Package leaflet: Information for the patient

FORTAMID 16 mg tablets

Betahistine dihydrochloride
Please read all of 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 could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Fortamid is and what it is used for
What you need to know before taking Fortamid
How to take Fortamid
Possible side effects
How to store Fortamid
Contents of the pack and other information

1. What FORTAMID is and what it is used for

Fortamid contains the active substance betahistine, which belongs to a group of medicines called
histamine analogues. It is used to treat the symptoms of Ménière's syndrome, such as:

dizziness (vertigo)
ringing in the ears (tinnitus)
hearing loss.

This medicine works by improving blood flow in the inner ear. This reduces the increase in pressure.

2. What you need to know before taking FORTAMID

Do not take Fortamid

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you have high blood pressure caused by an adrenal gland tumour (pheochromocytoma)
if you have a stomach ulcer (peptic or gastric).

Warnings and precautions
Talk to your doctor before taking Fortamid if:

you have asthma
you have previously had a stomach ulcer

Children and adolescents
Fortamid is not recommended in children and adolescents under 18 years of age due to
lack of data on safety and efficacy.
Other medicines and Fortamid
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

antihistamines, which could theoretically reduce the effect of Fortamid;
monoamine oxidase inhibitors (used to treat depression), which could affect Fortamid levels.

Fortamid with food and drinks
Take the tablets with or after meals. Fortamid may cause mild stomach disturbances (listed
in section 4). Taking Fortamid with meals may help reduce such disturbances.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Do not take Fortamid during pregnancy unless your doctor has decided it is necessary.
It is not known whether Fortamid passes into breast milk. Do not take Fortamid while breastfeeding unless
your doctor tells you to do so.
Driving and using machines
Clinical studies show that Fortamid does not appear to affect the ability to drive vehicles or
operate machinery. However, please bear in mind that the medical condition for which you are being treated with Fortamid
may cause dizziness or discomfort.

3. How to take FORTAMID

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
2-3 tablets per day.
Use in children and adolescents
Fortamid must not be used in children and adolescents under 18 years of age.
If you take more Fortamid than you should
Contact your doctor as soon as possible or go to the nearest hospital. Symptoms of overdose
include nausea, drowsiness, abdominal pain, seizures, pulmonary or cardiac complications.
If you forget to take Fortamid
Wait until it is time for your next dose. Do not take a double dose to make up for
the forgotten tablet or dose.
If you stop taking Fortamid
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects have been observed:
Common (may affect up to 1 in 10 people): headache, nausea (feeling unwell),
difficulty digesting (dyspepsia)
Frequency not known (frequency cannot be estimated from the available data)

Dizziness
Abnormal sense of touch (dysesthesia)
Tremor
Shortness of breath (dyspnea)
Bleeding in the stomach (gastrointestinal hemorrhage)
Stomach discomfort, stomach bloating, abdominal distension
Vomiting (feeling unwell)
Increased liver enzymes (detected by blood tests)
Skin rash (urticaria), itching or swelling (particularly of the eyelids, lips, tongue and throat)
Swelling (edema)
Hypersensitivity reaction (allergy) Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via the national reporting system: www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FORTAMID

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fortamid contains

The active substance is betahistine dihydrochloride.
The other components are: microcrystalline cellulose, mannitol, precipitated silica, talc, anhydrous citric acid.

Description of the appearance of Fortamid and contents of the pack
Fortamid 16 mg tablets are packaged in blisters containing 20 or 30 tablets.
Marketing Authorization Holder and Manufacturer
FARMACEUTICI FORMENTI S.p.A.
Via Vittor Pisani 16 – 20124 Milan
Italy
Manufacturer
FARMACEUTICI FORMENTI S.p.A.
Production site: Origgio (VA)
Via Di Vittorio 2
Italy