Package leaflet: Information for the user

Betahistine Aurobindo 8 mg tablets, 16 mg tablets, 24 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before you start 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Betahistine Aurobindo is and what it is used for
What you need to know before taking Betahistine Aurobindo
How to take Betahistine Aurobindo
Possible side effects
How to store Betahistine Aurobindo
Contents of the pack and other information

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

Betahistine is a type of medicine called a "histamine analogue".
Betaistina Aurobindo is used for:
Ménière's disease – the signs of which include:

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 buildup of pressure.

2. What you need to know before taking Betaistina Aurobindo

Do not take Betaistina Aurobindo

if you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6);
if you have phaeochromocytoma, a rare tumour 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 allergic rhinitis, as these conditions may worsen;
if you have low blood pressure;
betahistine dihydrochloride is not the appropriate treatment for the following types of vertigo:
benign paroxysmal positional vertigo,
dizziness related to a central nervous system disorder;
if you are pregnant or planning to become pregnant;
if you are breastfeeding.

If you have any of the conditions listed above, ask your doctor whether you can take
Betaistina Aurobindo tablets.
These patient groups 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, inform your doctor or pharmacist if you are taking any of the following
medicines:
Antihistamines – because betahistine might theoretically not work properly. In addition,
betahistine may reduce the effect of antihistamines.
Monoamine oxidase inhibitors (MAOIs) – used to treat depression or Parkinson’s disease.
These may increase exposure to betahistine.
If any of these situations apply to you (or if you are unsure), consult your doctor or pharmacist before
taking Betaistina Aurobindo.
Betaistina Aurobindo with food and drinks
Betaistina Aurobindo may be taken with or without food. However, Betaistina Aurobindo may
cause mild stomach problems (listed in section 4). Taking betahistine with food may
help reduce stomach-related issues.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
It is not known whether betahistine dihydrochloride has effects on the unborn child.
Do not take betahistine dihydrochloride tablets during pregnancy unless your doctor has decided it is absolutely necessary. Consult your doctor.
Do not breastfeed while taking betahistine dihydrochloride tablets unless your doctor has instructed you to do so. It is not known whether betahistine passes into breast milk.
Driving and using machines
It is unlikely that Betaistina Aurobindo will affect your ability to drive or operate tools or machinery. However, keep in mind that the condition for which you are being treated with Betaistina Aurobindo (Ménière’s disease) may cause dizziness or nausea, which could affect your ability to drive or use machinery.

3. How to take Betaistina Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Your doctor will adjust your dose according to your progress.
Continue taking the medicine. It may take some time for the medicine 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 reduce stomach-related issues.

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 24 mg to 48 mg daily.
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: one tablet twice a day. This dosage is used when you require 48 mg of betahistine per day.

Dosing
The daily dose must not exceed 48 mg.
In some cases, improvement may not begin until two weeks after starting treatment. Optimal results are achieved after several months of treatment.
If you take more than one tablet per day, distribute them evenly throughout the day.
For example, take one tablet in the morning, one in the afternoon, and one in the evening.
Try to take the tablet at the same time each day. This ensures a constant level of medicine in your body. Taking it at the same time will also help you remember to take your 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), symptoms may include nausea, drowsiness, or stomach ache. Other possible symptoms include rapid heartbeat (tachycardia), low blood pressure (hypotension), shortness of breath with a feeling of suffocation (bronchospasm), and fluid accumulation in tissues (edema). After ingestion of very high doses, seizures may occur.
Symptomatic treatment is recommended, as there is no specific antidote.
Contact your doctor or go to hospital immediately. Take the Betaistina Aurobindo packaging with you.

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

If you stop taking Betaistina Aurobindo
Continue taking the tablets until your doctor tells you to stop.
Even if you start to feel better, your doctor may ask you to continue taking the tablets for some time to ensure the medicine has fully worked.
If you have any questions 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 everybody experiences them. Few adverse reactions have been reported with betahistine.
The following serious side effects may occur during treatment with Betaistina Aurobindo:
Allergic reactions

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

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

feeling nauseous;
indigestion (dyspepsia);
headache.

The following side effects have been reported spontaneously during post-marketing use and in scientific literature. The frequency cannot be estimated from the 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 reported with the use of betahistine include:
Mild stomach problems such as vomiting, stomach ache, dry mouth, diarrhoea, stomach bloating (abdominal distension), and swelling. Taking betahistine with food may help reduce stomach problems.
Skin and subcutaneous tissue disorders:
Not known: cutaneous and subcutaneous hypersensitivity reactions, particularly angioneurotic oedema, urticaria, skin rash, and pruritus.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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, and on the
bottle after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via 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 substance 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 components are: microcrystalline cellulose, mannitol, povidone, crospovidone, citric acid, anhydrous colloidal silicon dioxide, talc and stearic acid.

Description of the appearance of Betaistina Aurobindo and contents of the pack
Tablets.
Betaistina Aurobindo 8 mg tablets
White to almost white, round, flat, uncoated tablet, marked with “X” on one side and “87” on the other.
Betaistina Aurobindo 16 mg tablets
White to almost white, round, uncoated tablet, marked with “X” and a score line on one side and “88” on the other.
The tablet can be divided into two equal doses.
Betaistina Aurobindo 24 mg tablets
White to almost white, round, uncoated tablet, marked with “X” and a score line on one side and “89” on the other.
The tablet can be divided into two equal doses.
Betaistina Aurobindo tablets are available in:
Blister packs made of Polyamide/Aluminium/PVC/Aluminium:
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 HDPE opaque white bottles with a polypropylene closure containing a cotton wad: 30 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the European Economic Area Member States under the following names:
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