HALBMOND

Crescent tablets

Important notes (mandatory information)

Halbmond tablets, 50 mg Active ingredient: Diphenhydramine hydrochloride. Areas of application: for short-term treatment of sleep disorders.

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

Patient information: Information for the user
Halbmond tablets, 50 mg
Active ingredient: Diphenhydramine hydrochloride

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 package leaflet or exactly as directed by your doctor or pharmacist.
- Keep the package leaflet. You may want to read it again later.
- Ask your pharmacist if you need more information or advice.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
- If you do not feel better or even worse after a few days, contact your doctor.

What is in this package leaflet
1. WHAT ARE HALBMOND TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING HALBMOND TABLETS?
3. HOW TO TAKE HALBMOND TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE HALBMOND TABLETS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE HALBMOND TABLETS AND WHAT ARE THEY USED FOR?

Halbmond tablets are a sleeping pill from the group of antihistamines.
Halbmond tablets are used for the short-term treatment of sleep disorders.
Sedatives/hypnotics should only be used for sleep disorders of clinically significant severity.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING HALBMOND TABLETS?

Halbmond tablets must not be taken

- if you are allergic to the active substance diphenhydramine hydrochloride, to other antihistamines or to any of the other ingredients of this medicine listed in section 6.
- in acute asthma.
- in glaucoma (narrow-angle glaucoma).
- in certain tumours of the adrenal medulla (phaeochromocytoma).
- in enlargement of the prostate gland with residual urine formation.
- in epilepsy.
- in potassium or magnesium deficiency.
- in slowed heart rate (bradycardia).
- in certain heart diseases (congenital aT syndrome or other clinically significant heart damage, especially coronary artery disease, conduction disorders, arrhythmias).
- with concomitant use of medicines that also prolong the so-called QT interval on the ECG or lead to hypokalaemia (see under "When taking Halbmond tablets with other medicines").
- with concomitant intake of alcohol or so-called "MAO inhibitors" (medicines for the treatment of depression).
- during pregnancy or breastfeeding.
- Children and adolescents under 18 years of age should not receive Halbmond tablets.

Warnings and precautions
Please talk to your doctor or pharmacist before taking Halbmond tablets.
Special care should be taken when taking Halbmond tablets if you suffer from any of the following conditions:
- impaired liver function
- chronic lung diseases or asthma
- certain gastric motility disorders (pyloric stenosis or achalasia of the cardia).

After repeated use of hypnotics over a longer period of time, a loss of effectiveness (tolerance) may occur.
As with other hypnotics, taking Halbmond tablets can lead to the development of physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment. This risk is also increased in patients with a history of alcohol, drug or drug dependence.
When stopping treatment with Halbmond tablets, sleep disorders may temporarily recur due to sudden discontinuation. It is therefore recommended to end the treatment by gradually reducing the dose if necessary.

Taking Halbmond tablets 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.
Diphenhydramine hydrochloride must not be given together with so-called "MAO inhibitors" (certain medicines for the treatment of depression).
Concomitant use of Halbmond tablets with other medicines containing diphenhydramine, including those applied externally, should be avoided.
Concomitant use with other centrally depressant medicines such as hypnotics, sedatives, pain relievers or anaesthetics, anxiolytics (anxiolytics), medicines for the treatment of depression or medicines for the treatment of seizures (antiepileptics) can lead to mutual reinforcement.
The so-called "anticholinergic" effect of diphenhydramine can be enhanced by drugs with similar effects such as atropine, biperiden, tricyclic antidepressants or monoamine oxidase inhibitors. Increased intraocular pressure, urinary retention or potentially life-threatening intestinal paralysis may occur.
The use of diphenhydramine together with blood pressure lowering medicines can lead to increased fatigue.
Concomitant use with medicines that also prolong the so-called QT interval on the ECG, e.g. medicines for heart rhythm disorders (antiarrhythmics class IA or III), certain antibiotics (e.g. erythromycin), cisapride, malaria medicines, medicines for allergies or gastrointestinal ulcers (antihistamines) or medicines for the treatment of special mental illnesses (neuroleptics) or lead to potassium deficiency (e.g. certain diuretics) should be avoided.
Diphenhydramine may falsify test results in allergy tests and should therefore not be used for at least 3 days before.

Taking Halbmond tablets with food, drink and alcohol
No alcohol should be consumed during treatment with Halbmond tablets, as this alters and intensifies the effect of diphenhydramine in an unpredictable manner.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Halbmond tablets must not be taken during pregnancy and breastfeeding.

Driving and operating machinery
No vehicles should be driven or dangerous machinery operated after taking Halbmond tablets. Even on the following day, residual fatigue and impaired responsiveness can still have a negative effect on driving ability or the ability to work with machinery, especially after insufficient sleep.

3. HOW TO TAKE HALBMOND TABLETS?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the usual dose for adults is 1 tablet (equivalent to 50 mg diphenhydramine hydrochloride). This dose should not be exceeded.
Patients with impaired liver or kidney function should receive lower doses.
In elderly or debilitated patients, who may be particularly sensitive, it is also recommended to adjust the dose if necessary.
Children and adolescents under 18 years of age should not be treated with Halbmond tablets.

Method of administration
Tablets for oral use

How and when should you take Halbmond tablets?
The tablets are taken in the evening 30 minutes before bedtime with some liquid (water). A sufficient sleep duration (7 -8 hours) should be ensured afterwards. The duration of treatment should be as short as possible. It should generally only last a few days and not exceed 2 weeks. If sleep disorders persist, please consult a doctor!

If you have taken more Halbmond tablets than you should
Overdoses of diphenhydramine can be dangerous - especially for children and toddlers. For this reason, a doctor should be informed immediately if an overdose or poisoning is suspected (e.g. poison control centre). Overdoses of diphenhydramine manifest themselves primarily, depending on the amount taken, through disorders of the central nervous system (confusion, states of excitement up to seizures, clouding of consciousness up to coma, respiratory disorders up to respiratory arrest) and of the cardiovascular system. Increased muscle reflexes, fever, dry mucous membranes, visual disturbances, constipation and urinary disorders may also occur. Rhabdomyolysis (severe muscle damage) has also been observed.

If you forget to take Halbmond tablets
Do not take a double dose if you have forgotten to take the previous dose.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Halbmond tablets can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

If you experience the following side effects, please discuss this with your doctor, who will then decide how to proceed.

The following side effects are to be expected especially at the beginning of treatment:
The most commonly reported side effects are drowsiness, dizziness and difficulty concentrating during the following day, especially after insufficient sleep, as well as dizziness and muscle weakness. Other common side effects include headache, gastrointestinal complaints such as nausea, vomiting or diarrhoea, and so-called "anticholinergic effects" such as dry mouth, constipation, heartburn, visual disturbances or difficulty urinating.
Certain heart rhythm disorders (prolongation of the OT interval on the ECG) may occur during treatment with Halbmond tablets. Hypersensitivity reactions, increased sensitivity of the skin to light, changes in the blood count, increased intraocular pressure, jaundice (cholestatic jaundice) and so-called "paradoxical reactions" such as restlessness, nervousness, agitation, anxiety, tremors or sleep disorders have also been reported.

Reporting of side effects
If you experience 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 TO STORE HALBMOND TABLETS?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the blister pack or carton. The expiry date refers to the last day of the month indicated.

Storage conditions: Do not store above 25°C!

Do not dispose of medicines in the household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Halbmond tablets contain
The active substance is: Diphenhydramine hydrochloride. 1 tablet contains 50 mg diphenhydramine hydrochloride.
The other ingredients are: Microcrystalline cellulose, cellulose granulate, cellulose powder, potato starch, magnesium stearate (Ph.Eur.), talc, highly dispersed silicon dioxide.

What Halbmond tablets look like and contents of the pack
Round, white, biconvex tablets with the image of a crescent moon on one side and the imprint "HALBMOND" and a score line on the other side.

Halbmond tablets are available in packs of 10 and 20 tablets.

Pharmaceutical entrepreneur and manufacturer

CHEPLAPHARM Arzneimittel GmbH
Bahnhofstraße 1 a
17498 Mesekenhagen

This leaflet was last revised in November 2013.

Source: Information from the package leaflet
Status: 11/2015
Active ingredient: Diphenhydramine hydrochloride. Areas of application: for short-term treatment of sleep disorders.