TETRAMIL

Package leaflet: Information for the patient

TETRAMIL 0.3% + 0.05% eye drops, solution

Pheniramine maleate and Tetrahydrozoline hydrochloride
Please read all of this leaflet carefully before you start 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 4 days.

Contents of this leaflet:

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

1. What TETRAMIL is and what it is used for

TETRAMIL contains pheniramine maleate, a medicine used to treat allergy (antihistamine), and
tetryzoline, a medicine used to relieve swelling (decongestant).
TETRAMIL is indicated in adults and adolescents from 12 years of age onwards for the treatment of:

• Allergic and inflammatory conditions of the conjunctiva (a membrane of the eye), accompanied by excessive sensitivity to light, tearing, sensation of a foreign body in the eye, and pain.

Consult your doctor if you do not feel better or if you feel worse after 4 days.

2. What you need to know before using TETRAMIL

Do not use TETRAMIL

• 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 certain medicines used to relieve nasal congestion (nasal decongestants) such as: xylometazoline, oxymetazoline and tetrizoline
• if you have increased pressure of the fluid inside the eye (glaucoma)
• if you suffer from severe eye diseases
• if you are pregnant (see section “Pregnancy and Breast-feeding”)
• if you are breast-feeding (see section “Pregnancy and Breast-feeding”)
• if you are taking medicines belonging to the class of monoamine oxidase inhibitors (used to treat depression) (see section “TETRAMIL and other medicines”). Do not use in children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using TETRAMIL.
In particular, consult your doctor:

• if you have high blood pressure (hypertension)
• if you have overactive thyroid gland (hyperthyroidism), i.e. a gland located at the base of the neck
• if you have heart disorders
• if you have increased blood sugar levels (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 nature (mechanical, chemical, thermal)
  Prolonged use of topical products may lead to sensitization phenomena. In such cases, discontinue treatment and seek appropriate therapy.

If symptoms persist or worsen after a short period of treatment, consult your doctor.
Prolonged use may cause adverse effects. Do not use this medicine for more than 4 consecutive days unless otherwise prescribed by a doctor, as undesirable effects may otherwise occur.

TETRAMIL multi-dose bottle and contact lenses:
Do not use TETRAMIL multi-dose bottle if you wear contact lenses, as it contains a preservative (benzalkonium chloride).
Remove contact lenses before application and wait at least 15 minutes before reinserting them.
In these cases, you may use the single-dose container, which does not contain preservatives.

Children
Do not use TETRAMIL in children aged between 0 and 12 years (see section 2. Do not use TETRAMIL).

Other medicines and TETRAMIL
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), as concomitant use of these products may cause a severe increase in blood pressure; therefore, simultaneous administration is contraindicated.

Pregnancy and breast-feeding
Do not use this medicine if you are pregnant or breast-feeding.
Ask your doctor for advice.

Driving and using machines
No effects of TETRAMIL on the ability to drive or use machinery are known.

TETRAMIL multi-dose bottle contains benzalkonium chloride, boric acid and borax
This medicine contains 0.044 mg of benzalkonium chloride per maximum daily dose (6+6 drops), equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter 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 eye or corneal disorders (the outermost transparent layer of the eye). If you experience abnormal sensations, burning or pain in the eye after using this medicine, speak with your doctor.
Do not administer to children under 2 years of age as this medicine contains boron, which may impair fertility in the future.

3. How to use TETRAMIL

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
The recommended dose is: one or two drops to be applied into the eye 2–3 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”).

Instructions for use of the multidose bottle

1. To open, press down on the closure cap while simultaneously unscrewing it.
2. After use, close by screwing the cap back on tightly.

Instructions for use of the single-dose container

1. Separate the container from others.
2. Open the container by twisting and removing the cap.
3. Use immediately after opening.
4. After use, discard the container even if partially used.

If you use more TETRAMIL than you should
If you use more TETRAMIL than recommended, contact your doctor or go to the nearest hospital immediately.
The product, 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 reduced activity of the central nervous system, manifesting as marked physical and mental relaxation (pronounced sedation, i.e. excessive drowsiness), coma.

If you forget to use TETRAMIL
Do not use a double dose to make up for the forgotten dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
During treatment with Tetramil, you may experience allergic reactions; in such case, STOP treatment immediately and contact your doctor, who, if necessary, may prescribe an appropriate treatment.
During treatment with TETRAMIL, you may also experience the following adverse reactions:

Effects related to the eye

• dilation of the pupil
• increased pressure inside the eye

Effects related to the whole body

• increased blood pressure (hypertension)
• heart disorders
• increased blood sugar levels (hyperglycaemia)
• nausea
• headache

In children, if accidentally ingested, the product may cause a state of drowsiness, even profound (stupor), and reduced activity (hypotonia).
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor. You may also report adverse reactions directly via the national reporting system at the website http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store TETRAMIL

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
The multidose bottle must not be used more than 30 days after first opening the container.
The single-dose container does not contain preservatives: after administration, discard the vial,
even if it has been only partially used.
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 use this medicine if you notice that the bottle or the single-dose container is punctured and/or
damaged.
Do not dispose of any medicine 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 TETRAMIL contains
Multidose bottle (100 ml of solution contain):

• The active substances are: pheniramine maleate 0.3 g and tetryzoline hydrochloride 0.05 g
• The other components are: Boric acid; Sodium chloride; Hypromellose; Borax; Disodium edetate; Benzalkonium chloride; Water for injections.

Single-dose container (100 ml of solution contain):

• The active substances are: pheniramine maleate 0.3 g and tetryzoline hydrochloride 0.05 g
• The other components are: Boric acid; Sodium chloride; Disodium edetate; Borax; Water for injections.

Description of the appearance of TETRAMIL and pack contents
TETRAMIL multidose bottle: dropper bottle containing 10 ml of clear, colourless solution.
TETRAMIL single-dose container: box containing 10 single-dose units of 0.5 ml of clear, colourless solution, each enclosed in PE-Al foil pouches.

Marketing Authorization Holder and Manufacturer
TEOFARMA S.r.l. - Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)
Manufacturer
FARMIGEA S.p.A - Via G.B. Oliva 8 - Pisa