Bevart

Package leaflet: Information for the user

BEVART 8 mg tablets, 16 mg tablets, 24 mg tablets

Betahistine dihydrochloride 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BEVART is and what it is used for
2. What you need to know before taking BEVART
3. How to take BEVART
4. Possible side effects
5. How to store BEVART
6. Contents of the pack and other information

1. What BEVART is and what it is used for

What BEVART is
BEVART contains betahistine. Betahistine is a type of medicine called an “histamine analogue”.
What BEVART is used for:
Menière’s syndrome, the symptoms of which include:

• sensation of dizziness (vertigo) and feeling unwell (nausea or vomiting)
• ringing in the ears (tinnitus)
• hearing loss or difficulty hearing

The sensation of dizziness (called “vestibular vertigo”) occurs when the inner ear, which controls the sense of balance, does not function properly.
How BEVART works
This medicine works by improving blood flow in the inner ear. This reduces the increase in pressure.

2. What you need to know before taking BEVART Do not take BEVART:

• if you are allergic to betahistine or to any of the other ingredients of this medicine (listed in section 6)
• if your doctor has told you that you have a stomach ulcer (peptic gastroduodenal ulcer)
• if your doctor has told you that you have a tumor of the adrenal glands (called “pheochromocytoma”)
• in childhood
• during pregnancy. This medicine is generally contraindicated during pregnancy.

If any of the conditions listed above apply to you or if you have any doubts, consult your doctor or pharmacist before taking BEVART.
Warnings and precautions
Before taking BEVART, consult your doctor or pharmacist:

• if you have previously had a stomach ulcer (peptic ulcer)
• if you suffer from asthma

If any of these conditions apply to you (or if you are unsure), ask your doctor whether you can take BEVART tablets. Your doctor may wish to monitor you during treatment with BEVART.
Children and adolescents
BEVART is not recommended for children and adolescents under 18 years of age.
Other medicines and BEVART
Inform your doctor or pharmacist if you are currently 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 they may theoretically reduce the effect of betahistine. In addition, betahistine may reduce the effect of antihistamines.
• Monoamine oxidase inhibitors – used to treat depression or Parkinson's disease. These may increase the levels of betahistine.

If any of these situations apply to you or if you have any doubts, consult your doctor or pharmacist before taking BEVART.
BEVART with food and drink
You may take BEVART tablets during or apart from meals. However, BEVART may cause mild stomach discomfort (listed in section 4). Taking betahistine with food may help reduce these stomach disturbances.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
It is not known whether betahistine has effects on the fetus, therefore:

• Stop treatment with BEVART and inform your doctor if you are pregnant, think you might be pregnant, or are planning a pregnancy
• Do not take BEVART during pregnancy unless your doctor has decided it is necessary.

It is not known whether betahistine is excreted in breast milk:

• do not breastfeed while taking BEVART unless your doctor tells you it is safe to do so.

Driving and using machines
Betahistine does not appear to affect the ability to drive or operate tools or machinery.
However, keep in mind that the medical condition for which you are being treated with BEVART may cause dizziness or malaise, which could affect your ability to drive or use machines.

3. How to take BEVART

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

• Your doctor will adjust the dose according to your response to the medicine.
• Keep taking the medicine. It may take some time for the medicine to start working.

How to take the tablets:

• Swallow the tablets with water.
• You may take the tablet during or apart from meals. However, BEVART may cause mild stomach discomfort (listed in section 4). Taking BEVART with food may help reduce these side effects.

How many tablets to take
BEVART tablets are available in three strengths: 8 mg, 16 mg and 24 mg. The usual dose is:
8 mg tablets  16 mg tablets  24 mg tablets
1–2 tablets three times a day  1 tablet two to three times a day  1 tablet twice a day

If you take more than one tablet per day, space the doses evenly throughout the day. For
example, take one tablet in the morning and one in the evening.
Try to take the tablets at the same time each day. This will ensure a constant level of medicine in your body. Taking the tablets at the same time every day will also help you remember to take the medicine.

If you take more BEVART than you should
If you take more BEVART than prescribed, you may experience nausea, drowsiness or stomach ache. Contact your doctor if you are concerned.

If you forget to take BEVART

• If you forget to take a tablet, skip the missed dose. Take the next dose at your usual time.
• Do not take a double dose to make up for the forgotten tablet.

If you stop taking BEVART
Do not stop treatment with BEVART without consulting your doctor, even if you start to feel better.
If you have any doubts about using 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 side effects may occur with this medicine:

Allergic reactions
If an allergic reaction occurs, stop treatment with BEVART and contact your doctor or go to hospital immediately. Symptoms may include:

• skin rash with redness, nodules, or inflamed and itchy skin
• swelling of the face, lips, tongue, or throat
• decrease in blood pressure
• loss of consciousness
• difficulty breathing

Stop taking BEVART and contact your doctor or go to hospital immediately
if you notice any of the symptoms described above.

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

• feeling unwell (nausea)
• indigestion (dyspepsia)
• headache

Other side effects reported with betahistine use include:

• Mild gastrointestinal disturbances such as vomiting, stomach discomfort, abdominal distension, and bloating. Taking betahistine with food may help reduce these disturbances.

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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store BEVART

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

6. Package contents and other information What BEVART 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, anhydrous colloidal silica, citric acid, purified talc.

Description of the appearance of BEVART and contents of the pack
BEVART 8 mg tablets
White to off-white, round, flat tablets with bevelled edges, imprinted with "8" on one side and "B" on the other side, with a diameter of 7 mm.
Pack size: 50 tablets.
BEVART 16 mg tablets
White to off-white, round, biconvex tablets, engraved with "16 / B" on one side and smooth on the other side, with a diameter of 8.5 mm.
The tablet can be divided into two equal halves.
Pack size: 30 tablets.
BEVART 24 mg tablets
White to off-white, round, biconvex tablets, engraved with "24 / B" on one side and smooth on the other side, with a diameter of 10 mm.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.
Pack size: 20 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farto S.r.l.
Via Dei Caboto 49
50127 Firenze, Italy

Manufacturer responsible for batch release
Meiji Pharma Spain S.A.
Avenida De Madrid 94
28802 Alcala De Henares, Madrid, Spain