ABBOTT SERC medicine for dizziness, hearing loss, tinnitus (4 blisters x 25 tablets)

Dosage form Box of 4 blisters x 25 tablets
Specifications Betahistine

Ingredient

Composition information	Content
Betahistine	8mg

Uses

Indications

SERC 8 mg is indicated in the following cases:

Ménière syndrome is determined by the following main symptoms:

Dizziness (dizzy dizziness with nausea/vomiting).

Pharmacokological

only partly understood the new mechanism of action of Betahistine.

There are some reasonable hypotheses that have been confirmed by animal studies and human data:

Betahistine acts on the histamine secretion system: Betahistine plays both roles as part of the H1 H1 antagonistic part as well as antagonist in the H3 H3 receptor in the nerve tissue and has a significant activity of H2 receptor. of receptors H3. Vestibular rehabilitation: Betahistine promotes the recovery of vestibular after one -side neurosurgical surgery, thanks to easy to make and increase the rehabilitation of the central vestibular. This effect is characterized by regulating the metabolism and histamine secretion through the intermediate of antagonism in H3 receptor. In humans, the recovery time after nerve surgery also decreases when treated with betahistine. Betahistine's value in the vestibular system.

The effect of Betahistine has been shown in studies in patients with dizziness in the vestibular and Ménière disease and has been shown by improving the condition and frequency of dizziness.

pharmacokinetic

absorption

When taken, Betahistine absorbs strongly and almost entirely through all segments of the digestive tube. After absorption, this drug will metabolize rapidly and almost completely let 2-picnylacetic acid lose pharmacological activity. Betahistine concentration in plasma is very low.

Therefore, all pharmacokinetic analysis is based on 2-paa measurement in plasma and urine.

When you eat full, see the cmax of the drug will be lower than when fasting. However, the complete absorption of Betahistamin is equivalent to both hunger states, showing that food only slows the absorption of Betahistine.

Distribution

percentage of betahistine is linked to plasma proteins below 5%.

Metabolism

After absorption, betahistine is quickly transformed and almost completely into 2-paa (without pharmacological activity).

After taking betahistine, the concentration of 2-paa in plasma (and urine) reaches the maximum after 1 hour drink and a half-after half.

Elimination

2-Paa substance quickly excreted through the urine. With doses between 8 and 48 mg, about 85% of the first dose is re -collected urine. The elimination of mother betahistine through the kidney or stool is less meaningful.

linear

The recovery rate is constant when given in the region 8 - 48 mg, proving that the pharmacokinetics of Betahistine are linear and shows that the metabolic path is not saturated.

Before taking ABBOTT SERC medicine for dizziness, hearing loss, tinnitus (4 blisters x 25 tablets)

How to use

SERC 8 mg drugs are used orally.

Dosage

always use the 8 mg SERC medicine as the doctor prescribed, if there is any question, please consult your doctor or pharmacist.

The dose for adults is 24 - 48 mg every day, divided into several times a day. Each time drink 1 - 2 tablets, use 3 times.

The starting dose is 8 - 16 mg x 3 times/day.

The doctor will adjust the dose depending on the response of each patient with the drug.

Symptoms will be improved after 2 weeks of taking the drug, the best results sometimes only achieved after a few months. There are indications for treatment right from the beginning of the disease will prevent the progression of the disease and/or prevent hearing loss in the slow -moving phases of the disease.

For children:

SERC 8 mg is not recommended for children under 18 years of age because there is no enough data on safety and effectiveness.

Old people:

Despite limited data from clinical studies in this patient group, extended post -marketing experiences show that the adjustment of the dose in this patient is not necessary.

kidney failure and/or liver failure:

There are no specific clinical studies in this patient group, but according to the post -marketing experience, the adjustment of the dose seems unnecessary.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Symptoms of overdose:

There are a few cases of overdose. Some patients experience mild to medium symptoms such as nausea, drowsiness and abdominal pain when taking doses of up to 640 mg. More serious complications include convulsions and complications of lungs and hearts encountered in cases of intentional overdose when used in combination with other drugs to overdose.

Overdose treatment:

There is no specific antidote. Overdose treatment includes standard support measures.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using 8 mg SERC, you may experience unwanted effects (ADR).

The following unwanted effects are studied with the frequency specified in patients treated with 8 mg SERC in clinical trials with placebo control: Common (from 1 to 10 cases in 100 treated patients).

Gastrointestinal disorders

Common: Vomiting and indigestion (indigestion).

Neurological disorders

Common: headache. The frequency cannot be estimated from available data and therefore classified as "unknown".

immune system disorders

allergies (sensitivity) including serious (hypersensitivity) allergic reactions can cause shortness of breath, swelling of the face and neck, dizziness.

Mild stomach pain (for example, vomiting, stomach pain, swelling and abnormal blisters). These effects are often lost when taking the medicine at a meal or a decrease in the dose.

In some very rare cases, there are hypersensitivity reactions in the skin especially sudden swelling (nervous edema) in the neck or limbs, urticaria, rash and itching.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

SERC 8 mg drug is contraindicated in the following cases:

Hypersensitivity (hypersensitivity) with active ingredients or any excipients of the preparation or if adrenal tumor is known as chromium cell tumors.

Be cautious when using

If you have bronchial asthma or have a history of stomach ulcer (gastrointestinal tract), your doctor will have to monitor you carefully when taking this medication.

The ability to drive and operate machinery

betahistine is indicated with Morbus Meniere (Meniere) and dizziness. Both of these diseases can have a negative effect on the ability to drive and operate machinery. In clinical studies specially designed to investigate the ability to drive and operate machinery, Betahistine does not cause negligible or negligible effects.

Pregnancy

There is no adequate data related to the use of 8 mg SERC drugs in pregnant women. Studies on animals are also not sufficient to indicate the effect of the drug during pregnancy, or with the development of embryos/fetuses, with the birth and the development of newborns, in this regard, it is unclear potential for embryo and newborn baby. This drug should not be used during pregnancy, before the doctor feels really needed.

Breastfeeding period

Unknown excretion of betahistine through breast milk. There are no studies on animals about the excretion of Betahistine through milk. Recommendation should not be used during breastfeeding.

For more information, ask your doctor about the importance of the drug for you, the benefits of breastfeeding and the potential risk to children.

Drug interaction

There has been no interaction research on the living body (in vivo). The data is based on a laboratory (in vitro) that does not see the inhibition of cytochrom P450 enzymes on the living body.

If you are taking Monoamine-Oxidase inhibitors [Maois, including sub-type B (for example, Selegiline), the drug is used to treat depression or Parkinson's disease, you should notify your doctor because these drugs can increase the effect of the SERC.

Betahistine has a structure similar to histamine, drug interaction between betahistine and antihistamine can affect the effectiveness of one of these drugs. Please inform your doctor if you are taking antihistamine before using the SERC.

Please notify your doctor or pharmacist if you are taking or new medications, including non -prescribing drugs.

Storage

No storage at temperatures above 30 ° C.

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