Gittalun Drinking Tablets Effervescent Tablets, 20 pcs

Instructions for use for Gittalun Drinking Tablets Effervescent Tablets, 20 pcs

Important notes (compulsory information):

Gittalun® Drinking Tablets 25 mg effervescent tablets. Active substance: Doxylamineuccinate. Areas of application: To calm down before falling asleep and in case of restless sleep, as far as medical treatment in need of treatment.

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


LEAFLET: INFORMATION FOR THE USER
Gittalun® Drinking Tablets
25 mg effervescent tablets
For use in adults
Active substance: Doxylamineuccinate

Read the entire leaflet carefully because it contains important information for you.
This medicine is available without prescription. In order to achieve the best possible treatment success, Gittalun drinking tablets must be used in accordance with properly.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If your symptoms aggravate or no improvement occurs, you should definitely visit a doctor.
• If one of the listed side effects are significantly affected or if you notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

Contents of this leaflet:
1. What are Gittalun drinking tablets and what are they used for?
2. What do you need to consider before taking Gittalun drinking tablets?
3. What are Gittalun to take drinking tablets?
4. Which side effects are possible?
5. How to keep Gittalun drinking tablets?
6. Further information

1. What are Gittalun drinking tablets and what are they used for?

Gittalun drinking tablets are a medicine with tired features (antihistamine, sedative).
Gittalun drinking tablets are applied for reassurance before falling asleep and in case of restless sleep, as far as medical treatment in need of treatment.

Note:
Not all unrest states that affect the insent of sleep requires drug therapy. Often they are an expression of a physical or mental illness and can be influenced by other measures or therapy of the basic disease. For longer-lasting sleep disorders, there should therefore be no continuous treatment with Gittalun drinking tablets, but the attending physician should be visited.

2. What do you need to consider before taking Gittalun drinking tablets?

Gittalun drinking tablets may not be taken

• if they are hypersensitive (allergic) against doxylamine or any of the other ingredients of Gittalun drinking tablets or other antihistamines.
• with acute asthma attack; Green star (narrow angle glaucoma); Adocation tumor (pheochromocytoma); Enlargement of the projecting gland (Prostate hypertrophy) with residual harvesting; Acute poisoning through alcohol, sleep or painkillers as well as psychotropharmaca (Neuroleptics, tranquilizer, antidepressants, lithium); Falling sick; Simultaneous treatment with inhibitors of monoamine oxidase.

Children and adolescents should not be treated with Gittalun drinking tablets.

Take special care with Gittalun drinking tablets:
With limited liver function, prevention of the heart and hypertension, chronic breathing difficulties and asthma, insufficient closure of gastric entrance with reflux of food into the esophagus (gastroesophageal reflux).
Special caution is also advised in patients with neurologically recognizable brain damage in the cerebral cortex and convulsive accidents in the prehistory, since already can be triggered by taking small amounts of doxylamine convulsions (grand cases.
Ask in such cases before taking Gittalun Drinking Tablets Bitte her doctor.

Taking Gittalun Drinking Tablets together with other medicines:
Replacing the effects of Gittalun drinking tablets and

• centrally effective medicines (such as psychopharmaca, sleep, pain, anesthesia, medium against seizure disorder).
• Alcohol, which in particular can change the effect of doxylamine unpredictably.
• Medicines with also anticholiner effect (eg Biperides at Parkinsonic disease, tricyclic antidepressants and monoamine oxidase inhibitors for depression treatment), with the sequence of z. B. life-threatening intestinal paralysis, urinary behavior, acute increase in intraocular pressure.

Can be attenuated the effect of

• Phenytoin (against seizure of error).
• Neuroleptics.

With simultaneous use of gittalun drinking tablets

• and drugs against high blood pressure acting on the central nervous system (guanabenz, clonidine, alphamethyldopa), may increase fatigue, mattedness.
• can symptoms of starting inner ear damage caused by other medicines (eg Aminoglycosidantibiotics, some painkillers, some durable means), be weakened.
• can be falsified results from skin tests (incorrectly negative).
• should epinephrine not be used (vascular expansion, blood pressure drop, accelerated heart rate).
• and monoamine oxidase inhibitors can lead to blood pressure drop and a reinforced functional limitation of the central nervous system and the breathing. Therefore, a simultaneous therapy with both substances must be taken.

Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is non-prescription medicines.

Taking Gittalun drinking tablets together with food and beverages:
Alcohol enjoyment should be avoided during the use of Gittalun drinking tablets.

Pregnancy and breast feeding period:
Ask your doctor or pharmacist for advice before taking / application of all medicines.
Gittalun drinking tablets are to be taken during pregnancy only on the express statement of the doctor.
Since the active ingredient goes into breast milk, breastfeeding should be interrupted for the duration of treatment.

Driveion and use of machines:
This medicine can also change the reaction assets as well as the fact that the ability to actively participate in road traffic or to operate machines is impaired. This applies even more in combination with alcohol. You can then no longer respond to unexpected and sudden events quickly and specifically enough.
Do not drive a car or other vehicles! Do not operate any electrical tools or machinery! Do not work without a safe grip!

Important information about specific ingredients of Gittalun Drinking Tablets:
An effervescent tablet contains 25 mmol (575 mg) sodium. If you need to meet a saline diet, you should consider this.

3. What are Gittalun to take drinking tablets?

Always take Gittalun drinking tablets exactly as directed in this leaflet. Please ask your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by the doctor, adults take about 1 Hour before sleeping a gittalun drinking tablet (equivalent to 25 mg of doxylamineuccinate) in half a glass of water. With stronger sleep disorders, 2 gittalun drinking tablets (equivalent to 50 mg of doxylamineuccinate) can be taken as the highest dose 2 gittalun.
Ensure sufficient sleep duration to affect oneg of their reactivity to avoid the following morning.
With acute sleep disorders, the treatment should be limited as on individual procedures. In order to check the need for continued application in chronic sleep disorders, the dose should be gradually reduced or discontinued after two week daily intake.

If you take more Gittalun drinking tablets than you should:
An overdose can be seen that it can first come to centrally conditional symptoms such as restlessness, increased muscle reflections, unconsciousness, depression of breathing as well as cardiac arrest. Further signs of an overdose are pupil expansion, accelerated heart activity (Tachycardia), fever, hot, red skin and dry mucous membranes. If these symptoms occur, a doctor should be communicated immediately.

For overdose, stomach flushes with activated carbon are recommended as immediate measures. When the mammal arm complaints occur, central nervous disorders, mouth dryness, emptying disorders of the bubble (micturistic complaints) as well as visual distortions are to take the appropriate measures depending on the appearance.

4. Which side effects are possible?

Like all medicines, GittaTalun can have trinking tablets, but they do not have to occur each other.

Depending on the sensitivity of the individual patient and the dose occupied, the following side effects may occur: Dizziness, concentration disturbances, headaches, depression, muscle weakness, ear growing and dizziness, prolonged reaction time, drowsiness and mattedness.

In addition, there is the possibility of the occurrence of so-called "Paradoxic" reactions such as restlessness, excitement, tension, insomnia, nightmares, confusion, hallucinations, trembling. Rarely can convulsions of the brain may occur.

Vegetative accompanying effects such as blurred sight, mouth dryness, feeling of the clogged nose, increase in intraocular pressure, clogging and disorders during urination may occur, as nausea, vomiting, diarrhea, loss of appetite or appetite gain, stomach pain. Very rare it can come to a life-threatening intestinal paralysis.

Acceleration or irregularity of heartbeat, blood pressure rise or waste and increase of an existing heart power weakness can occur. ECG changes were observed.
To impair the respiratory function, it can come through thickening of mucus and laying or closing the bronchi.

About allergic skin reactions and light sensitivity of the skin (Direct sunlight avoid!) Under therapy with antihistamines has also been reported, furthermore about hepatic impairment (cholestatic ectic ectus) and over disturbances of body temperature regulation. Flood damage can occur in exceptional cases.

In patients with adrenal tumor (pheochromocytoma), there may be a release of substances from the tumor that have a very strong effect on the cardiovascular system.
After a long-term daily use, sleep disorders can be reinforced by sudden settling of therapy.

Hints:
Through careful and individual adjustment of the daily doses, the frequency and extent of side effects can be reduced. The risk of side effects occur in older patients is greater, in this group of people can also increase the risk of falling.

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 share effects directly
Federal Institute for Pharmaceuticals and Medical Products,
Dept. Pharmacovigilance,
Kurt-Georg-Kiesinger-Allee 3,
D53175 Bonn,
Website: www.bfarm.de
Show. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Gittalun drinking tablets?

Store drug out of reach of children.
You may not use the drug after the expiry date specified on the folding box and on the tablet tube according to "usable to.

Upewahrungsbedingungen:
Do not store more than 25 ° C.
Protect from moisture.
The tablets tube must be immediately closed tightly after removal of an effervescent tablet.

6. Further information

What GITTALUN drinking tablets contain:
The active ingredient is doxylamineuccinate.
1 effervescent tablet contains 25 mg doxylamine succinate.
The other ingredients are: anhydrous citric acid, sodium bicarbonate, disodium hydrogen phosphate, sodium sulfate, macrogol 6000

How GITTALUN drinking tablets look like and contents of the pack:
Original packs of 10 and 20 effervescent tablets for oral use

Pharmaceutical entrepreneur and manufacturer

Pharmaceutic entrepreneur:
SanofiAventis
Germany GmbH
65926 Frankfurt am Main
Postal address:
Mailbox 80 08 60
65908 Frankfurt am Main
Phone: 0800 56 56 010
Fax: 0800 56 56 011

Manufacturer:
Boehringer Ingelheim
Pharma GmbH & Co. KG
Sales division Thomae
Binger Str. 173
55216 Ingelheim am Rhein
Phone: 0800/77 90 900
Fax: 06132/72 99 99

This leaflet was last in June 2017 revised.

Source: Information of the leaflet
Status: 08/2017