Normoglaucon, 1 mg/ml + 20 mg/ml, collyrium, solution, 10 ml

Name of the medical product
Normoglaucon, 1 mg/ml + 20 mg/ml, collyrium, solution

Qualitative and quantitative composition
1 ml of collyrium solution contains:

Active substances:
Metipranolol hydrochloride: 1,118 mg (equivalent to 1 mg of metipranolol) of pilocarpine hydrochloride: 20.0 mg

Pharmaceutical form and content
Collyrium, solution of 10 ml

Pharmacotherapeutic class
Pharmacotherapeutic group: 15.4.3. - Medicines used in the treatment of glaucoma; Beta-blockers

ATC code: S01EB51

Market Authorisation Holder
L. Lepori, Lda
Rua João Chagas 53, Piso 3,
1495-764 Cruz Quebrada - Dafundo

Therapeutic indications
Reduction of intraocular pressure in patients with glaucoma (open, closed angle)
In situations in which monotherapy with pilocarpine or beta-blockers is insufficient.

Contraindications and side effects
Acute iritis and other situations in which pupil contraction is not desired, as acute inflammatory disease of the eye’s anterior chamber.

Hypersensitivity to any of the components present in this medicine. Bronchial asthma, obstructive pulmonary diseases, shock, metabolic acidosis, hypertiroidism, gastritis and duodenal ulcer, obstructions of the digestive tube (ileum), miction disorders to urinary obstruction, congestive cardiac insufficiency, atrioventricular blockage of 2nd and 3rd degree, sinusal syndrome, S-A blockage, bradycardia (less than 50 beats/minute), hypotension, advanced disorders of peripheral circulation, as well as corneal dystrophic injuries.

Do not use this medicine after the beginning of the 3rd trimester of pregnancy.

The side effects described below were registered with the administration of metipranolol and pilocarpine; their intensity is mild to moderate and there are no studies that allow to establish their frequency

• Administration site disorders: slight pricking sensation.
• Nervous system: Headaches (transient).
• Ophthalmological system: ciliary spasms, vision reduction, cysts in the iris, conjunctival hyperaemia (transient), irritation of the conjunctiva, reduction of lachrymal secretion, hyposensitivity of the cornea, iritis (rarely), closed angle acute glaucoma (very rare), retinal detachment (extremely rare cases), reversible uveitis (rare).
• Skin and appendages: cutaneous allergies (rarely).

Possible systemic effects associated to the absorption of the drug should be considered:
hypotension, hypertension, bradycardia, cardiac arrhythmias, blockage of the AV nodule (rarely), dizziness, nauseas, diarrhoea, vomits, abdominal discomfort, bronchoconstriction, rhinitis, urticaria, redness, sudoresis, hypo or hyperglycaemia, hypercalemia, dysuria, nycturia and impotence.

Treatment with Normoglaucon should be carefully controlled in patients with reduction of lachrymal secretion, particularly, in individuals wearing contact lens.

Drug interactions and other forms of interaction
The simultaneous application with other beta-blocking receptors (like tablets)
alter the reduction of intraocular pressure . Signs of hypoglicemia may occur when oral antidiabetics or insulin are concomitantly administered. The use of Normoglaucon may prolog the depolarization effect of relaxing muscles and may reduce their stabilization effect. The frequency-reduction action of cardioactive glycosides may be increased with Normoglaucon.

Warnings and special precautions for use
Like with any other glaucoma treatment, it is recommended the regular monitoring of intraocular pressure (every 4-6 weeks).

Discard after 30 days of first opening.

Normoglaucon contains benzalconium chloride which may cause the discoloration of the contact lens

Effects on pregnant and breast-feeding women
So far there are no studies available on the risks of Normoglaucon use during pregnancy. Metipranolol may cross the placenta and be excreted into breast milk, thus, its application demands a carefully clinical monitoring and the evaluation of the possible benefits-risks relationship.

Effects on the ability to drive and use machines
If used directly, this medicine may cause a transient decrease in visual capacity: therefore, drivers and machine operators should exercise caution.

List of excipients
Benzalcomium chloride, Sodium chloride, Disodium Edetate, Choridric acid, Sodium hydroxide and Purified water.

Usual posology, with reference to maximum dose
Instil 1 drop of Normoglaucon in the conjunctival sac, 4 times a day.

Posology should be adjusted according to the level of intraocular pressure desired.

In closed angle glaucoma, the posology is 1 drop in each eye, 4 times a day. In this situation it is advisable the simultaneous treatment with other drugs such as acetozolamide and/or endovenously administered hyperosmolars.

Indication of the most favourable moment for the administration of the medicine
Consult your doctor.

Duration of the average treatment when it should be limited
According to the doctor’s indications.

Instructions about what to do if you forget to administer one or more doses
If you forgot to take the medicine, take it as soon as possible, but do not duplicate the dose.

Indication of how to discontinue the treatment when its discontinuation causes withdrawal effects
Not applicable

Measures to adopt in case of overdosage and/or intoxication, symptoms, emergency measures and antidotes
Overdosage is not to be considered.

Advice to the patient
If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

Check if the product is within the expiry date mentioned in the package. Keep the medicine out of reach and sight of children.

Special precautions for storage
Do not store above 25ºC.

After the 1st opening the product is valid for 30 days.

Date of the revision of the leaflet
February 2006

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