Skip to Content

MINIMS TETRACAINE HYDROCHLORIDE 1% W/V EYE DROPS SOLUTION

Active substance(s): AMETHOCAINE HYDROCHLORIDE / TETRACAINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Art.76863 P9UKIE01
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

ULOTKA PIL

Nazwa produktu
Product Name

Minims Tetracaine
Hydrochloride 0,5% and
1% w/v DRP SOL

Kolor nadruku Colours

Kraj
Country (ISO)

United Kingdom (UK),
Ireland (IE)

Nr wykrojnika
Spec No

5338

Kod Wytwórcy
Manufacturer code

76863

Kod farmaceutyczny
Pharmacode

-

Black

Opracowane przez
Designed by
Nr korekty
Proof No

6

Data
Date

09.04.2015

Kod wersji
Valeant version code

P9UKIE01

Inny kod
Other code

76863 (Data Matrix)

Rozmiar czcionki
Font size

minimum 8 pt

Wymiar ulotki
PIL size

160 x 240 mm

Krój czcionki
Font used

Frutiger Neue LT W1G
Condensed
Frutiger Neue LT W1G
Condensed Bold

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
MAH transfer from Chauvin Pharmaceuticals Ltd UK to B+L UK Ltd
PMR_ICN-14-0811-A
Packing Site: Laboratoire Chauvin, Aubenas, France

Akceptacja Techniczna Technical Approval

- g/m2

Minims® Tetracaine Hydrochloride 0.5% w/v
Minims® Tetracaine Hydrochloride 1% w/v
Eye Drops, solution
Tetracaine Hydrochloride

Read all this leaflet carefully before you start using your medicine. It contains a summary of the information available on your medicine.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone else.
In this leaflet:
1. What Minims® Tetracaine Hydrochloride eye drops are and what they are used for
2. Before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Further information

1. What Minims® Tetracaine Hydrochloride eye drops are and what are they used for
Minims® Tetracaine Hydrochloride contains a local anaesthetic. It is used to numb the eye temporarily. Your doctor or eye specialist may
use it to examine or treat your eye without it being painful.
This medicine should be avoided in premature babies.

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

2. Before you use your eye drops
Do not use these drops if
• if you are allergic to the active substance (tetracaine) or any of the other ingredients (refer to the end of this leaflet).
• if you are allergic to other similar types of local anaesthetic.
• if you are taking medicines used to treat bacterial infection or diabetes called “sulphonamides”.
• in premature babies.
Take special care
Your eye drops are not intended for long term use. Frequent use of local anaesthetic in the eye over long periods of time may severely
affect your eyesight.
Do you use any of these medicines?
• medicines called “sulphonamides” used to treat bacterial infection or diabetes.
If the answer to any of these questions is yes, tell your doctor or eye specialist.
If you are pregnant, may be pregnant, or are breastfeeding
Tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative.
Contact lenses
Your doctor will ask you to remove your contact lenses prior to the administration of the drops. There is no information on the effect of this
product on contact lenses. Therefore, do not wear your contact lenses until the effects of the drops have completely worn off.
Driving and using machines
As with all eye drops, your vision may be blurred after putting the drops in. Wait until your vision is clear before driving or using machines.

3. How to use your eye drops
A doctor or eye specialist will use these eye drops to examine your eye.
The drops are for single use only and provided in single use Minims units, to examine both eyes if necessary. Once opened, use immediately.
Discard any unused portion.
Dosage
The usual dose is 1 drop of solution in one or both eyes.
If necessary, your doctor or eye specialist will tell you to use more than one drop.
Method of administration
The doctor or eye specialist will put the drops in your eye for you.
He/she may ask you to press gently on the inner corner of your eyelid for 3 minutes. This will help stop the solution draining into your
nose and throat. This is especially advisable in children, the elderly and population at risk.
He/she will then throw away the Minims unit, even if some solution remains.
Your eye will remain numb, depending on how many drops you received. Avoid touching the eye until the anaesthetic has worn off.

P9UKIE01_76863_Minims-Tetracaine_Hydrochloride_05_1_WV_DRP20SDU_UK_IE_v2.indd 1

2015-04-09 09:52:37

Art.76863 P9UKIE01
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

ULOTKA PIL

Your doctor or eye specialist will make sure that your eye is properly protected.
If you use more Minims® Tetracaine Hydrochloride than you should, an overdose is very unlikely to occur. If you suddenly feel unwell
after receiving the drops, tell your doctor or eye specialist or contact your nearest emergency department immediately.

Nazwa produktu
Product Name

Minims Tetracaine
Hydrochloride 0,5% and
1% w/v DRP SOL

Kolor nadruku Colours

Kraj
Country (ISO)

United Kingdom (UK),
Ireland (IE)

Nr wykrojnika
Spec No

5338

Kod Wytwórcy
Manufacturer code

76863

Kod farmaceutyczny
Pharmacode

76863 (Data Matrix)
160 x 240 mm

4. Possible side effects

Black

Opracowane przez
Designed by
Nr korekty
Proof No

6

Data
Date

09.04.2015

Kod wersji
Valeant version code

P9UKIE01

Inny kod
Other code

Rozmiar czcionki
Font size

minimum 8 pt

Wymiar ulotki
PIL size

Krój czcionki
Font used

Frutiger Neue LT W1G
Condensed
Frutiger Neue LT W1G
Condensed Bold

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
MAH transfer from Chauvin Pharmaceuticals Ltd UK to B+L UK Ltd
PMR_ICN-14-0811-A
Packing Site: Laboratoire Chauvin, Aubenas, France

Akceptacja Techniczna Technical Approval

- g/m2

Minims® Tetracaine may sting or burn when the drops are first put in and your vision may become blurred. This will gradually wear off.
Occasionally, the skin around the eyes can become sore, superficial defect or swelling of cornea (the transparent membrane covering the
surface of the eye) may also be observed after short-term application of these eye-drops. If you find that you have itching, discomfort,
soreness around your eyes or blurred vision that is causing you a problem, you should tell your doctor or pharmacist.
The cornea (the transparent membrane covering the surface of the eye) may be damaged by prolonged administration of anaesthetic eye drops.
If any of the side effects gets serious, please seek immediate medical attention. If you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store your eye drops
Keep out of the reach and sight of children.
Do not use the eye drops after the expiry date which is stated on the overwrap of each unit and on the carton after the letters “EXP”.
The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light.
The drops are for single use only and provided in single use Minims units, to examine both eyes if necessary. Once opened, use
immediately. Discard any unused portion.
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. Further information

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

What do your eye drops contain
• The active ingredient is tetracaine hydrochloride. Each unit contains approximately 0.5 ml eye drops solution of tetracaine
hydrochloride 0.5% w/v (2.5 mg) or 1% w/v (5 mg).
• The other ingredients are hydrochloric acid (for pH adjustment) and purified water.
This medicine does not contain a preservative as it is a sterile single use unit.
Contents of the pack
Each carton contains 20 units.
Marketing Authorisation Holder:
Bausch & Lomb UK Ltd.
106 London Road - Kingston-upon-Thames - KT2 6TN - UK
Tel: +44 (0)20 8781 2900 / Fax: +44 (0)20 8781 2901
Manufacturer:
Laboratoire Chauvin - Z.I.Ripotier - 07200 Aubenas - France
Marketing Authorisation Numbers:
Minims® Tetracaine Hydrochloride 0.5% w/v:
PL 03468/0082 (UK) ; PA 555/21/1 (Ireland)
Minims® Tetracaine Hydrochloride 1% w/v:
PL 03468/0083 (UK) ; PA 555/21/2 (Ireland)
DATE OF PREPARATION: April 2015
Art.76863

P9UKIE01_76863_Minims-Tetracaine_Hydrochloride_05_1_WV_DRP20SDU_UK_IE_v2.indd 2

2015-04-09 09:52:37

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide