Patient Information Leaflet

Aludran, 20 mg + 40 mg, tablets
Cinnarizinum + Dimenhydrinatum
Please read this leaflet carefully before using the 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 others, even if their symptoms are similar.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Aludran is and what it is used for

Aludran contains two active substances: cinnarizine and 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 help reduce symptoms of vertigo (sensation of dizziness or "spinning") and nausea (feeling of sickness). When used together, these two substances are more effective than when used separately.
Aludran is used in adults to treat vertigo of various origins. There may be several different causes of vertigo. Treatment with Aludran may help improve daily activities that are impaired due to vertigo.

2. Information before using Aludran

When not to use Aludran:

if the patient is allergic to cinarizine, dimenhydrinate or diphenhydramine, other antihistamine medicines (such as astemizole, chlorpheniramine and terfenadine, used as allergy medicines) or any of the other ingredients of this medicine (listed in section 6),
in patients with angle-closure glaucoma (a type of eye disease),
in patients with epilepsy,
in patients with increased intracranial pressure (e.g. due to a tumour),
in patients with alcohol abuse,
in patients with urinary tract or prostate disorders that make urination difficult,
in patients with liver or kidney failure.

Warnings and precautions
Before starting to use Aludran, consult a doctor or pharmacist if the patient has:

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

Use of Aludran may worsen the patient's condition. Aludran may still be suitable for the patient, but the doctor must take these factors into account.
Additionally, Aludran may alter skin reactions to allergens during skin tests.
Children and adolescents
Safety and efficacy have not been established in children and adolescents under 18 years of age. Data are not available.
Aludran with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Aludran may interact with other medicines the patient is taking.
If Aludran is used together with the following medicines, it may cause fatigue or drowsiness:

barbiturates (medicines often used as sedatives)
opioids (strong painkillers such as morphine)
sedatives (a type of medicine used in the treatment of depression and anxiety)
monoamine oxidase inhibitors (used in the treatment of depression and anxiety)

Aludran may enhance the effects of the following medicines:

tricyclic antidepressants (used in the treatment of depression and anxiety)
atropine (a muscle-relaxing medicine, often used during ophthalmological examinations)
ephedrine (may be used in the treatment of cough or nasal congestion)
procarbazine (a medicine used in the treatment of certain cancers)
medicines used to lower blood pressure.

Aminoglycosides (a type of antibiotic) may damage the inner ear. When Aludran is used, such damage may go unnoticed.
Do not take Aludran with medicines used to treat irregular heartbeat (antiarrhythmic medicines).
Taking Aludran with food, drink and alcohol
Do not drink alcohol while taking Aludran, as it may cause drowsiness and fatigue.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and using machines
Aludran may cause drowsiness. If this side effect occurs, the patient must not drive or operate machinery.
Aludran contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Aludran

This medicine should always be taken according to the instructions provided by the doctor or pharmacist.
In case of doubts, consult your doctor or pharmacist.
The recommended dose is one tablet taken three times a day.
Route of administration
Aludran should be taken orally.
The tablet should be swallowed whole, without chewing, with a drink.
Aludran may cause indigestion, which can be alleviated by taking the tablets after meals.
Aludran is usually used for up to 4 weeks. Your doctor will inform you if a longer treatment period with Aludran is necessary.
Taking a higher than recommended dose of Aludran
If an excessive number of tablets is accidentally taken or if tablets are swallowed by a child, contact a doctor immediately.
If too many tablets of Aludran are taken, the patient may experience a strong feeling of fatigue, dizziness, and seizures. Pupil dilation and inability to urinate may occur. Dryness of the mouth, sudden facial flushing, increased heart rate, fever, sweating, and headache may appear.
In case of taking a large amount of Aludran, epileptic seizure, hallucinations, high blood pressure, trembling sensation, excitement, and breathing difficulties may occur. Coma may develop.
Missing a dose of Aludran
If a dose is missed, simply skip it. Take the next tablet at the usual time. Do not take a double dose to make up for the missed tablet.
Stopping Aludran treatment
Do not discontinue taking Aludran without consulting your doctor. If the treatment is stopped prematurely, symptoms of dizziness (dizziness and vertigo) may return.
In case of any further doubts regarding 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.
Common adverse reactions (may occur in up to 1 in 10 people): drowsiness, dry mouth, headache, and abdominal pain. These reactions are usually mild and resolve within a few days, even if Aludran continues to be taken.
Uncommon adverse reactions (may occur in up to 1 in 100 people): sweating, skin flushing, indigestion, nausea (feeling sick), diarrhoea, nervousness, muscle spasms, confusion, tinnitus (ringing in the ears), paraesthesia (tingling sensation in hands or feet), tremor (shaking).
Rare adverse reactions (may occur in up to 1 in 1,000 people): blurred vision, allergic reactions (e.g. skin reactions), light sensitivity, and difficulty in passing urine.
Very rare adverse reactions (may occur in up to 1 in 10,000 people): possible decrease in the number of white blood cells and platelets, and a significant reduction in red blood cells, leading to weakness, bruising and increased susceptibility to infections. If an infection with fever or a serious deterioration in general health occurs, contact a doctor and inform them about the medicine being taken.
Other possible adverse reactions (frequency cannot be estimated from available data), which may occur with this type of medicine include: weight gain, constipation, chest tightness, jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders), worsening of angle-closure glaucoma symptoms (an eye condition associated with increased intraocular pressure), uncontrolled movements, unusual excitability or agitation (especially in children), severe skin reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Aludran

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and
the outer carton following the word EXP. The expiry date refers to the last day of the stated month.
Store in the original outer packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Aludran contains

The active substances in Aludran are: cinarizine and dimenhydrinate. Each tablet contains 20 mg of cinarizine and 40 mg of dimenhydrinate.
Other ingredients are: microcrystalline cellulose, maize starch, sodium croscarmellose, hypromellose 2910 (6 mPa·s), colloidal anhydrous silica, magnesium stearate and talc.

What Aludran looks like and contents of the pack
Aludran is a white to off-white, round tablet with a diameter of approximately 8 mm, embossed with "V5" on one side and smooth on the other.
The medicine is available in packs containing 20, 60 and 100 tablets, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Tel. +48 22 642 07 75
Manufacturer/Importer
Terapia S.A.
Fabricii Street No. 124
400632 Cluj-Napoca
Romania
Torrent Pharma (Malta) Ltd
Central Business Centre, Level 2
Triq Hal Tarxien
II-Gudja, GDJ 1907
Malta