Brand name Serc 24 mg tablets

Form tablets

Active substance / Dosage

BETAHISTINE DIHYDROCHLORIDE · 24.0 mg

Prescription type Prescription Only Medicine

ATC code

N07C N07CA N07CA01

Registration number 78431

Manufacturer Neuraxpharm Spain S.L.U.

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Serc 24 mg is and what it is used for
2. What you need to know before taking Serc 24 mg
3. How to take Serc 24 mg
4. Possible adverse effects
5. Storage of Serc 24 mg
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Serc 24 mg tablets

Betahistine (betahistine dihydrochloride)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What Serc 24 mg is and what it is used for
What you need to know before taking Serc 24 mg
How to take Serc 24 mg
Possible side effects
How to store Serc 24 mg
Contents of the pack and other information

1. What Serc 24 mg is and what it is used for

Serc 24 mg tablets belong to a group of medicines called antivertiginous agents: preparations for vertigo. The active substance is betahistine dihydrochloride.

Serc 24 mg tablets are used to treat Menière's syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and sensation of noise in the ear (tinnitus).

The active substance of this medicine is an analogue of histamine that acts by improving circulation in the inner ear and thereby reduces pressure. The inner ear is one of the organs responsible for the sense of balance.

2. What you need to know before taking Serc 24 mg

Do not take Serc 24 mg:

if you are allergic to the active substance betahistine or to any of the other ingredients of this medicine (listed in section 6)
if you have a tumor of the adrenal glands called phaeochromocytoma.

Warnings and precautions

Talk to your doctor or pharmacist before taking betahistine:

if you have bronchial asthma,
if you have or have had stomach ulcers,
if you suffer from skin rashes and intense itching (urticaria), skin eruptions (exanthema), or hay fever.

Patients should be carefully monitored by their doctor during treatment with this medicine.

Children and adolescents

Serc 24 mg is not recommended for use in children and adolescents under 18 years of age due to lack of experience in these age groups.

Taking Serc 24 mg with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Concomitant administration of this medicine with antiallergic drugs such as antihistamines (especially H1 antagonists) may reduce the effectiveness of both medicines.

Caution is recommended when using betahistine together with MAO inhibitors (including selective MAO-B inhibitors such as selegiline), as this may lead to inhibition of betahistine metabolism.

Concomitant administration of this medicine with monoamine oxidase inhibitors (MAOIs), used in the treatment of Parkinson's disease, may increase the effect of betahistine.

Taking Serc 24 mg with food and drink:

It is recommended to take Serc 24 mg during or after meals to avoid gastric discomfort.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is unknown whether this medicine affects the fetus; therefore, Serc 24 mg should not be taken during pregnancy unless considered necessary by your doctor.

It is unknown whether this medicine passes into breast milk; therefore, if you are taking Serc 24 mg, you should not breast-feed.

There are no data available on the effect of this medicine on fertility.

Driving and using machines

Serc 24 mg is indicated for Menière's syndrome. This condition may negatively affect your ability to drive or operate machinery. In clinical trials specifically designed to investigate the ability to drive or use machines, betahistine had no effect or only negligible effects.

Serc 24 mg contains lactose:

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

3. How to take Serc 24 mg

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The dose varies depending on the individual and their response to treatment.

The recommended initial dose is 24 mg once daily.

Maximum daily dose: the patient may increase the dose to 24 mg taken twice daily (48 mg divided into two doses).

Maintenance dose: this will be established according to the response to treatment, up to the lowest effective dose.

It is best to take the tablets with food.

Depending on your response, your doctor will determine the maintenance dose for you.

The effect of the medicine usually does not become apparent until after about two weeks.

You should take Serc 24 mg for as long as your doctor recommends; do not stop treatment prematurely, as the expected results will not be achieved.

Use in children and adolescents

This medicine must not be used in children and adolescents, as its safety and efficacy have not been established.

If you take more Serc 24 mg than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

You may experience the following symptoms due to an overdose: nausea, drowsiness, abdominal pain.

Also possible are increased heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), and fluid accumulation in tissues (edema). Seizures may occur after very high doses. Symptomatic treatment is recommended, as there is no specific antidote.

If you forget to take Serc 24 mg:

Do not take a double dose to make up for forgotten doses.

If you forget to take a dose, wait until your next scheduled dose and continue your treatment as normal.

If you stop taking Serc 24 mg:

You should take Serc 24 mg for as long as your doctor recommends. Do not stop treatment prematurely, as the expected results will not be achieved.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

The following serious adverse effects may occur during treatment with betahistine:

Allergic reactions such as: Swelling of the face, lips, tongue or neck. This may cause breathing difficulties.

Red skin rash, skin inflammation and itching.

If you experience any of these adverse effects, you must stop treatment immediately and contact your doctor.

Frequent adverse effects (may affect up to 1 in 10 people)

Headache, occasional drowsiness, nausea, indigestion, mild stomach problems such as vomiting, stomach pain and bloating.

Taking betahistine with food may help reduce these stomach problems.

Frequency not known (frequency cannot be estimated from the available data)

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Serc 24 mg

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

Store below 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Serc 24 mg tablets

The active substance is betahistine in the form of betahistine dihydrochloride.
The other components are: povidone K90 (E-1201), microcrystalline cellulose (E-460i), lactose monohydrate, colloidal anhydrous silica, crospovidone, and stearic acid (E-570).

Appearance of the medicine and contents of the pack

Serc 24 mg tablets are presented as biconvex tablets (Snap-Tab), with a score line on one side and white in colour.

The tablets can be divided into equal doses.

Packs of 30 or 60 tablets in PVC/PVDC/aluminium blisters.