Spersadex mono Gtt Opht 0.1% Fl 5 ml

What is Spersadex mono 0.1%, eye drops, solution when is it used?

Spersadex mono 0.1% eye drops contain an anti-inflammatory substance (the corticosteroid dexamethasone). They are used for non-infectious inflammations in the anterior segment of the eye (especially if these are of allergic origin).Spersadex mono 0.1% may only be used if prescribed by a doctor.

What precautions should be taken?

• Never use the medicine on your own for the treatment of other diseases or for third parties.Your doctor must regularly check your eyes throughout the entire duration of treatment with this medicine.

When should Spersadex mono 0.1% eye drops not be used?

• If you are allergic to the active ingredient dexamethasone or any of the other ingredients of Spersadex mono 0.1% eye drops.If there are diseases such as glaucoma, ulcers or external injuries to the cornea.For eye diseases caused by viruses, bacteria or fungi.

When should caution be advised when using Spersadex mono 0.1% eye drops?

This medicine can have side effects that can impair vision (see ?What side effects can Spersadex mono 0.1% eye drops??). Do not drive or use machines until these effects wear off.Corticosteroids can mask, activate, or worsen an infection in the eye. If Spersadex mono 0.1% is used for a long time, this can lead to delayed wound healing. It can also lead to an increase in intraocular pressure and, as a result, to glaucoma. During the treatment with Spersadex mono 0.1% you should be under constant medical supervision, whereby the intraocular pressure has to be measured regularly by the doctor. This is particularly important in children and adolescents, as an increased intraocular pressure triggered by Spersadex mono 0.1% can occur more quickly than in adults.If the eye complaints treated with Spersadex mono 0.1% worsen after 2-3 days of treatment or if new symptoms occur, you should consult your doctor immediately.If you suffer from diseases which result in thinning of the tissues around the eye (cornea or sclera): Topical use of corticosteroids can cause perforation of the eye.If you have diabetes (especially type I diabetes), there is a risk of cataracts. The use of corticosteroids in diabetics increases the risk of early and rapidly occurring cataracts.If swelling occurs on the trunk and face (Cushing's syndrome), you should tell your doctor.The simultaneous use of Spersadex mono 0.1% and mydriatics increases the risk of an increase in intraocular pressure. If Spersadex mono 0.1% is combined with antiglaucoma medications, the effects of the preparations administered can be impaired.Since the active ingredient of Spersadex mono 0.1% can enter the bloodstream even after topical application, particular caution is required when used in patients with blood pressure problems.Inform your doctor if you suffer from other diseases (such as increased intraocular pressure, cardiovascular diseases, high blood pressure, cardiac arrhythmias or diabetes in the elderly, hyperthyroidism, "dry nasal mucosa") or if you have allergies.The use of Spersadex mono 0.1% eye drops in children under 2 years of age is not recommended.Since Spersadex mono 0.1% eye drops cannot be combined with any other medicinal product (including tablets with certain active ingredients), you should, if you take other medicines (including those you bought yourself) at the same time as Spersadex mono 0.1% eye drops, or apply them to the eye , discuss this with the doctor so that an optimal schedule can be set up for the individual applications. There must be an interval of 5 minutes between the individual applications between two drugs that are administered locally to the eye.In order to avoid lengthy complications that can be caused by using an incorrectly selected or incorrectly dosed eye preparation, you must not use Spersadex mono 0.1% (even with later new inflammations) without a doctor's prescription.If your eye disease does not improve after 7-8 days of treatment, you must definitely consult your ophthalmologist.

Note for contact lens wearers

Spersadex mono 0.1% contains benzalkonium, a preservative that can cause eye irritation and discolor soft contact lenses. Avoid contact with soft lenses. After treatment with Spersadex mono 0.1%, you must wait at least 15 minutes before the lenses can be reinserted.

Can Spersadex mono 0.1% eye drops be used during pregnancy or when breastfeeding?

Use during pregnancy is not recommended.It may only be used during breastfeeding with the express permission of your doctor.

How do you use Spersadex mono 0.1% eye drops?

Adults, adolescents and children from 2 years

1 drop is given 3-5 times per day into the conjunctival sac of the affected eye. Hold the dropper bottle with one hand with the head tilted backwards as vertically as possible over the eye, with the other hand pull the lower eyelid slightly downwards and by pressing the bottle let a drop fall into the conjunctival sac (avoid touching the eye or the lower eyelid with the drip attachment). For reasons of sterility, make sure that the neck of the bottle and the tip of the dropper do not come into contact with hands or objects during use.The use of Spersadex mono 0.1% in children under 2 years of age is not recommended.If too much Spersadex mono 0.1% gets into the eye, rinse the eye out with lukewarm water. Do not add any more drops until it is time for the next scheduled application.If you forget to use Spersadex mono 0.1%, continue the treatment as planned. Do not use a double dose to make up for a missed dose.Do not change the dosage prescribed by your doctor on your own initiative. Neither the daily dose nor the duration of therapy may be changed without consulting your doctor. In acute cases, the doctor will inform you about more frequent use. If you think that the medicine is too weak or too strong, talk to your doctor or pharmacist.

What side effects can Spersadex mono 0.1% eye drops have?

The following side effects may occur after using Spersadex mono 0.1%:

Common (may affect up to 10 in 100 people):

Effects on the eyes: discomfort.

Uncommon (may affect up to 1 in 100 people):

Effects on the eyes: Inflammation of the cornea, dry eyes, conjunctivitis, sensitivity to light, blurred vision, itching, sensation of foreign bodies, increased tear flow, abnormal sensations in the eye, encrustations of the eyelid margin, irritation, redness.Effects on the body: taste disturbances.

Post-marketing experience shows the following side effects:

Hypersensitivity reactions (allergies), drowsiness, headache, swelling of the trunk and face (Cushing's syndrome), underactive adrenal glands, corneal inflammation, increased eye pressure, glaucoma, decreased visual acuity, drooping of the eyelids, corneal erosion, eye pain, dilated pupils.In very rare cases, patients with pronounced corneal damage during treatment with eye drops containing phosphate developed clouding of the cornea due to calcium deposits.If you notice any side effects that are not described here, you should inform your doctor or pharmacist.Active substances contained in the eye preparations can enter the bloodstream. Side effects can therefore occur in other parts of the body besides the eyes.

What should also be noted?

The drug may only be used up to the date marked ?EXP? on the container.Close the bottle immediately after use. Store Spersadex mono 0.1% in the closed original packaging at room temperature (15-25 ° C).Do not use Spersadex mono 0.1% for longer than one month after opening the bottle.After the treatment has ended, take the medicine and the remaining contents to your doctor or pharmacist for destruction.You should always keep medicines out of the reach of children.Your doctor or pharmacist can provide you with further information. These people have the detailed information for specialists.

What does Spersadex mono 0.1% eye drops contain?

1 ml Spersadex mono 0.1% contains 1 mg dexamethasone sodium phosphate as an active ingredient, benzalkonium chloride as a preservative and other excipients.

Approval number

31069 (Swissmedic).

Where can you get Spersadex mono 0.1% eye drops? Which packs are available?

In pharmacies against a doctor's prescription, which only entitles the holder to purchase once.

• Spersadex Mono eye drops 0.1 % 5 ml
  

Marketing authorization holder

OmniVision AG, 8212 Neuhausen, Germany.?