Betahistine Doc Generici
ItalyTable of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAISTINA DOC Generici 8 mg tablets, 16 mg tablets
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people,
even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in
this leaflet, contact your doctor or pharmacist. See section 4.,
Contents of this leaflet :
- What BETAISTINA DOC Generici is and what it is used for
- What you need to know before taking BETAISTINA DOC Generici
- How to take BETAISTINA DOC Generici
- Possible side effects
- How to store BETAISTINA DOC Generici
- Package contents and other information
1. WHAT BETAISTINA DOC Generici IS AND WHAT IT IS USED FOR
BETAISTINA DOC Generici contains betahistine. This medicine is an analogue of histamine.
It is used to treat the following symptoms associated with Ménière's syndrome:
- dizziness (vertigo)
- ringing in the ears (tinnitus)
- hearing loss
This medicine works by increasing blood flow in the inner ear. This reduces the increase in pressure.
2. WHAT YOU SHOULD KNOW BEFORE TAKING BETAISTINA DOC GENERICS
Generics
Do not take BETAISTINA DOC Generics
- If you are allergic to betahistine or to any of the other ingredients of this medicine (listed in section 6)
- If you have high blood pressure caused by a tumour of the adrenal gland
If any of these conditions applies to you, do not take this medicine and consult your
doctor.
Warnings and precautions
Talk to your doctor before taking BETAISTINA DOC Generics
- If you have a stomach ulcer
- If you have asthma
- If you are pregnant or planning to become pregnant
- If you are breastfeeding
If any of these conditions applies to you, talk to your doctor before taking this
medicine.
Your doctor will tell you whether taking this medicine is safe for you.
Your doctor may also wish to monitor your asthma while you are taking this medicine.
Children and adolescents
The use of this medicine in children and adolescents under 18 years of age
is not recommended.
Other medicines and BETAISTINA DOC Generics
No interactions between BETAISTINA DOC Generics and other medicines are known. If you notice
an undesirable effect, consult your doctor or pharmacist.
Inform your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines:
- Antihistamines (used especially for treating allergies such as hay fever and motion sickness): this may (theoretically) reduce the effect of BETAISTINA DOC Generics. In addition, BETAISTINA DOC Generics may reduce the effect of antihistamines.
- Monoamine oxidase inhibitors - MAOIs (used to treat depression or Parkinson's disease): this may increase exposure to BETAISTINA DOC Generics.
BETAISTINA DOC Generics with food, drinks and alcohol
You may drink alcohol while taking BETAISTINA DOC Generics.
You may take BETAISTINA DOC Generics with or without food.
Pregnancy and breastfeeding
Do not take BETAISTINA DOC Generics if you are pregnant unless your doctor decides
it is absolutely necessary.
Ask your doctor for advice.
Do not breastfeed while taking BETAISTINA DOC Generics unless instructed otherwise by your
doctor. It is not known whether BETAISTINA DOC Generics passes into breast milk.
Driving and using machines
You may drive and use machinery while undergoing this treatment, provided
this medicine does not make you drowsy.
Make sure you know how this medicine affects you before driving or using
machinery.
BETAISTINA DOC Generics contains lactose.
If your doctor has informed you of an intolerance to certain sugars, contact him/her before
taking this medicine.
3. HOW TO TAKE BETAISTINA DOC Generici
Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
- Swallow the tablets with water
- Take the tablet with or without food
How much BETAISTINA DOC Generici to take
BETAISTINA DOC Generici is available in two strengths: 8 mg tablets and
16 mg tablets.
The recommended dose is:
8 mg tablets: one to two tablets three times a day
16 mg tablets: half to one tablet three times a day
The usual maintenance dose ranges between 24 and 48 mg per day.
Continue taking the tablets. The tablets may take some time before they start working.
Always follow your doctor’s instructions, as your doctor may adjust the dose.
Use in children
BETAISTINA DOC Generici is not recommended for use in children.
If you take more BETAISTINA DOC Generici than you should
If you or someone else takes more BETAISTINA DOC Generici than prescribed
(an overdose), speak to a doctor immediately or go to the nearest hospital.
Take the medicine pack with you.
If you forget to take BETAISTINA DOC Generici
If you forget to take a tablet, wait until the next scheduled dose.
Do not try to make up for the missed dose.
If you stop taking BETAISTINA DOC Generici
Continue taking the tablets until your doctor tells you to stop.
Even if you start to feel better, your doctor may want you to continue taking the
tablets for some time to ensure the medicine has worked fully.
If you have any questions about the use of this medicine, consult your doctor or
pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, this medicine can cause adverse reactions, although not
all people experience them.
The following serious adverse reactions may occur during treatment with
BETAISTINA DOC Generici:
Allergic reactions such as:
- swelling of the face, lips, tongue, or neck. This may cause difficulty in breathing
- red skin rash, inflamed skin with itching
If any of these adverse reactions occur, stop treatment immediately and contact your doctor.
Common adverse reactions (may affect from 1 to 10 patients in 100):
Nausea, indigestion, and headache
Other adverse reactions
Somnolence, itching, rash, urticaria, mild gastrointestinal disturbances such as vomiting, stomach ache, and abdominal bloating. Taking BETAISTINA DOC Generici with food may reduce stomach-related problems.
If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can also be reported directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse reactions helps provide more information on the safety of this medicine.
.
5. HOW TO STORE BETAISTINA DOC Generici
Keep this medicine out of the sight and reach of children.
This medicine should preferably be kept locked in a cupboard or
in the medicine cabinet.
Do not use this medicine after the expiry date stated on the packaging after the word “Exp”. The expiry date refers to the last day of that month.
Store in a dry place and in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer used. This will help protect
the environment.
6. PACKAGING CONTENTS AND OTHER INFORMATION
What BETAISTINA DOC Generici contains
The active substance is betahistine dihydrochloride.
One tablet of BETAISTINA DOC Generici 8 mg contains 8 mg of betahistine
dihydrochloride.
One tablet of BETAISTINA DOC Generici 16 mg contains 16 mg of betahistine
dihydrochloride.
The other components are povidone, microcrystalline cellulose, monohydrate lactose,
anhydrous colloidal silica, crospovidone and stearic acid.
Description of the appearance of BETAISTINA DOC Generici and packaging
BETAISTINA DOC Generici 8 mg tablets: round, white tablet, engraved with “B8” on one side.
The tablets are packed in blisters: 30, 50, 100 or 120 tablets in a cardboard box.
BETAISTINA DOC Generici 16 mg tablets: round, white tablet, engraved with “B16” on one side and a break line on the other. The tablet can be divided into two equal parts.
The tablets are packed in blisters: 20, 30, 42, 50, 60 or 84 tablets in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano, Italy
Manufacturer responsible for batch release
Losan Pharma GmbH
Otto Hahnstrasse 13,
D-79395 Neuenburg,
Germany
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 2,
D-73614 Schorndorf,
Germany
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