Name
FEXACTIV 3 mg/ml + 0.5 mg/ml eye drops, solution
Pheniramine maleate + Tetrizoline hydrochloride
What is it and what is it used for?
FEXACTIV contains the active ingredients pheniramine maleate and tetryzoline 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.
FEXACTIV is used in adults and adolescents over 12 years of age to treat the symptoms of allergies and inflammation of the membrane of the eye (conjunctiva) accompanied by hypersensitivity to light (photophobia), tearing, foreign body sensation, and pain.
Contact your doctor if you do not feel better or if you feel worse after 4 days of treatment.
What you need to know before taking the medicine
Do not use FEXACTIV:
- 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 other medicines of the same family as pheniramine maleate and tetryzoline hydrochloride, in particular xylometazoline, oxymetazoline, naphazoline;
- if you have a disease caused by high pressure inside the eye (narrow-angle glaucoma) or if you suffer from other serious eye diseases;
- if it is for a child under 12 years old;
- if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”);
- if you are being treated at the same time with medicines used for depression (monoamine oxidase inhibitors, such as tranylcypromine, phenelzine, pargyline) (see “Other medicines and FEXACTIV”).
Warnings and precautions
Talk to your doctor or pharmacist before using FEXACTIV:
- if you suffer from high blood pressure (hypertension);
- if you suffer from excessive activity of a gland called the thyroid (hyperthyroidism);
- if you have heart problems;
- if you have high blood sugar levels (hyperglycemia, diabetes);
- if you suffer from infections or pus in the eye;
- if you have foreign bodies in your eye;
- if you have eye problems of various kinds (mechanical, chemical, heat-related).
The use of topical medications, especially if prolonged, can cause allergies (sensitization phenomena). In this case, your doctor will ask you to discontinue treatment and recommend appropriate therapy.
Do not use this medicine for more than 4 consecutive days unless otherwise prescribed by your doctor, as otherwise side effects may occur.
Children and adolescents
FEXACTIV should not be used in children under 12 years of age.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with FEXACTIV you may experience allergic reactions. In this case, STOP treatment immediately and contact your doctor who, if necessary, will be able to give you appropriate treatment.
During treatment with FEXACTIV you may also experience the following side effects:
Effects affecting the eye:
• pupil dilation;
• increased pressure inside the eye.
Effects that affect the whole organism:
• increased blood pressure (hypertension);
• heart disorders;
• increased blood sugar levels (hyperglycemia);
• nausea;
• heachache.
If accidentally ingested in children, the preparation can cause a state of even profound drowsiness (somnolence) and decreased activity (hypotonia).
Hypersensitivity reactions may rarely occur. If this occurs, discontinue treatment and consult your doctor who, if necessary, will prescribe appropriate therapy.
Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience 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.