Melet

Package leaflet: Information for the patient

MELET 3 mg/ml + 0.5 mg/ml eye drops, solution

Pheniramine maleate + Tetrazoline hydrochloride
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after 4 days of treatment.

Contents of this leaflet:

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

1. What MELET is and what it is used for

MELET contains the active substances pheniramine maleate and tetrizoline hydrochloride.
Pheniramine maleate belongs to a group of medicines called "antihistamines" and works by counteracting allergy symptoms.
Tetrizoline hydrochloride belongs to a group of medicines called "decongestants" and works by reducing the dilation of blood vessels.
MELET is used to treat allergies and inflammations of the eye membrane (conjunctiva) associated with light sensitivity (photophobia), tearing, foreign body sensation, and pain.
Consult your doctor if you do not feel better or feel worse after 4 days of treatment.

2. What you should know before using MELET

Do not use MELET:

• if you are allergic to pheniramine maleate or tetrahydrozoline hydrochloride, or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines belonging to the same family as pheniramine maleate and tetrahydrozoline hydrochloride, particularly xylometazoline, oxymetazoline, naphazoline;
• if you have a disease caused by high pressure inside the eye (narrow-angle/closed-angle glaucoma) or suffer from other serious eye diseases;
• if it is for a child under 12 years of age;
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you are currently being treated with medicines used for depression (monoamine oxidase inhibitors, such as tranylcypromine, phenelzine, pargyline) (see "Other medicines and MELET").

Warnings and precautions
Talk to your doctor or pharmacist before using MELET:

• if you suffer from high blood pressure (hypertension);
• if you suffer from overactivity of a gland called the thyroid (hyperthyroidism);
• if you have heart disorders;
• if you have high blood sugar levels (hyperglycaemia, diabetes);
• if you have infections or pus in the eye;
• if you have foreign bodies in the eye;
• if you have eye problems of various kinds (mechanical, chemical, thermal).

The use, especially if prolonged, of topically applied medicines may cause allergies (sensitization phenomena). In such cases, your doctor will ask you to stop treatment and will recommend appropriate therapy.
Do not use this medicine for more than 4 consecutive days, unless otherwise prescribed by your doctor, as otherwise undesirable effects may occur. MELET in the multidose bottle formulation contains benzalkonium chloride as a preservative, which may cause allergic reactions. During treatment, you should not wear contact lenses and may only wear them 15 minutes after using the medicine. If you are allergic to benzalkonium chloride or wear contact lenses, you may use MELET in single-dose containers, which do not contain preservatives.
Children and adolescents
MELET must not be used in children under 12 years of age.
Other medicines and MELET
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are taking medicines belonging to the class of monoamine oxidase inhibitors (used to treat depression). Concomitant use of MELET and these medicines may cause a severe increase in blood pressure; therefore, simultaneous administration is contraindicated.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use MELET only if clearly needed and under direct medical supervision.
Driving and using machines
No effects on the ability to drive or operate machinery are known. However, MELET bottle contains benzalkonium chloride, which may cause allergic reactions; therefore, if your vision becomes blurred immediately after applying MELET, you should not drive or use machinery until your vision clears.
MELET in the multidose bottle formulation contains benzalkonium chloride
This medicine in the multidose bottle formulation contains 0.012 mg of benzalkonium chloride per maximum recommended daily dose of 6 drops (0.24 ml), equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. 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 transparent outermost layer of the eye). If you experience an abnormal sensation, burning, or pain in the eye after using this medicine, consult your doctor.

3. How to use MELET

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 drops applied into the affected eye 2 or 3 times a day.
Do not exceed the recommended doses.
Higher doses of the product, even if administered locally and for a short period of time, may cause serious adverse effects affecting the whole body (see section 4 "Possible side effects").
Do not use this product for more than 4 consecutive days unless otherwise prescribed by your doctor, due to the risk of adverse effects occurring otherwise.
If symptoms persist or worsen, consult your doctor.
Instructions for use
To open, press the closure cap and simultaneously unscrew it. After use, close tightly by screwing firmly back into place.
Use in children and adolescents
MELET must not be used in children under 12 years of age.
If you use more MELET than you should
In case of accidental ingestion/overdose of MELET, contact your doctor immediately and go to the nearest hospital.
The medicine, if accidentally ingested or used for a prolonged period at excessive doses, may cause toxic effects. Accidental ingestion of the medicine, especially in children, may cause depression of the central nervous system, which may manifest as marked physical and mental relaxation: severe drowsiness (marked sedation), coma.
If you forget to use MELET
Do not use a double dose to make up for the missed dose.
If you stop using MELET
If you have any doubts about using this medicine, consult your doctor or pharmacist. Before stopping treatment, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with MELET, you may experience allergic reactions; in this case, STOP treatment immediately and contact your doctor, who, if necessary, can provide you with appropriate therapy.
During treatment with MELET, you may also experience the following side effects:

Effects concerning the eye:

• dilation of the pupil;
• increased pressure inside the eye.

Effects concerning the whole body:

• increased blood pressure (hypertension);
• heart disorders;
• increased blood sugar levels (hyperglycemia);
• nausea;
• headache. In children, accidental ingestion of the product may cause drowsiness, even profound (stupor), and reduced activity (hypotonia).

Rarely, hypersensitivity reactions may occur. In such cases, discontinue treatment and consult your doctor, who, if necessary, will provide you with appropriate therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the 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 MELET

Do not store above 30°C.
After first opening the multidose bottle, use the medicine within 28 days.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What MELET contains

• The active substances are: pheniramine maleate and tetrizoline hydrochloride. 100 ml of solution contain 0.30 g of pheniramine maleate and 0.05 g of tetrizoline hydrochloride.
• The other components are: boric acid, borax, benzalkonium chloride, water for injections.

Description of the appearance of MELET and pack contents
MELET is an eye drop solution (to be administered drop by drop directly into the eye).
MELET is available in packs containing 1 dropper bottle made of LDPE with a volume of 10 ml.

Marketing Authorization Holder
Genetic S.p.A. Via G. Della Monica, 26 - 84083 Castel San Giorgio (SA).

Manufacturer
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA)

Patient Information Leaflet

MELET 3 mg/ml + 0.5 mg/ml eye drops, solution in single-dose container

Maleate of pheniramine + Hydrochloride of tetrizoline
Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after 4 days of treatment.

Contents of this leaflet:

1. What MELET is and what it is used for
2. What you need to know before using MELET
3. How to use MELET
4. Possible side effects
5. How to store MELET
6. Package contents and other information

1. What MELET is and what it is used for

MELET contains the active substances pheniramine maleate and tetrizoline hydrochloride.
Pheniramine maleate belongs to a group of medicines called "antihistamines" and works by counteracting allergy symptoms.
Tetrizoline hydrochloride belongs to a group of medicines called "decongestants" and works by reducing the dilation of blood vessels.
MELET is used to treat allergies and inflammation of the eye membrane (conjunctiva), accompanied by light sensitivity (photophobia), tearing, sensation of a foreign body, and pain.
Consult your doctor if you do not feel better or if you feel worse after 4 days of treatment.

2. What you need to know before using MELET

Do not use MELET:

• if you are allergic to pheniramine maleate or tetrazoline hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines belonging to the same family as pheniramine maleate and tetrazoline hydrochloride, particularly xylometazoline, oxymetazoline, naphazoline;
• if you have a disease caused by high pressure inside the eye (narrow-angle/closed-angle glaucoma) or if you suffer from other serious eye diseases;
• if it is for a child under 12 years of age;
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you are concurrently being treated with medicines used for depression (monoamine oxidase inhibitors, such as tranylcypromine, phenelzine, pargyline) (see "Other medicines and MELET").

Warnings and precautions
Talk to your doctor or pharmacist before using MELET:

• if you have high blood pressure (hypertension);
• if you have excessive activity of a gland called the thyroid (hyperthyroidism);
• if you have heart disorders;
• if you have high blood sugar levels (hyperglycemia, diabetes);
• if you have infections or pus in the eye;
• if you have foreign bodies in the eye;
• if you have various types of eye problems (mechanical, chemical, thermal).

The use, especially if prolonged, of locally applied medicines may cause allergic reactions (sensitization phenomena). In such cases, your doctor will ask you to stop treatment and recommend appropriate therapy.
Do not use this medicine for more than 4 consecutive days, unless otherwise prescribed by a doctor, as otherwise undesirable effects may occur.
Children and adolescents
MELET must not be used in children under 12 years of age.
Other medicines and MELET
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are taking medicines belonging to the class of monoamine oxidase inhibitors (used to treat depression). Concomitant use of MELET and these types of medicines may cause a severe increase in blood pressure; therefore, simultaneous administration is contraindicated.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use MELET only if clearly necessary and under direct medical supervision.
Driving and using machines
No effects on the ability to drive vehicles or use machinery are known.

3. How to use MELET

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 drops applied into the affected eye 2 or 3 times a day.
Do not exceed the recommended doses.
Higher doses of the product, even if administered locally and for a short period of time, may cause serious adverse effects on the whole organism (See section 4 “Possible side effects”).
Do not use this product for more than 4 consecutive days unless otherwise prescribed by a doctor, due to the risk of adverse effects occurring.
If symptoms persist or worsen, consult your doctor.

Instructions for use

1. Separate the container from others;
2. Open the container by twisting and removing the cap;
3. Use immediately after opening: after use, the container must be discarded even if partially used.

Use in children and adolescents
MELET must not be used in children under 12 years of age.

If you use more MELET than you should
In case of ingestion/overdose of MELET, contact your doctor immediately and go to the nearest hospital.
The medicine, if accidentally ingested or used for prolonged periods at excessive doses, may cause toxic effects. Accidental ingestion of the medicine, especially in children, may cause depression of the central nervous system, manifesting as marked physical and mental relaxation: pronounced drowsiness (marked sedation), coma.

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

If you stop using MELET
If you have any doubts about using this medicine, consult your doctor or pharmacist. Before stopping treatment, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
During treatment with MELET, you may experience allergic reactions; in this case, STOP treatment immediately and contact your doctor, who, if necessary, can provide you with appropriate treatment.
During treatment with MELET, you may also experience the following side effects:

Effects related to the eye:

• dilation of the pupil;
• increased pressure inside the eye.

Effects affecting the whole body:

• increased blood pressure (hypertension);
• heart disturbances;
• increased blood sugar levels (hyperglycaemia);
• nausea;
• headache. In children, if accidentally ingested, the product may cause drowsiness, even profound (stupor), and reduced activity (hypotonia).

Rarely, hypersensitivity reactions may occur. In such cases, discontinue treatment and consult your doctor, who, if necessary, will provide appropriate therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact 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 MELET

Do not store at temperatures above 30°C.
The medicine does not contain preservatives: use the single-dose container immediately after opening
and discard any residual medicine, even if only partially used.
Do not use the medicine more than 28 days after opening the aluminium sachet containing the
single-dose containers.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

7. Package contents and other information

What MELET contains

• The active substances are: pheniramine maleate and tetryzoline hydrochloride. 100 ml of solution contain 0.30 g of pheniramine maleate and 0.05 g of tetryzoline hydrochloride.
• The other components are: boric acid, borax, water for injections.

Description of the appearance of MELET and package contents
MELET is an ophthalmic solution supplied in single-dose containers (to be instilled drop by drop directly into the eye).
MELET is available in packs of 10 single-dose containers made of LDPE, 0.5 ml each, packed in PET/Al/PE sachets. Each sachet contains a strip of 5 single-dose containers.
Marketing Authorization Holder
Genetic S.p.A., Via G. Della Monica, 26 - 84083 Castel San Giorgio (SA).
Manufacturer
Genetic S.p.A., Contrada Canfora - 84084 Fisciano (SA)