ACUVER solution 60 ml.

ACUVER WHAT IS AND WHAT IT IS USED
The active ingredient betahistine improves blood flow to the inner ear. Akuver is effective for the treatment of vertigo caused by the breach of the blood flow in the inner ear.

Akuver is used to treat the symptoms of Meniere's disease comprising:
vertigo with nausea and vomiting;
ringing in the ears;
hearing impaired.

2 BEFORE YOU TAKE ACUVER
Do not take Akuver:
if you are allergic (hypersensitive) to betahistine or any of the other ingredients of Akuver;
during pregnancy and lactation;
if you suffer from a certain type of cancer of the adrenal glands called pheochromocytoma.
Take special care with Akuver:
If you currently have or previously suffered from a stomach ulcer;
if you suffer from asthma (lung disease, accompanied by shortness of breath);
If you suffer from hives (urticaria), rash (exanthema) or hay fever;
if you have very low blood pressure;
if you are taking anti-allergy medicines (antihistamines) simultaneously taking Akuver (see also "Taking other medicines").
Children and adolescents up to 18 years
Akuver not recommended for children and adolescents below 18 years due to lack of experience in its use in these age groups.
If Akuver oral solution accidentally inhales and not swallow, may have received cough wheezing (bronchoconstriction) and lowering blood pressure.

Taking other medicines
Adoption of anti-allergic drugs such as antihistamines (especially H1-antagonists) simultaneously Akuver may reduce the effectiveness of the two drugs.
If you are taking or have recently taking other medicines, including medicines that are available without a prescription, please tell your doctor or pharmacist.

Taking Akuver with food and drink
Recommended Akuver be taken during or after a meal to avoid stomach upset.

Pregnancy and lactation
Akuver not take if you are pregnant or breastfeeding.
Not enough experience with betahistinov dihydrochloride in pregnant or lactating women.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
One of the possible effects of Akuver is drowsiness; said medicament contains a small amount of ethanol (alcohol). Adoption of Akuver can slow your reflexes and thus impair your ability to drive and use machines.

Important information about some of the ingredients of Akuver
Akuver contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3 HOW TO TAKE ACUVER?
Always take Akuver exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The standard dosage for adults is:
3 times a day, 1-2 injections in 1 cup of water (at least 100 ml).
This equates to 3 times daily 8-16 mg betahistinov dihydrochloride. One injection equals 0.8 milliliters of solution.
The daily dose should not exceed 6 sprays or 48 mg betahistinov dihydrochloride.

Method of administration
Akuver is administered orally!
Before first use, remove the screw and replace it with a volumetric pump attached.
Before you take the drug Akuver dissolve in a glass of water (at least 100 milliliters).
Exam drug during or after meals.
Duration of treatment
To ensure a satisfactory effect, treatment should continue for several months.
Children and adolescents under 18 years of age
Akuver not recommended for children and adolescents up to the age of 18 as there is no experience in this age group.

If you take more than you should Akuver
May occur following overdose symptoms: headache, flushing, dizziness (vertigo), fast heart beat (palpitations, tachycardia), a fall in blood pressure (hypotension), tightening of the airways with shortness of breath (bronchospasm), fluid retention in the tissues (edema).
Following administration of very high doses may occur convulsions.
If you suspect overdose contact your doctor immediately!

If you forget to take a dose Akuver
Do not take a double dose to make up for missed and take your next dose when it came time.

Discontinuation of Akuver
Do not stop your treatment with Akuver without check with your doctor!

If you have further questions on the use of this medicine, ask your doctor or pharmacist.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Akuver can cause side effects, although they do not occur in everyone.
Very common: More than 1 in 10 patients;
Common: 1 to 10 of 100 patients;
Uncommon: 1 to 10 of 1000 patients;
Rare: 1 to 10 of 10 000 patients;
Very rare: less than 1 in 10,000 patients;
Not known: frequency can not be estimated from the available data.
Reported side effects:
Nervous system disorders:
Rare: drowsiness, feeling tension headaches.
Cardiac disorders:
Rare: palpitations, chest tightness.
Gastrointestinal disorders:
Rare: nausea, nausea, heartburn, stomach upset and pain, gas, diarrhea, vomiting.
In most cases, gastric discomfort can be avoided by taking Akuver during or after a meal or with dose reduction.

Reactions of the skin or subcutaneous tissue disorders:
Very rare: rash, itching, hives (urticaria).
General disorders:
Rare: feeling of warmth.
If any side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5 HOW TO STORE ACUVER?
Keep out of reach of children.
Akuver not use after the expiry date printed on the carton. Shelf life is the last day of that month.
This medicinal product does not require any special storage conditions.
Keep the medicine in the original container to protect it from light.
Do not refrigerate or freeze.
120 ml: Use within two months after first opening.
60 ml: Use within 1 month after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the unnecessary amount. These measures help to protect the environment.

6 FURTHER INFORMATION
What are the ingredients of Akuver?
The active substance is betahistinov dihydrochloride
1 spray delivers 0,8 ml solution containing 8 mg of betahistinov dihydrochloride.
The other ingredients are: saccharin sodium, glycerol, ethanol (96% vol.), Sodium benzoate (E211), hydrochloric acid (3,5% w / w) as a buffering agent, and purified water.

Akuver looks like and contents of the pack?
This medicinal product is an oral solution with a volumetric pump: the solution is clear.

container:
Amber glass bottle (acid resistant glass type III) with child resistant screw cap and applied a volumetric pump (plastic).
Pack sizes: 60 ml and 120 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
CYATHUS Exquirere Pharmaforschungs GmbH, Austria.

manufacturer:
Laboratorio Farmacoloeico Milanese Srl, Italy.