SERC 8 mg TABLETS
How to use SERC 8 mg TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Serc 8 mg Tablets
Betahistine Dihydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the Package Leaflet
- What is Serc and what is it used for
- What you need to know before you take Serc
- How to take Serc
- Possible side effects
- Storage of Serc
- Contents of the pack and other information
1. What is Serc and what is it used for
Serc belongs to a group of medicines called antivertigo medicines, and its active ingredient is betahistine dihydrochloride.
Serc is used for the treatment of Meniere's Syndrome, which is a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and a sensation of noise in the ear (tinnitus).
The active ingredient of this medicine is a histamine analogue that acts by improving circulation in the inner ear and thus reducing pressure. The inner ear is one of the organs responsible for the sense of balance.
2. What you need to know before taking Serc
Do not take Serc
- If you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).
- If your doctor has told you that you have a certain type of adrenal gland cancer called pheochromocytoma.
Warnings and precautions
Consult 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.
Using Serc with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Taking Serc at the same time as antiallergic medicines such as antihistamines (especially H1 antagonists) may reduce the effectiveness of both medicines.
Taking Serc at the same time as monoamine oxidase inhibitors (MAOIs) (used to treat Parkinson's disease) may increase the effect of Serc.
Using Serc with food, drinks, and alcohol
It is recommended to take Serc during or after meals to avoid stomach upset.
Children and Adolescents
Serc is not recommended for use in children and adolescents under 18 years of age due to the lack of experience in these age groups.
Pregnancy, Breastfeeding, and Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known if this medicine affects the fetus, so Serc should not be taken during pregnancy, unless your doctor considers it necessary.
It is not known if this medicine passes into breast milk, so if you are taking Serc, you should not breastfeed your child.
Driving and Using Machines
Betahistine is indicated for Meniere's syndrome. This disease may negatively affect the ability to drive and use machines. In clinical trials specifically designed to investigate the ability to drive or use machines, betahistine had no effects or they were insignificant.
3. How to Take Serc
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.
Your doctor will adjust the dose based on your response to treatment, from an initial dose of 1 tablet of 8 mg three times a day up to 2 tablets of 8 mg three times a day (maximum dose). The maintenance dose will be adjusted based on your response, being the minimum effective dose, 1 tablet of 8 mg three times a day.
The tablets should be taken with water.
In some cases, the improvement may not begin to become apparent until two weeks after the start of treatment. The optimal result is obtained after several months of treatment.
The tablets can be taken with or without food. However, if you take them in the absence of food, they may cause mild stomach problems (listed in section 4). Taking the tablets with food may help reduce stomach problems.
Use in Children and Adolescents
Serc is not recommended for use in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.
If You Take More Serc Than You Should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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. You may also experience rapid heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), fluid accumulation in the tissues (edema). Convulsions may occur after taking very high doses.
Symptomatic treatment is recommended since there is no specific antidote.
If You Forget to Take Serc
Do not take a double dose to make up for forgotten doses. If you forget to take a dose, wait until the next dose and continue with the normal treatment.
If You Stop Taking Serc
You should take Serc for as long as your doctor recommends. Do not stop treatment before, as the expected results will not be achieved.
If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible Side Effects
Like all medicines, Serc can cause side effects, although not everybody gets them.
The classification by frequency is as follows:
Very common: may affect more than 1 in 10 patients |
Common: may affect up to 1 in 10 patients |
Uncommon: may affect up to 1 in 100 patients |
Rare: may affect up to 1 in 1,000 patients |
Very rare: may affect up to 1 in 10,000 patients |
Frequency not known: frequency cannot be estimated from the available data In clinical trials, the following side effects were found: |
Gastrointestinal disorders
Common: nausea and dyspepsia (discomfort in the upper abdomen with a feeling of bloating).
Nervous system disorders
Common: headache.
After marketing and in the scientific literature, the following side effects have been reported with a frequency not known:
Immune system disorders
Hypersensitivity reactions, for example, anaphylaxis.
Gastrointestinal disorders
Mild stomach problems (e.g., vomiting, gastrointestinal pain, abdominal distension, and bloating). These effects can usually be treated by taking the medicine during meals or reducing the dose.
Skin and subcutaneous tissue disorders
Hypersensitivity reactions of the skin and subcutaneous tissue, in particular, angioneurotic edema (swelling of the skin and mucous membranes, especially of the face, mouth, tongue, and hands), urticaria, skin eruption, and itching (pruritus).
Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Serc
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Keep in the original package.
Do not use Serc after the expiry date which is stated on the packaging and on the blister after EXP. The expiry date is the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the Pack and Other Information
Composition of Serc 8 mg Tablets:
- The active ingredient is betahistine dihydrochloride. Each tablet contains 8 mg of betahistine as dihydrochloride.
- The other ingredients are microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica, and talc.
Appearance of the Product and Contents of the Pack
Serc 8 mg is presented in the form of white, round tablets. Each pack contains 60 tablets.
Other presentations:
Serc 16 mg is presented in the form of white, round, scored tablets. Each pack contains 30 tablets.
Serc 8 mg/ml oral solution is presented in the form of an oral solution in a 60 ml brown glass bottle with a dosing syringe. The syringe has markings for 1, 2, and 3 ml and a maximum capacity of approximately 3.5 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970- Sant Joan Despí
Barcelona- Spain
Manufacturer
Mylan Laboratories SAS
Route de Belleville Lieu dit Maillard
01400 Châtillon sur Chalaronne (France)
This leaflet was last revised inAugust 2015
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Average pharmacy price2.73 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to SERC 8 mg TABLETSDosage form: TABLET, 24 mgActive substance: betahistineManufacturer: Accord Healthcare S.L.U.Prescription requiredDosage form: TABLET, 16 mgActive substance: betahistineManufacturer: Aurovitas Spain, S.A.U.Prescription requiredDosage form: TABLET, 8 mgActive substance: betahistineManufacturer: Aurovitas Spain, S.A.U.Prescription required
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