Patient leaflet - Betahistine Dihydrochloride 24 mg tablets
1. What Betahistine Tablets are and what they are used for Betahistine is a type of medicine called a “histamine analogue”. Betahistine is used for:
Ménière's disease - the signs of this include:
- feeling dizzy and feeling or being sick
- ringing in the ears
- hearing loss or hearing problems
How Betahistine Tablets works
The mechanism of action of Betahistine Tablets is only partially known. Research shows that Betahistine Tablets can prevent an attack of Meniere's disease or reduce the severity of attacks.
2. What you need to know before you use Betahistine Tablets
Do not take Betahistine Tablets:
- If you are allergic to betahistine (dichloride) or any of the other ingredients of this medicine (listed in section 6).
- if you have phaeochromocytoma, (a rare adrenal gland disorder).
Do not take this medicine if any of the above points apply to you. If you are not sure, ask your doctor or pharmacist for advice before taking Betahistine Tablets.
Warning and precautions
Please note the following points before you start using Betahistine Tablets and tell your doctor.
- if have symptoms that may indicate a stomach ulcer or if you had a stomach ulcer in the past • if you have asthma
- if you have nettle rash, skin rash or a cold in the nose caused by an allergy, since these complaints may be exacerbated:
- if you have low blood pressure.
If any of the above points apply to you (or if you are not sure), ask your doctor or pharmacist for advice before using Betahistine Tablets. Your doctor may wish monitor you closely if you use Betahistine Tablets.
Children
The use of Betahistine Tablets is not recommended for those under 18 years old.
Other medicines and Betahistine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Including medicines obtained without a prescription.
Always tell your doctor or pharmacist if you are using any of the following medicines:
Anti-histamines (medicines primarily used in the treatment of allergy such as hay fever and/or motion sickness). These can (in theory) reduce the effect of Betahistine Tablets. Betahistine Tablets may also reduce the effect of anti-histamines.
Monoamine-oxidase inhibitors (MAO Inhibitor)- medicines used to treat depression or to treat Parkinson’s disease. These can increase the exposure of Betahistine Tablets.
If any of the above points apply to you or you are not sure, ask your doctor or pharmacist for advice before using Betahistine Tablets.
Betahistine Tablets with food and drink
You can take Betahistine Tablets with or without food. However, Betahistine Tablets may cause mild stomach complaints (see section 4). Taking it with food may help reduce stomach complaints.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether Betahistine Tablets affects the unborn child.
- Stop using Betahistine Tablets and tell your doctor if you are pregnant or think you may be pregnant.
- Do not use Betahistine Tablets if you are pregnant, unless your doctor has told you it is needed.
- It is not known whether Betahistine Tablets passes into breast milk. Do not use Betahistine Tablets if you are breast feeding unless your doctor has told you to.
Driving and using machines
Betahistine is used in Ménière's disease. This condition may negatively affect your ability to drive and use machines. Betahistine Tablets is unlikely to affect your ability to drive or use machines.
Betahistine Tablets contains lactose monohydrate
This medicine contains 150 mg lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Betahistine Tablets
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- Your doctor may adjust the dosage, based on your results.
- Do not stop using Betahistine Tablets. It may take a while for the medicine to work.
How do I take Betahistine Tablets?
- Take the tablets with water.
You can take Betahistine Tablets with or without food.
However, Betahistine Tablets may cause mild stomach complaints (see section 4). Taking it with food may help reduce stomach complaints.
Initial oral treatment is 24-48mg daily divided over three equal doses, taken preferably with meals. For this purpose 8 and 16mg formulations are available. Maintenance doses are generally in the range 24 - 48mg daily. If a high daily maintenance dose is needed, the 24mg strength can be used 2 times a day (1 tablet in the morning and evening). Daily dose should not exceed 48 mg.
Try to take your tablets at the same time each day. This will make sure that there is a steady amount of medicine in your body. It will also make it easier for you to remember to take your medicine.
The tablet can be divided into equal doses.
If you take more Betahistine Tablets than you should
If you take more Betahistine Tablets than you should, the following symptoms may occur: dry mouth, drop in blood pressure, nausea, vomiting, indigestion, coordination problems and, if very high doses are taken, seizures, as well as fatigue, heart or lung problems. Seek medical attention immediately, they will take the necessary measures.
If you forget to take Betahistine Tablets
If you miss a dose, do not take it at a later time.
Take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Betahistine Tablets
Do not stop using Betahistine Tablets without telling your doctor, even if you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with the use of this medicine:
If you have an allergic reaction, stop taking Betahistine Tablets and go straight to your doctor or hospital. Symptoms of an allergy can be:
- A red or lumpy skin rash or inflamed itchy skin
- Swelling of your face, lips, tongue or neck
- Drop in your blood pressure
- Loss of consciousness
- Breathing difficulties.
Other side effects
Common (may affect up to 1 in 10 people):
- Feeling sick (nausea)
- Indigestion (dyspepsia)
- Headache.
Frequency not known (frequency cannot be estimated from the available data):
- Hypersensitivity reactions, e.g. (allergic shock)
- Dizziness
- Feeling weak or a lack of energy
- Chest pain
- Pounding of heart
- Increased heart rate (tachycardia)
- Mild stomach problems such as feeling sick (vomiting), stomach ache, swelling of the stomach and bloating. Taking Betahistine Tablets with food can help reduce stomach problems
- Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)
- Skin rashes, including with the formation of wheals (urticaria)
- Severe itching (pruritus).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Betahistine Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on both the carton and blister after “EXP”. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Betahistine Tablets contains
The active substance is betahistine dihydrochloride. Each tablet contains 24 mg betahistine dihydrochloride.
The other ingredients of the tablets are lactose monohydrate, povidone K25, anhydrous citric acid (E330), maize starch, cellulose, microcrystalline, crospovidone (Type B) and hydrogenated vegetable oil.
What Betahistine Tablets look like and contents of the pack
Tablet.
White to off white, round, approximately 10mm in diameter, biconvex, uncoated tablets with inscription ‘GRI’ on one side and breakline on other side.
The tablet can be divided into equal doses.
Tablets are available in PVC-PVdC/Aluminium blisters. Pack size of 20, 30, 50, 60, 84, 90 and 100 tablets in a carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Limited Sage House
319 Pinner Road North Harrow Middlesex
HA1 4HF
United Kingdom
Manufacturer
Accord Healthcare Limited Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF United Kingdom.
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 Barcelona,
Spain
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare B.V., Winthontlaan 200,
3526 KV Utrecht, The Netherlands
This leaflet was last revised in August 2025.
If you would like a leaflet with larger text, please contact
01271 385257.