BETAISTINA 8 mg Coated Tablet

Зміст інструкції

1. Betaistina Accord 8 mg tablets, 16 mg tablets
   1. What is Betaistina Accord and what is it used for
   2. What you need to know before you take Betaistina Accord
   3. How to take Betaistina Accord
   4. Possible side effects
   5. How to store Betaistina Accord
   6. Package Contents and Other Information
2. Betaistina Accord 24 mg tablets
   1. What is Betaistina Accord and what is it used for
   2. What you need to know before using Betaistina Accord
   3. How to use Betaistina Accord
   4. Possible side effects
   5. How to store Betaistina Accord
   6. Contents of the pack and other information

Betaistina Accord 8 mg tablets, 16 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Betaistina Accord is and what it is used for
• 2. What you need to know before you take Betaistina Accord
• 3. How to take Betaistina Accord
• 4. Possible side effects
• 5. How to store Betaistina Accord
• 6. Contents of the pack and other information

1. What is Betaistina Accord and what is it used for

Betaistine is a medicine analogous to histamine used to treat the symptoms of
Ménière's syndrome, such as dizziness (vertigo), ringing in the ears (tinnitus), hearing loss and nausea.
This medicine works by increasing blood flow to the inner ear. This
reduces the increase in pressure.

2. What you need to know before you take Betaistina Accord

Do not take Betaistina Accord

• if you are allergic (hypersensitive) to betaistine dihydrochloride or any of the excipients of Betaistina Accord (see section 6, Contents of the pack and other information).
• if you have high blood pressure due to a tumor of the adrenal gland (pheochromocytoma), a rare tumor of the adrenal gland

Warnings and precautions

• if you have a stomach ulcer (peptic ulcer)
• if you suffer from asthma
• if you have hives, skin rashes or a cold caused by an allergy, because these conditions may be aggravated
• if you have low blood pressure

If you suffer from any of the above conditions, consult your doctor before taking
Betaistina Accord.
These types of patients must be monitored by a doctor during treatment.

Other medicines and Betaistina Accord
An interaction is understood to mean that medicines or substances taken at the same time
may influence each other's functioning or undesirable effects.
No interactions of betaistine with other medicines have been observed so far.
It is possible that betaistine may affect the effectiveness of antihistamines. Antihistamines are medicines used in particular for the treatment of allergies, such as
hay fever, and motion sickness. Consult your doctor or pharmacist if you are taking
antihistamines (medicines against allergies) at the same time.
Monoamine oxidase inhibitors (MAO) used to treat depression or
Parkinson's disease may increase exposure to Betaistina Accord.
Tell your doctor or pharmacist if you are taking (or have recently taken) any
other medicines, including those without a prescription.

Betaistina Accord with food and drink
You can take Betaistina Accord with or after meals.

Pregnancy, breastfeeding and fertility
Do not take betaistine if you are pregnant, unless your doctor has decided that it is
absolutely necessary. Ask your doctor for advice before taking betaistine.
Do not breastfeed while taking betaistine, unless indicated by your doctor. It is
not known whether betaistine is excreted in breast milk.

Driving and using machines
Betaistina Accord is unlikely to affect your ability to drive or use tools or
machinery. However, remember that the disorders for which you are being treated with Betaistina Accord
(dizziness, tinnitus and hearing loss associated with Ménière's disease) may make you feel
dizzy or unwell and may affect your ability to drive vehicles and use
machinery.

Betaistina Accord contains lactose monohydrate
This medicine contains 50 mg of lactose monohydrate for the 8 mg strength and
100 mg of lactose monohydrate for the 16 mg strength. Patients with rare hereditary intolerance to galactose, subjects with Lapp lactase deficiency or
glucose-galactose malabsorption should not take this medicine. If
your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Betaistina Accord

Take this medicine following exactly the instructions of your doctor. If you have
any doubts, consult your doctor or pharmacist.
Betaistina is not recommended in children and adolescents under the age of 18 years,
because there is no data available on efficacy and safety for this age group.
The usual dose is:
Adults
The usual starting dose is 1 or 2 tablets of 8 mg or half a tablet of 16 mg three
times a day.
Maintenance doses are generally in the range of 24-48 mg per day.
Improvement is sometimes observed only after a couple of weeks of treatment.
Method of use
Swallow the tablets with some water with or after meals.
Take the medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
The initial oral treatment is 8 to 16 mg three times a day, preferably taken with
meals.
Maintenance doses are generally in the range of 24-48 mg per day.
The daily dose should not exceed 48 mg. The dose may be adjusted according to the
needs of the individual patient. Improvement is sometimes observed only after a couple of
weeks of treatment.
No data are available for patients with hepatic impairment.
No data are available for patients with renal impairment.
Since there are limited data in elderly patients, betaistina should be used with caution in
this population.

Use in children and adolescents (6-18 years)
It is not recommended for use in children and adolescents under the age of 18 years,
because there is no data available on efficacy and safety.

If you take more Betaistina Accord than you should
If you take a number of tablets higher than prescribed, inform your doctor.
The symptoms of an overdose with Betaistina Accord are nausea, vomiting, digestive problems,
coordination problems and, at higher doses, convulsions.

If you forget to take Betaistina Accord
Wait until it is time to take the next dose. Do not take a double dose to
compensate for the missed tablet.

If you stop taking Betaistina Accord
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following serious side effects may occur during treatment with
betaistine:
Allergic reactions such as:

• swelling of the face, lips, tongue and neck. This can cause difficulty breathing.
• skin rash with redness, itchy, inflamed skin.

If any of these side effects occur, you must stop treatment immediately
and contact your doctor.

Common side effects (may affect up to 1 in 10 patients):
Headache, occasional drowsiness, nausea, indigestion, mild stomach discomfort such as
vomiting, stomach pain and bloating. Taking betaistine with food may be
helpful in reducing these stomach problems.

Not known (frequency cannot be estimated based on the available data):
itching, rash, hives, abnormal heartbeat (palpitations), bronchospasm
may occur in patients with bronchial asthma.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Betaistina Accord

• Store at a temperature below 30°C.
• Store the tablets in the original package to protect the medicine from moisture.
• Keep out of sight and reach of children.
• Do not take the tablets after the expiry date which is reported on the package. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Betaistina Accord contains
The active ingredient is betahistine dihydrochloride.
Each tablet contains 8 mg or 16 mg of betahistine dihydrochloride.
The tablets contain the following components:
Lactose monohydrate, povidone K25, anhydrous citric acid, corn starch, microcrystalline
cellulose, crospovidone, hydrogenated vegetable oil.

Description of the appearance of Betaistina Accord and package contents
Betaistina Accord 8 mg tablets
White, round, flat tablets with beveled edges, imprinted with ‘BE’ on one side
and with a score line on the other.
The score line on the tablet is to aid swallowing and not for dividing the tablet into equal doses.
Betaistina Accord 16 mg tablets
White, round, flat tablets with beveled edges, imprinted with ‘BF’ on one side
and with a score line on the other.
The tablet can be divided into two equal halves.
For the 8 mg dosage, the tablets are packaged in blister strips (PVC/PVdC-aluminum). Pack sizes of 14, 20, 30, 50, 60, 84, 90 and 120 tablets.
For the 16 mg dosage, the tablets are packaged in blister strips (PVC/PVdC-aluminum). Pack sizes of 14, 20, 30, 60, 84, 90 and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF,
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations.

Betaistina Accord 24 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Betaistina Accord is and what it is used for
• 2. What you need to know before you take Betaistina Accord
• 3. How to take Betaistina Accord
• 4. Possible side effects
• 5. How to store Betaistina Accord
• 6. Contents of the pack and other information

1. What is Betaistina Accord and what is it used for

Betaistina is a medicine analogous to histamine.
Betaistina is used for:
Ménière's syndrome, whose symptoms include:

• sensation of dizziness and feeling unwell
• ringing in the ears
• hearing loss or hearing difficulties

How Betaistina Accord works
The mechanism of action of Betaistina Accord is only partially known. Research shows that
Betaistina Accord can prevent an attack of Ménière's syndrome or reduce the severity of the
attacks.

2. What you need to know before using Betaistina Accord

Do not use Betaistina Accord

• if you are allergic to betaistine (dichlorhydrate) or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from pheochromocytoma (a rare disorder of the adrenal glands).

If any of the above conditions apply to you (or if you have any doubts), consult your
doctor or pharmacist before taking Betaistina Accord.

Warnings and precautions
Talk to your doctor before using Betaistina Accord.

• if you have symptoms that may indicate a stomach ulcer, if you have had a peptic ulcer in the past
• if you suffer from asthma
• if you have hives, skin rashes or a cold caused by an allergy, because these conditions may be aggravated
• if you have low blood pressure.

If any of the above conditions apply to you (or if you have any doubts), talk to your
doctor or pharmacist before taking Betaistina Accord. Your doctor may want to monitor you closely
while you are taking Betaistina Accord.

Children and adolescents
Betaistina Accord is not recommended for children and adolescents under the age of 18 years.

Other medicines and Betaistina Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• antihistamines - (medicines used mainly to treat allergies, such as hay fever, and motion sickness). These could, in theory, reduce the effect of Betaistina Accord. Also, Betaistina Accord may reduce the effect of antihistamines. It is possible that Betaistina Accord may affect the effectiveness of antihistamines.
• Monoamine oxidase inhibitors (MAO inhibitors) - used to treat depression or Parkinson's disease. These can increase exposure to Betaistina Accord.

If any of the above conditions apply to you (or if you have any doubts), consult your
doctor or pharmacist before taking Betaistina Accord.

Betaistina Accord with food and drink
You can take Betaistina Accord during or away from meals. However, Betaistina Accord may cause
mild stomach discomfort (listed in section 4). Taking Betaistina Accord during meals
may help to reduce these discomforts.

Pregnancy and breastfeeding, fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
It is not known whether Betaistina Accord has effects on the fetus:

• stop treatment with Betaistina Accord and inform your doctor if you are pregnant or think you may be.
• do not take Betaistina Accord if you are pregnant unless your doctor has decided it is necessary.
• it is not known whether Betaistina Accord is secreted in breast milk. Do not breastfeed while taking Betaistina Accord unless your doctor tells you to.

Driving and using machines
Betaistine is used in Meniere's syndrome. This condition can negatively affect the
ability to drive vehicles and use machinery. Betaistina Accord does not appear to have effects on the
ability to drive or operate machinery.

Betaistina Accord contains lactose monohydrate
This medicine contains 150 mg of lactose monohydrate. If your doctor has diagnosed you with
an intolerance to certain sugars, contact him before taking this medicine.

3. How to use Betaistina Accord

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

• The doctor will adjust the dose based on individual response.
• Do not stop taking Betaistina Accord. The onset of the medicine's effect may take some time.

How to take Betaistina Accord tablets

• Swallow the tablet with water.
• You can take Betaistina Accord during or away from meals. However, Betaistina Accord may cause mild stomach discomfort (listed in section 4). Taking Betaistina Accord during meals may help reduce such discomfort.

The initial oral treatment is 24-48 mg per day divided into three equal doses, to be taken
preferably during meals. For this purpose, 8 and 16 mg formulations are available. Maintenance doses are generally between 24 and 48 mg per day. If a high maintenance daily dose is required, the 24 mg dose can be used 2 times a day (1
tablet in the morning and in the evening). The daily dose should not exceed 48 mg. Try to take
the tablets every day at the same time. This will ensure that there is a constant amount of
medicine in your body. This will also make it easier for you to remember to take your medicine.
The tablet can be divided into equal doses.

If you use more Betaistina Accord than you should
If you use more Betaistina Accord than you should, you may experience a feeling of nausea, feeling
unwell, drowsiness or stomach ache. If you are concerned, contact your doctor.

If you forget to take Betaistina Accord
If you forget to take a dose, skip the missed dose. Take the next dose at the usual time.
Do not use a double dose to make up for a missed dose.

If you stop taking Betaistina Accord
Do not stop treatment with Betaistina Accord without your doctor's advice, even if you start to
feel better. If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:

Allergic reactions:
If an allergic reaction occurs, stop treatment with Betaistina Accord and see your
doctor or go to hospital immediately. Symptoms may include:

• skin rash with red or bumpy skin or inflamed and itchy skin
• swelling of the face, lips, tongue or throat
• decrease in blood pressure
• loss of consciousness
• difficulty breathing

Stop taking Betaistina Accord and see your doctor or go
to hospital immediately if you notice any of the symptoms described above.
Other side effects include:
Common(may affect up to 1 in 10 people)

• feeling unwell (nausea)
• heartburn (dyspepsia)
• headache.

Rare(may affect up to 1 in 1,000)

• palpitations
• chest pressure

Other side effects reported with the use of Betaistina Accord
mild stomach discomfort such as feeling unwell (vomiting), stomach pain,
abdominal distension and bloating. Taking Betaistina Accord during meals may help to
reduce these disorders.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Betaistina Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. Store in the
original packaging to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Betaistina Accord contains
The active ingredient is betahistine dihydrochloride.
Each tablet contains 24 mg of betahistine dihydrochloride.
The excipients of the tablets are: lactose monohydrate, povidone K25, anhydrous citric acid,
corn starch, microcrystalline cellulose, crospovidone (type B), hydrogenated vegetable oil.

Description of the appearance of Betaistina and contents of the pack
Tablet
Tablets of a white to off-white colour, round, approximately 10 mm in
diameter, biconvex, uncoated tablets imprinted with “GRI” on one side and with a score line
on the other.
The tablet can be divided into equal doses.
The tablets are packaged in blisters (PVC/PVdC-aluminium). Packaged in cartons of 20, 30,
50, 60, 84, 90 and 100 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edificio Est 6°piano,
08039 Barcelona, Spain

Manufacturer
Accord Healthcare Limited
Sage house, 319 Pinner road,
North Harrow, Middlesex, HA1 4HF
United Kingdom
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040 Barcelona,
Spain