Betahistine dihydrochloride accord

Patient Information Leaflet

Betahistine dihydrochloride Accord, 24 mg, tablets
Betahistini dihydrochloridum
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not share it with others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents:

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

Betahistine belongs to a group of medicines known as "histamine antagonists".
Betahistine is used to treat symptoms of Ménière’s disease, such as:

• Vertigo of labyrinthine origin, nausea or vomiting,
• Tinnitus (ringing in the ears),
• Hearing loss or hearing difficulties.

How Betahistine dihydrochloride Accord works
The mechanism of action of Betahistine dihydrochloride Accord is only partially understood.
Studies indicate that Betahistine dihydrochloride Accord prevents attacks of Ménière’s disease or reduces their severity.

2. Important information before using Betahistine dihydrochloride Accord

When not to use Betahistine dihydrochloride Accord

• if the patient has a known allergy to betahistine (dihydrochloride) or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has a phaeochromocytoma, a rare type of adrenal gland tumour.

Do not take this medicine if the patient has any of the conditions listed above.
If the patient is unsure, they should consult a doctor or pharmacist before taking Betahistine dihydrochloride Accord.

Warnings and precautions

Before starting treatment with Betahistine dihydrochloride Accord, discuss with a doctor:

• if the patient currently has or has had peptic ulcer disease (stomach ulcer) in the past;
• in patients with bronchial asthma;
• in patients with urticaria, skin rash, or allergic rhinitis – due to the possibility of worsening these symptoms;
• in patients with low blood pressure.

If any of the above conditions apply, the patient should consult a doctor to determine whether Betahistine dihydrochloride Accord can be used. The doctor must monitor such patients during treatment.

Children and adolescents

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

Betahistine dihydrochloride Accord and other medicines

Inform the doctor or pharmacist about all medicines currently taken or recently used, including those obtained without a prescription.

In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

Antihistamines – primarily used in the treatment of allergies such as hay fever and motion sickness. These medicines may theoretically affect the action of betahistine.
Betahistine may also reduce the effectiveness of antihistamines.

Monoamine oxidase inhibitors (MAO inhibitors) – used in the treatment of depression and Parkinson's disease – may increase exposure to betahistine.

If any of the above apply (or if there are any doubts), the patient should speak with a doctor or pharmacist before taking Betahistine dihydrochloride Accord.

Betahistine dihydrochloride Accord with food and drink

Betahistine dihydrochloride Accord may be taken with or without food. However, Betahistine dihydrochloride Accord may cause mild gastrointestinal discomfort (listed in section 4). Taking betahistine 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 baby, she should consult a doctor or pharmacist before using this medicine.

It is unknown whether Betahistine dihydrochloride Accord affects the unborn child:

• Discontinue use of Betahistine dihydrochloride Accord and inform the doctor if the patient is pregnant or suspects pregnancy.
• Do not take Betahistine dihydrochloride Accord during pregnancy unless the doctor decides it is necessary.
• It is unknown whether Betahistine dihydrochloride Accord passes into human milk. Do not breastfeed while taking Betahistine dihydrochloride Accord unless authorized by a doctor.

Driving and using machines

Betahistine is used in the treatment of Ménière’s disease. This condition may negatively affect the ability to drive or operate machinery. It is unlikely that Betahistine dihydrochloride Accord affects the ability to drive or operate tools and machines.

Betahistine dihydrochloride Accord contains monohydrate lactose

The medicine contains 150 mg of monohydrate lactose per tablet. If the patient has been previously diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to take Betahistine dihydrochloride Accord

Betahistine dihydrochloride Accord must always be taken as prescribed by your doctor.
If in doubt, consult your doctor or pharmacist again.

• Your doctor will adjust the dose according to your condition.
• You should 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 may be taken with or without food. However, Betahistine dihydrochloride Accord may cause mild gastrointestinal discomfort (listed in section 4). Taking the medicine with food may help reduce gastrointestinal symptoms.

The initial oral dose is 24 mg to 48 mg per day, divided into three doses taken with meals. For this purpose, 8 mg and 16 mg tablet strengths are available. Maintenance doses generally range from 24 mg to 48 mg per day. If a higher maintenance daily dose is required, a dose of 24 mg twice daily (one tablet in the morning and one in the evening) may be used. The daily dose should not exceed 48 mg.
Try to take the tablets at the same time each day. This will help ensure a consistent amount of medicine in your body. Taking the tablets at the same time every day will also help you remember to take them.
The tablet may be divided into two equal doses.

If you take more Betahistine dihydrochloride Accord than prescribed:
If you or someone else has taken too many Betahistine dihydrochloride Accord tablets, symptoms such as dry mouth, low blood pressure, nausea, vomiting, indigestion, coordination problems, and, in cases of very high doses, seizures, as well as fatigue, heart or lung problems may occur. Seek immediate medical attention—your doctor will take the necessary actions.

If you forget to take Betahistine dihydrochloride Accord:
Wait until it is time for your next scheduled dose.
Do not take a double dose to make up for the missed tablet.

Stopping 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 how to use this medicine, speak to your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:
During treatment with betahistine, the following adverse reactions may occur:

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

• nausea,
• indigestion,
• headache.

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

• Hypersensitivity reactions, e.g. anaphylaxis (allergic shock).

If the patient experiences allergic reactions, treatment with Betahistine dihydrochloride Accord, 24 mg, tablets must be discontinued immediately and the patient should consult a doctor or go to the nearest hospital. Symptoms of an allergic reaction may include:

• red or bumpy skin rash or inflammatory skin condition with itching,
• swelling of the face, lips, tongue or throat,
• low blood pressure,
• loss of consciousness,
• breathing difficulties,
• dizziness,
• feeling of weakness or lack of energy,
• chest pain,
• palpitations,
• rapid heartbeat (tachycardia),
• mild gastrointestinal disturbances such as: vomiting, stomach pain, bloating and gas. Taking Betahistine dihydrochloride Accord with food may help reduce gastrointestinal discomfort.
• swelling of deeper skin layers caused by fluid accumulation (angioedema),
• skin rashes including blister formation (urticaria),
• severe itching (pruritus).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 Betahistine dihydrochloride Accord

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging and blister labeled EXP.
The expiry date refers to the last day of the stated month.
No special temperature storage requirements for this medicine.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with 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 components of the medicine are: lactose monohydrate, povidone K25, anhydrous citric acid (E 330), corn starch, microcrystalline cellulose, crospovidone (type B), 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, marked with the code "GRI" on one side and a dividing line on the reverse side.
The tablet may be divided into two equal doses.
Tablets are packed in blisters (PVC/PVDC/Aluminium).
The cardboard box contains 20, 30, 50, 60, 84, 90 or 100 tablets.

Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 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.
Lutomierska 50
95-200 Pabianice
Poland

Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands

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