Fenistil 1 mg/ml drops - allergy drug 20 ml

Product Description

Antihistamine drug for the treatment of itching of various origins, drug and food allergies.

Indications

Fenistil contains the active ingredient dimethindene 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.

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

Composition

Active Ingredients
1 ml of solution contains: active ingredient dimethindene maleate 1 mg

Excipients
Disodium phosphate dodecahydrate; propylene glycol; benzoic acid; disodium edetate; citric acid monohydrate; sodium saccharin; purified water.

Dosage

Adults and children over 12 years of age: The recommended daily dose is 3–6 mg of dimethindene maleate per day, divided into three administrations. This corresponds to the administration of:
1 mg/ml drops: 20–40 drops 3 times a day

Children
In children under 12 years of age, use the medicine only with a medical prescription.
The recommended daily dose is 0.1 mg/kg of body weight/day, i.e. 2 drops per kg of body weight per day, divided into three daily administrations.
20 drops = 1 ml = 1 mg of dimethindene maleate.
Fenistil drops must not be subjected to high temperatures: add the drops to the bottle at the last moment, when the contents are lukewarm. If the child is able to eat with a spoon, administer the drops undiluted in a teaspoon. Their taste is pleasant.

Elderly
The safety and efficacy of dimethindene in patients over 65 years of age have not been systematically evaluated.

Warnings and precautions

Talk to 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 susceptible to developing certain conditions. subject to side effects such as agitation and fatigue.

What you need to know before taking the medicine
Do not take Fenistil:

• if you are allergic to dimethindene maleate or any of the other ingredients of this medicine;
• if you have a disease characterised by high pressure inside the eye (glaucoma);
• if you have an enlarged prostate (prostatic hypertrophy);
• if you have bladder problems (bladder neck obstruction);
• if you have a narrowing in a part of the stomach or intestine (for example 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 characterised by obstruction of the bronchi (chronic bronchopneumopathy 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 to treat depression and Parkinson's disease (monoamine oxidase inhibitors).

Fenistil should not be used in newborns less than 1 month old, particularly if they were born prematurely.

Take special care:

• if you have severe liver problems;
• to sunlight or sunlamps. You should not expose yourself to sunlight or sunlamps after taking Fenistil, because they may cause liver damage. Antihistamines may cause spots or redness on the skin.

Children

Fenistil should not be used in infants under 1 month of age, especially if born prematurely.
Fenistil should be used with caution in children under 1 year of age, because the sedative effect of the antihistamine may be associated with breathing arrest during sleep. Fenistil should be used in children under 12 years of age only if clearly necessary and after consulting a doctor.
In older children, Fenistil should be used with caution. Antihistamines such as Fenistil may cause excitability.

Interactions

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

Tell your doctor if you are using:

• medicines of the class of monoamine oxidase inhibitors, used for example to treat depression and Parkinson's disease;
• tranquilizers or anxiolytics (medicines used for anxiety);
• opioid analgesics (medicines to reduce pain);
• anticonvulsants (medicines used for epilepsy);
• antihistamines (medicines for allergies);
• antiemetics (medicines used to prevent and suppress vomiting);
• antipsychotics (medicines used in severe psychiatric disorders);
• hypnotics (medicines that induce sleep);
• scopolamine (medicine used to treat conditions characterised by painful cramps in the stomach, intestines, urinary tract or genitals);
• tricyclic antidepressants (medicines used to treat depression);
• bronchodilators (medicines used to treat asthma and bronchopulmonary diseases);
• gastrointestinal antispasmodics (medicines used for stomach and abdominal spasms);
• mydriatics (medicines used to dilate the pupils);
• urological antimuscarinics (medicines used to treat overactive bladder);
• procarbazine (medicine used to treat some cancers e.g. Hodgkin's lymphoma);
• antibiotics. The use of antihistamines may mask the early signs of ear damage from some antibiotics;
• oral anticoagulants (medicines used to reduce blood clotting taken by mouth).

Side effects

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

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

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

• tiredness

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 disorders
• nausea
• dry mouth and throat

Very rare side effects (may affect up to 1 in 1,000 people)

• swelling
• fatigue
• feeling sick
• feeling tired
• feeling sick ... 10,000)
  • skin rash
  • appearance of spots or redness on the skin following exposure to sunlight or sunlamps
  • severe allergic reactions even after the first intake, including swelling (oedema) of the face, throat and difficulty breathing (dyspnoea)
  • signs of excitement such as euphoria, tremor, insomnia, convulsions
  • sedation
  • weakness (asthenia)
  • coordination disorders
  • vision disorders
  • dry nose
  • tightness in the chest and difficulty breathing due to a reduction and thickening of bronchial secretion
  • loss of appetite (anorexia)
  • vomiting
  • diarrhoea or constipation
  • difficulty urinating and urinary retention

  Side effects with unknown frequency (frequency cannot be estimated from the available data)

  • oedema (swelling due to fluid accumulation)
  • skin rash
  • muscle spasms

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

  Reporting of side effects

  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 us to: help provide more information on the safety of this medicine.

  Format

  20 ml bottle

  Product Code:FRCM045993