TETRAMIL*COLL FL10ML 0.3+0.05%

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 tetrizoline, a medicine to relieve swelling (decongestant).
TETRAMIL is indicated in 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, feeling of a foreign body 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 tetrizoline 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 tetrizoline
- if you suffer from increased pressure of the fluid inside 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), i.e. a gland located at the base of the neck
• if you suffer from heart problems
• if you suffer from high blood sugar levels (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)
The use, especially prolonged, of topical products can lead to sensitization phenomena.
In this case, discontinue treatment and resort to appropriate therapy.

If symptoms persist or worsen after a short period of treatment, consult your doctor.
Prolonged use may lead to problems; do not use this medicine for more than 4 consecutive days, unless otherwise prescribed by your doctor, as otherwise adverse 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 (merthiolate).
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 everyone experiences 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 pressure inside the eye

Effects concerning the entire 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, tell 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.