Polvertic

Package Leaflet: Information for the Patient

Polvertic, 24 mg, Tablets

Betahistini dihydrochloridum

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Polvertic and What is it Used For
• 2. Important Information Before Taking Polvertic
• 3. How to Take Polvertic
• 4. Possible Side Effects
• 5. How to Store Polvertic
• 6. Package Contents and Other Information

1. What is Polvertic and What is it Used For

Polvertic contains betahistine, which improves blood flow in the inner ear.
Polvertic is used for:

• treatment of Meniere's disease, characterized by the following symptoms:
• dizziness (with nausea, vomiting)
• progressive hearing loss
• tinnitus
• symptomatic treatment of dizziness of vestibular origin.

2. Important Information Before Taking Polvertic

When Not to Take Polvertic

• if the patient is allergic to betahistine or any other component of the medication (listed in section 6);
• if the patient has a pheochromocytoma (a rare tumor of the adrenal gland).

Warnings and Precautions

Particular caution should be exercised when taking Polvertic:

• if the patient has a stomach ulcer (peptic ulcer) or has had a stomach ulcer in the past;
• if the patient has asthma;
• if the patient has hives, other skin rashes, or rhinitis associated with allergies, as betahistine may exacerbate these conditions;
• if the patient has low blood pressure.

If the patient has any of the above conditions, they should consult their doctor before taking betahistine.
Patient with the above conditions should remain under medical supervision during treatment.

Polvertic and Other Medications

Interactions mean that medications or other substances may change each other's effects
or increase the risk of side effects when taken at the same time.
So far, no interactions between betahistine and other medications have been observed.
Betahistine may affect the action of antihistamines. Antihistamines are mainly used to treat allergies, e.g., hay fever and motion sickness. When taking antihistamines, consult a doctor or pharmacist before taking betahistine.
Inform the doctor or pharmacist about all medications currently or recently taken, as well as any planned medications.

Pregnancy and Breastfeeding

It is not known whether betahistine is safe during pregnancy.
Betahistine should be avoided during breastfeeding, as it passes into breast milk.
If the patient is pregnant, breastfeeding, or planning to become pregnant, they should consult their doctor before taking this medication.

Driving and Operating Machinery

Betahistine has no effect or negligible effect on the ability to drive and operate machinery.

Polvertic Contains Lactose

One tablet contains 210 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

3. How to Take Polvertic

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The recommended dose is usually:
Adults
Half or one tablet twice a day.
It may take several weeks to notice an improvement.
Use in Children and Adolescents
The medication is not recommended for children and adolescents under 18 years of age.
Use in Elderly Patients
No dose adjustment is necessary in elderly patients.
Use in Patients with Renal and/or Hepatic Impairment
No dose adjustment is necessary in patients with renal and/or hepatic impairment.

How to Take Polvertic

Tablets are best taken during meals.

Overdose of Polvertic

In case of overdose, consult a doctor.
Symptoms of betahistine overdose include: nausea, vomiting, digestive disorders, coordination disorders, and - in case of higher doses - seizures.

Missed Dose of Polvertic

Wait until the next scheduled dose. Do not take a double dose to make up for the missed dose.
In case of further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Polvertic can cause side effects, although not everybody gets them.
During betahistine treatment, the following seriousside effects may occur:

• Allergic reactions, such as:
• swelling of the face, lips, tongue, or throat, which may cause breathing difficulties;
• red rash on the skin, skin inflammation with itching. If an allergic reaction (hypersensitivity) occurs after taking this medication, stop taking it and consult a doctor.

Common side effects(occurring in less than 1 in 10 patients):

• Nausea and digestive disorders.

Other Side Effects:

• Headaches, itching, rash, hives;
• Mild gastrointestinal disorders such as: vomiting, stomach pain and intestinal pain, bloating, gas. These side effects may disappear if the medication is taken during meals or after reducing the dose.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Polvertic

Store below 25°C in the original packaging.
The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister pack after: EXP. The expiry date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Polvertic Contains

• The active substance is betahistine dihydrochloride. One tablet contains 24 mg of betahistine dihydrochloride.
• Other ingredients are: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone (type A), and stearic acid.

What Polvertic Looks Like and Contents of the Package

White or almost white, round, biconvex tablet with a score line on one side. The tablet can be divided into equal doses.
A carton containing 20, 30, 40, 50, 60, 100, or 120 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1 und 2
Baden-Wuerttemberg
73614 Schorndorf
Germany
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Date of Last Update of the Leaflet:July 2021