Entop 50 mg/5 mg Spray

Entop Spray contains two active ingredients lidocaine (lignocaine) hydrochloride and phenylephrine hydrochloride. The active ingredients are local anaesthetic (lidocaine) which causes numbness and a sympathomimetic medicine (phenylephrine) that reduces bleeding. Entop Spray is used for the following:

• To numb the inside of your nose or throat before surgery or endoscopy (a procedure used to look inside the body using an endoscope)
• To help numb the nose if a foreign body (such as a small bead or any other small object becomes wedged in the nose) needs removing
• To numb the inside of your nose or throat before having a fine telescope passed into your nose or throat to view (laryngoscopy and endoscopy).

Do not use Entop Spray:

• if you are hypersensitive (allergic) to lidocaine hydrochloride or phenylephrine hydrochloride or to any of the other ingredients of Entop Spray (listed in section 6).
• if you are hypersensitive to other local anaesthetics or sympathomimetic medicines
• if you are pregnant or breastfeeding
• if you have low blood volume in your body (hypovolaemia)
• if you have high blood pressure (hypertension)
• if you have problems with your heart such as coronary heart disease and complete heart block (problems with electrical signals in your heart).
• if you have an overactive thyroid gland (thyrotoxicosis)
• if you have the eye condition glaucoma (increased pressure in the eyeball)
• if you have problems passing urine
• for children under 12 years of age

Warnings and precautions

Take special care with Entop Spray

Tell your doctor or pharmacist before you are given Entop spray if you have or have had:

• You have been given or used local anaesthetics before and had an allergic reaction, or have reacted to any of the ingredients listed above
• Heart disease (i.e. heart attack or bradycardia which means a slower than normal heartbeat rate. Lidocaine, the anaesthetic medicine may make the effect of any heart rhythm regulating medicines much greater and therefore may adversely affect your heart)
• Are taking other medicines (See 'Other medicines and Entop Spray') and have a condition that affects both your heart or blood vessels, diabetes mellitus, high blood pressure, an overactive thyroid gland, low blood oxygen levels, high blood carbon dioxide levels and inherited blood disorder called porphyria
• You suffer from liver disease
• You suffer from kidney problems (kidney disease may change the blood concentrations of certain chemicals such as potassium in your blood, and this may in turn affect the action of lidocaine on the heart muscle)
• You suffer from asthma and you are allergic to sulphite.
• A genetic predisposition to malignant hyperthermia and pre-existing abnormal neurological conditions
• You have any cut or sore area in your nose or throat
• Have epilepsy (fits)
• Have angina pectoris (disease affecting the heart blood vessels)
• Have a history of high pressure in the eye as this medicine can cause your pupils to dilate which can aggravate this condition

Priming before use

Attach Flexi Nozzle and depress 5 times until full spray is seen. Do not share medicines prescribed for you with any other person. Entop Spray is administered into the nose or throat by your doctor or doctor’s assistant in the following doses:

Adults and children over 12 years of age: 5 squirts (sprays) per nostril

Each squirt (sprays) measures 100 microlitres of fluid. The dose of lidocaine in each squirt is 5 mg and the dose of phenylephrine in each squirt is 0,5 mg. These doses are given once only. Your doctor may decide to increase or decrease this dose depending on your condition. Only your doctor should alter the recommended dosage.

What effects will I notice after taking the medication

You will notice a feeling of numbness in the mouth, nose or throat which is caused by the medicine. You might also notice that the side of the nose to which the medication has been applied becomes congested and may prove difficult to breathe through. This sensation will pass within a few hours.

If you use more Entop Spray than you should

Since a healthcare provider will administer Entop Spray, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use Entop Spray

Do not receive a double dose to make up for forgotten individual doses.

Entop Spray can have side effects. Not all side effects reported for Entop Spray are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Entop Spray, please consult your healthcare provider for advice.

If any of the following happens, stop taking Entop Spray and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting (dizziness).

These are all very serious side effects. If you have them, you may have had a serious reaction to Entop Spray. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• a sensation that the heart is racing, pounding, fluttering or skipping a beat, often bothersome, but hardly ever a sign of heart disease

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent bitter taste in the mouth. It only lasts for one to two minutes and then disappears

Less frequent

• involuntary shaking or movement, ranging from slight to severe and commonly affecting hands, legs, face, head or vocal cords
• nervousness, light headedness
• nausea, vomiting
• enlargement of the pupils (mydriasis)
• ringing in the ears

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Store at or below 30 °C.

Do not use after the expiry date stated on the label / carton / bottle.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).