Noclaud

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Noclaud
100 mg, tablets
Cilostazol
Please read the following information carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any questions or doubts.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Noclaud is and what it is used for

Noclaud contains the active substance cilostazol, which belongs to a group of medicines called phosphodiesterase type 3 inhibitors. It produces various effects, including the dilation of certain blood vessels and reduction of the clotting activity of certain blood cells known as platelets within blood vessels.

Noclaud has been prescribed to treat "intermittent claudication". Intermittent claudication is a cramp-like pain in the lower limbs occurring during walking, caused by inadequate blood flow to the legs. Noclaud increases the distance a patient can walk without pain by improving blood circulation in the lower limbs.

Cilostazol is recommended only for patients in whom lifestyle modifications (including smoking cessation and increased physical activity) and other appropriate interventions have not sufficiently relieved symptoms. It is important that patients continue to maintain these lifestyle changes while being treated with cilostazol.

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 the patient has heart failure,
• if the patient experiences chest pain at rest, or has had a heart attack or any heart surgery within the last six months,
• if the patient has currently or previously experienced a brief 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 peptic ulcer,
• stroke within the last six months,
• diabetic eye disease,
• poorly controlled 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 [if in doubt, consult a doctor or pharmacist],
• if the patient has severe kidney disease or moderate to severe liver disease,
• if the patient is pregnant.

Warnings and precautions
Before starting treatment with Noclaud, discuss this with your doctor or pharmacist

• if the patient has severe heart disease or any heart-related problems,
• if the patient has problems with blood pressure.

During treatment with Noclaud

• If surgery is required, including tooth extraction, inform the doctor or dentist that you are taking Noclaud.
• If you notice an increased tendency to bruise or bleed, stop taking Noclaud and inform your doctor immediately.

Children and adolescents
Noclaud is not intended for use in children.
Noclaud and other medicines
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, inform your doctor if you are taking certain medicines commonly used to treat
pain and (or) muscle or joint inflammation, and medicines that reduce blood clotting. These include:

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

If these medicines are taken together with Noclaud, your doctor may carry out routine blood tests.
Some medicines taken at the same time may interfere with the action of Noclaud. They may increase
the side effects of Noclaud or reduce its effectiveness. Noclaud may similarly affect other medicines.
Before starting treatment with Noclaud, inform your doctor if you are taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics)
• ketoconazole (used to treat fungal infections)
• omeprazole (used to treat increased stomach acidity)
• diltiazem (used to treat high blood pressure or chest pain)
• cisapride (used for stomach disorders)
• lovastatin, simvastatin, or atorvastatin (used to treat high cholesterol levels in the blood)
• halofantrine (used to treat malaria)
• pimozide (used to treat psychiatric disorders)
• ergot derivatives (used to treat migraine, e.g. ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (used to treat seizures)
• St. John’s wort (herbal remedy)

If you are unsure whether any of the above applies to the medicines you are taking, consult your
doctor or pharmacist.
Before starting treatment with Noclaud, the patient should inform the doctor if they are taking
medicines for high blood pressure, as Noclaud may cause an additional blood pressure-lowering
effect. If blood pressure drops too much, it may lead to a rapid heartbeat. 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 may still be acceptable to use the above-mentioned medicines together with Noclaud; your doctor
will decide which treatment is appropriate for you.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant,
you should consult your doctor or pharmacist before using this medicine.
Noclaud MUST NOT be used during pregnancy.
Noclaud is NOT RECOMMENDED for use in breastfeeding mothers.
Driving and operating machinery
Noclaud may cause dizziness. If dizziness occurs after taking Noclaud, DO NOT drive, use tools, or
operate any machinery. Inform your doctor or pharmacist.

3. How to use Noclaud

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

• The recommended dose is 2 x 100 mg (two 50 mg tablets or one 100 mg tablet) twice daily (morning and evening). Dose adjustment is not required in 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. Tablets should always be taken with water.

Some benefits of using Noclaud may become noticeable after 4–12 weeks of treatment.
The doctor will assess the treatment efficacy after 3 months and may recommend discontinuation of cilostazol therapy
if the treatment response is insufficient.
Use in children and adolescents
Noclaud is not intended for use in children.
Taking more than the recommended dose of Noclaud
If for any reason a patient takes more Noclaud tablets than prescribed, physical and subjective symptoms
such as severe headache, diarrhoea, low blood pressure, and arrhythmia may occur.
In case of overdose, seek immediate medical advice from a doctor or go to the nearest hospital.
Remember to bring the packaging along so it is clear which medicine has been taken.
Missed dose of Noclaud
There is no cause for concern if a dose is missed. Wait and take the next dose at the scheduled time, then continue taking the medicine as directed. DO NOT take a double dose to make up for a missed tablet.
Stopping Noclaud
If treatment with Noclaud is discontinued, leg pain may return or worsen. Therefore, Noclaud should only be discontinued in the event of adverse reactions requiring urgent medical attention (see section 4) or on the advice of a doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur, urgent medical attention may be required.
You must immediately stop taking Noclaud and contact your doctor or go to the nearest hospital.

• stroke
• heart attack
• heart problems which may cause breathlessness or ankle swelling
• irregular heartbeat (new or worsening symptom)
• noticeable bleeding
• easy bruising
• severe illness with blisters on the skin, in the mouth, eyes, and genital area
• yellowing of the skin or whites of the eyes due to liver or blood disorders (jaundice)

You should also inform your doctor immediately if you develop fever or sore throat.
Blood tests may be necessary, and your doctor will decide on further treatment.
The following adverse effects of cilostazol have been reported. Inform your doctor as soon as possible
if any of these occur:

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

• headache
• abnormal stools
• diarrhoea

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

• fast heartbeat
• palpitations
• chest pain
• dizziness
• sore throat
• cold (nasal congestion)
• abdominal pain
• abdominal discomfort (dyspepsia)
• nausea or vomiting
• loss of appetite (anorexia)
• excessive belching or passing wind (bloating with flatulence)
• swelling of ankles, feet or face
• skin rash or skin changes
• skin itching
• petechial skin bleeding (small red or purple spots caused by bleeding)
• general weakness

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

• heart attack
• irregular heart function (new or worsening symptom)
• heart disorders which may cause breathlessness or ankle swelling
• lung inflammation
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g. in stomach, eye or muscles, nosebleeds, blood in sputum or urine)
• decreased number of red blood cells in blood
• dizziness upon standing
• fainting
• anxiety
• sleep disturbances
• nightmares
• allergic reaction
• muscle pain and discomfort
• diabetes and increased blood sugar levels
• stomach pain (gastritis)
• malaise

In people with diabetes, there may be an increased risk of bleeding into the eye.
Rare adverse effects (may affect up to 1 in 1,000 people)

• tendency to bleed longer than normal
• increased number of platelets in blood
• kidney problems

The following adverse effects have been reported during treatment with cilostazol, but the frequency is unknown (cannot be estimated from the available data):

• changes in blood pressure
• decreased number of red blood cells, white blood cells and platelets in blood
• difficulty breathing
• difficulty moving
• fever
• hot flushes
• rash and other skin eruptions
• reduced skin sensation
• watery or sticky eye discharge (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine

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

5. How to store Noclaud

No special storage instructions are required.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice visible signs of deterioration (e.g. fading).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Noclaud contains

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

What Noclaud looks like and contents of the pack
Appearance:
Odourless or almost odourless, white or almost white, round, flat tablets with bevelled edges. The tablets are embossed with a stylized letter E and the number 602 on one side, without any marking on the other side.
Packaging:
Available pack sizes are 28 or 56 tablets in PVC/PVDC//Aluminium blisters in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation 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 in:
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 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Hungarian Marketing Authorisation Numbers: OGYI-T-22586/03
OGYI-T-22586/04
OGYI-T-22586/06
Parallel Import Authorisation Number: 264/18
The medicinal product is registered in the European Economic Area countries under the following names:
Hungary Noclaud 100 mg tabletta
Czech Republic Noclaud
Latvia Sollazon 100 mg tabletes
Lithuania Sollazon 100 mg tabletės
Poland Noclaud