BETAHISTINE TEVA 16 MG

Israel - English - Ministry of Health

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Active ingredient:
BETAHISTINE DIHYDROCHLORIDE
Available from:
ABIC MARKETING LTD, ISRAEL
ATC code:
N07CA01
Pharmaceutical form:
TABLETS
Composition:
BETAHISTINE DIHYDROCHLORIDE 16 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
DISPHAR INTERNATIONAL B.V., THE NETHERLANDS
Therapeutic group:
BETAHISTINE
Therapeutic area:
BETAHISTINE
Therapeutic indications:
Meniere's syndrom. Symptomatic treatment of peripheral vertigo.
Authorization number:
150 24 33758 00
Authorization date:
2018-06-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

26-10-2016

The dosage and the treatment regimen will be

determined by the doctor only. The usual dosage is

generally:

One tablet three times a day.

The doctor may lower the dosage to half a tablet three

times a day.

Do not exceed the recommended dose.

This medicine is not intended for children and

adolescents below the age of 18 years.

Do not chew; swallow the tablets with water.

The tablet can be halved at the score line.

Tests and follow-up

In asthma patients medical monitoring is required during

the course of treatment with Betahistine.

If you accidentally took a higher dosage

If you took an overdose or if a child accidentally

swallowed the medicine, immediately refer to a doctor

or to a hospital emergency room and bring the package

of the medicine with you. Do not induce vomiting without

explicit instruction from a doctor!

Possible side effects of overdose – nausea, sleepiness

or abdominal pains.

If you forgot to take this medicine at the scheduled

time, do not take a double dose. Take the next dose at

the regular time and consult a doctor.

Adhere to the treatment as recommended by the

doctor.

Even if there is an improvement in your health, do not

stop treatment with this medicine without consulting the

doctor or pharmacist.

Do not take medicines in the dark! Check the label and

the dose each time you take medicine. Wear glasses if

you need them.

If you have further questions regarding use of this

medicine, consult the doctor or pharmacist.

4. SIDE EFFECTS:

As with any medicine, use of Betahistine Teva

16 mg

may cause side effects in some users. Do not be alarmed

when reading the list of side effects. You may not suffer

from any of them.

Discontinue use of this medicine and refer to a doctor

immediately if:

If you suffer from allergic reactions, such as:

Swelling of the face, lips, tongue or neck, which may

cause difficulty breathing.

A red skin rash, inflamed and itchy skin.

Additional side effects:

Occurring frequently (affect less than 1 in 10 patients):

nausea, indigestion, headache.

Occur at an unknown frequency: itching, rash, mild

gastrointestinal disorders, such as vomiting, abdominal

pain and bloating. Taking this medicine with a meal can

reduce the side effects associated with the digestive

system.

If one of the side effects worsens, or if you suffer from

a side effect not mentioned in this leaflet, consult

the doctor.

5. HOW SHOULD THE MEDICINE BE STORED?

Avoid poisoning! This medicine and any other medicine

must be kept in a safe place out of the reach and sight

of children and/or infants in order to avoid poisoning.

Do not use the medicine after the expiry date (exp. date)

that appears on the package. The expiry date refers to

the last day of that month.

Store in a dry place, below 25ºC. Store in the original

package in order to protect from light.

Do not discard medicines in the waste bin. Ask

the pharmacist how to dispose of medicines no

longer in use. These measures will help protect the

environment.

6. FURTHER INFORMATION

In addition to the active ingredient, the medicine

also contains:

Lactose monohydrate, Microcrystalline cellulose,

Crospovidone, Stearic acid, Colloidal silica anhydrous,

Povidone K90.

What the medicine looks like and the contents of

the package:

Tablet form: a round, white to almost white tablet, with

B16 appearing on one side and a score line on the other

side.

The package contains 30 tablets.

License holder and address: Abic Marketing Ltd.,

P.O.B. 8077, Nathanya.

Manufacturer and address: Disphar International B.V.,

Hengelo, The Netherlands.

Registration number of the medicine in the

National Drug Registry of the Ministry of Health:

150.24.33758.00

This leaflet was checked and approved by the Ministry

of Health in July 2013.

PATIENT PACKAGE INSERT IN ACCORDANCE

WITH THE PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

The medicine is dispensed with

a doctor’s prescription only

Betahistine Teva

®

16 mg

Tablets

The active ingredient and its quantity:

Each tablet contains: Betahistine dihydrochloride 16 mg

For the list of inactive ingredients, please see section 6.

Read this leaflet carefully in its entirety before using

this medicine. This leaflet contains concise information

about the medicine. If you have further questions, refer

to the doctor or pharmacist.

This medicine has been prescribed for the treatment of

your ailment. Do not pass it on to others. It may harm

them even if it seems to you that their ailment is similar.

This medicine is not intended for children and

adolescents below the age of 18 years.

1. WHAT IS THE MEDICINE INTENDED FOR?

The medicine is intended to treat Meniere's syndrome,

which is manifested by dizziness, ringing in the ears

(tinnitus), and for the symptomatic treatment of

peripheral vertigo.

The medicine works by improving the blood flow in the

inner ear, which reduces the build-up of pressure.

Therapeutic group:

Histamine analog.

2. BEFORE USING THE MEDICINE:

Do not use the preparation if:

If you are sensitive to the active ingredient or to any

of the ingredients of the medicine (see details in

section 6).

If you suffer from high blood pressure as a result of

an adrenal tumor (pheochromocytoma).

Special warnings regarding use of the medicine:

If you are sensitive to any food or medicine, inform the

doctor before taking this medicine.

In asthma patients medical monitoring is required during

the course of treatment with Betahistine.

The preparation contains lactose and may cause an

allergy in people sensitive to lactose.

Before treatment with Betahistine Teva

®

16 mg, tell

the doctor if:

If you are pregnant, planning to become pregnant or

breastfeeding.

If you are suffering, or have suffered in the past, from

impaired function of: the respiratory system (e.g.,

asthma) or the digestive system (e.g., ulcer).

If you are taking, or have recently taken, other

medicines, including non-prescription medicines and

nutritional supplements, tell the doctor or pharmacist.

It is especially important to inform the doctor or pharmacist

if you are taking medicines from the following groups:

Antihistamines – these medicines may lower the effect

of Betahistine Teva

. Also, Betahistine Teva

may lower

the effect of antihistamines.

Monoamine oxidase inhibitors (MAOIs) – for treatment

of depression or Parkinson’s – these medicines may

increase the effect of Betahistine Teva

Use of the medicine and food:

Take the medicine with or without a meal.

Use of the medicine and alcohol consumption:

Wines and alcoholic beverages can be consumed during

the course of treatment with this medicine.

Pregnancy and breastfeeding:

Do not take this medicine if you are pregnant, unless

the doctor has decided that it is absolutely necessary.

Consult the doctor.

Do not breastfeed while using this medicine, unless the

doctor has instructed you otherwise. It is not known if the

medicine passes into the breastmilk.

Driving and use of machines:

Taking this medicine is not expected to impair the ability

to drive or operate machinery. Despite this, remember that

the ailments for which Betahistine is taken, may cause

dizziness or nausea, which may affect the ability to drive

and operate machinery.

Important information about some of the ingredients

of the medicine:

The medicine contains 140 mg lactose.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use according to the doctor's instructions. Check

with the doctor or pharmacist if you are unsure.

Use this medicine at specified time intervals, as

determined by the attending doctor.

It may take time until the effect of the tablets becomes

apparent.

BETA TAB PL SH 070813

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