Package leaflet: Information for the patient

Polvertic, 8 mg, tablets
Polvertic, 16 mg, tablets
Betahistini dihydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Polvertic is and what it is used for
Important information before taking Polvertic
How to take Polvertic
Possible side effects
How to store Polvertic
Contents of the pack and other information

1. What Polvertic is and what it is used for

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

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

2. Important information before using Polvertic

When not to use Polvertic

if the patient is allergic to betahistine or any of the other ingredients of this medicine (listed in section 6);
if the patient has a chromaffin tumour of the adrenal gland (pheochromocytoma) – a rare tumour of the adrenal glands.

Warnings and precautions
Exercise particular caution when using Polvertic:

if the patient has gastric ulcer (peptic ulcer) or has previously had a gastric ulcer;
if the patient has asthma;
if the patient has urticaria, other types of skin rash or allergic rhinitis, as betahistine may worsen these conditions;
if the patient has low blood pressure.

If the patient has any of the above conditions, they should consult a doctor before using betahistine.
Patients with the above conditions should remain under medical supervision during treatment.

Polvertic with other medicines
An interaction means that medicines or other substances may alter each other's effects or increase the risk of adverse reactions when used simultaneously.
To date, no interactions between betahistine and other medicines have been observed.
Betahistine may affect the action of antihistamines. Antihistamines are mainly used in the treatment of allergies, e.g. hay fever and motion sickness. If antihistamines are being used, consult a doctor or pharmacist before taking betahistine.

Pregnancy and breastfeeding
It is not known whether the use of betahistine during pregnancy is safe.
Avoid using the medicine during breastfeeding, as betahistine passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Driving and operating machinery
Betahistine has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

Polvertic contains lactose
Polvertic 8 mg: One tablet contains 70 mg of monohydrate lactose.
Polvertic 16 mg: One tablet contains 140 mg of monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

3. How to use Polvertic

This medicine should always be used exactly as recommended by your doctor. If in doubt,
consult your doctor or pharmacist.
Recommended dosage:
Adults
Initial dose is 1–2 tablets of 8 mg or 0.5–1 tablet of 16 mg three times daily. The maintenance
dose is 24 mg–48 mg per day.
It may take several weeks before improvement is observed.
Use in children and adolescents
Polvertic is not recommended for use in 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 should preferably be taken with meals.
Taking more Polvertic than recommended
If you take more than the recommended dose, consult your doctor immediately.
Symptoms of betahistine overdose include: nausea, vomiting, gastrointestinal disturbances,
coordination disorders, and—after higher doses—seizures.
If you forget to take Polvertic
Wait until it is time to take the next dose. Do not take a double dose to make up for the
missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
During treatment with betahistine, the following serious adverse reactions may occur:

Allergic reactions, such as:
- swelling of the face, lips, tongue or throat, which may cause difficulty in breathing;
- red skin rash, skin inflammation with itching. If an allergic (hypersensitivity) reaction has occurred after taking this medicine, stop taking it immediately and consult a doctor.

Common adverse reactions (occur in less than 1 in 10 patients):

Nausea and digestive disturbances.

Other adverse reactions:

Headache, itching, rash, urticaria;
Mild gastrointestinal discomfort such as: vomiting, stomach and intestinal pain, bloating, gas. These adverse reactions may resolve if the medicine is taken during a meal or after dose reduction.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store Polvertic

Store below 25 °C. Keep in the original packaging to protect from moisture.
Store in a place out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the cardboard box and blister pack following: EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot/LOT indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Polvertic contains

The active substance in this medicine is betahistine dihydrochloride. Each Polvertic 8 mg tablet contains 8 mg of betahistine dihydrochloride. Each Polvertic 16 mg tablet contains 16 mg of betahistine dihydrochloride.
Other ingredients are: povidone K90, microcrystalline cellulose, monohydrate lactose, colloidal anhydrous silica, crospovidone (type A) and stearic acid.

What Polvertic looks like and contents of the pack
Polvertic 8 mg: round, white tablet marked "B8" on one side.
Blister pack containing 30, 50, 100 or 120 tablets in a cardboard box.
Polvertic 16 mg: round, white tablet marked "B16" on one side and a division line on the other side. The tablet can be divided into equal doses.
Blister pack containing 20, 30, 42, 50, 60, 84 or 100 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 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 Branch in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba