Minims Phenylephrine Hydrochloride 2.5%w/v – patient leaflet, side effects, dosage

1. What Minims^TM Phenylephrine Hydrochloride eye

Minims^TM Phenylephrine Hydrochloride contains a mydriatic agent. It is may use it to examine your eye more closely or as part of a treatment p Minims^TM Phenylephrine Hydrochloride 2.5% is indicated for children, a Minims^TM Phenylephrine Hydrochloride 10% is not indicated for childre specialist will use an alternative medicine in these patients.

2. What you need to know before you use Minims^TM

used to enlarge the pupil of your eye. Your doctor or eye specialist rogram.

dults and the elderly.

n or the elderly, as this concentration is too strong. The doctor or eye

Phenylephrine Hydrochloride eye drops he other ingredients of this medicine (listed in section 6).

ts and anti-hypertensive agents (including beta-blockers). ith iridectomy) and patients with a narrow angle prone to w the age of 12 years.

ren below the age of 12 years as children appear more sensitive to in children aged 12 to 18 years as adequate clinical experience is missing.

Do not use Minims^TM Phenylephrine Hydrochloride drops:

• If you are allergic to the active substance (phenylephrine) or any of t
• If you have a heart disease.
• If you have fast heartbeats (tachycardia).
• If you have high blood pressure.
• If you have bulges in major blood vessels (aneurysms).
• If you have an overactive thyroid gland (hyperthyroidism).
• If you have high blood sugar level (diabetes mellitus).
• In patients on monoamine oxidase inhibitors, tricyclic antidepressan
• In patients with closed angle glaucoma (unless previously treated w glaucomaprecipitated by mydriatics.
• In patients wearing contact lenses.

Do not use Minims^TM Phenylephrine Hydrochloride 10% in children belo Warnings and precautions

Use with caution in the elderly.

Minims^TM Phenylephrine Hydrochloride 10% should not be used in child the risk of serious side effects.

Minims^TM Phenylephrine Hydrochloride 10% is not recommended to be used Ask yourself the following questions:

• Do you have narrow arteries in the head (cerebral arteriosclerosis)?
• Do you have asthma?
• Do your eyes develop increased internal pressure when the pupil is e that this problem will not affect you.
• Are your eyes red or inflamed?

If the answer to any of these questions is yes, tell your doctor or eye sp The active substance can cause the cornea to become cloudy if the surf membrane covering the surface of the eye. Your doctor or eye specialist Other medicines and Minims^TM Phenylephrine Hydrochlori

Tell your doctor or eye specialist if you are taking, have recently taken o

• Medicines for depression
• Any medicines to reduce your blood pressure (including medicines c

• Medicines to treat irregular heartbeats (quinidine or medicines calle The active substance can react with several types of anaesthetic (e.g. h operation your doctor will make sure that this problem does not affect Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or ar before taking this medicine as he/ she may decide to use these drops o Contact lenses

Your doctor will ask you to remove your contact lenses prior to the adm product on contact lenses. Therefore, do not wear your contact lenses u Driving and using machines

Some people find bright light (such as daylight) uncomfortable for a fe This may make it difficult for you to drive. As with all eye drops, your vi clear before driving or using machines.

3. How to use Minims^TM Phenylephrine Hydrochlorid

nlarged? The doctor or eye specialist will have checked to make sure ecialist.

ace of the cornea is damaged. The cornea is the transparent will take this into account before deciding to give you these eye drops. de r might take any other medicines.

alled betablockers)

d cardiac glycosides)

alothane). Your doctor will know about this. If you are having an you.

e planning to have a baby, ask your doctor or eye specialist for advice r to prescribe you an alternative.

inistration of the drops. There is no information on the effect of this ntil the effects of the drops have completely worn off.

w hours after receiving Minims^TM Phenylephrine Hydrochloride. sion may be blurred after putting the drops in. Wait until your vision is e eye drops henylephrine Hydrochloride to prevent the stinging effect of

Sometimes a drop of local anaesthetic may be used prior to Minims^TM P

Art. 77414 P1UK01

R&D

Bausch + Lomb ULOTKA PIL

Nazwa produktu

Product Name

Minims Phenylephrine Hydrochloride 10% (and 2,5%) w/v DRP 20 SDU

K

olor nadruku Col

ours

Kraj

Country (ISO)

UK, HK, SG

N S

r wykrojnika pec No

5338 revision F

Opracowane przez Designed by

Shelby Fleskes

shelby.fleskes@bausch.com

K M

od Wytwórcy anufacturer cod

e

77414

3

Data Date

19.03.2024

K P

od farmaceutycz harmacode

ny

77414 (DM)

Kod wersji

Internal version code

P1UK01

I

O

nny kod ther code

-

minimum 8 pt

Wymiar ulotki IL size

P

160 x 240 mm

Krój czcionki Font used

Frutiger Neue LT W1G font family

G P

ramatura papier aper weight

u

60 g/m²

Komentarze Comments (Reason for the change)

-PMR_BNL_23_0228-A -Update B+L logo on carton and leaflet. Update of Only’ text on carton. Remove trademark statemen Editorial updates to the leaflet.

-Packing Site: Laboratoire Chauvin / Bausch & Lo

Aubenas address on carton and leaflet. Add ‘UK ts on carton and leaflet and replace R with TM.

mb Aubenas

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs D

ept. Approval

phenylephrine eye drops. The drops are for single use only and provided Once opened, use immediately. Discard any unused portion. Dosage

The recommended dose is one drop in each eye. If necessary this can b Phenylephrine 2.5% w/v: For examination of the eye, the normal dose this can be repeated once only at least one hour after the first drop. Phenylephrine 10% w/v: For adults the same dose is recommended. Howev age of 12 years. Phenylephrine 10% w/v is not recommended for use in child as part of a treatment programme your doctor may suggest an additional do Method of administration

Parents must be careful not to get this preparation in their children’s m and the child’s hands or cheeks following administration. The doctor or eye specialist will normally put the drops in your eye for in yourself, then follow these instructions carefully:

1. 1. Wash your hands.
2. 2. Use a mirror, this will help you to see what you are doing.
3. 3. Carefully dry your eyes using a tissue. Twist and pull cap to separate
4. 4. Pull your lower eyelid down gently, and then carefully place 1 drop i
5. 5. Close your eye and blink a few times to make sure your eye is cover
6. 6. Close the eyelids. It is advisable to press gently on the inner corner o stop the solution draining into your nose and throat.
7. 7.

   Repeat steps 4, 5 and 6 for the other eye if necessary, then throw away th If you use more Minims^TM Phenylephrine Hydrochloride than occur. If you suddenly feel unwell after receiving the drops, tell your doctor or If you forget to use Minims^TM Phenylephrine Hydrochlorid it is nearly time for the next dose, but you should not take a double do

   in single use Minims units, to treat both eyes if both eyes are affected.

   e repeated once only at least one hour after the first drop. for adults, elderly and children, is one drop in each eye. If necessary er, Minims Phenylephrine 10% w/v should not be used in children below the ren aged 12 to 18 years or elderly patients. If you are receiving this product se schedule of one drop every 24 hours of the 2.5% w/v product.

   outh or cheeks and to wash their hands you, but if you are putting the eye drops from the Minims body (Diagram 1).

   nside your lower eyelid.

   ed by the liquid.

   f your eyelid for 3 minutes. This will help e Minims unit, even if some solution remains.

   you should, an overdose is very unlikely to eye specialist or contact your nearest emergency department immediately. e, you should take the missed dose as soon as you remember, unless se to make up for a missed dose.

   Diagram 1

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not e Minims^TM Phenylephrine Hydrochloride may sting when the drops are first Serious side effects

• Rarely, more serious reactions, including spasm of the artery of the hear phenylephrine solutions. These have usually occurred in patients using Other side effects

Not known: frequency cannot be estimated from the available data.

• In some cases bright light can be uncomfortable for a few hours afte
• Occasionally allergic reactions or conjunctival sensitivity (abnormal s the white outer surface of the eye) to various substances with disco
• The active substance can sometimes affect your circulatory system, causin is aware of an irregular, hard, or rapid heartbeat), tachycardia (fast heartb
• Paleness around the eyes in preborn babies (this is relevant to the 2 Additional side effects in children:

Not known: frequency cannot be estimated from the available data

• Fluid or swelling in the lungs (this is relevant to the 10% formulatio Reporting of side effects

If you or your child get any side effects, talk to your doctor, the doctor t listed in this leaflet. You can also report side effects directly via: The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the

5. How to store your eye drops

verybody gets them.

put in and your vision may become blurred. This will gradually wear off.

t, heart irregularities and heart attacks, have been reported after using some 10 % phenylephrine and already suffering from heart disease.

r receiving the drops.

ensitivity of the conjunctiva (thin, clear, moist membrane that coats mfort upon instillation) can occur.

g increased blood pressure and palpitations (a sensation in which a person eats) and other heart irregularities (extrasystoles and cardiac arrythmias). .5% formulation).

n).

reating your child or pharmacist. This includes any side effects not safety of this medicine.

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

Do not use the eye drops after the expiry date which is stated on the o 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 i The drops are for single use only and provided in single use Minims units, immediately. Discard any unused portion. Medicines should not be disp to dispose of medicines no longer required. These measures will help t

6. Contents of the pack and other information

verwrap of each unit and on the carton after the letters “EXP”.

n order to protect from light.

to treat both eyes if both eyes are affected. Once opened, use osed of via wastewater or household waste. Ask your pharmacist how

o protect the environment.

nit contains approximately 0.5 ml eye drops solution of Phenylephrine detate and purified water.

e unit.

acturer:

ire Chauvin ustrielle de Ripotier ue Jean Monnet ubenas, France

What do your eye drops contain

• The active ingredient is phenylephrine hydrochloride. Each Minims u hydrochloride 2.5% w/v (12.5 mg) or 10% w/v (50 mg).
• The other ingredients are sodium metabisulphite (E223), disodium e This medicine does not contain a preservative as it is a sterile single us Contents of the pack

Each carton contains 20 units.

Marketing Authorisation Holder:

UK

Bausch & Lomb UK Ltd.

106 London Road - Kingston-upon-Thames - KT2 6TN - UK

Manuf

Laborato Zone Ind 50 Aven 07200 A This leaflet was last revised in: November 2023

Art. 77

414 P1UK0

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