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Microsoft word - vestibo tabl._leaflet_engl.doc

- Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. THIS LEAFLET CONTAINS THE FOLLOWING INFORMATION:
1. What Vestibo is and what it is used for
2. What you should know before you take Vestibo
3. How to use Vestibo
4. Possible side effects
5. How to store Vestibo
6. Further information
Vestibo 8 mg, 16 mg, tablets
Active substance in one tablet: Betahistine 8 mg Active substance in one tablet: Betahistine 16 mg Other ingredients: povidone, cellulose microcrystalline, lactose monohydrate, silica colloidal anhydrous, crospovidone, stearic acid. Vestibo 8 mg tablets is marketed in sizes of 30, 60, and 100 tablets in one pack.
Vestibo 16 mg tablets is marketed in sizes of 30 and 60 tablets in one pack.
Vestibo exerts its effect as a result of action on specific receptors (histamine H1-
and H3-receptors) that are found in the inner ear and in some areas of the brain. It
improves capillary microcirculation and permeability, and normalizes the
pressure of the endolymph in the organ of balance, located in the inner ear. It has no negative effect on the work of the heart; occasionally it may lead to a mild drop of the arterial blood pressure. The clinical manifestations of these effects are reduced incidence of dizziness/vertigo, reduction of tinnitus, improvement of Vestibo is used for treatment of Meniere’s disease, which is manifested with:
• dizziness/vertigo (with nausea and/or vomiting); • hearing loss (hard of hearing); Symptomatic treatment of vestibular vertigo (dizziness resulting from disease of 2. WHAT YOU SHOULD KNOW BEFORE YOU START TAKING
Do not take Vestibo in hypersensitivity (allergy) to betahistine hydrochloride or
Take special care with this medicinal product to the following:
- patients with peptic ulcer disease, due to the risk of occurring dyspepsia (acidity, heartburn, nausea, stomach upset) during treatment; - patients with bronchial asthma, urticaria, rash and allergic rhinitis (patients with allergic diseases are at increased risk, due to a likelihood of worsening of the symptoms of allergy during the course of treatment with betahistine); - patients suffering from histamine (cluster) headache and migraine, due to a danger for provoking attacks and relapses during the course of treatment with - patients taking antihistamine products (medicines for the treatment of allergy). Patients with phaeochromocytoma should be treated with this product solely under medical supervision, since Betahistine may induce catecholamine release from the tumor and, as a result, may cause a severe hypertension crisis (excessive Taking Vestibo with food and drinks
There is no evidence for the need of special diet or restriction of specific foods and drinks during the course of treatment with this product. Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine! Data from animal studies and observations have shown the absence of harmful effect on the progeny. Betahistine safety during pregnancy in humans has not been confirmed, therefore this product is not recommended for use by pregnant Breast feeding
Ask your doctor or pharmacist for advice before taking any medicine! It is excreted into maternal breast milk, attaining concentrations similar to those in blood. There is no evidence of negative effects on breast-fed infants. Treatment with this product should be avoided during breast feeding. Driving and using machines
Betahistine usually has no effect on vigilance/alertness and on the ability for concentration of attention, but sometimes drowsiness may occur during treatment with this product. This may result in temporary impairment of the ability to drive Concomitant use with other medicinal products:
Please, inform your doctor or pharmacist if you are using or have recently used other medicinal products, even if these had not been prescribed by a doctor! Vestibo should not be used concomitantly with antihistamine medicinal products
(medicines for the treatment of allergic diseases). Ethanol, pyrimethamine, salbutamol potentiate the effect of betahistine. 3. HOW TO TAKE VESTIBO
Always take Vestibo exactly as your doctor has instructed you! Dosage is determined according to the individual patient’s response. Depending on the severity of your complaints, the doctor shall determine the necessary dose Daily dose 24 - 48 mg, in two or three divided doses. This product should not be used in children and adolescents under 18 years of The efficacy and safety of the product have not been confirmed for these groups. Improvement in some patients may occur after 14 days of treatment. If you have the impression that the effect of Vestibo is too strong or too weak, If you have taken more Vestibo than you should:
If you take a larger than the prescribed dose, you should immediately seek help The symptoms of overdose include possible nausea, vomiting, dyspepsia, ataxia In case of overdose, it is necessary to evacuate the gastric content by induced emesis, gastric probe and lavage, and to administer appropriate medicines for the If symptoms of overdose occur, immediately contact a doctor! If you forget to take Vestibo
If you miss taking a dose, take it at the next regular dosing time. 4. POSSIBLE SIDE EFFECTS
Like all medicines, Vestibo can have side effects. During treatment with this product, the following adverse reactions may occur Central nervous system: drowsiness, fatigue, headache; Gastrointestinal system: mild stomach upset that can be avoided by taking this If you notice any side effects not mentioned in this leaflet, please inform your 5. HOW TO STORE VESTIBO
Keep out of the reach and sight of children! Store in the original package container at temperature not above 25ºC. Do not use after the expiry date stated on the package! Expiry term: 3 (three) years from the manufacturing date. 6. FURTHER INFORMATION
If any additional information about this product is required, please contact the local office of the marketing authorization holder. This leaflet was last approved in March 2005.


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