8 mg & 16 mg & 24 mg tablet
Betahistine dihydrochloride
What Betahistine STADA is and what it is used for
Betahistine Stada contains betahistine dihydrochloride. This medicine is called a histamine analogue.
It is used to treat Menière’s syndrome, with symptoms that include:
- dizziness ( vertigo )
- ringing in the ears ( tinnitus
- hearing loss.
This drug works by improving blood circulation in the inner ear and thus lowers the pressure.
Betahistine dihydrochloride contained in Betahistine Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before using Betahistine STADA
Do not use Betahistine STADA
- if you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6)
- you have high blood pressure specifically due to a tumor in the adrenal glands ( pheochromocytoma ).
If any of the above applies to you, do not take this medicine and talk to your doctor.
Warnings and cautions
Talk to your doctor before taking Betahistine Stada if:
- you have stomach ulcers
- you have asthma
- you have hives, rashes, or runny nose caused by allergies, as your symptoms may worsen
- you have low blood pressure.
Your doctor will tell you if it is safe for you to start taking this medicine. Your doctor may also want to monitor your asthma while you are taking this medicine.
Children and young people
Do not use this medicine in children and adolescents under 18 years of age, as there is no information on the safety and efficacy in these patients.
Other medicines and Betahistine STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important that you tell your doctor or pharmacist if you are taking any of the following medicines:
- antihistamines – these can (in theory) lower the effect of Betahistine Stada. Betahistine Stada may also reduce the effect of the antihistamine you
- monoamine oxidase inhibitors ( MAOIs ) – used to treat depression or Parkinson’s disease. These can increase the amount of Betahistine Stada in your body.
Pregnancy, breastfeeding, 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.
Do not take Betahistine Stada if you are pregnant unless your doctor has decided it is absolutely necessary. Ask your doctor for advice.
Do not breast-feed while using Betahistine Stada unless your doctor tells you to. It is not known if Betahistine Stada is excreted in human milk.
Driving and using machines
Betahistine Stada does not affect your ability to drive or use tools or machines. Keep in mind, however, that the disease you are being treated for with Betahistine Stada or the medicine Betahistine Stada may make you dizzy or nauseous and may therefore affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Betahistine STADA
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage
The recommended dose is:
Adults
- the recommended starting dose is 16 mg three times a day (48 mg)
- your doctor may reduce your dose to 8 mg three times a day (24 mg)
Always follow your doctor’s instructions, as your doctor may need to adjust your dose.
The daily dose should not exceed 48 mg.
Use for children and adolescents
Betahistine Stada is not recommended for use in children and adolescents.
Method of administration
- Swallow the tablets whole with water.
- Take the tablet in conjunction with or after a meal. Betahistine Stada can cause mild stomach problems (listed in section 4); Taking it with food can help reduce the likelihood of these problems occurring.
- If you take more than one tablet each day, distribute your tablets evenly throughout the day. Take, for example, one tablet in the morning, one at lunch, and one in the evening.
- Try to take the tablet at the same time each day. This ensures that there is an even amount of medication in your body. Making a schedule also helps you remember to take your tablets.
Treatment time
Keep taking your medicine until your doctor tells you to stop. It may take a while before it starts to work.
If you forget to use Betahistine STADA
Wait until it’s time to take the next dose. Do not take a double dose to make up for a forgotten tablet.
If you stop using Betahistine STADA
Keep taking your tablets until your doctor tells you to stop.
Even when you start to feel better, your doctor may want you to continue taking the tablets for a while to ensure that the medicine has worked completely.
If you have any further questions on the use of this product, 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 serious side effects may occur during treatment with Betahistine Stada:
Allergic reactions such as:
- hives or inflamed itchy skin
- swelling of the face, lips, tongue, or neck
- drop in blood pressure
- fainting
- breathing difficulties.
If any of these side effects occur, stop treatment immediately and contact your doctor.
Other side effects include:
Common (may affect up to 1 in 10 people):
- nausea
- indigestion
- headache.
Other side effects have been reported with the use of betahistine
Mild stomach problems, such as nausea (vomiting), stomach pain, gas in the stomach, and bloating. These side effects can usually be improved by taking Betahistine Stada with a meal.
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Betahistine STADA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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.
6. Contents of the packaging and other information
Content declaration
The active substance is beta-histidine dihydrochloride
Each tablet contains 8 mg of betahistine dihydrochloride
Each tablet contains 16 mg of betahistine dihydrochloride
Each tablet contains 24 mg of betahistine dihydrochloride
The other ingredients are microcrystalline cellulose, mannitol, povidone, crospovidone, anhydrous citric acid, colloidal anhydrous silica, talc, and stearic acid.
What the medicine looks like and the contents of the pack
Betahistine Stada 8 mg tablet:
White to off-white round (diameter 7.0 mm), flat uncoated tablets debossed with “X” on one side and “87” on the other side.
Betahistine Stada 16 mg tablet:
White to off-white round (diameter 8.5 mm), uncoated tablets debossed with “X” and a notch on one side and “88” on the other side.
The tablet can be divided into equal doses.
Betahistine Stada 24 mg tablet:
White to off-white round (diameter 10.0 mm), uncoated tablets debossed with “X” and a notch on one side and “89” on the other side.
The tablet can be divided into equal doses.
Betahistine Stada 8 mg, 16 mg and 24 mg are supplied in polyamide / aluminum / PVC / aluminum blisters of 20, 30, 50, 60 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark