Indications
Ménière’s Syndrome as defined by the following core symptoms:
- vertigo (with nausea/vomiting)
- hearing loss (hardness of hearing)
- tinnitus (ringing in the ears
Symptomatic treatment of vestibular vertigo.
Dosage and administration
- Always take Advoserc exactly as your doctor has prescribed. If you have any questions, you should check with your doctor or pharmacist.
- If you forget to take your tablet(s), do not take a double dose to compensate for it. If you require further information, please ask your doctor or pharmacist for advice.
- The dosage for adults is 24 To 48 mg divided over the day.
- 8 mg tablets: 1 To 2 tablets 3 times per day.
- 16 mg tablets: 1/2 To 1 tablet 3 times per day.
- 24 mg tablets: 1 tablet 2 times per day
Your doctor will adjust the dosage according to your response to the medication. Improvement of symptoms may take up to two weeks and the best results are sometimes obtained only after a few months. There are indications that treatment from the onset of the disease prevents its progression and/or the loss of hearing in later phases of the disease.
Pediatric population
Advoserc is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy.
Contraindications
Do not take Advoserc if you are hypersensitive to the active substance or to any of the excipients.
Warnings and special precautions for use
If you suffer from a phaeochromocytoma or bronchial asthma, your doctor will need to monitor you carefully while you are taking this medication. Furthermore, please inform your doctor or pharmacist if you have a history of peptic ulcer before taking this medication.
Effects on ability to drive and use machines
Betahistine is regarded to have no or negligible effects on the ability to drive and use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.
Important information about the ingredients
This product contains mannitol, which may have a mild laxative effect.
Interactions with other medications
- No in vivo interaction studies have been performed. Based on in vitro data, no in vivo inhibition on Cytochrome P450 enzymes is expected.
- Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
Pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.
Pregnancy
There is no adequate data for the use of betahistine in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition (giving birth) and postnatal development. The potential risk for humans in this regard is unknown. Betahistine should not be used during pregnancy unless is it deemed necessary by your doctor.
Lactation
It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretion of betahistine in milk. It is recommended not to take any medication while nursing. However if you are nursing, talk to your doctor regarding the importance of this medicine to you, the benefits of nursing and the potential risks to your child.
Undesirable effects
Like all medicines, Advoserc may have side effects. If you notice any side effects not mentioned in this leaflet, or if any of the side effects get serious, please inform your doctor or pharmacist.
Undesirable Effects by System Organ Class:
Immune System disorders: Hypersensitivity (allergic) reactions (such as anaphylaxis) have been reported.
Gastrointestinal disorders: In some cases mild gastric complaints have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.
Skin and subcutaneous tissue disorders: In very rare cases cutaneous (skin) hypersensitivity reactions have been reported, in particular angioneurotic oedema (sudden onset of face, neck or limb swelling), urticaria (hives), rash and pruritus (itchiness).
Overdose
Symptoms of overdose
- A few overdose cases have been reported. Some patients experienced mild to moderate symptoms such as nausea, somnolence (sleepiness) and abdominal pain with doses up to 640 mg.
- More serious complications including convulsions, and pulmonary and cardiac complications were observed in cases of intentional overdose of Advoserc, especially when taken in combination with other overdosed drugs.
Treatment of overdose
No specific antidote is known. Treatment of overdose should include standard supportive measures.
Pharmacodynamics
- Pharmacotherapeutic group: Anti-vertigo preparations. The mechanism of action of betahistine is partly known.
- In biochemical studies, betahistine was found to have weak H, receptor agonistic and potent Hs antagonistic properties in both the central and autonomic nervous systems. Pharmacological testing in animals has shown that the blood circulation in the striae vascularis of the inner ear improves, probably by means of a relaxation of the precapillary sphincters of the microcirculation of the inner ear
- Betahistine was also found to have a dose dependent inhibiting effect on spike generation of neurons in lateral and medial vestibular nuclei.
- Betahistine accelerates the vestibular recovery after unilateral neurectomy, by promoting and facilitating central vestibular compensation; this effect, charac terized by an up-regulation of histamine turnover and release, is mediated through H, Receptor antagonism.
Taken together these properties contribute to the beneficial therapeutic effects seen with regard to Ménière’s disease and vestibular vertigo. - Betahistine increases histamine turnover and release by blocking presynaptic H3-receptors and inducing H3-receptor downregulation. This effect provides explanation for the efficacy of betahistine in the treatment of vertigo and vestibular diseases.
Pharmacokinetics
Orally administered betahistine is readily and almost completely absorbed from all parts of the gastrointestinal tract. After absorption, the drug is rapidly and almost completely metabolized into 2-PAA (which has no pharmacological activity). Plasma levels of betahistine care very low (i.e., below the detection limit of 100 pg/ml). All pharmacokinetic analyses are therefore based on 2-PAA measurements in plasma and urine.
The plasma concentration of 2-PAA reaches a maximum 1 hour after intake. The half-life is approximately 3.5 hours. 2-PAA is readily excreted in the urine. In the dose range of 8 to 48 mg, about 85% of the original dose is excreted in the urine. Renal or fecal excretion of betahistine itself is of minor importance. Recovery rates are constant over the oral dose range of 8-48 mg indicating that the pharmacokinetics of betahistine are linear, and suggesting that the involved metabolic pathway is not saturated. Under fed conditions Cmax is lower compared to fasted conditions. However, total absorption of betahistine is similar under both conditions, indicating that food intake only slows down the absorption of betahistine.
Incompatibilities
Not applicable.
Shelf life and storage conditions
- Store in the original package in order to protect from light.
- Do not use the medicine after the expiry date stated on carton.
- Keep this medicine out of the reach and sight of children.
For Arabic Information: بيتاسيرك: الإستعمالات، الجرعة، التوصيات، الآثار السلبية
Related Media files
- Betaserc_PIL – Information leaflet.
- Hestotec_PIL – Information leaflet.
- بيتاسيرك – نشرة معلومات المريض
- ميكروسيرك- نشرة معلومات المريض
- فيرسيرك – نشرة معلومات المريض
Our goal is to provide you with the most relevant and up-to-date information. However, because pharmaceutical products affect each person differently, we cannot guarantee that this article includes all the information you should know, and you should always consult your doctor, pharmacist or health provider. Copyright: “All rights reserved (c) pharmacia1 .com” – Contact us via the contact form, or simply write a comment at the bottom of the page.atc code: N07CA01 ، Antivertigo preparations ، betahistine .