OPHTALMIN-N

OPHTALMIN-N eye drops

Important notes (mandatory information)

Ophtalmin-N 0.5 mg/ml eye drops. Active ingredient: Tetryzoline hydrochloride. Areas of application: Eye irritation, e.g. caused by smoke, wind, chlorinated water and light, and allergic inflammations of the eye, e.g. hay fever and pollen allergy.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ophtalmin-N 0.5 mg/ml eye drops, for use in children aged 2 years and over and adults
Active ingredient: Tetryzoline hydrochloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What this package leaflet contains

1. WHAT IS OPHTALMIN-N AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPHTALMIN-N
3. HOW TO USE OPHTALMIN-N
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE OPHTALMIN-N
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS OPHTALMIN-N AND WHAT IS IT USED FOR?

Ophtalmin-N is a medicine for influencing the organ nerve system (autonomic nervous system) from the drug group of alpha-sympathomimetics. Ophtalmin-N is used for: Eye irritation, e.g. caused by smoke, wind, chlorinated water and light, and allergic inflammations of the eye, e.g. hay fever and pollen allergy.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPHTALMIN-N

Ophtalmin-N must not be used in the following cases:

• Narrow-angle glaucoma,
• Hypersensitivity to tetryzoline hydrochloride, the active ingredient of Ophtalmin-N, or any of the other ingredients listed in section 6,
• Children under 2 years of age.

The following describes when you may only use Ophtalmin-N under certain conditions and only with special caution. Please consult your doctor about this. This also applies if this information applied to you in the past.

You may only use Ophtalmin-N after consulting your doctor if you have:

• severe cardiovascular diseases (e.g. coronary heart disease, high blood pressure or pheochromocytoma),
• metabolic disorders, e.g. overactive thyroid (hyperthyroidism) or diabetes mellitus
• treatment with blood pressure-raising medication (e.g. MAO inhibitors)
• dry rhinitis
• keratoconjunctivitis sicca (so-called dry eye) and
• glaucoma.

Note

Ophtalmin-N is not suitable for treating the so-called "dry eye" (keratoconjunctivitis sicca). Explanations: Glaucoma is a disease in which there is increased intraocular pressure (so-called glaucoma). If the disease is caused by a narrowing of the anterior chamber angle, it is called narrow-angle glaucoma. Coronary heart disease is caused by narrowing of the blood vessels of the heart. This can lead to heart failure (heart insufficiency), heart rhythm disorders (arrhythmias), paroxysmal pain (angina pectoris) and loss of heart tissue (heart attack). A pheochromocytoma is a usually benign tumour, primarily of the adrenal medulla, which releases substances that lead to very high blood pressure at times.

Warnings and precautions

Please note that eye irritation or redness is often a sign of a serious eye disease and you should therefore consult an ophthalmologist. See an ophthalmologist immediately if

1. the eye redness occurs acutely or unilaterally,
2. eye or headaches are added to your current symptoms,
3. you notice a deterioration in vision or floating spots in front of your eyes!

Ophtalmin-N must not be used in narrow-angle glaucoma. In other forms of glaucoma, Ophtalmin-N may only be used with special caution and under medical supervision.

What precautions must be taken?
Ophtalmin-N must not be swallowed and should therefore be kept out of reach of children.

Notes for contact lens wearers

In the case of conjunctivitis, it is generally more beneficial to wear glasses than to use contact lenses, as the eye is irritated. If you want to wear contact lenses despite the symptoms, you should remove hard and soft lenses before using Ophtalmin-N and reinsert them at the earliest 15 minutes after instillation. Soft contact lens wearers should note that the preservative benzalkonium chloride contained in Ophtalmin-N can accumulate in these lenses and discolour them.

Children

Ophtalmin-N must not be used in children under 2 years of age. Long-term use and overdose, especially in children, should be avoided. Use in children and at higher doses should therefore only be under medical supervision. To avoid possible absorption of Ophtalmin-N throughout the body, especially in children, the tear ducts should be pressed with the fingertips for 2-3 minutes after instillation.

When using Ophtalmin-N together with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. The blood pressure-raising effect of MAO inhibitors and tricyclic antidepressants (medicines for treating a pathological mood disorder [depression]) can be increased. Please note that this information may also apply to medicines that you have recently used. If you are also using other eye drops/eye ointments, there should be a time interval of approx. 5 minutes between them.

Pregnancy and breast-feeding

Ophtalmin-N must not be used during pregnancy and breast-feeding.

Driving and using machines

It is unlikely that the slight temporary irritation that may occur after using Ophtalmin-N will lead to a significant impairment of vision. If there is a short-term impairment of vision, you should wait until it has passed before participating in road traffic or operating machinery.

Ophtalmin-N contains benzalkonium chloride

The preservative benzalkonium chloride can cause irritation to the eye. Avoid contact with soft contact lenses. Benzalkonium chloride can discolour soft contact lenses. You must remove contact lenses before use and may reinsert them at the earliest 15 minutes after use.

3. HOW TO USE OPHTALMIN-N

Always use Ophtalmin-N exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. The following information applies unless your doctor has prescribed Ophtalmin-N differently: For use on the eye. Instil 1 drop of Ophtalmin-N into the conjunctival sac of each eye 2 to 3 times a day with the head slightly tilted back, without touching the eye or other surfaces with the container opening. Use for more than 5 days should only be under medical supervision.

If you have used more Ophtalmin-N than you should

Signs of overdose in the eye are dilated pupils. Signs similar to those of swallowing Ophtalmin-N may occur in a mild form (see also 4. "What side effects are possible?"). If the liquid is swallowed, the following symptoms may occur: nausea, cyanosis (bluish skin due to reduced oxygen content in the blood), fever, convulsions, increased and irregular heartbeat, cardiac arrest, high blood pressure, pulmonary oedema (increased tissue water in the lungs), respiratory problems and mental disorders, possibly also inhibition of central nervous functions with drowsiness, lowering of body temperature, too slow heartbeat, shock-like drop in blood pressure, respiratory arrest and coma (deep unconsciousness). In small children, central nervous disorders, reduced breathing and circulatory collapse can occur. If these symptoms occur, call the nearest doctor for help! Possible medical countermeasures include administration of medical charcoal, gastric lavage and oxygen ventilation. Vasopressors (medicines for raising blood pressure) must not be given. Fever and convulsions should be treated if necessary. If anticholinergic symptoms occur, an antidote, e.g. physostigmine, should be administered.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Conjunctival irritation (eye redness with tears and photophobia) and occasionally blurred vision and glare due to dilated pupils (mydriasis). Ophtalmin-N often passes into the body's circulation, which can lead to palpitations, headaches, tremors especially in the hands (tremor), weakness, sweating and increased blood pressure. Very rarely, after long-term use, corneal keratinisation with occlusion of the tear puncta and tearing has been reported. In very rare cases, patients with pronounced corneal defects developed corneal opacities due to the formation of calcium phosphate during therapy with phosphate-containing eye drops.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

What countermeasures should be taken in the event of side effects?
Please stop using Ophtalmin-N and talk to your doctor about further treatment.

5. HOW TO STORE OPHTALMIN-N

The medicine must not be used after the expiry date (see carton and label). The expiry date refers to the last day of the month. The eye drops can be used for 6 weeks after opening. Do not store above 25°C. Keep out of reach of children. The medicine should not be disposed of via wastewater. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ophtalmin-N contains

The active ingredient is: Tetryzoline hydrochloride. 1 ml solution contains 0.50 mg tetryzoline hydrochloride. The other ingredients are: Benzalkonium chloride; Sorbitol (Ph.Eur.); Sodium dihydrogen phosphate dihydrate; Sodium monohydrogen phosphate dodecahydrate (Ph. Eur.); Hypromellose; Water for injections.

Dosage form and contents

Pack of 10 ml and 3 x 10 ml eye drops per bottle.

Pharmaceutical entrepreneur and manufacturer

Dr. Winzer Pharma GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Tel: 0800 - 090 94 90 - 90
Fax: 0800 - 090 94 90 - 88
Email: service@drwinzer.de

This package leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 02/2017
Active ingredient: Tetryzoline hydrochloride. Areas of application: Eye irritation, e.g. caused by smoke, wind, chlorinated water and light, and allergic inflammations of the eye, e.g. hay fever and pollen allergy.