20.9 mg / ml gel
lidocaine hydrochloride
1. What Instillagel is and what it is used for
How does Instillagel work?
Instillagel is a local anesthetic. Instillagel is intended for use in the urethra. Gel one consists of a viscous, clear solution of lidocaine hydrochloride with the addition of chlorhexidine. Instillagel provides good lubrication of catheters and instruments and does not obstruct vision during a cystoscopy (considering the inside of the bladder).
What is Instillagel used for?
When inserting a catheter or probe into or through the urethra or other procedure in the urethra in men. Certain types of cystoscopy (looking at the inside of the bladder). All procedures and manipulations in the urethra on women. Local treatment for painful cataracts.
Instillagel is intended for adults and children aged two years and older.
2. What you need to know before using Instillagel
Do not use Instillagel
- if you are allergic to lidocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- Instillagel should not be given to children under 2 years of age.
Pregnancy, breastfeeding and fertility
Temporary use of Instillagel during pregnancy is unlikely to have any adverse effects on the fetus.
Lidocaine passes into breast milk but is unlikely to affect breastfed infants.
Driving and using machines
Instillagel has no or negligible effect on the ability to drive and use machines.
Instillagel contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and propylene glycol
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause an allergic reaction (possibly delayed). Each syringe also contains 5.75 g of propylene glycol (equivalent to 523 mg/ml) which may cause skin irritation.
3. How to use Instillagel
Dosage instructions
Instillagel is only given by hospital staff, who can give you more information. Dose one is determined by the doctor who adjusts it individually for you.
Talk to your doctor or nurse if you think you have been given too little or too much Instillagel.
4. Possible side effects
Very rare (may affect up to 1 in 10,000 people):
- Allergic reactions (in severe cases anaphylaxis ) caused by an amide-type local anesthetic and / or chlorhexidine .
Very rare (may affect up to 1 in 10,000 people):
- Allergic reactions caused by methyl hydroxybenzoate and propylhydroxybenzoate (possibly delayed).
Has been reported (occurs in an unknown number of users):
- Side effects that appear in the body as a whole can occur with severe damage to the urethra. Such side effects can be, for example, anaphylaxis (very severe allergic reaction ), drop in blood pressure, slow heart rate or seizures.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Instillagel
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 carton.
No special storage instructions.
Use immediately after breaking.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is lidocaine hydrochloride 20.9 mg / ml. An 11 ml gel syringe contains 230 mg lidocaine hydrochloride.
- The other ingredients are chlorhexidine gluconate , methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol, sodium hydroxide, hydroxyethylcellulose and purified water.
What the medicine looks like and contents of the pack
Packaging: Disposable syringes 10 x 11 ml. Free from Latex. Sterile.
Marketing Authorization Holder and Manufacturer
Farco – Pharma GmbH
Gereonsmühlengasse 1-11
DE-50670 Cologne
Germany
Tel: +49/221 59 40 61
Fax: +49/221 59 36 14
Local representative
FrostPharma AB Berga backe 2 182 53 Danderyd