FENISTIL*ORAL DROPS 20ML 1MG/ML

Fenistil 1 mg/ml oral drops, solution
Fenistil 1 mg film-coated tablets
Dimetindene maleate

What it is and what it is used for
Fenistil contains the active ingredient dimetindene maleate, which belongs to the group of medicines known as “antihistamines” and is used for allergies and itching of various origins.

Fenistil is indicated for the treatment of:
• itching of various origins
• allergies caused by medicines and foods.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not take Fenistil
• if you are allergic to dimetindene maleate or any of the other ingredients of this medicine (listed in section 6)
• if you have a disease characterized by high pressure inside the eye (glaucoma)
• if you have an enlarged prostate (benign prostatic hyperplasia)
• if you have bladder problems (bladder neck obstructions)
• if you have a narrowing in a part of the stomach or intestine (e.g., of the pylorus or duodenum)
• if you have a narrowing in a part of the urinary or genital system
• if you have asthma
• if you have a lung disease characterized by an obstruction of the bronchi (chronic obstructive pulmonary disease)
• if you have heart and blood vessel problems
• if you have high blood pressure
• if you have an overactive thyroid gland (hyperthyroidism)
• if you have epilepsy
• if you are using other medicines, for example, for the treatment of depression and Parkinson's (monoamine oxidase inhibitors) (see section “Other medicines and Fenistil”).

Fenistil should not be used in infants younger than 1 month of age, especially if born prematurely.

Warnings and precautions
Consult your doctor or pharmacist before taking Fenistil.
Do not exceed the recommended dose and use only for short periods of treatment.
Elderly patients should consult their doctor before taking Fenistil because they are more prone to side effects such as agitation and fatigue.

Pay particular attention:
• if you have severe liver problems
• to sunlight or sunlamps. You should not expose yourself to sunlight or sunlamps after taking Fenistil, because antihistamines can cause the appearance of spots or redness on the skin.

Children
Fenistil should not be used in infants younger than 1 month of age, especially if born prematurely.
Fenistil should be used with caution in children younger than 1 year of age, because the sedative effect of the antihistamine can be associated with respiratory arrest during sleep. Fenistil should be used in children younger than 12 years of age only when strictly necessary and after consulting a doctor.
In younger children, antihistamines such as Fenistil can cause excitability.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people)
• fatigue

Common side effects (may affect up to 1 in 10 people)
• drowsiness
• nervousness

Rare side effects (may affect up to 1 in 1,000 people)
• agitation
• headache
• dizziness
• stomach and/or intestinal problems
• nausea
• dry mouth and throat

Very rare side effects (may affect up to 1 in 10,000 people)
• skin rashes
• appearance of spots or redness on the skin following exposure to sunlight or sunlamps
• severe allergic reactions even after the first dose, including swelling (edema) of the face, throat, and difficulty breathing (dyspnea)
• signs of excitation, such as euphoria, tremor, insomnia, convulsions
• sedation
• weakness (asthenia)
• coordination disorders
• visual disturbances
• dry nose
• feeling of tightness in the chest and difficulty breathing due to a reduction and thickening of bronchial secretions
• loss of appetite (anorexia)
• vomiting
• diarrhea or constipation
• difficulty urinating and urinary retention

Side effects with unknown frequency (frequency cannot be estimated from the available data)
• edema (swelling due to fluid accumulation)
• skin rash
• muscle spasms

Following the instructions in the leaflet reduces the risk of side effects.

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.