1. What KernHistine is and what it is used for
Betahistine dihydrochloride belongs to a group of medicinal products called antivertigo drugs. KernHistine is used for the treatment of Meniere’s disease, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss and tinnitus (buzzing in the ears).
 

2. What you need to know before you take KernHistine
Do not take KernHistine
– if you are allergic (hypersensitive) to the active substance or any of the other ingredients of KernHistine (listed in section 6).
– if you have a certain cancer of the adrenal glands called pheochromocytoma.
Warnings and precautions
Take special care with KernHistine
– if you have bronchial asthma
– if you have or have had a stomach ulcer
– if you suffer from blemishes on the skin and itching (urticaria), rash (exanthema) or hay fever
– if you have very low blood pressure
– if you are on treatment with allergy drugs (antihistamines) at the same time as you are taking KernHistine (also see “Other
medicines and KernHistine”).
Other medicines and KernHistine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those bought
without a prescription. The administration of allergy medicines such as antihistamines (especially H1 antagonists) at the same time could reduce the efficacy of both medicines.
Taking KernHistine with food and drink
It is advisable to take KernHistine during or after meals to prevent stomach upsets.
Children and adolescents
KernHistine is not recommended for use in children and adolescents under 18 years of age, as there is no experience in these age groups.
Pregnancy and breast-feeding
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 any medicine. KernHistine should not be taken during pregnancy unless your doctor believes that
it is necessary. KernHistine should not be taken while breast-feeding.
Driving and using machines
The effect of KernHistine on the ability to drive and use machines is null or insignificant.
Important information about some of the ingredients of KernHistine
This medicine contains lactose. If you doctor has told you that you are intolerant to some sugars, seek his or her advice before taking this medicine.

3. How to take KernHistine
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Remember to take your medicine. The initial recommended dose is 16 mg (2 tablets), three times a day; this means a daily maximum of 48 mg (6 tablets) taken at 3
different times. Your doctor will set the maintenance dose according to your response.

You should take KernHistine for as long as your doctor recommends. Do not stop the treatment earlier, as you will not obtain the expected results.
 

If you take more KernHistine than you should
If you take more KernHistine than you should, you may suffer the following symptoms because of an overdose: headache, redness of the face, dizziness, rapid heartbeat (tachycardia), low blood pressure (hypotension), breathing difficulties and shortness of breath (bronchospasm),
accumulation of fluids in the tissues (oedema). Seizures can occur after taking very high doses.
See your doctor or pharmacist or go to the nearest hospital immediately.
If you take more KernHistine than you should, it is recommended that you receive treatment for your symptoms as there is no
specific antidote.

If you forget to take KernHistine
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, wait until the next dose and continue with
the treatment as normal.

4. Possible side effects
Like all medicines, KernHistine can cause side effects, although not everybody gets them.
Very common: more than 1 in every 10 patients.
Common: between 1 and 10 in every 100 patients.
Uncommon: between 1 and 10 in every 1,000 patients.
Rare: between 1 and 10 in every 10,000 patients.
Very rare: less than 1 in every 10,000 patients.
Unknown frequency: cannot be estimated from the available data.
Gastrointestinal disorders
Common: nausea and dyspepsia.
Rare: stomach pain and discomfort, bloating, vomiting.

Skin and subcutaneous tissue disorders
Very rare: rash, itching (pruritus), blemishes on the skin and intense itching (urticaria).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store KernHistine
Keep out of the reach and sight of children.
Store below 30ºC.
Do not use KernHistine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What KernHistine contains:
– The active substance is betahistine dihydrochloride. Each tablet contains 8 mg of betahistine dihydrochloride.
– The other ingredients are lactose monohydrate, microcrystalline cellulose (E-460i), povidone (E-1201), anhydrous colloidal silica, crospovidone, stearic acid and talc.

What KernHistine looks like and contents of the pack
KernHistine comes in the form of round, white tablets, scored on one side and with a “K” on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Each pack contains 60 tablets.

Marketing Authorisation Holder and Manufacturer
Kern Pharma, S.L.
Polígono Ind. Colón II
C/ Venus 72
08228 Terrassa (Barcelona) – Spain