Package leaflet: Information for the patient

Betaistina TecniGen, 8 mg, tablets
Betaistina TecniGen, 16 mg, tablets
Betaistina TecniGen, 24 mg, tablets
Betahistine dihydrochloride
Please 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 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, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

What is in this leaflet

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

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

Betaistina TecniGen contains betahistine (dihydrochloride). Betahistine is a type of medicine known as an "histamine analogue".
Betaistina TecniGen is used to treat:
Ménière's disease, the symptoms of which include:

Sensation of dizziness (vertigo) and feeling unwell (nausea or vomiting)
Hearing loss or hearing difficulties
Ringing in the ears (tinnitus)

How Betaistina TecniGen works
The medicine works by improving blood flow in the inner ear. This reduces the increase in pressure.

2. What you need to know before taking Betaistina TecniGen

Do not take Betaistina TecniGen:

if you are allergic to betahistine or to any of the other ingredients of this medicine (listed in section 6)
if you have high blood pressure due to a tumour of the adrenal gland (called "pheochromocytoma").

If any of these situations apply to you, do not take this medicine and speak to your doctor or
pharmacist before taking Betaistina TecniGen.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Betaistina TecniGen

if you have ever had a stomach ulcer
if you suffer from asthma.

If any of these situations apply to you (or you are unsure), talk to your doctor before taking this
medicine.
Your doctor may wish to monitor you closely while you are taking Betaistina TecniGen.
Children and adolescents
The use of BETAISTINA DOC is not recommended in children and adolescents under 18 years of age.
Other medicines and Betaistina TecniGen
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:

Monoamine oxidase inhibitors (MAOIs) – used to treat depression or Parkinson’s disease. These may increase exposure to Betaistina TecniGen.
Antihistamines: these may (theoretically) reduce the effect of Betaistina TecniGen. In addition, Betaistina TecniGen may reduce the effect of antihistamines.

If any of the above conditions apply to you (or you are unsure), discuss this with your doctor or pharmacist
before taking Betaistina TecniGen.
Betaistina TecniGen with food and drinks
You may take Betaistina TecniGen during or apart from meals. However, Betaistina TecniGen may cause
mild stomach discomfort (listed in section 4). Taking Betaistina TecniGen with food may
help reduce such discomfort.
Pregnancy and breastfeeding
It is not known whether Betaistina TecniGen has an effect on the fetus:

Stop taking Betaistina TecniGen and consult your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
Do not take Betaistina TecniGen during pregnancy unless your doctor has decided it is necessary.

It is not known whether Betaistina TecniGen passes into breast milk:

Do not breastfeed while taking Betaistina TecniGen unless your doctor tells you to do so.

Driving and using machines
Clinical studies show that Betaistina TecniGen does not appear to affect the ability to drive
or operate machinery. However, please bear in mind that the condition for which you are being treated (i.e. Ménière’s syndrome) with Betaistina TecniGen may cause dizziness or discomfort.
Betaistina TecniGen contains mannitol
It may have a mild laxative effect.

3. How to take Betaistina TecniGen

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

Swallow the tablet with water.
You may take the tablet with or without food. However, Betaistina TecniGen may cause mild stomach problems (listed in section 4). Taking Betaistina TecniGen with food may help reduce stomach discomfort.

Dosage
The recommended daily dose is 24 mg of betahistine per day, given in 2 or 3 divided doses, and may be
increased on prescription up to 48 mg per day. Betaistina TecniGen 24 mg has been specifically
developed for the higher daily dose of 48 mg per day.
The recommended initial dose is:
One to two tablets, three times a day.
Half to one tablet, three times a day.
The tablet may be divided into equal doses.
Half to one tablet, twice a day.
The tablet may be divided into equal doses.
Distribute the tablets evenly throughout the day. For example, take one tablet in the
morning and one in the evening.
Try to take the tablet at the same time each day. This will ensure a constant amount of
medicine in your body. Taking it at the same time(s) each day will also help you remember to take the
tablets.
Use in children and adolescents
The safety and efficacy of Betaistina TecniGen in children and adolescents have not yet been established.
Duration of treatment
Continue taking the medicine. It may take some time for the medicine to start working.
Your doctor will adjust the dose depending on your improvement.
If you take more Betaistina TecniGen than you should
If you or someone else takes too much Betaistina TecniGen (an overdose), speak to a doctor or go
immediately to hospital. Take the medicine pack with you. The following effects may occur:

Feeling unwell (nausea)
Drowsiness
Stomach ache

If you forget to take Betaistina TecniGen

Wait until it is time for your next dose. Take the next dose at your usual time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Betaistina TecniGen
Do not stop taking Betaistina TecniGen without speaking to your doctor, even if you start to feel
better.
If you have any questions 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 everyone gets them. The following side effects may occur with this medicine:
Allergic reactions
If you have an allergic reaction, stop taking Betahistine TecniGen and consult your doctor or go to hospital immediately. Signs may include:

Skin rash with redness, hives or inflamed and itchy skin
swelling of the face, lips, tongue or throat
a drop in blood pressure
loss of consciousness
difficulty breathing.

Stop taking Betahistine TecniGen and consult a doctor or go to hospital immediately
if you notice any of the signs listed above.
Other side effects include:
Common: may affect up to 1 in 10 people

feeling unwell (nausea)
indigestion (dyspepsia)
headache.

Other adverse reactions reported with the use of Betahistine TecniGen

Mild stomach problems such as nausea (vomiting), stomach ache, stomach bloating (abdominal distension) and swelling.

Taking Betahistine TecniGen with food may help reduce stomach problems.
If you experience any side effect, talk to your doctor, pharmacist or nurse. This includes any side effect not listed in this leaflet.
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 TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of that month.
Store below 30 ºC.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Betaistina TecniGen 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: anhydrous citric acid, microcrystalline cellulose, mannitol (E421), colloidal anhydrous silica, talc.

Description of the appearance of Betaistina TecniGen and contents of the pack
Betaistina TecniGen 8 mg tablets are white, round, flat, uncoated tablets, smooth on both sides.
Betaistina TecniGen 16 mg tablets are uncoated, white, round, biconvex tablets with a groove on one side, marked with a raised "I" on both sides of the groove and smooth on the other side.
Betaistina TecniGen 24 mg tablets are uncoated, white, round, biconvex tablets with a groove on one side, marked with "II" impressed on both sides of the groove and smooth on the other side.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Italy

Manufacturers
S.C. SANTA S.A.
Str. Carpatilor nr. 60, currently Nr. 47, 48, 58, 133, 156
Brasov, jud. Brasov
Cod 500269
Romania

S.C. POLISANO PHARMACEUTICALS S.A.
Sos. Alba Iulia nr. 156,
Cod 550052
Sibiu Jud.
Sibiu
Romania

Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2 Abrunheira,
2710-089 Sintra
Portugal

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Beta-histina Tecnigen
Portugal: Beta-histina Tecnigen
Spain: Betahistina TecniGen 8 mg tablets EFG
Betahistina TecniGen 16 mg tablets EFG
Betahistina TecniGen 24 mg tablets EFG