Aludran

Package Leaflet: Information for the Patient

Aludran, 20 mg + 40 mg, Tablets

Cinnarizine + Dimenhydrinate

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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 package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Aludran and what is it used for.
• 2. Important information before taking Aludran.
• 3. How to take Aludran.
• 4. Possible side effects.
• 5. How to store Aludran.
• 6. Package contents and other information.

1. What is Aludran and what is it used for

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

2. Important information before taking Aludran

When not to take Aludran:

• if you are allergic to cinnarizine, dimenhydrinate, or diphenhydramine, other antihistamine medications (such as astemizole, chlorpheniramine, and terfenadine, used as allergy medications) or any of the other ingredients of this medication (listed in section 6),
• 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 urethral or prostate disorders that make urination difficult,
• in patients with liver or kidney failure.

Warnings and precautions

Before taking Aludran, discuss 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 Aludran may worsen your condition. Aludran may still be suitable for you, but your doctor must consider these factors.
Additionally, Aludran may alter skin reactions to allergens during skin tests.

Children and adolescents

The safety and efficacy of Aludran in children and adolescents under 18 years of age have not been established. Data are not available.

Aludran and other medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
Aludran may interact with other medications you are taking.
If Aludran is taken with the following medications, it may cause drowsiness:

• barbiturates (medications often used as sedatives)
• opioids (strong pain medications such as morphine)
• sedatives (a type of medication used to treat depression and anxiety)
• monoamine oxidase inhibitors (used to treat depression and anxiety)

Aludran may enhance the effects of the following medications:

• tricyclic antidepressants (used to treat depression and anxiety)
• atropine (a medication that relaxes muscles and is often used during eye exams)
• ephedrine (may be used to treat cough or cold)
• procarbazine (a medication used to treat certain types of cancer)
• medications used to lower blood pressure.

Aminoglycosides (a type of antibiotic) may damage the inner ear. When taking Aludran, such damage may go unnoticed.
Do not take Aludran with medications used to treat irregular heart rhythms (anti-arrhythmic medications).

Taking Aludran with food, drink, and alcohol

Do not drink alcohol while taking Aludran, as it may cause drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.

Driving and using machines

Aludran may cause drowsiness. If this occurs, do not drive or operate machinery.

Aludran contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Aludran

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one tablet taken three times a day.
Route of administration
Aludran should be taken orally.
Swallow the tablet whole with a drink of water. Do not chew the tablet.
Aludran may cause stomach upset, which can be alleviated by taking the tablets after a meal.
Aludran is usually taken for up to 4 weeks. Your doctor will tell you if you need to take it for longer.

Overdose of Aludran

If you accidentally take more tablets than recommended or if a child swallows some tablets, contact your doctor immediately.
If you take too many Aludran tablets, you may experience extreme drowsiness, dizziness, and tremors. 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 Aludran, you may experience a seizure, hallucinations, high blood pressure, a feeling of trembling, excitement, and difficulty breathing. You may also become comatose.

Missing a dose of Aludran

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

Stopping Aludran treatment

Do not stop taking Aludran without consulting your doctor. If you stop taking Aludran too early, your dizziness symptoms (dizziness and "spinning") may return.
If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Aludran can cause side effects, although not everybody gets them.
Common side effects(may affect up to 1 in 10 people): drowsiness, dry mouth, headache, and stomach pain. These reactions are usually mild and disappear within a few days, even if you continue taking Aludran.
Uncommon side effects(may affect up to 1 in 100 people): sweating, flushing, stomach upset, nausea (feeling queasy), diarrhea, nervousness, tremors, confusion, ringing in the ears (tinnitus), paresthesia (tingling in hands or feet), and tremors.
Rare side effects(may affect up to 1 in 1,000 people): blurred vision, allergic reactions (e.g., skin reactions), sensitivity to light, and difficulty urinating.
Very rare side effects(may affect up to 1 in 10,000 people): possible decrease in white blood cell count 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 worsening of your general condition, contact your doctor and inform them about the medication you are taking.
Other possible side effects (frequency cannot be estimated from available data) that may occur with this type of medication 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 restlessness (especially in children), and severe skin reactions.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +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 this medication.

5. How to store Aludran

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month.
Store in the original package to protect from moisture.
Do not throw away any medications via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Aludran contains

• The active substances are cinnarizine and dimenhydrinate. Each tablet contains 20 mg of cinnarizine and 40 mg of dimenhydrinate.
• The other ingredients are microcrystalline cellulose, cornstarch, sodium croscarmellose, hypromellose 2910 (6 mPa·s), colloidal anhydrous silica, magnesium stearate, and talc.

What Aludran looks like and package contents

Aludran is a white to off-white, round tablet with a diameter of approximately 8 mm, with "V5" embossed on one side and smooth on the other.
The medication is available in packages containing 20, 60, and 100 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer/Importer

Terapia S.A.
Str. Fabricii nr. 124
400632 Cluj-Napoca
Romania
Torrent Pharma (Malta) Ltd
Central Business Centre, Level 2
Triq Hal Tarxien
II- Gudja, GDJ 1907
Malta

Date of last revision of the package leaflet: