
Calmaben - Coated tablets
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Mode of actionDiphenhydramine 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.
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.
What should you pay attention to before taking it?
2. What should you be aware of before taking Calmaben?
Calmaben Coated Tablets must not be taken
- if you are allergic to diphenhydramine hydrochloride or any of the other ingredients listed in section 6. You must not take Calmaben if you are allergic to diphenhydramine hydrochloride or to any of the other ingredients of this medicine listed in section 6.
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- if you have an acute asthma attack,
- if you have raised intraocular pressure, e.g. glaucoma,
- if you have a tumour of the adrenal gland (known as an adrenocortical tumour),
- if you are taking Calmaben Dragees. pheochromocytoma)
- if you have enlargement of the prostate with residual urine
- if you have seizures
- if you have congenital ECG abnormalities
- if you have arrhythmia or slow heartbeat
- if you have a seizure
- if you have a seizure
- if you have a seizure
- if you have a seizure.If you have congenital abnormalities in your ECG
- If you have arrhythmia or slow heartbeat
.- if you are taking medicines for heart rhythm disorders 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 for the treatment of depression (so-called MAO inhibitors).
Warnings and precautions
Please talk to your doctor or pharmacist before taking Calmaben.
Extreme caution is required when taking Calmaben Coated Tablets
- if you have chronic lung disease and asthma or if your airways are obstructed
- if your stomach outlet is narrowed or if you have a dysfunction of the stomach inlet
.If your liver function is impaired
- Do not take Calmaben after midnight if you have to be fully alert the next morning. If you do not get enough sleep after taking Calmaben, you may feel tired in the morning
- if you are pregnant. The onset of pregnancy must be reported to the doctor
- if you wish to undergo an allergy test, the preparation should not be taken.
- Calmaben Coated Tablets must be kept out of the reach of children.
Children and adolescents
Calmaben must not be taken by children under 12 years of age.
Taking Calmaben Coated Tablets with other medicines
Calmaben and some other medicines may interfere with each other. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Calmaben should not be taken at the same time as other medicines containing diphenhydramine hydrochloride, including topical medicines.
Calmaben should not be taken with alcohol or alcoholic beverages.
Diphenhydramine hydrochloride and MAO inhibitors (certain medicines 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.
Additional administration of medicines for ECG abnormalities (e.g. medicines for cardiac arrhythmias) must be avoided.
Antihypertensive medicines taken with Calmaben may cause increased fatigue.
The simultaneous use of Calmaben and
- 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,
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- centrally depressant drugs such as sleeping pills, anaesthetics, opioid painkillers, psychotropic drugs and alcohol can lead to an unpredictable, mutual amplification of the effects. This affects the ability to react, drive and operate machinery.
In allergy tests, Calmaben can lead to false-negative test results. It should then be stopped at least 72 hours beforehand.
Taking Calmaben Coated Tablets with food and drink
No interactions have been observed.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Calmaben must not be used during pregnancy or by women who are breast-feeding.
Women who are planning to become pregnant or think they may be pregnant must not take Calmaben.
Driving and ability to use machinery
! Caution: this medicine may impair the ability to react and drive: Calmaben causes drowsiness and reduces the ability to react, thus reducing the ability to actively participate 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 know that you have an intolerance to certain sugars.
How should the medicine be taken?
3. How should Calmaben Coated Tablets be taken?
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 bedtime witha sufficient amount of non-alcoholic liquid (e.g. 1 glass of water).
A sufficient sleep duration of 7-8 hours should be guaranteed in order to reduce the risk of impaired reactions, especially the ability to drive, the following morning.
No more than 1 tablet should be taken, and the duration of treatment should be as short as possible.
In the case of prolonged sleep disorders, the preparation should be discontinued after two weeks at the latest and the need for use should be reassessed.
Use in children
Calmaben dragées are not suitable for children under 12 years of age.
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If you have taken a larger amount of Calmaben Coated Tablets than you should
If you experience any signs of overdose, please contact a doctor or hospital immediately.
Signs of an overdose include impaired consciousness, altered states of consciousness, hallucinations, dizzy spells, and a feeling of being in a coma.In addition, altered states of consciousness, hallucinations, anxiety, agitation, restlessness, convulsions, fever, reddening of the skin and dry mucous membranes, dilated pupils, cardiac arrhythmia and palpitations may occur.
Note to doctor:
Therapeutic measures:
For the treatment of poisoning with diphenhydramine hydrochloride, symptomatic measures such as artificial respiration, intravenous administration of fluids and external cooling in case of overheating are sufficient in most cases.
Gastric emptying should be performed; due to the anticholinergic properties ofDiphenhydramine, gastric lavage may be beneficial even hours after overdose.In case of hypotension, vasopressors such as noradrenaline or phenylephrine can be used, but adrenaline should not be given as it may paradoxically lower blood pressure further.
Convulsions can be controlled with diazepam intravenously. 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 Coated Tablets
Do not take double the amount if you have forgotten to take it before.
If you stop taking Calmaben Coated Tablets
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
What are the possible side effects?
4. side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur in the following frequencies:
-Very common ( 1/10)
-Frequent ( 1/100, <1/10)
-Occasional ( 1/1.000, < 1/100)
-Rarely ( 1/10,000, < 1/1,000)
-Very rarely (< 1/10.000)
-Not known (frequency cannot be estimated based on available data)
The following side effects may occur:
Disorders of the skin and subcutaneous cell tissue
Occasional symptoms include dryness of the mouth, nose and throat
Rarely, allergic skin reactions and photosensitivity of the skin (avoid directSunlight!).
General disorders and complaints at the place of administration
Rarely, headache may occur.
Very rarely: Hypersensitivity reactions
Diseases of the nervous system
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Occasionally, depending on individual sensitivity, the most common side effects are drowsiness, dizziness and impaired concentration the next day, especially after too short a period of sleep, as well as dizziness.
Very rarely, especially in children: Reactions in the form of central agitation such as restlessness,irritability, nervousness, anxiety, tremor or insomnia
Eye disorders
Rarely: Visual disturbances
Very rarely increase in intraocular pressure
Diseases of the gastrointestinal tract
Occasionally gastrointestinal complaints (nausea, vomiting, diarrhoea, constipation,gastrooesophageal reflux) occur.
Liver and biliary diseases
Rarely: Liver dysfunction (jaundice) has been observed in some cases during therapy with antihistamines.
Diseases of the blood and lymphatic system
Very rarely: Changes in blood count
Diseases of the kidneys and urinary tract
Infrequent: difficulty urinating.
Skeletal muscle, connective tissue and bone disorders
Infrequent: muscle weakness.
After prolonged use of diphenhydramine hydrochloride, sleep disturbances may reappear temporarily due to sudden discontinuation.
Dependence after long-term inappropriate use is possible, as with other sleeping pills.
Reporting of side effects
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not mentioned in this leaflet.
You can also report side effects directly through the national reporting system:
Federal Office for Safety in Health Care
Traisengasse 5
1200 WIEN
AUSTRIA
Fax: + 43 (0) 50 555 36207
Website: http://www.basg.gv.at/
By reporting side effects, you can help ensure that more information is made available about the safety of this medicinal product.
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.
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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
6. contents of the pack and other information
What Calmaben Coated Tablets contain
- 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%,montan glycol wax.
What Calmaben Coated Tablets look like and contents of the pack
White coated tablets for oral use.
Blister (aluminium PVC/PVdC) of
10 pieces in a folding box
30 pieces in a folding box
Information leaflet
Download the information leafletWirkstoff: DIPHENHYDRAMIN HYDROCHLORID
EAN: 9088882428816, 09088882428816
PZN: 2428819