Minutes of the FIA Council Meeting held on Tuesday 10th May 2005 at The Saracens Head Hotel, Towcester at 10.00 a.m. Mike Phillips – ChairmanMike Gilmore – TreasurerPeter LythgoeJohn ColtonLee FunnellDr. Nick Channon 1. Apologies Minutes of the previous meeting held on 9th March 2005 The minutes of the previous meeting held on 9th March 2005 were taken as read and agreed and we
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Calmaben gi englischPACKAGE LEAFLET: INFORMATION FOR THE USER
Calmaben – coated tablets
Active substance: diphenhydramine hydrochloride Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Calmaben coated
tablets to get the best results from it.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
What Calmaben coated tablets is and what it is used for Before you take Calmaben coated tablets How to take Calmaben coated tablets How to store Calmaben coated tablets WHAT CALMABEN COATED TABLETS IS AND WHAT IT IS USED FOR
Mode of action
Diphenhydramine hydrochloride, the active substance of Calmaben coated tablets, is an anti-allergy,
anti-itching and hypnotic agent (sleeping tablet) used to treat insomnia (problems in falling and
Due to their marked sleep-inducing effect, Calmaben coated tablets make it easier to fall asleep and prolong the duration of sleep. After taking Calmaben coated tablets, it generally takes 30 minutes for it to take effect.
Calmaben coated tablets is a hypnotic agent (sleeping tablet) for the short-term treatment of insomnia
(problems in falling and staying asleep).
Note:Not all sleep disorders require the use of hypnotic agents (sleeping tablets). They are often the symptoms of physical or mental disorders and can also be influenced by other measures or treatment of the underlying disease.
BEFORE YOU TAKE CALMABEN COATED TABLETS
Do not take Calmaben coated tablets
if you are allergic (hypersensitive) to diphenhydramine hydrochloride, other antihistamines or any of the other ingredients of Calmaben coated tablets if you have increased pressure inside the eye, e.g. glaucoma if you have a tumour of the adrenal gland (known as phaeochromocytoma) if you have an enlarged prostate with residual urine formation if you have a heart rhythm disorder or slowed heart rate if you are also taking medicines for heart rhythm disorders if you have a potassium or magnesium deficiency if you have been consuming alcohol or taking medicines used to treat depression (known as MAO inhibitors).
Calmaben must not be taken by children under 12 years of age.
Take special care with Calmaben coated tablets
if you have a chronic lung disease and suffer from asthma or if your airways are heavily congested if the exit to your stomach is narrowed or if the entrance to your stomach does not work properly if you need to be fully alert on the next morning, you should not take Calmaben coated tabletsafter midnight. Morning fatigue can be expected if you do not get enough sleep after taking Calmaben coated tablets.
if you are pregnant. You must tell your doctor if you become pregnant.
if you would like to perform an allergy test, you should not take this medicine.
Taking other medicines
Calmaben coated tablets can affect the way in which some medicines work and vice versa. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Calmaben coated tablets should not be taken at the same time as other medicines containingdiphenhydramine hydrochloride, including medicines for topical use.
You must avoid taking Calmaben coated tablets at the same time as alcohol or alcoholic beverages.
Equally, this medicine and MAO inhibitors (certain antidepressants) must not be taken at the same time, as this can lead to a drop in blood pressure, central nervous system disturbances and respiratory dysfunction.
Co-administration of medicines used to treat ECG abnormalities (e.g. medications to treat heart rhythm disorders) must be avoided.
Medicines that lower the blood pressure can lead to increased tiredness when combined with Calmaben coated tablets.
Taking Calmaben coated tablets at the same time as- medicines containing atropine, biperiden (used to treat Parkinson’s disease) or antidepressants can lead to life-threatening intestinal paralysis, urine retention or increased pressure inside the eye, medicines that suppress the central nervous system, such as sleeping tablets, anaesthetics, opioid painkillers, psychotropic agents and alcohol, can unpredictably enhance their respective effects. This will affect reaction skills and the ability to drive and use machines.
In allergy tests, Calmaben coated tablets can lead to false-negative test results. It should therefore be discontinued at least 72 hours before such tests.
Taking Calmaben coated tablets with food and drink
No interactions have been observed.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Calmaben must not be used during pregnancy or by breast-feeding women.
Women who are planning a pregnancy, or think they are pregnant, must not take Calmaben coated tablets. Please consult your doctor or pharmacist. Driving and using machines
Warning: This medicine can impair response skills and the ability to drive: Calmaben coated tablets cause drowsiness and decreases responsiveness, thereby reducing the ability to drive and use machines. This applies particularly in combination with alcohol.
Important information about some of the other ingredients of Calmaben coated tablets
This medicine contains sucrose (sugar). If you have been told that you have an intolerance to some
sugars, please talk to your doctor before taking Calmaben coated tablets.
HOW TO TAKE CALMABEN COATED TABLETS
Adults and adolescents aged 12 years and older should take 1 coated tablet 30 minutes before bedtime with plenty of non-alcoholic liquid (e.g. 1 glass of water). A sufficient sleep duration of 7-8 hours should be ensured to reduce the risk of impaired reaction skills, especially the ability to drive, on the following morning.
Calmaben coated tablets coated tablets are not suitable for children under 12 years of age.
No more than 1 coated tablet should be taken; the duration of treatment should be as short as possible.
If sleep disorders persist, the product should be discontinued after two weeks at the latest and the need for its use should be reviewed.
You should check with your doctor or pharmacist if you are not sure.
If you take more Calmaben coated tablets than you should
If signs of overdose occur, please contact a doctor or hospital immediately.
Signs of overdose are impaired consciousness. Furthermore, the following may occur: altered states of consciousness, hallucinations, anxiety, agitation, restlessness, seizures, fever, skin redness and dry mucous membranes, dilated pupils, heart rhythm disorders and racing heart. Notes for the doctor:Therapeutic measures:For the treatment of intoxication with diphenhydramine hydrochloride, symptomatic measures aresufficient in most cases, such as artificial respiration, intravenous hydration and external cooling in the event of hyperthermia.
Gastric emptying should be performed; due to the anticholinergic properties of diphenhydramine, gastric lavage may be beneficial even hours after an overdose.
In the event of a decrease in blood pressure, vasopressors such as noradrenaline or phenylephrine can be used. However, adrenaline must not be given, as there may be a further paradoxical decrease in blood pressure. Seizures can be controlled with intravenous diazepam. Do not administer any stimulants.
As an antidote for an overdose with diphenhydramine hydrochloride, multiple doses of physostigmine (0.02 – 0.06 mg/kg body weight IV) can be given when the anticholinergic symptoms subside. In the event of an overdose with physostigmine, atropine is recommended.
If you forget to take Calmaben coated tablets
Do not take a double dose to make up for a forgotten dose.
If you stop taking Calmaben coated tablets
After prolonged use, sleep disorders may temporarily return if you suddenly stop taking
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Calmaben coated tablets can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The following frequencies are used for the evaluation of side effects: affecting more than 1 in 1,000 and less than 1 in 100 patients treated affecting more than 1 in 10,000 and less than 1 in 1,000 patients treated affecting less than 1 in 10,000 patients treated Skin and subcutaneous tissue disorders
Uncommon symptoms are dry mouth, nose and throat
Rarely, allergic skin reactions and skin sensitivity to light (avoid direct sunlight) may occur.
General disorders and administration site conditions
Rarely, headache may occur.
Very rare: hypersensitivity reactions
Nervous system disorders
Uncommon: depending on individual sensitivity, the most frequently reported side effects are
drowsiness, light-headedness, poor concentration on the next day, especially in users who have not
had enough sleep, as well as dizziness.
Very rarely, especially in children: reactions in the form of central excitation, such as restlessness,
irritability, nervousness, states of anxiety, trembling or insomnia
Rare: visual disturbances
Very rare: increased pressure inside the eye
Uncommon: gastrointestinal complaints (nausea, vomiting, constipation, gastroesophageal reflux)
Rare: liver dysfunction (jaundice) has been observed in some cases during antihistamine therapy.
Blood and lymphatic system disorders
Very rare: changes in the blood picture
Renal and urinary disorders
Uncommon: difficulty in passing water.
Musculoskeletal and connective tissue disorders
Uncommon: muscle weakness
As with other hypnotics (sleeping tablets), dependence is possible after prolonged, incorrect use.
HOW TO STORE CALMABEN COATED TABLETS
Keep the coated tablets in the outer carton in order to protect from light and moisture.
Keep out of the reach and sight of children.
Do not use Calmaben coated tablets after the expiry date which is stated on the folding carton after<<Use by:>>. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Calmaben coated tablets contain
The active substance is: diphenhydramine hydrochloride 1 coated tablet contains 50 mg diphenhydramine hydrochloride. The other ingredients are: crospovidone, colloidal anhydrous silica, maltodextrin, copovidone, microcrystalline cellulose, magnesium stearate, gum arabic, 53.9 mg sucrose, methylcellulose, calcium carbonate, povidone, talc, titanium dioxide (E171), glycerol 85%, montan glycol wax.
What Calmaben coated tablets look like and contents of the pack
White coated tablets for oral use.
Blister (Al-PVC/PVdC) with 10 tablets in an outer cartonBlister (Al-PVC/PVdC) with 30 tablets in an outer carton Marketing Authorisation Holder and Manufacturer
Pharm. Fabrik Montavit Ges.m.b.H.
A-6060 Absam, Austria
Tel: +43 5223 57926 0
Fax: +43 5223 52294
e-mail: [email protected]
MA No.: 1-23847
This leaflet was last approved in 12/2010.
CERTIFICATO DI GARANZIA VALIDITÀ 2 ANNI dalla data di acquisto CONDIZIONI DI GARANZIA • L’apparecchio e/o il pacco batteria sono garantiti contro qualsiasi difetto derivato dai materiali o dalla costruzione, a condizioneche questi non abbiano subito manomissioni da parte del cliente o da personale non autorizzato da FLAEM NUOVA S.p.A. • La garanzia copre la sostituzione o la ri