Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Betahistine 8 mg tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Betahistine dihydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 (vertigo)
- ringing in the ears (tinnitus)
- hearing loss or hearing difficulty
Other medicines and Betahistine Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Anti-histamines – This is because in theory betahistine may not work properly. Also, betahistine may lower the effect of anti-histamines. Monoamine-oxidase inhibitors (MAOIs) – used to treat depression or Parkinson's disease. These may increase the exposure of betahistine. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Betahistine. Taking Betahistine with food and drink Betahistine can be taken with or without food. However, Betahistine can cause mild stomach problems (listed in section 4). Taking betahistine with food can help reduce stomach problems. 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 dihydrochloride affects the unborn child. Do not take betahistine dihydrochloride tablets if you are pregnant unless your doctor has decided that it is absolutely necessary. Ask your doctor for advice. Do not breast-feed while using betahistine dihydrochloride tablets unless instructed by your doctor. It is not known if betahistine passes into breast milk. Driving and using machines Betahistine is not likely to affect your ability to drive or use tools or machinery. However, remember that the disease for which you are being treated with Betahistine (Ménière's disease) can make you feel dizzy or sick, and can affect your ability to drive and use machines.
How this medicine works This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure.
3. How to take Betahistine
Do not take Betahistine
- if you are allergic to betahistine or to any of the other ingredients of this medicine (listed in section 6)
- if you have a pheochromocytoma, a rare tumour of the adrenal gland Warnings and precautions Talk to your doctor or pharmacist before taking Betahistine.
- if you have or have had a stomach ulcer (peptic ulcer)
- 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
- Betahistine dihydrochloride is not the appropriate treatment for the following forms of vertigo:
- attacks of benign positional vertigo,
- dizziness related to a disease of the central nervous system.
- if you are pregnant or planning to become pregnant
- if you are breast-feeding If you suffer from any of the above conditions, consult your doctor about whether you may take Betahistine tablets. These groups of patients should be monitored by a doctor during treatment. Use in Children and adolescents Betahistine is not recommended for use in children and adolescents (below 18 years of age)
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. • •
Your doctor will adjust your dose, depending on your progress. Keep taking your medicine. The medicine can take a while to start to work.
What you need to know before you take it
e Betahistine
Black A/s: 170 x 300 mm
Packaging Development
Product Name
Component
Item Code
Date & Time
Betahistine
Leaflet
P1540066
22.10.2025 & 6.40 PM Reviewed / Approved by
Customer / Country
Version No.
Reason Of Issue
Milpharm_Unit-3
01
Revision
No. of Colours : 01
Team Leader
Ramesh P
Dimensions
Initiator
Jaya Durga
170 x 300 mm
Artist: Additional Information :
40066 Supersede Item Code: P15334940
Sign / Date
Try to take your tablet at the same time each day. This will make sure that there is a steady amount of the medicine in your body. Taking at the same time will also help you remember to take your tablets. Betahistine is not recommended for use in children. If you take more Betahistine than you should If you or someone else takes too many Betahistine tablets (an overdose), you may feel sick (nauseous), sleepy or have stomach pain. It can also appear, acceleration of the heartbeat (tachycardia), low blood pressure (hypotension), shortness of breath with a feeling of suffocation (bronchospasm), accumulation of fluids in the tissues (edema). Seizures can occur after taking very high doses. Symptomatic treatment is recommended as there is no specific antidote. Talk to a doctor or go to a hospital immediately. Take the Betahistine pack with you. If you forget to take Betahistine Wait until you have to take your next dose. Do not take a double dose to make up for a forgotten tablet. If you stop taking Betahistine Keep taking your tablets until your doctor tells you to stop. Even when you start feeling better, your doctor may want you to carry on taking the tablets for some time to make sure that the medicine has worked completely. 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. Very few adverse effects have been reported with betahistine. The following serious side effects may occur during treatment with Betahistine: Allergic reactions:
- a red or lumpy skin rash or inflamed itchy skin
- swelling of your face, lips, tongue or neck
- a drop in your blood pressure
- loss of consciousness
- difficulty breathing If any of these side effects occur you should stop treatment immediately and contact your doctor. Other side effects include: Common (may affect up to 1 in 10 people):
- feeling sick (nausea)
- indigestion (dyspepsia)
- headache. The following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as "not known" Blood and lymphatic system disorders Not known: Thrombocytopenia. Immune system disorders: Not known: hypersensitivity reactions, e.g. anaphylaxis. Other side effects that have been reported with the use of betahistine Mild stomach problems such as being sick (gastralgia, vomiting), stomach pain, dry mouth, diarrhea, stomach swelling (abdominal distension) and bloating. Taking betahistine with food can help reduce stomach problems. Skin and subcutaneous tissue disorders Not known: cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic oedema, urticarial, rash, and 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
How to take it
Betahistine
- Swallow the tablets with water.
- Take the tablet with or after a meal. However, Betahistine can cause mild stomach problems (listed in Section 4). Taking Betahistine with food can help reduce stomach problems. How much Betahistine to take Always follow your doctor's instructions because your doctor might adjust your dose. The recommended dose is: Adults The recommended dose is 24 mg to 48 mg per day. 8 mg tablets: one or two tablets three times a day. 16 mg tablets: half or one tablet three times a day. 24 mg tablets: 1 tablet two times per day. This form of the medication is used when you need 48 mg of betahistine per day. Dosage Daily dose should not exceed 48 mg. In some cases, improvement does not begin to become apparent until two weeks after starting treatment. The optimal result is obtained after several months of treatment.
P1540066
Possible side effects
you can help provide more information on the safety of this medicine.
How to store it
Betahistine Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the label, carton, bottle after (EXP).The expiry date refers to the last day of that month. 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.
Contents of the pack and other information
What Betahistine contains –
The active substance is betahistine dihydrochloride. Each tablet contains 8 mg betahistine dihydrochloride. Each tablet contains 16 mg betahistine dihydrochloride.
–
The other ingredients are microcrystalline cellulose, mannitol, povidone, crospovidone, citric acid, colloidal anhydrous silica, talc and stearic acid.
What Betahistine looks like and the contents of the pack Tablet. Betahistine 8 mg tablets White to off-white round, flat uncoated tablets debossed with 'X' on one side and '87' on the other side. Betahistine 16 mg tablets White to off-white round uncoated tablets debossed with 'X' and a break line on one side and '88' on the other side. The tablet can be divided into equal doses. Betahistine Tablets are available in: Blisters of Polyamide/ Aluminium/ PVC/ Aluminium: 8 mg: 10, 20, 30, 50, 60, 84, 90, 100 & 120 tablets 16 mg: 10, 20, 30, 60, 84 & 90 tablets White opaque round HDPE bottle with polypropylene closure containing cotton coil: 30 and 1000 tablets. Not all pack sizes may be marketed Marketing Authorisation Holder Milpharm Limited 1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF United Kingdom Manufacturer APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta or Milpharm Limited 1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF United Kingdom This leaflet was last approved in 10/2025.
P1540066
If you take more than one tablet each day, spread your tablets evenly over the day. For example, take one tablet in the morning, one at midday and one in the evening.
Frequently asked questions about Betahistine 8 mg tablets
How do I take Betahistine 8 mg tablets?
Betahistine 8 mg tablets comes as tablet containing 8mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Betahistine 8 mg tablets?
The active substance in Betahistine 8 mg tablets is betahistine dihydrochloride.
Are there equivalent medicines to Betahistine 8 mg tablets?
Medicines with the same active substance, strength and form include: Serc – 8 mg Tablets, Betahistine Dihydrochloride 8 mg Tablets, Betahistine Dihydrochloride 8mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Betahistine 8 mg tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Betahistine 8 mg tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: betahistine dihydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Betahistine is indicated for treatment of Ménière's syndrome, symptoms of which may include vertigo, tinnitus, hearing loss and nausea
4.2. Posology and method of administration
Dosage
Adults:
Initial oral treatment is 8 to 16 mg three times daily, taken preferably with meals.
Maintenance doses are generally in the range 24 - 48 mg daily. The daily dose should be given in 2 or 3 divided doses throughout the day. Daily dose should not exceed 48 mg. Dosage can be adjusted to suit individual patient needs. Sometimes improvement could be observed only after a couple of weeks of treatment. The best results are sometimes obtained after a few months. There are indications that treatment from the onset of the disease prevents the progression of the disease and/or the loss of hearing in later phases of the disease.
Betahistine 8 mg/16 mg:
8 mg tablets
16 mg tablets
1 - 2 tablets
3 times/day
½ - 1 tablet
3 times/day
Betahistine 24 mg:
The recommended starting dose is 24 mg betahistine.
If the maximum daily dose of 48 mg is indicated adults take one 24 mg tablet twice daily (in the morning and in the evening).
24 mg tablets
1 tablet
2 times/day
Renal impairment
There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary.
Hepatic impairment
There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary.
Elderly population
Although there are limited data from clinical studies in this patient group, extensive post marketing experience suggests that no dose adjustment is necessary in this population.
Paediatric population:
Betahistine tablets are not recommended for use in children and adolescents below age 18 due to lack of data on safety and efficacy.
Method of administration
Take the tablets preferably with meals or after meals with a glass of water. Betahistine may cause mild indigestion (listed in section 4.8). Taking betahistine with food may help to relieve indigestion.
4.3. Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
Betahistine is contraindicated in patients with phaeochromocytoma. As betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumor resulting in severe hypertension.
4.4. Special warnings and precautions for use
Caution is advised in the treatment of patients with peptic ulcer or a history of peptic ulceration, because of the occasional dyspepsia encountered in patients on betahistine.
Patients with bronchial asthma and peptic ulcer should be monitored carefully during the treatment with betahistine.
Caution is advised in prescribing betahistine to patients with either urticaria, rashes or allergic rhinitis, because of the possibility of aggravating these symptoms.
Caution is advised in patients with severe hypotension.
Betahistine is not the appropriate treatment for the following pathologies:
• Benign paroxysmal vertigo
• Dizziness related to central nervous system disease.
Precautions for use
Taking the drug in the middle of meals helps avoid gastralgia.
4.5. Interaction with other medicinal products and other forms of interaction
There are no proven cases of hazardous interactions. No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.
Although an antagonism between Betahistine and antihistamines could be expected on a theoretical basis, no such interactions have been reported.
There is a case report of an interaction with ethanol and a compound containing pyrimethamine with dapsone and another of potentiation of betahistine with salbutamol.
In vitro data indicate an inhibition of betahistine metabolism by drugs that inhibit monoamino-oxidase (MAO) including MAO subtype B (e.g. selegiline). Caution is recommended when using betahistine and MAO inhibitors (including MAO-B selective) concomitantly.
Betahistine is a histamine analogue, concurrent administration of H1 antagonists may cause a mutual attenuation of effect of the active agents.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of betahistine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, embryonal/foetal development, parturition and postnatal development at clinically relevant therapeutic exposure. As a precautionary measure, it is preferable to avoid the use of betahistine during pregnancy.
Breast-feeding
It is not known whether betahistine is excreted in human milk. Betahistine is excreted in rat milk. Effects seen post-partum in animal studies were limited to very high doses. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.
Fertility
Animal studies did not show effects on fertility in rats (see section 5.3).
4.7. Effects on ability to drive and use machines
Betahistine is indicated for vertigo, tinnitus and hearing loss associated with Ménière's syndrome which can negatively affect the ability to drive and use machines. In clinical studies specifically designed to investigate the ability to drive and use machines, betahistine had no or negligible effects.
4.8. Undesirable effects
The following undesirable effects have been experienced with the below indicated frequencies in betahistine-treated patients in placebo-controlled clinical trials and in post-marketing reports: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare ( ≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Nervous system disorders:
Common: headache
Gastrointestinal disorders:
Common: nausea & dyspepsia
In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”
Blood and lymphatic system disorders
Not known: Thrombocytopenia.
Immune system disorders:
Not known: hypersensitivity reactions, e.g. anaphylaxis.
Gastrointestinal disorders:
Not known: Mild gastric complaints (e.g. vomiting, gastrointestinal pain, dry mouth, diarrhea, abdominal distension and bloating). These can normally be dealt with by taking the dose during meals or by lowering the dose.
Skin and subcutaneous tissue disorders
Not known: cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic oedema, urticarial, rash, and pruritus
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain).Other symptoms of betahistine overdose are vomiting, dyspepsia, ataxia and seizures. More serious complications (convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs. No specific antidote. Gastric lavage and symptomatic treatment are recommended within one hour after intake. Treatment of overdose should include general supportive measures.
💬 Ask about this leaflet
Ask anything about Betahistine 8 mg tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.