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 Dihydrochloride 16 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
The name of your medicine is Betahistine Tablets. This medicine is called a histamine analogue. It is used to treat:
- Dizziness (vertigo)
- Ringing in the ears (tinnitus)
- Hearing loss suffered by people with Ménière's disease This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure. 2.
What you need to know before you take it
e Betahistine Tablets
Do not take Betahistine Tablets:
- If you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6).
- If you have high blood pressure due to an adrenal tumour (phaeochromocytoma). If any of the above applies to you, do not take this medicine and talk to your doctor. Warnings and precautions: Talk to your doctor or pharmacist before taking Betahistine Tablets if:
- You have a stomach ulcer
- You have asthma
- You are pregnant or planning to become pregnant
- You are breast-feeding Your doctor will tell you whether it is safe for you to start taking this medicine. Your doctor may also want to monitor your asthma while you take Betahistine Tablets. Other medicines and Betahistine Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• •
Anti-histamines – these may (in theory) lower the effect of Betahistine Tablets. 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.
Betahistine Tablets with food and drink You can take Betahistine Tablets 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 and breast-feeding Do not take Betahistine 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 Tablets unless instructed by your doctor. It is not known if Betahistine passes into breast milk. Driving and using machines Betahistine Tablets are not likely to affect your ability to drive or use tools or machinery. However, remember that diseases for which you are being treated with Betahistine (vertigo, tinnitus and hearing loss associated with Meniere's syndrome) can make you feel dizzy or be sick, and can affect your ability to drive or use machines. 3.
How to take it
Betahistine Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. • • •
Betahistine Tablets are available in 3 strengths, 8 mg, 16 mg and 24 mg tablets. The usual starting dose is 16 mg three times a day (48 mg). Your doctor may lower your dose to 8 mg three times a day (24 mg).
Keep taking your tablets. The tablets can take a while to start to work. Betahistine Tablets are not recommended for those under 18 years old. Method of administration
- Swallow the tablets with water.
- Preferably take the tablet with a meal. If you take more Betahistine Tablets than you should If you or someone else takes too much Betahistine Tablets (an overdose), talk to a doctor or go to a hospital straight away, Take the medicine pack with you. If you forget to take Betahistine Tablets If you miss a tablet, wait until the next dose is due. Do not take a double dose to make up for a forgotten dose. How to stop taking Betahistine Tablets 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, Betahistine Tablets can cause side effects, although not everybody gets them.
The following serious side effects may occur during treatment with Betahistine Tablets: Allergic reactions such as:
- Swelling of your face, lips, tongue or neck. This may cause difficulty breathing.
- A red skin rash, inflamed itchy skin If any of these side effects occur, you should stop treatment immediately and contact your doctor. Common side effects (may affect up to 1 in 10 people): Nausea, indigestion, headaches. Other side effects Itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking Betahistine Tablets with food can help reduce any stomach problems. Reporting of side effects If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 it
Betahistine Tablets
Keep this medicine out of the sight and reach of children. This medicine should preferably be locked in the cupboard or medicine cabinet. Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month. Store in the original pack in order to protect from moisture. If your doctor stops your treatment, return any unused tablets to a pharmacist. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment. 6.
Contents of the pack and other information
What Betahistine Dihydrochloride Tablets contain The active substance is betahistine dihydrochloride. Each tablet contains 8 mg of betahistine dihydrochloride. Each tablet contains 16 mg of betahistine dihydrochloride. The other ingredients are: Microcrystalline cellulose, mannitol, colloidal anhydrous silica, citric acid and purified talc. What Betahistine Dihydrochloride Tablets look like and contents of the pack Tablet. Betahistine Dihydrochloride 8 mg Tablets are white to off-white, round, flat, bevel-edged tablets debossed '8' on one side and 'B' on other side with a diameter of 7 mm. Betahistine Dihydrochloride 16 mg Tablets are white to off-white, round, biconvex, scored tablets debossed '16/B' on one side and plain on other side with a diameter of 8.5 mm. The tablet can be
divided into equal doses. Betahistine Dihydrochloride Tablets are available in blister packs of 84 and 120 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Amarox Limited Congress House, 14 Lyon Road Harrow, HA1 2EN United Kingdom Manufacturer Medreich PLC Warwick House, Plane Tree Crescent, Feltham, TW13 7HF United Kingdom. or Amarox Limited Congress House, 14 Lyon Road Harrow, HA1 2EN United Kingdom
To listen to or request a copy of this leaflet in Braille, large print or audio please call, 0203 972 0004 (UK only) Please be ready to give the following information: Product name Betahistine Dihydrochloride 8 mg Tablets Betahistine Dihydrochloride 16 mg Tablets This leaflet was last revised in 08.2023.
Reference number PL 49445/0124 PL 49445/0125
Frequently asked questions about Betahistine Dihydrochloride 16 mg Tablets
How do I take Betahistine Dihydrochloride 16 mg Tablets?
Betahistine Dihydrochloride 16 mg Tablets comes as tablet containing 16mg. 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 Dihydrochloride 16 mg Tablets?
The active substance in Betahistine Dihydrochloride 16 mg Tablets is betahistine dihydrochloride.
Are there equivalent medicines to Betahistine Dihydrochloride 16 mg Tablets?
Medicines with the same active substance, strength and form include: Serc – 16 mg Tablets, Betahistine 16 mg tablets, Betahistine Dihydrochloride 16mg 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 Dihydrochloride 16 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 Dihydrochloride 16 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
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.
4.2. Posology and method of administration
Posology
Adults (including the elderly):
Initially 16 mg three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.
Paediatric population:
Betahistine should not be used in children aged below 18 years due to insufficient data on safety and efficacy.
Elderly:
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 patient population.
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.
Method of administration.
Oral use.
Swallow the tablets with water. Preferably take the tablet with a meal.
4.3. Contraindications
Phaeochromocytoma. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to betahistine dihydrochloride in bronchial asthma patients has been shown in a relatively few patients. These patients need to be carefully monitored during the therapy.
4.5. Interaction with other medicinal products and other forms of interaction
No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.
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.
As betahistine is an analogue of histamine, interaction of betahistine with antihistamines may in theory affect the efficacy of one of these drugs.
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 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.
4.7. Effects on ability to drive and use machines
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome 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 [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)].
Gastrointestinal disorders
Common: nausea and dyspepsia
Nervous System disorders
Common: headache
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”.
Immune System disorders
Hypersensitivity reactions e.g. anaphylaxis have been reported.
Gastrointestinal disorders
Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.
Skin and subcutaneous tissue disorders
Cutaneous and subcutaneous hypersensitivity reactions have been reported, in particular angioneurotic oedema, urticaria, 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, website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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). More serious complications (e.g. convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs. Treatment of overdose should include standard supportive measures.
💬 Ask about this leaflet
Ask anything about Betahistine Dihydrochloride 16 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.