8 mg, 16 mg Tablets
1. What Betahistin 2care4 is and what it is used for
Betahistine 2care4 is a type of medicine called histamine analogue. Betahistine 2care4 increases circulation in the inner ear and thus lowers the pressure.
Betahistin 2care4 is used to treat Menière’s syndrome, which can cause symptoms such as dizziness (often accompanied by nausea and / or vomiting), tinnitus (ringing in the ears) and hearing loss.
Betahistine dihydrochloride contained in Betahistin 2care4 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 you use Betahistin 2care4
Do not use Betahistin 2care4
Do not take Betahistin 2care4
- if you are allergic to betahistine dihydrochloride or any of the other ingredients of this medicine (listed in section 6).
- if you have a tumor in the adrenal glands ( pheochromocytoma ).
Warnings and cautions
Talk to your doctor, pharmacist or nurse before taking Betahistine 2care4.
- if you have or have had stomach ulcers .
- if you have asthma .
- if you have hives ( urticaria ), skin rash (exanthema) or runny nose caused by allergies (allergic rhinitis ).
- if you have very low blood pressure .
- if you are taking antihistamines .
- if you have impaired liver function.
- if you have impaired kidney function.
Children and young people
Betahistine is not recommended for use in children and adolescents below 18 years of age as there is no information on efficacy and safety in these age groups.
Other medicines and Betahistin 2care4
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before starting treatment with Betahistin 2care4, inform your treating physician about the concomitant use of other medicines, especially if you are taking:
- monoamine oxidase inhibitors ( MAOIs ) (medicines for depression or Parkinson’s disease ).
- antihistamines (allergy medicines).
Betahistine 2care4 with food, drink and alcohol
You should take the tablets at the same time as or after a meal. Swallow the tablets with a little water.
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 2care4 if you are pregnant unless your doctor has decided it is absolutely necessary.
Ask your doctor for advice.
It is not known if Betahistin 2care4 is excreted in human milk:
- Do not breast-feed while taking Betahistine 2care4 unless your doctor tells you to.
Driving and using machines
No effect on the ability to drive or use machines has been observed. However, betahistine dihydrochloride may cause drowsiness which may affect the ability to drive and 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.
Betahistine 2care4 contains betahistine dihydrochloride
3. How to use Betahistin 2care4
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
The daily dose varies from 24 to 48 mg and should be divided into two or three separate doses . The 16 mg tablets can be divided into two equal doses.
Improvement will not be noticed until after two weeks of treatment and a satisfactory result is achieved after several months.
You should take the tablets at the same time as or after a meal. Swallow the tablets with a little water. The tablet / half tablet should be swallowed whole.
Use for children and adolescents
Betahistine 2care4 is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Use for the elderly
Betahistine 2care4 should be used with caution if you are over 65 years of age.
Impaired liver and kidney function
Betahistine 2care4 should be used with caution if you have impaired liver or kidney function.
Very few cases of overdose have been reported and in most of these cases no clear signs of overdose were seen. The patient fully recovered in all cases.
Signs of overdose are headache, flushing, dizziness, rapid pulse , low blood pressure , difficulty breathing and swelling of the upper respiratory tract.
If you forget to use Betahistin 2care4
If you forget to take a dose , take it as soon as you remember. If it is soon time to take your next dose, wait until then. Do not take a double dose to make up for a forgotten dose .
If you stop using Betahistin 2care4
Normally, the treatment should last for several months in order to achieve a satisfactory result. Contact a doctor if you have any questions. You should only stop taking beta-histamine if you have discussed it with your doctor.
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.
Serious side effects are
No known frequency (occurs in unknown number of users)
Stop taking Betahistine 2care4 immediately and contact your doctor if you get any of the following reactions:
- Hypersensitivity reactions , e.g. skin rash, difficulty breathing, low blood pressure or fainting ( anaphylaxis ).
- Swelling of the face, lips or tongue ( angioneurotic edema ).
Other side effects may occur
Common (may affect up to 1 in 10 people)
- Nausea.
- Indigestion.
- Headache.
No known frequency (occurs in the unknown number of users):
- Mild stomach upset (eg vomiting, abdominal pain and flatulence), drowsiness. These side effects can usually be improved by taking a dose with a meal.
- Hypersensitivity reaction in the skin (eg hives, rash, and itching ).
Reporting of side effects ar
If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. You can also report side effects directly via
The Medical Products Agency
Box 26
751 03 Uppsala
By reporting side effects , you can help increase drug safety information.
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 Betahistin 2care4
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 carton or jar 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-his tide dihydrochloride.
One tablet contains 8 mg or 16 mg betahistine dihydrochloride.
The other ingredients are anhydrous citric acid, microcrystalline cellulose, mannitol, colloidal anhydrous silica and talc.
What the medicine looks like and the contents of the pack
Package contents
8 mg: White, round, and flat uncoated tablets, smooth on both sides with a diameter of about 7 mm.
16 mg: White, round and biconvex uncoated tablets with a notch on one side and “I” debossed on each side of the notch and smooth on the other side, with a diameter of approximately 8.7 mm.
Blisters of PVC / PVdC / aluminum foil packed in cardboard boxes.
White HDPE cans with polypropylene screw caps.
20, 30, 50, 60, 100 and 120 tablets in blister packs,
20, 30, 50, 60, 100 and 120 tablets in HDPE bottles.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
2care4 Generics ApS
Stenhuggervej 12-14
6710 Esbjerg V
Denmark
Manufacturer:
SC SANTA SA,
Page Carpatilor no. 60,
objective no. 47, 48, 58;
Brasov, Jud. Brasov
COD 500269
Romania
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Betahistin 2care4