FENISTIL

FENISTIL drops

Important notes (mandatory information)

Fenistil drops. Active ingredient: Dimetindene maleate.

Indications

for the symptomatic relief of histamine-related itching; chickenpox-associated itching in small children; allergic rhinitis in patients over 6 years of age; hives (urticaria); insect bites.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Fenistil drops, oral solution
Active ingredient: Dimetindene maleate 1 mg/ml

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

What this leaflet contains

1. WHAT ARE FENISTIL DROPS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FENISTIL DROPS?
3. HOW TO TAKE FENISTIL DROPS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE FENISTIL DROPS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE FENISTIL DROPS AND WHAT ARE THEY USED FOR?

Fenistil drops contain dimetindene maleate. They belong to a group of medicines called antihistamines. They are used to relieve the symptoms of allergies such as rash, itching, hay fever or other forms of allergic rhinitis. Fenistil drops inhibit the action of histamine. Histamine is a substance that the body releases during an allergic reaction. It relieves the itching and irritation caused by the rash, reduces swelling and relieves the symptoms of allergic rhinitis such as runny nose, sneezing, itchy nose and itchy, watery eyes.

Indications

For the symptomatic relief of:

• histamine-related itching;
• chickenpox-associated itching in small children;
• allergic rhinitis in patients over 6 years of age;
• hives (urticaria);
• insect bites.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FENISTIL DROPS?

Fenistil drops must not be taken:

• if you are allergic to dimetindene maleate or or any of the other ingredients of this medicine listed in section 6.
• Infants and children under 1 year of age must not take Fenistil drops.

Warnings and precautions

Please talk to your doctor before taking Fenistil drops if any of the following apply to you:

• Glaucoma
• congenital or acquired enlargement of the prostate (bladder neck stenosis/prostate hypertrophy)
• Epilepsy.

Children and adolescents

Antihistamines may cause agitation in younger children.

Taking Fenistil drops with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Fenistil drops should only be taken after consulting your doctor if you are taking/using the following medicines:

• Antidepressants (tricyclic antidepressants and monoamine oxidase inhibitors)
• Anticholinergics such as medicines for asthma or bronchospasm, stomach or abdominal cramps, pupil-dilating medicines (mydriatics), medicines for urge incontinence and overactive bladder (urological antispasmodics)
• Medicines that have a sedative effect on the central nervous system (sedatives), anti-anxiety medications (anxiolytics) or sleeping pills (hypnotics, neuroleptics)
• Medicines for the treatment of epilepsy (anticonvulsants)
• strong, centrally acting painkillers (opioid analgesics)
• Antihistamines (medicines for the treatment of cough, cold or allergies)
• Medicines for nausea and vomiting (antiemetics)
• Procarbazine (a medicine for the treatment of cancer)
• Scopolamine (a medicine for motion sickness)
• Alcohol

The concomitant use of tricyclic antidepressants or anticholinergics may increase the risk of worsening glaucoma or urinary retention. In addition, the concomitant use of tricyclic antidepressants in patients at risk of glaucoma could trigger a seizure.

Taking Fenistil drops with alcohol

Fenistil drops, like many antihistamines, can enhance the effects of alcohol. Alcohol can enhance the sedative effect of Fenistil.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Taking Fenistil drops during breast-feeding is not recommended.

Driving and using machines

Like many other antihistamines, Fenistil can cause drowsiness or impair attention in some people. In this case, caution is advised when driving or operating machinery. This applies to an even greater extent in combination with alcohol.

3. HOW TO TAKE FENISTIL DROPS?

Take Fenistil drops exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• Adults and adolescents aged 12 years and over take 20 – 40 drops 3 times a day. For patients who tend to be drowsy, it is recommended to take 40 drops before bedtime and 20 drops in the morning.
• Children aged 1 to 11 years: The recommended daily dose is 2 drops per kg body weight, divided into 3 single doses. Body weight (KG) times 2, then divided by 3 equals the number of drops to be taken 3 times a day (2 x KG/3). Example: A child weighing 15 kg should take 10 drops 3 times a day.

Dosage examples

Weight in kg	Number of drops 3x daily
7.5	5
10.5	7
15	10
18	12
22.5	15
25.5	17
30	20
33	22
37.5	25
40.5	27
45	30
48	32

• Elderly people (aged 65 years and over): The usual dose for adults should be taken.

Instructions for use

To drop, hold the bottle vertically downwards. If you have difficulty dripping, tap the bottom of the bottle several times with your finger. For patients who tend to be drowsy, it is recommended to take 40 drops before bedtime and 20 drops in the morning. The drops are taken undiluted (e.g. with a teaspoon).

Please talk to your doctor or pharmacist if you have the impression that the effect of Fenistil drops is too strong or too weak.

If you have taken more Fenistil drops than you should

In case of overdose, please inform your doctor or pharmacist immediately so that he/she can decide on the severity and any further measures required.

If you forget to take Fenistil drops

Do not take double the amount if you have forgotten the previous dose, but continue taking as described in the dosage instructions.

If you stop taking Fenistil drops

If you interrupt the treatment or stop taking it prematurely, you must expect that the desired effect will not occur or that the symptoms will worsen again. Therefore, please consult your doctor or pharmacist if you want to stop or interrupt the treatment.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Fenistil drops can have side effects, although not everybody gets them. Stop taking Fenistil drops immediately and see a doctor if you notice any of the following symptoms, which may be signs of an allergic reaction:

• Shortness of breath or difficulty swallowing
• Swelling of the face, lips, tongue or throat
• severe itching with rash, muscle cramps

These side effects are very rare (may affect up to 1 in 10,000 people).

Other side effects that may occur are usually mild and transient. The more common side effects occur especially at the beginning of treatment.

Very common side effect (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
• Gastrointestinal complaints, nausea, dry mouth, dry throat

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE FENISTIL DROPS?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 25°C. Store the bottle in the outer carton. Note on shelf life after opening Shelf life after opening 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fenistil drops contain

The active ingredient is dimetindene maleate. 1 ml solution (approx. 20 drops) contains 1 mg dimetindene maleate. The other ingredients are: Purified water; sodium monohydrogen phosphate dodecahydrate; citric acid monohydrate; benzoic acid; sodium edetate; saccharin sodium; propylene glycol.

What Fenistil drops look like and contents of the pack

Fenistil drops are a clear, colourless oral solution and are available in packs of 20 ml, 50 ml and 60 ml (3 x 20 ml) solution. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
80258 Munich

Barthstraße 4
80339 Munich

Telephone (089) 78 77-209
Telefax (089) 78 77-304
E-mail: medical.contactcenter@gsk.com

This leaflet was last revised in February 2017.

Source: Package leaflet information
Status: 10/2019
Active ingredient: Dimetindene maleate. Indications: for the symptomatic relief of histamine-related itching; chickenpox-associated itching in small children; allergic rhinitis in patients over 6 years of age; hives (urticaria); insect bites.