Tamesad

Patient Information Leaflet: Information for the User

TAMESAD 1.5 mg/ml eye drops, solution

Dexamethasone sodium phosphate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Tamesad is and what it is used for
2. What you need to know before using Tamesad
3. How to use Tamesad
4. Possible side effects
5. How to store Tamesad
6. Contents of the pack and other information

1. What Tamesad is and what it is used for

Tamesad contains the active substance sodium phosphate dexamethasone, which belongs to a group of anti-inflammatory medicines called corticosteroids.
Tamesad is an eye medicine indicated for the treatment of the following conditions:

• Seasonal inflammation of the conjunctiva, the membrane lining the inner surface of the eyelid and the eye (vernal conjunctivitis), and conjunctival inflammation caused by allergies (allergic conjunctivitis).
• Allergic inflammation of the eyelids (allergic blepharitis) and allergic inflammation of both the eyelids and conjunctiva (allergic blepharoconjunctivitis);
• Allergic inflammation of the cornea and conjunctiva (allergic keratoconjunctivitis);
• Superficial or deep inflammation of the sclera, the outermost membrane of the eyeball (scleritis, episcleritis);
• Inflammation inside the eye (uveitis).
  If you do not notice an improvement or if you notice a worsening after completing the prescribed course of treatment, consult your doctor.

2. What you should know before using Tamesad

Do not use Tamesad

• if you are allergic to sodium dexamethasone phosphate or to any of the other ingredients of this medicine (listed in section 6);
• if you have high pressure inside the eye (intraocular hypertension);
• if you have a viral infection caused by Herpes simplex;
• if you have an acute ulcerative viral infection of the cornea;
• if you suffer from simultaneous inflammation of the conjunctiva and ulcerative inflammation of the cornea (conjunctivitis with ulcerative keratitis), even in the initial stage (positive fluorescein test, a diagnostic test);
• if you have tuberculosis;
• if you have a fungal infection (mycosis) of the eye;
• if you have acute purulent inflammation of the eye (acute purulent ophthalmia, purulent conjunctivitis, purulent and herpetic blepharitis);
• if you have inflammation of the sebaceous glands at the base of the eyelashes (stye);
• if you have corneal injuries, such as lesions or abrasions;

It is contraindicated in children under three years of age; it is also generally contraindicated during
pregnancy and breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before using Tamesad.
Exercise particular caution and inform your doctor:

• if you need to use the medicine for a longer period. The use, especially if prolonged, of corticosteroids may lead to increased intraocular pressure. Have frequent eye pressure checks if you use Tamesad for more than two weeks. Since corticosteroids may also promote the development of cataracts (progressive clouding of the lens), long-term use of the medicine (from 1 to 4 years) and high doses of ophthalmic corticosteroids are not recommended;
• if you suffer from viral infections or conjunctival inflammations (conjunctivitis) caused by bacteria, viruses, or fungi, as local administration of corticosteroids may worsen the disease or mask signs of infection progression (see section 2 “Do not use Tamesad”);
• if you have eye injuries, as the use of corticosteroids in the presence of injuries may delay healing of damaged tissues, promoting the onset and spread of possible infections;
• if you suffer from viral infections, as corticosteroids may worsen the disease, leading to irreversible corneal clouding;
• if you suffer from diseases causing thinning of the cornea;
• if you have corneal inflammation caused by the Herpes simplex virus (herpetic keratitis), as the use of Tamesad is not recommended in this case (see “Do not use Tamesad”). In strictly necessary cases, use may be permitted under close supervision by an ophthalmologist;
• if you have dry eyes (ocular dryness) and need to use Tamesad eye drops, solution in multi-dose bottle frequently or for prolonged periods, or if you have corneal lesions. The multi-dose bottle formulation contains benzalkonium chloride, a preservative that may cause eye irritation and corneal damage (see “Tamesad eye drops, solution in multi-dose bottle contains benzalkonium chloride”);
• If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates present in this medicine may, very rarely, cause opaque spots on the cornea due to calcium accumulation during treatment (see “Tamesad eye drops contain phosphate buffer”).

Contact your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Tamesad. Consult your doctor before stopping treatment on your own.
These risks are particularly important in children and in patients treated with a medicine called
ritonavir or cobicistat.
Contact your doctor if blurred vision or other visual disturbances occur.
Children and adolescents
Do not use Tamesad in children under 3 years of age (see “Do not use Tamesad”).
In children aged 3 to 12 years, the medicine should be administered only when strictly necessary and under direct medical supervision.
Other medicines and Tamesad
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor if you are taking ritonavir or cobicistat, as they may increase blood levels of
dexamethasone (see “Warnings and precautions”).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Use during pregnancy
If you are pregnant, use Tamesad only when strictly necessary and under direct medical supervision (see
“Do not use Tamesad”).
Use during breastfeeding
Tamesad is generally contraindicated during breastfeeding.
Driving and using machines
Tamesad does not affect the ability to drive vehicles or use machinery.
Tamesad eye drops, solution in multi-dose bottle contains benzalkonium chloride
One 5 ml bottle of Tamesad eye drops, solution contains 1 mg of benzalkonium chloride, equivalent to 0.2 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color.
Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the eye's most superficial transparent layer). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak to your doctor.
Tamesad eye drops contain phosphate buffer
One 5 ml bottle of Tamesad eye drops, solution contains 33.13 mg of phosphate buffer, equivalent to 6.63 mg/ml of phosphates.
One single-dose container of 0.30 ml of Tamesad eye drops, solution contains 1.99 mg of phosphate buffer, equivalent to 6.63 mg/ml of phosphates.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, very rarely, cause opaque spots on the cornea due to calcium accumulation during treatment.

3. How to use Tamesad

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose: 1 drop 3-4 times a day, or as prescribed by the physician.
Use in children and adolescents
Tamesad should be administered to children aged 3 to 12 years only when clearly necessary and under direct medical supervision.
Instill the drop of medicine into the fold between the eyelid and the eye (conjunctival fornix).

Instructions for use

Eye drops, solution in multidose bottle of 5 ml:

1. Remove the seal
2. Remove the cap from the bottle
3. If you wear contact lenses, remove the lenses before instillation of the eye drops and wait at least 15 minutes before reinserting them.
4. Invert the bottle and instil by pressing; avoid letting the tip of the container come into contact with the eye or other surfaces.

Eye drops, solution in single-dose containers of 0.3 ml:

1. Make sure the single-dose container is intact.
2. Detach the single-dose container from the strip.
3. Open by rotating the tab until the container opens.
4. Invert the container and instil by pressing.

If you use more Tamesad than you should
In case of accidental ingestion/overdose of Tamesad, contact your doctor immediately or go to the nearest hospital.
No cases of overdose have been reported.
The medicine, if accidentally ingested or used for prolonged periods at excessive doses, may cause toxic effects.

If you forget to use Tamesad
Do not use a double dose to make up for the missed dose.

If you stop using Tamesad
Do not stop treatment without first consulting your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Possible side effects due to the corticosteroid are:

• increased intraocular pressure after 15-20 days of local application in predisposed patients or in patients suffering from glaucoma;
• clouding of the lens (cataract) following prolonged treatment;
• development or worsening of infections caused by Herpes simplex or fungi;
• delayed healing;

In all these cases, stop treatment and consult your doctor to receive appropriate therapy.
With the use of Tamesad, mild itching or burning may occasionally also occur.
Very rarely, cases of calcification of the outermost transparent layer of the eye (the cornea) have been reported associated with the use of eye drops containing phosphates in patients with significantly damaged cornea.
Side effects not known (frequency cannot be determined from available data):

• Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling and weight gain in the body and face (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”);
• blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamesad

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp". The expiry date refers to the last day of that month and applies to the product in intact original packaging, stored correctly.
Do not store above 25°C.
The multidose bottle eye drops must be used within 28 days after first opening the bottle; after this period, discard any remaining medicine.
The single-dose container eye drops must be used immediately after opening the container; discard any remaining medicine.
After opening the aluminium pouch, the containers must be used within 28 days: after this period, discard any remaining containers.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Tamesad contains
Tamesad 1.5 mg/ml eye drops, solution in multidose container

• The active substance is dexamethasone sodium phosphate. 1 ml of solution contains 1.5 mg of dexamethasone sodium phosphate.
• The other components are: trisodium citrate dihydrate, monobasic sodium phosphate dihydrate (E339), disodium phosphate dihydrate (E339), benzalkonium chloride, water for injections.

Tamesad 1.5 mg/ml eye drops, solution in single-dose container

• The active substance is dexamethasone sodium phosphate. 1 ml of solution contains 1.5 mg of dexamethasone sodium phosphate.

• The other components are: trisodium citrate dihydrate, monobasic sodium phosphate dihydrate (E339), disodium phosphate dihydrate (E339), water for injections.

Description of the appearance of Tamesad and contents of the pack
Tamesad is an eye drops solution.
Pack sizes: one bottle containing 5 ml.
Pack of 20 single-dose containers of 0.30 ml each; each strip of 5 containers is packaged in an aluminium foil pouch.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)