Patient Information Leaflet

Betaistina EG STADA 8 mg tablets, 16 mg tablets, 24 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before you take 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Betaistina EG STADA is and what it is used for
What you need to know before taking Betaistina EG STADA
How to take Betaistina EG STADA
Possible side effects
How to store Betaistina EG STADA
Package contents and other information

1. What Betaistina EG STADA is and what it is used for

Betahistine, the active substance of Betaistina EG STADA, is similar to histamine, a substance that
occurs naturally in the body.
It is used to treat Ménière's syndrome, the symptoms of which include:

dizziness (vertigo),
ringing in the ears (tinnitus),
hearing loss.

This medicine works by improving blood flow in the inner ear. This action reduces the increase in pressure.

2. What you should know before taking Betaistina EG STADA

Do not take Betaistina EG STADA if

you are allergic to betahistine or to any of the other ingredients of this medicine (listed in section 6),
you have a tumor of the adrenal glands (pheochromocytoma).

If you have any of the conditions listed above, do not use this medicine and consult your doctor.
Warnings and precautions
Talk to your doctor before taking Betaistina EG STADA if:

you have or have had a stomach ulcer (peptic ulcer). Treatment with Betaistina EG STADA may cause dyspepsia;
you have a chronic respiratory disease (bronchial asthma);
you have hives, skin rashes, or a runny nose due to an allergy (allergic rhinitis) – your symptoms may worsen when taking Betaistina EG STADA;
your blood pressure is low.

Your doctor will determine whether it is safe for you to start taking this medicine. Your doctor may also wish to monitor your asthma during treatment with this medicine.
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age. Its safety and efficacy are not known in these patients.
Other medicines and Betaistina EG STADA
Inform 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 (theoretically) they could reduce the effect of Betaistina EG STADA. Betaistina EG STADA might also reduce the effect of antihistamines.
Monoamine oxidase inhibitors (MAOIs) – used to treat depression or Parkinson's disease. These may increase the amount of Betaistina EG STADA in your body.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Betaistina EG STADA during pregnancy unless your doctor has decided it is absolutely necessary. Consult your doctor.
Do not breastfeed while taking Betaistina EG STADA unless your doctor tells you to do so.
It is not known whether Betaistina EG STADA is excreted in breast milk.
Driving and using machines
It is unlikely that Betaistina EG STADA will impair your ability to drive or operate tools or machinery. However, bear in mind that the illness for which you are being treated with Betaistina EG STADA, or Betaistina EG STADA itself, may cause dizziness or nausea, thereby affecting your ability to drive or use machinery.

3. How to take Betaistina EG STADA

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is:
Adults

The recommended initial dose is 16 mg three times a day (48 mg).
The maintenance dose is 24–48 mg/day, divided into two or three doses.
Your doctor may reduce the dose to 8 mg three times a day (24 mg).

Always follow your doctor's instructions, as they may need to adjust the dose.
The daily dose must not exceed 48 mg.
Use in children and adolescents
Betaistina EG STADA is not recommended for use in children and adolescents.
Method of administration

Swallow the tablets with water.
Take the tablet regardless of meals. Betaistina EG STADA may cause mild stomach problems (listed in section 4). Taking the medicine with food may help reduce the likelihood of stomach-related side effects.
If you take more than one tablet per day, divide the doses evenly throughout the day. For example, take one tablet in the morning, one around midday, and one in the evening.
Try to take the tablet at the same time each day. This will ensure a constant level of the medicine in your body. Taking it at the same time every day will also help you remember to take the tablets.

Betaistina EG STADA 16 mg tablets
The tablet may be divided into equal doses.
Betaistina EG STADA 24 mg tablets
The score line is intended solely to assist in breaking the tablet if you have difficulty swallowing it whole.
Duration of treatment
Continue taking this medicine for as long as your doctor tells you to. The effect of the medicine may only become apparent after some time has passed.
If you take more Betaistina EG STADA than you should
If you or someone else takes too many Betaistina EG STADA tablets (overdose), you may experience discomfort (nausea), drowsiness, or stomach ache. Other symptoms of betahistine overdose include vomiting, dyspepsia (stomach upset), ataxia (difficulty controlling movements / coordination problems), and epileptic seizures. More serious complications (seizures, breathing or heart problems) have been observed in cases of intentional betahistine overdose, particularly when associated with overdose of other medicines.
Contact your doctor or go to hospital immediately. Take the Betaistina EG STADA packaging with you.
If you forget to take Betaistina EG STADA
Wait until it is time for your next dose. Do not take a double dose to make up for the missed tablet.
If you stop taking Betaistina EG STADA
Continue taking the tablets until your doctor tells you to stop.
Even if you start to feel better, your doctor may want you to continue taking the tablets for some time to ensure the medicine has had full effect.
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 gets them.
The following serious side effects may occur during treatment with Betaistina EG STADA:
Allergic reactions such as:

skin rash with red or granular skin, or inflamed skin with itching
swelling of the face, lips, tongue or neck
drop in blood pressure
loss of consciousness
breathing difficulties
If you experience any of these side effects, stop treatment immediately and contact your doctor.

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

feeling unwell (nausea)
indigestion (dyspepsia)
headache

Other side effects reported with the use of betahistine include:
Mild stomach problems such as feeling unwell (vomiting), stomach ache, sensation of bloated stomach (abdominal distension), and swelling. Taking Betaistina EG STADA with food may help reduce stomach problems.
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 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 EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or the carton after the word "Exp." The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
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 EG STADA 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 (E 421), povidone, crospovidone, citric acid, anhydrous colloidal silicon dioxide, talc and stearic acid.

Description of the appearance of Betaistina EG STADA and the contents of the pack
Betaistina EG STADA 8 mg tablets
Flat, white to off-white, round tablets (approximately 7 mm in diameter), marked with "JI" on one side and smooth on the other.
Betaistina EG STADA 16 mg tablets
Biconvex, round tablets (approximately 9 mm in diameter), white to off-white in colour, marked with "J2" on one side and a score line on the other.
The tablet can be divided into equal doses.
Betaistina EG STADA 24 mg tablets
Biconvex, round tablets (approximately 10 mm in diameter), white to off-white in colour, marked with "J4" on one side and a score line on the other.
The score line is intended solely to assist in breaking the tablet if you have difficulty swallowing it whole.
Betaistina EG STADA 8 mg is supplied in PVC/PVDC-aluminium blisters and unit-dose divisible blisters, available in packs of 20, 30, 50, 60, 100, and 50x1 tablets.
Betaistina EG STADA 16 mg and 24 mg are supplied in PVC/PVDC-aluminium blisters and unit-dose divisible blisters, available in packs of 20, 30, 50, 60, 100, and 20x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturers
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany
Stada M&D S.R.L., Strada Trascaului Nr 10, 401135 Turda, Cluj, Romania

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
DE Betahistin STADA 8 mg; 16 mg; 24 mg Tabletten
DK Betahistindihydrochlorid STADA
IT Betaistina EG STADA