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 16mg 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 These tablets contain Betahistine dihydrchloride. They are used to treat vertigo, tinnitus (ringing in the ears) and hearing loss associated with Meniere's disease. They work by reducing the pressure in your inner ear.
Common side effects (may affect up to 1 in 10 people): Nausea, indigestion and headache Other side effects Itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking Betahistine dihydrochloride tablets with meal can help reduce any stomach problems.
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What you need to know before you take it
e Betahistine dihydrochloride Tablets Do not take Betahistine dihydrochloride tablets:
- if you are allergic (hypersensitive) to Betahistine dihydrochloride or any of the other ingredients of Betahistine dihydrochloride Tablets (listed in section 6). The symptoms of an allergic reaction include itching, nettle rash, wheezing or swelling of the hands, throat, mouth or eyelids.
- if you have phaeochromocytoma (high blood pressure due to adrenal tumour).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App.
If you think any of the above points apply to you, do not take the tablets. Talk to your doctor rst and follow the advice given.
How to take it
Betahistine dihydrochloride Tablets
If you would like this leaet in a different format please contact the Marketing authorisation holder as listed above.
Always take Betahistine dihydrochloride tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablets with water and always take with or after meal.
This leaet was last revised in 05/2020.
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If you take more Betahistine dihydrochloride tablets than you should An overdose of this medicine may be dangerous. If you accidently take too many tablets tell your doctor or go to the nearest hospital casualty department immediately. The symptoms of a Betahistine dihydrochloride tablets overdose are nausea, vomiting, digestion problems, coordination problems and – with higher doses – ts.
Usual dose for adults and the elderly: The usual starting dose of Betahistine dihydrochloride 16 mg three times a day. After you have been taking treatment for a while your doctor may change the dose to between 24 and 48 mg a day.
PACKAGE LEAFLET: INFORMATION FOR THE USER Betahistine Dihydrochloride 8mg & 16mg Tablets Betahistine dihydrochloride Read all of this leaet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaet. See section 4.
Possible side effects
Like all medicines, these tablets can cause side effects, although not everybody gets them. The following serious side effects may occur during treatment with Betahistine: Allergic reactions such as: Swelling of your face, lips, tongue or neck. This may cause difculty in breathing. A red skin rash, inamed itchy skin. If any of these side effects occur you should stop treatment immediately and contact your doctor.
How to store it
Betahistine dihydrochloride Tablets Do not store above 30° C. Do not put them into another container as they might get mixed up. Keep out of the sight and reach of children. Do not use Betahistine dihydrochloride tablets after the expiry date which is stated on the carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Warnings and Precautions Talk to your doctor or pharmacist before taking Betahistine dihydrochloride Tablets
- if have a stomach ulcer
- if you suffer from asthma.
- if you suffer from conditions relating to lactose such as galactose intolerance, Lapp lactase deciency or glucose-galactose malabsorption.
Contents of the pack and other information
Other medicines and Betahistine dihydrochloride tablets Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
What Betahistine dihydrochloride tablets contains The active substance is betahistine dihydrochloride (8mg or 16mg). The other ingredients are lactose, maize starch, microcrystalline cellulose, citric acid, crospovidone, povidone and sodium stearyl fumarate. Betahistine dihydrochloride tablets are gluten free.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Antihistamines, which are used to treat allergic conditions.
- Monoamine-oxidase inhibitors (MAOIs) – used to treat depression or Parkinson's disease. These may inhibit metabolism of Betahistine Dihydrochloride.
What Betahistine dihydrochloride tablets look like and contents of the pack Betahistine dihydrochloride tablets are round white tablets. The 8mg tablets have 'R3' stamped on one side with a scoreline on the other and the 16mg tablets have 'R4' stamped on one side with a scoreline on the other. Betahistine dihydrochloride 8 mg and 16mg tablets are available in packs of 84, 100 and 120 Tablets. Not all pack sizes may be marketed.
Pregnancy, breast-feeding and fertility Ask your doctor for advice before taking Betahistine dihydrochloride tablet if you are pregnant or planning to become pregnant or you re breast feeding.
Marketing Authorisation Holder Flamingo Phama (UK) Ltd. 1st Floor, Kirkland House, 11-15 Peterborough Road, Harrow, Middlesex,HA1 2AX, United Kingdom.
Driving and using machines There is no indication that taking Betahistine dihydrochloride tablets affect the ability to drive and use machines. However, take care and, if affected, do not drive or operate machines.
Manufacturer Flamingo Pharma (UK) Limited The Bloc, 38 Springeld Way, Anlaby, Hull, HU10 6RJ, United Kingdom
Betahistine dihydrochloride tablets contains lactose These tablets contain lactose which is a type sugar. Contact your doctor before taking these tablets if you are lactose intolerant.
Frequently asked questions about Betahistine Dihydrochloride 16mg Tablets
How do I take Betahistine Dihydrochloride 16mg Tablets?
Betahistine Dihydrochloride 16mg 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 16mg Tablets?
The active substance in Betahistine Dihydrochloride 16mg Tablets is betahistine dihydrochloride.
Are there equivalent medicines to Betahistine Dihydrochloride 16mg Tablets?
Medicines with the same active substance, strength and form include: Serc – 16 mg Tablets, Betahistine 16 mg tablets, Betahistine Dihydrochloride 16 mg 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 16mg 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 16mg 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 the treatment of vertigo, tinnitus and hearing loss associated with Ménière's syndrome.
4.2. Posology and method of administration
Posology:
Adults (including the elderly);
Initially two tablets three times daily, taken preferably with meals. Maintenance doses are generally in the range 24-48mg daily.
Paediatric population: not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Geriatric 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 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.
4.3. Contraindications
Betahistine is contraindicated in patients with a phaeochromocytoma and hypersensitivity to betahistine dihydrochloride or 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.
Lactation:
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 at: 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 16mg 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.