Noclaud

Leaflet attached to the packaging: 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 necessary.
• 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 the symptoms of their illness 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 packaging and other information

1. What is Noclaud and what is it used for

Noclaud contains the active ingredient cilostazol and 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 who have not had sufficient relief from symptoms after lifestyle modifications (including quitting smoking and increasing exercise intensity) and other appropriate interventions. It is essential that the patient continues to follow the 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 the patient has had a heart attack or any heart surgery in the last six months, or if they experience chest pain at rest,
• if the patient has had a transient loss of consciousness due to heart disease or any severe heart rhythm disorders,
• if the patient has a condition that increases the risk of bleeding or bruising, such as:
• active stomach 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 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, the patient should discuss it with their doctor or pharmacist

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

During treatment with Noclaud

• If surgery is required, including dental surgery, the patient should inform their doctor or dentist about the use of Noclaud
• In case of bleeding or bruising, the patient should stop using Noclaud and inform their doctor.

Children and adolescents

Noclaud is not intended for children.

Noclaud and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their 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 medicines include:

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

If the patient is taking such medicines with Noclaud, their doctor may perform certain routine blood tests.
Some medicines taken at the same time as Noclaud may interfere with its effects. They may increase the risk of side effects or reduce the effectiveness of Noclaud. Noclaud may also affect other medicines. Before starting treatment with Noclaud, the patient should inform their 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 migraine, e.g., ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (used to treat epilepsy)
• St. John's Wort (herbal preparation)

In case of doubt about whether the above applies to the medicines taken by the patient, they should consult their doctor or pharmacist.
Before starting treatment with Noclaud, the patient should inform their doctor if they are taking medicines for high blood pressure, as Noclaud may cause additional blood pressure-lowering effects. If blood pressure drops too low, 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 these 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 the patient experiences dizziness after taking Noclaud, they MUST NOTdrive vehicles, use tools, or operate machines. They should inform their doctor or pharmacist.

3. How to use Noclaud

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their 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 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. 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 stopping cilostazol treatment if the therapy is not effective enough.

Use in children and adolescents

Noclaud is not intended for children.

Use of a higher than recommended dose of Noclaud

If the patient has taken more tablets of Noclaud than they should, they 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, the patient should immediately contact their doctor or local hospital. They should remember to take the packaging with them so that it is clear what medicine was taken.

Missing a dose of Noclaud

There is no reason to worry if a dose is missed. The patient should wait and take the next dose at the right time, and then continue taking the medicine as directed. They MUST NOTtake a double dose to make up for the missed tablet.

Stopping treatment with Noclaud

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

4. Possible side effects

Like all medicines, Noclaud can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they may need urgent medical attention. They should stop using Noclaud and contact their 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)

The patient should also inform their doctor immediately if they experience fever or sore throat.
It may be necessary to perform certain blood tests, and the doctor will decide on further treatment.

Reported side effects of cilostazol

The patient should inform their doctor as soon as possible if they experience any of the following side effects:

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
• palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• discomfort in the abdominal area (dyspepsia)
• 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 bruising (e.g., in the stomach, eye, or muscle, bleeding from the nose, 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 patients with diabetes, there may be a higher risk of bleeding into the eye.
Rare side effects(may affect up to 1 in 1,000 people)

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

During treatment with cilostazol, the following side effects have been reported, but their frequency is unknown(cannot be estimated from the available data):

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

If any of the side effects worsen, the patient should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be collected on the safety of the 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 packaging. The expiry date refers to the last day of the month.
Do not use this medicine if visible signs of deterioration are observed (e.g., discoloration).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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, and magnesium stearate.

What Noclaud looks like and what the packaging 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.
Packaging:
28 (2 x 14) or 56 (4 x 14) tablets in PVC/PVDC/Al blisters in a cardboard box with a patient information leaflet.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturer:

Egis Pharmaceuticals PLC
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
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
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export: 83/149/14-C

Parallel import authorization number: 270/22

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

Hungary
Noclaud 100 mg tablet
Bulgaria
Ноклауд 100 mg таблетки
Czech Republic
Noclaud
Latvia
Sollazon 100 mg tabletes
Lithuania
Sollazon 100 mg tabletės
Poland
Noclaud
Romania
Noclaud 100 mg comprimate
Slovakia
Noclaud 100 mg
Date of approval of the leaflet: 29.06.2022
[Information about the trademark]