Calmaben - Coated tablets

Mode of action
Diphenhydramine hydrochloride, the active ingredient of Calmaben, is a remedy for allergies and itching, as well as a sleep aid for treating problems falling asleep and staying asleep.

Application

1. What is Calmaben and what is it used for?

Mode of action
Diphenhydramine hydrochloride, the active ingredient in Calmaben, is a remedy for allergies and itching and a sleeping pill for treating problems falling asleep and staying asleep.

Due to their pronounced sleep-promoting effect, Calmaben dragées make it easier to fall asleep and prolong the duration of sleep. The effect is generally felt 30 minutes after taking the medicine.

Applications
Calmaben is a sleep aid for the short-term treatment of problems falling asleep or staying asleep.
Calmaben is used in adults and adolescents aged 12 years and over.

Note:
Not all sleep disorders require the use of sleeping pills. They are often an expression of physical or mental illness and can also be influenced by other measures or treatment of the underlying disease.

How is it applied?

What is Calmaben and what is it used for?

Mode of action
Diphenhydramine hydrochloride, the active ingredient in Calmaben, is a remedy for allergies and itching, as well as a sleeping pill for treating problems falling asleep or sleeping through the night.

Due to their pronounced sleep-promoting effect, Calmaben makes it easier to fall asleep and prolongs the duration of sleep. The effect generally occurs 30 minutes after taking the medicine.

Applications
Calmaben is a sleep aid for the short-term treatment of problems falling asleep and staying asleep.
Calmaben is used in adults and adolescents aged 12 years and over.

Note:
Not all sleep disorders require the use of sleeping pills. They are often an expression of physical or mental illness and can also be influenced by other measures or treatment of the underlying illness.

If you do not feel better or even worse after 7 days, consult your doctor.

What should you pay attention to before taking it?

What should you be aware of before taking Calmaben?

MONTAVIT Ges.m.b.H..
Calmaben must not be taken,
- if you are allergic to diphenhydramine hydrochloride or any of the other ingredients listed in section 6. other ingredients of this medicine mentioned in section 6.
- if you have an acute asthma attack.
- if you have increased intraocular pressure, e.g. glaucoma.
- if you have a tumour of the adrenal gland (known as a tumour of the adrenal gland). pheochromocytoma).
- if you have enlargement of the prostate with residual urine formation.
- if you suffer from seizures.
- if you have congenital abnormalities in your ECG.
- if you have cardiac arrhythmias or slowed heart activity.
- if you are taking medicines for cardiac arrhythmias at the same time.
- if you have a potassium or magnesium deficiency.
- if you are pregnant or breastfeeding.
- if you have consumed alcohol or are taking medicines to treat depression (known as MAO inhibitors).

Warnings and Precautions
Please talk to your doctor or pharmacist before taking Calmaben.

Special care is needed when taking Calmaben,
- if you have chronic lung disease and asthma or your airways are severely obstructed.
- if your stomach outlet is narrowed or there is a dysfunction of the stomach inlet.
- if your liver function is impaired.
- you should not take Calmaben after midnight if full attention is required the next morning. If you do not get enough sleep after taking Calmaben, expect morning tiredness.
- if you are pregnant. The onset of pregnancy must be reported to the doctor.
- If you are going to have an allergy test, the preparation should not be taken.
- Calmaben must be kept out of reach of children.

Children and adolescents
Calmaben must not be taken by children under 12 years of age.

Taking Calmabenwith other medicines
Calmaben and some other medicines may interfere with each other. Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription, or if you intend to take/use any other medicines.

Calmaben should not be taken at the same time as other medicines containing diphenhydramine hydrochloride, including topical agents.

Avoid taking Calmaben and alcohol or drinks containing alcohol at the same time.
Also, diphenhydramine hydrochloride and MAO inhibitors (certain drugs used to treat depression) must not be taken at the same time, as this may cause a drop in blood pressure and disturbances in the central nervous system and respiratory function.

The additional administration of medicines against deviations in the ECG (e.g. medicines against cardiac arrhythmias) must be avoided.

Hypertensive medicines taken together with Calmaben may cause increased tiredness.

The simultaneous use of Calmaben and

MONTAVIT Ges.m.b.H.
- medicines containing atropine, agents for the treatment of Parkinson's disease (biperidine) or for the treatment of depression may lead to life-threatening intestinal paralysis, urinary retention or increase in intraocular pressure.
- centrally depressant drugs such as sleeping pills, anaesthetics, opioid painkillers, psychotropic drugs and alcohol can lead to an unpredictable, mutual amplification of effects. This affects the ability to react, drive and operate machinery.

In allergy tests, Calmaben may give false-negative test results. It should therefore be stopped at least 72 hours before.

Please talk to your doctor or pharmacist before taking Calmaben.

Taking Calmabenwith food and drink
No interactions have been observed.

Pregnancy and breast-feeding
Calmaben must not be used during pregnancy or by women who are breast-feeding.

Women who are planning a pregnancy or think they may be pregnant must not take Calmaben.

Trafficability and ability to operate machinery
Caution: this medicinal product may impair the ability to react and drive !
: Calmaben causes drowsiness, and reduces
responsiveness, thereby reducing the ability to take an active part in road traffic and operate machinery. This applies to a greater extent in combination with alcohol.

Calmaben contains sucrose (sugar)
This medicine contains sucrose (sugar). Please take Calmaben only after consulting your doctor if you are known to have an intolerance to certain sugars.

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How should the medicine be taken?

How to take Calmaben ?

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents aged 12 years and over take 1 sugar-coated tablet 30 minutes before going to bed with sufficient non-alcoholic liquid (e.g. 1 glass of water).

A sufficient sleep duration of 7-8 hours should be ensured in order to reduce the risk of impaired reactions, in particular the ability to drive, the following morning.

No more than 1 dragée should be taken, the duration of treatment should be as short as possible.

MONTAVIT Ges.m.b.H.
In the case of prolonged sleep disorders, the preparation should be discontinued after two weeks of use at the latest and the need for use should be reassessed.

Use in children
Calmaben is not suitable for children under 12 years of age.

If you have taken a larger amount of Calmabenthan you should
If you develop any signs of overdose, please contact a doctor or hospital immediately.

Signs of overdose include impaired consciousness, altered states of consciousness, hallucinations, anxiety, agitation, restlessness, convulsions, fever, flushing of the skin and dry mucous membranes, pupil dilation, cardiac arrhythmia and/or palpitations occur.

Note to physician:
Therapeutic measures:
For the treatment of poisoning with diphenhydramine hydrochloride, symptomatic measures such as artificial respiration, intravenous fluid administration and external cooling in case of overheating are sufficient in most cases.
Gastric emptying should be performed, due to the anticholinergic properties of diphenhydramine, gastric lavage may be beneficial even hours after the overdose.
In case of a drop in blood pressure, vasopressors such as noradrenaline or phenylephrine may be used, but adrenaline should not be given as it may paradoxically lower blood pressure further. Convulsions can be controlled with intravenous diazepam. Do not give stimulants!
As an antidote to diphenhydramine hydrochloride overdose, physostigmine (0.02-0.06 mg/kg body weight intravenously) can be given several times when anticholinergic
symptoms decrease. In case of physostigmine overdose, atropine is recommended.

If you forget to take Calmaben
Do not take double the amount if you have forgotten to take it before.

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

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What are the possible side effects?

How should Calmaben be stored?

Do not store above 30 °C.

MONTAVIT Ges.m.b.H.
Store in the original packaging to protect the contents from light.

Keep this medicinal product out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the blister after <<usable until:>>. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5 How to store Calmaben Coated Tablets?

Do not store above 30°C.
Store in the original pack to protect the contents from light.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister after <>. The expiry date refers to the last day of the month.

MONTAVIT Ges.m.b.H.
Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

.What Calmabencontains
- The active substance is: Diphenhydramine hydrochloride
1 coated tablet contains 50 mg diphenhydramine hydrochloride.
- The other ingredients are: Crospovidone, highly dispersed silicon dioxide, maltodextrin, copovidone, microcrystalline cellulose, magnesium stearate, gum arabic, 53.9 mg sucrose, methyl cellulose, calcium carbonate, povidone, talc, titanium dioxide (E-171), glycerol 85%, montanglycol wax.

How Calmabenlooks and contents of the pack
White, coated tablets for oral use.

Blister (aluminium PVC/PVdC) of
10 units in a folding carton
30 units in a folding carton

Not all pack sizes may be marketed

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