Noclaud

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging 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 you can read it again if you need to.
• 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 taking Noclaud
• 3. How to take Noclaud
• 4. Possible side effects
• 5. How to store Noclaud
• 6. Package contents 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 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 for the patient to continue making lifestyle modifications while being treated with cilostazol.

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 resting chest pain or if the patient has had a "heart attack" or any heart surgery in the last six months,
• if the patient has currently or has had a 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 to take 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 taking or have recently taken, and about 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 and 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 to take 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),
• pimozyd (used to treat mental disorders),
• ergot derivatives (used to treat migraine, e.g., ergotamine, dihydroergotamine),
• carbamazepine or phenytoin (used to treat seizures),
• ginkgo biloba (herbal preparation).

In case of doubt, whether the above applies to the medicines you are taking, consult your doctor or pharmacist.
Before starting to take Noclaud, 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 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 be possible to continue taking these medicines together with Noclaud, and the doctor will be able to decide what treatment is suitable for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Noclaud MUST NOTbe taken during pregnancy.
IT IS NOT RECOMMENDEDto take Noclaud while breastfeeding.

Driving and using machines

Noclaud may cause dizziness. If you experience dizziness after taking Noclaud, DO NOTdrive, DO NOTuse tools, and DO NOToperate any machinery. Inform your doctor or pharmacist.

3. How to take Noclaud

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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 necessary for elderly patients. However, the doctor may prescribe a lower dose if the patient is taking medicines that may affect the action of Noclaud.
• Take Noclaud 30 minutes before breakfast and dinner. Always swallow the tablets 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 more than the recommended dose of Noclaud

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 heartbeat.
If you have taken more tablets than the prescribed dose, contact your doctor or local hospital immediately. 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 need to worry if you miss a dose. Wait and take the next dose at the right time, and then take the medicine as recommended. DO NOTtake a double dose to make up for the missed tablet.

Stopping treatment with Noclaud

If you stop taking Noclaud, the pain in your lower limbs may return or worsen.
Therefore, only stop taking Noclaud if you experience side effects that require urgent medical attention (see section 4) or if your doctor tells you to.
If you have any further doubts about taking this medicine, 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. Stop taking 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 heartbeat (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).

You should also tell your doctor immediately if you 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. Tell 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 heartbeat,
• palpitations (irregular heartbeat),
• chest pain,
• dizziness,
• sore throat,
• runny nose (rhinitis),
• abdominal pain,
• discomfort in the abdominal area (dyspepsia),
• nausea or vomiting,
• loss of appetite (anorexia),
• excessive gas or belching (flatulence),
• 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 heartbeat (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),
• decrease in the number of red blood cells in the blood,
• dizziness when standing up,
• fainting,
• anxiety,
• sleep disorders,
• nightmares,
• allergic reaction,
• muscle pain or tenderness,
• diabetes and high blood sugar levels,
• 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,
• increase in platelet count in the blood,
• kidney problems.

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

• changes in blood pressure,
• decrease in the number of red blood cells, white blood cells, and platelets in the blood,
• breathing difficulties,
• mobility problems,
• fever,
• hot flashes,
• rash and other skin changes,
• numbness or tingling of the skin,
• conjunctivitis (discharge or sticky eyes),
• tinnitus (ringing in the ears),
• liver problems, including hepatitis,
• changes in urine.

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Noclaud

There are no special storage instructions.
Keep the medicine out of the 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. Package contents and other information

What Noclaud contains

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

What Noclaud looks like and what the pack 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:
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, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:83/149/14-C
Parallel import authorization number:98/20

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: 23.12.2024

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