Cinazyn

Package leaflet: Information for the user

Cinazyn 25 mg tablets, 75 mg/5 ml oral drops, suspension, 75 mg hard capsules, 100 mg hard capsules

cinnarizine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Cinazyn is and what it is used for

Cinazyn contains the active substance cinnarizine, a calcium channel blocker (calcium antagonist), belonging to the class of antivertigo medicines.
This medicine is indicated for the treatment of:

• disturbances in cerebral blood circulation (cerebral insufficiency), particularly caused by arterial changes (arteriosclerosis), including: tremors, tinnitus, mood disturbances (irritability and asocial behaviour), memory loss, poor concentration;
• problems with blood circulation in the hands and feet (peripheral vascular diseases), including: bluish discoloration of hands and feet, reduced blood flow to the muscles causing difficulty walking (intermittent claudication), leg ulcers (varicose ulcers), non-painful sensations in arms and legs such as burning, tingling, pricking (paresthesias), nocturnal cramps, cold hands and feet. For this indication, the tablets are used in combination with other medicines.

Furthermore, Cinazyn tablets and Cynazin oral drops are indicated for the treatment of
balance disorders including: vertigo, tremors, tinnitus,
rhythmic and involuntary eye movements (nystagmus), nausea and vomiting.

2. What you need to know before taking Cinazyn

Do not take Cinazyn

• if you are allergic to cinnarizine or to 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 cerebral stroke).

Warnings and precautions
Talk to your doctor or pharmacist before taking Cinazyn.
Take this medicine with caution if you consume alcohol or take medicines that depress brain activity, 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 effect. (See section “How to take Cinazyn”).
If you have Parkinson’s disease, take Cinazyn only if your doctor considers that treatment with this medicine does not pose a risk of worsening your condition.
Inform your doctor that you are taking Cinazyn if you are scheduled for an allergy test, as this medicine may interfere with test results (inhibit positive reactions to skin reactivity tests) if taken up to 4 days before the test.

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

• medicines that depress brain activity (central nervous system depressants);
• tricyclic antidepressants, medicines used to treat depression.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Cinazyn if you are pregnant or think you might be pregnant, or if you are breastfeeding.

Driving and using machines
Cinazyn may cause drowsiness, especially at the beginning of treatment. Therefore, if you experience this symptom, exercise caution when driving or operating machinery.

Cinazyn tablets contain

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

Cinazyn hard capsules contain

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

Cinazyn oral drops, suspension contains

• ethanol. This medicine contains 20 mg of alcohol (ethanol) in each ml of suspension, 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, including delayed reactions;
• 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 your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or your child) take this medicine.

3. How to take Cinazyn

Take this medicine exactly as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Take Cinazyn preferably after meals to reduce stomach discomfort (see section “Warnings and precautions”).
Do not exceed the recommended doses.
If you are taking this medicine for the treatment of vertigo, your doctor will gradually increase the dose.
Symptom improvement may occur rapidly.
If necessary, your doctor may prescribe you a maintenance therapy to achieve a prolonged effect.

Cinazyn tablets
The recommended dose is 1-2 tablets, three times daily.

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

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

Cinazyn hard capsules

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

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

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

If you forget to take Cinazyn
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult 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 gastrointestinal disturbances may occur. These disturbances are usually 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. In medical literature, a single isolated case of cholestatic jaundice has been published.
In elderly patients, worsening or onset of extrapyramidal symptoms, sometimes associated with depressive feelings, has been described during long-term treatments. In such cases, treatment must be discontinued.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website
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 stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via 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 substance is cinnarizine. Each tablet contains 25 mg of cinnarizine.
• The other components are: povidone, sucrose, monohydrate lactose, pregelatinized corn starch, talc, hydrogenated vegetable oil.

Cinazyn 75 mg/ml oral drops, suspension

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

Cinazyn 75 mg hard capsules

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

Cinazyn 100 mg hard capsules

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

Description of the appearance of Cinazyn and contents of the pack
Cinazyn 25 mg tablets
Box containing 50 tablets. The tablets have a score line on one side, which is intended to facilitate breaking the tablet for easier swallowing and not for dividing it into equal doses.

Cinazyn 75 mg/ml oral drops, suspension
30 ml bottle.

Cinazyn 75 mg hard capsules
Box containing 20 or 60 capsules.

Cinazyn 100 mg hard capsules
Box containing 50 capsules.

Marketing Authorization Holder
ITALCHIMICI S.p.A. – Via Matteo Civitali, 1 – 20148 Milan, Italy.

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

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

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