of Phenylephrine Hydrochloride .
Adults, and Children over 12 years:
Up to a maximum of 8 sprays in total.
Children below 12 years of age
Not recommended
4.3. Contraindications
Hypersensitivity to Lidocaine Hydrochloride, local anaesthetics of the amide type, Phenylephrine Hydrochloride or to any of the excipients listed in section 6.1.
Lidocaine and phenylephrine topical solution should not be administered to those who are pregnant or breast-feeding.
Hypovolaemia, hypertension, acute ischaemic heart disease and complete heart block.
Thyrotoxicosis, glaucoma or urinary retention.
Patients receiving other sympathomimetic drugs.
Lidocaine and phenylephrine topical solution should not be given to patients taking monoamine oxidase inhibitors or within 2 weeks of their use. (see also 'Interactions' below).
4.4. Special warnings and precautions for use
Lidocaine and phenylephrine topical solution should be administered with caution to patients taking β-adrenergic blocking agents (see section below headed 'Interactions with other Medicaments and other forms of Interaction',) and those with cardiovascular disease, diabetes mellitus, hypertension or hyperthyroidism, hypoxia, hypercapnia and porphyria.
Lidocaine and phenylephrine topical solution should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application.
Lidocaine and phenylephrine topical solution should also be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic function and in severe shock.
Oral topical anaesthesia may interfere with swallowing, and numbness of the tongue or buccal mucosa may increase the danger of biting trauma.
The physician or pharmacist should check that sympathomimetic containing preparations are not simultaneously administered by several routes i.e. orally and topically (nasal, aural and eye preparations)
Sympathomimetic-containing products should be used with great care in patients suffering from angina.
4.5. Interaction with other medicinal products and other forms of interaction
Monoamine Oxidase Inhibitors (MAOIs):
Phenylephrine is metabolised by MAOs in the gut. Irreversible MAOIs may therefore increase the effect of oral phenylephrine, resulting in a dangerous hypertensive crisis. This effect has not been reported with reversible MAOIs and phenylephrine given by nasal spray. In view of this risk however, this product should not be used on patients taking irreversible MAOIs, or within three weeks of their discontinuation.
Antihypertensive agents, Antiarrythmics and Cardiac glycosides:
Anti-hypertensive agents such as β-adrenergic blocking agents may have their effects reversed by the co-administration of phenylephrine, with possible fatal reactions.
Hypertensive reactions have been reported in a patient stabilised on debrisoquine when given phenylephrine by mouth, in patients receiving reserpine or guanethidine when given phenylephrine eye drops, and a fatal reaction occurred in a patient receiving propranolol and hydrochlorothiazide also after the instillation of phenylephrine eye drops.
Products that contain phenylephrine should be used with caution in patients receiving guanethedine, reserpine, digitalis and methyldopa.
Lidocaine may cause an increased risk of myocardial depression: increased risk of lidocaine toxicity with propranolol.
Lidocaine should be used with caution in patients receiving antiarrhythmic drugs, such as tocainide, since the toxic effects are additive.
Antimicrobials:
Increased risk of ventricular arrythmias with quinuprisin/dalfoprisin. Concomitant use should be avoided.
Diuretics:
Effects of lidocaine antagonised by hypokalaemia with acetazolamide, loop diuretics and thiazides.
Antidepressants:
Lidocaine should be used with caution if patients are being treated with the reboxitine.
Sympathomimetic-containing products should be used with great care in patients receiving phenothiazines or tricyclic antidepressants.
Muscle relaxants:
The action of Suxamethonium may be prolonged by lidocaine.
Phenylephrine may cause hypertension when used concomitantly with doxapram or oxytocin.
There is an increased risk of ergotism when phenylephrine and ergot alkaloids are taken concomitantly.
Halogenated anaesthetic agents
Concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane may provoke or worsen ventricular arrhythmias.
4.6. Fertility, pregnancy and lactation
Lidocaine and phenylephrine topical solution should not be administered to those who are pregnant or breast-feeding.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
The lidocaine and phenylephrine topical solution may interfere with swallowing, and numbness of the tongue or buccal mucosa may increase the danger of biting trauma.
Local anaesthetics, (e.g. lidocaine) and sympathomimetics, (e.g. phenylephrine) may produce systemic adverse effects as a result of the raised plasma concentrations which ensue when the rate of absorption into the circulation exceeds the rate of breakdown, for example, by absorption of large amounts through mucous membranes or damaged skin or from highly vascular areas.
Possible Systemic Effects due to Lidocaine
The systemic toxicity of local anaesthetics mainly involves the central nervous system and the cardiovascular system. Excitation of the CNS may be manifested by restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, nausea and vomiting, muscle twitching and tremors, and convulsions. Numbness of the tongue and perioral region may appear as an early sign of systemic toxicity. Excitation may be transient and followed by depression with drowsiness, respiratory failure and coma. There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilatation resulting in hypotension and bradycardia; arrhythmias and cardiac arrest may occur.
Some local anaesthetics cause methaemoglobinaemia.
Possible Systemic Effects due to Phenylephrine.
Sympathomimetics may produce a wide range of adverse effects, most of which mimic the results of excessive stimulation of the sympathetic nervous system. These effects are mediated via the various types of adrenergic receptor, and the adverse effects of an individual drug depend to some extent upon its relative agonist activity on these different types of receptor at a given dose.
Central effects of sympathomimetic agents include fear, anxiety, nervousness, restlessness, tremors, insomnia, confusion, irritability, psychotic states and epileptiform convulsions. Appetite may be reduced and nausea and vomiting may occur.
Effects on the cardiovascular system are complex. Stimulation of alpha-adrenergic receptors produced vasoconstriction with resultant hypertension. This vasoconstriction is sometimes sufficiently severe to produce gangrene when sympathomimetics are infiltrated into the digits. The rise of blood pressure may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia, but stimulation of β1-adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain, palpitations, and cardiac arrest: hypotension with dizziness and fainting, and flushing, may occur. An increased incidence of sudden death, sometimes attributed to the induction of ventricular arrhythmias, has been associated with the excessive use of sympathomimetic agents in aerosol form; although the association has been questioned by some authorities, it is important to avoid excessive doses.
Other effects that may occur with sympathomimetic agents include difficulty in micturition, particularly in the case of prostatic hypertrophy, and urinary retention, dyspnoea, weakness, altered metabolism, sweating, hyperpyrexia and hypersalivation. Headache is also common.
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 professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Symptoms
Because a severe toxic reaction to phenylephrine is of rapid onset and short duration, treatment is primarily supportive. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine (dose 5 to 10mg i.v.) has been recommended.
Treatment
Treatment of a patient with toxic manifestations consists of ensuring adequate ventilation and arresting convulsions. Ventilation should be maintained with oxygen by assisted or controlled respiration as required. If convulsions occur they must be treated rapidly by intravenous administration of succinylcholine 50-100mg and/or 5-15mg diazepam. As succinylcholine will arrest respiration, it should only be used if the clinician has the ability to perform endotracheal intubation and to manage a totally paralysed patient. Thiopentone may also be used to abort convulsions in dosage 100-200mg. Adrenaline in repeated doses and sodium bicarbonate should be given as rapidly as possible.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Lidocaine hydrochloride, Phenylephrine hydrochloride. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- VERSATIS 700 mg prescription partial — not the same combinationLIDOCAINUM · skin / topical
- INSTILLIDO 20 mg/ml prescription partial — not the same combinationLIDOCAINUM · skin / topical
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Lidocaine hydrochloride, Phenylephrine hydrochloride. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Versatis partial — not the same combinationLidocainum · skin / topical
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Lidocaine Hydrochloride 5% w/v and Phenylephrine Hydrochloride 0.5% w/v Topical Solution. 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.