NOCLAUD 100 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGE: PATIENT INFORMATION
2. Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!
3. Noclaud
4. 100 mg, tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Noclaud and what is it used for
6. Important information before using Noclaud
   1. When not to use Noclaud
   2. Warnings and precautions
   3. Children and adolescents
   4. Noclaud and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
7. How to use Noclaud
   1. Use in children and adolescents
   2. Using a higher dose of Noclaud than recommended
   3. Missing a dose of Noclaud
   4. Stopping the use of Noclaud
8. Possible side effects
   1. Reported side effects of cilostazol
   2. Reporting side effects
9. How to store Noclaud
10. Contents of the package and other information
    1. What Noclaud contains
    2. What Noclaud looks like and what the package contains
    3. Appearance:
    4. Package:
    5. Marketing authorization holder in Hungary, the country of export:
    6. Manufacturer:
    7. Parallel importer:
    8. Repackaged by:
    9. Marketing authorization number in Hungary, the country of export: OGYI-T-22586/03, OGYI-T-22586/04, OGYI-T-22586/06Parallel import authorization number: 264/18
    10. The medicinal product is registered in the Member States of the European Economic Area under the following names:
    11. Date of leaflet approval: 21.09.2023

LEAFLET INCLUDED IN THE PACKAGE: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Noclaud

100 mg, tablets

Cilostazol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Noclaud and what is it used for
• 2. Important information before using Noclaud
• 3. How to use Noclaud
• 4. Possible side effects
• 5. How to store Noclaud
• 6. Contents of the package and other information

1. What is Noclaud and what is it used for

Noclaud, which contains the active ingredient cilostazol, belongs to a group of medicines called phosphodiesterase type 3 inhibitors. It has various effects, including the dilation of certain blood vessels and the reduction of the activity of blood clotting (aggregation) of certain blood cells, called platelets, within blood vessels.
Noclaud has been prescribed to treat "intermittent claudication". Intermittent claudication is a type of cramp-like pain in the lower limbs that occurs during walking and is caused by insufficient blood flow to the legs. Noclaud increases the distance that the patient can walk without experiencing pain by improving blood circulation in the lower limbs.
Cilostazol is recommended only for patients for whom lifestyle modifications (including quitting smoking and increasing exercise intensity) and other appropriate interventions have not sufficiently alleviated symptoms. It is essential that the patient continues to implement lifestyle modifications during cilostazol treatment.

2. Important information before using Noclaud

When not to use Noclaud

• if the patient is allergic to cilostazol or any of the other ingredients of this medicine (listed in section 6),
• if heart failure is present,
• if there is chest pain at rest or if the patient has had a "heart attack" or any heart surgery in the last six months,
• if the patient has currently or in the past experienced transient loss of consciousness due to heart disease or any severe heart rhythm disorders,
• if the patient has been diagnosed with a condition that increases the risk of bleeding or bruising, such as:
• active gastric ulcer,
• stroke in the last six months,
• eye problems due to diabetes,
• uncontrolled high blood pressure.
• treatment with both acetylsalicylic acid and clopidogrel or any combination of two or more medicines that may increase the risk of bleeding (in case of doubt, consult a doctor or pharmacist),
• if there is severe kidney disease or moderate to severe liver disease,
• if the patient is pregnant.

Warnings and precautions

Before starting to use Noclaud, you should discuss it with your doctor or pharmacist

• if the patient has severe heart disease or any heart rhythm problems,
• if the patient has high blood pressure problems.

During treatment with Noclaud

• If surgery is required, including tooth extraction, the doctor or dentist should be informed about the use of Noclaud.
• In case of a tendency to bruise or bleed, the use of Noclaud should be discontinued and the doctor informed.

Children and adolescents

Noclaud is not intended for children.

Noclaud and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should inform your doctor about taking certain medicines that are usually used to treat pain and/or inflammation of muscles or joints, as well as medicines that reduce blood clotting. These include:

• acetylsalicylic acid
• clopidogrel
• anticoagulant medicines (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins).

In the case of using such medicines together with Noclaud, the doctor may perform certain routine blood tests.
Some medicines used at the same time may interfere with the action of Noclaud. They may enhance the side effects of Noclaud or reduce its effectiveness. Noclaud may similarly affect other medicines. Before starting to use Noclaud, you should inform your doctor about taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics)
• ketoconazole (used to treat fungal infections)
• omeprazole (used to treat increased stomach acid)
• diltiazem (used to treat high blood pressure or chest pain)
• cisapride (used to treat stomach disorders)
• lovastatin, simvastatin, or atorvastatin (used to treat high cholesterol)
• halofantrine (used to treat malaria),
• pimozide (used to treat mental disorders)
• ergot derivatives (used to treat migraines, e.g., ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (used to treat seizures)
• St. John's Wort (herbal preparation)

In case of doubt whether the above applies to the medicines you are taking, you should consult your doctor or pharmacist.
Before starting to use Noclaud, you should inform your doctor if you are taking medicines for high blood pressure, as Noclaud may cause additional blood pressure-lowering effects. If excessive blood pressure lowering occurs, it may lead to rapid heart rate. These medicines include:

• diuretics (e.g., hydrochlorothiazide, furosemide)
• calcium channel blockers (e.g., verapamil, amlodipine)
• ACE inhibitors (e.g., captopril, lisinopril)
• angiotensin II receptor blockers (e.g., valsartan, candesartan)
• beta-blockers (e.g., labetalol, carvedilol).

It is possible that the concurrent use of the above medicines and Noclaud will still be acceptable, and the doctor will be able to decide what treatment is appropriate for the patient.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Noclaud MUST NOTbe used during pregnancy.
IT IS NOT RECOMMENDEDto use Noclaud in breastfeeding mothers.

Driving and using machines

Noclaud may cause dizziness. If dizziness occurs after taking Noclaud, DO NOTdrive vehicles, do not use any tools, or operate any machines. You should inform your doctor or pharmacist.

3. How to use Noclaud

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

• The recommended dose is 2 x 100 mg (two 50 mg tablets or one 100 mg tablet) twice a day (morning and evening). No dose adjustment is required for elderly patients. However, the doctor may prescribe a lower dose if the patient is taking medicines that may affect the action of Noclaud.
• Noclaud should be taken 30 minutes before breakfast and dinner. The tablets should always be swallowed with water.

Some benefits of using Noclaud may be noticeable after 4-12 weeks of treatment.
The doctor will assess the effectiveness after 3 months of treatment and may recommend discontinuing cilostazol treatment if the therapy is not effective enough.

Use in children and adolescents

Noclaud is not intended for children.

Using a higher dose of Noclaud than recommended

If, for any reason, you have taken more Noclaud tablets than you should, you may experience objective and subjective symptoms such as severe headaches, diarrhea, low blood pressure, and irregular heart rhythm.
In case of taking a higher dose than prescribed, you should immediately contact your doctor or local hospital. Remember to take the packaging with you so that it is clear what medicine has been taken.

Missing a dose of Noclaud

There is no reason to worry if you miss a dose. You should wait and take the next dose at the right time, and then take the medicine as directed. DO NOTtake a double dose to make up for the missed tablet.

Stopping the use of Noclaud

If you stop using Noclaud, the pain in your lower limbs may return or worsen. Therefore, you should only stop using Noclaud if you experience side effects that require urgent medical attention (see section 4) or on the advice of your doctor.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Noclaud can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you may need urgent medical attention. You should immediately stop using Noclaud and contact your doctor or go to the nearest hospital.

• stroke
• heart attack
• heart problems that can cause shortness of breath or swelling of the ankles
• irregular heart rhythm (new or worsening symptom)
• visible bleeding
• easy bruising
• severe skin disease with blisters on the skin, in the mouth, eyes, and genitals
• yellowing of the skin or whites of the eyes due to liver or blood disorders (jaundice)

You should also immediately inform your doctor if you experience fever or sore throat.
It may be necessary to perform certain blood tests, and your doctor will decide on further treatment.

Reported side effects of cilostazol

Very common side effects(may affect more than 1 in 10 people)

• headache
• abnormal stools
• diarrhea

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

• rapid heart rate
• heart palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• stomach pain
• discomfort in the abdominal area (indigestion)
• nausea or vomiting
• loss of appetite
• excessive gas or belching (bloating with gas)
• swelling of the ankles, feet, or face
• rash or skin changes
• itching
• petechiae (small red or purple spots on the skin)
• general weakness

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

• heart attack
• irregular heart rhythm (new or worsening symptom)
• heart problems that can cause shortness of breath or swelling of the ankles
• pneumonia
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g., in the stomach, eye, or muscle, nosebleeds, and blood in sputum or urine),
• reduced red blood cell count
• dizziness when standing up
• fainting
• anxiety
• sleep disorders
• nightmares
• allergic reaction
• muscle pain
• diabetes and high blood sugar
• stomach pain (gastritis)
• malaise

In people with diabetes, there may be a higher risk of bleeding into the eye.
Rare side effects(may affect up to 1 in 1000 people)

• tendency to bleed longer than normal
• increased platelet count
• kidney problems

The following side effects have been reported during the use of cilostazol, but their frequency is unknown(the frequency cannot be estimated from the available data);

• blood pressure changes
• reduced red blood cell, white blood cell, and platelet count
• breathing difficulties
• movement difficulties
• fever
• hot flashes
• rash and other skin eruptions
• numbness of the skin
• discharge or sticky discharge from the eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine

If any of the side effects get worse, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Noclaud

There are no special precautions for storage.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Do not use this medicine if you notice visible signs of deterioration (e.g., discoloration).
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Noclaud contains

• The active substance of Noclaud is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other ingredients are: microcrystalline cellulose, cornstarch, calcium carmellose, hypromellose 2910, magnesium stearate.

What Noclaud looks like and what the package contains

Appearance:

Odorless or almost odorless, white or almost white, round, flat tablets with beveled edges. The tablets have a stylized letter E and the number 602 embossed on one side, with no markings on the other side.

Package:

The available packages are 28 or 56 tablets in PVC/PVDC/Aluminum blisters in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, the country of export:

Egis Gyógyszergyár Zrt.
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturer:

Egis Gyógyszergyár Zrt.
Bökényföldi út 118-120.
1165 Budapest
Hungary

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing authorization number in Hungary, the country of export: OGYI-T-22586/03, OGYI-T-22586/04, OGYI-T-22586/06
Parallel import authorization number: 264/18

The medicinal product is registered in the Member States of the European Economic Area under the following names:

Hungary Noclaud 100 mg tablet
Czech Republic Noclaud
Latvia Sollazon 100 mg tablets
Lithuania Sollazon 100 mg tablets
Poland Noclaud

Date of leaflet approval: 21.09.2023

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