Vertix

Package Leaflet: Information for the User

Vertix, 24 mg, Tablets

Betahistini Dihydrochloridum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Vertix and what is it used for
• 2. Important information 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 is Vertix and what is it used for

What is Vertix

Vertix contains betahistine. Vertix is a type of medicine called a "histamine analogue".

What is Vertix used for

Vertix is used to treat Meniere's disease, which is characterized by the following symptoms:

• vertigo (with nausea, vomiting),
• progressive hearing loss,
• tinnitus.

Vertix is also used for the symptomatic treatment of vertigo of vestibular origin.

How Vertix works

Vertix works by improving blood flow in the inner ear. This reduces increased pressure.

2. Important information before taking Vertix

When not to take Vertix:

Warnings and precautions:

Before taking Vertix, discuss it with your doctor or pharmacist if:

• you have ever had stomach ulcers,
• you have asthma,
• you have hives, skin rash, or allergic rhinitis, as these conditions may worsen,
• you have low blood pressure. If any of the above apply to you (or if you are in doubt), consult your doctor or pharmacist before taking Vertix. Your doctor may want to monitor you closely while taking Vertix.

Children and adolescents

Vertix is not recommended for children and adolescents under 18 years of age.

Vertix with other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

• antihistamines - they may (theoretically) affect the action of Vertix. Vertix may also reduce the effect of antihistamines.
• monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. They may enhance the effect of Vertix. If any of the above apply to you (or if you are in doubt), consult your doctor or pharmacist before taking Vertix.

Vertix with food and drink

Vertix can be taken with or without food. However, Vertix may cause mild stomach upset (listed in section 4). Taking Vertix with food may help reduce stomach upset.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

• stop taking Vertix and inform your doctor if you become pregnant or think you may be pregnant.
• 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 allows it.

Driving and using machines

it is unlikely that Vertix will affect your ability to drive or use machines.

Vertix contains lactose

if you have been told you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Vertix

always take this medicine exactly as your doctor has told you.

• your doctor will adjust the dose according to your condition.
• 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.
• you can take the tablet with or without food. However, Vertix may cause mild stomach upset (listed in section 4). Taking Vertix with food may help reduce stomach upset.

How much to take

the usual dose is one tablet twice a day.

If you take more Vertix than you should

if you take more Vertix than you should, you may experience nausea, drowsiness, or stomach pain. if in doubt, consult your doctor.

If you forget to take Vertix

if you miss a dose, take the next dose at the scheduled time.

If you stop taking Vertix

do not stop taking Vertix without consulting your doctor, even if you feel better.

4. Possible side effects

like all medicines, Vertix can cause side effects, although not everybody gets them.

Allergic reactions

if you experience an allergic reaction, stop taking Vertix and consult your doctor or go to the nearest hospital immediately. symptoms may include:

• red or lumpy skin rash or skin inflammation with itching,
• swelling of the face, lips, tongue, or throat,
• low blood pressure,
• loss of consciousness,
• difficulty breathing.

Other side effects:

Common(affects less than 1 in 10 people):

• nausea,
• digestive disorders,
• headache.

Reporting side effects

if you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

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 carton and blister after "EXP". the expiry date refers to the last day of that month.

store in a temperature below 25°C, in the original packaging.

do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. this will help protect the environment.

6. Contents of the pack and other information

What Vertix contains

the active substance is betahistine dihydrochloride.

each Vertix tablet contains 24 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, 24 mg, tablets: white or almost white, round tablet with a score line on one side.

the tablet can be divided into two halves. the score line is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.

Vertix 24 mg is available in packs of 20, 30, 50, 60, 100 tablets.

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

Date of last revision of the leaflet: 06/2020