Vertisan 8 mg and 16 mg Betahistine Dihydrochloride Tablets
What Is Vertisan And What Vertisan Used For?
Betahistine, the active substance in Vertisan, is similar to histamine, a substance found naturally in the human body.
Vertisan used for to treat Meniere’s syndrome, with symptoms such as:
- Dizziness (often accompanied by nausea and vomiting)
- Tinnitus (ringing in the ears)
- Hearing loss
Betahistine dihydrochloride found in Vertisan may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before Using Vertisan?
Do Not Use Vertisan:
- 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 of the adrenal glands ( pheochromocytoma ).
Warnings And Precautions:
Talk to your doctor, pharmacist, or nurse before taking this tablet.
- If you suffer from stomach or intestinal ulcers
- If you suffer from chronic respiratory disease ( bronchial asthma )
- If you suffer from hives, skin rashes, or allergic hay fever – your symptoms may worsen if you take this medicine.
- If you suffer from very low blood pressure
- If you simultaneously take other medicines for the treatment of allergies or colds – another healthcare professional onn “Other medicines and Vertisan”)
- There is limited data for patients with liver and kidney problems and elderly patients. Betahistine should therefore be used with caution in these patients.
Children And Young People:
Children and adolescents should not use this medicine under 18 due to insufficient data on safety and efficacy.
Other Medicines And Vertisan:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If Vertisan is taken at the same time as certain medicines for the treatment of allergies or colds ( antihistamines ), the effect of both medicines may be reduced.
Suppose you are taking any antihistamine medicine when you start taking this medicine. In that case, the dose of the antihistamine medicine must be slowly reduced over about 6 days before you start treatment with this medicine.
Some medicines used in treating depression or Parkinson’s disease (eg monoamine oxidase inhibitors ) can delay the breakdown of betahistine.
Pregnancy, Breastfeeding, And Fertility:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
This medicine should not be used during pregnancy unless recommended by a doctor.
It is not known whether Vertisan is excreted in breast milk. The medicine should, therefore, only be used during breastfeeding if this has been discussed with a doctor.
Driving Ability And Use Of Machinery:
Meniere’s syndrome can hurt the ability to drive and use machines. In clinical studies specifically designed to examine the ability to drive and use machines, betahistine had no or negligible effect.
However, betahistine can cause drowsiness, affecting the ability to drive and use machines.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects or side effects.
A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Vertisan contains lactose
This medicine contains lactose. If you have an intolerance to some sugars, contact your doctor before taking it.
How To Use Vertisan?
- Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- The recommended dose is
- Unless otherwise recommended, the usual dose is:
- Vertisan 8 mg tablets
- 1-2 tablets Vertisan 8 mg 3 times daily (equivalent to 24 – 48 mg betahistine dihydrochloride).
- Vertisan 16 mg tablets
- ½ – 1 tablet Vertisan 16 mg 3 times daily (equivalent to 24 – 48 mg betahistine dihydrochloride).
- The tablet can be divided into two equal doses.
- Swallow the tablets/halves unchewed together with a sufficient amount of liquid with or after a meal.
Your doctor will inform you about how long to take Vertisan tablet. Usually, the treatment is long and lasts several months.
If You Have Used Too Much Vertisan
If you have used too much medicine or, for example, a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you have taken more tablets of it than you should have, the following symptoms may occur due to overdose:
- Headache
- Facial flushing
- Drop in blood pressure
- Rapid pulse, difficulty breathing due to narrowing of the airways ( bronchial asthma )
- Swelling of the mucous membranes in the upper airways due to water retention (Quincke’s edema ).
Seek emergency medical help if you experience any of these symptoms. The doctor will take the appropriate countermeasures.
If You Forget To Use Vertisan:
If you forget to take a tablet, skip that tablet. Please take the next tablet the next time you would normally take it. Do not take a double dose to make up for a forgotten tablet.
If You Stop Using Vertisan:
Do not stop taking tablet until your doctor tells you to. Ask your doctor, pharmacist, or nurse if you have any further questions about this medicine.
Possible Vertisan Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them. Stop taking medicine and contact your doctor immediately if you experience the following symptoms ( angioneurotic edema ):
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives
- Difficulty breathing
Side effects are listed below by frequency: Common(may affect up to 1 in 10 users):
- Headache
- Nausea
- Indigestion
Rare(may affect up to 1 in 1,000 users):
- Feeling your heartbeat and chest pressure
- Existing asthma may worsen
- Nausea
- Heartburn
- Discomfort
- Pain in the stomach
- Gas in the stomach
- Feeling of warmth
Has been reported (occurring in an unknown number of users):
- Drowsiness
- Vomiting
- Allergic reactions
- Hypersensitivity reaction in and on the skin, especially hives, rash, and itching
Note:
Ask your doctor about appropriate measures if you notice any of the above side effects. Stomach upset can be avoided if Vertisan tablet is taken with or after a meal or if the dose is reduced.
How To Store Vertisan?
- Keep this medicine out of sight and reach of children.
- Use before the expiry date stated on the carton and the blister pack after EXP. The expiration date is the last day of the specified month.
- Store at a maximum of 25 °C.
Medicines should not be thrown down the drain. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Contents Declaration
- The active substance is betahistine dihydrochloride.
- Vertisan 8 mg tablets
- One tablet contains 8 mg betahistine dihydrochloride.
- Vertisan 16 mg tablets
- One tablet contains 16 mg betahistine dihydrochloride.
- Other ingredients are lactose monohydrate, corn starch, microcrystalline cellulose, citric acid, povidone K 25, crospovidone type A, and hydrogenated vegetable oil.
Appearance And Package Sizes Of The Medicine:
- Vertisan 8 mg tablets
- White to cream-colored, round tablets.
- Vertisan 16 mg tablets
- Round to cream-colored, flat white tablets with beveled edges with external scoring and scoring on both sides. The tablet can be divided into two equal doses.
- Vertisan is packaged in aluminum blisters containing 20, 24, 30, 48, 50, 60, 96, or 100 tablets.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer:
HENNIG ARZNEIMITTEL GmbH & Co. KG
Liebigstrasse 1-2
DE-65439 Flörsheim am Main
Germany
Local representative
Immedica Pharma AB, Norrtullsgatan 15, SE 111 29 Stockholm. Phone number +46 8 533 39 500.
Email: info@immedica.com.
This medicine is approved in the European Economic Area under the names:
| Austria | Betahistine Hennig 8 mg Tablet / Betahistine Hennig 16 mg Tablet |
| Germany | Betavert N 8 mg Tablet / Betavert N 16 mg Tablet |
| Italy | Betigo 8 mg compresse / Betigo 16 mg compresse |
| Sweden | Vertisan 8 mg tablets / Vertisan 16 mg tablets |