Package Insert: Information for the Patient

Betahistina Stada 24 mg Tablets EFG

Betahistina dihidrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Betahistina Stada contains dihydrochloride of betahistina. This medication belongs to a group of medications called antivertiginous: preparations against vertigoandis a type of medication called histamine analogue.

It is used for the treatment of Ménière's Syndrome, the symptoms of which include:

• Dizziness with nausea and vomiting (vertigo)
• sensation of noise inside the ear (tinnitus)
• hearing loss

This medication acts by improving circulation in the inner ear and therefore reduces pressure.The inner ear is one of the organs responsible for the sense of balance.

Do not take Betahistina Stada

• if you are allergic to betahistina or any of the other components of this medication (listed in section 6).

• if you have a cancer of the adrenal glands called phaeochromocytoma.

Do not take this medication if you suffer from any of the symptoms mentioned above and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take betahistina:

• if you have or have had stomach ulcers,
• if you have bronchial asthma,

• if you suffer from skin rashes and intense itching (urticaria), skin eruption (exanthema) or nasal secretion caused by an allergy (hay fever), as these symptoms may worsen.

• if you have low blood pressure

Your doctor will tell you if it is safe to start taking this medication. Your doctor may also want to control your asthma while taking this medication.

Children and adolescents

This medication is not recommended for use in children and adolescents under 18 years old. There is no experience about the safety and efficacy in these patients.

Other medications and Betahistina Stada

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take other medications, even those acquired without a prescription.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• antihistamines (especially H1 antagonists), betahistina may reduce the effect of antihistamines.
• MAO inhibitors (including MAO-B selective, such as selegiline), may cause inhibition of betahistina metabolism.
• monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. These may increase the amount of betahistina in your body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take betahistina if you are pregnant unless your doctor considers it absolutely necessary. Consult your doctor.

You should not breastfeed your child while using this medication unless your doctor tells you to. It is unknown if betahistina passes into breast milk.

Driving and operating machines

This medicationis indicated for Meniere's syndrome. This disease may negatively affectyour ability to drive and use machines. In clinical trials specifically designed to investigate the ability to drive or use machines, betahistina had no effects or were insignificant.

Betahistina Stada contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is:

Adults

• The recommended starting dose is 24 mg once a day.
• Maximum daily dose: The patient may increase the dose to 24 mg taken twice a day (48 mg divided into two doses). Maintenance dose: It will be established according to the response to treatment until the minimum effective dose is reached.

Always follow your doctor's instructions, as they can adjust your dose.

It is best to take the tablets with food.

Your doctor will indicate the maintenance dose based on your response.

The effect of the medication usually does not manifest until after about two weeks.

Use in children and adolescents

Betahistina is not recommended for use in children and adolescents, as its safety and efficacy have not been established.

If you take more Betahistina Stadathan you should

If you or others take too many betahistina tablets (overdose), you may experience nausea, drowsiness, or abdominal pain. You may also experience rapid heartbeat (tachycardia), low blood pressure (hypotension), difficulty breathing with a sensation of choking (bronchospasm), fluid accumulation in tissues (edema). Seizures may occur after taking very high doses. It is recommended that you receive symptomatic treatment, as there is no specific antidote. Talk to your doctor or go to the hospital immediately. Bring the betahistina packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Betahistina Stada

Wait until the next dose.Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Betahistina Stada

Continue taking the tablets until your doctor tells you to stop.

Even when you start feeling better, your doctor may instruct you to continue taking the tablets for a while to ensure that the medication has had its full effect.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following severe adverse effects may occur during treatment with betahistina:

Allergic reactions such as:

• Redness or swelling on the skin, skin rash, or itching on inflamed skin
• Swelling of the face, lips, tongue, or neck
• Difficulty breathing

If any of these adverse effects occur, you should immediately discontinue treatment and contact your doctor.

Other adverse effects include:

Frequent (may affect up to 1 in 10 people):

• Uncomfortable feeling (nausea)
• Indigestion (dyspepsia)
• Headache
• Occasional drowsiness
• Mild gastrointestinal discomfort such as nausea, gastrointestinal pain, bloating, and abdominal distension.

Taking betahistina with meals may help reduce stomach problems.

Unknown frequency (frequency cannot be estimated from available data)

Itching, rash, urticaria, abnormal heartbeats (palpitations).

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through thedrains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Betahistina CompositionStada 24 mg tablets:

• The active ingredient is dihydrochloride of betahistina. Each tablet contains 24 mg of dihydrochloride of betahistina.
• The other components are lactose monohydrate, microcrystalline cellulose, povidone, anhydrous colloidal silica, crospovidone, talc, and stearic acid.

Product appearance and packaging contents

White, round tablets with a groove on one face and a “K” engraved on the other face.

The groove is only for breaking the tablet if it is difficult to swallow whole.

Betahistina 24 mg is presented in PVC/PVDC/aluminum blisters in packaging of 30 and 60 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 – Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Kern Pharma, S.L.

Colón II Industrial Estate

C/Venus 72

08228 Terrassa (Barcelona)

Spain

This leaflet was approved in:November 2021

The detailed information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/