Active ingredients: Dimethindene (dimethindene maleate)
Fenistil 1 mg / ml oral drops, solution
Fenistil 1 mg coated tablets
Why is Fenistil used? What is it for?
Fenistil contains the active substance 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.
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment.
Contraindications When Fenistil should not be used
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 characterized by "high pressure in the eye" (glaucoma)
- if you have an enlarged prostate (prostatic hypertrophy)
- if you have bladder problems (bladder neck obstructions)
- if you have a narrowing of a part of the stomach or intestines (for example the pylorus or duodenum)
- if you have a narrowing of the urinary or genital tract
- if you have asthma
- if you have lung disease characterized by 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 eg to treat depression and Parkinson's (monoamine oxidase inhibitors) (see section "Other medicines and Fenistil").
- if you are pregnant or breast-feeding (see section "Pregnancy and breast-feeding").
Fenistil should not be used in infants less than 1 month of age, particularly if born premature
Precautions for use What you need to know before taking Fenistil
Talk to your doctor or pharmacist before taking Fenistil.
Pay particular attention:
- if you have severe liver problems
- in sunlight or sunlamps. You should not expose yourself to sunlight or sunlamps after taking Fenistil, as antihistamines can cause spots or redness on the skin.
Children
Fenistil should not be used in infants less than 1 month of age, particularly if born premature.
Fenistil should be used with caution in children less than 1 year of age, because the sedative effect of the antihistamine may be associated with stopping breathing during sleep.
Fenistil should be used in children under the age of 12 only in cases of real need and after consulting your doctor.
In younger children, antihistamines such as Fenistil can cause excitability.
Interactions Which drugs or foods can modify the effect of Fenistil
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.
Tell your doctor if you are using:
- medicines of the class of monoamine oxidase inhibitors, used for example for the treatment of depression and for Parkinson's
- tranquilizers or anxiolytics (medicines used for anxiety)
- opioid analgesics (medicines to reduce pain)
- anticonvulsants (medicines used for epilepsy)
- antihistamines (allergy medicines)
- 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 characterized 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 can mask the early signs of ear damage from some antibiotics.
- oral anticoagulants (medicines used to reduce blood clotting taken by mouth).
Fenistil with alcohol
Do not drink alcohol while being treated with Fenistil as it can cause side effects which can also be life threatening.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Fenistil should not be used during pregnancy or if you suspect or are planning to become pregnant.
Feeding time
Fenistil should not be used during breastfeeding.
Driving and using machines
Fenistil may cause drowsiness and slow reflexes, therefore it may reduce the ability to drive or use machines.
Fenistil 1 mg coated tablets contain lactose, sucrose and wheat starch.
Fenistil 1 mg coated tablets contain lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Fenistil 1 mg coated tablets contain wheat starch. This medicine can be given to people with celiac disease. People with wheat allergy (other than celiac disease) should not take this medicine.
Dose, Method and Time of Administration How to use Fenistil: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist. Do not exceed the recommended doses. Do not take Fenistil for long periods of time. Also, take special care in determining the dose in children and the elderly.
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment, if the disorder occurs repeatedly or if you notice any recent change in its characteristics.
Use in adults and children over 12 years of age
The recommended daily dose is 3-6 mg of Fenistil per day, divided into 3 administrations, i.e .:
- 20-40 drops 3 times a day or
- 1-2 coated tablets 3 times a day.
The coated tablets should be swallowed whole with some water or other liquid.
If you suffer from drowsiness it is recommended to take 2 coated tablets (or alternatively 40 drops) in the evening before going to sleep and 1 coated tablet (or alternatively 20 drops) during breakfast.
Use in children under 12 years
Use only after consulting your doctor.
The recommended daily dose is 0.1 mg per kilogram of body weight per day, which corresponds to 2 drops per kilogram of body weight per day, divided into three doses per day.
Do not expose Fenistil oral drops to high temperatures: if you have to give Fenistil oral drops to a small child, add the drops to the bottle only when the contents are warm.
If the child is able to eat with the spoon, put the undiluted drops in a coffee spoon.
The drops have a pleasant taste.
Use in the elderly
The dose of Fenistil should be carefully determined in the elderly (over 65 years) as the safety and efficacy of Fenistil have not been accurately evaluated.
How to open and close the bottle of Fenistil oral drops
OPENING: Turn counterclockwise while holding the cap
CLOSURE: Screw the cap fully on by turning it clockwise
Overdose What to do if you have taken too much Fenistil
If you take more Fenistil than you should
In case of accidental ingestion of an excessive dose of Fenistil, notify your doctor immediately or go to the nearest hospital.
If you have taken an overdose of Fenistil you may experience: drowsiness (especially in adults), stimulation of the central nervous system (especially in children) with excitement, loss of movement coordination (ataxia), hallucinations, tremors, convulsions, muscle twitching, dilation of the pupil of the eye (mydriasis), dry mouth, flushing of the face, urinary retention, fever. You may also experience low blood pressure.
Your doctor will treat the ingestion of an overdose of Fenistil based on your condition.
If you forget to take Fenistil
Do not take a double dose to make up for a forgotten dose.
If you stop taking Fenistil
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Fenistil
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 disorders
- 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 intake, including swelling (edema) of the face, throat and difficulty in breathing (dyspnoea)
- signs of arousal e.g. euphoria, tremor, insomnia, convulsions
- sedation
- weakness (asthenia)
- coordination disorders
- visual disturbances
- dryness of the nose
- tightness in the chest and difficulty in breathing due to a reduction and thickening of bronchial secretion
- loss of appetite (anorexia)
- He retched
- diarrhea or constipation
- difficulty urinating and urinary retention
Undesirable effects with frequency not known (frequency cannot be estimated from the available data)
- edema (swelling from fluid accumulation)
- rash on the skin
- muscle spasms
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable 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/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after Expiry. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Fenistil 1 mg coated tablets
Store in the original packaging.
Fenistil 1 mg / ml oral drops, solution
Store below 25 ° C.
Keep the bottle in the original package to protect the medicine from light.
The shelf life after first opening the bottle is 2 years.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
What Fenistil contains
Fenistil 1 mg coated tablets
- The active ingredient is dimethindene maleate. Each tablet contains 1 mg of dimethindene maleate (equivalent to 0.72 mg of dimethindene)
- The other ingredients are lactose, wheat starch, magnesium stearate, talc, sucrose, calcium carbonate, gum arabic, titanium dioxide, macrogol.
Fenistil 1 mg / ml oral drops, solution
- The active ingredient is dimethindene maleate. 1ml of solution contains 1 mg of dimethindene maleate
- The other ingredients are disodium phosphate dodecahydrate, propylene glycol, benzoic acid, disodium edetate, citric acid monohydrate, sodium saccharin, purified water.
What Fenistil looks like and contents of the pack
Fenistil 1 mg coated tablets
Each pack of Fenistil 1 mg coated tablets contains 30 coated tablets, packed in blisters.
Fenistil 1 mg / ml oral drops, solution
Each package of Fenistil 1 mg / ml oral drops, solution contains a bottle of 20 ml of solution, equipped with a dropper.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FENISTIL 1 MG / ML ORAL DROPS, SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fenistil oral drops, solution
1 ml of solution contains: active ingredient dimethindene maleate 1 mg.
For the full list of excipients, see section 6.1
Fenistil coated tablets
Each coated tablet contains: active ingredient dimethindene maleate 1 mg.
Excipients: lactose, sucrose, wheat starch.
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Oral drops, solution
Coated tablets
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
- Symptomatic treatment of itching of various origins
- Symptomatic treatment of medical and food allergies
04.2 Posology and method of administration
Adults and children over 12 years of age:
The usual daily dose is 3-6 mg of dimethindene maleate per day, divided into three doses.
This corresponds to the administration of:
- 1 mg / ml drops: 20-40 drops 3 times a day
- 1 mg coated tablets: 1-2 coated tablets 3 times a day
In patients with a tendency to drowsiness, 2 coated tablets (or 40 drops) are prescribed in the evening, before bedtime and 1 coated tablet (or 20 drops) during breakfast.
In severe cases this dose can be increased to 1 tablet 3 times a day.
Children
In children under the age of 12, use the medicine only on prescription.
The daily dose is approximately 0.1 mg / kg of body weight. Therefore, the usual dose for children aged 1 month to 12 years of age is as follows, divided into 3 doses per day:
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 warm. If the child is able to eat with a spoon, administer the drops undiluted in a coffee spoon. taste is pleasant.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients (see section 6.1) or other closely related substances from a chemical point of view. Glaucoma, prostatic hypertrophy, bladder neck obstructions, pyloric, duodenal or other tracts of the gastrointestinal and urogenital tracts. Asthma and chronic obstructive pulmonary disease. Cardiovascular diseases and hypertension. Hyperthyroidism. Epilepsy. Concomitant treatment with monoamine oxidase inhibitors. Pregnancy and lactation. Infants under the age of 1 month In children under the age of 12 use the medicine only on prescription.
04.4 Special warnings and appropriate precautions for use
Use with caution in patients with severe liver disease.
Antihistamines can cause photosensitization: after administering the medicine avoid exposure to sunlight.
Pediatric population
Particular attention should be paid to determining the dose in children and the elderly. In children under the age of 12, use the medicine only on prescription. Caution is recommended when administering any antihistamine to children under 1 year of age: the sedative effect may be associated with episodes of sleep apnea.
Keep this medicine out of the reach and sight of children.
Information on excipients:
Fenistil tablets contains
- lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
- sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicine.
Fenistil tablets contain wheat starch (which may contain gluten, but only in trace amounts): this medicine can be given to people with celiac disease. People with wheat allergy (other than celiac disease) should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
The CNS effect of CNS depressants (such as tranquilizers, opioid analgesics, anticonvulsants, antihistamines, antiemetics, antipsychotics, anxiolytics, hypnotics and alcohol) can be enhanced by dimethindene maleate. life in danger.
Tricyclic antidepressants and anticholinergics may exert an additive antimuscarinic effect with that of antihistamines, increasing the risk of worsening glaucoma or urinary retention.
To minimize CNS depression and possible potentiation, the concomitant administration of procarbazine and antihistamines should be used with caution.
The use of antihistamines can mask the early signs of ototoxicity of some antibiotics and can reduce the duration of action of oral anticoagulants.
04.6 Pregnancy and lactation
The safety of use during pregnancy has not been evaluated in humans. Fenistil is contraindicated in pregnancy and lactation.
04.7 Effects on ability to drive and use machines
At common therapeutic doses, the most frequent undesirable effect is sedation which can cause drowsiness, of which those who drive vehicles or who attend to operations that require integrity of the degree of vigilance must be warned.
04.8 Undesirable effects
Undesirable effects include drowsiness, especially at the start of treatment. In very rare cases, allergic reactions may occur.
Side effects are listed below according to system organ classes and frequency. Frequencies are defined as: very common (≥1 / 10); common (≥1 / 100,
Skin and subcutaneous tissue disorders:
Isolated cases of edema, skin rash.
Musculoskeletal and connective tissue disorders:
Muscle spasm.
Disorders of the immune system
Very rare: rash, photosensitization, anaphylactoid reactions (including face edema, pharyngeal edema and dyspnoea).
Psychiatric disorders
Rare: agitation
Very rare: signs of arousal (such as euphoria, tremor, insomnia, convulsions).
Nervous system disorders
Very common: fatigue
Common: somnolence, nervousness
Rare: headache, dizziness
Very rare: sedation, asthenia, coordination disturbances, visual disturbances.
Respiratory, thoracic and mediastinal disorders
Very rare: dry nose, reduction and thickening of bronchial secretion accompanied by chest tightness and difficulty in breathing.
Gastrointestinal disorders
Rare: gastrointestinal disturbances, nausea, dry mouth and throat
Very rare: anorexia, vomiting, diarrhea or constipation.
Renal and urinary disorders
Very rare: difficulty in urination and urinary retention.
04.9 Overdose
In case of overdose, as with other H1 antihistamines, the following symptoms may occur: depression of the central nervous system with drowsiness (especially in adults), stimulation of the central nervous system and anticholinergic effects (especially in children) with excitement, ataxia, hallucinations, tonic-clonic spasms, mydriasis, dry mouth, flushing of the face, urinary retention and fever. Hypotension may also appear. In the terminal phase there can be worsening coma with cardiorespiratory collapse and death.
No lethal outcome has been reported following overdose of Fenistil.
There is no specific antidote in case of an overdose of antihistamines; the usual emergency measures should be implemented: induction of vomiting, gastric lavage if it has not been possible to induce vomiting, administration of activated charcoal, saline laxatives and the usual cardio-respiratory support measures. Do not administer stimulants; vasopressor drugs can be used to treat hypotension.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antihistamines for systemic use.
ATC code: R06AB03.
Mechanism of action and pharmacodynamic effects
Dimethindene maleate, a phenindene derivative, is a histamine antagonist at the H1 receptor level. It has a high affinity to bind to these receptors.
In vitro studies have shown a favorable relationship between the concentrations of dimethindene which determine on the one hand the inhibition and on the other hand the induction of the release of histamine by the peritoneal mast cells of the rat.
Furthermore, dimethindene maleate has been shown to exhibit a certain antichininic activity and a modest anticholinergic activity.
It considerably reduces the hyper-impermeability of the capillaries which accompanies the immediate hypersensitivity reactions.
In combination with an H2-type antihistamine it suppresses virtually all the effects of histamine on the circulatory level.
In studies of wheal and histamine erythema, the mean duration of effect of a single 4 mg dose of dimethindene in drop form was approximately 24 hours; the maximal inhibition of the wheal and erythema areas by the long-acting drops and tablets was comparable.
05.2 Pharmacokinetic properties
The systemic bioavailability of dimethindene drops is about 70%; Following administration of a single 4 mg dose of dimethindene as drops, the maximum serum concentration was approximately 14 mg / mL and the area under the plasma concentration curve (AUC) was approximately 101 h. ng.ml-1.
T-max was achieved within 2 hours of administration of the oral solution or coated tablets. The apparent half-life of dimethindene was approximately 6 hours.
At concentrations between 0.2 and 5 mcM, approximately 90% of dimethindene is bound to plasma proteins.
Metabolic processes include hydroxylation and methoxylation of the compound. Dimethindene and its metabolites are excreted by both the bile and the urine.
5-10% of the administered dose of dimethindene is excreted unchanged in the urine.
05.3 Preclinical safety data
The toxicology of dimethindene maleate has been accurately determined in both rodents and non-rodents using various routes of administration. The LD50 was found to be respectively: 800 and 630 mg / kg in rat and mouse orally, 110 and 137 mg / kg in rat and mouse by intraperitoneal route and 20 and 40 mg / kg in rat and dog by route. intravenous.
During the chronic toxicity tests carried out in the rat (12 months per os) and in the dog (6 months per os) no particular toxic effects were highlighted.
All studies have shown that dimethindene maleate does not have mutagenic potential.
The research carried out on animals aimed at evaluating the safety of the preparation did not show either a potential teratogenic power or other undesirable effects affecting the embryo and / or the fetus.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Fenistil oral drops
Disodium phosphate dodecahydrate; propylene glycol; benzoic acid; edetate disodium; citric acid monohydrate; sodium saccharin; purified water.
Fenistil coated tablets
Lactose, wheat starch, magnesium stearate, talc, sucrose, calcium carbonate, gum arabic, titanium dioxide, macrogol.
06.2 Incompatibility
None known.
06.3 Period of validity
Oral drops, solution:
- in intact packaging: 3 years
- after first opening: 2 years
Coated tablets: 5 years
06.4 Special precautions for storage
Fenistil coated tablets: store in the original container.
Fenistil oral drops: store below 25 ° C. Keep the bottle in the carton to protect from light.
06.5 Nature of the immediate packaging and contents of the package
Oral drops, solution
20 ml dropper bottle in dark glass with safety cap.
Coated tablets
Carton of 30 coated tablets of 1 mg in opaque PVC blisters.
06.6 Instructions for use and handling
The unused product and the waste derived from this medicine must be disposed of in the appropriate drug collectors at pharmacies.
07.0 MARKETING AUTHORIZATION HOLDER
Novartis Consumer Health S.p.A., Origgio (VA)
08.0 MARKETING AUTHORIZATION NUMBER
20 ml oral drops, A.I.C. solution n. 020124020
30 coated tablets A.I.C. n. 020124018
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: 01.06. 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 29.01.2011
