Fenistil

Package leaflet: Information for the patient

Fenistil 0.1% gel

dimetindene maleate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 5–7 days.

Contents of this leaflet:

1. What Fenistil gel is and what it is used for
2. What you need to know before using Fenistil gel
3. How to use Fenistil gel
4. Possible side effects
5. How to store Fenistil gel
6. Contents of the pack and other information

1. What Fenistil gel is and what it is used for

Fenistil gel contains the active substance dimetindene maleate, which belongs to a group of medicines known as "antihistamines", and is used to relieve itching of various origins and local inflammatory reactions.
Fenistil gel is indicated for the local treatment of symptoms associated with:

• inflammatory skin conditions accompanied by itching (pruritic dermatoses)
• sunburn (solar erythema)
• insect bites.

Consult your doctor if you do not feel better or if you feel worse after 5–7 days.

2. What you need to know before using Fenistil gel

Do not use Fenistil gel

• if you are allergic to dimethindene maleate or to any of the other ingredients of this medicine (listed in section 6)
• under occlusive dressings, i.e. bandages that do not allow air to pass through

Warnings and precautions
Talk to your doctor or pharmacist before using Fenistil gel.
Take particular care:

• do not apply Fenistil gel over large areas of skin, especially on damaged or inflamed skin, blistered areas, open sores, or surfaces producing serum or pus
• avoid contact of Fenistil gel with the eyes
• avoid prolonged exposure to sunlight of the treated areas
• the use, particularly if prolonged, of topical medicines may cause skin reactions. If this occurs, stop treatment with Fenistil gel and consult your doctor, who will recommend appropriate therapy.

Children
Fenistil gel should be used in children under 2 years of age only after consulting a doctor.
In infants and young children, do not use Fenistil gel over large areas of skin, and especially on areas of damaged or inflamed skin.

Other medicines and Fenistil gel
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those not requiring a prescription.
Fenistil gel is only minimally absorbed into the body; therefore, interactions with other medicines are very unlikely.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Fenistil gel may be used during pregnancy and breastfeeding only after consulting a doctor, in cases of clear medical need, and solely under direct medical supervision.
Do not apply Fenistil gel over large areas of skin, especially if inflamed or damaged, or on the breasts during breastfeeding.

Driving and using machines
Fenistil gel does not affect or affects negligibly the ability to drive and use machines.

Fenistil gel contains propylene glycol and benzalkonium chloride
Fenistil gel contains 300 mg of propylene glycol per dose (2 g of gel), equivalent to 150 mg/g of gel, which may cause skin irritation.
Fenistil gel contains 0.1 mg of benzalkonium chloride per dose (2 g of gel), equivalent to 0.05 mg/g of gel, which may irritate the skin.
If you are breastfeeding, do not apply this medicine on the breast, as the infant could ingest it through breast milk.

3. How to use Fenistil gel

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Be careful not to exceed the recommended doses without medical advice. Use Fenistil gel only for short periods of treatment (no longer than 5-7 days).

• Apply a small amount of Fenistil gel to the affected area, 2-3 times daily (every 8-12 hours), depending on the intensity of itching and/or other inflammatory symptoms.
• Gently massage to promote deeper penetration of the gel.

If you use more Fenistil gel than you should
If Fenistil gel is accidentally swallowed or if an excessive dose is used, contact your doctor immediately or go to the nearest hospital.
If you have accidentally swallowed Fenistil gel, you may experience: drowsiness (especially in adults), stimulation of the central nervous system (particularly in children and elderly patients) with excitement, loss of coordination (ataxia), hallucinations, muscle contractions, dilation of the pupil of the eye (mydriasis), dry mouth, facial flushing, urinary retention, fever. You may also experience low blood pressure.
Your doctor will treat an overdose of Fenistil gel according to your condition.

If you forget to use Fenistil gel
Do not use a double dose to make up for the missed dose.

If you stop using Fenistil gel
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment and consult your doctor if you experience any of the following side effects during treatment with Fenistil gel:

Uncommon side effects (may affect up to 1 in 100 people)

• dry skin
• skin burning sensation

Very rare side effects (may affect up to 1 in 10,000 people)

• allergic inflammation of the skin (allergic dermatitis)

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

• skin allergic reactions

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may 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.

5. How to store Fenistil gel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the packaging and the leaflet.

6. Package contents and other information

What Fenistil gel contains

• The active substance is dimethindene maleate. 100 g of gel contain 100 mg of dimethindene maleate (equivalent to 71.6 mg of dimethindene).
• The other ingredients are benzalkonium chloride, edetate disodium, carbomer, sodium hydroxide, propylene glycol, purified water.

Description of the appearance of Fenistil gel and contents of the pack
Each pack contains one tube of 30 g of gel for cutaneous use.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan, Italy
Manufacturer
Haleon Germany GmbH,
Barthstraße 4, 80339
Munich (Germany)

Package leaflet: information for the patient

Fenistil 1 mg/ml oral drops, solution, 1 mg coated tablets

dimetindene maleate
Please read this leaflet carefully before taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

1. What Fenistil is and what it is used for
2. What you need to know before taking Fenistil
3. How to take Fenistil
4. Possible side effects
5. How to store Fenistil
6. Contents of the pack and other information

1. What Fenistil is and what it is used for

Fenistil contains the active substance dimetindene maleate, which belongs to a 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 food.

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

2. What you need to know before taking Fenistil

Do not take Fenistil

• if you are allergic to dimethindene maleate or to any of the other ingredients of this medicine (listed in section 6)
• if you have a disease characterized by increased 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 of a portion of the stomach or intestine (e.g. of the pylorus or duodenum)
• if you have a narrowing of a portion of the urinary or genital tract
• if you have asthma
• if you have a lung disease characterized by obstruction of the bronchi (chronic obstructive pulmonary disease)
• if you have heart or blood vessel problems
• if you have high blood pressure
• if you have an overactive thyroid gland (hyperthyroidism)
• if you have epilepsy
• if you are taking other medicines, for example for the treatment of depression and Parkinson’s disease (monoamine oxidase inhibitors) (see section “Other medicines and Fenistil”).

Fenistil must not be used in infants under 1 month of age, especially if born prematurely.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fenistil.
Do not exceed the recommended dose and use only for short treatment periods.
Elderly patients should consult their doctor before taking Fenistil, as they are more susceptible to
adverse effects such as agitation and fatigue.
Exercise particular caution:

• if you have severe liver problems
• regarding exposure to sunlight or solar lamps. You must not expose yourself to sunlight or solar lamps after taking Fenistil, because antihistamines can cause skin spots or redness.

Children
Fenistil must 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 when strictly necessary and after consulting a doctor.
In younger children, antihistamines such as Fenistil may cause excitability.
Other medicines and Fenistil
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.
Inform your doctor if you are taking:

• medicines belonging to the class of monoamine oxidase inhibitors, used for example in the treatment of depression and Parkinson’s disease
• tranquillisers 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 (a medicine used to treat conditions characterized by painful stomach, intestinal, urinary or genital cramps)
• tricyclic antidepressants (medicines used for the treatment of depression)
• bronchodilators (medicines used for the treatment of asthma and bronchopulmonary diseases)
• gastrointestinal antispasmodics (medicines used for abdominal and stomach spasms)
• mydriatics (medicines used to dilate the pupils)
• urological antimuscarinics (medicines used to treat overactive bladder)
• procarbazine (a medicine used for the treatment of certain tumours, e.g. Hodgkin's lymphoma)
• antibiotics. The use of antihistamines may mask the early signs of ear damage caused by some antibiotics.
• oral anticoagulants (medicines used to reduce blood coagulation taken by mouth).

Fenistil and alcohol
Do not consume alcohol during treatment with Fenistil, as it may cause adverse effects that could even endanger your life.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Pregnant women should consult their doctor before taking this medicine.
Breastfeeding
Fenistil is not recommended during breastfeeding.
Driving and using machines
Fenistil may cause drowsiness and slowed reflexes, thus it may impair your ability to drive vehicles or operate machinery.
Fenistil 1 mg film-coated tablets contain lactose, sucrose and wheat starch.
Fenistil 1 mg film-coated tablets contain lactose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Fenistil 1 mg film-coated tablets contain wheat starch. The wheat starch in this medicine contains only a very small amount of gluten; it is very unlikely to cause problems if you have coeliac disease.
One tablet contains no more than 0.2 micrograms of gluten.
If you are allergic to wheat (a condition different from coeliac disease), do not take this medicine.
Fenistil 1 mg/ml oral drops, solution contains benzoic acid and propylene glycol.
This medicine contains 2 mg of benzoic acid per dose (40 drops), equivalent to 1 mg/ml.
This medicine contains 200 mg of propylene glycol per dose (40 drops), equivalent to 100 mg/ml.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.
Fenistil 1 mg/ml oral drops, solution contains less than 1 mmol (23 mg) of sodium per dose (40 drops), i.e. essentially 'sodium-free'.

3. How to take Fenistil

Take this medicine exactly as stated in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses. Take Fenistil only for short-term treatment. In addition, take particular care when determining the dose in children and elderly patients.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment, if the condition recurs repeatedly, or if you notice any recent changes 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 doses, i.e.:

• 20–40 drops three times a day, or
• 1–2 coated tablets three times a day.

The coated tablets must be swallowed whole with a little water or other liquid.
If you experience drowsiness, it is recommended to take 2 coated tablets (or alternatively 40 drops) in the evening before going to bed and 1 coated tablet (or alternatively 20 drops) with breakfast.

Use in children under 12 years of age
Use only after consulting your doctor.
The recommended daily dose is 0.1 mg per kilogram of body weight per day, corresponding to 2 drops per kilogram of body weight per day, divided into three daily doses.
Do not expose Fenistil oral drops to high temperatures: if you need to administer Fenistil oral drops to a young child, add the drops to the feeding bottle only when the contents are lukewarm.
If the child is able to eat with a spoon, place the undiluted drops into a teaspoon. The drops have a pleasant taste.

Use in the elderly
The dose of Fenistil should be carefully determined in elderly patients (over 65 years of age), as the safety and efficacy of Fenistil have not been thoroughly evaluated in this population.

How to open and close the Fenistil oral drops bottle

OPENING: CLOSING:
Turn anticlockwise Screw the cap tightly
while pressing down on the cap by turning clockwise

If you take more Fenistil than you should
In case of accidental ingestion of an excessive dose of Fenistil, contact your doctor immediately or go to the nearest hospital.
If you have taken an excessive dose of Fenistil, you may experience: drowsiness (especially in adults), central nervous system stimulation (especially in children) with excitement, loss of coordination (ataxia), hallucinations, tremors, seizures, muscle contractions, dilation of the pupil of the eye (mydriasis), dry mouth, facial flushing, urinary retention, and fever. You may also experience low blood pressure.
Your doctor will treat the overdose based on your condition.

If you forget to take Fenistil
Do not take a double dose to make up for the missed dose.

If you stop taking Fenistil
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 disturbances
• nausea
• dryness of the 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 solar lamps
• severe allergic reactions, even after the first dose, including swelling (edema) of the face, throat, and breathing difficulties (dyspnea)
• signs of excitation such as euphoria, tremor, insomnia, seizures
• sedation
• weakness (asthenia)
• coordination disturbances
• visual disturbances
• dry nose
• chest tightness and breathing difficulties due to reduced and thickened bronchial secretions
• 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)

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may 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.

5. How to store Fenistil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 packaging to protect the medicine from light.
Once opened, the medicine may be used until the expiry date stated on the packaging.
It is important to always keep the medicine information available; therefore, retain both the carton and the leaflet.

6. Package contents and other information

What Fenistil contains
Fenistil 1 mg coated tablets

• The active substance is dimethinden maleate. Each tablet contains 1 mg of dimethinden maleate (equivalent to 0.72 mg of dimethinden).
• The other components are lactose, wheat starch, magnesium stearate, talc, sucrose, calcium carbonate, arabic gum, titanium dioxide, macrogol.

Fenistil 1 mg/ml oral drops, solution

• The active substance is dimethinden maleate. 1 ml of solution contains 1 mg of dimethinden maleate.
• The other components are disodium phosphate dodecahydrate, propylene glycol, benzoic acid, disodium edetate, citric acid monohydrate, sodium saccharin, purified water.

Description of the appearance of Fenistil and package contents
Fenistil 1 mg coated tablets
Each pack of Fenistil 1 mg coated tablets contains 30 coated tablets, packaged in blisters.
Fenistil 1 mg/ml oral drops, solution
Each pack of Fenistil 1 mg/ml oral drops, solution contains a 20 ml bottle of solution with a dropper.

Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan, Italy

Manufacturer
Fenistil 1 mg/ml oral drops, solution
Haleon Germany GmbH,
Barthstraße 4, 80339
Munich (Germany)

Fenistil 1 mg coated tablets
Novartis Farmacéutica SA
Barberà del Vallès
Barcelona - Spain
or
Recipharm Uppsala AB
Björkgatan 30,
Uppsala - Sweden