CINAZYN 25 mg Tablet

Зміст інструкції

1. Cinazyn 25 mg tablets, 75 mg/ml oral drops, suspension, 75 mg hard capsules, 100 mg hard capsules
   1. What is Cinazyn and what is it used for
   2. What you need to know before taking Cinazyn
   3. How to take Cinazyn
   4. Possible side effects
   5. How to store Cinazyn
   6. Package Contents and Other Information

Cinazyn 25 mg tablets, 75 mg/ml oral drops, suspension, 75 mg hard capsules, 100 mg hard capsules

cinnarizine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Cinazyn is and what it is used for
• 2. What you need to know before you take Cinazyn
• 3. How to take Cinazyn
• 4. Possible side effects
• 5. How to store Cinazyn
• 6. Contents of the pack and other information

1. What is Cinazyn and what is it used for

Cinazyn contains the active ingredient cinnarizine, which blocks the calcium channel (calcium antagonist), belonging to the category of anti-vertigo medications.
This medicine is indicated for the treatment of:

• disorders of blood circulation in the brain (cerebral irrigation disorders), in particular caused by alterations of the arteries (arteriosclerosis), which include: tremors, ringing in the ears, mood disorders (irritability and asociality), memory loss, poor concentration;
• problems with blood circulation in the hands and feet (peripheral vasculopathies), which include: bluish discoloration of hands and feet, reduced blood flow to the muscles causing difficulty walking (intermittent claudication), leg lesions (varicose ulcers), non-painful sensation in the arms and legs of burning, tingling, pricking (paresthesia), nocturnal cramps, cold hands and feet. For this indication, the tablets are used in association with other medicines.

In addition, Cinazyn tablets and Cynazin oral drops are indicated for the treatment of
balance disorders including: dizziness, tremors, ringing in the ears,
rhythmic and involuntary oscillation of the eyes (nystagmus), nausea and vomiting.

2. What you need to know before taking Cinazyn

Do not take Cinazyn

• if you are allergic to cinnarizine or any of the other ingredients of this medicine (listed in section 6);
• if you have brain damage caused by a sudden interruption of blood flow (acute stroke).

Warnings and precautions
Talk to your doctor or pharmacist before taking Cinazyn.
Take this medicine with caution if you are taking alcohol or medicines that depress the activity
of the brain as it may cause drowsiness, especially at the beginning of treatment
(See sections “Other medicines and Cinazyn” and “Cinazyn with alcohol”).
This medicine may cause upper abdominal pain (epigastric discomfort), therefore take Cinazyn after meals to reduce this discomfort (See the
section “How to take Cinazyn”).
If you suffer from Parkinson's disease, take Cinazyn only if your doctor believes that treatment
with this medicine does not carry the risk of worsening this condition.
Tell your doctor that you are taking Cinazyn if you need to undergo an allergy test, as
this medicine may falsify the results (inhibit positive reactions to indicators of
skin reactivity) if you take it up to 4 days before performing the test.

Other medicines and Cinazyn
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Take Cinazyn with caution and tell your doctor if you are taking the following medicines as
they may potentiate the sedative effects:

• medicines that depress the activity of the brain (depressants of the Central Nervous System);
• tricyclic antidepressants, medicines used to treat depression.

Cinazyn with alcohol
This medicine may cause drowsiness, especially at the beginning of therapy. Therefore,
avoid drinking alcoholic beverages during treatment with Cinazyn.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
If you are pregnant or think you may be pregnant or are breastfeeding, do not take Cinazyn.

Driving and using machines
Cinazyn may cause drowsiness, especially at the beginning of treatment. Therefore, if you experience
this symptom, caution is required when driving vehicles and using machines.

Cinazyn tablets contains

• sucrose and lactose monohydrate.If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Cinazyn hard capsules contains

• sodium.This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially “sodium-free”.

Cinazyn oral drops, suspension contains

• ethyl alcohol.This medicine contains 20 mg of alcohol (ethanol) in each ml of suspension, which is equivalent to 20 mg/ml (2% w/v). The amount in 1 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects;
• methyl p-hydroxybenzoate and propyl p-hydroxybenzoate.These may cause allergic reactions, even delayed ones;
• sorbitol.This medicine contains 371 mg of sorbitol per ml of suspension. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize fructose, talk to your doctor before you (or the child) take this medicine.

3. How to take Cinazyn

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take Cinazyn preferably after meals to reduce stomach discomfort (See the “Warnings and precautions” paragraph).
Do not exceed the recommended doses.
If you are taking this medicine for the treatment of vertigo, your doctor will gradually increase the dose.
Improvement of symptoms may occur quickly.
If necessary, your doctor may prescribe maintenance therapy to obtain a long-lasting effect.

Cinazyn tablets
The recommended dose is 1-2 tablets, 3 times a day.

Cinazyn oral drops, suspension
1 ml of suspension corresponds to 25 drops (equal to 75 mg of active substance).

• Treatment of blood circulation disorders in the brain (cerebral circulatory disorders)The recommended dose is:
• 8-15 drops (equal to 24-45 mg of active substance), 3 times a day or
• 25 drops (equal to 75 mg of active substance), 2 times a day.
• Treatment of blood circulation disorders in the hands and feet (peripheral circulatory disorders)The recommended dose is 25 drops (equal to 75 mg of active substance), 2-3 times a day.
• Treatment of balance disorders (vestibular disorders)The recommended dose is:
• 8 drops (equal to 24 mg of active substance), 3 times a day or
• 12 drops (equal to 36 mg of active substance), 2 times a day.
• Treatment of motion sicknessThe recommended dose is 8 drops (equal to 24 mg of active substance), to be taken half an hour before starting the journey and to be repeated every 6 hours.

Cinazyn hard capsules

• Treatment of blood circulation disorders in the brain (cerebral circulatory disorders)The recommended dose is 1 capsule, 2 times a day.
• Treatment of blood circulation disorders in the hands and feet (peripheral circulatory disorders)The recommended dose is 1 capsule, 2-3 times a day.

Use in the elderly
If you are an elderly person, your doctor may decide to reduce the dose.

If you take more Cinazyn than you should
Following the intake of an excessive dose of this medicine, vomiting, drowsiness, coma, tremor, reduction of muscle tone (hypotonia) may occur.
In case of accidental ingestion/intake of an excessive dose of Cinazyn, immediately notify your doctor or go to the nearest hospital.

If you forget to take Cinazyn
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Drowsiness and gastro-intestinal disturbances may occur. These disturbances are generally
transient and can be prevented by gradually establishing the optimal dosage.
In rare cases, headache, dry mouth, weight gain,
sweating or allergic reactions may be observed.
Similarly, very rare cases of lichen planus and lupus-like symptoms have been reported. A
single isolated case of cholestatic jaundice has been published in the medical literature.
In elderly patients, cases of worsening or onset of extrapyramidal phenomena, sometimes
associated with a feeling of depression, have been described during long-term treatments. In such
cases, treatment should be discontinued.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse..
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Cinazyn

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after
“Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Cinazyn contains
Cinazyn 25 mg tablets

• The active ingredient is cinnarizine. Each tablet contains 25 mg of cinnarizine.
• The other ingredients are: povidone, sucrose, lactose monohydrate, pregelatinized corn starch, talc, hydrogenated vegetable oil.

Cinazyn 75 mg/ml oral drops, suspension

• The active ingredient is cinnarizine. 1 ml of suspension (=25 drops) contains 75 mg of cinnarizine.
• The other ingredients are: microcrystalline cellulose and carmellose, ethyl alcohol, polysorbate 20, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, banana flavour, sorbitol 70%, purified water.

Cinazyn 75 mg hard capsules

• The active ingredient is cinnarizine. Each hard capsule contains 75 mg of cinnarizine.
• The other ingredients are: internal: microcrystalline cellulose, talc, sodium stearate, anhydrous colloidal silica; capsule: gelatin, titanium dioxide (E 171).

Cinazyn 100 mg hard capsules

• The active ingredient is cinnarizine. Each hard capsule contains 100 mg of cinnarizine.
• The other ingredients are: internal: microcrystalline cellulose, talc, sodium stearate, anhydrous colloidal silica; capsule: gelatin, titanium dioxide (E171).

Description of the appearance of Cinazyn and contents of the pack
Cinazyn 25 mg tablets
Pack of 50 tablets. The tablets have a score line on one side which
is intended to help break the tablet for easier swallowing and not
to divide it into equal doses.

Cinazyn 75 mg/ml oral drops, suspension
Bottle of 30 ml.

Cinazyn 75 mg hard capsules
Pack of 20 or 60 capsules.

Cinazyn 100 mg hard capsules
Pack of 50 capsules.

Marketing Authorisation Holder
ITALCHIMICI S.p.A.– Via Matteo Civitali, 1 – 20148 Milano.

Manufacturer
Tablets
ITC Production S.r.l. – Via Pontina km 29 – 00071 Pomezia (RM).
Fine Foods & Pharmaceuticals N.T.M. S.p.A. – Via Grignano, 43 – 24041 Brembate (BG).

Hard capsules
ITC Production S.r.l. – Via Pontina km 29 – 00071 Pomezia (RM).
Fine Foods & Pharmaceuticals N.T.M. S.p.A. – Via Grignano, 43 – 24041 Brembate (BG).

Oral drops, suspension
ITC Production S.r.l. – Via Pontina km 29 – 00071 Pomezia (RM).
Zeta Farmaceutici S.p.A. – Via Galvani, 10 – 36066 Sandrigo (VI).