FENISTIL

FENISTIL coated tablets

Important notes (mandatory information)

Fenistil Dragees, coated tablets. Active ingredient: Dimetindene maleate. Areas of application: 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).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Fenistil Dragees, coated tablets for children from 3 years of age and adults
Active ingredient: Dimetindene maleate 1 mg per coated tablet

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Fenistil Dragees must be taken as directed in order to achieve the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor in any case.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT ARE FENISTIL DRAGEES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FENISTIL DRAGEES?
3. HOW SHOULD FENISTIL DRAGEES BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD FENISTIL DRAGEES BE STORED?
6. FURTHER INFORMATION

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

Fenistil Dragees is an antiallergic agent for the treatment of allergic diseases and itching. Areas of application: 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).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FENISTIL DRAGEES?

Fenistil Dragees must not be taken:

• if you are hypersensitive (allergic) to dimetindene maleate or any of the other ingredients of Fenistil Dragees (see section 6 "Further information").
• by children under 3 years of age.

Special care should be taken when taking Fenistil Dragees:

• in patients with glaucoma.
• in congenital or acquired bladder neck stenosis (prostate hypertrophy).
• in epilepsy.

If any of the above applies to you, ask your doctor before taking the medicine.

When taking Fenistil Dragees with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. Fenistil Dragees should only be taken after consulting your doctor if you are taking/using the following medicines:

• Antidepressants
• Anticholinergics (medicines for stomach or abdominal cramps)
• Sedatives, tranquilizers or sleeping pills
• Antiepileptics (medicines for the treatment of epilepsy)
• Opioid analgesics (strong centrally acting painkillers)
• Antihistamines
• Antiemetics (medicines for nausea and vomiting)
• Procarbazine (cytostatic)

The concomitant use of tricyclic antidepressants could trigger an attack in patients at risk of glaucoma.

When taking Fenistil Dragees with food and drink

Fenistil Dragees, like many antihistamines, can enhance the effect of alcohol.

Children and adolescents

Antihistamines can possibly cause states of excitement in younger children.

Pregnancy and breast-feeding

If you are pregnant, you should only take Fenistil Dragees after consulting your doctor. Taking Fenistil Dragees during breast-feeding is not recommended. Ask your doctor or pharmacist for advice before taking/using any medicine.

Driving and operating machinery

Even when used as intended, this medicine can alter reactions to such an extent that, for example, the ability to actively participate in road traffic or to operate machinery is impaired. This applies to an even greater extent in combination with alcohol.

Important information about certain other ingredients of Fenistil Dragees

This medicine contains glucose, sucrose and lactose. Therefore, please only take Fenistil Dragees after consulting your doctor if you know that you suffer from an intolerance to certain sugars. 1 coated tablet corresponds to approx. 0.008 bread units (BE). If you have to follow a diabetic diet, you should take this into account.

3. HOW SHOULD FENISTIL DRAGEES BE TAKEN?

Always take Fenistil Dragees exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not quite sure.

Unless otherwise prescribed by your doctor, the usual dose is:

• Children from 12 years of age and adults take 1-2 coated tablets 3 times a day.
• Children from 3 to 12 years of age take a maximum of 1 coated tablet 3 times a day.

Method of administration

The coated tablets should be taken with sufficient liquid. Please talk to your doctor or pharmacist if you have the impression that the effect of Fenistil Dragees is too strong or too weak.

If you have taken more Fenistil Dragees than you should

In the event of an overdose, please inform your doctor or pharmacist immediately so that they can decide on the severity and any further measures that may be necessary.

If you forget to take Fenistil Dragees

Do not take twice the amount the next time, but continue taking the medicine as described in the dosage instructions.

If you stop taking Fenistil Dragees

If you interrupt the treatment or stop using the medicine 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 the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Fenistil Dragees can have side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Side effects such as drowsiness can occur especially at the beginning of treatment. In very rare cases, allergic reactions may occur.

Immune system disorders:

• Very rare: anaphylactoid reactions including facial edema, pharyngeal edema, rash, muscle cramps and shortness of breath.

Psychiatric disorders:

• Rare: agitation.

Nervous system disorders:

• Very common: fatigue.
• Common: drowsiness, nervousness.
• Rare: headache, dizziness.

Gastrointestinal disorders:

• Rare: 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 package 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 SHOULD FENISTIL DRAGEES BE STORED?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the folding box and blister.

6. FURTHER INFORMATION

What Fenistil Dragees contain

The active ingredient is dimetindene maleate. 1 coated tablet contains 1 mg dimetindene maleate. The other ingredients are: lactose monohydrate; sucrose; talc; microcrystalline cellulose; macrogol 35,000; glucose syrup; titanium dioxide; magnesium stearate; povidone 29,000; highly dispersed silicon dioxide; montanglycol wax; gelatin.

Appearance of Fenistil Dragees and contents of the pack

Fenistil Dragees are white, round, coated tablets and are available in packs of 20 coated tablets, 50 coated tablets and 100 coated tablets.

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 package leaflet was last revised in June 2016.

Source: Information from the package leaflet
Status: 10/2019
Active ingredient: Dimetindene maleate. Areas of application: 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).