Betahistine Accord

Package leaflet: Information for the user

Betaistina Accord 8 mg tablets, 16 mg tablets

Generic medicine
Please read 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could 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:

1. What Betaistina Accord is and what it is used for
2. What you need to know before taking 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 Betaistina Accord is and what it is used for

Betahistine is a medicine similar 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 in the inner ear. This reduces the increase in pressure.

2. What you need to know before taking Betaistina Accord

Do not take Betaistina Accord

• if you are allergic (hypersensitive) to betahistine dihydrochloride or to 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 an adrenal gland tumour (pheochromocytoma), a rare tumour 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 hay fever caused by an allergy, as these conditions may be worsened
• if you have low blood pressure

If you have any of the above conditions, consult your doctor before taking Betaistina Accord.
Patients with these conditions must be monitored by a doctor during treatment.

Other medicines and Betaistina Accord
An interaction means that medicines or substances taken at the same time may affect each other’s performance or side effects.
No interactions between betahistine and other medicines have been observed so far.
Betahistine may affect the effectiveness of antihistamines. Antihistamines are medicines used particularly for treating allergies such as hay fever and motion sickness. Consult your doctor or pharmacist if you are taking antihistamines (allergy medicines) at the same time.
Monoamine-oxidase inhibitors (MAO inhibitors) used to treat depression or Parkinson’s disease may increase exposure to Betaistina Accord.
Inform 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 may take Betaistina Accord with or after meals.

Pregnancy, breast-feeding and fertility
Do not take betahistine if you are pregnant, unless your doctor has decided it is absolutely necessary. Ask your doctor for advice before taking betahistine.
Do not breast-feed while taking betahistine, unless instructed by your doctor. It is not known whether betahistine 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 conditions for which you are being treated with Betaistina Accord (dizziness, tinnitus and hearing loss associated with Ménière’s disease) may cause dizziness or make you feel unwell, and may therefore affect your ability to drive vehicles or operate machinery.

Betaistina Accord contains lactose monohydrate
This medicine contains 50 mg of lactose monohydrate per 8 mg strength and 100 mg of lactose monohydrate per 16 mg strength. Patients with rare hereditary problems of galactose intolerance, 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/her before taking this medicine.

3. How to take Betaistina Accord

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Betaistina is not recommended for children and adolescents under 18 years of age, as there are no available efficacy and safety data in this age group.

Usual dose
Adults
The usual initial dose is 1 or 2 tablets of 8 mg, or half a 16 mg tablet, taken three times daily.
Maintenance doses are generally within the range of 24–48 mg per day.
Improvement may sometimes only become apparent after a few weeks of treatment.

Instructions for use
Swallow the tablets with some water, with or after meals.
Take the medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
The initial oral dose ranges from 8 to 16 mg three times daily, preferably taken with meals.
Maintenance doses are generally within the range of 24–48 mg per day.
The daily dose must not exceed 48 mg. The dose may be adjusted according to individual patient needs. Improvement may sometimes only become apparent after a few weeks of treatment.

There are no available data in patients with hepatic impairment.
There are no available data in patients with renal impairment.
Due to limited data in these patient populations, betaistina should be used with caution.

Use in children and adolescents (6–18 years)
Not recommended for use in children and adolescents under 18 years of age, as there are no available efficacy and safety data.

If you take more Betaistina Accord than you should
If you take more tablets than prescribed, inform your doctor immediately.
Symptoms of overdose with Betaistina Accord include nausea, vomiting, digestive disturbances, coordination problems, and, at higher doses, seizures.

If you forget to take Betaistina Accord
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 Accord
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• swelling of the face, lips, tongue, and throat.

This may cause breathing difficulties.

• skin rash with redness, itchy and inflamed skin.

If you experience any of these side effects, 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 gastrointestinal disturbances such as vomiting, stomach pain and bloating. Taking betahistine with food may help reduce these gastrointestinal disturbances.
Not known (frequency cannot be estimated from the available data):
Itching, skin rash, urticaria, irregular heartbeat (palpitations), bronchospasms may occur in patients with bronchial asthma.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at the website 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 below 30°C.
• Keep the tablets in the original packaging to protect the medicine from moisture.
• Keep out of the sight and reach of children.
• Do not take the tablets after the expiry date stated on the packaging. 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Betaistina Accord contains
The active substance is betahistine dihydrochloride.
Each tablet contains 8 mg or 16 mg of betahistine dihydrochloride.
The tablets contain the following excipients:
Monohydrate lactose, povidone K25, anhydrous citric acid, maize 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 bevelled edges, marked with 'BE' on one side and a score line on the other.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

Betaistina Accord 16 mg tablets
White, round, flat tablets with bevelled edges, marked with 'BF' on one side and a score line on the other.
The tablet can be divided into two equal halves.

For the 8 mg dosage, tablets are packaged in blister strips (PVC/PVdC-aluminium). Pack sizes of 14, 20, 30, 50, 60, 84, 90 and 120 tablets.
For the 16 mg dosage, tablets are packaged in blister strips (PVC/PVdC-aluminium). 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 Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare single member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece

This medicinal product is authorised in the European Economic Area countries under the following names.