Vertix

Patient Information Leaflet

Vertix, 8 mg tablets
Vertix, 16 mg tablets
Betahistini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Vertix is and what it is used for

What Vertix is
Vertix contains betahistine. Vertix is a type of medicine known as a "histamine analogue".
What Vertix is used for
Vertix is used in the treatment of Ménière's disease, which is characterized by the following symptoms:

• Vertigo (with nausea, vomiting);
• Progressive hearing loss;
• Tinnitus.

Vertix is also used for symptomatic treatment of vestibular-origin vertigo.
How Vertix works
Vertix works by improving blood flow in the inner ear. This leads to a reduction in elevated pressure.

2. Important information before taking Vertix

When not to take Vertix:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has been diagnosed by a doctor with a tumour of the adrenal gland (‘phaeochromocytoma’).

Do not take Vertix if any of the above apply to the patient. In case of
doubt, speak to a doctor or pharmacist before taking Vertix.
Warnings and precautions
Before starting treatment with Vertix, discuss with a doctor or pharmacist if:

• the patient has ever had stomach ulcers,
• the patient suffers from bronchial asthma,
• the patient suffers from urticaria, skin rash or allergic rhinitis, due to the possibility of worsening of these symptoms,
• the patient has low blood pressure.

If any of the above apply to the patient (or if there is any uncertainty), speak to a doctor or pharmacist before taking Vertix. The doctor may wish
to closely monitor the patient during treatment with Vertix.
Children and adolescents
Vertix is not recommended for use in children and adolescents under 18 years of age.
Vertix and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
An interaction means that medicines or other substances may affect each other's actions or
cause adverse effects when taken at the same time.
To date, no interactions between betahistine and other medicines have been observed.
In particular, inform the doctor or pharmacist if the patient is taking any of the following
medicines:

• antihistamines – these may (theoretically) affect the action of Vertix. Vertix may also reduce the effectiveness of antihistamine medicines.
• Monoamine oxidase inhibitors (MAOIs), used in the treatment of depression or Parkinson’s disease. These may enhance the effect of Vertix. If any of the above apply to the patient (or if there is any uncertainty), speak to a doctor or pharmacist before taking Vertix.

Vertix with food and drink
Vertix may be taken with or without food. However, Vertix may cause
mild gastrointestinal discomfort (listed in section 4). Taking Vertix with food
may help reduce gastrointestinal discomfort.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
It is not known whether Vertix affects the unborn child:

• Discontinue taking Vertix and inform the doctor if the patient is pregnant or suspects pregnancy.
• Do not take Vertix during pregnancy unless the doctor decides it is necessary.

It is not known whether Vertix passes into breast milk:

• Do not breastfeed while taking Vertix unless otherwise advised by the doctor.

Driving and using machines
It is unlikely that Vertix will affect the ability to drive or operate
tools and machines.
However, bear in mind that the conditions treated with Vertix (Meniere’s disease and vertigo) may cause sensations of spinning and nausea, and may affect the ability to drive and operate machines.
Vertix contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.

3. How to take Vertix

This medicine should always be taken as directed by the doctor. If in doubt, consult your doctor or pharmacist.

• The doctor will adjust the dose according to the patient's condition.
• You should continue taking the medicine. It may take some time for the medicine to start working.

How to take the medicine

• Swallow the tablet with water.
• The tablet may be taken with or without food. However, Vertix may cause mild gastrointestinal discomfort (listed in section 4). Taking Vertix with food may help reduce gastrointestinal symptoms.

How much medicine to take
Vertix is available in two strengths: 8 mg and 16 mg. The usual dose is:

• Vertix 8 mg – one or two tablets three times daily.
• Vertix 16 mg – half to one tablet two or three times daily.

If more than one tablet per day is prescribed, the doses should be evenly spaced throughout the day, for example, one tablet in the morning and one in the evening. Try to take the tablets at the same times each day. This ensures a steady level of the medicine in the body. Taking the medicine at the same time each day will also help you remember to take it.

Taking more Vertix than recommended
If you take more Vertix than prescribed, symptoms such as nausea, drowsiness, or abdominal pain may occur. If in doubt, contact your doctor.

Missing a dose of Vertix
If you have missed a dose of Vertix, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Vertix
Do not stop taking Vertix without consulting your doctor, even if you feel better.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody experiences them.
The following adverse reactions may occur during treatment with this medicine:

Allergic reactions
If an allergic reaction occurs, discontinue use of Vertix and consult a doctor immediately or go to the nearest hospital. Symptoms may include:

• skin rash, red or itchy spots, or inflammatory skin reactions with itching,
• swelling of the face, lips, tongue or neck,
• low blood pressure,
• loss of consciousness,
• breathing difficulties. If any of the above symptoms occur, stop taking Vertix immediately and contact a doctor or go to hospital.

Other adverse reactions:
Common (occurring in less than 1 in 10 people):

• nausea,
• digestive disturbances,
• headache.

Other adverse reactions reported during treatment with Vertix:

• Mild gastrointestinal discomfort such as vomiting, stomach and intestinal pain, bloating and gas. Taking Vertix with food may help reduce gastrointestinal discomfort.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Vertix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister pack after: "EXP". The expiry date refers to the last day of the specified month.
Store below 25°C, in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This helps protect
the environment.

6. Contents of the packaging and other information

What Vertix contains
The active substance is betahistine dihydrochloride.
Each tablet of Vertix 8 mg contains 8 mg of betahistine dihydrochloride.
Each tablet of Vertix 16 mg contains 16 mg of betahistine dihydrochloride.
The other ingredients are: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone (type A), and stearic acid.

What Vertix looks like and contents of the pack
Vertix 8 mg tablets: round, white or almost white tablets marked with "B8" on one side, smooth on the other side.
Vertix 8 mg is available in packs containing 30, 50, 100, or 120 tablets.

Vertix 16 mg tablets: round, white or almost white tablets marked with "B16" on one side and a score line on the other side.
Vertix 16 mg is available in packs containing 20, 30, 42, 50, 60, or 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Recordati Polska sp. z o.o.
ul. Królewska 16
00-103 Warsaw
Poland

Manufacturer:
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 2
D-73614 Schorndorf
Germany