Other medicines and Betahistine

Package leaflet: Tell your doctor or pharmacist if you are taking, have
Information for the user recently taken or might take any other medicines.
Betahistine 8 mg tablets In particular, tell your doctor or pharmacist if you are taking
Betahistine 16 mg tablets any of the following medicines:
betahistine dihydrochloride 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
Read all of this leaflet carefully before you start depression or Parkinson’s disease. These may increase
taking this medicine because it contains important the exposure of betahistine.
information for you. If any of the above apply to you (or you are not sure), talk
- Keep this leaflet. You may need to read it again. to your doctor or pharmacist before taking Betahistine.
- If you have any further questions, ask your doctor or
pharmacist. Taking Betahistine with food and drink
- This medicine has been prescribed for you only. Do Betahistine can be taken with or without food. However,
not pass it on to others. It may harm them, even if their Betahistine can cause mild stomach problems (listed in
signs of illness are the same as yours. section 4). Taking betahistine with food can help reduce
- If you get any side effects, talk to your doctor or stomach problems.
pharmacist. This includes any possible side effects not Pregnancy, breast-feeding and fertility
listed in this leaflet. See section 4. If you are pregnant or breast-feeding, think you may be
What is in this leaflet pregnant or are planning to have a baby, ask your doctor
1. What Betahistine is and what it is used for or pharmacist for advice before taking this medicine.
2. What you need to know before you take Betahistine It is not known whether betahistine dihydrochloride affects
3. How to take Betahistine the unborn child.
4. Possible side effects Do not take betahistine dihydrochloride tablets if you
5. How to store Betahistine are pregnant unless your doctor has decided that it is
6. Contents of the pack and other information absolutely necessary. Ask your doctor for advice.
Do not breast-feed while using betahistine dihydrochloride
1. What Betahistine is and what it is used for tablets unless instructed by your doctor. It is not known if
betahistine passes into breast milk.
Betahistine is a type of medicine called a “histamine
analogue”. Driving and using machines
Betahistine is used for: Betahistine is not likely to affect your ability to drive or use
Ménière’s disease – the signs of this include: tools or machinery.
• feeling dizzy (vertigo) However, remember that the disease for which you are
• ringing in the ears (tinnitus) being treated with Betahistine (Ménière’s disease) can
• hearing loss or hearing difficulty make you feel dizzy or sick, and can affect your ability to
drive and use machines.
How this medicine works
3. How to take Betahistine
This medicine works by improving blood flow in the inner
ear. This lowers the build up of pressure. Always take this medicine exactly as your doctor or
2. What you need to know before you take pharmacist has told you. Check with your doctor or
Betahistine pharmacist if you are not sure.
• Your doctor will adjust your dose, depending on your
Do not take Betahistine
progress.
• if you are allergic to betahistine or to any of the other
• Keep taking your medicine. The medicine can take a
ingredients of this medicine (listed in section 6)
while to start to work.
• if you have a pheochromocytoma, a rare tumour of the
adrenal gland How to take Betahistine
• Swallow the tablets with water.
Warnings and precautions
• Take the tablet with or after a meal. However,
Talk to your doctor or pharmacist before taking
Betahistine can cause mild stomach problems (listed
Betahistine.
in Section 4). Taking Betahistine with food can help
• if you have or have had a stomach ulcer (peptic ulcer)
reduce stomach problems.
• if you have asthma
• if you have nettle rash, skin rash or a cold in the nose How much Betahistine to take
caused by an allergy, since these complaints may be Always follow your doctor’s instructions because your
exacerbated. doctor might adjust your dose.
• if you have low blood pressure The recommended dose is:
• Betahistine dihydrochloride is not the appropriate
treatment for the following forms of vertigo: Adults
• attacks of benign positional vertigo, The recommended dose is 24 mg to 48 mg per day. 8 mg
• dizziness related to a disease of the central tablets: one or two tablets three times a day.
nervous system. 16 mg tablets: half or one tablet three times a day. 24 mg
• if you are pregnant or planning to become pregnant tablets: 1 tablet two times per day. This form of the
• if you are breast-feeding medication is used when you need 48 mg of betahistine
per day.
If you suffer from any of the above conditions, consult your Dosage
doctor about whether you may take
Daily dose should not exceed 48 mg.
Betahistine tablets.
These groups of patients should be monitored by a doctor In some cases, improvement does not begin to
during treatment. become apparent until two weeks after starting
treatment. The optimal result is obtained after several
Use in Children and adolescents
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months of treatment.
Betahistine is not recommended for use in children and
adolescents (below 18 years of age)

Black
 If you take more than one tablet each Reporting of side effects
day, spread your tablets evenly over the If you get any side effects, talk to your doctor or
day. For example, take one tablet in the pharmacist. This includes any possible side effects not
morning, one at midday and one in the listed in this leaflet. You can also report side effects
evening. directly (see details below). By reporting side effects you
Try to take your tablet at the same time can help provide more information on the safety of this
each day. This will make sure that there medicine.
is a steady amount of the medicine in The United Kingdom
your body. Taking at the same time will Yellow Card Scheme
also help you remember to take your Website: [Link]/yellowcard or search for
tablets. Betahistine is not recommended MHRA Yellow Card in the Google Play or Apple App
for use in children. Store.
If you take more Betahistine than you should 5. How to store Betahistine
If you or someone else takes too many Betahistine tablets
(an overdose), you may feel sick (nauseous), sleepy or Keep this medicine out of the sight and reach of children.
have stomach pain. It can also appear, acceleration of the
This medicinal product does not require any special
heartbeat (tachycardia), low blood pressure (hypotension),
storage conditions.
shortness of breath with a feeling of suffocation
(bronchospasm), accumulation of fluids in the tissues Do not use this medicine after the expiry date which is
(edema). Seizures can occur after taking very high doses. stated on the label, carton, bottle after (EXP).The expiry
Symptomatic treatment is recommended as there is no date refers to the last day of that month.
specific antidote. Do not throw away any medicines via wastewater or
Talk to a doctor or go to a hospital immediately. Take the household waste. Ask your pharmacist how to throw away
Betahistine pack with you. medicines you no longer use. These measures will help
protect the environment.
If you forget to take Betahistine
Wait until you have to take your next dose. Do not take a 6. Contents of the pack and other information
double dose to make up for a forgotten tablet.
What Betahistine contains
If you stop taking Betahistine
Keep taking your tablets until your doctor tells you to stop. - The active substance is betahistine dihydrochloride.
Even when you start feeling better, your doctor may want Each tablet contains 8 mg betahistine dihydrochloride.
you to carry on taking the tablets for some time to make Each tablet contains 16 mg betahistine
sure that the medicine has worked completely. dihydrochloride.
- The other ingredients are microcrystalline cellulose,
If you have any further questions on the use of this
mannitol, povidone, crospovidone, citric acid, colloidal
medicine, ask your doctor or pharmacist.
anhydrous silica, talc and stearic acid.
4. Possible side effects What Betahistine looks like and the contents of the
Like all medicines, this medicine can cause side effects, pack
although not everybody gets them. Very few adverse Tablet.
effects have been reported with betahistine. Betahistine 8 mg tablets
The following serious side effects may occur during White to off-white round, flat uncoated tablets debossed
treatment with Betahistine: with ‘X’ on one side and ‘87’ on the other side.
Allergic reactions: Betahistine 16 mg tablets
• a red or lumpy skin rash or inflamed itchy skin White to off-white round uncoated tablets debossed with
• swelling of your face, lips, tongue or neck ‘X’ and a break line on one side and ‘88’ on the other side.
• a drop in your blood pressure The tablet can be divided into equal doses.
• loss of consciousness
• difficulty breathing Betahistine Tablets are available in:
If any of these side effects occur you should stop Blisters of Polyamide/ Aluminium/ PVC/ Aluminium:
treatment immediately and contact your doctor. 8 mg: 10, 20, 30, 50, 60, 84, 90, 100 & 120 tablets
16 mg: 10, 20, 30, 60, 84 & 90 tablets
Other side effects include:
Common (may affect up to 1 in 10 people): White opaque round HDPE bottle with polypropylene
• feeling sick (nausea) closure containing cotton coil: 30 and 1000 tablets.
• indigestion (dyspepsia) Not all pack sizes may be marketed
• headache.
Marketing Authorisation Holder
The following undesirable effects have been reported
UK_ Milpharm Limited
spontaneously during post-marketing use and in scientific
Ares Block, Odyssey Business Park
literature. A frequency cannot be estimated from the
West End Road
available data and is therefore classified as “not known”
Ruislip HA4 6QD
Blood and lymphatic system disorders United Kingdom
Not known: Thrombocytopenia.
Manufacturer
Immune system disorders: APL Swift Services (Malta) Limited
Not known: hypersensitivity reactions, e.g. anaphylaxis. HF26, Hal Far Industrial Estate, Hal Far
Other side effects that have been reported with the Birzebbugia, BBG 3000
use of betahistine Malta
Mild stomach problems such as being sick (gastralgia, or
vomiting), stomach pain, dry mouth, diarrhea, stomach
swelling (abdominal distension) and bloating. Taking Milpharm Limited
betahistine with food can help reduce stomach problems. Ares Block, Odyssey Business Park
West End Road
Skin and subcutaneous tissue disorders Ruislip HA4 6QD
Not known: cutaneous and subcutaneous hypersensitivity
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United Kingdom
reactions, in particular angioneurotic oedema, urticarial,
rash, and pruritus. This leaflet was last approved in 06/2023.