Latanoprost 50micrograms/ml / Timolol 5mg/ml eye drops

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
29-06-2018
Tabia za bidhaa Tabia za bidhaa (SPC)
29-06-2018

Viambatanisho vya kazi:

Timolol maleate; Latanoprost

Inapatikana kutoka:

Martindale Pharmaceuticals Ltd

ATC kanuni:

S01ED51

INN (Jina la Kimataifa):

Timolol maleate; Latanoprost

Kipimo:

5mg/1ml ; 50microgram/1ml

Dawa fomu:

Eye drops

Njia ya uendeshaji:

Ocular

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 11060000; GTIN: 5026468744657

Taarifa za kipeperushi

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST+TIMOLOL
50 MICROGRAMS/ML + 5 MG/ML EYE DROPS, SOLUTION
LATANOPROST + TIMOLOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
•
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet, please tell your doctor or pharmacist. See
section 4.
WHAT IS IN THIS LEAFLET:
1. What Latanoprost+Timolol is and what it is used for
2. What you need to know before you use Latanoprost+Timolol
3. How to use Latanoprost+Timolol
4. Possible side effects
5. How to store Latanoprost+Timolol
6. Contents of the pack and other information
1.
WHAT LATANOPROST+TIMOLOL IS AND WHAT IT IS USED FOR
Latanoprost+Timolol contains two medicines: latanoprost and timolol.
Latanoprost belongs to a group of medicines known as “prostaglandin
analogues”.
Timolol belongs to a group of medicines known as “beta-blockers”.
Latanoprost works by increasing the natural outflow of fluid from the
eye into the bloodstream. Timolol
works by slowing the formation of fluid in the eye.
Latanoprost+Timolol is used to reduce the pressure in your eye if you
have conditions known as open angle
glaucoma or ocular hypertension. Both these conditions are linked to
an increase in the pressure within your
eye, eventually affecting your eyesight.
Your doctor will usually prescribe you Latanoprost+Timolol when other
medicines have not worked
adequately.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST+TIMOLOL
Latanoprost+Timolol can be used in adult men and women (including the
elderly), but is not recommended
for use if you are less than 18 years of age.
DO NOT USE LATANOPROST+TIMOLOL
•
if yo
                                
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Tabia za bidhaa

                                OBJECT 1
LATANOPROST+TIMOLOL 50 MICROGRAMS/ML + 5
MG/ML EYE DROPS, SOLUTION
Summary of Product Characteristics Updated 29-Sep-2015 | Martindale
Pharma
1. Name of the medicinal product
Latanoprost+Timolol 50 micrograms/ml + 5 mg/ml eye drops, solution.
2. Qualitative and quantitative composition
1 ml solution contains latanoprost 50 micrograms and timolol maleate
6.8 mg equivalent to 5 mg timolol.
Excipient: Benzalkonium chloride 0.20 mg/ml.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution.
The solution is a clear, colourless liquid.
4. Clinical particulars
4.1 Therapeutic indications
Reduction of intraocular pressure (IOP) in patients with open angle
glaucoma and ocular hypertension
who are insufficiently responsive to topical beta-blockers or
prostaglandin analogues.
4.2 Posology and method of administration
Recommended dosage for adults (including older people):
Recommended therapy is one eye drop in the affected eye(s) once daily.
If one dose is missed, treatment should continue with the next dose as
planned. The dose should not
exceed one drop in the affected eye(s) daily.
Method of administration:
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15
minutes.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic absorption is
reduced. This may result in a decrease in systemic side effects and an
increase in local activity.
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least five
minutes apart.
_Paediatric population:_
Safety and effectiveness in children and adolescents has not been
established. No data are available.
4.3 Contraindications
Latanoprost+Timolol is contraindicated in patients with:
• Hypersensitivity to the active substances or to any of the
excipients listed in section 6.1.
• Reactive airway disease including bronchial asthma or a history of
bronchial asthma, severe chronic
obstructive pulmonary disease.
• Sinus bradycardia,
                                
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