10% (100 mg / ml) eye drops , solution, single-dose container
phenylephrine hydrochloride
What Phenylephrine hydrochloride Bausch and Lomb is and what it is used for
Phenylephrine hydrochloride Bausch & Lomb contains a substance that enlarges the eye’s pupil. Your doctor may use this to examine your eye or as part of a treatment program.
What you need to know before using Phenylephrine hydrochloride Bausch and Lomb
Do not use Phenylephrine hydrochloride Bausch and Lomb
- if you are allergic to phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- if you have a shallow anterior chamber or a narrow chamber angle with the risk of acute increased pressure in the eye
- to children under 12 years
Warnings and cautions
Talk to your doctor or nurse before using Phenylephrine hydrochloride Bausch & Lomb if you have an overactive thyroid gland, high blood pressure, or cardiovascular disease.
Phenylephrine hydrochloride Bausch & Lomb should not be used in children under 12 years of age as children appear to be more susceptible to the risk of serious side effects.
Phenylephrine hydrochloride Bausch & Lomb is not recommended for use in children aged 12 to 18 years due to a lack of adequate clinical experience.
Other medicines and Phenylephrine hydrochloride Bausch and Lomb
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you use:
- Antidepressants ( MAOIs, non-selective monoamine reuptake inhibitors)
- Some antipsychotics (phenothiazines)
- Some medicines for high blood pressure ( beta-blockers or clonidine )
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
It is not known how safe it is to use this medicine during pregnancy.
Phenylephrine hydrochloride Bausch & Lomb should therefore only be used during pregnancy if the treatment is necessary and then the lowest possible dose should be used.
Breast-feeding
It is unknown how much phenylephrine hydrochloride is excreted in human milk. When breastfeeding, the potential risks of treatment should be carefully weighed against its benefits.
Driving and using machines
Phenylephrine hydrochloride Bausch & Lomb may cause transient blurred vision. You should therefore not drive or use machines until your vision is normal again.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Phenylephrine hydrochloride Bausch and Lomb
Phenylephrine hydrochloride Bausch & Lomb is given by healthcare professionals.
The recommended dose is 1 – 2 drops in each eye.
If you use more Phenylephrine hydrochloride Bausch and Lomb than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Children have an increased risk of side effects due to overdose. There may be an increased risk of complications in elderly patients with cardiovascular disease.
Common (may affect up to 1 in 10 people):
Burning after instillation, blurred vision, photosensitivity.
Uncommon (may affect up to 1 in 100 people):
High heart rate, high blood pressure
Has been reported (occurs in an unknown number of users):
Acute increased pressure in the eye, allergic reaction
Additional side effects are in children
Fluid or swelling of the lungs – has been reported (occurs in an unknown number of users)
How to store Phenylephrine hydrochloride Bausch and Lomb
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. Do not freeze. Store the single-dose containers in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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.
Contents of the package and other information
Content declaration
- The active substance is phenylephrine hydrochloride 100 mg/ml
- The other ingredients are disodium edetate, sodium metabisulfite, and purified water.
What the medicine looks like and the contents of the pack
Single-dose soft plastic container, 20 x 0.5 ml, separately packed in an outer casing.
Marketing Authorization Holder and Manufacturer
BAUSCH HEALTH IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24 – D24PPT3 – Ireland
Manufacturer
Laboratoire Chauvin SA
ZI Ripotier
07200 Aubenas – France