NOCLAUD 100 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: 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. Read the leaflet carefully before taking 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 taking Noclaud
   1. When not to take Noclaud
   2. Warnings and precautions
   3. Children and adolescents
   4. Noclaud and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
7. How to take Noclaud
   1. Use in children and adolescents
   2. Taking a higher dose of Noclaud than recommended
   3. Missing a dose of Noclaud
   4. Stopping treatment with Noclaud
8. Possible side effects
   1. Reported side effects of cilostazol.
   2. Inform your doctor as soon as possible if you experience:
   3. Very common side effects
   4. Common side effects
   5. Uncommon side effects
   6. Rare side effects
   7. Reporting side effects
9. How to store Noclaud
10. Contents of the packaging and other information
    1. What Noclaud contains
    2. What Noclaud looks like and what the packaging contains
    3. Marketing authorization holder in Hungary, the country of export:
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:
    7. Parallel import authorization number: 418/19
    8. The medicinal product is registered in the Member States of the European Economic Area under the following names:
    9. Date of approval of the leaflet: 07.11.2024

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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Noclaud and what is it used for
• 2. Important information before taking Noclaud
• 3. How to take 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, containing 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, which is caused by insufficient blood flow to the legs. Noclaud increases the distance that a 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 smoking cessation and increased exercise intensity) and other appropriate interventions have not sufficiently alleviated symptoms. It is essential that patients continue to implement lifestyle modifications during cilostazol treatment.

2. Important information before taking Noclaud

When not to take 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 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 there is severe kidney disease or moderate to severe liver disease,
• if the patient is pregnant.

Warnings and precautions

Before starting treatment with Noclaud, 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, inform the doctor or dentist about taking Noclaud.
• In case of noticing a tendency to bruise or bleed, stop taking Noclaud and inform the doctor.

Children and adolescents

Noclaud is not intended for 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 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
• anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins).

If such medicines are taken together with Noclaud, the doctor may perform certain routine blood tests.
Some medicines taken at the same time as Noclaud may interfere with its action. They may enhance the side effects of Noclaud or reduce its effectiveness. Noclaud may similarly affect other medicines. Before starting treatment with Noclaud, 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 taken by the patient, consult a 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 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Noclaud MUST NOTbe taken during pregnancy.
IT IS NOT RECOMMENDEDto take Noclaud during breastfeeding.

Driving and operating machinery

Noclaud may cause dizziness. If dizziness occurs after taking Noclaud, DO NOTdrive vehicles, do not use any tools, and do not operate any machinery. Inform the doctor or pharmacist.

3. How to take Noclaud

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Noclaud is available in the following strengths: 50 mg, 100 mg.

• 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. Tablets should always be swallowed with water.

Some benefits of taking 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.

Taking a higher dose of Noclaud than recommended

If the patient has taken more Noclaud tablets 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, contact a doctor or local hospital immediately. Remember to take the packaging with you to show which medicine was taken.

Missing a dose of Noclaud

There is no reason to worry if a dose is missed. 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 treatment with Noclaud

If treatment with Noclaud is stopped, the pain in the lower limbs may return or worsen. Therefore, treatment with Noclaud should only be stopped if side effects occur that require urgent medical attention (see section 4) or on the advice of a doctor.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Noclaud can cause side effects, although not everybody gets them.
If any of the following side effects occur, urgent medical attention may be necessary. Stop taking Noclaud and contact a 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, in the mouth, eyes, and genitals
• yellowing of the skin or whites of the eyes due to liver or blood disorders (jaundice)

Also, inform the doctor immediately if fever or sore throat occurs.
It may be necessary to perform certain blood tests, and the doctor will decide on further treatment.

Reported side effects of cilostazol.

Inform your doctor as soon as possible if you experience:

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)
• abdominal pain
• discomfort in the abdominal area (indigestion)
• nausea or vomiting
• loss of appetite
• excessive belching or passing wind
• swelling of the ankles, feet, or face
• rash or skin changes
• itching
• petechiae (small blood 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

During treatment with cilostazol, the following side effects have been reported, 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
• mobility problems
• fever
• hot flashes
• rash and other skin changes
• numbness of the skin
• discharge or sticky secretion from the eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• urine changes

If any side effect worsens, inform the doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 side effects will help gather more information on the safety of this medicine.

5. How to store Noclaud

There are no special precautions for storage.
Keep the medicine 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 you notice visible signs of deterioration (e.g., discoloration).
Medicines should not be disposed of via wastewater or household waste. Ask your 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, and no markings on the other side.
Packaging:56 tablets in PVC/PVDC/Al blisters in a cardboard box with an attached patient information leaflet.
For more detailed information, 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.
H-1106 Budapest
Hungary

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Hungary, the country of export: OGYI-T-22586/04

Parallel import authorization number: 418/19

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 approval of the leaflet: 07.11.2024

[Information about the trademark]