Dolestan tablets, 20 pcs

Instructions for use for Dolestan tablets, 20 pcs

Important notes (compulsory information):

Dolestan 25 mg tablets. Active substance: Diphenhydramine hydrochloride. Applications: For short-term treatment of sleep disorders.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Dolestan 25 mg tablets for application in adults
Active substance: Diphydramine hydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information.

Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What is in this leaflet

1. What is Dolestan and what is it used for?
2. What should you consider before taking Dolestan?
3. How to take Dolestan?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Dolesan?
6. Content of the pack and further information

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

Dolestan is a sleeper from the group of antihistamines. Dolestan is used for short-term treatment of sleep disorders.

2. What should you consider before taking Dolestan?

Dolestan must not be taken:

• if they are allergic to diphenhydramine hydrochloride, against other antihistamines or one of the other ingredients of this medicine mentioned in section 6,
• at acute asthma,
• with green star (narrow angle glaucoma),
• for certain tumors of the adrenal leaflet (Pheochromocytom),
• when enlarging the protruding gland with residual harvesting,
• in epilepsy,
• for potassium or magnesium deficiency,
• with slow heartbeat (bradycardia),
• for certain heart disease (innate QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary vessels, excitement duct disorders, arrhythmias),
• with simultaneous use of medicines, which also extend the so-called QT intervali in the ECG or lead to hypocalemia (see "Taking Dolestan together with other medicinal products")
• while taking alcohol or so-called "Mao-inhibitors" (means for the treatment of depression)
• during pregnancy or lactation.

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

Take special care with Dolestan is required if you suffer from one of the following diseases:

• impaired liver function,
• chronic lung diseases or asthma,
• certain gastric functional disorders (pylorus stenosis or achalasia of the cardia).

After repeatedly taking sleeping resources over a longer period of time, there may be a loss of efficacy (tolerance). As with other sleeping resources, the intake of Dolestan can lead to the development of physical and mental dependence. The risk of dependency increases with the dose and duration of treatment. Even in patients with alcohol, Pharmaceutical or drug dependence In the history, this risk is increased. When stopping a treatment with Doleestan can temporarily reappear due to sudden settling sleep disorders. Therefore, it is recommended to end the treatment if necessary by gradually reducing the dose.

Children and adolescents:
For the effectiveness and compatibility of Diphenhydramine as a sleep aid in children and adolescents, there are no sufficient experience. Therefore, Dolestan should be prescribed in children and adolescents under the age of 18 only after careful consideration of risk and benefits.

Taking Dolestan together with other medicines:
Inform your doctor or pharmacist if you take / apply other medicines, recently taken / applied / applied or intend to take / use other medicines. Diphenhydramine hydrochloride must not be given together with so-called "Mao-inhibitors" (certain means for treating depression). The simultaneous intake of Dolestan with other drugs, which also contain diphenhydramine, including those that are applied externally, is to be avoided. Simultaneous application with other centrally attenuating medicines such as sleep, Calming, pain or anesthesia, anxiety-soluvines (Anxiolytics), medicaments for the treatment of depression or agents for the treatment of seizure disorders (antiepileptica) can lead to mutual reinforcement. The so-called "Anticholinerge" effect of diphenhydramine can be reinforced by drugs with similar effects such as atropine, berids, tricyclic antidepressants or monoamine oxidase inhibitors. There may be an increase in the eyes inner pressure, urinary content or a u.. life-threatening intestinal paralysis. The use of diphenhydramine together with blood pressure-lowering medicines can lead to increased fatigue. Simultaneous use with medicaments, which also extend the so-called Qt interval in the ECG, e.g. B. funds against cardiac arrhythmias (Antiarrhythmics class IA or III), certain antibiotics (e.g., Erythromycin), cisaprid, malaria agents, agents against allergies or gastrointestinal ulcers (antihistamines) or agents for the treatment of special spiritual mental illnesses (Neuroleptics), or can lead to a potassium deficiency (e.g. Certain urinary driving means) must be avoided. Diphenhydramine may be able to falsify the test results for allergy tests and should therefore no longer be used at least 3 days before.

Taking Dolestan together with food, drinks and alcohol:
During treatment with Dolestan, no alcohol must be drunk, since the effect of diphenhydramine is changed and reinforced in a unpredictable manner.

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Dolestan may not be taken during pregnancy and lactation.

Driving and ability to operate machines:
After taking Dolestan, no vehicles may be led or dangerous machines are served. Also on the following day, residual fatigue and impaired response ability can affect the ability to drive or the ability to work with machines, especially after inadequate sleeping duration.

3. What is Dolestan take?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by the doctor, the usual dose for adults is 2 Tablets (corresponding to 50 mg diphenhydramine hydrochloride). This dose should not be exceeded. Patients with impaired liver or renal function should receive lower doses. Even with older or weakened patients, the u.U. Respond to particularly sensitive, it is recommended to adjust the dose if necessary.

Application in children and adolescents:
Children and adolescents under the age of 18 are to be treated only after careful consideration of risk and benefits with Dolestan.

Type of application:
The tablets are sufferuT in the evening 30 minutes before sleeping with some liquid (water). Subsequently, a sufficient sleep duration (7-8 hours) should to be guaranteed.

Duration of application:
The duration of the treatment should be as short as possible. It should generally be only a few days and do not exceed 2 weeks. For persistent sleep disorders, please visit a doctor! Please talk to your doctor or pharmacist if you have the impression that the effect of Dolestan is too strong or too weak.

If you take a greater amount of Dolestan than you should:
Overdoses with diphenhydramine can be dangerous - Especially for children and toddlers. For this reason, a doctor should be informed if there is an overdose or poisoning immediately (e.g., poisoning noteRuF)! Overdons with diphenhydramine express themselves primarily dependent on the amount taken - by disturbances of the central nervous system (Confusion, excitement states up to convulsive accidents, awareness of consciousness up to the coma, respiratory disorders up to respiratory arrest) and the cardiovascular system. In addition, increased muscle reflections, fever, dry strain skinsheets, vision, clogging and disorders of urinary excretion can occur. Rhabdomyolysen (severe muscle damage) have also been observed.

If you forget to take Dolestan:
Do not take the double amount when you forget the previous taking.

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

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other.

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Possible side effects:
Diseases of the nervous system:
Often: drowsiness, dizziness and concentration disorders during the following day, especially after insufficient sleep duration, dizziness, headache.

Eye diseases:
Often: visual disturbances.

Heart diseases:
During treatment with Dolestan, certain cardiac arrhythmias can occur (extension of the QT interval in ECG).

Diseases of the gastrointestinal tract:
Often: gastrointestinal complaints such as nausea, vomiting or diarrhea and so-called "anticho-liner effects" such as mouth dryness, constipation, heartburn.

Skeletal muscles, connective tissue and bone diseases:
Often: muscle weakness.

Diseases of kidneys and urinary tract:
Frequently: Complaints in urination.

In addition, hypersensitivity reactions, increased photosensitivity of the skin, changes in the blood image, increase in intraocular pressure, jaundice (cholestatic ectic) and so-called "paradoxical reactions" as resting, nervousness, excitement, anxiety, tremor or sleep disorders have been reported.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. What is Dolestan be kept?

Maintain This medicine for children inaccessible. You may not use this medicine according to the expiry date specified on the outer carton or container according to "until". The expiry date refers to the last day of the specified month. Storage conditions: No special storage conditions are required for this medicine.

6. Content of the pack and further information

What Dolestan contains:
The active ingredient is: diphenhydramine hydrochloride. 1 tablet contains 25 mg diphenhydramine hydrochloride. The other ingredients are: Microcrystalline cellulose, cellulose granules, cellulose powder, potato starch, magnesium stearate, talc, high-disperses silicon dioxide.

Like Dolestan looks and content of the pack:
Dolestan are white tablets with one-sided breaker and embossing "D" on one side. Dolestan is in packs of 20 Tablets (N2) available.

Pharmaceutical entrepreneur and manufacturer:
Krewel Meuselbach GmbH
Kreagelstraße 2
53783 Eitorf
Telephone: 02243 / 87-0
Fax: 02243 / 87-175
E-Mail: [email protected]

This leaflet was recently revised in February 2015.

Source: Information of the leaflet
Status: 03/2017