Betahistine Viatris Drug / Medication Data

Shopper Medication Data (CMI) abstract

The full CMI on the subsequent web page has extra particulars. In case you are apprehensive about utilizing this medication,
communicate to your physician or pharmacist.

Why am I utilizing BETAHISTINE VIATRIS?

BETAHISTINE VIATRIS comprises the lively ingredient betahistine dihydrochloride. BETAHISTINE
VIATRIS is used to deal with a dysfunction of your internal ear. This dysfunction could embody one
or extra of the next signs, in a single or each ears: ringing within the ears (tinnitus),
lack of clear listening to and issues with stability (vertigo). These signs might also
be related to nausea, vomiting and headache. Usually these signs collectively are
known as Meniere’s Syndrome.

What ought to I do know earlier than I exploit BETAHISTINE VIATRIS?

Don’t use when you’ve got ever had an allergic response to betahistine dihydrochloride
or any of the elements listed on the finish of the CMI.

Don’t take this medication when you’ve got peptic ulcer or a uncommon abnormality of the adrenal
gland often known as phaeochromocytoma.

Speak to your physician when you’ve got another medical situations (e.g. peptic ulcer, bronchial asthma
or a historical past of pores and skin situations), take another medicines, or are pregnant or plan
to grow to be pregnant or are breastfeeding.

What if I’m taking different medicines?

Some medicines could intervene with BETAHISTINE VIATRIS and have an effect on the way it works.

How do I exploit BETAHISTINE VIATRIS?

The standard grownup beginning dose is half to 1 pill taken thrice a day.

Take BETAHISTINE VIATRIS at about the identical time every day throughout or instantly after
a meal.

What ought to I do know whereas utilizing BETAHISTINE VIATRIS?

Issues you need to do

Remind any physician or pharmacist you go to that you’re utilizing BETAHISTINE VIATRIS.

If you will have surgical procedure, inform the surgeon that you’re taking this medication.

Issues you shouldn’t do

Don’t cease taking BETAHISTINE VIATRIS, or change the dosage, with out checking with
your physician.

Don’t use this medication to deal with another complaints except your physician or pharmacist
tells you to.

Driving or utilizing machines

BETAHISTINE VIATRIS is indicated for Meniere’s syndrome with signs of vertigo,
listening to loss and tinnitus which may negatively have an effect on the power to drive and use
machines.

BETAHISTINE VIATRIS is proven to haven’t any or negligible results to have an effect on the power
to drive.

Taking care of your medication

Maintain your tablets within the pack till it’s time to take them.

Maintain the drugs in a cool, dry place the place the temperature stays under 30°C.

Maintain it the place youngsters can’t attain it.

Are there any unwanted side effects?

Inform your physician or pharmacist in case you discover any of the next and so they fear you:
pores and skin irritations, abdomen upsets, dizziness, quick heartbeat, headache and issue
sleeping (insomnia). Abdomen upsets will be overcome by taking BETAHISTINE VIATRIS
throughout meals.

Inform your physician as quickly as potential in case you discover any pores and skin reactions or issue
respiration.

Lively ingredient:
betahistine dihydrochloride

Shopper Medication Data (CMI)

This leaflet supplies vital details about utilizing BETAHISTINE VIATRIS. You also needs to communicate to your physician or pharmacist if you want additional info
or when you’ve got any considerations or questions on utilizing BETAHISTINE VIATRIS.

The place to search out info on this leaflet:

Why am I utilizing BETAHISTINE VIATRIS?

BETAHISTINE VIATRIS comprises the lively ingredient betahistine dihydrochloride. BETAHISTINE VIATRIS works by bettering the blood circulation of the internal ear and restoring
it to regular. It additionally acts on the nerve endings within the internal ear to normalise the
means through which the nerves reply to outdoors influences.

BETAHISTINE VIATRIS is used to deal with a dysfunction of your internal ear. This dysfunction could
embody a number of of the next signs, in a single or each ears:

ringing within the ears (tinnitus)

lack of clear listening to

issues with stability (vertigo)

These signs might also be related to nausea, vomiting and headache. Usually these
signs collectively are known as Meniere’s Syndrome.

What ought to I do know earlier than I exploit BETAHISTINE VIATRIS?

Warnings

Don’t use BETAHISTINE VIATRIS if:

you’re allergic to betahistine dihydrochloride, or any of the elements listed
on the finish of this leaflet.

At all times examine the elements to ensure you need to use this medication.

Some signs of an allergic response embody pores and skin rash, itching, shortness of breath
or swelling of the face, lips or tongue, which can trigger issue in swallowing
or respiration.

Don’t give BETAHISTINE VIATRIS to a baby below the age of 18 years.

Don’t take BETAHISTINE VIATRIS when you’ve got a uncommon abnormality of the adrenal gland
often known as phaeochromocytoma.

Don’t take BETAHISTINE VIATRIS when you’ve got or have had a peptic ulcer.

Don’t take BETAHISTINE VIATRIS if the packaging is broken or reveals indicators of tampering.

Examine together with your physician in case you:

Have or have had any of the next medical situations:

a peptic ulcer

bronchial asthma

a historical past of allergic pores and skin situations

Throughout therapy, chances are you’ll be liable to creating sure unwanted side effects. It’s important
you perceive these dangers and learn how to monitor for them. See further info
below Part 6. Are there any unwanted side effects?

Being pregnant and breastfeeding

Examine together with your physician if you’re pregnant or intend to grow to be pregnant.

Don’t take this medication if you’re pregnant.

It could have an effect on your creating child in case you take it throughout being pregnant.

Speak to your physician if you’re breastfeeding or intend to breastfeed.

Don’t breastfeed if you’re taking this medication.

The lively ingredient in BETAHISTINE VIATRIS could cross into breast milk and subsequently
there’s a chance your child could also be affected.

This medication isn’t addictive.

What if I’m taking different medicines?

Inform your physician or pharmacist if you’re taking another medicines, together with any
medicines, nutritional vitamins or dietary supplements that you just purchase with no prescription out of your pharmacy,
grocery store or well being meals store.

Some medicines and BETAHISTINE VIATRIS could intervene with one another
These embody:

any anti-histamine drugs, that are used to deal with allergic reactions and allergic reactions

These medicines could also be affected by BETAHISTINE VIATRIS, or could have an effect on how properly it
works. It’s possible you’ll want to make use of totally different quantities of your medication, or take totally different medicines.

Examine together with your physician or pharmacist if you’re unsure about what medicines, nutritional vitamins
or dietary supplements you take and if these have an effect on BETAHISTINE VIATRIS.

How do I exploit BETAHISTINE VIATRIS?

How a lot to take

The standard grownup beginning dose is half to 1 pill taken thrice a day.

Nonetheless, your physician could prescribe a special dose relying on the severity of your
situation.

Comply with the directions offered and proceed taking BETAHISTINE VIATRIS so long as
your physician tells you.

In case you observe your physician’s directions, BETAHISTINE VIATRIS ought to begin working
inside a number of days, though in some instances it could take a number of weeks. The size of time
that you need to take BETAHISTINE VIATRIS tablets varies from affected person to affected person. Some
sufferers reply quickly to therapy and others could take a while. Please be affected person
together with your therapy and take your tablets frequently.

When to take BETAHISTINE VIATRIS

Take BETAHISTINE VIATRIS at about the identical time every day.

Taking it on the identical time every day may have one of the best impact. It should additionally show you how to
keep in mind when to take it.

Take BETAHISTINE VIATRIS throughout or instantly after a meal.

In case you take BETAHISTINE VIATRIS on an empty abdomen, it could trigger abdomen upsets.

The best way to take BETAHISTINE VIATRIS

Swallow the pill entire with a full glass of water.

In case you neglect to take BETAHISTINE VIATRIS

Whether it is virtually time on your subsequent dose, skip the dose you missed and take your subsequent
dose if you end up meant to.

In any other case, take it as quickly as you keep in mind, after which return to taking your medication
as you’ll usually.

Don’t take a double dose to make up for the dose you missed.

This may increasingly improve the prospect of getting an undesirable facet impact.

In case you use an excessive amount of BETAHISTINE VIATRIS

In case you assume that you’ve used an excessive amount of BETAHISTINE VIATRIS, chances are you’ll want pressing
medical consideration.

It is best to instantly:

telephone the Poisons Data Centre
(Australia phone 13 11 26) for recommendation, or

contact your physician, or

go to the Emergency Division at your nearest hospital.

It is best to do that even when there are not any indicators of discomfort or poisoning.

Signs of an overdose could embody nausea.

What ought to I do know whereas utilizing BETAHISTINE VIATRIS?

Issues you need to do

If you will have surgical procedure, inform the surgeon that you’re taking this medication.

Name your physician immediately in case you:

in case you grow to be pregnant if you are taking this medication

Remind any physician, dentist or pharmacist you go to that you’re utilizing BETAHISTINE
VIATRIS.

Issues you shouldn’t do

Don’t cease taking this medication all of the sudden, or change the dosage, with out checking
together with your physician.

Don’t use this medication to deal with another complaints except your physician or pharmacist
tells you to.

Don’t give this medication to anybody else, even when they’ve the identical situation as
you.

Driving or utilizing machines

BETAHISTINE VIATRIS is indicated for Meniere’s syndrome with signs of vertigo,
listening to loss and tinnitus which may negatively have an effect on the power to drive and use
machines.

BETAHISTINE VIATRIS is proven to haven’t any or negligible results to have an effect on the power
to drive.

Taking care of your medication

Maintain your tablets within the pack till it’s time to take them.

In case you take the tablets out of the field or the blister pack they could not hold properly.

Comply with the directions within the carton on learn how to handle your medication correctly.

Retailer it in a cool dry place under 30°C away from moisture, warmth or daylight; for
instance, don’t retailer it:

within the lavatory or close to a sink, or

within the automotive or on window sills.

Maintain it the place younger youngsters can’t attain it.

A locked cabinet at the very least one-and-a-half metres above the bottom is an effective place
to retailer medicines.

Eliminating any undesirable medication

In case you not want to make use of this medication or it’s outdated, take it to any pharmacy
for secure disposal.

Don’t use this medication after the expiry date.

Are there any unwanted side effects?

Inform your physician or pharmacist as quickly as potential if you don’t really feel properly when you
are taking BETAHISTINE VIATRIS.

All medicines can have unwanted side effects. In case you do expertise any unwanted side effects, most of
them are minor and short-term. Nonetheless, some unwanted side effects may have medical consideration.

See the data under and, if it’s essential to, ask your physician or pharmacist in case you
have any additional questions on unwanted side effects.

Severe unwanted side effects

Inform your physician or pharmacist in case you discover the rest which may be making you
really feel unwell.

Different unwanted side effects not listed right here could happen in some individuals.

Reporting unwanted side effects

After you’ve gotten obtained medical recommendation for any unwanted side effects you expertise, you possibly can
report unwanted side effects to the Therapeutic Items Administration on-line at www.tga.gov.au/reporting-problems . By reporting unwanted side effects, you possibly can assist present extra info on the protection of
this medication.

At all times ensure you communicate to your physician or pharmacist earlier than you resolve to cease
taking any of your medicines.

Product particulars

This medication is just out there with a health care provider’s prescription.

What BETAHISTINE VIATRIS comprises

Lively ingredient

(important ingredient)

betahistine dihydrochloride

Different elements

(inactive elements)

citric acid monohydrate

colloidal anhydrous silica

mannitol

microcrystalline cellulose

purified talc

Don’t take this medication if you’re allergic to any of those elements.

What BETAHISTINE VIATRIS appears like

BETAHISTINE VIATRIS 16 mg tablets are uncoated spherical, biconvex, scored, white to virtually
white with bevelled edges, one facet inscribed with “267” on both facet of the rating
(AUST R 286806).

Who distributes BETAHISTINE VIATRIS

Viatris Pty Ltd

Stage 1, 30 The Bond

30-34 Hickson Highway

Millers Level NSW 2000

www.viatris.com.au

Telephone: 1800 274 276

This leaflet was ready in July 2022.

BETAHISTINE VIATRIS_cmiJul22/00

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