BETAISTINA 8 mg Coated Tablet

Зміст інструкції

1. Betaistina Aurobindo 8 mg tablets, 16 mg tablets, 24 mg tablets
   1. What is Betaistina Aurobindo and what is it used for
   2. What you need to know before taking Betaistina Aurobindo
   3. How to take Betaistina Aurobindo
   4. Possible side effects
   5. How to store Betaistina Aurobindo
   6. Package Contents and Other Information

Betaistina Aurobindo 8 mg tablets, 16 mg tablets, 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 Aurobindo is and what it is used for
• 2. What you need to know before you take Betaistina Aurobindo
• 3. How to take Betaistina Aurobindo
• 4. Possible side effects
• 5. How to store Betaistina Aurobindo
• 6. Contents of the pack and other information

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

Betaistine is a type of medicine called a “histamine analogue”.
Betaistina Aurobindo is used for:
Ménière’s disease – whose signs include:

• experiencing dizziness (vertigo),
• ringing in the ears (tinnitus),
• hearing loss or difficulty hearing.

How this medicine works
This medicine works by improving blood flow in the inner ear. This reduces
the build-up of pressure.

2. What you need to know before taking Betaistina Aurobindo

Do not take Betaistina Aurobindo

• if you are allergic to betaistine or any of the other ingredients of this medicine (listed in section 6);
• if you have a pheochromocytoma, a rare tumor of the adrenal gland.

Warnings and precautions
Talk to your doctor or pharmacist before taking Betaistina Aurobindo

• if you have or have had a stomach ulcer (peptic ulcer);
• if you suffer from asthma;
• if you suffer from urticaria, skin rashes or a cold caused by an allergy as these conditions may worsen;
• if you have low blood pressure;
• betaistine dihydrochloride is not the appropriate treatment for the following forms of vertigo:
• benign positional vertigo attacks,
• dizziness related to a disease of the central nervous system;
• if you are pregnant or planning a pregnancy;
• if you are breastfeeding.

If you suffer from any of the above conditions, ask your doctor if you can take the
tablets of Betaistina Aurobindo.
These groups of patients must be monitored by a doctor during treatment.

Use in children and adolescents
Betaistina Aurobindo is not recommended for use in children and adolescents (under 18
years of age).

Other medicines and Betaistina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines:
Antihistamines – as in theory betaistine may not work properly. Also, the
betaistine may reduce the effect of antihistamines.
Monoamine oxidase inhibitors (MAOIs) – used to treat depression or Parkinson’s
disease. These may increase exposure to betaistine.
If any of these apply to you (or if you are not sure) ask your doctor or pharmacist before
taking Betaistina Aurobindo.

Betaistina Aurobindo with food and drink
Betaistina Aurobindo can be taken with or without food. However, Betaistina Aurobindo may
cause mild stomach problems (listed in section 4). Taking betaistine with food may
help to reduce stomach problems.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether betaistine dihydrochloride has effects on the unborn child.
Do not take betaistine dihydrochloride tablets if you are pregnant unless your doctor has decided that it is absolutely necessary. Ask your doctor for advice.
Do not breastfeed while using betaistine dihydrochloride tablets unless your doctor
tells you to. It is not known whether betaistine passes into breast milk.

Driving and using machines
It is unlikely that Betaistina Aurobindo will affect your ability to drive and use tools
or machinery. However, remember that the condition for which you are being treated with Betaistina Aurobindo
(Ménière’s disease) may cause you dizziness or nausea, and may affect your ability to drive and
use machinery.

3. How to take Betaistina Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, ask your doctor or pharmacist.

• Your doctor will adjust your dose based on your progress.
• Continue to take the medicine. The medicine may need some time to start working.

How to take Betaistina Aurobindo
Swallow the tablets with water.
Take the tablet with or after a meal. However Betaistina Aurobindo may cause mild
stomach problems (listed in section 4). Taking Betaistina Aurobindo with food
may help to reduce stomach problems.

How much Betaistina Aurobindo to take
Always follow your doctor's instructions as they may adjust your dose.
The recommended dose is:

Adults
The recommended dose is from 24 mg to 48 mg per day. 8 mg tablets: one or two tablets three
times a day.
16 mg tablets: half or one tablet three times a day.
24 mg tablets: 1 tablet twice a day. This dosage of the medicine is
used when you need 48 mg of betaistine per day.

Dosage
The daily dose should not exceed 48 mg.
In some cases, improvement does not begin to appear before two weeks after the start of
treatment. The optimal result is obtained after several months of treatment.
If you take more than one tablet a day, distribute them evenly throughout the day.
For example, take one tablet in the morning, one mid-day and one in the evening.
Try to take the tablet every day at the same time. This will ensure a constant amount
of drug in your body. Taking it at the same time will also help you remember to take the
tablets. The use of Betaistina Aurobindo is not recommended in children.

If you take more Betaistina Aurobindo than you should
If you or someone else takes too many Betaistina Aurobindo tablets (overdose), you
may experience nausea, drowsiness or stomach pain. They may also experience an increased heart rate (tachycardia), low blood pressure (hypotension), shortness of breath with
a feeling of suffocation (bronchospasm), fluid accumulation in the tissues (edema). After
taking very high doses, seizures may occur.
Symptomatic treatment is recommended as there is no specific antidote.
Contact your doctor or go to hospital immediately. Bring the Betaistina
Aurobindo pack with you.

If you forget to take Betaistina Aurobindo
Wait until the time you need to take your next dose. Do not take a double dose to
make up for the missed tablet.

If you stop taking Betaistina Aurobindo
Continue to take the tablets until your doctor tells you to stop.
Even if you start to feel better, your doctor may have you continue taking the tablets for
some time to make sure the medicine has worked completely.
If you have any questions about using 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. With betaistine, few adverse effects have been reported.
During treatment with Betaistina Aurobindo, the following serious side effects may occur:

Allergic reactions

• skin rash with redness and nodules or inflamed skin with itching;
• swelling of the face, lips, tongue or neck;
• low blood pressure;
• loss of consciousness;
• difficulty breathing. If any of these side effects occur, you must stop treatment immediately and contact your doctor.

Other side effects include:
Common (may affect up to 1 in 10 people):

• feeling of nausea;
• indigestion (dyspepsia);
• headache.

The following side effects have been reported spontaneously during post-marketing use and
in scientific literature. The frequency cannot be estimated based on available data and
is therefore classified as “not known”.
Blood and lymphatic system disorders:
Not known: thrombocytopenia.
Immune system disorders:
Not known: hypersensitivity reactions, e.g. anaphylaxis.

Other side effects have been reported with the use of betaistine
Mild stomach problems such as vomiting, stomach pain, dry mouth, diarrhea, bloating
(abdominal distension) and swelling. Taking betaistine with food may
help reduce stomach problems.
Skin and subcutaneous tissue disorders:
Not known: hypersensitivity reactions of the skin and subcutaneous tissue, in particular angioedema,
urticaria, rash and itching.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at 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 Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the label, on the carton, on the
bottle after EXP. 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 Aurobindo Contains

• The active ingredient is betahistine dihydrochloride. Each tablet contains 8 mg of betahistine dihydrochloride. Each tablet contains 16 mg of betahistine dihydrochloride. Each tablet contains 24 mg of betahistine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, mannitol, povidone, crospovidone, citric acid, anhydrous colloidal silica, talc and stearic acid.

Description of the Appearance of Betaistina Aurobindo and Package Contents
Tablets.
Betaistina Aurobindo 8 mg tablets
Tablet from white to almost white, round, flat, uncoated, with imprinted “X” on one side and
“87” on the other side.
Betaistina Aurobindo 16 mg tablets
Tablet from white to almost white, round, uncoated, with imprinted “X” and score line on
one side and “88” on the other side.
The tablet can be divided into two equal doses.
Betaistina Aurobindo 24 mg tablets
Tablet from white to almost white, round uncoated, with imprinted “X” and score line on
one side and “89” on the other side.
The tablet can be divided into two equal doses.
Betaistina Aurobindo tablets are available in:
Blisters in Polyamide/Aluminum/PVC/Aluminum:
8 mg: 10, 20, 30, 50, 60, 84, 90, 100 and 120 tablets.
16 mg: 10, 20, 30, 60, 84 and 90 tablets.
24 mg: 10, 20, 30, 50, 60 and 90 tablets.
Round opaque white HDPE bottle with polypropylene closure containing a cotton wad:
30 and 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102 – 21047 Saronno (VA)

Manufacturers
APL Swift Services (Malta) Limited – HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000

• Malta

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Cyprus: Betahistine Aurobindo 8 mg δισκία
Czech Republic: Betahistin Aurovitas
France: Betahistine Arrow Génériques 8 mg, comprimé
Betahistine Arrow Génériques 24 mg, comprimé sécable
Ireland: Vertigon 8 mg/16 mg tablets
Italy: Betaistina Aurobindo
Netherlands: Betahistine diHCl Aurobindo 8 mg/16 mg/24 mg, tabletten
Portugal: Beta-histina Aurobindo
Spain: Betahistina Aurovitas 8 mg/16 mg comprimidos EFG