Vertix

Package leaflet: Information for the user

Vertix, 24 mg, tablets
Betahistini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Leaflet contents:

1. What Vertix is and what it is used for
2. What you need to know before taking 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 characterised 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 doctor has diagnosed the patient with a tumour of the adrenal gland (‘phaeochromocytoma’). Do not take Vertix if any of the above apply. If in doubt, speak to your doctor or pharmacist before taking Vertix.

Warnings and precautions:
Before starting treatment with Vertix, discuss with your doctor or pharmacist if:

• the patient has ever had stomach ulcers,
• the patient suffers from bronchial asthma,
• the patient has urticaria, skin rash or allergic rhinitis, as these conditions may worsen,
• the patient has low blood pressure. If any of the above apply (or if there are any doubts), speak to your doctor or pharmacist before taking Vertix. Your 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 your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
An interaction means that medicines or other substances may affect each other’s action or cause adverse effects when taken together.
To date, no interactions between betahistine and other medicines have been observed.
In particular, inform your 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 (or if there are any doubts), speak to your 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 symptoms.
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 her doctor or pharmacist before taking this medicine.
It is not known whether Vertix affects the unborn child:

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

It is not known whether Vertix passes into breast milk:

• Do not breastfeed while taking Vertix unless your doctor advises otherwise.

Driving and operating machinery
It is unlikely that Vertix affects the ability to drive or operate tools and machinery.
However, bear in mind that the conditions treated with Vertix (Meniere’s disease and vertigo) may cause sensations of spinning and nausea, which may affect the ability to drive and operate machinery.
Vertix contains lactose.
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their 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 can 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.

How much medicine to take
The usual dose is one tablet twice 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 constant level of medicine in the body.
Taking the medicine at the same times each day will also help you remember to take it.

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

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

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

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience 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:

• red or blotchy skin rash or inflammatory skin condition with itching,
• swelling of the face, lips, tongue or throat,
• low blood pressure,
• loss of consciousness,
• breathing difficulties. Discontinue taking Vertix immediately and contact a doctor or go to a hospital if any of the above symptoms occur.

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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 provide more information on the safety of this medicine.

5. How to store the medicine Vertix

The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the outer carton and on the blister after: "EXP". The expiry date refers to the last day of the stated 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Vertix contains
The active substance is betahistine dihydrochloride.
Each tablet of Vertix contains 24 mg of betahistine dihydrochloride.
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 24 mg, tablets: round, white or almost white tablet with a central dividing score line on one side.
The tablet may be divided into two halves. The division line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dose division.
Vertix 24 mg is available in packs containing 20, 30, 50, 60 or 100 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 Warszawa
Manufacturer:
Catalent Germany Schorndorf GmbH
Steinbeisstraße 2
D-73614 Schorndorf
Germany