TETRAMIL*10 SINGLE-DOSE VIALS 0.5ML

TETRAMIL 0.3% +0.05% eye drops, solution
Pheniramine maleate and Tetrizoline hydrochloride

What it is and what it is used for
TETRAMIL contains pheniramine maleate, a medicine to treat allergies (antihistamine) and tetryzoline, a medicine to relieve swelling (decongestant).
TETRAMIL is indicated for adults and adolescents aged 12 years and over for the treatment of:
• Allergies and inflammations of the conjunctiva (a membrane of the eye), accompanied by excessive light sensitivity, watery eyes, foreign body sensation in the eye, pain.

Consult your doctor if you feel worse after 4 days.

What you need to know before taking the medicine
Do not use TETRAMIL
- if you are allergic to pheniramine maleate or tetryzoline hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to certain nasal decongestants such as: xylometazoline, oxymetazoline, and tetryzoline
- if you suffer from increased pressure of the fluid contained within the eye (glaucoma)
- if you suffer from severe eye diseases
- if you are pregnant (see section "Pregnancy and Breastfeeding")
- if you are breastfeeding (see section "Pregnancy and Breastfeeding")
- 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
Consult your doctor or pharmacist before using TETRAMIL.

In particular, consult your doctor:
• if you suffer from high blood pressure (hypertension)
• if you suffer from an overactive thyroid (hyperthyroidism), which is a gland located at the base of the neck
• if you suffer from heart problems
• if you suffer from high blood sugar (diabetes)
• if you suffer from infections or pus in the eye
• if you have foreign bodies in the eye
• if you have eye problems of various kinds (mechanical, chemical, heat-related)
Prolonged use of topical products, in particular, may lead to sensitization phenomena.
In this case, stop the treatment and seek appropriate therapy.

If symptoms persist or worsen after a short period of treatment, consult your doctor.
Prolonged use can lead to problems; do not use this medicine for more than 4 consecutive days, unless otherwise prescribed by a doctor, as otherwise unwanted effects may 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 (thiomersal).
Remove contact lenses before application and wait at least 15 minutes before re-applying them.
In these cases, you can 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).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Tetramil, you may experience allergic reactions, in which 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 side effects:

Effects concerning the eye
• pupil dilation
• increased intraocular pressure

Effects concerning the whole body
• increased blood pressure (hypertension)
• heart problems
• increased blood sugar levels (hyperglycemia)
• nausea
• headache

In children, if accidentally ingested, the preparation can cause drowsiness, even profound (coma), and decreased activity (hypotonia).

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