DORM

DORM tablets

Important notes (mandatory information)

Dorm Tablets. Active ingredient: Diphenhydramine hydrochloride. Areas of application: is a remedy for difficulty falling asleep and staying asleep.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Dorm Tablets 50 mg
Active ingredient: Diphenhydramine hydrochloride

Read the entire package leaflet carefully because it contains important information for you. This medicine is also available without a prescription. However, Dorm 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 side effects listed here affect you significantly or if you notice side effects that are not listed in this package leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS DORM AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING DORM?
3. HOW TO TAKE DORM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DORM?
6. FURTHER INFORMATION

1. WHAT IS DORM AND WHAT IS IT USED FOR?

Dorm is a remedy for difficulty falling asleep and staying asleep.

2. WHAT YOU NEED TO KNOW BEFORE TAKING DORM?

Dorm must not be taken in the case of:

• acute asthma,
• glaucoma,
• enlarged prostate.

In the case of stomach and/or duodenal ulcers as well as narrowed gastrointestinal passage and narrowing of the bladder outlet, intolerances may occur when taking diphenhydramine hydrochloride. Diphenhydramine hydrochloride should not be taken in the case of epilepsy and during pregnancy. This medicine contains lactose and sorbitol. Therefore, please only take Dorm after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

Taking Dorm 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. The effect of these medicines may be intensified if diphenhydramine hydrochloride is taken at the same time as other centrally acting medicines (e.g. psychotropic drugs, sleeping pills, painkillers). This applies in particular to simultaneous alcohol consumption.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking/using any medicines. Diphenhydramine hydrochloride should not be taken during pregnancy.

Driving and operating machinery

Even when used as intended, the ability to react can be affected to such an extent that the ability to actively participate in road traffic or to operate machinery is impaired. This should therefore be taken into account when taking the medicine during the day.

3. HOW TO TAKE DORM?

Always take Dorm exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not quite sure. Unless otherwise prescribed, adults should take 1 tablet 15 to 30 minutes before going to bed with a little liquid in the case of waking up at night or difficulty falling asleep. If diphenhydramine hydrochloride is taken to treat sleep disorders, it is important to ensure that there is sufficient time to sleep in order to avoid impairments to the ability to react (driving ability) the following morning. In the case of acute sleep disorders or acute anxiety, treatment should be limited to single doses if possible. In order to check the need for continued use in the case of chronic sleep disorders or chronic anxiety neurosis, the dose should be gradually reduced and the medication discontinued after two weeks of daily use. It should be taken into account that medication-related sleep disorders or anxiety and restlessness may initially occur again (so-called withdrawal phenomenon).

If you have taken more Dorm than you should

Stop taking Dorm and contact your doctor.

If you forget to take Dorm

Do not take a double dose.

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, Dorm can have side effects, although not everybody gets them. The following frequency information is used to assess side effects

The following categories are used for the frequency information on 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.

Side effects can occur particularly in the case of overdose or individual hypersensitivity.

Uncommon: Taking diphenhydramine hydrochloride can lead to skin reactions, gastrointestinal disorders, dry mouth and difficulty urinating. Furthermore, hypersensitivity to sunlight and ultraviolet radiation can be caused. After long-term daily use, sleep disorders can occur again if the therapy is stopped suddenly.

Please inform your doctor or pharmacist if any of the side effects listed here affect you significantly or if you notice side effects that are not listed in this package leaflet.

5. HOW TO STORE DORM?

Keep medicines out of the reach of children! Do not use the medicine after the expiry date which is stated on the blister strip. The expiry date refers to the last day of the month.

Storage conditions

Protect from moisture!

6. FURTHER INFORMATION

What Dorm contains

The active ingredient is: Diphenhydramine hydrochloride. 1 Dorm tablet contains 50 mg diphenhydramine hydrochloride. The other ingredients are: Lactose monohydrate, corn starch, microcrystalline cellulose (E460), sodium carboxymethyl starch type A, sorbitol (E420), talc (E553b), povidone K25 (E1201), stearic acid (vegetable).

What Dorm looks like and contents of the pack

White tablets. Dorm is available in a pack of 20 tablets.

Pharmaceutical entrepreneur
Berco-Arzneimittel Gottfried Herzberg GmbH
Bahnhofstr. 23
47533 Kleve
Tel.: 02821-25300

Manufacturer

Artesan Pharma GmbH & Co. KG
Wendlandstr. 1
29439 Lüchow
Tel.: 05841-9390

This package leaflet was last revised in August 2012.

Source: Information from the package leaflet.
Status: 04/2016
Active ingredient: Diphenhydramine hydrochloride. Areas of application: is a remedy for difficulty falling asleep and staying asleep.