Polvertic

Package Leaflet: Information for the Patient

Polvertic, 8 mg, tablets

Polvertic, 16 mg, tablets

Betahistini dihydrochloridum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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. Contents of the pack 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 you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6);
• if you have a pheochromocytoma (a rare tumor of the adrenal gland).

Warnings and precautions

Be particularly cautious when taking Polvertic:

• if you have a stomach ulcer (peptic ulcer) or have had a stomach ulcer;
• if you have asthma;
• if you have hives, other skin rashes, or nasal congestion associated with allergies, as betahistine may worsen these conditions;
• if you have low blood pressure.

If you have any of the above conditions, you should ask your doctor if you can take betahistine.
Patient with the above conditions should remain under medical supervision during treatment.

Polvertic and other medicines

Interactions mean that medicines or other substances may change each other's action
or increase side effects when taken at the same time.
So far, no interactions with other medicines have been observed with betahistine.
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 your doctor or pharmacist before taking betahistine.

Pregnancy and breastfeeding

It is not known whether the use of betahistine during pregnancy is safe.
Betahistine should be avoided during breastfeeding, as it passes into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Betahistine has no or negligible influence on the ability to drive and use machines.

Polvertic contains lactose

Polvertic, 8 mg: One tablet contains 70 mg of lactose monohydrate.
Polvertic, 16 mg: One tablet contains 140 mg of lactose monohydrate.
If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Polvertic

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults
The initial dose is 1-2 tablets of 8 mg or 0.5-1 tablet of 16 mg three times a day. The maintenance dose is 24 mg - 48 mg per day.
It may take several weeks before an improvement is observed.
Use in children and adolescents
Do not recommend the use of the medicine 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 are best taken during meals.

Overdose of Polvertic

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

Missed dose of Polvertic

Wait until it is time for the next dose. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with betahistinethe following seriousside effects may occur:

• Allergic reactions, such as:
• swelling of the face, lips, tongue or throat, which may cause difficulty breathing;
• red rash on the skin, skin inflammation with itching. If an allergic reaction (hypersensitivity) occurs after taking this medicine, 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 and intestinal pain, bloating, gas. These side effects may disappear if the medicine is taken during meals or after reducing the dose.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Polvertic

Store in a temperature below 25°C. Store in the original package to protect from moisture.
Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Polvertic contains

• The active substance 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.
• The 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 pack

Polvertic, 8 mg: round, white tablet with "B8" inscription on one side.
Blister, 30, 50, 100 or 120 tablets in a carton.
Polvertic, 16 mg: round, white tablet with "B16" inscription on one side and a dividing line on the other side. The tablet can be divided into equal doses.
Blister, 20, 30, 42, 50, 60, 84 or 100 tablets in a carton.
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
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 Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: