Betahistine dihidrohloride Accord

Package Leaflet: Information for the Patient

Betahistine dihydrochloride Accord, 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Betahistine dihydrochloride Accord and what is it used for.
• 2. Important information before taking Betahistine dihydrochloride Accord.
• 3. How to take Betahistine dihydrochloride Accord.
• 4. Possible side effects.
• 5. How to store Betahistine dihydrochloride Accord.
• 6. Contents of the pack and other information.

1. What is Betahistine dihydrochloride Accord and what is it used for

Betahistine belongs to a group of medicines called "histamine antagonists".
Betahistine is used to treat symptoms of Meniere's disease, such as:

• dizziness and nausea or vomiting,
• ringing in the ears (tinnitus)
• hearing loss or difficulty hearing.

How Betahistine dihydrochloride Accord works

The mechanism of action of Betahistine dihydrochloride Accord is only partially known.
Studies have shown that Betahistine dihydrochloride Accord prevents Meniere's disease attacks
or alleviates their course.

2. Important information before taking Betahistine dihydrochloride Accord

When not to take Betahistine dihydrochloride Accord

If you have any of the above conditions, do not take the medicine. If you are unsure, consult your doctor or pharmacist before taking Betahistine dihydrochloride Accord.

Warnings and precautions

Before starting to take Betahistine dihydrochloride Accord, discuss it with your doctor:

If you have any of the above conditions, ask your doctor if you can take Betahistine dihydrochloride Accord. Your doctor should monitor these patient groups during treatment.

Children and adolescents

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

Betahistine dihydrochloride Accord with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, including those obtained without a prescription.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:
Antihistamines - used mainly to treat allergies, such as hay fever and motion sickness. These medicines may theoretically affect the action of betahistine. Betahistine may also reduce the effect of antihistamines.
Monoamine oxidase inhibitors (MAOIs) used to treat depression and Parkinson's disease may increase exposure to betahistine.
If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking Betahistine dihydrochloride Accord.

Betahistine dihydrochloride Accord with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
It is not known whether Betahistine dihydrochloride Accord affects the fetus:

• Stop taking Betahistine dihydrochloride Accord and inform your doctor if you are pregnant or suspect you are pregnant.
• Do not take Betahistine dihydrochloride Accord during pregnancy unless your doctor decides it is necessary.
• It is not known whether Betahistine dihydrochloride Accord passes into breast milk: Do not breastfeed while taking Betahistine dihydrochloride Accord unless your doctor allows it.

Driving and using machines

Betahistine is used to treat Meniere's disease. This disease can negatively affect the ability to drive and operate machines. It is unlikely that Betahistine dihydrochloride Accord will affect the ability to drive and operate tools and machines.

Betahistine dihydrochloride Accord contains lactose monohydrate

The medicine contains 150 mg of lactose monohydrate in one tablet. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Betahistine dihydrochloride Accord

Always take Betahistine dihydrochloride Accord exactly as your doctor has told you. If you are unsure, 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 Betahistine dihydrochloride Accord

• Swallow the tablet with water.
• The tablet can be taken with or after food. However, Betahistine dihydrochloride Accord may cause mild stomach upset (listed in section 4). Taking the medicine with food may help reduce stomach upset.

The initial oral dose is 24 mg to 48 mg per day, in three divided doses taken with food. For this purpose, 8 mg and 16 mg strengths of the product are available.
Maintenance doses are generally in the range of 24 - 48 mg per day. If a higher daily maintenance dose is needed, a dose of 24 mg can be used twice a day (1 tablet in the morning and evening). The daily dose should not exceed 48 mg.
Try to take the tablets at the same time each day. This will help you to remember to take the tablets.
The tablet can be divided into two equal doses.

Overdose of Betahistine dihydrochloride Accord:

If you or someone else has taken too many tablets of Betahistine dihydrochloride Accord, nausea (nausea), drowsiness, or stomach pain may occur. Seek medical attention immediately.

Missed dose of Betahistine dihydrochloride Accord:

Wait until the next scheduled dose. Do not take a double dose to make up for the missed tablet.

Stopping treatment with Betahistine dihydrochloride Accord:

Do not stop taking Betahistine dihydrochloride Accord without consulting your doctor, even if you feel better. If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Betahistine dihydrochloride Accord can cause side effects, although not everybody gets them.
The following side effects may occur:
The following side effects may occur during treatment with betahistine:

Allergic reactions:

If you experience an allergic reaction, stop treatment immediately and consult your doctor or go to the nearest hospital. Symptoms of an allergic reaction 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

If you experience any of the above side effects, stop treatment immediately and consult your doctor or go to the hospital.

Other side effects include:

Common (may affect up to 1 in 10 people):

• nausea (nausea),
• heartburn,
• headache.

Rare (may affect up to 1 in 1000 people):

• palpitations
• chest tightness

Other side effects that have been reported during treatment with betahistine

Mild stomach upset, such as vomiting, stomach pain, bloating, and gas. Taking Betahistine dihydrochloride Accord with food may help reduce stomach upset.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Betahistine dihydrochloride Accord

Keep out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging and blister after EXP.
The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
Store in the original packaging to protect from moisture;
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Betahistine dihydrochloride Accord contains

• The active substance is betahistine dihydrochloride. One tablet contains 24 milligrams of betahistine dihydrochloride.
• Other ingredients of the medicine are: lactose monohydrate, povidone K25, anhydrous citric acid, corn starch, microcrystalline cellulose, crospovidone, hydrogenated vegetable oil

What Betahistine dihydrochloride Accord looks like and contents of the pack

White or almost white, round, biconvex tablets with a diameter of 10 mm with the inscription "GRI" on one side and a dividing line on the other side.
The tablet can be divided into two equal doses.
Tablets are packaged in blisters (PVC/PVDC/Aluminum).
A cardboard box contains 20, 30, 50, 60, 84, 90, or 100 tablets.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer

Laboratori Fundació DAU
C/C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona
Spain
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Name of the Member State

Date of last revision of the leaflet: June 2022