Instillido

PATIENT INFORMATION LEAFLET

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR

THE PATIENT

Instillido, 20 mg/mL, Gel in a Prefilled Syringe

Lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate)

READ THE LEAFLET CAREFULLY BEFORE USING THE MEDICINE, AS IT CONTAINS IMPORTANT INFORMATION FOR THE PATIENT.

• KEEP THIS LEAFLET, YOU MAY NEED TO READ IT AGAIN.
• IF YOU HAVE ANY FURTHER QUESTIONS, ASK YOUR DOCTOR, PHARMACIST, OR NURSE.
• THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. DO NOT PASS IT ON TO OTHERS. IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS YOURS.
• IF YOU EXPERIENCE ANY SIDE EFFECTS, INCLUDING THOSE NOT LISTED IN THIS LEAFLET, TELL YOUR DOCTOR, PHARMACIST, OR NURSE. SEE SECTION 4.

TABLE OF CONTENTS OF THE LEAFLET

• 1. What is Instillido and what is it used for
• 2. Important information before using Instillido
• 3. How to use Instillido
• 4. Possible side effects
• 5. How to store Instillido
• 6. Contents of the pack and other information

1. WHAT IS INSTILLIDO AND WHAT IS IT USED FOR

Instillido is a sterile gel containing the active substance lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate). In this leaflet, it will be referred to as lidocaine.
Lidocaine has a local anesthetic effect and is used to anesthetize the part of the body to which the gel is applied. It causes the nerves to stop transmitting pain information to the brain, thereby eliminating the sensation of pain.
Thanks to its local anesthetic properties, allowing it to cover the surface of catheters, endoscopes, or other medical devices, Instillido is intended to reduce discomfort and facilitate the procedure during certain examinations and procedures. Instillido is used for:

• administration into the urethra before insertion or replacement of a catheter and during cystoscopy, when the doctor inserts a tube through the urethra to examine the bladder.
• use during proctoscopy/rectoscopy (medical procedures in which an instrument called an endoscope is used to examine the rectum or anus). During this procedure, the Instillido medical device is administered into the rectum/anus and/or the surface of the instrument is covered with it before insertion.

Due to its local anesthetic effect, Instillido is also used:

• to alleviate pain caused by cystitis.

Instillido is indicated for use in adults, adolescents (over 12 years of age), and children aged 2 to 12 years.
The doctor will explain to the patient in which specific procedure or condition Instillido is used.
The medicine is usually administered by a doctor, but it can also be administered by the patient or their caregiver, e.g., for self-catheterization (see section 3. "How to use Instillido").

2. IMPORTANT INFORMATION BEFORE USING INSTILLIDO

WHEN NOT TO USE INSTILLIDO

• if the patient is allergic to lidocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic to certain other local anesthetics (amidotype).
• in children under 2 years of age.

WARNINGS AND PRECAUTIONS

Before starting treatment with Instillido, discuss it with your doctor or pharmacist.
Before using this medicine, the doctor must know if the patient has or has had any of the following conditions, diseases, or situations:

• wounds, mucosal damage, or ulcers/ inflammation at the proposed administration site or around it.
• liver or kidney function disorders, acute condition, weakness, or sepsis ("blood infection"). The doctor may reduce the dose of Instillido.
• slow heart rate, heart function disorders, or respiratory system disorders (respiratory diseases).
• weak heart (heart failure) or conduction disorders (atrioventricular block).
• medical shock.
• seizure tendency (epileptic seizures) or epilepsy.
• muscle disease (myasthenia gravis).
• a rare inherited disease affecting the blood, called glucose-6-phosphate dehydrogenase deficiency.
• a disease related to the level of blood pigment called methemoglobinemia.
• porphyria (blood disorder).
• the patient is taking medicines used to treat heart rhythm disorders, known as class III antiarrhythmic drugs (e.g., amiodarone), as the effect on the heart may be enhanced. See also section "Instillido and other medicines".

The doctor should also be informed if the patient is using other medicines containing lidocaine frequently and/or in large doses, as this may cause serious side effects.
If a large amount of Instillido is administered into the urethra and a large amount of gel enters the bladder, or if the urethra is ulcerated/inflamed, this may generally lead to increased absorption of lidocaine through the mucous membranes, especially in children and elderly patients, causing serious side effects (see also section 3 "Using a higher dose of Instillido than recommended").

INSTILLIDO AND OTHER MEDICINES

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Lidocaine may affect the way other medicines work, and other medicines may affect how lidocaine works.
In particular, tell your doctor if you are taking any of the following medicines:

• antiarrhythmic drugs- medicines used to treat heart rhythm disorders (e.g., mexiletine, amiodarone).
• calcium channel blockers- medicines used to treat heart diseases or high blood pressure (e.g., diltiazem, verapamil).
• beta-blockers(e.g., propranolol, metoprolol) - used to treat high blood pressure or angina pectoris (chest pain). These medicines may have an enhanced effect on the heart.
• other medicines containing lidocaineor certain other local anesthetics(amidotype), as their effect may be enhanced in an unpredictable way.
• cimetidineused to treat excessive acidity of stomach juice, stomach ulcer disease, and duodenal ulcer. Concomitant use of this medicine may increase the risk of side effects.
• fluvoxamineused to treat depression.
• erythromycin(antibiotic).
• protease inhibitors used to treat HIV infections (e.g., ritonavir).
• medicines used to treat infections, called sulfonamidesand nitrofurantoin.
• medicines used to treat epilepsy, called phenytoinand phenobarbital.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
During pregnancy and breastfeeding, Instillido should only be used after careful consideration by the doctor of the benefits and risks.

DRIVING AND USING MACHINES

The effect on the ability to drive and use machines is unlikely, but it cannot be completely ruled out in cases of increased individual sensitivity. If drowsiness, dizziness, or vision disturbances occur, do not drive or operate any tools or machines.

3. HOW TO USE INSTILLIDO

The medicine is usually administered by a doctor.
If the patient is performing the treatment themselves, e.g., performing self-catheterization (inserting a plastic tube (catheter) into their own urethra), this medicine should always be used in accordance with the doctor's recommendations and the following instructions for applying the gel. If in doubt, consult a doctor.
The onset of action of Instillido is observed within 5-15 minutes of application. The anesthetic effect usually lasts from 20 to 30 minutes.

DOSE

The doctor will decide on the most suitable dosage, depending on the patient's age and health status, as well as the site of application, method used, and patient's reaction.
The recommended dose is:
Adults

ADMINISTRATION INTO THE URETHRA

Men
To achieve the desired level of pain relief, 20 mL of gel is usually required.
If anesthesia is particularly important, e.g., during sounding or cystoscopy, the doctor may administer a larger amount of gel (up to 40 mL).
For catheterization, small volumes of gel (5-10 mL) are usually sufficient for lubrication.
Women
The doctor will adjust the amount of gel administered individually, depending on the anatomical conditions of the urethra. Usually, 5-10 mL of gel is administered in small portions to fill the entire urethra.

PAIN RELIEF CAUSED BY CYSTITIS

For sufficient pain relief, 10-20 mL of gel is usually required.
The doctor decides on the frequency and duration of administration based on the patient's condition and symptoms. The maximum dose is: 20 mL of gel once a day.

PROCTOSCOPY/RECTOSCOPY

To achieve sufficient pain relief, the doctor usually administers 10-20 mL of gel into the rectum/anus and covers the surface of the endoscope with a small amount of gel.
Maximum dose
The dose depends on the site of application. The safe dose for use in the urethra and bladder in adults is 40 mL of gel (approximately 800 mg of lidocaine hydrochloride). The maximum recommended daily dose is approximately 800 mg of lidocaine hydrochloride.
Special patient populations
The doctor may decide to reduce the dose if the patient is elderly, seriously ill, weakened, has liver or kidney problems, or has sepsis or blood infection ("blood poisoning"). Do not exceed the maximum dose of lidocaine hydrochloride of 2.9 mg/kg body weight.

CHILDREN AND ADOLESCENTS

Children under 2 years
Instillido should not be used in children under 2 years of age.
Children (2-12 years) and adolescents (over 12 years)
The doctor will determine the dose based on the child's age, weight, and physical condition.
In children (2-12 years), do not exceed the maximum dose of lidocaine hydrochloride of 2.9 mg/kg body weight.

ADMINISTRATION METHOD

Prefilled syringes with a scale containing 6 mL or 11 mL of gel are available. The doctor will choose the size based on the required amount.
Each mark on the syringe corresponds to approximately 1 mL of gel (20.1 mg of lidocaine hydrochloride).
For (self-)catheterization (insertion into the urethra)
Follow the instructions below:

• 1. Wash your hands. Wash and disinfect the genital area.
• 2. When everything is ready for use, open the blister.
• 3. Before removing the cap from the syringe tip, press the plunger to remove any resistance.

This will facilitate easy and even emptying of the syringe.
 Figure 1 

• 4. Remove the cap from the syringe tip. The syringe is now ready for use.  Figure 2 
• 5. Insert the tip into the urethral opening and press the plunger slowly and evenly to expel the gel into the urethra.  Figure 3 
• 6. After administration of the gel, wait a few minutes until the anesthetic starts to take full effect. Full anesthetic effect occurs within 5 to 15 minutes after administration of the entire contents of the prefilled syringe.

Figure 1 Figure 2

Figure 3

Men:
Women:

For cystoscopy
The doctor administers the medicine into the urethra and/or covers the surface of the endoscope with it.
For proctoscopy/rectoscopy
The doctor administers the medicine into the rectum/anus and/or covers the surface of the endoscope with it.

The syringe is intended for single use only.

Use immediately after opening the blister. The syringe and any unused gel should be discarded after one application.

DURATION OF TREATMENT

For examinations/procedures, Instillido is usually used only in one or two doses or for a short treatment period.
If the patient has been prescribed Instillido for self-administration, the doctor will decide, based on the patient's condition, how long the medicine should be used.

USING A HIGHER DOSE OF INSTILLIDO THAN RECOMMENDED

Administration of Instillido by a doctor
Since this medicine is usually administered to the patient by a trained doctor, it is unlikely that the patient will receive too high a dose of Instillido. Nevertheless, if the patient thinks they have received too high a dose of Instillido or starts to experience the following symptoms of overdose, they must immediately tell the person administering Instillido. The doctor will know how to deal with these symptoms and apply the necessary treatment.
Self-administration of Instillido or administration by a caregiver during self-catheterization
Whether the patient experiences symptoms of overdose depends on the concentration of this medicine in the blood. The higher the concentration of lidocaine in the blood, the more serious the symptoms of overdose may be. Usually, only small amounts of the active substance, lidocaine, from Instillido are absorbed into the blood. Too much lidocaine may be absorbed if the application surface is damaged.
The first symptoms of overdose are, for example, hearing problems, vision problems, speech problems, and/or coordination problems, yawning, restlessness, dizziness, nausea, and vomiting.

IN CASE OF OVERDOSE, CONTACT A DOCTOR OR HOSPITAL EMERGENCY DEPARTMENT IMMEDIATELY, EVEN IF NO SYMPTOMS OCCUR.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Instillido can cause side effects, although not everybody gets them.
Lidocaine is generally well tolerated provided that the medicine is used in accordance with the recommendations in section "3. How to use Instillido" and the necessary precautions are taken (see section "2. Important information before using Instillido").

SOME SIDE EFFECTS CAN BE SERIOUS. SEEK MEDICAL HELP IMMEDIATELY IF THE PATIENT EXPERIENCES AN ALLERGIC REACTION (HYPERSENSITIVITY) CAUSING:

• swelling of the hands, feet, face, lips, mouth, tongue, or throat
• difficulty breathing
• shortness of breath caused by bronchospasm
• skin problems, such as itching or rash
• hives
• low blood pressure and shock These side effects are rare (may occur in less than 1 in 1,000 people).

Other side effects may include:
Very rare (may occur in less than 1 in 10,000 people)

• irritation at the site of administration.

Symptoms of overdose may occur due to accelerated absorption (from the site of administration into the blood) or overdose (see also section 3 "Using a higher dose of Instillido than recommended").

REPORTING OF SIDE EFFECTS

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE INSTILLIDO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/packaging after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for the storage of this medicinal product regarding temperature. Store the blisters in the outer packaging to protect from light.
Store the prefilled syringe in the unopened blister until use.
Instillido prefilled syringes are for single use only. The syringe and any unused gel should be discarded after one application.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

WHAT INSTILLIDO CONTAINS

• The active substance of Instillido is lidocaine in the form of lidocaine hydrochloride monohydrate. 1 mL of gel contains 20.1 mg of lidocaine hydrochloride, which corresponds to 21.5 mg of lidocaine hydrochloride monohydrate.

Prefilled syringe 6 mL
One prefilled syringe with 6 mL of gel contains 120.6 mg of lidocaine hydrochloride.
Prefilled syringe 11 mL
One prefilled syringe with 11 mL of gel contains 221.1 mg of lidocaine hydrochloride.

• The other ingredients are: hypromellose, sodium hydroxide (for pH adjustment), purified water.

WHAT INSTILLIDO LOOKS LIKE AND CONTENTS OF THE PACK

Transparent, almost colorless, sterile gel.
Instillido is available in a sterile prefilled syringe made of PP with a PP plunger and a bromobutyl rubber (siliconized) stopper and a tip cap made of bromobutyl rubber (siliconized). Each prefilled syringe is packaged individually in a PP/paper blister. The prefilled syringe contains 6 mL or 11 mL of gel. Outer packaging: cardboard box.
Each mark on the syringe corresponds to approximately 1 mL of gel (20.1 mg of lidocaine hydrochloride).
Pack sizes:
Pack containing 10 prefilled syringes, each with 6 mL of gel.
Pack containing 10 prefilled syringes, each with 11 mL of gel.
Not all pack sizes may be marketed.

MARKETING AUTHORIZATION HOLDER

Farco-Pharma GmbH
Gereonsmühlengasse 1-11
50670 Köln
Germany
E-mail: [email protected]

MANUFACTURER

Klosterfrau Berlin GmbH
Motzener Straße 41
12277 Berlin
Germany

THIS MEDICINE IS AUTHORIZED IN THE MEMBER STATES OF THE EUROPEAN ECONOMIC AREA UNDER THE FOLLOWING NAMES:

DATE OF LAST REVISION OF THE LEAFLET: 07/2023.

Member State	Medicine name
Denmark	Instillido
France	Glydo 20 mg/ml gel
Germany	Instillido 20 mg/ml Gel in einer Fertigspritze
Sweden	Instillido 19 mg/ml gel
United Kingdom (Northern Ireland)	Glydo 19 mg/ml gel in pre-filled syringe
Norway	Instillido 20 mg/ml gel i forhåndsfylt sprøyte
Finland	Instillido 20 mg/ml geeli
Belgium	Instillido 20 mg/ml gel
Croatia	Instillido 20 mg/ml gel
Spain	Instillido 20 mg/ml gel en jeringa precargada
Poland	Instillido, 20 mg/mL, żel w ampułko-strzykawce
Estonia	Instillido 20 mg/ml geel
Lithuania	Lidocaine hydrochloride Instillido 20 mg/ml gelis
Slovenia	Instillido 20 mg/ml gel v napolnjeni injekcijski brizgi
Romania	Instillido 20 mg/ml gel
Bulgaria	Instillido 20 mg/ ml gel Инстилидо 20 mg/ml гел