Artigo

Package Leaflet: Information for the User

Artigo, 20 mg + 40 mg, coated tablets
Cinnarizine + Dimenhydrinate

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

1. What is Artigo and what is it used for

The medicine contains two active substances. One of them is cinnarizine, and the other is dimenhydrinate.
These substances belong to different groups of medicines. Cinnarizine belongs to a group of medicines called
calcium antagonists. Dimenhydrinate belongs to a group of antihistamine medicines.
Both substances reduce the symptoms of dizziness (feeling of dizziness or "spinning") and nausea. If both substances are used at the same time, they work more
effectively than when used separately.
Artigo is used in adults to treat dizziness of various origins. There may be several different causes of dizziness. Taking Artigo can help with
performing daily activities that are difficult due to dizziness.

2. Important information before taking Artigo

When not to take Artigo:

• if you are allergic to cinnarizine, dimenhydrinate, or diphenhydramine or any of the other ingredients of this medicine (listed in section 6),
• in patients under 18 years of age,
• if you are allergic to any other antihistamine medicine (e.g., astemizole, chlorpheniramine, and terfenadine used as anti-allergic medicines). Do not take this medicine without a doctor's recommendation.
• in patients with closed-angle glaucoma (a type of eye disease),
• in patients with epilepsy,
• in patients with increased intracranial pressure (e.g., due to a tumor),
• in patients who abuse alcohol,
• in patients with urinary tract and prostate diseases that make urination difficult,
• in patients with liver or kidney failure.

Warnings and precautions

Before taking Artigo, discuss it with your doctor or pharmacist if you have:

• low or high blood pressure,
• increased eye pressure,
• intestinal obstruction,
• enlarged prostate,
• hyperthyroidism,
• severe heart disease,
• Parkinson's disease.

Taking Artigo may worsen your condition. Artigo may still be suitable for you, but your doctor must consider these factors.

Artigo and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Artigo may interact with other medicines you are taking.
If Artigo is taken with the following medicines, it may cause drowsiness:

• barbiturates (medicines often used as sedatives),
• opioids (strong painkillers such as morphine),
• sedatives (medicines used to treat depression and anxiety).

Artigo may enhance the effects of the following medicines:

• tricyclic antidepressants (used to treat depression and anxiety),
• atropine (a muscle relaxant often used during eye exams),
• ephedrine (may be used to treat certain tumors),
• medicines used to lower blood pressure.

Aminoglycosides (a type of antibiotic) can damage the inner ear. When taking Artigo, such damage may go unnoticed.
Do not take Artigo with medicines used to treat irregular heartbeat (anti-arrhythmic medicines).
Additionally, Artigo may alter skin reactions to allergens during skin tests.

Taking Artigo with food, drink, and alcohol

Artigo may cause indigestion. This can be reduced by taking the tablets after a meal. Do not drink alcohol while taking Artigo, as it may cause drowsiness and sleepiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Artigo during pregnancy or breastfeeding, or if you think you may be pregnant.

Driving and using machines

Artigo may cause drowsiness. If you experience this side effect, do not drive or operate machinery.
The medicine contains less than 1 mmol (23 mg) of sodiumper recommended dose, i.e., 3 tablets per day, which means the medicine is considered "sodium-free).

3. How to take Artigo

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose
The recommended dose is 1 tablet taken three times a day after a meal and swallowed with a liquid. The tablet should be swallowed whole without chewing.
Artigo is usually taken for 4 weeks. Your doctor will tell you if you need to extend the treatment period with Artigo.

Taking more Artigo than recommended

If you accidentally take more tablets or if a child swallows some, contact your doctor immediately.
If you take too many Artigo tablets, you may experience extreme drowsiness, dizziness, and convulsions. Your pupils may become dilated, and you may have difficulty urinating. You may also experience dry mouth, sudden flushing of the face, increased heart rate, fever, sweating, and headache.
If you take a large amount of Artigo, you may experience: seizures, hallucinations, high blood pressure, feeling of trembling, excitement, and difficulty breathing. You may fall into a coma.

Missing a dose of Artigo

If you miss a dose of Artigo, simply omit it. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Artigo

Do not stop taking Artigo without your doctor's advice. If you stop taking the medicine too early, your dizziness symptoms (dizziness and "spinning") may return.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Artigo can cause side effects, although not everybody gets them.
Common side effects(occur in up to 1 in 10 people): drowsiness, dry mouth, headache, and abdominal pain. These reactions are usually mild and disappear within a few days, even if you continue taking Artigo.
Uncommon side effects(occur in up to 1 in 100 people): sweating, skin flushing, indigestion, nausea, diarrhea, nervousness, cramps, confusion, ringing in the ears (tinnitus), paresthesia (tingling of hands or feet), tremors.
Rare side effects(occur in up to 1 in 1,000 people): decreased vision, allergic reactions (e.g., skin reactions), sensitivity to light, and difficulty urinating.
Very rare side effects(occur in less than 1 in 10,000 people): possible decrease in white blood cell and platelet count, as well as a significant decrease in red blood cell count, leading to weakness, bruising, and increased risk of infection. If you experience an infection with fever and a severe deterioration of your general condition, contact your doctor and inform them about the medicine you are taking.
Other possible side effects (frequency cannot be estimated from available data) that may occur with this type of medicine include: weight gain, constipation, feeling of pressure in the chest, jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders), worsening of closed-angle glaucoma symptoms (an eye disease characterized by increased eye pressure), uncontrolled movements, unusual excitement or anxiety (especially in children), severe skin reactions.

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 Pharmacovigilance 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 medicine.

5. How to store Artigo

There are no special precautions for storing the medicine.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to 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. This will help protect the environment.

6. Contents of the pack and other information

What Artigo contains

• The active substances are: cinnarizine 20 mg and dimenhydrinate 40 mg.
• The other ingredients are: microcrystalline cellulose, sodium carmellose, anhydrous colloidal silica, magnesium stearate, talc, polyvinyl alcohol, titanium dioxide (E171), macrogol 4000.

What Artigo looks like and contents of the pack

White, round, biconvex, coated tablets, 7.9 mm - 8.3 mm in diameter.
The tablets are packaged in PVC/PVDC/Al blisters placed in a cardboard box.
The pack contains: 10, 20, 30, 50, 60, or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Phone: +48 61 66 51 500

Date of last revision of the leaflet: