Verticontrol

Package leaflet: Information for the patient

Verticontrol, 8 mg, tablets
Verticontrol, 16 mg, tablets
Verticontrol, 24 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 so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms of illness are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Verticontrol and what is it used for
2. Important information before taking Verticontrol
3. How to take Verticontrol
4. Possible side effects
5. How to store Verticontrol
6. Contents of the pack and other information

1. What is Verticontrol and what is it used for

Verticontrol contains the active substance betahistine. Verticontrol is a type of medicine
called a "histamine analogue". This medicine is used in the treatment of vertigo (of vestibular origin),
tinnitus (ringing in the ears), and hearing loss in patients with Ménière's disease, as well as in the treatment of vertigo caused by dysfunction of the inner ear structures responsible for balance (known as "vestibular vertigo").
Verticontrol works by improving blood flow in the inner ear. This leads to a reduction in elevated pressure.

2. Important information before taking Verticontrol

When not to take Verticontrol

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has high blood pressure caused by an adrenal gland tumour ("phaeochromocytoma").

If any of the above conditions apply to the patient, Verticontrol must not be taken. The patient should
contact their treating physician.
Warnings and precautions
Before starting to take Verticontrol, discuss this with a doctor or pharmacist:

• if the patient has peptic ulcer disease (peptic ulcer)
• if the patient has asthma (the doctor may also monitor asthma during treatment with Verticontrol)
• if the patient is pregnant or planning to become pregnant
• if the patient is breastfeeding

If any of the above situations apply, talk to a doctor before using this medicine.
The doctor will advise whether it is safe to start taking this medicine.
Children and adolescents
Verticontrol is not recommended for use in children under 18 years of age due to
insufficient data on safety and efficacy in this age group.
Verticontrol and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor or pharmacist if the patient is taking any of the
following medicines:

• antihistamines – these may (theoretically) affect the action of Verticontrol. Verticontrol may also reduce the effectiveness of antihistamines.
• monoamine oxidase inhibitors (MAOIs) – used in the treatment of depression or Parkinson's disease. These may enhance the effect of Verticontrol.

Taking Verticontrol with food and drink
Verticontrol may be taken with or without food. However, Verticontrol may cause mild gastrointestinal discomfort (listed in section 4). Taking Verticontrol with food may help reduce gastrointestinal symptoms.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not take Verticontrol during pregnancy unless the doctor decides it is absolutely
necessary. Seek medical advice.
Do not breastfeed while taking Verticontrol unless advised by a doctor. It is not known whether betahistine contained in Verticontrol passes into human milk.
Driving and operating machinery
It is unlikely that Verticontrol affects the ability to drive or operate tools and machinery. However, it should be noted that the conditions for which the patient is being treated with Verticontrol (dizziness, tinnitus and hearing loss associated with Ménière's disease) may cause sensations of spinning and nausea, and may affect the ability to drive and operate machinery.

3. How to take Verticontrol

This medicine should always be taken as directed by the physician. In case of any doubts, consult
your doctor or pharmacist.
Adults (including elderly patients):
Verticontrol is available in three strengths: 8 mg, 16 mg, and 24 mg. The usual dosage is:

• Verticontrol 8 mg tablets – one or two tablets three times daily.
• Verticontrol 16 mg tablets – half or one tablet three times daily.
• Verticontrol 24 mg tablets – one tablet twice daily.

Your doctor may adjust the dose depending on your response to treatment.

Use in children and adolescents
Verticontrol is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy in this age group.
Elderly patients and patients with hepatic or renal impairment
Dose adjustment is not required.
How to take Verticontrol
Swallow the tablet with a glass of water. The tablet may be taken with or without food. Since Verticontrol may cause mild gastrointestinal discomfort (see section 4), taking Verticontrol with food may reduce this effect.
If more than one tablet is taken daily, doses should be evenly spaced throughout the day. For example, take one tablet in the morning and one in the evening.
Take the tablets at the same time each day. This ensures a constant level of the medicine in the body. Taking the medicine at the same time each day will also help you remember to take it.
Continue taking Verticontrol tablets regularly. It may take some time before the medicine starts to work.
Verticontrol 16 mg tablets: The tablet may be divided into equal doses.
Verticontrol 24 mg tablets: The score line facilitates breaking the tablet to aid swallowing in patients who have difficulty swallowing the tablet whole, but not for dividing into equal doses.
If you take more Verticontrol than recommended
If you take more Verticontrol than you should, you may experience nausea, drowsiness, or abdominal pain. If you or someone else has taken an overdose of this medicine, contact your doctor immediately or go to the nearest hospital. Take the medicine pack with you.
If you forget to take Verticontrol
If you miss a dose of Verticontrol, take the next dose at the scheduled time. Do not take a double dose to make up for the missed tablet.
Stopping Verticontrol
Take the tablets until your doctor advises you to stop. Do not stop taking Verticontrol without consulting your doctor, even if you feel better. Your doctor may recommend continuing treatment for some time to ensure the medicine has fully taken effect.
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 will experience them.
The following serious adverse reactions may occur during treatment with Verticontrol:

• Severe allergic reactions, which may include red or lumpy rash, inflammatory skin reactions with itching, swelling of the face, lips, tongue or throat, low blood pressure, loss of consciousness, breathing difficulties. If any of these adverse reactions occur, you must immediately stop taking the medicine and contact your doctor.

Other adverse reactions:
Common (may occur in up to 1 in 10 people):

• nausea
• indigestion (dyspepsia)
• headache

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

• mild gastrointestinal disturbances such as vomiting, abdominal pain, bloating and gas. Taking Verticontrol with food may help reduce gastrointestinal discomfort.

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 for Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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 helps to provide more information on the safety of the medicine.

5. How to store Verticontrol

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Verticontrol contains

• The active substance is betahistine dihydrochloride. Each tablet of Verticontrol 8 mg contains 8 mg of betahistine dihydrochloride. Each tablet of Verticontrol 16 mg contains 16 mg of betahistine dihydrochloride. Each tablet of Verticontrol 24 mg contains 24 mg of betahistine dihydrochloride.
• The other ingredients are: microcrystalline cellulose (PH 102), mannitol, talc, citric acid, colloidal anhydrous silica.

What the medicine looks like and contents of the pack
Verticontrol 8 mg tablets: white, round (approximately 7.00 mm in diameter), flat tablet with bevelled edges, smooth on both sides.
Verticontrol 16 mg tablets: white, round (approximately 8.70 mm in diameter), biconvex, film-coated tablet embossed with the letter "I" on one side and smooth on the other side.
Verticontrol 24 mg tablets: white, round (approximately 10.00 mm in diameter), biconvex, film-coated tablet embossed with the letters "II" on one side and smooth on the other side.
Verticontrol 8 mg tablets are available in cardboard boxes containing blisters (PVC/ACLAR(PCTFE)/Aluminium and PVC/PVDC/Aluminium) with 100 tablets.
Verticontrol 16 mg tablets are available in cardboard boxes containing blisters (PVC/ACLAR(PCTFE)/Aluminium and PVC/PVDC/Aluminium) with 48, 60 or 100 tablets.
Verticontrol 24 mg tablets are available in cardboard boxes containing blisters (PVC/ACLAR(PCTFE)/Aluminium and PVC/PVDC/Aluminium) with 32, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warszawa
tel. + 48 22 642 07 75

Importer
Terapia S.A.
Fabricii Street Nr 124,
400632 Cluj-Napoca
Romania
Emona Biopharma
Dunajska cesta 156
1000 Ljubljana
Slovenia

This medicinal product is authorised in the European Economic Area countries under the following names:
Croatia: Betahistindiklorid Terapia 8 mg, 16 mg, 24 mg tablete
Poland: Verticontrol
Romania: Diclorhidrat de betahistină Terapia 8 mg, 16 mg, 24 mg comprimate