Vertix

Package Leaflet: Information for the User

Vertix, 8 mg tablets

Vertix, 16 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. 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 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:

• dizziness (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:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if your doctor has diagnosed you with a pheochromocytoma (a tumor of the adrenal gland).

Do not take Vertix if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking Vertix.

Warnings and precautions

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

• you have ever had stomach ulcers,
• you have asthma,
• you have hives, skin rash, or hay fever, as these symptoms may worsen,
• you have low blood pressure.

If any of the above applies 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 you are 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 the medicines you are taking now or have taken recently, as well as 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 applies to you (or if you are in doubt), consult your doctor or pharmacist before taking Vertix.

Vertix with food and drink

You can take Vertix 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, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.

• stop taking Vertix and inform your doctor if you are pregnant or suspect you are 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.

However, remember that the diseases being treated with Vertix (Meniere's disease and vertigo) can cause dizziness and nausea and may affect your ability to drive or use machines.

Vertix contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Vertix

Always take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.

• 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

Vertix is available in two strengths: 8 mg, 16 mg. The usual dose is:

• Vertix 8 mg - one or two tablets three times a day.
• Vertix 16 mg - half to one tablet two or three times a day.

if you are taking more than one tablet a day, space out the doses evenly throughout the day, e.g., take one tablet in the morning and one in the evening. Try to take the tablets at the same time each day. This will help keep a steady amount of medicine in your body.

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 you are in doubt, consult your doctor.

If you forget to take Vertix

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

do not take a double dose to make up for a forgotten dose.

If you stop taking 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, ask your doctor or pharmacist.

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.

Stop taking Vertix and consult your doctor or go to the hospital immediately if you experience any of the above symptoms

Other side effects:

Common(occurring in less than 1 in 10 people):

• nausea,
• digestive disorders,
• headache.

Other side effects that have been reported with Vertix

• mild stomach upset, such as vomiting, stomach pain, bloating, and gas. Taking Vertix with food may help reduce stomach upset.

Reporting side effects