Betahistine dihidrohloride Accord

Package Leaflet: Information for the Patient

Betahistine dihydrochloride Accord, 8 mg, tablets

Betahistine dihydrochloride Accord, 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, pharmacist, or nurse.
• 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 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 dihydrochloride Accord is a medicine that contains betahistine, which is a histamine analogue indicated for the treatment of symptoms of Meniere's syndrome, such as: vertigo (of labyrinthine origin), "ringing" in the ears (tinnitus), hearing loss, and nausea. The medicine works by improving blood flow in the inner ear. This prevents an increase in pressure in the ear.

2. Important information before taking Betahistine dihydrochloride Accord

When not to take Betahistine dihydrochloride Accord

• if you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6);
• in patients with high blood pressure caused by a tumor of the adrenal gland (phaeochromocytoma), a rare type of adrenal gland tumor.

Warnings and precautions

• if you have stomach ulcers (peptic ulcers);
• in patients with bronchial asthma;
• in patients who have hives, skin rash, allergic rhinitis - due to the possibility of exacerbating these symptoms;
• if you have low blood pressure.

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

Betahistine dihydrochloride Accord and other medicines

Interaction means that medicines or substances can affect each other's action or side effects when taken together. So far, no interactions have been observed between betahistine and other medicines. It is possible that betahistine affects the action of antihistamine medicines. Antihistamine medicines are mainly used to treat allergies, such as hay fever and motion sickness. You should contact your doctor or pharmacist if you are taking antihistamine medicines (medicines used to treat allergies). Monoamine oxidase inhibitors (MAOIs) used to treat depression and Parkinson's disease may increase exposure to betahistine. You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription.

Betahistine dihydrochloride Accord with food, drink, and alcohol

The medicine can be taken during or after a meal.

Pregnancy, breastfeeding, and fertility

Do not take Betahistine dihydrochloride Accord if you are pregnant. The medicine can only be used if your doctor considers it necessary. It is not known whether betahistine passes into breast milk, so you should not breastfeed while taking betahistine. Before taking betahistine and any other medicine, consult your doctor.

Driving and using machines

Betahistine dihydrochloride Accord does not affect the ability to drive and use machines. However, keep in mind that the disease for which you are taking Betahistine dihydrochloride Accord (vertigo, tinnitus, and hearing loss being symptoms of Meniere's syndrome) may cause dizziness or nausea, which may affect your ability to drive and use machines.

Betahistine dihydrochloride Accord contains lactose

The medicine contains 50 mg of lactose monohydrate in 8 mg tablets and 100 mg of lactose monohydrate in 16 mg tablets. The medicine should not be taken by patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type), or glucose-galactose malabsorption syndrome. You should inform your doctor about any known sugar intolerance.

3. How to take Betahistine dihydrochloride Accord

Always take Betahistine dihydrochloride Accord exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Betahistine is not indicated for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy in this patient group. The usual initial dose is one to two 8 mg tablets or half to one 16 mg tablet three times a day. The maintenance dose is usually between 24 mg and 48 mg per day. You may not notice an improvement until after a few weeks of treatment.

How to take:

Swallow the tablet whole with water. Take the tablets during or after a meal. Take the medicine exactly as your doctor has told you. If you have any doubts, ask your doctor. The initial dose is 8 to 16 mg taken orally three times a day, it is recommended to take the medicine during a meal. The maintenance dose is 24 to 48 mg/day. The daily dose should not exceed 48 mg. The dose may be adjusted according to individual patient needs. Improvement has sometimes been observed after a few weeks of treatment. There are no data on patients with liver or kidney function disorders. Data on elderly patients are limited, therefore caution should be exercised when using betahistine in this patient group.

Use in children and adolescents (from 6 to 18 years)

It is not recommended to use in children and adolescents under 18 years of age due to lack of data on safety and efficacy.

Overdose of Betahistine dihydrochloride Accord:

In case of overdose, contact your doctor. Symptoms of overdose of Betahistine dihydrochloride Accord are: nausea, vomiting, digestion problems, coordination problems, and in case of high doses - seizures

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:

If you have any doubts about taking the medicine, ask 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: During treatment with betahistine, the following serious side effects may occur:

• allergic reactions such as: swelling of the face, lips, tongue, or throat. These may cause difficulty breathing.
• red skin rash, itching of the skin

If you experience any of these symptoms, stop treatment and contact your doctor immediately.

Common side effects (occurring in 1 in 10 patients):

headache, drowsiness, nausea, indigestion, mild gastrointestinal disorders such as vomiting, abdominal pain, and bloating. Taking the medicine with food may reduce the occurrence and severity of these symptoms.

Frequency not known (cannot be estimated from available data):

itching, rash, hives, palpitations, in patients with bronchial asthma, bronchospasm may occur.

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 Monitoring of Adverse Reactions to Medicinal Products, 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. 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.

• store below 30°C;
• store in the original packaging to protect from moisture;
• do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month;
• medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. 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 8 mg or 16 mg of betahistine dihydrochloride.
• The other ingredients 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

Betahistine dihydrochloride Accord 8 mg, tablets. Tablets: round, flat, white with beveled edges, with the inscription "BE" on one side and a score line on the other side. The score line on the tablet is only to facilitate breaking and not to divide into equal doses. Betahistine dihydrochloride Accord 16 mg, tablets. Tablets: round, flat, white with beveled edges, with the inscription "BF" on one side and a score line on the other side. The tablet can be divided into two equal parts. The 8 mg tablets are packaged in blisters (PVC/PVDC/Aluminum). The carton box contains 14, 20, 30, 50, 60, 84, 90, or 120 tablets. The 16 mg tablets are packaged in blisters (PVC/PVDC/Aluminum). The carton box contains 14, 20, 30, 60, 84, 90, or 120 tablets.

Marketing Authorization Holder

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o., ul. Lutomierska 50, 95-200 Pabianice, Poland, 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:

Country Name of the medicinal product

Netherlands Betahistine 2HCL Accord 8/16 mg Tabletten France Betahistine dihydrochloride Accord 8 mg Comprimes Ireland Betahistine dihydrochloride 8/16 mg Tablets Italy Betahistina Accord 8/16 mg Compresse Poland Betahistine dihydrochloride Accord United Kingdom Betahistine dihydrochloride 8/16 mg Tablets

Date of revision of the leaflet: May 2022