GLYDO 19 MG / ML GEL IN PRE-FILLED SYRINGE - patient leaflet, side effects, dosage

— If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Glydo is and what it is used for

2. What you need to know before you use Glydo

3. How to use Glydo

4. Possible side effects

5. How to store Glydo

6. Contents of the pack and other information

1. what glydo is and what it is used for

Glydo is a sterile gel that contains the active substance lidocaine hydrochloride. It will be referred to as “lidocaine” throughout this leaflet.

Lidocaine has a local anaesthetic effect and is used to numb the parts of the body the gel is applied to. It stops the nerves from being able to pass pain messages to the brain and so stops you feeling pain.

Due to its local anaesthetic effect and the lubricant properties for catheters, endoscopes or other medical instruments, Glydo is designed to relieve discomfort and ease the process during certain types of examinations or procedures. Glydo is used

— for instillation (insertion) into the urethra before a catheter is inserted or replaced and for a cystoscopy, when a doctor inserts a tube through the urethra to visualise your bladder.

— for proctoscopy/rec­toscopy (medical procedures in which an instrument called an endoscope is used to examine the anal cavity or rectum). During this procedure, Glydo is instilled into the anal cavity/rectum and/or the instrument used is lubricated with Glydo before insertion

Due to its local anaesthetic effect, Glydo is also used

— to help relieve the pain from inflammation of the urinary bladder.

Glydo is indicated in adults, adolescents (above 12 years of age) and children from 2 to 12 years.

Your doctor will explain to you for which specific procedure or condition Glydo is being used.

The administration will usually be performed by a doctor but it can also be administered by you or your caregiver e.g. for self-catheterisation (see section 3. “How to use Glydo“).

2. what you need to know before you use glydo

Do not use Glydo

— if you are allergic to lidocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

• — if you are allergic to certain other local anaesthetics (of the amide type).

• — in children below 2 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before using Glydo.

Before using this medicine, your doctor needs to know if you have, or have had, any of the following:

• — if you have any wounds, injury to the mucous membranes or an ulcer/ inflammation in or around the proposed application site.

• — if your liver or kidney function is impaired, if you are acutely ill, in a weak condition or have sepsis (“blood poisoning”). Your doctor may reduce your dose of Glydo.

• — if you have a slow heartbeat, a heart or respiratory tract dysfunction (problems with your airways).

• — if you have a weak heart (heart failure) or heart conduction disturbances (atrioventricular block).

• — if you suffer from a medical shock.

• — if you are prone to convulsions (seizures) or if you have epilepsy.

• — if you are suffering from a certain muscle disease (myasthenia gravis).

• — if you have a rare inherited illness that affects the blood called ”glucose-6-phosphate dehydrogenase deficiency”.

• — if you have a problem with blood pigment levels called “methaemoglobi­naemia”.

• — if you suffer from porphyria (a blood formation disorder).

— if you are on treatment with certain medications to treat heart rhythm disorders, known as class III antiarrhythmics (e.g. amiodarone), as the effects on the heart may be increased. See also section “Other medicines and Glydo”.

Please also notify your doctor if you use other medicines containing lidocaine frequently and/or at high doses, as this may lead to serious side effects.

If a lot of Glydo is instilled into the urethra and a large amount of gel gets into the bladder

or if the urethra is ulcerous/inflamed, this may generally lead to increased absorption of lidocaine through the mucous membranes, particularly in children and elderly patients, resulting in serious side effects (see also section 3, “If you have been administered / if you use more Glydo than you should“).

Other medicines and Glydo

Tell your doctor or pharmacist if you are taking/ using, have recently taken/used or might take/ use any other medicines. Lidocaine may affect or be affected by other medicines.

In particular, tell your doctor if you are taking/ using any of the following:

— antiarrhythmics – medicines to treat irregular heart beat (e.g. mexiletine, amiodarone).

— calcium channel blockers – medicines taken for heart conditions or high blood pressure (e.g. diltiazem, verapamil).

— beta-blockers (e.g. propranolol, metoprolol) – for the treatment of high blood pressure or angina (chest pain).

These medicines may have an enhanced effect on the heart.

— other medicines containing lidocaine or certain other local anaesthetics (of the amide type), as this may enhance their respective effects in an unpredictable manner.

• - cimetidine to treat hyperacidity, stomach and duodenal ulcers. Using this medicine at the same time can increase the risk of side effects.

• - fluvoxamine to treat depression.

• - erythromycin (antibiotic).

• - protease inhibitors used to treat HIV (e.g ritonavir).

• - medicines used to treat infections, called sulphonamides and nitrofurantoin.

• - medicines used to treat epilepsy, called phenytoin and phenobarbital.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

During pregnancy and breast-feeding, Glydo should only be used after your doctor has carefully considered the benefits and risks.

Driving and using machines

Effects on the ability to drive and use machines are unlikely, but cannot be completely ruled out in cases of increased individual sensitivity. If you feel drowsy, dizzy or if you have vision disturbances, do not drive or use any tools or machinery.

3. how to use glydo

The administration will usually be performed by a doctor with appropriate training and relevant experience.

If you are treating yourself, such as for selfcatheterisation (inserting a small plastic tube (catheter) into one’s own urethra), always use this medicine exactly as your doctor has told you and follow the instructions below for how to apply the gel. Check with your doctor if you are not sure.

Glydo starts to work within 5 – 15 minutes after the application. The effect usually lasts 20 to 30 minutes.

Dose

Your doctor will decide on the most suitable dosage for your particular case according to your age and medical condition as well as for the site of application, the method used and your response.

The recommended dose is:

Adults

For instillation (insertion) into the urethra

Male patients

For adequate pain relief, 20 ml gel is usually required.

When anaesthesia is especially important, e.g., during sounding or cystoscopy, your doctor may instil a larger quantity of gel (up to 40 ml).

For catheterisation, small volumes (5–10 ml) are usually adequate for lubrication.

Female patients

The doctor will adapt the amount of gel to be inserted to the individual anatomical conditions of the urethra. Usually 5–10 ml of gel are instilled in small portions to fill the whole urethra.

For pain relief from inflammation o f the urinary bladder

10–20 ml gel are usually required for adequate pain relief.

The doctor decides on the frequency and duration of use based on your condition and symptoms.

The maximum dose is: 20 ml gel once a day.

Proctoscopy/rec­toscopy

For adequate pain relief, your doctor will usually instil 10–20 ml gel into the anal cavity/ rectum and will apply a small amount to lubricate the endoscope.

Maximum Dosage

The dose depends on the application site. A safe dose for use in the urethra and bladder in adults is 40 ml gel (756 mg lidocaine hydrochloride). The maximum recommended daily dose is 756 mg lidocaine hydrochloride.

Special population

Your doctor may decide to reduce the dose if you are elderly, acutely ill, in a weak condition, if you have liver or kidney problems or if you have sepsis (“blood poisoning”). A maximum dose of 2.9 mg/kg body weight lidocaine hydrochloride must not be exceeded.

Use in children and adolescents

Children < 2 years of age

Glydo must not be used in children below 2 years of age.

Children (2 –12 years) and adolescents (above 12 years of age)

The doctor will determine the dose depending on the child’s age, weight and physical condition.

A maximum dose of 2.9 mg/kg body weight lidocaine hydrochloride must not be exceeded in children (2 – 12 years).

Method of administration

The pre-filled graduated syringes are available with 6 ml or 11 ml gel. Your doctor will choose the appropriate size depending on the amount you need.

Each graduation on the syringe is equivalent to approximately 1 ml of gel (18.9 mg lidocaine hydrochloride)

For (self-)catheterisation (urethral use)

Follow these directions carefully:

• 1. Wash your hands. Clean and disinfect the genital area.

• 2. When ready to use, open the blister.

• 3. Before removing the tip cap from the end of the syringe, press in the plunger to remove any resistance that may be present. This helps ensure that the syringe will empty easily and uniformly. [Picture 1]

• 4. Remove the tip cap from the syringe. The syringe is now ready for use. [Picture 2]

• 5. Insert the nozzle into the opening of the urethra and press the plunger slowly and evenly to push out the gel into the urethra. [Picture 3]

• 6. Wait for a few minutes after instillation of the gel for the anaesthetic to take full effect. Full anaesthetic effect will occur within 5 to 15 minutes after complete instillation.

Picture 2:

If you have been administered / if you use more Glydo than you should

Administration of Glydo by a doctor

Since this medicine is usually administered to you by a trained doctor, it is unlikely that you will be given too much of Glydo. Nevertheless, if you think you have been given too much medicine or you begin to experience the overdose symptoms listed below, you must tell the person giving you Glydo immediately. Your doctor will know how to manage these symptoms and give you any necessary treatment.

Administration of Glydo by yourself or a caregiver for self-catheterisation

Whether you develop symptoms of an overdose or not depends on the level of this medicine present in your blood. The more lidocaine is in your blood, the more severely you might experience symptoms of an overdose. Normally only small amounts of the active ingredient lidocaine are absorbed into the blood from Glydo. Too much lidocaine can be absorbed if the surface being treated is damaged.

The first symptoms of overdose are for example:

problems with hearing, seeing, speaking and/or coordination of movements, yawning, restlessness, dizziness, nausea and vomiting.

In case of overdose, contact a doctor or a hospital emergency department immediately, even if there are no symptoms.

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

Picture 3:

For cystoscopy

Your doctor will administer this medicine in the urethra and/or apply it to the endoscope.

For proctoscopy/rec­toscopy

K Your doctor will administer this medicine in ?? the anal cavity/rectum and/or apply it to the endoscope.

The syringe is for single use only. Use immediately after opening the blister.

The syringe and any gel not used in a single application must be discarded.

Duration of treatment

For examinations/pro­cedures Glydo is usually only used for one or two doses or for a short course of treatment.

If you have been prescribed Glydo for selfadministration, your doctor will decide how long you should continue to use this medicine depending on your condition.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Lidocaine is generally well tolerated provided the medicine is used as directed in section 3. “How to use Glydo 19“ and the necessary precautions are taken (see section 2. “What you need to know before you use Glydo“).

Some side effects may be serious. Seek immediately medical help if you have an allergic (hypersensitivity) reaction causing:

— swelling of the hands, feet, face, lips, mouth, tongue or throat

— difficulties in breathing

— shortness of breath due to narrowing of the airways (bronchospasm)

— skin problems such as itchy skin or rash

— hives

— drop in blood pressure and shock

These side effects are rare (may affect up to 1 in 1,000 people).

Other side effects may include:

Very rare (may affect up to 1 in 10,000 people) — administration site irritation.

Symptoms of overdose may occur due to accelerated absorption (from the site of application into the blood) or overdose (please see also section 3. “If you have been administered / if you use more Glydo than you should”).

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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, website:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store glydo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label/blister/car­ton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Keep the blisters in the outer carton in order to protect from light.

Keep the pre-filled syringe in its unopened blister until use.

Glydo syringes are intended for single use. The syringe and any gel not used in a single application must be discarded.

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.

6. contents of the pack and other information

What Glydo contains

— The active substance is lidocaine hydrochloride

• 1 ml gel contains 18.9 mg lidocaine hydrochloride (equivalent to 20.1 mg lidocaine hydrochloride monohydrate).

6 ml – pre-filled syringe

One pre-filled syringe with 6 ml gel contains 113.4 mg lidocaine hydrochloride.

• 11 ml – pre-filled syringe

What Glydo looks like and contents of the pack

Clear, nearly colourless, sterile gel.

Glydo is available in a sterile pre-filled syringe containing 6 ml or 11 ml gel. The syringes are individually packed in a sterile transparent blister pack.

Each graduation on the syringe is equivalent to approximately 1 ml of gel (18.9 mg lidocaine hydrochloride).

Pack sizes:

Box of 10 pre-filled syringes with 6 ml gel each.

Box of 10 pre-filled syringes with 11 ml gel each.

Not all pack sizes may be marketed.

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