TAMESAD 1.5 mg/ml Eye drops, solution

Зміст інструкції

1. TAMESAD 1.5 mg/ml eye drops, solution
   1. What is Tamesad and what is it 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

TAMESAD 1.5 mg/ml eye drops, solution

Desametasone sodium phosphate

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Tamesad and what is it used for

Tamesad contains the active ingredient desametasone sodium phosphate which belongs to a group of medications
called corticosteroids with anti-inflammatory properties.
Tamesad is a medicine for the eyes indicated in the treatment of the following conditions:

• seasonal inflammation of the conjunctiva, the membrane that lines the inner surface of the eyelid and the eye (spring conjunctivitis) and inflammation of the conjunctiva caused by allergies (allergic conjunctivitis).
• inflammation of the eyelids caused by allergies (allergic blepharitis) and inflammation of the eyelids and conjunctiva caused by allergies (allergic blepharoconjunctivitis);
• inflammation of the cornea and conjunctiva caused by allergies (allergic keratoconjunctivitis);
• superficial or deep inflammation of the sclera, the outermost membrane of the eyeball (scleritis, episcleritis);
• inflammation inside the eye (uveitis). Consult your doctor if you do not notice an improvement or if you notice a worsening at the end of the prescribed therapy.

2. What you need to know before using Tamesad

Do not use Tamesad

• if you are allergic to desametasone sodium phosphate or any other ingredients of this medicine (listed in section 6);
• if you have high pressure inside your eye (intraocular hypertension);
• if you have an infection caused by the Herpes simplexvirus;
• if you have a viral infection of the cornea in an acute, ulcerating stage;
• if you suffer from simultaneous inflammation of the conjunctiva and ulcerating 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 an acute purulent inflammation of the eye (acute purulent ophthalmia, purulent conjunctivitis, purulent blepharitis and herpetic);
• if you have inflammation of the sebaceous glands at the base of the eyelashes (stye);
• if you have wounds to the cornea, such as injuries 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.

Pay particular attention and tell your doctor:

• if you need to use the medicine for a longer period. Use, especially if prolonged, of corticosteroids can determine an increase in intraocular pressure. Undergo frequent checks of your eye pressure if you use Tamesad for more than two weeks. Since corticosteroids also promote the onset of cataracts (progressive clouding of the lens), the use of the medicine for long periods of time (1 to 4 years) and high doses of corticosteroids for ophthalmic use are discouraged;
• if you suffer from viral infections or inflammation of the conjunctiva (conjunctivitis) caused by bacteria, viruses or fungi, as local administration of corticosteroids may worsen the disease or mask the signs of disease progression (see section 2 “Do not use Tamesad”).;
• if you have eye injuries, as the use of corticosteroids in the presence of injuries delays tissue healing, promoting the onset and spread of any infections;
• if you suffer from viral infections, as corticosteroids can worsen the disease with irreversible corneal opacity;
• if you suffer from diseases that lead to thinning of the cornea;
• if you have corneal inflammation caused by the Herpes simplexvirus (herpetic keratitis), as in this case the use of Tamesad is not recommended (see “Do not use Tamesad”). In strictly necessary cases, use may eventually be permitted under strict supervision of the ophthalmologist;
• if you have dry eyes (ocular dryness) and need to use Tamesad eye drops, multi-dose solution frequently or for prolonged periods, or if you have corneal lesions. The multi-dose bottle contains benzalkonium chloride, a preservative that can cause eye irritation and corneal damage (see “Tamesad eye drops, multi-dose solution contains benzalkonium chloride”).
• If you have severe damage to the outermost transparent layer of the eye (the cornea), the phosphates present in this medicine may, in very rare cases, cause opaque spots on the cornea due to calcium accumulation during treatment (see “Tamesad eye drops contains phosphate buffer”).

Talk to your doctor if you feel swelling and weight gain around the trunk and face as
these are usually the first manifestations of a syndrome called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Tamesad. Talk to your doctor before stopping treatment on your own.
These risks are particularly important in children and patients treated with a medicine called
ritonavir or cobicistat.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Do not use Tamesad in children under 3 years of age (see “Do not use Tamesad”).
In children from 3 to 12 years of age, the medicine should be administered only when absolutely necessary and under the direct
control of the doctor.

Other medicines and Tamesad
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Talk to your doctor if you are using ritonavir or cobicistat, as they may increase the level of
desametasone in the blood (see “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Use during pregnancy
If you are pregnant, use Tamesad only when absolutely necessary under the direct control of the doctor (see
“Do not use Tamesad”).
Use during breastfeeding
Tamesad is generally contraindicated during breastfeeding.

Driving and operating machinery
Tamesad does not impair the ability to drive vehicles or operate machinery.

Tamesad eye drops, multi-dose solution contains benzalkonium chloride
1 bottle of 5 ml of Tamesad eye drops, solution contains 1 mg of benzalkonium chloride equivalent to 0.2
mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change
in their color.
Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the most superficial layer of the eye). If you experience an abnormal
sensation in the eye, burning or pain after using this medicine, talk to your doctor.

Tamesad eye drops contains phosphate buffer
1 bottle of 5 ml of Tamesad eye drops, solution contains 33.13 mg of phosphate buffer equivalent to 6.63
mg/ml of phosphates.
1 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
cause, in very rare cases, opaque spots on the cornea due to calcium accumulation during
treatment.

3. How to use Tamesad

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

The recommended dose is: 1 drop 3-4 times a day or as prescribed by your doctor.

Use in children and adolescents
Tamesad should be administered to children from 3 to 12 years old only when necessary and under the
direct supervision of a doctor.
Instill the drop of the medicine into the fold between the eyelid and the eye (into the conjunctival fornix).

Instructions for use
Eye drops, solution in a multi-dose bottle of 5 ml:

• 1) Remove the cap
• 2) Remove the cap from the bottle
• 3) If you wear contact lenses, remove the lenses before instilling the eye drops and wait at least 15 minutes before reinserting them.
• 4) Turn the bottle upside down and instill by pressing; avoid contact between the container's tip and 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 is open.
• 4) Turn the container upside down and instill by pressing.

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

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

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

4. Possible side effects

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

• increased pressure inside the eye after 15-20 days of local application in predisposed patients or those suffering from glaucoma;
• opacification of the lens (cataract) following prolonged treatments;
• development or worsening of infections from Herpes simplexor fungi;
• delayed wound healing;

In all these cases, discontinue treatment and consult your doctor to resort to appropriate therapy.
With the use of Tamesad, mild itching or burning may also occasionally 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.
Adverse reactions not known (frequency cannot be estimated based on available data):

• Hormonal problems: increased hair growth on the body (especially in women), weakness and muscle atrophy, purple stretch marks on the skin of the body, 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 of the body and face (called “Cushing’s syndrome”) (see section 2, “Warnings and precautions”);
• blurred vision.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at: 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 the product in intact packaging,
correctly stored.
Do not store at a temperature above 25°C.
The multi-dose bottle eye drops must be used within 28 days of 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 sachet, the containers must be used within 28 days: after this period, discard any remaining containers.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

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

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

• The active ingredient is desamethasone sodium phosphate. 1 ml of solution contains 1.5 mg of desamethasone

sodium phosphate.

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

Description of the appearance of Tamesad and contents of the pack
Tamesad is presented as eye drops, solution .
Pack of one bottle containing 5 ml.
Pack of 20 single-dose containers of 0.30 ml; each strip of 5 containers is packaged in an aluminum
sachet.

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)