Download Package leaflet - KrewelMeuselbach

Package leaflet: Information for the patient
Dolestan® forte
50 mg Tablets
Active substance: diphenhydramine hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet
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What Dolestan® forte is and what it is used for
What you need to know before you take Dolestan® forte
How to take Dolestan® forte
Possible side effects
How to store Dolestan® forte
Contents of the pack and other information
What Dolestan® forte is and what it is used for
Dolestan® forte is a soporific that belongs to the antihistamine group.
Dolestan® forte is used for the short-term treatment of sleep disorders.
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What you need to know before you take Dolestan® forte
Do not take Dolestan® forte:
- if you are allergic to diphenhydramine hydrochloride, other antihistamines or any of
the other ingredients of this medicine (listed in section 6),
- if you suffer from acute asthma,
- if you suffer from angle-closure glaucoma,
- if you suffer from a specific tumour of the medulla of the adrenal glands
(phaeochromocytoma),
- if you have an enlarged prostate with postvoid residual urine,
- if you suffer from epilepsy,
- if you suffer from potassium or magnesium deficiency,
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- if you have a slow heartbeat (bradycardia),
- if you suffer from specific heart disorders (congenital QT syndrome or other
clinically significant heart defects, in particular coronary heart disease, conduction
disorders, arrhythmia),
- if you at the same time take medicines that also prolong the so-called QT interval in
the ECG or cause hypokalaemia (see "Other medicines and Dolestan® forte"),
- if you consume alcohol or take so-called MAO inhibitors (medicines used to treat
depression) at the same time,
- during pregnancy or breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dolestan® forte.
Take special care with Dolestan® forte if you suffer from one of the following diseases:
- impaired liver function,
- chronic lung diseases or asthma,
- specific forms of stomach dysfunction (pylorostenosis or achalasia of the cardia).
When soporifics are taken over a longer period of time, you may experience a loss of
efficacy (tolerance).
Like with other soporifics, taking Dolestan® forte may result in physical and
psychological dependence. The risk of a dependency increases with the dose and
duration of treatment. This risk is also increased in patients with a history of alcohol or
(recreational) drug dependency.
When treatment with Dolestan® forte is terminated, stopping it suddenly may cause
sleep disorders to temporarily recur. It is therefore recommended to terminate treatment
by gradually tapering the dose if required.
Children and adolescents
Dolestan® forte is not recommended for the treatment of children and adolescents under
14 years. A low-dose dosage form is available for adolescents.
Other medicines and Dolestan® forte
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or
might take/use any other medicines.
Diphenhydramine hydrochloride must not be given at the same time as so-called "MAO
inhibitors" (specific medicines used to treat depression).
Taking Dolestan® forte at the same time as other medicines that also contain
diphenhydramine, including ones for external use, should be avoided.
When used at the same time as other CNS depressants such as soporifics, painkillers or
anaesthetic drugs, tranquillisers (anxiolytics), medicines used to treat depression or
medicines used to treat seizures (antiepileptic drugs), the medicines may enhance the
effect of one another.
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The so-called "anticholinergic" effect of diphenhydramine may be enhanced by
substances with a similar effect such as atropine, biperiden, tricyclic antidepressants or
monoamine oxidase inhibitors. An increase in intraocular pressure, urinary retention or a
possibly life-threatening bowel paralysis may occur.
Use of diphenhydramine at the same time as medicines decreasing blood pressure may
cause increased tiredness.
Using this medicine at the same time as medicines that also prolong the so-called QT
interval in the ECG, e.g. medicines used to treat hearth rhythm disorders (class IA or III
antiarrhythmic agents), specific antibiotics (e.g. erythromycin), cisapride, antimalarials,
medicines used to treat allergies or stomach/intestinal ulcers (antihistamines) or
medicines used to treat specific mental health disorders (neuroleptic medications) or
substances that may cause potassium deficiency (e.g. specific diuretic medications)
should be avoided.
Diphenhydramine may distort results of allergy tests and should therefore not be taken
for at least 3 days before an allergy test.
Dolestan® forte with food, drink and alcohol
No alcohol may be consumed during treatment with Dolestan® forte since this will
unpredictably alter and enhance the effect of diphenhydramine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this medicine.
Dolestan® forte must not be taken during pregnancy and breast-feeding.
Driving and using machines
You must not drive or operate dangerous machines after taking Dolestan® forte.
Residual tiredness and slowed reaction time may adversely affect the ability to drive and
use machines even on the day after taking the medicine, in particular if you have not
slept enough.
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How to take Dolestan® forte
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless prescribed otherwise by your doctor, the usual dose for adults is 1 tablet
(equivalent to 50 mg diphenhydramine hydrochloride).
This dose should not be exceeded.
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Patients with impaired liver or kidney function should receive lower doses.
In elderly or weakened patients, who may possibly react sensitively, it is recommended
to adjust the dose if required.
Use in children and adolescents
Dolestan® forte is not recommended for the treatment of children and adolescents under
14 years. A low-dose dosage form is available for adolescents.
Method of administration
Take the tablets 30 minutes before going to bed in the evening with some liquid (water),
without chewing.
Ensure that you will be able to sleep for long enough after taking the medicine
(7-8 hours).
Duration of administration
The duration of treatment should be as short as possible. It should in general only be a
few days and not exceed 2 weeks.
If your sleep disorder persists, please consult a doctor!
Talk to your doctor or pharmacist if you think that the effect of Dolestan® forte is too
strong or too weak.
If you take more Dolestan® forte than you should
Diphenhydramine overdoses can be dangerous, in particular for children and toddlers.
For that reason, a doctor must be consulted immediately if an overdose or poisoning is
suspected (e.g. poisons information service)!
The forms in which diphenhydramine overdoses manifest primarily depend on the
amount taken, and they are characterised by disorders affecting the central nervous
system (confusion, agitation to the point of seizures, clouding of consciousness to the
point of coma, breathing problems to the point of apnoea) and cardiovascular system.
Furthermore, increased muscle reflexes, fever, dry mucosa, visual disturbances,
constipation and urinary disorders may occur.
Rhabdomyolysis (severe muscular damage) has also been observed.
If you forget to take Dolestan® forte
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
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Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
The stated frequencies of the side effects are based on the following categories:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:
may affect more than 1 in 10 treated
may affect 1 to 10 in 100 treated
may affect 1 to 10 in 1,000 treated
may affect 1 to 10 in 10,000 treated
may affect less than 1 in 10,000 treated
cannot be estimated from the available data
Possible side effects:
Nervous system disorders:
Common: drowsiness, lightheadedness and problems concentrating on the day after
taking the medicine, in particular if the patient has not slept enough, dizziness,
headache.
Eye disorders:
Common: visual disturbances.
Cardiac disorders:
specific heart rhythm disorders (prolonged QT interval in the ECG) may occur during
treatment with Dolestan® forte.
Gastrointestinal disorders:
Common: gastrointestinal complaints such as feeling and being sick or diarrhoea and
so-called "anticholinergic effects" such as dry mouth, constipation, heartburn.
Musculoskeletal and connective tissue disorders:
Common: muscle weakness.
Renal and urinary disorders:
Common: complaints when passing water.
Furthermore, hypersensitivity reactions, increased sensitivity of the skin to light, blood
count changes, increased intraocular pressure, jaundice (cholestatic icterus) and socalled "paradoxical reactions" such as restlessness, nervousness, agitation, anxiety,
trembling or sleep disorders have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the
national reporting system listed in Appendix V. By reporting side effects you can help
provide more information on the safety of this medicine.
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How to store Dolestan® forte
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and
container after "EXP".
The expiry date refers to the last day of that month.
Storage conditions:
Do not store above 30 °C.
Store in the original package in order to protect from moisture.
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Contents of the pack and other information
What Dolestan® forte contains
The active substance is diphenhydramine hydrochloride.
One tablet contains 50 mg diphenhydramine hydrochloride.
The other ingredients are:
microcrystalline cellulose, cellulose granules, powdered cellulose, potato starch,
magnesium stearate, talc, colloidal silica.
What Dolestan® forte looks like and contents of the pack
Dolestan® forte are white tablets with one-sided score line and "Dolestan forte"
embossed on one side.
Dolestan® forte is available in packs of 20 tablets (N2).
Marketing Authorisation Holder and Manufacturer
Krewel Meuselbach GmbH
Krewelstr. 2
53783 Eitorf
tel: +49 (0)2243 / 87-0
fax: +49 (0)2243 / 87-175
e-mail: [email protected]
This leaflet was last revised in March 2014.
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