Histotec Film coated tablets

Histotec is used to prevent and treat a disorder of the inner ear known as Meniere’s disease. The symptoms include dizziness (vertigo), ringing in the ears (tinnitus), and loss of hearing, probably caused by fluid in the ear. This medicine helps relieve the symptoms by reducing the amount of fluid. Histotec Tablet should be swallowed whole with water and taken at the same time(s) each day to get the most benefit. Your doctor will decide what is the correct dose to relieve your symptoms and how often you need to take it. You may need to take this medicine for several months and you should take it for as long as prescribed by your doctor, even if you start feeling better.

The most common side effects include headache, feeling sick, and indigestion (dyspepsia). You may also get stomach pain and bloating. Taking the medicine with food can help reduce stomach problems. Before taking this medicine, you should talk to your doctor if you have a stomach ulcer, asthma, or high or low blood pressure. You must also tell him/her what other medicines you are taking, to make sure you are safe. Also speak to your doctor if you are pregnant, trying to become pregnant, or breastfeeding.

Composition

Histotec Film coated tablets
Histotec Film coated tablets

Each Film coated tablets contains: Betahistine dihydrochloride 8, 16 mg.

Inactive ingredients: Lactose, avicel, plasidone XL, stearic acid, aerosil 200, polyvinyl pyrolidone (K90).

Therapeutic indications

Vertigo, tinnitus and hearing loss associated with Meniere’s syndrome.

Posology and Method of administration

  • Adults (including the elderly): Initially 16 mg three times daily taken preferably with meals.
  • Maintenance doses are generally in the range 24 – 48 mg daily.
  • Children: No dosage recommendations.

Contraindications

  • Phaeochromocytoma.
  • Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

  • Caution is advised in the treatment of patients with a history of peptic ulcer.
  • Clinical intolerance to Histotec in bronchial asthma patients has been shown in a relatively few patients. These patients need to be carefully monitored during the therapy.

Interaction with other medicinal products

No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected. Although an antagonism between Histotec and antihistamines could be expected on a theoretical basis, no such interactions have been reported.

Pregnancy and lactation

Pregnancy: There are no adequate data from the use of betahistine in pregnant women. Betahistine should not be used during pregnancy unless clearly necessary.

Lactation: It is not known whether betahistine is excreted in human milk. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.

Effects on ability to drive and to use machines

Betahistine is regarded to have no or negligible effects on the ability to drive and to use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.

Undesirable effects

Gastrointestinal disorders: Common: nausea and dyspepsia.

The following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.

  • Immune System disorders: Hypersensitivity reactions (e.g. anaphylaxis) have been reponed.
  • Gastrointestinal disorders: Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.
  • Nervous System disorders: Headache.
  • Skin and subcutaneous tissue disorders: Cutaneous and subcutaneous hypersensitivity reactions have been reported. in particular angioneurotic oedema, urticaria, rash. and pruritus.

Overdose

A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain).

More serious complications (e.g. convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs.

Treatment of overdose should include standard supportive measures.

Pharmacological properties

Pharmacodynamic properties

The active ingredient is a specific histamine agonist with virtually no H2-activity. It appears to act on the precapillary sphincter in the stria vascularis of the inner ear, thus reducing the pressure in the endolymphatic space.

Pharmacokinetic properties

Betahistine is rapidly and completely absorbed after oral administration of the drug in tablets. It is excreted almost quantitatively in urine as 2-pyridylacetic acid within 24 hours after administration. No unchanged betahistine has been detected.

Package and storage

Storage: Store in a dry place at a temperature not exceeding 30 °C. Store in the original package.

Package:

  • Histotec 8 mg Film coated tablets: Carton box containing 3 Blisters (AL/PVC) of 10 Film coated tablets each and insert leaflet.
  • Histotec 16 mg Scored film coated tablets: Carton box containing 2 Blisters (AL/PVC) of 10 scored film coated tablets each and insert leaflet.

Marketing Authorization Holder and Manufacturer : EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO. (E. I. P. I. CO. )-10th OF RAMADAN CITY, AREA B1 P.O.BOX 149 TENTH, EGYPT.

N07CA01 betahistine E. I. P. I. CO. EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.

Histotec – Information Leaflet

AR- Patient_Information_Leaflet
Histotec – AR- Patient_Information_Leaflet
ENG-Patient-Information-Leaflet
Histotec – ENG-Patient-Information-Leaflet
Council of Arab Health Ministers and Union of Arab pharmacists
Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sells the medicament.
The doctor and the pharmacist are experts in medicine, its benefits and risks.
Do not by yourself intenupt the period of treatment prescribed for you.
Do not repeat the same prescription without consulting your doctor.
Keep medicament out of children reach.

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