Azalonum 20 mg / 40 mg. 30 tablets

What Azalonum is and what it is used for

Azalonum contains two active substances. One is cinnarizine and the other is dimenhydrinate. The two ingredients belong to different drug groups. Cinnarizine is part of a group of medicines called calcium channel blockers. Dimenhydrinate belongs to a group called antihistamines.

Both substances work by reducing the symptoms of vertigo (feeling dizzy or light-headed) and nausea. When these two substances are used together, they are more effective than when each is administered alone.

Azaloneum is used to treat various types of vertigo in adults. Vertigo can have many different causes.

2. What you need to know before you take Azalonum

Do not take Azalonum:

if you are allergic to cinnarizine, dimenhydrinate or diphenhydramine, or to any of the other ingredients of this medicine (listed in section 6).

if you are allergic to other antihistamines (such as astemizole, chlorpheniramine and terfenadine, used as anti-allergy medicines). You should not take this medicine unless your doctor has told you to.

if you suffer from angle-closure glaucoma (a specific type of eye disease);

if you have epilepsy;

if you have increased pressure in the brain (e.g. as a result of a tumour)

if you abuse alcohol.

if you have prostate problems that cause difficulty urinating.

if you suffer from liver or kidney failure.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Azalonum if you suffer from:

low or high blood pressure,

increased intraocular pressure,

bowel obstruction,

enlarged prostate,

overactive thyroid gland,

severe heart disease,

Parkinson's disease.

Azaloneum use may worsen these conditions. Azaloneum may still be right for you, but your doctor should take these facts into account.

Other drugs and Azalonum

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Azaloneum may interact with other medications you are taking.

Azaloneum may make you feel tired or drowsy when taken with the medicines listed below:

barbiturates (medicines often taken for relaxation)

narcotic analgesics (strong painkillers such as morphine)

tranquilizers (a type of medicine used to treat depression and anxiety)

monoamine oxidase inhibitors (used to treat depression and anxiety)

Azaloneum can enhance the effects of the following drugs:

tricyclic antidepressants (used to treat depression and anxiety)

atropine (a medicine that relaxes muscles and is often used in eye exams)

ephedrine (can be used to treat cough and stuffy nose)

medicines to lower blood pressure.

Procarbazine (a medicine used to treat certain types of cancer) may increase the effect of cenarizine/dimenhydrinate.

Aminoglycosides (a type of antibiotic) can damage the inner ear. If you take Azalonum, you may not notice that such damage has occurred.

You should not take Azalonum together with medicines used to correct heart rhythm problems (antiarrhythmics). Azaloneum may also change the way the skin reacts to allergy tests.

Azalonum with food, drink and alcohol

Azaloneum can cause indigestion, which can be reduced by taking the tablets after a meal. Do not drink alcohol while taking Azalum, as it may make you feel tired or drowsy.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Azaloneum should not be used in pregnant or breastfeeding women.

Driving and using machines

Azaloneum may make you feel drowsy. If this happens to you, do not drive or operate machinery.

3. How to take Azalonum

Always take this medicine 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 three times a day. Swallow the tablet whole with a little liquid after a meal. You will usually take Azalonum for up to 4 weeks. Your doctor will let you know if you need to take Azalonum for a longer time.

Use in children and adolescents

This medicine is not recommended for children or adolescents under 18 years of age because the effects of the medicine in children and adolescents are not known.

If you have taken more than the required dose of Azalonum

If you have accidentally taken more tablets or a child has taken the tablets, you should seek medical help immediately.

If you take too much Azaloneum, you may feel very tired, dizzy and shaky. Your pupils may dilate and you may not be able to urinate. You may feel dry mouth, red face, have a fast heart rate, high fever, sweating and headache.

If you have taken a large amount of Azaloneum, you may have seizures, hallucinations, high blood pressure, feel shaky, overexcited, and have difficulty breathing. Coma may occur.

If you forget to take Azalonum

If you forget to take an Azalonum tablet, just skip that tablet. Take the next Azalonum tablet at the usual time. Do not take a double dose to make up for a missed tablet.

If you have stopped taking Azalonum

Do not stop taking Azalonum until your doctor tells you to. If you stop treatment too soon, you are likely to have symptoms of vertigo (dizziness and lightheadedness) again.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

drowsiness,

dry mouth,

headache,

stomach ache.

They are usually mild and go away within a few days, even if you continue to take Azalonum.

Uncommon side effects (may affect up to 1 in 100 people):

sweating

reddening of the skin,

indigestion,

nausea

diarrhea,

nervousness,

cramps,

forgetting

tinnitus (ringing in the ears),

paresthesias (numbness of the hands and feet),

tremor (shaking).

Rare side effects (may affect up to 1 in 1,000 people):

impaired 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):

decreased number of white blood cells and platelets, and

a severely reduced number of red blood cells, which can cause weakness, bruising or an increased chance of infections.

If you suffer from infections with high fever and severe deterioration of general health, visit your doctor and inform him about the medicine you are taking.

Other possible side effects (frequency cannot be estimated from the available data) that may occur with this type of medicine include:

weight gain,

constipation

chest tightness

jaundice (yellowing of the skin and whites of the eyes caused by liver or blood problems), worsening of angle-closure glaucoma (an eye disease with increased intraocular pressure), uncontrollable movements,

unusual agitation and restlessness (especially in children),

severe skin reactions.

5. How to store Azalonum

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on each blister and carton after EXP. The expiry date corresponds to the last day of the month stated.

This medicinal product does not require special storage conditions.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Azalonum contains

The active substances are: 20 mg cinnarizine and 40 mg dimenhydrinate.

The other ingredients are: microcrystalline cellulose, croscarmellose sodium, corn starch, hypromellose, anhydrous silica, talc and magnesium stearate.

What Azalonum looks like and contents of the pack

White to off-white, round, biconvex tablets with a diameter of 8 mm.

Blister packs containing 20, 30, 50 or 100 tablets are available.

Not all types of packaging can be put on sale.